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Omalizumab as Monotherapy and as Adjunct Therapy to Multi-Allergen OIT in Food Allergic Participants (OUtMATCH)

Primary Purpose

Peanut Allergy, Multi-food Allergy

Status

Active

Phase

Phase 3

Locations

United States

Study Type

Interventional

Intervention

Omalizumab

Placebo for Omalizumab

Multi-Allergen Oral Immunotherapy

Placebo for Multi-Allergen Oral Immunotherapy

Double-Blind Placebo-Controlled Food Challenge Based Treatment

About this trial

This is an interventional treatment trial for Peanut Allergy focused on measuring peanut allergic, multi-food allergic, omalizumab, placebo, multi-allergen oral immunotherapy (OIT), double-blind placebo-controlled food challenge (DBPCFC), oral food challenge (OFC)

Eligibility Criteria

1 Year - 55 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Individuals who meet all of the following criteria are eligible for enrollment as study participants:

Participant and/or parent/legal guardian must be able to understand and provide informed consent and/or assent, as applicable;
Peanut allergic: participant must meet all of the following criteria to minimize the chance that the participant will develop natural tolerance to peanut over the course of the study:
1. Positive skin prick test (SPT) defined as ≥4 mm wheal greater than saline control) to peanut,
2. Positive peanut immunoglobulin E (IgE), ≥6 kUA/L, at Screening or within three months of Screening, determined by ImmunoCap, and
3. Positive double-blind placebo-controlled food challenge (DBPCFC), defined as experiencing dose-limiting symptoms at a single dose of ≤100 mg of peanut protein.
Allergic to at least two of the six other foods (milk, egg, wheat, cashew, hazelnut, walnut): each participant must meet all of the following criteria for at least two of the six other foods to minimize the chance that the participant will develop natural tolerance to at least two of the six other foods over the course of the study:
1. Positive SPT (≥4 mm wheal) to food,
2. Positive food specific IgE (≥6 kUA/L) at Screening or within three months of Screening, determined by ImmunoCap, and
3. Positive DBPCFC, defined as experiencing dose-limiting symptoms at a single dose of ≤300 mg of food protein.
With body weight (as measured at Screening) and total serum IgE level (as measured within three months of Screening) suitable for omalizumab dosing;
If female of child-bearing potential, must have a negative urine or serum pregnancy test;
For women of childbearing potential, must agree to,during the treatment period and for 60 days after the last dose of study drug:
- remain abstinent (refrain from heterosexual intercourse), or
- use acceptable contraceptive methods (barrier methods, or
- oral, injected, or implanted hormonal methods of contraception, or
- other forms of hormonal contraception that have comparable efficacy).
Plan to remain in the study area of an OUtMATCH clinical research unit (CRU) during the trial; and
Be willing to be trained on the proper use of an epinephrine autoinjector for the duration of the study.

Exclusion Criteria:

Individuals who meet any of the following criteria are not eligible for enrollment as study participants:

Inability or unwillingness of a participant and/or parent/legal guardian to give written informed consent and/or assent or comply with the study protocol;
Clinically significant laboratory abnormalities at Screening;
Dose-limiting symptoms to the placebo portion of the Screening DBPCFC;
Sensitivity or suspected/known allergy to any ingredients (including excipients) of the
- active or placebo oral food challenge (OFC) material,
- multi-allergen oral immunotherapy (OIT), or
- drugs related to omalizumab (e.g., monoclonal antibodies, polyclonal gamma globulin).
  - Note: Guidance for determination of sensitivity to excipients will be detailed in the study's Manual of Procedures (MOP).
Poorly controlled atopic dermatitis (AD) at Screening, per the Principal Investigator's PI's) discretion;
Poorly controlled or severe asthma/wheezing at Screening, defined by at least one of the following criteria:
1. Global Initiative for Asthma (GINA) criteria regarding asthma control latest guidelines,
2. History of two or more systemic corticosteroid courses within six months of Screening or one course of systemic corticosteroids within three months of Screening to treat asthma/wheezing,
3. Prior intubation/mechanical ventilation for asthma/wheezing,
4. One hospitalization or Emergency Department (ED) visit for asthma/wheezing within six months of Screening,
5. Forced expiratory volume in one second (FEV1) <80 percent of predicted or FEV1/forced vital capacity (FVC) <75 percent, with or without controller medications (only for participants who are aged seven years or older and are able to perform spirometry), or
6. Inhaled corticosteroid (ICS) dosing of >500 mcg daily fluticasone (or equivalent ICS based on the National Institutes of Health, National Heart, Lung, and Blood Institute (NHLBI) dosing chart).
History of severe anaphylaxis to participant-specific foods that will be used in this study, defined as neurological compromise or requiring intubation;
Treatment with a burst of oral, intramuscular (IM), or intravenous (IV) steroids of more than two days for an indication other than asthma/wheezing within 30 days of Screening;
Currently receiving oral, intramuscular, or intravenous corticosteroids, tricyclic antidepressants, or beta-blockers (oral or topical);
Past or current history of eosinophilic gastrointestinal (GI) disease within three years of Screening;
Past or current history of cancer, or currently being investigated for possible cancer;
Previous adverse reaction to omalizumab;
Past or current history of any immunotherapy to any of the foods being treated in this study (e.g., OIT, sublingual immunotherapy [SLIT], EPIT) within 6 months of Screening;
Treatment with monoclonal antibody therapy, such as omalizumab (Xolair®), dupilumab (Dupixent®), benralizumab (Fasenra™), mepolizumab (Nucala®), reslizumab (Cinqair®), or other immunomodulatory therapy within six months of Screening;
Currently on "build-up phase" of inhalant allergen immunotherapy (i.e., has not reached maintenance dosing). Note: Individuals tolerating maintenance allergen immunotherapy can be enrolled;
Inability to discontinue antihistamines for the minimum wash-out periods required for SPTs,or OFCs;
Current participation in another therapeutic or interventional clinical trial or participation within 90 days of Screening;
Use of investigational drugs within 24 weeks of Screening;
Pregnant or breastfeeding, or intending to become pregnant during the study or within 60 days after the last dose of omalizumab or placebo for omalizumab;
Has a first-degree relative already enrolled in the study; or
Past or current medical problems (e.g., severe latex allergy), history of other chronic diseases (other than asthma/wheezing, AD, or rhinitis) requiring therapy (e.g., heart disease, diabetes), findings from physical assessment, or abnormalities in clinical laboratory testing that are not listed above, which, in the opinion of the PI, may:
- pose additional risks from participation in the study,
- may interfere with the participant's ability to comply with study requirements, or
- may impact the quality or interpretation of the data obtained from the study.

Sites / Locations

Arkansas Children's Hospital Research Institute: Department of Pediatrics, Allergy & Immunology
Stanford School of Medicine: Sean N. Parker Center for Allergy & Asthma Research
National Jewish Health: Division of Pediatric Allergy and Clinical Immunology
Emory University School of Medicine: Children's Healthcare of Atlanta Pediatrics
Johns Hopkins Children's Center: Department of Allergy & Immunology
Massachusetts General Hospital, Department of Medicine: Allergy & Clinical Immunology Unit
Icahn School of Medicine at Mount Sinai: Department of Pediatrics Allergy & Immunology
North Carolina Children's Hospital: Department of Pediatrics, Division of Allergy, Immunology and Rheumatology
Children's Hospital of Philadelphia: Division of Allergy and Immunology
University of Texas Southwestern Medical Center: Division of Allergy and Immunology

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm Type

Experimental

Placebo Comparator

Experimental

Other

Arm Label

Stage 1:Omalizumab as Monotherapy

Stage 1: Omalizumab OLE

Stage 1: Placebo for Omalizumab as Monotherapy

Stage 2: Omalizumab

Stage 2: Omalizumab-Facilitated OIT

Stage 2: Omalizumab + Placebo OIT

Stage 3: DBPCFC Based Treatment

Arm Description

Eligible participants are randomized to receive omalizumab by subcutaneous injection either every 2 weeks or every 4 weeks for 16 to 20 weeks. The dose administered and the dosing interval are determined by serum total IgE level and body weight (measured before the start of treatment) per the study drug dosing table. After 16 weeks of treatment, each participant will complete double-blind placebo-controlled food challenge (DBPCFCs) to each of their three specific foods to a cumulative dose of 6044 mg protein of each food. Throughout Stage 1, each participant will be instructed to strictly avoid all foods to which they are allergic. The first 60 participants who complete all four DBPCFCs at the end of Stage 1 will participate in the Stage 1 Open Label Extension (OLE).All other participants who complete all four DBPCFCs will move Stage 2 of the study.

OLE: Open Label Extension, Long-Term Treatment with Omalizumab. Participants will receive 24 weeks of open label omalizumab in accordance with the omalizumab dosing table defined in the study protocol. Omalizumab is administered by subcutaneous injection either every 2 weeks or every 4 weeks for 24 weeks. The dose administered and the dosing interval are determined by serum total IgE level and body weight (measured before the start of treatment) per the study drug dosing table. After 24 weeks of treatment, each participant will complete DBPCFCs to each of their three specific foods to a cumulative dose of 8044 mg protein of each food. Each participant who completes all four DBPCFCs at the end of the Stage 1 OLE will move on to Stage 3 of the study. Throughout Stage 1 OLE, each participant will be instructed to strictly avoid all foods to which they are allergic.

Eligible participants are randomized to receive placebo for omalizumab by subcutaneous injection either every 2 weeks or every 4 weeks for 16 to 20 weeks. The dose administered and the dosing interval are determined by serum total IgE level and body weight (measured before the start of treatment) per the study drug dosing table. After 16 weeks of treatment, each participant will complete DBPCFCs to each of their three specific foods to a cumulative dose of 6044 mg protein of each food. Throughout Stage 1, each participant will be instructed to strictly avoid all foods to which they are allergic. The first 60 participants who complete all four DBPCFCs at the end of Stage 1 will participate in the Stage 1 OLE. All other participants who complete all four DBPCFCs will move Stage 2 of the study.

Participants will receive eight weeks of treatment with open label omalizumab in accordance with the omalizumab dosing table specified in the study protocol, administered by subcutaneous injection. The dose administered and the dosing interval are determined by serum total IgE level and body weight (measured before the start of treatment) per the study drug dosing table. After completion of eight weeks of open label omalizumab, participants will be randomized 1:1 to either: Omalizumab-facilitated oral immunotherapy (OIT): Open label omalizumab + Multi-allergen OIT for eight weeks, followed by placebo for omalizumab + Multi-allergen OIT for 44 weeks OR Omalizumab + placebo OIT: Open label omalizumab + placebo for Multi-allergen OIT for eight weeks, followed by omalizumab + placebo for Multi-allergen OIT for 44 weeks. Throughout Stage 2, each participant will be instructed to strictly avoid all foods to which they are allergic.

OIT: oral immunotherapy-Omalizumab as Adjunct Therapy to Multi-Allergen Oral Immunotherapy Participants randomized to open label omalizumab + Multi-allergen OIT for eight weeks, followed by placebo for omalizumab + Multi-allergen OIT for 44 weeks. Throughout Stage 2, each participant will be instructed to strictly avoid all foods to which they are allergic.

OIT: oral immunotherapy Participants randomized to open label omalizumab + placebo for Multi-allergen OIT for eight weeks, followed by omalizumab + placebo for Multi-allergen OIT for 44 weeks. Throughout Stage 2, each participant will be instructed to strictly avoid all foods to which they are allergic.

DBPCFC Based Treatment-Long-term Follow-up Treatment Plan for Peanut and Each of the Two Other Participant-Specific Foods. Upon completion of the DBPCFCs at the end of Stage 1 OLE or Stage 2, each participant will receive a separate treatment plan for peanut and each of the two other participant-specific foods based on the results of the DBPCFCs. A treatment plan will include instructions for one of the following: Long-term follow-up with dietary consumption of a food; Long-term follow-up with avoidance of a food; or Rescue OIT for a food. The treatment plan for each food may change throughout Stage 3 depending on a participant's response to treatment. Once a participant enters Stage 3, the participant will have a minimum of 12 months follow-up until at least December 2022. Note: Participants will be instructed to strictly avoid a food if they receive rescue OIT for the food during Stage 3.

Outcomes

Primary Outcome Measures

Number of Participants by Stage 1 Treatment Assignment, Omalizumab versus Placebo, Who Successfully Consume a Single Dose of ≥600 mg of Peanut Protein Without Dose-Limiting Symptoms During the DBPCFC Conducted at the End of Treatment Stage 1

Number of participants who successfully consume a single dose of ≥600 mg of peanut protein without dose-limiting symptoms during the double-blind placebo-controlled oral food challenge (DBPCFC) conducted in a controlled clinic setting, at the end of Stage 1 treatment, to compare the ability of participants to consume foods without dose-limiting symptoms during a DBPCFC after treatment with either omalizumab or placebo for omalizumab. Dose-limiting symptoms are those that in the view of the principal investigator indicate a true allergic reaction.

Secondary Outcome Measures

Number of Participants by Stage 1 Treatment Assignment, Omalizumab versus Placebo, who successfully consume a single dose of ≥1000 mg of cashew protein without dose-limiting symptoms during the DBPCFC conducted at the end of Stage 1

Number of participants who successfully consume a single dose of ≥1000 mg of cashew protein without dose-limiting symptoms during the double-blind placebo-controlled oral food challenge (DBPCFC) conducted in a controlled clinic setting, at the end of Stage 1 treatment, to compare the ability of participants to consume foods without dose-limiting symptoms during a DBPCFC after treatment with either omalizumab or placebo for omalizumab. Dose-limiting symptoms are those that in the view of the principal investigator indicate a true allergic reaction.

Number of Participants by Stage 1 Treatment Assignment, Omalizumab versus Placebo, who successfully consume a single dose of ≥1000 mg of milk protein without dose-limiting symptoms during the DBPCFC at the end of Stage 1

Number of participants who successfully consume a single dose of ≥1000 mg of milk protein without dose-limiting symptoms during the double-blind placebo-controlled oral food challenge (DBPCFC) conducted in a controlled clinic setting, at the end of Stage 1 treatment, to compare the ability of participants to consume foods without dose-limiting symptoms during a DBPCFC after treatment with either omalizumab or placebo for omalizumab. Dose-limiting symptoms are those that in the view of the principal investigator indicate a true allergic reaction.

Number of Participants by Stage 1 Treatment Assignment, Omalizumab versus Placebo, who successfully consume a single dose of ≥1000 mg of egg protein without dose-limiting symptoms during the DBPCFC at the end of Stage 1

Number of participants who successfully consume a single dose of ≥1000 mg of egg protein without dose-limiting symptoms during the double-blind placebo-controlled oral food challenge (DBPCFC) conducted in a controlled clinic setting, at the end of Stage 1 treatment, to compare the ability of participants to consume foods without dose-limiting symptoms during a DBPCFC after treatment with either omalizumab or placebo for omalizumab. Dose-limiting symptoms are those that in the view of the principal investigator indicate a true allergic reaction.

Number of participants who successfully consume a single dose of ≥600 mg of milk protein without dose-limiting symptoms during the double-blind placebo-controlled oral food challenge (DBPCFC) at the end of Stage 1

Proportion of participants who successfully consume a single dose of ≥600 mg of milk protein without dose-limiting symptoms during the double-blind placebo-controlled oral food challenge (DBPCFC) conducted in a controlled clinic setting, at the end of Stage 1 treatment, to compare the ability of participants to consume foods without dose-limiting symptoms during a DBPCFC after treatment with either omalizumab or placebo for omalizumab. Dose-limiting symptoms are those that in the view of the principal investigator indicate a true allergic reaction.

Number of participants who successfully consume a single dose of ≥600 mg of egg protein without dose-limiting symptoms during the double-blind placebo-controlled oral food challenge (DBPCFC) at the end of Stage 1

Proportion of participants who successfully consume a single dose of ≥600 mg of egg protein without dose-limiting symptoms during the double-blind placebo-controlled oral food challenge (DBPCFC) conducted in a controlled clinic setting, at the end of Stage 1 treatment, to compare the ability of participants to consume foods without dose-limiting symptoms during a DBPCFC after treatment with either omalizumab or placebo for omalizumab. Dose-limiting symptoms are those that in the view of the principal investigator indicate a true allergic reaction.

Number of participants who successfully consume a single dose of ≥600 mg of wheat protein without dose-limiting symptoms during the double-blind placebo-controlled oral food challenge (DBPCFC) at the end of Stage 1

Proportion of participants who successfully consume a single dose of ≥600 mg of wheat protein without dose-limiting symptoms during the double-blind placebo-controlled oral food challenge (DBPCFC) conducted in a controlled clinic setting, at the end of Stage 1 treatment, to compare the ability of participants to consume foods without dose-limiting symptoms during a DBPCFC after treatment with either omalizumab or placebo for omalizumab. Dose-limiting symptoms are those that in the view of the principal investigator indicate a true allergic reaction.

Number of participants who successfully consume a single dose of ≥600 mg of cashew protein without dose-limiting symptoms during the double-blind placebo-controlled oral food challenge (DBPCFC) at the end of Stage 1

Proportion of participants who successfully consume a single dose of ≥600 mg of cashew protein without dose-limiting symptoms during the double-blind placebo-controlled oral food challenge (DBPCFC) conducted in a controlled clinic setting, at the end of Stage 1 treatment, to compare the ability of participants to consume foods without dose-limiting symptoms during a DBPCFC after treatment with either omalizumab or placebo for omalizumab. Dose-limiting symptoms are those that in the view of the principal investigator indicate a true allergic reaction.

Number of participants who successfully consume a single dose of ≥600 mg of hazelnut protein without dose-limiting symptoms during the double-blind placebo-controlled oral food challenge (DBPCFC) at the end of Stage 1

Proportion of participants who successfully consume a single dose of ≥600 mg of hazelnut protein without dose-limiting symptoms during the double-blind placebo-controlled oral food challenge (DBPCFC) conducted in a controlled clinic setting, at the end of Stage 1 treatment, to compare the ability of participants to consume foods without dose-limiting symptoms during a DBPCFC after treatment with either omalizumab or placebo for omalizumab. Dose-limiting symptoms are those that in the view of the principal investigator indicate a true allergic reaction.

Number of participants who successfully consume a single dose of ≥600 mg of walnut protein without dose-limiting symptoms during the double-blind placebo-controlled oral food challenge (DBPCFC) at the end of Stage 1

Proportion of participants who successfully consume a single dose of ≥600 mg of walnut protein without dose-limiting symptoms during the double-blind placebo-controlled oral food challenge (DBPCFC) conducted in a controlled clinic setting, at the end of Stage 1 treatment, to compare the ability of participants to consume foods without dose-limiting symptoms during a DBPCFC after treatment with either omalizumab or placebo for omalizumab. Dose-limiting symptoms are those that in the view of the principal investigator indicate a true allergic reaction.

Number of participants who successfully consume a single dose of ≥600 mg of food protein without dose-limiting symptoms for at least two treated food allergens during the double-blind placebo-controlled oral food challenge (DBPCFC), at the end of Stage 1

Proportion of participants who successfully consume a single dose of ≥600 mg of food protein without dose-limiting symptoms for at least two treated food allergens during the double-blind placebo-controlled oral food challenge (DBPCFC) conducted in a controlled clinic setting, at the end of Stage 1 treatment, to compare the ability of participants to consume foods without dose-limiting symptoms during a DBPCFC after treatment with either omalizumab or placebo for omalizumab. Dose-limiting symptoms are those that in the view of the principal investigator indicate a true allergic reaction.

Number of participants who successfully consume a single dose of ≥600 mg of food protein without dose-limiting symptoms for at least three treated food allergens during the double-blind placebo-controlled oral food challenge (DBPCFC), at the end of Stage

Proportion of participants who successfully consume a single dose of ≥600 mg of food protein without dose-limiting symptoms for all three treated food allergens during the double-blind placebo-controlled oral food challenge (DBPCFC) conducted in a controlled clinic setting, at the end of Stage 1 treatment, to compare the ability of participants to consume foods without dose-limiting symptoms during a DBPCFC after treatment with either omalizumab or placebo for omalizumab. Dose-limiting symptoms are those that in the view of the principal investigator indicate a true allergic reaction.

Number of participants who successfully consume a single dose of ≥1000 mg of peanut protein without dose-limiting symptoms during the double-blind placebo-controlled oral food challenge (DBPCFC) at the end of Stage 1.

Proportion of participants who successfully consume a single dose of ≥1000 mg of peanut protein without dose-limiting symptoms during the double-blind placebo-controlled oral food challenge (DBPCFC) conducted in a controlled clinic setting, at the end of Stage 1 treatment, to compare the ability of participants to consume foods without dose-limiting symptoms during a DBPCFC after treatment with either omalizumab or placebo for omalizumab. Dose-limiting symptoms are those that in the view of the principal investigator indicate a true allergic reaction.

Number of participants who successfully consume a single dose of ≥1000 mg of wheat protein without dose-limiting symptoms during the double-blind placebo-controlled oral food challenge (DBPCFC) at the end of Stage 1.

Proportion of participants who successfully consume a single dose of ≥1000 mg of wheat protein without dose-limiting symptoms during the double-blind placebo-controlled oral food challenge (DBPCFC) conducted in a controlled clinic setting, at the end of Stage 1 treatment, to compare the ability of participants to consume foods without dose-limiting symptoms during a DBPCFC after treatment with either omalizumab or placebo for omalizumab. Dose-limiting symptoms are those that in the view of the principal investigator indicate a true allergic reaction.

Number of participants who successfully consume a single dose of ≥1000 mg of hazelnut protein without dose-limiting symptoms during the double-blind placebo-controlled oral food challenge (DBPCFC) at the end of Stage 1.

Proportion of participants who successfully consume a single dose of ≥1000 mg of hazelnut protein without dose-limiting symptoms during the double-blind placebo-controlled oral food challenge (DBPCFC) conducted in a controlled clinic setting, at the end of Stage 1 treatment, to compare the ability of participants to consume foods without dose-limiting symptoms during a DBPCFC after treatment with either omalizumab or placebo for omalizumab. Dose-limiting symptoms are those that in the view of the principal investigator indicate a true allergic reaction.

Number of participants who successfully consume a single dose of ≥1000 mg of walnut protein without dose-limiting symptoms during the double-blind placebo-controlled oral food challenge (DBPCFC) at the end of Stage 1.

Proportion of participants who successfully consume a single dose of ≥1000 mg of walnut protein without dose-limiting symptoms during the double-blind placebo-controlled oral food challenge (DBPCFC) conducted in a controlled clinic setting, at the end of Stage 1 treatment, to compare the ability of participants to consume foods without dose-limiting symptoms during a DBPCFC after treatment with either omalizumab or placebo for omalizumab. Dose-limiting symptoms are those that in the view of the principal investigator indicate a true allergic reaction.

Number of participants who successfully consume a single dose of ≥1000 mg of food protein without dose-limiting symptoms for at least two treated food allergens during the double-blind placebo-controlled oral food challenge (DBPCFC) at the end of Stage 1

Proportion of participants who successfully consume a single dose of ≥1000 mg of food protein without dose-limiting symptoms for at least two treated food allergens during the double-blind placebo-controlled oral food challenge (DBPCFC) conducted in a controlled clinic setting, at the end of Stage 1 treatment, to compare the ability of participants to consume foods without dose-limiting symptoms during a DBPCFC after treatment with either omalizumab or placebo for omalizumab. Dose-limiting symptoms are those that in the view of the principal investigator indicate a true allergic reaction.

Number of participants who successfully consume a single dose of ≥1000mg of food protein without dose-limiting symptoms for all three treated food allergens during the double-blind placebo-controlled oral food challenge (DBPCFC) at the end of Stage 1

Proportion of participants who successfully consume a single dose of ≥1000mg of food protein without dose-limiting symptoms for all three treated food allergens during the double-blind placebo-controlled oral food challenge (DBPCFC) conducted in a controlled clinic setting, at the end of Stage 1 treatment, to compare the ability of participants to consume foods without dose-limiting symptoms during a DBPCFC after treatment with either omalizumab or placebo for omalizumab. Dose-limiting symptoms are those that in the view of the principal investigator indicate a true allergic reaction.

Number of participants who successfully consume ≥1 dose of 2000 mg of peanut protein without dose-limiting symptoms during the double-blind placebo-controlled oral food challenge (DBPCFC) at the end of Stage 1

Proportion of participants who successfully consume ≥1 dose of 2000 mg of peanut protein without dose-limiting symptoms during the double-blind placebo-controlled oral food challenge (DBPCFC) conducted in a controlled clinic setting, at the end of Stage 1 treatment, to compare the ability of participants to consume foods without dose-limiting symptoms during a DBPCFC after treatment with either omalizumab or placebo for omalizumab. Dose-limiting symptoms are those that in the view of the principal investigator indicate a true allergic reaction.

Number of participants who successfully consume ≥1 dose of 2000 mg of milk protein without dose-limiting symptoms during the double-blind placebo-controlled oral food challenge (DBPCFC) at the end of Stage 1

Proportion of participants who successfully consume ≥1 dose of 2000 mg of milk protein without dose-limiting symptoms during the double-blind placebo-controlled oral food challenge (DBPCFC) conducted in a controlled clinic setting, at the end of Stage 1 treatment, to compare the ability of participants to consume foods without dose-limiting symptoms during a DBPCFC after treatment with either omalizumab or placebo for omalizumab. Dose-limiting symptoms are those that in the view of the principal investigator indicate a true allergic reaction.

Number of participants who successfully consume ≥1 dose of 2000 mg of egg protein without dose-limiting symptoms during the double-blind placebo-controlled oral food challenge (DBPCFC) at the end of Stage 1

Proportion of participants who successfully consume ≥1 dose of 2000 mg of egg protein without dose-limiting symptoms during the double-blind placebo-controlled oral food challenge (DBPCFC) conducted in a controlled clinic setting, at the end of Stage 1 treatment, to compare the ability of participants to consume foods without dose-limiting symptoms during a DBPCFC after treatment with either omalizumab or placebo for omalizumab. Dose-limiting symptoms are those that in the view of the principal investigator indicate a true allergic reaction.

Number of participants who successfully consume ≥1 dose of 2000 mg of wheat protein without dose-limiting symptoms during the double-blind placebo-controlled oral food challenge (DBPCFC) at the end of Stage 1

Proportion of participants who successfully consume ≥1 dose of 2000 mg of wheat protein without dose-limiting symptoms during the double-blind placebo-controlled oral food challenge (DBPCFC) conducted in a controlled clinic setting, at the end of Stage 1 treatment, to compare the ability of participants to consume foods without dose-limiting symptoms during a DBPCFC after treatment with either omalizumab or placebo for omalizumab. Dose-limiting symptoms are those that in the view of the principal investigator indicate a true allergic reaction.

Number of participants who successfully consume ≥1 dose of 2000 mg of cashew protein without dose-limiting symptoms during the double-blind placebo-controlled oral food challenge (DBPCFC) at the end of Stage 1

Proportion of participants who successfully consume ≥1 dose of 2000 mg of cashew protein without dose-limiting symptoms during the double-blind placebo-controlled oral food challenge (DBPCFC) conducted in a controlled clinic setting, at the end of Stage 1 treatment, to compare the ability of participants to consume foods without dose-limiting symptoms during a DBPCFC after treatment with either omalizumab or placebo for omalizumab. Dose-limiting symptoms are those that in the view of the principal investigator indicate a true allergic reaction.

Number of participants who successfully consume ≥1 dose of 2000 mg of hazelnut protein without dose-limiting symptoms during the double-blind placebo-controlled oral food challenge (DBPCFC) at the end of Stage 1

Proportion of participants who successfully consume ≥1 dose of 2000 mg of hazelnut protein without dose-limiting symptoms during the double-blind placebo-controlled oral food challenge (DBPCFC) conducted in a controlled clinic setting, at the end of Stage 1 treatment, to compare the ability of participants to consume foods without dose-limiting symptoms during a DBPCFC after treatment with either omalizumab or placebo for omalizumab. Dose-limiting symptoms are those that in the view of the principal investigator indicate a true allergic reaction.

Number of participants who successfully consume ≥1 dose of 2000 mg of walnut protein without dose-limiting symptoms during the double-blind placebo-controlled oral food challenge (DBPCFC) at the end of Stage 1

Proportion of participants who successfully consume ≥1 dose of 2000 mg of walnut protein without dose-limiting symptoms during the double-blind placebo-controlled oral food challenge (DBPCFC) conducted in a controlled clinic setting, at the end of Stage 1 treatment, to compare the ability of participants to consume foods without dose-limiting symptoms during a DBPCFC after treatment with either omalizumab or placebo for omalizumab. Dose-limiting symptoms are those that in the view of the principal investigator indicate a true allergic reaction.

Proportion of participants who successfully consume ≥1 dose of 2000 mg of food protein without dose-limiting symptoms for at least two treated food allergens during the double-blind placebo-controlled oral food challenge (DBPCFC) conducted in a controlled clinic setting, at the end of Stage 1 treatment, to compare the ability of participants to consume foods without dose-limiting symptoms during a DBPCFC after treatment with either omalizumab or placebo for omalizumab. Dose-limiting symptoms are those that in the view of the principal investigator indicate a true allergic reaction.

Proportion of participants who successfully consume ≥1 dose of 2000 mg of food protein without dose-limiting symptoms for all three treated food allergens during the double-blind placebo-controlled oral food challenge (DBPCFC) conducted in a controlled clinic setting, at the end of Stage 1 treatment, to compare the ability of participants to consume foods without dose-limiting symptoms during a DBPCFC after treatment with either omalizumab or placebo for omalizumab. Dose-limiting symptoms are those that in the view of the principal investigator indicate a true allergic reaction.

Proportion of participants who successfully consume 2 doses of 2000 mg of peanut protein without dose-limiting symptoms during the double-blind placebo-controlled oral food challenge (DBPCFC) conducted in a controlled clinic setting, at the end of Stage 1 treatment, to compare the ability of participants to consume foods without dose-limiting symptoms during a DBPCFC after treatment with either omalizumab or placebo for omalizumab. Dose-limiting symptoms are those that in the view of the principal investigator indicate a true allergic reaction.

Proportion of participants who successfully consume 2 doses of 2000 mg of milk protein without dose-limiting symptoms during the double-blind placebo-controlled oral food challenge (DBPCFC) conducted in a controlled clinic setting, at the end of Stage 1 treatment, to compare the ability of participants to consume foods without dose-limiting symptoms during a DBPCFC after treatment with either omalizumab or placebo for omalizumab. Dose-limiting symptoms are those that in the view of the principal investigator indicate a true allergic reaction.

Number of participants who successfully consume 2 doses of 2000 mg of egg protein without dose-limiting symptoms during the double-blind placebo-controlled oral food challenge (DBPCFC) at the end of Stage 1

Proportion of participants who successfully consume 2 doses of 2000 mg of egg protein without dose-limiting symptoms during the double-blind placebo-controlled oral food challenge (DBPCFC) conducted in a controlled clinic setting, at the end of Stage 1 treatment, to compare the ability of participants to consume foods without dose-limiting symptoms during a DBPCFC after treatment with either omalizumab or placebo for omalizumab. Dose-limiting symptoms are those that in the view of the principal investigator indicate a true allergic reaction.

Number of participants who successfully consume 2 doses of 2000 mg of wheat protein without dose-limiting symptoms during the double-blind placebo-controlled oral food challenge (DBPCFC) at the end of Stage 1

Proportion of participants who successfully consume 2 doses of 2000 mg of wheat protein without dose-limiting symptoms during the double-blind placebo-controlled oral food challenge (DBPCFC) conducted in a controlled clinic setting, at the end of Stage 1 treatment, to compare the ability of participants to consume foods without dose-limiting symptoms during a DBPCFC after treatment with either omalizumab or placebo for omalizumab. Dose-limiting symptoms are those that in the view of the principal investigator indicate a true allergic reaction.

Number of participants who successfully consume 2 doses of 2000 mg of cashew protein without dose-limiting symptoms during the double-blind placebo-controlled oral food challenge (DBPCFC) at the end of Stage 1

Proportion of participants who successfully consume 2 doses of 2000 mg of cashew protein without dose-limiting symptoms during the double-blind placebo-controlled oral food challenge (DBPCFC) conducted in a controlled clinic setting, at the end of Stage 1 treatment, to compare the ability of participants to consume foods without dose-limiting symptoms during a DBPCFC after treatment with either omalizumab or placebo for omalizumab. Dose-limiting symptoms are those that in the view of the principal investigator indicate a true allergic reaction.

Number of participants who successfully consume 2 doses of 2000 mg of hazelnut protein without dose-limiting symptoms during the double-blind placebo-controlled oral food challenge (DBPCFC) at the end of Stage 1

Proportion of participants who successfully consume 2 doses of 2000 mg of hazelnut protein without dose-limiting symptoms during the double-blind placebo-controlled oral food challenge (DBPCFC) conducted in a controlled clinic setting, at the end of Stage 1 treatment, to compare the ability of participants to consume foods without dose-limiting symptoms during a DBPCFC after treatment with either omalizumab or placebo for omalizumab. Dose-limiting symptoms are those that in the view of the principal investigator indicate a true allergic reaction.

Number of participants who successfully consume 2 doses of 2000 mg of walnut protein without dose-limiting symptoms during the double-blind placebo-controlled oral food challenge (DBPCFC) at the end of Stage 1

Proportion of participants who successfully consume 2 doses of 2000 mg of walnut protein without dose-limiting symptoms during the double-blind placebo-controlled oral food challenge (DBPCFC) conducted in a controlled clinic setting, at the end of Stage 1 treatment, to compare the ability of participants to consume foods without dose-limiting symptoms during a DBPCFC after treatment with either omalizumab or placebo for omalizumab. Dose-limiting symptoms are those that in the view of the principal investigator indicate a true allergic reaction.

Number of participants who successfully consume 2 doses of 2000 mg of food protein without dose-limiting symptoms for at least two treated food allergens during the double-blind placebo-controlled oral food challenge (DBPCFC) at the end of Stage 1

Proportion of participants who successfully consume 2 doses of 2000 mg of food protein without dose-limiting symptoms for at least two treated food allergens during the double-blind placebo-controlled oral food challenge (DBPCFC) conducted in a controlled clinic setting, at the end of Stage 1 treatment, to compare the ability of participants to consume foods without dose-limiting symptoms during a DBPCFC after treatment with either omalizumab or placebo for omalizumab. Dose-limiting symptoms are those that in the view of the principal investigator indicate a true allergic reaction.

Number of participants who successfully consume 2 doses of 2000 mg of food protein without dose-limiting symptoms for all three treated food allergens during the double-blind placebo-controlled oral food challenge (DBPCFC) at the end of Stage 1

Proportion of participants who successfully consume 2 doses of 2000 mg of food protein without dose-limiting symptoms for all three treated food allergens during the double-blind placebo-controlled oral food challenge (DBPCFC) conducted in a controlled clinic setting, at the end of Stage 1 treatment, to compare the ability of participants to consume foods without dose-limiting symptoms during a DBPCFC after treatment with either omalizumab or placebo for omalizumab. Dose-limiting symptoms are those that in the view of the principal investigator indicate a true allergic reaction.

33. Number of foods consumed at a single dose of ≥600 mg protein without dose-limiting symptoms during the DBPCFC at the end of Stage 1.

Number of foods consumed at a single dose of ≥1000 mg protein without dose-limiting symptoms during the DBPCFC at the end of Stage 1.

Number of foods consumed at ≥1 dose of 2000 mg protein without dose-limiting symptoms during the DBPCFC at the end of Stage 1

Number of foods consumed at 2 doses of 2000 mg protein without dose-limiting symptoms during the DBPCFC at the end of Stage 1.

Proportion of participants who successfully consume a single dose of ≥600 mg of peanut protein without dose-limiting symptoms during the double-blind placebo-controlled oral food challenge (DBPCFC) conducted in a controlled clinic setting, at the end of Stage 2 treatment, to compare the ability of participants to consume foods without dose-limiting symptoms during a DBPCFC after treatment with either omalizumab-facilitated oral immunotherapy (OIT) or omalizumab + placebo OIT. Dose-limiting symptoms are those that in the view of the principal investigator indicate a true allergic reaction.

Proportion of participants who successfully consume a single dose of ≥600 mg of milk protein without dose-limiting symptoms during the double-blind placebo-controlled oral food challenge (DBPCFC) conducted in a controlled clinic setting, at the end of Stage 2 treatment, to compare the ability of participants to consume foods without dose-limiting symptoms during a DBPCFC after treatment with either omalizumab-facilitated oral immunotherapy (OIT) or omalizumab + placebo OIT. Dose-limiting symptoms are those that in the view of the principal investigator indicate a true allergic reaction.

Proportion of participants who successfully consume a single dose of ≥600 mg of egg protein without dose-limiting symptoms during the double-blind placebo-controlled oral food challenge (DBPCFC) conducted in a controlled clinic setting, at the end of Stage 2 treatment, to compare the ability of participants to consume foods without dose-limiting symptoms during a DBPCFC after treatment with either omalizumab-facilitated oral immunotherapy (OIT) or omalizumab + placebo OIT. Dose-limiting symptoms are those that in the view of the principal investigator indicate a true allergic reaction.

Proportion of participants who successfully consume a single dose of ≥600 mg of wheat protein without dose-limiting symptoms during the double-blind placebo-controlled oral food challenge (DBPCFC) conducted in a controlled clinic setting, at the end of Stage 2 treatment, to compare the ability of participants to consume foods without dose-limiting symptoms during a DBPCFC after treatment with either omalizumab-facilitated oral immunotherapy (OIT) or omalizumab + placebo OIT. Dose-limiting symptoms are those that in the view of the principal investigator indicate a true allergic reaction.

Proportion of participants who successfully consume a single dose of ≥600 mg of cashew protein without dose-limiting symptoms during the double-blind placebo-controlled oral food challenge (DBPCFC) conducted in a controlled clinic setting, at the end of Stage 2 treatment, to compare the ability of participants to consume foods without dose-limiting symptoms during a DBPCFC after treatment with either omalizumab-facilitated oral immunotherapy (OIT) or omalizumab + placebo OIT. Dose-limiting symptoms are those that in the view of the principal investigator indicate a true allergic reaction.

Proportion of participants who successfully consume a single dose of ≥600 mg of hazelnut protein without dose-limiting symptoms during the double-blind placebo-controlled oral food challenge (DBPCFC) conducted in a controlled clinic setting, at the end of Stage 2 treatment, to compare the ability of participants to consume foods without dose-limiting symptoms during a DBPCFC after treatment with either omalizumab-facilitated oral immunotherapy (OIT) or omalizumab + placebo OIT. Dose-limiting symptoms are those that in the view of the principal investigator indicate a true allergic reaction.

Proportion of participants who successfully consume a single dose of ≥600 mg of walnut protein without dose-limiting symptoms during the double-blind placebo-controlled oral food challenge (DBPCFC) conducted in a controlled clinic setting, at the end of Stage 2 treatment, to compare the ability of participants to consume foods without dose-limiting symptoms during a DBPCFC after treatment with either omalizumab-facilitated oral immunotherapy (OIT) or omalizumab + placebo OIT. Dose-limiting symptoms are those that in the view of the principal investigator indicate a true allergic reaction.

Proportion of participants who successfully consume a single dose of ≥600 mg of food protein without dose-limiting symptoms for at least two treated food allergens during the double-blind placebo-controlled oral food challenge (DBPCFC) conducted in a controlled clinic setting, at the end of Stage 2 treatment, to compare the ability of participants to consume foods without dose-limiting symptoms during a DBPCFC after treatment with either omalizumab-facilitated oral immunotherapy (OIT) or omalizumab + placebo OIT. Dose-limiting symptoms are those that in the view of the principal investigator indicate a true allergic reaction.

Number of participants who successfully consume a single dose of ≥600 mg of food protein without dose-limiting symptoms for all three treated food allergens during the double-blind placebo-controlled oral food challenge (DBPCFC) at the end of Stage 2

Proportion of participants who successfully consume a single dose of ≥600 mg of food protein without dose-limiting symptoms for all three treated food allergens during the double-blind placebo-controlled oral food challenge (DBPCFC) conducted in a controlled clinic setting, at the end of Stage 2 treatment, to compare the ability of participants to consume foods without dose-limiting symptoms during a DBPCFC after treatment with either omalizumab-facilitated oral immunotherapy (OIT) or omalizumab + placebo OIT. Dose-limiting symptoms are those that in the view of the principal investigator indicate a true allergic reaction.

Proportion of participants who successfully consume a single dose of ≥1000 mg of peanut protein without dose-limiting symptoms during the double-blind placebo-controlled oral food challenge (DBPCFC) conducted in a controlled clinic setting, at the end of Stage 2 treatment, to compare the ability of participants to consume foods without dose-limiting symptoms during a DBPCFC after treatment either omalizumab-facilitated oral immunotherapy (OIT) or omalizumab + placebo OIT. Dose-limiting symptoms are those that in the view of the principal investigator indicate a true allergic reaction.

Proportion of participants who successfully consume a single dose of ≥1000 mg of milk protein without dose-limiting symptoms during the double-blind placebo-controlled oral food challenge (DBPCFC) conducted in a controlled clinic setting, at the end of Stage 2 treatment, to compare the ability of participants to consume foods without dose-limiting symptoms during a DBPCFC after treatment either omalizumab-facilitated oral immunotherapy (OIT) or omalizumab + placebo OIT. Dose-limiting symptoms are those that in the view of the principal investigator indicate a true allergic reaction.

Proportion of participants who successfully consume a single dose of ≥1000 mg of egg protein without dose-limiting symptoms during the double-blind placebo-controlled oral food challenge (DBPCFC) conducted in a controlled clinic setting, at the end of Stage 2 treatment, to compare the ability of participants to consume foods without dose-limiting symptoms during a DBPCFC after treatment either omalizumab-facilitated oral immunotherapy (OIT) or omalizumab + placebo OIT. Dose-limiting symptoms are those that in the view of the principal investigator indicate a true allergic reaction.

Proportion of participants who successfully consume a single dose of ≥1000 mg of wheat protein without dose-limiting symptoms during the double-blind placebo-controlled oral food challenge (DBPCFC) conducted in a controlled clinic setting, at the end of Stage 2 treatment, to compare the ability of participants to consume foods without dose-limiting symptoms during a DBPCFC after treatment with either omalizumab-facilitated oral immunotherapy (OIT) or omalizumab + placebo OIT. Dose-limiting symptoms are those that in the view of the principal investigator indicate a true allergic reaction.

Proportion of participants who successfully consume a single dose of ≥1000 mg of cashew protein without dose-limiting symptoms during the double-blind placebo-controlled oral food challenge (DBPCFC) conducted in a controlled clinic setting, at the end of Stage 2 treatment, to compare the ability of participants to consume foods without dose-limiting symptoms during a DBPCFC after treatment either omalizumab-facilitated oral immunotherapy (OIT) or omalizumab + placebo OIT. Dose-limiting symptoms are those that in the view of the principal investigator indicate a true allergic reaction.

Proportion of participants who successfully consume a single dose of ≥1000 mg of hazelnut protein without dose-limiting symptoms during the double-blind placebo-controlled oral food challenge (DBPCFC) conducted in a controlled clinic setting, at the end of Stage 2 treatment, to compare the ability of participants to consume foods without dose-limiting symptoms during a DBPCFC after treatment either omalizumab-facilitated oral immunotherapy (OIT) or omalizumab + placebo OIT. Dose-limiting symptoms are those that in the view of the principal investigator indicate a true allergic reaction.

Proportion of participants who successfully consume a single dose of ≥1000 mg of walnut protein without dose-limiting symptoms during the double-blind placebo-controlled oral food challenge (DBPCFC) conducted in a controlled clinic setting, at the end of Stage 2 treatment, to compare the ability of participants to consume foods without dose-limiting symptoms during a DBPCFC after treatment with either omalizumab-facilitated oral immunotherapy (OIT) or omalizumab + placebo OIT. Dose-limiting symptoms are those that in the view of the principal investigator indicate a true allergic reaction.

Proportion of participants who successfully consume a single dose of ≥1000 mg of food protein without dose-limiting symptoms for at least two treated food allergens during the double-blind placebo-controlled oral food challenge (DBPCFC) conducted in a controlled clinic setting, at the end of Stage 2 treatment, to compare the ability of participants to consume foods without dose-limiting symptoms during a DBPCFC after treatment with either omalizumab-facilitated oral immunotherapy (OIT) or omalizumab + placebo OIT. Dose-limiting symptoms are those that in the view of the principal investigator indicate a true allergic reaction.

Proportion of participants who successfully consume a single dose of ≥1000mg of food protein without dose-limiting symptoms for all three treated food allergens during the double-blind placebo-controlled oral food challenge (DBPCFC) conducted in a controlled clinic setting, at the end of Stage 2 treatment, to compare the ability of participants to consume foods without dose-limiting symptoms during a DBPCFC after treatment with either omalizumab-facilitated oral immunotherapy (OIT) or omalizumab + placebo OIT. Dose-limiting symptoms are those that in the view of the principal investigator indicate a true allergic reaction.

Proportion of participants who successfully consume ≥1 dose of 2000 mg of peanut protein without dose-limiting symptoms during the double-blind placebo-controlled oral food challenge (DBPCFC) conducted in a controlled clinic setting, at the end of Stage 2 treatment, to compare the ability of participants to consume foods without dose-limiting symptoms during a DBPCFC after treatment with either omalizumab-facilitated oral immunotherapy (OIT) or omalizumab + placebo OIT. Dose-limiting symptoms are those that in the view of the principal investigator indicate a true allergic reaction.

Proportion of participants who successfully consume ≥1 dose of 2000 mg of milk protein without dose-limiting symptoms during the double-blind placebo-controlled oral food challenge (DBPCFC) conducted in a controlled clinic setting, at the end of Stage 2 treatment, to compare the ability of participants to consume foods without dose-limiting symptoms during a DBPCFC after treatment with either omalizumab-facilitated oral immunotherapy (OIT) or omalizumab + placebo OIT. Dose-limiting symptoms are those that in the view of the principal investigator indicate a true allergic reaction.

Number of participants who successfully consume ≥1 dose of 2000mg of egg protein without dose-limiting symptoms during the double-blind placebo-controlled oral food challenge (DBPCFC) at the end of Stage 2

Proportion of participants who successfully consume ≥1 dose of 2000 mg of egg protein without dose-limiting symptoms during the double-blind placebo-controlled oral food challenge (DBPCFC) conducted in a controlled clinic setting, at the end of Stage 2 treatment, to compare the ability of participants to consume foods without dose-limiting symptoms during a DBPCFC after treatment with either omalizumab-facilitated oral immunotherapy (OIT) or omalizumab + placebo OIT. Dose-limiting symptoms are those that in the view of the principal investigator indicate a true allergic reaction.

Number of participants who successfully consume ≥1 dose of 2000mg of wheat protein without dose-limiting symptoms during the double-blind placebo-controlled oral food challenge (DBPCFC) at the end of Stage 2

Proportion of participants who successfully consume ≥1 dose of 2000mg of wheat protein without dose-limiting symptoms during the double-blind placebo-controlled oral food challenge (DBPCFC) conducted in a controlled clinic setting, at the end of Stage 2 treatment, to compare the ability of participants to consume foods without dose-limiting symptoms during a DBPCFC after treatment with either omalizumab-facilitated oral immunotherapy (OIT) or omalizumab + placebo OIT. Dose-limiting symptoms are those that in the view of the principal investigator indicate a true allergic reaction.

Number of participants who successfully consume ≥1 dose of 2000mg of cashew protein without dose-limiting symptoms during the double-blind placebo-controlled oral food challenge (DBPCFC) at the end of Stage 2

Proportion of participants who successfully consume ≥1 dose of 2000mg of cashew protein without dose-limiting symptoms during the double-blind placebo-controlled oral food challenge (DBPCFC) conducted in a controlled clinic setting, at the end of Stage 2 treatment, to compare the ability of participants to consume foods without dose-limiting symptoms during a DBPCFC after treatment with either omalizumab-facilitated oral immunotherapy (OIT) or omalizumab + placebo OIT. Dose-limiting symptoms are those that in the view of the principal investigator indicate a true allergic reaction.

Proportion of participants who successfully consume ≥1 dose of 2000 mg of hazelnut protein without dose-limiting symptoms during the double-blind placebo-controlled oral food challenge (DBPCFC) conducted in a controlled clinic setting, at the end of Stage 2 treatment, to compare the ability of participants to consume foods without dose-limiting symptoms during a DBPCFC after treatment with either omalizumab-facilitated oral immunotherapy (OIT) or omalizumab + placebo OIT. Dose-limiting symptoms are those that in the view of the principal investigator indicate a true allergic reaction.

Proportion of participants who successfully consume ≥1 dose of 2000 mg of walnut protein without dose-limiting symptoms during the double-blind placebo-controlled oral food challenge (DBPCFC) conducted in a controlled clinic setting, at the end of Stage 2 treatment, to compare the ability of participants to consume foods without dose-limiting symptoms during a DBPCFC after treatment with either omalizumab-facilitated oral immunotherapy (OIT) or omalizumab + placebo OIT. Dose-limiting symptoms are those that in the view of the principal investigator indicate a true allergic reaction.

Number of participants who successfully consume ≥1 dose of 2000 mg of food protein without dose-limiting symptoms for at least two treated food allergens during the double-blind placebo-controlled oral food challenge (DBPCFC) at the end of Stage 2

Proportion of participants who successfully consume ≥1 dose of 2000 mg of food protein without dose-limiting symptoms for at least two treated food allergens during the double-blind placebo-controlled oral food challenge (DBPCFC) conducted in a controlled clinic setting, at the end of Stage 2 treatment, to compare the ability of participants to consume foods without dose-limiting symptoms during a DBPCFC after treatment with either omalizumab-facilitated oral immunotherapy (OIT) or omalizumab + placebo OIT. Dose-limiting symptoms are those that in the view of the principal investigator indicate a true allergic reaction.

Number of participants who successfully consume ≥1 dose of 2000 mg of food protein without dose-limiting symptoms for all three treated food allergens during the double-blind placebo-controlled oral food challenge (DBPCFC) at the end of Stage 2

Proportion of participants who successfully consume ≥1 dose of 2000 mg of food protein without dose-limiting symptoms for all three treated food allergens during the double-blind placebo-controlled oral food challenge (DBPCFC) conducted in a controlled clinic setting, at the end of Stage 2 treatment, to compare the ability of participants to consume foods without dose-limiting symptoms during a DBPCFC after treatment with either omalizumab-facilitated oral immunotherapy (OIT) or omalizumab + placebo OIT. Dose-limiting symptoms are those that in the view of the principal investigator indicate a true allergic reaction.

Number of participants who successfully consume ≥2 doses of 2000 mg of peanut protein without dose-limiting symptoms during the double-blind placebo-controlled oral food challenge (DBPCFC) at the end of Stage 2

Proportion of participants who successfully consume ≥2 doses of 2000 mg of peanut protein without dose-limiting symptoms during the double-blind placebo-controlled oral food challenge (DBPCFC) conducted in a controlled clinic setting, at the end of Stage 2 treatment, to compare the ability of participants to consume foods without dose-limiting symptoms during a DBPCFC after treatment with either omalizumab-facilitated oral immunotherapy (OIT) or omalizumab + placebo OIT. Dose-limiting symptoms are those that in the view of the principal investigator indicate a true allergic reaction.

Number of participants who successfully consume ≥2 doses of 2000 mg of milk protein without dose-limiting symptoms during the double-blind placebo-controlled oral food challenge (DBPCFC) at the end of Stage 2

Proportion of participants who successfully consume ≥2 doses of 2000 mg of milk protein without dose-limiting symptoms during the double-blind placebo-controlled oral food challenge (DBPCFC) conducted in a controlled clinic setting, at the end of Stage 2 treatment, to compare the ability of participants to consume foods without dose-limiting symptoms during a DBPCFC after treatment with either omalizumab-facilitated oral immunotherapy (OIT) or omalizumab + placebo OIT. Dose-limiting symptoms are those that in the view of the principal investigator indicate a true allergic reaction.

Number of participants who successfully consume ≥2 doses of 2000 mg of egg protein without dose-limiting symptoms during the double-blind placebo-controlled oral food challenge (DBPCFC) at the end of Stage 2

Proportion of participants who successfully consume ≥2 doses of 2000 mg of egg protein without dose-limiting symptoms during the double-blind placebo-controlled oral food challenge (DBPCFC) conducted in a controlled clinic setting, at the end of Stage 2 treatment, to compare the ability of participants to consume foods without dose-limiting symptoms during a DBPCFC after treatment with either omalizumab-facilitated oral immunotherapy (OIT) or omalizumab + placebo OIT. Dose-limiting symptoms are those that in the view of the principal investigator indicate a true allergic reaction.

Number of participants who successfully consume ≥2 doses of 2000 mg of wheat protein without dose-limiting symptoms during the double-blind placebo-controlled oral food challenge (DBPCFC) at the end of Stage 2

Proportion of participants who successfully consume ≥2 doses of 2000 mg of wheat protein without dose-limiting symptoms during the double-blind placebo-controlled oral food challenge (DBPCFC) conducted in a controlled clinic setting, at the end of Stage 2 treatment, to compare the ability of participants to consume foods without dose-limiting symptoms during a DBPCFC after treatment with either omalizumab-facilitated oral immunotherapy (OIT) or omalizumab + placebo OIT. Dose-limiting symptoms are those that in the view of the principal investigator indicate a true allergic reaction.

Number of participants who successfully consume ≥2 doses of 2000 mg of cashew protein without dose-limiting symptoms during the double-blind placebo-controlled oral food challenge (DBPCFC) conducted in a controlled clinic setting, at the end of Stage 2

Proportion of participants who successfully consume ≥2 doses of 2000 mg of cashew protein without dose-limiting symptoms during the double-blind placebo-controlled oral food challenge (DBPCFC) conducted in a controlled clinic setting, at the end of Stage 2 treatment, to compare the ability of participants to consume foods without dose-limiting symptoms during a DBPCFC after treatment with either omalizumab-facilitated oral immunotherapy (OIT) or omalizumab + placebo OIT. Dose-limiting symptoms are those that in the view of the principal investigator indicate a true allergic reaction.

Number of participants who successfully consume ≥2 doses of 2000 mg of hazelnut protein without dose-limiting symptoms during the double-blind placebo-controlled oral food challenge (DBPCFC) at the end of Stage 2

Proportion of participants who successfully consume ≥2 doses of 2000 mg of hazelnut protein without dose-limiting symptoms during the double-blind placebo-controlled oral food challenge (DBPCFC) conducted in a controlled clinic setting, at the end of Stage 2 treatment, to compare the ability of participants to consume foods without dose-limiting symptoms during a DBPCFC after treatment with either omalizumab-facilitated oral immunotherapy (OIT) or omalizumab + placebo OIT. Dose-limiting symptoms are those that in the view of the principal investigator indicate a true allergic reaction.

Number of participants who successfully consume ≥2 doses of 2000 mg of walnut protein without dose-limiting symptoms during the double-blind placebo-controlled oral food challenge (DBPCFC) at the end of Stage 2

Proportion of participants who successfully consume ≥2 doses of 2000 mg of walnut protein without dose-limiting symptoms during the double-blind placebo-controlled oral food challenge (DBPCFC) conducted in a controlled clinic setting, at the end of Stage 2 treatment, to compare the ability of participants to consume foods without dose-limiting symptoms during a DBPCFC after treatment with either omalizumab-facilitated oral immunotherapy (OIT) or omalizumab + placebo OIT. Dose-limiting symptoms are those that in the view of the principal investigator indicate a true allergic reaction.

Number of participants who successfully consume ≥2 doses of 2000 mg of food protein without dose-limiting symptoms for at least two treated food allergens during the double-blind placebo-controlled oral food challenge (DBPCFC) at the end of Stage 2

Proportion of participants who successfully consume ≥2 doses of 2000 mg of food protein without dose-limiting symptoms for at least two treated food allergens during the double-blind placebo-controlled oral food challenge (DBPCFC) conducted in a controlled clinic setting, at the end of Stage 2 treatment, to compare the ability of participants to consume foods without dose-limiting symptoms during a DBPCFC after treatment with either omalizumab-facilitated oral immunotherapy (OIT) or omalizumab + placebo OIT. Dose-limiting symptoms are those that in the view of the principal investigator indicate a true allergic reaction.

Number of participants who successfully consume ≥2 doses of 2000 mg of food protein without dose-limiting symptoms for all three treated food allergens during the double-blind placebo-controlled oral food challenge (DBPCFC) at the end of Stage

Proportion of participants who successfully consume ≥2 doses of 2000 mg of food protein without dose-limiting symptoms for all three treated food allergens during the double-blind placebo-controlled oral food challenge (DBPCFC) conducted in a controlled clinic setting, at the end of Stage 2 treatment, to compare the ability of participants to consume foods without dose-limiting symptoms during a DBPCFC after treatment with either omalizumab-facilitated oral immunotherapy (OIT) or omalizumab + placebo OIT. Dose-limiting symptoms are those that in the view of the principal investigator indicate a true allergic reaction.

Number of participants who successfully consume 3 doses of 2000 mg of peanut protein without dose-limiting symptoms during the double-blind placebo-controlled oral food challenge (DBPCFC) at the end of Stage 2

Proportion of participants who successfully consume 3 doses of 2000 mg of peanut protein without dose-limiting symptoms during the double-blind placebo-controlled oral food challenge (DBPCFC) conducted in a controlled clinic setting, at the end of Stage 2 treatment, to compare the ability of participants to consume foods without dose-limiting symptoms during a DBPCFC after treatment with either omalizumab-facilitated oral immunotherapy (OIT) or omalizumab + placebo OIT. Dose-limiting symptoms are those that in the view of the principal investigator indicate a true allergic reaction.

Number of participants who successfully consume 3 doses of 2000 mg of milk protein without dose-limiting symptoms during the double-blind placebo-controlled oral food challenge (DBPCFC) at the end of Stage 2

Proportion of participants who successfully consume 3 doses of 2000 mg of milk protein without dose-limiting symptoms during the double-blind placebo-controlled oral food challenge (DBPCFC) conducted in a controlled clinic setting, at the end of Stage 2 treatment, to compare the ability of participants to consume foods without dose-limiting symptoms during a DBPCFC after treatment with either omalizumab-facilitated oral immunotherapy (OIT) or omalizumab + placebo OIT. Dose-limiting symptoms are those that in the view of the principal investigator indicate a true allergic reaction.

Number of participants who successfully consume 3 doses of 2000 mg of egg protein without dose-limiting symptoms during the double-blind placebo-controlled oral food challenge (DBPCFC) at the end of Stage 2

Proportion of participants who successfully consume 3 doses of 2000 mg of egg protein without dose-limiting symptoms during the double-blind placebo-controlled oral food challenge (DBPCFC) conducted in a controlled clinic setting, at the end of Stage 2 treatment, to compare the ability of participants to consume foods without dose-limiting symptoms during a DBPCFC after treatment with either omalizumab-facilitated oral immunotherapy (OIT) or omalizumab + placebo OIT. Dose-limiting symptoms are those that in the view of the principal investigator indicate a true allergic reaction.

Proportion of participants who successfully consume 3 doses of 2000 mg of wheat protein without dose-limiting symptoms during the double-blind placebo-controlled oral food challenge (DBPCFC) conducted in a controlled clinic setting, at the end of Stage 2 treatment, to compare the ability of participants to consume foods without dose-limiting symptoms during a DBPCFC after treatment with either omalizumab-facilitated oral immunotherapy (OIT) or omalizumab + placebo OIT. Dose-limiting symptoms are those that in the view of the principal investigator indicate a true allergic reaction.

Number of participants who successfully consume 3 doses of 2000 mg of cashew protein without dose-limiting symptoms during the double-blind placebo-controlled oral food challenge (DBPCFC) at the end of Stage 2

Proportion of participants who successfully consume 3 doses of 2000 mg of cashew protein without dose-limiting symptoms during the double-blind placebo-controlled oral food challenge (DBPCFC) conducted in a controlled clinic setting, at the end of Stage 2 treatment, to compare the ability of participants to consume foods without dose-limiting symptoms during a DBPCFC after treatment with either omalizumab-facilitated oral immunotherapy (OIT) or omalizumab + placebo OIT. Dose-limiting symptoms are those that in the view of the principal investigator indicate a true allergic reaction.

Number of participants who successfully consume 3 doses of 2000 mg of hazelnut protein without dose-limiting symptoms during the double-blind placebo-controlled oral food challenge (DBPCFC) at the end of Stage 2

Proportion of participants who successfully consume 3 doses of 2000 mg of hazelnut protein without dose-limiting symptoms during the double-blind placebo-controlled oral food challenge (DBPCFC) conducted in a controlled clinic setting, at the end of Stage 2 treatment, to compare the ability of participants to consume foods without dose-limiting symptoms during a DBPCFC after treatment with either omalizumab-facilitated oral immunotherapy (OIT) or omalizumab + placebo OIT. Dose-limiting symptoms are those that in the view of the principal investigator indicate a true allergic reaction.

Number of participants who successfully consume 3 doses of 2000 mg of walnut protein without dose-limiting symptoms during the double-blind placebo-controlled oral food challenge (DBPCFC) at the end of Stage 2

Proportion of participants who successfully consume 3 doses of 2000 mg of walnut protein without dose-limiting symptoms during the double-blind placebo-controlled oral food challenge (DBPCFC) conducted in a controlled clinic setting, at the end of Stage 2 treatment, to compare the ability of participants to consume foods without dose-limiting symptoms during a DBPCFC after treatment with either omalizumab-facilitated oral immunotherapy (OIT) or omalizumab + placebo OIT. Dose-limiting symptoms are those that in the view of the principal investigator indicate a true allergic reaction.

Number of participants who successfully consume 3 doses of 2000 mg of food protein without dose-limiting symptoms for at least two treated food allergens during the double-blind placebo-controlled oral food challenge (DBPCFC) at the end of Stage 2

Proportion of participants who successfully consume 3 doses of 2000 mg of food protein without dose-limiting symptoms for at least two treated food allergens during the double-blind placebo-controlled oral food challenge (DBPCFC) conducted in a controlled clinic setting, at the end of Stage 2 treatment, to compare the ability of participants to consume foods without dose-limiting symptoms during a DBPCFC after treatment with either omalizumab-facilitated oral immunotherapy (OIT) or omalizumab + placebo OIT. Dose-limiting symptoms are those that in the view of the principal investigator indicate a true allergic reaction.

Number of participants who successfully consume 3 doses of 2000 mg of food protein without dose-limiting symptoms for all three treated food allergens during the double-blind placebo-controlled oral food challenge (DBPCFC) at the end of Stage 2

Proportion of participants who successfully consume 3 doses of 2000 mg of food protein without dose-limiting symptoms for all three treated food allergens during the double-blind placebo-controlled oral food challenge (DBPCFC) conducted in a controlled clinic setting, at the end of Stage 2 treatment, to compare the ability of participants to consume foods without dose-limiting symptoms during a DBPCFC after treatment with either omalizumab-facilitated oral immunotherapy (OIT) or omalizumab + placebo OIT. Dose-limiting symptoms are those that in the view of the principal investigator indicate a true allergic reaction.

Number of foods consumed at a single dose of ≥600 mg protein without dose-limiting symptoms during the DBPCFC at the end of Stage 2.

Number of foods consumed at a single dose of ≥1000 mg protein without dose-limiting symptoms during the DBPCFC at the end of Stage 2.

Number of foods consumed at ≥1 dose of 2000 mg protein without dose-limiting symptoms during the DBPCFC at the end of Stage 2.

Number of foods consumed at ≥2 doses of 2000 mg protein without dose-limiting symptoms during the DBPCFC at the end of Stage 2.

Number of foods consumed at 3 doses of 2000 mg protein without dose-limiting symptoms during the DBPCFC at the end of Stage 2.

During Stage 1: Occurrence of Adverse Event(s) Related to Study Therapy Regimen, Omalizumab versus Placebo

To evaluate safety during treatment with either omalizumab or placebo for omalizumab during Stage 1 masked (blinded) treatment.

During Stage 1 OLE : Occurrence of Adverse Event(s) Related Study to Therapy Regimen, Open Label Extension (OLE)

To evaluate safety during this open label omalizumab study therapy regimen during Stage 1.

During Stage 2: Occurrence of Adverse Event(s) Related to Study Therapy Regimen

To evaluate safety during treatment with either omalizumab-facilitated oral immunotherapy (OIT) or omalizumab + placebo OIT during Stage 2.

During Stage 3: Occurrence of Adverse Event(s) Related to Oral Food Intake

To evaluate safety after the conclusion of treatment with either omalizumab-facilitated oral immunotherapy (OIT) or omalizumab + placebo OIT during a follow-up period in which participants either received guided dietary instructions and/or rescue OIT for up to three foods (Stage 3).

Number of weeks in each eight-week period during Stage 3 where ≥300 mg protein of each food is consumed at least twice per week

To compare dietary consumption of foods after the conclusion of treatment with either omalizumab facilitated OIT or omalizumab + placebo OIT during a follow-up period in which participants either received guided dietary instructions and/or rescue oral immunotherapy (OIT) for up to three foods (Stage 3).

Number of weeks in each eight-week period during Stage 3 where each food is not consumed

Full Information

NCT ID

NCT03881696

First Posted

March 15, 2019

Last Updated

April 21, 2023

Sponsor

National Institute of Allergy and Infectious Diseases (NIAID)

Collaborators

Genentech, Inc., Novartis Pharmaceuticals, Rho Federal Systems Division, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT03881696

Brief Title

Omalizumab as Monotherapy and as Adjunct Therapy to Multi-Allergen OIT in Food Allergic Participants

Acronym

OUtMATCH

Official Title

Omalizumab as Monotherapy and as Adjunct Therapy to Multi-Allergen Oral Immunotherapy (OIT) in Food Allergic Children and Adults (CoFAR-11)

Study Type

Interventional

2. Study Status

Record Verification Date

April 2023

Overall Recruitment Status

Active, not recruiting

Study Start Date

July 22, 2019 (Actual)

Primary Completion Date

November 2023 (Anticipated)

Study Completion Date

August 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

National Institute of Allergy and Infectious Diseases (NIAID)

Collaborators

Genentech, Inc., Novartis Pharmaceuticals, Rho Federal Systems Division, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

This study is a multi-center, randomized, double-blind, placebo-controlled study in participants 1 to less than 56 years of age who are allergic to peanut and at least two other foods (including milk, egg, wheat, cashew, hazelnut, or walnut). While each participant may be allergic to more than two other foods, the primary endpoint/outcome in this study will only be assessed in peanut and two other foods for each participant. The primary objective of the study is to compare the ability to consume foods without dose-limiting symptoms during a double-blind placebo-controlled food challenge (DBPCFC), after treatment with either omalizumab or placebo for omalizumab.

Detailed Description

Food allergy affects about 15 million people in the United States. This includes 6 million children. The current treatment for food allergy is to avoid eating the foods that may cause an allergic reaction and have medications such as epinephrine (adrenaline) in case of a reaction. However, accidental exposures can be extremely difficult to avoid, particularly if you are allergic to multiple foods. The risks of accidental exposures and life-threatening reactions can place a large burden on patients and their families. Investigators in this study would like to learn if omalizumab injections alone or in combination with multi-allergen oral immunotherapy (OIT) will help people with multiple food allergies eat foods to which they are allergic. Oral means that you will take the food allergen (peanut and 2 other foods to which you are allergic) by mouth. If you are allergic to more than 3 foods, this study will only provide OIT for peanut and 2 other foods. There are 3 stages to the study: In Stage 1, investigators would like to learn: • If omalizumab stops or decreases allergic reactions to peanut and other common food allergens after taking it for a length of time. Stage 1 will also have an extra part so that 60 participants will receive omalizumab and everyone (the investigators conducting the research and study participants) will know it. This is why it is called the open label extension. This part of the study will assist investigators in learning if receiving omalizumab for a longer time may work better at decreasing allergic reactions. In Stage 2, investigators would like to learn: • How a short course of omalizumab combined with Multi-allergen OIT compares with a longer course of omalizumab in decreasing allergic reactions. In Stage 3, investigators would like to learn: • If, after participants stop both treatments, will they be able to eat the peanut and the 2 other foods in the form that is normally eaten. In all stages, investigators would like to learn: How safe and effective the treatments are and How the OIT affects the immune system. Participation will last up to 56 months (4 years and 8 months).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Peanut Allergy, Multi-food Allergy

Keywords

peanut allergic, multi-food allergic, omalizumab, placebo, multi-allergen oral immunotherapy (OIT), double-blind placebo-controlled food challenge (DBPCFC), oral food challenge (OFC)

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Sequential Assignment

Masking

ParticipantCare ProviderInvestigator

Allocation

Randomized

Enrollment

471 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Stage 1:Omalizumab as Monotherapy

Arm Type

Experimental

Arm Description

Arm Title

Stage 1: Omalizumab OLE

Arm Type

Experimental

Arm Description

Arm Title

Stage 1: Placebo for Omalizumab as Monotherapy

Arm Type

Placebo Comparator

Arm Description

Arm Title

Stage 2: Omalizumab

Arm Type

Experimental

Arm Description

Arm Title

Stage 2: Omalizumab-Facilitated OIT

Arm Type

Experimental

Arm Description

Arm Title

Stage 2: Omalizumab + Placebo OIT

Arm Type

Experimental

Arm Description

Arm Title

Stage 3: DBPCFC Based Treatment

Arm Type

Other

Arm Description

Intervention Type

Drug

Intervention Name(s)

Omalizumab

Other Intervention Name(s)

Xolair®

Intervention Description

Omalizumab will be supplied in pre-filled syringes (PFS). PFS of omalizumab will be provided to the clinical research units as 75 mg and 150 mg dosage forms.

Intervention Type

Drug

Intervention Name(s)

Placebo for Omalizumab

Other Intervention Name(s)

Placebo

Intervention Description

Placebo contains the same ingredients as the omalizumab formulation, excluding omalizumab. Placebo will be supplied in pre-filled syringes (PFS). PFS of placebo will be provided to the clinical research units as 75 mg and 150 mg dosage forms.

Intervention Type

Drug

Intervention Name(s)

Multi-Allergen Oral Immunotherapy

Other Intervention Name(s)

Multi-Allergen OIT

Intervention Description

Multi-allergen OIT will be any of the following drug products: peanut, milk, egg, wheat, cashew, hazelnut, and walnut (all food protein flours). A prescription for each participant for the appropriate dose of each of the allergens will be prepared. The pharmacist will compound the appropriate allergens and dispense the Multi-allergen OIT dose in a blinded (masked) fashion. The Clinical Research Unit (CRU) staff will administer food flour to the participant orally in an age-appropriate food vehicle (e.g., applesauce, pudding, etc.). Dosage will be administered according to the study protocol.

Intervention Type

Drug

Intervention Name(s)

Placebo for Multi-Allergen Oral Immunotherapy

Other Intervention Name(s)

Placebo for Multi-Allergen OIT

Intervention Description

Oat flour will be used for placebo for Multi-allergen OIT. Route: by mouth/oral. Dosage will be administered according to the study protocol.

Intervention Type

Other

Intervention Name(s)

Double-Blind Placebo-Controlled Food Challenge Based Treatment

Other Intervention Name(s)

DBPCFC Based Treatment

Intervention Description

Each participant will receive a separate treatment plan for peanut and each of the two other participant-specific foods. A treatment plan will include instructions for one of the following: Long-term follow-up with dietary consumption of a food; or Long-term follow-up with avoidance of a food; or Rescue OIT for a food. The treatment plan for each food may change depending on a participant's response to prescribed treatment over time.

Primary Outcome Measure Information:

Title

Description

Time Frame

During the DBPCFC at the end of Stage 1: 16 to 20 weeks after Stage 1 treatment initiation

Secondary Outcome Measure Information:

Title

Description

Time Frame

During the DBPCFC at the end of Stage 1: 16 to 20 weeks after Stage 1 treatment initiation

Title

Description

Time Frame

During the DBPCFC at the end of Stage 1: 16 to 20 weeks after Stage 1 treatment initiation

Title

Description

Time Frame

During the DBPCFC at the end of Stage 1: 16 to 20 weeks after Stage 1 treatment initiation

Title

Description

Time Frame

During the DBPCFC at the end of Stage 1: 16 to 20 weeks after Stage 1 treatment initiation

Title

Description

Time Frame

During the DBPCFC at the end of Stage 1: 16 to 20 weeks after Stage 1 treatment initiation

Title

Description

Time Frame

During the DBPCFC at the end of Stage 1: 16 to 20 weeks after Stage 1 treatment initiation

Title

Description

Time Frame

During the DBPCFC at the end of Stage 1: 16 to 20 weeks after Stage 1 treatment initiation

Title

Description

Time Frame

During the DBPCFC at the end of Stage 1: 16 to 20 weeks after Stage 1 treatment initiation

Title

Description

Time Frame

During the DBPCFC at the end of Stage 1: 16 to 20 weeks after Stage 1 treatment initiation

Title

Description

Time Frame

During the DBPCFC at the end of Stage 1: 16 to 20 weeks after Stage 1 treatment initiation

Title

Description

Time Frame

During the DBPCFC at the end of Stage 1: 16 to 20 weeks after Stage 1 treatment initiation

Title

Description

Time Frame

During the DBPCFC at the end of Stage 1: 16 to 20 weeks after Stage 1 treatment initiation

Title

Description

Time Frame

During the DBPCFC at the end of Stage 1: 16 to 20 weeks after Stage 1 treatment initiation

Title

Description

Time Frame

During the DBPCFC at the end of Stage 1: 16 to 20 weeks after Stage 1 treatment initiation

Title

Description

Time Frame

During the DBPCFC at the end of Stage 1: 16 to 20 weeks after Stage 1 treatment initiation

Title

Description

Time Frame

During the DBPCFC at the end of Stage 1: 16 to 20 weeks after Stage 1 treatment initiation

Title

Description

Time Frame

During the DBPCFC at the end of Stage 1: 16 to 20 weeks after Stage 1 treatment initiation

Title

Description

Time Frame

During the DBPCFC at the end of Stage 1: 16 to 20 weeks after Stage 1 treatment initiation

Title

Description

Time Frame

During the DBPCFC at the end of Stage 1: 16 to 20 weeks after Stage 1 treatment initiation

Title

Description

Time Frame

During the DBPCFC at the end of Stage 1: 16 to 20 weeks after Stage 1 treatment initiation

Title

Description

Time Frame

During the DBPCFC at the end of Stage 1: 16 to 20 weeks after Stage 1 treatment initiation

Title

Description

Time Frame

During the DBPCFC at the end of Stage 1: 16 to 20 weeks after Stage 1 treatment initiation

Title

Description

Time Frame

During the DBPCFC at the end of Stage 1: 16 to 20 weeks after Stage 1 treatment initiation

Title

Description

Time Frame

During the DBPCFC at the end of Stage 1: 16 to 20 weeks after Stage 1 treatment initiation

Title

Description

Time Frame

During the DBPCFC at the end of Stage 1: 16 to 20 weeks after Stage 1 treatment initiation

Title

Description

Time Frame

During the DBPCFC at the end of Stage 1: 16 to 20 weeks after Stage 1 treatment initiation

Title

Description

Time Frame

During the DBPCFC at the end of Stage 1: 16 to 20 weeks after Stage 1 treatment initiation]

Title

Description

Time Frame

During the DBPCFC at the end of Stage 1: 16 to 20 weeks after Stage 1 treatment initiation

Title

Description

Time Frame

During the DBPCFC at the end of Stage 1: 16 to 20 weeks after Stage 1 treatment initiation

Title

Description

Time Frame

During the DBPCFC at the end of Stage 1: 16 to 20 weeks after Stage 1 treatment initiation

Title

Description

Time Frame

During the DBPCFC at the end of Stage 1: 16 to 20 weeks after Stage 1 treatment initiation

Title

Description

Time Frame

During the DBPCFC at the end of Stage 1: 16 to 20 weeks after Stage 1 treatment initiation

Title

Description

Time Frame

During the DBPCFC at the end of Stage 1: 16 to 20 weeks after Stage 1 treatment initiation

Title

Description

Time Frame

During the DBPCFC at the end of Stage 1: 16 to 20 weeks after Stage 1 treatment initiation

Title

Description

Time Frame

During the DBPCFC at the end of Stage 1: 16 to 20 weeks after Stage 1 treatment initiation

Title

33. Number of foods consumed at a single dose of ≥600 mg protein without dose-limiting symptoms during the DBPCFC at the end of Stage 1.

Time Frame

During the DBPCFC at the end of Stage 1: 16 to 20 weeks after Stage 1 treatment initiation

Title

Number of foods consumed at a single dose of ≥1000 mg protein without dose-limiting symptoms during the DBPCFC at the end of Stage 1.

Time Frame

During the DBPCFC at the end of Stage 1: 16 to 20 weeks after Stage 1 treatment initiation

Title

Number of foods consumed at ≥1 dose of 2000 mg protein without dose-limiting symptoms during the DBPCFC at the end of Stage 1

Time Frame

During the DBPCFC at the end of Stage 1: 16 to 20 weeks after Stage 1 treatment initiation

Title

Number of foods consumed at 2 doses of 2000 mg protein without dose-limiting symptoms during the DBPCFC at the end of Stage 1.

Time Frame

During the DBPCFC at the end of Stage 1: 16 to 20 weeks after Stage 1 treatment initiation

Title

Description

Time Frame

During the DBPCFC at the end of Stage 2: 60 to 64 Weeks after Stage 2 treatment initiation

Title

Description

Proportion of participants who successfully consume a single dose of ≥600 mg of milk protein without dose-limiting symptoms during the double-blind placebo-controlled oral food challenge (DBPCFC) conducted in a controlled clinic setting, at the end of Stage 2 treatment, to compare the ability of participants to consume foods without dose-limiting symptoms during a DBPCFC after treatment with either omalizumab-facilitated oral immunotherapy (OIT) or omalizumab + placebo OIT. Dose-limiting symptoms are those that in the view of the principal investigator indicate a true allergic reaction.

Time Frame

During the DBPCFC at the end of Stage 2: 60 to 64 Weeks after Stage 2 treatment initiation

Title

Description

Proportion of participants who successfully consume a single dose of ≥600 mg of egg protein without dose-limiting symptoms during the double-blind placebo-controlled oral food challenge (DBPCFC) conducted in a controlled clinic setting, at the end of Stage 2 treatment, to compare the ability of participants to consume foods without dose-limiting symptoms during a DBPCFC after treatment with either omalizumab-facilitated oral immunotherapy (OIT) or omalizumab + placebo OIT. Dose-limiting symptoms are those that in the view of the principal investigator indicate a true allergic reaction.

Time Frame

During the DBPCFC at the end of Stage 2: 60 to 64 Weeks after Stage 2 treatment initiation

Title

Description

Proportion of participants who successfully consume a single dose of ≥600 mg of wheat protein without dose-limiting symptoms during the double-blind placebo-controlled oral food challenge (DBPCFC) conducted in a controlled clinic setting, at the end of Stage 2 treatment, to compare the ability of participants to consume foods without dose-limiting symptoms during a DBPCFC after treatment with either omalizumab-facilitated oral immunotherapy (OIT) or omalizumab + placebo OIT. Dose-limiting symptoms are those that in the view of the principal investigator indicate a true allergic reaction.

Time Frame

During the DBPCFC at the end of Stage 2: 60 to 64 Weeks after Stage 2 treatment initiation

Title

Description

Proportion of participants who successfully consume a single dose of ≥600 mg of cashew protein without dose-limiting symptoms during the double-blind placebo-controlled oral food challenge (DBPCFC) conducted in a controlled clinic setting, at the end of Stage 2 treatment, to compare the ability of participants to consume foods without dose-limiting symptoms during a DBPCFC after treatment with either omalizumab-facilitated oral immunotherapy (OIT) or omalizumab + placebo OIT. Dose-limiting symptoms are those that in the view of the principal investigator indicate a true allergic reaction.

Time Frame

During the DBPCFC at the end of Stage 2: 60 to 64 Weeks after Stage 2 treatment initiation

Title

Description

Proportion of participants who successfully consume a single dose of ≥600 mg of hazelnut protein without dose-limiting symptoms during the double-blind placebo-controlled oral food challenge (DBPCFC) conducted in a controlled clinic setting, at the end of Stage 2 treatment, to compare the ability of participants to consume foods without dose-limiting symptoms during a DBPCFC after treatment with either omalizumab-facilitated oral immunotherapy (OIT) or omalizumab + placebo OIT. Dose-limiting symptoms are those that in the view of the principal investigator indicate a true allergic reaction.

Time Frame

During the DBPCFC at the end of Stage 2: 60 to 64 Weeks after Stage 2 treatment initiation

Title

Description

Proportion of participants who successfully consume a single dose of ≥600 mg of walnut protein without dose-limiting symptoms during the double-blind placebo-controlled oral food challenge (DBPCFC) conducted in a controlled clinic setting, at the end of Stage 2 treatment, to compare the ability of participants to consume foods without dose-limiting symptoms during a DBPCFC after treatment with either omalizumab-facilitated oral immunotherapy (OIT) or omalizumab + placebo OIT. Dose-limiting symptoms are those that in the view of the principal investigator indicate a true allergic reaction.

Time Frame

During the DBPCFC at the end of Stage 2: 60 to 64 Weeks after Stage 2 treatment initiation

Title

Description

Proportion of participants who successfully consume a single dose of ≥600 mg of food protein without dose-limiting symptoms for at least two treated food allergens during the double-blind placebo-controlled oral food challenge (DBPCFC) conducted in a controlled clinic setting, at the end of Stage 2 treatment, to compare the ability of participants to consume foods without dose-limiting symptoms during a DBPCFC after treatment with either omalizumab-facilitated oral immunotherapy (OIT) or omalizumab + placebo OIT. Dose-limiting symptoms are those that in the view of the principal investigator indicate a true allergic reaction.

Time Frame

During the DBPCFC at the end of Stage 2: 60 to 64 Weeks after Stage 2 treatment initiation

Title

Description

Proportion of participants who successfully consume a single dose of ≥600 mg of food protein without dose-limiting symptoms for all three treated food allergens during the double-blind placebo-controlled oral food challenge (DBPCFC) conducted in a controlled clinic setting, at the end of Stage 2 treatment, to compare the ability of participants to consume foods without dose-limiting symptoms during a DBPCFC after treatment with either omalizumab-facilitated oral immunotherapy (OIT) or omalizumab + placebo OIT. Dose-limiting symptoms are those that in the view of the principal investigator indicate a true allergic reaction.

Time Frame

During the DBPCFC at the end of Stage 2: 60 to 64 Weeks after Stage 2 treatment initiation

Title

Description

Proportion of participants who successfully consume a single dose of ≥1000 mg of peanut protein without dose-limiting symptoms during the double-blind placebo-controlled oral food challenge (DBPCFC) conducted in a controlled clinic setting, at the end of Stage 2 treatment, to compare the ability of participants to consume foods without dose-limiting symptoms during a DBPCFC after treatment either omalizumab-facilitated oral immunotherapy (OIT) or omalizumab + placebo OIT. Dose-limiting symptoms are those that in the view of the principal investigator indicate a true allergic reaction.

Time Frame

During the DBPCFC at the end of Stage 2: 60 to 64 Weeks after Stage 2 treatment initiation

Title

Description

Time Frame

During the DBPCFC at the end of Stage 2: 60 to 64 Weeks after Stage treatment initiation

Title

Description

Time Frame

During the DBPCFC at the end of Stage 2: 60 to 64 Weeks after Stage 2 treatment initiation

Title

Description

Proportion of participants who successfully consume a single dose of ≥1000 mg of wheat protein without dose-limiting symptoms during the double-blind placebo-controlled oral food challenge (DBPCFC) conducted in a controlled clinic setting, at the end of Stage 2 treatment, to compare the ability of participants to consume foods without dose-limiting symptoms during a DBPCFC after treatment with either omalizumab-facilitated oral immunotherapy (OIT) or omalizumab + placebo OIT. Dose-limiting symptoms are those that in the view of the principal investigator indicate a true allergic reaction.

Time Frame

During the DBPCFC at the end of Stage 2: 60 to 64 Weeks after Stage 2 treatment initiation

Title

Description

Time Frame

During the DBPCFC at the end of Stage 2: 60 to 64 Weeks after Stage 2 treatment initiation

Title

Description

Proportion of participants who successfully consume a single dose of ≥1000 mg of hazelnut protein without dose-limiting symptoms during the double-blind placebo-controlled oral food challenge (DBPCFC) conducted in a controlled clinic setting, at the end of Stage 2 treatment, to compare the ability of participants to consume foods without dose-limiting symptoms during a DBPCFC after treatment either omalizumab-facilitated oral immunotherapy (OIT) or omalizumab + placebo OIT. Dose-limiting symptoms are those that in the view of the principal investigator indicate a true allergic reaction.

Time Frame

During the DBPCFC at the end of Stage 2: 60 to 64 Weeks after Stage 2 treatment initiation

Title

Description

Proportion of participants who successfully consume a single dose of ≥1000 mg of walnut protein without dose-limiting symptoms during the double-blind placebo-controlled oral food challenge (DBPCFC) conducted in a controlled clinic setting, at the end of Stage 2 treatment, to compare the ability of participants to consume foods without dose-limiting symptoms during a DBPCFC after treatment with either omalizumab-facilitated oral immunotherapy (OIT) or omalizumab + placebo OIT. Dose-limiting symptoms are those that in the view of the principal investigator indicate a true allergic reaction.

Time Frame

During the DBPCFC at the end of Stage 2: 60 to 64 Weeks after Stage 2 treatment initiation

Title

Description

Proportion of participants who successfully consume a single dose of ≥1000 mg of food protein without dose-limiting symptoms for at least two treated food allergens during the double-blind placebo-controlled oral food challenge (DBPCFC) conducted in a controlled clinic setting, at the end of Stage 2 treatment, to compare the ability of participants to consume foods without dose-limiting symptoms during a DBPCFC after treatment with either omalizumab-facilitated oral immunotherapy (OIT) or omalizumab + placebo OIT. Dose-limiting symptoms are those that in the view of the principal investigator indicate a true allergic reaction.

Time Frame

During the DBPCFC at the end of Stage 2: 60 to 64 Weeks after Stage 2 treatment initiation

Title

Description

Proportion of participants who successfully consume a single dose of ≥1000mg of food protein without dose-limiting symptoms for all three treated food allergens during the double-blind placebo-controlled oral food challenge (DBPCFC) conducted in a controlled clinic setting, at the end of Stage 2 treatment, to compare the ability of participants to consume foods without dose-limiting symptoms during a DBPCFC after treatment with either omalizumab-facilitated oral immunotherapy (OIT) or omalizumab + placebo OIT. Dose-limiting symptoms are those that in the view of the principal investigator indicate a true allergic reaction.

Time Frame

During the DBPCFC at the end of Stage 2: 60 to 64 Weeks after Stage 2 treatment initiation

Title

Description

Proportion of participants who successfully consume ≥1 dose of 2000 mg of peanut protein without dose-limiting symptoms during the double-blind placebo-controlled oral food challenge (DBPCFC) conducted in a controlled clinic setting, at the end of Stage 2 treatment, to compare the ability of participants to consume foods without dose-limiting symptoms during a DBPCFC after treatment with either omalizumab-facilitated oral immunotherapy (OIT) or omalizumab + placebo OIT. Dose-limiting symptoms are those that in the view of the principal investigator indicate a true allergic reaction.

Time Frame

During the DBPCFC at the end of Stage 2: 60 to 64 Weeks after Stage 2 treatment initiation

Title

Description

Proportion of participants who successfully consume ≥1 dose of 2000 mg of milk protein without dose-limiting symptoms during the double-blind placebo-controlled oral food challenge (DBPCFC) conducted in a controlled clinic setting, at the end of Stage 2 treatment, to compare the ability of participants to consume foods without dose-limiting symptoms during a DBPCFC after treatment with either omalizumab-facilitated oral immunotherapy (OIT) or omalizumab + placebo OIT. Dose-limiting symptoms are those that in the view of the principal investigator indicate a true allergic reaction.

Time Frame

During the DBPCFC at the end of Stage 2: 60 to 64 Weeks after Stage 2 treatment initiation

Title

Number of participants who successfully consume ≥1 dose of 2000mg of egg protein without dose-limiting symptoms during the double-blind placebo-controlled oral food challenge (DBPCFC) at the end of Stage 2

Description

Proportion of participants who successfully consume ≥1 dose of 2000 mg of egg protein without dose-limiting symptoms during the double-blind placebo-controlled oral food challenge (DBPCFC) conducted in a controlled clinic setting, at the end of Stage 2 treatment, to compare the ability of participants to consume foods without dose-limiting symptoms during a DBPCFC after treatment with either omalizumab-facilitated oral immunotherapy (OIT) or omalizumab + placebo OIT. Dose-limiting symptoms are those that in the view of the principal investigator indicate a true allergic reaction.

Time Frame

During the DBPCFC at the end of Stage 2: 60 to 64 Weeks after Stage 2 treatment initiation

Title

Number of participants who successfully consume ≥1 dose of 2000mg of wheat protein without dose-limiting symptoms during the double-blind placebo-controlled oral food challenge (DBPCFC) at the end of Stage 2

Description

Proportion of participants who successfully consume ≥1 dose of 2000mg of wheat protein without dose-limiting symptoms during the double-blind placebo-controlled oral food challenge (DBPCFC) conducted in a controlled clinic setting, at the end of Stage 2 treatment, to compare the ability of participants to consume foods without dose-limiting symptoms during a DBPCFC after treatment with either omalizumab-facilitated oral immunotherapy (OIT) or omalizumab + placebo OIT. Dose-limiting symptoms are those that in the view of the principal investigator indicate a true allergic reaction.

Time Frame

During the DBPCFC at the end of Stage 2: 60 to 64 Weeks after Stage 2 treatment initiation

Title

Number of participants who successfully consume ≥1 dose of 2000mg of cashew protein without dose-limiting symptoms during the double-blind placebo-controlled oral food challenge (DBPCFC) at the end of Stage 2

Description

Proportion of participants who successfully consume ≥1 dose of 2000mg of cashew protein without dose-limiting symptoms during the double-blind placebo-controlled oral food challenge (DBPCFC) conducted in a controlled clinic setting, at the end of Stage 2 treatment, to compare the ability of participants to consume foods without dose-limiting symptoms during a DBPCFC after treatment with either omalizumab-facilitated oral immunotherapy (OIT) or omalizumab + placebo OIT. Dose-limiting symptoms are those that in the view of the principal investigator indicate a true allergic reaction.

Time Frame

During the DBPCFC at the end of Stage 2: 60 to 64 Weeks after Stage 2 treatment initiation

Title

Description

Proportion of participants who successfully consume ≥1 dose of 2000 mg of hazelnut protein without dose-limiting symptoms during the double-blind placebo-controlled oral food challenge (DBPCFC) conducted in a controlled clinic setting, at the end of Stage 2 treatment, to compare the ability of participants to consume foods without dose-limiting symptoms during a DBPCFC after treatment with either omalizumab-facilitated oral immunotherapy (OIT) or omalizumab + placebo OIT. Dose-limiting symptoms are those that in the view of the principal investigator indicate a true allergic reaction.

Time Frame

During the DBPCFC at the end of Stage 2: 60 to 64 Weeks after Stage 2 treatment initiation

Title

Description

Proportion of participants who successfully consume ≥1 dose of 2000 mg of walnut protein without dose-limiting symptoms during the double-blind placebo-controlled oral food challenge (DBPCFC) conducted in a controlled clinic setting, at the end of Stage 2 treatment, to compare the ability of participants to consume foods without dose-limiting symptoms during a DBPCFC after treatment with either omalizumab-facilitated oral immunotherapy (OIT) or omalizumab + placebo OIT. Dose-limiting symptoms are those that in the view of the principal investigator indicate a true allergic reaction.

Time Frame

During the DBPCFC at the end of Stage 2: 60 to 64 Weeks after Stage 2 treatment initiation

Title

Description

Proportion of participants who successfully consume ≥1 dose of 2000 mg of food protein without dose-limiting symptoms for at least two treated food allergens during the double-blind placebo-controlled oral food challenge (DBPCFC) conducted in a controlled clinic setting, at the end of Stage 2 treatment, to compare the ability of participants to consume foods without dose-limiting symptoms during a DBPCFC after treatment with either omalizumab-facilitated oral immunotherapy (OIT) or omalizumab + placebo OIT. Dose-limiting symptoms are those that in the view of the principal investigator indicate a true allergic reaction.

Time Frame

Time Frame: During the DBPCFC at the end of Stage 2: 60 to 64 Weeks after Stage 2 treatment initiation

Title

Description

Proportion of participants who successfully consume ≥1 dose of 2000 mg of food protein without dose-limiting symptoms for all three treated food allergens during the double-blind placebo-controlled oral food challenge (DBPCFC) conducted in a controlled clinic setting, at the end of Stage 2 treatment, to compare the ability of participants to consume foods without dose-limiting symptoms during a DBPCFC after treatment with either omalizumab-facilitated oral immunotherapy (OIT) or omalizumab + placebo OIT. Dose-limiting symptoms are those that in the view of the principal investigator indicate a true allergic reaction.

Time Frame

During the DBPCFC at the end of Stage 2: 60 to 64 Weeks after Stage 2 treatment initiation

Title

Description

Time Frame

During the DBPCFC at the end of Stage 2: 60 to 64 Weeks after Stage 2 treatment initiation

Title

Description

Time Frame

During the DBPCFC at the end of Stage 2: 60 to 64 Weeks after Stage 2 treatment initiation

Title

Description

Time Frame

During the DBPCFC at the end of Stage 2: 60 to 64 Weeks after Stage 2 treatment initiation

Title

Description

Time Frame

During the DBPCFC at the end of Stage 2: 60 to 64 Weeks after Stage 2 treatment initiation

Title

Description

Time Frame

During the DBPCFC at the end of Stage 2: 60 to 64 Weeks after Stage 2 treatment initiation

Title

Description

Time Frame

During the DBPCFC at the end of Stage 2: 60 to 64 Weeks after Stage 2 treatment initiation

Title

Description

Time Frame

During the DBPCFC at the end of Stage 2: 60 to 64 Weeks after Stage 2 treatment initiation

Title

Description

Time Frame

During the DBPCFC at the end of Stage 2: 60 to 64 Weeks after Stage 2 treatment initiation

Title

Description

Time Frame

During the DBPCFC at the end of Stage 2: 60 to 64 Weeks after Stage 2 treatment initiation

Title

Description

Time Frame

During the DBPCFC at the end of Stage 2: 60 to 64 Weeks after Stage 2 treatment initiation

Title

Description

Time Frame

During the DBPCFC at the end of Stage 2: 60 to 64 Weeks after Stage 2 treatment initiation

Title

Description

Time Frame

During the DBPCFC at the end of Stage 2: 60 to 64 Weeks after Stage 2 treatment initiation

Title

Description

Time Frame

During the DBPCFC at the end of Stage 2: 60 to 64 Weeks after Stage 2 treatment initiation

Title

Description

Time Frame

During the DBPCFC at the end of Stage 2: 60 to 64 Weeks after Stage 2 treatment initiation

Title

Description

Time Frame

During the DBPCFC at the end of Stage 2: 60 to 64 Weeks after Stage 2 treatment initiation

Title

Description

Time Frame

During the DBPCFC at the end of Stage 2: 60 to 64 Weeks after Stage 2 treatment initiation

Title

Description

Time Frame

During the DBPCFC at the end of Stage 2: 60 to 64 Weeks after Stage 2 treatment initiation

Title

Description

Time Frame

During the DBPCFC at the end of Stage 2: 60 to 64 Weeks after Stage 2 treatment initiation

Title

Number of foods consumed at a single dose of ≥600 mg protein without dose-limiting symptoms during the DBPCFC at the end of Stage 2.

Time Frame

During the DBPCFC at the end of Stage 2: 60 to 64 Weeks after Stage 2 treatment initiation

Title

Number of foods consumed at a single dose of ≥1000 mg protein without dose-limiting symptoms during the DBPCFC at the end of Stage 2.

Time Frame

During the DBPCFC at the end of Stage 2: 60 to 64 Weeks after Stage 2 treatment initiation

Title

Number of foods consumed at ≥1 dose of 2000 mg protein without dose-limiting symptoms during the DBPCFC at the end of Stage 2.

Time Frame

During the DBPCFC at the end of Stage 2: 60 to 64 Weeks after Stage 2 treatment initiation

Title

Number of foods consumed at ≥2 doses of 2000 mg protein without dose-limiting symptoms during the DBPCFC at the end of Stage 2.

Time Frame

During the DBPCFC at the end of Stage 2: 60 to 64 Weeks after Stage 2 treatment initiation

Title

Number of foods consumed at 3 doses of 2000 mg protein without dose-limiting symptoms during the DBPCFC at the end of Stage 2.

Time Frame

During the DBPCFC at the end of Stage 2: 60 to 64 Weeks after Stage 2 treatment initiation

Title

During Stage 1: Occurrence of Adverse Event(s) Related to Study Therapy Regimen, Omalizumab versus Placebo

Description

To evaluate safety during treatment with either omalizumab or placebo for omalizumab during Stage 1 masked (blinded) treatment.

Time Frame

Up to 20 Weeks after initiating Stage 1 randomized treatment initiation

Title

During Stage 1 OLE : Occurrence of Adverse Event(s) Related Study to Therapy Regimen, Open Label Extension (OLE)

Description

To evaluate safety during this open label omalizumab study therapy regimen during Stage 1.

Time Frame

Up to 28 Weeks after initiating Stage 1 Open Label omalizumab study therapy regimen

Title

During Stage 2: Occurrence of Adverse Event(s) Related to Study Therapy Regimen

Description

To evaluate safety during treatment with either omalizumab-facilitated oral immunotherapy (OIT) or omalizumab + placebo OIT during Stage 2.

Time Frame

Up to 64 Weeks after initiating Stage 2 study therapy regimen

Title

During Stage 3: Occurrence of Adverse Event(s) Related to Oral Food Intake

Description

Time Frame

Up to 2 years after initiating Stage 3 Oral Food Intake regimen

Title

Number of weeks in each eight-week period during Stage 3 where ≥300 mg protein of each food is consumed at least twice per week

Description

Time Frame

From initial 8-week period during Stage 3 up to the last possible 8-week period during Stage 3 (i.e., Up to N=13 possible 8-week intervals during a 2-year period of time in Stage 3)

Title

Number of weeks in each eight-week period during Stage 3 where each food is not consumed

Description

Time Frame

From initial 8-week period during Stage 3 up to the last possible 8-week period during Stage 3 (i.e., Up to N=13 possible 8-week intervals during a 2-year period of time in Stage 3)

10. Eligibility

Sex

All

Minimum Age & Unit of Time

1 Year

Maximum Age & Unit of Time

55 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Individuals who meet all of the following criteria are eligible for enrollment as study participants: Participant and/or parent/legal guardian must be able to understand and provide informed consent and/or assent, as applicable; Peanut allergic: participant must meet all of the following criteria to minimize the chance that the participant will develop natural tolerance to peanut over the course of the study: Positive skin prick test (SPT) defined as ≥4 mm wheal greater than saline control) to peanut, Positive peanut immunoglobulin E (IgE), ≥6 kUA/L, at Screening or within three months of Screening, determined by ImmunoCap, and Positive double-blind placebo-controlled food challenge (DBPCFC), defined as experiencing dose-limiting symptoms at a single dose of ≤100 mg of peanut protein. Allergic to at least two of the six other foods (milk, egg, wheat, cashew, hazelnut, walnut): each participant must meet all of the following criteria for at least two of the six other foods to minimize the chance that the participant will develop natural tolerance to at least two of the six other foods over the course of the study: Positive SPT (≥4 mm wheal) to food, Positive food specific IgE (≥6 kUA/L) at Screening or within three months of Screening, determined by ImmunoCap, and Positive DBPCFC, defined as experiencing dose-limiting symptoms at a single dose of ≤300 mg of food protein. With body weight (as measured at Screening) and total serum IgE level (as measured within three months of Screening) suitable for omalizumab dosing; If female of child-bearing potential, must have a negative urine or serum pregnancy test; For women of childbearing potential, must agree to,during the treatment period and for 60 days after the last dose of study drug: remain abstinent (refrain from heterosexual intercourse), or use acceptable contraceptive methods (barrier methods, or oral, injected, or implanted hormonal methods of contraception, or other forms of hormonal contraception that have comparable efficacy). Plan to remain in the study area of an OUtMATCH clinical research unit (CRU) during the trial; and Be willing to be trained on the proper use of an epinephrine autoinjector for the duration of the study. Exclusion Criteria: Individuals who meet any of the following criteria are not eligible for enrollment as study participants: Inability or unwillingness of a participant and/or parent/legal guardian to give written informed consent and/or assent or comply with the study protocol; Clinically significant laboratory abnormalities at Screening; Dose-limiting symptoms to the placebo portion of the Screening DBPCFC; Sensitivity or suspected/known allergy to any ingredients (including excipients) of the active or placebo oral food challenge (OFC) material, multi-allergen oral immunotherapy (OIT), or drugs related to omalizumab (e.g., monoclonal antibodies, polyclonal gamma globulin). Note: Guidance for determination of sensitivity to excipients will be detailed in the study's Manual of Procedures (MOP). Poorly controlled atopic dermatitis (AD) at Screening, per the Principal Investigator's PI's) discretion; Poorly controlled or severe asthma/wheezing at Screening, defined by at least one of the following criteria: Global Initiative for Asthma (GINA) criteria regarding asthma control latest guidelines, History of two or more systemic corticosteroid courses within six months of Screening or one course of systemic corticosteroids within three months of Screening to treat asthma/wheezing, Prior intubation/mechanical ventilation for asthma/wheezing, One hospitalization or Emergency Department (ED) visit for asthma/wheezing within six months of Screening, Forced expiratory volume in one second (FEV1) <80 percent of predicted or FEV1/forced vital capacity (FVC) <75 percent, with or without controller medications (only for participants who are aged seven years or older and are able to perform spirometry), or Inhaled corticosteroid (ICS) dosing of >500 mcg daily fluticasone (or equivalent ICS based on the National Institutes of Health, National Heart, Lung, and Blood Institute (NHLBI) dosing chart). History of severe anaphylaxis to participant-specific foods that will be used in this study, defined as neurological compromise or requiring intubation; Treatment with a burst of oral, intramuscular (IM), or intravenous (IV) steroids of more than two days for an indication other than asthma/wheezing within 30 days of Screening; Currently receiving oral, intramuscular, or intravenous corticosteroids, tricyclic antidepressants, or beta-blockers (oral or topical); Past or current history of eosinophilic gastrointestinal (GI) disease within three years of Screening; Past or current history of cancer, or currently being investigated for possible cancer; Previous adverse reaction to omalizumab; Past or current history of any immunotherapy to any of the foods being treated in this study (e.g., OIT, sublingual immunotherapy [SLIT], EPIT) within 6 months of Screening; Treatment with monoclonal antibody therapy, such as omalizumab (Xolair®), dupilumab (Dupixent®), benralizumab (Fasenra™), mepolizumab (Nucala®), reslizumab (Cinqair®), or other immunomodulatory therapy within six months of Screening; Currently on "build-up phase" of inhalant allergen immunotherapy (i.e., has not reached maintenance dosing). Note: Individuals tolerating maintenance allergen immunotherapy can be enrolled; Inability to discontinue antihistamines for the minimum wash-out periods required for SPTs,or OFCs; Current participation in another therapeutic or interventional clinical trial or participation within 90 days of Screening; Use of investigational drugs within 24 weeks of Screening; Pregnant or breastfeeding, or intending to become pregnant during the study or within 60 days after the last dose of omalizumab or placebo for omalizumab; Has a first-degree relative already enrolled in the study; or Past or current medical problems (e.g., severe latex allergy), history of other chronic diseases (other than asthma/wheezing, AD, or rhinitis) requiring therapy (e.g., heart disease, diabetes), findings from physical assessment, or abnormalities in clinical laboratory testing that are not listed above, which, in the opinion of the PI, may: pose additional risks from participation in the study, may interfere with the participant's ability to comply with study requirements, or may impact the quality or interpretation of the data obtained from the study.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Robert A. Wood, MD

Organizational Affiliation

Department of Pediatrics at the Johns Hopkins University School of Medicine

Official's Role

Study Chair

First Name & Middle Initial & Last Name & Degree

Sharon Chinthrajah, MD

Organizational Affiliation

Department of Medicine, Stanford University School of Medicine

Official's Role

Study Chair

Facility Information:

Facility Name

Arkansas Children's Hospital Research Institute: Department of Pediatrics, Allergy & Immunology

City

Little Rock

State/Province

Arkansas

ZIP/Postal Code

72202

Country

United States

Facility Name

Stanford School of Medicine: Sean N. Parker Center for Allergy & Asthma Research

City

Stanford

State/Province

California

ZIP/Postal Code

94305

Country

United States

Facility Name

National Jewish Health: Division of Pediatric Allergy and Clinical Immunology

City

Denver

State/Province

Colorado

ZIP/Postal Code

80206

Country

United States

Facility Name

Emory University School of Medicine: Children's Healthcare of Atlanta Pediatrics

City

Atlanta

State/Province

Georgia

ZIP/Postal Code

30307

Country

United States

Facility Name

Johns Hopkins Children's Center: Department of Allergy & Immunology

City

Baltimore

State/Province

Maryland

ZIP/Postal Code

21287

Country

United States

Facility Name

Massachusetts General Hospital, Department of Medicine: Allergy & Clinical Immunology Unit

City

Boston

State/Province

Massachusetts

ZIP/Postal Code

02114

Country

United States

Facility Name

Icahn School of Medicine at Mount Sinai: Department of Pediatrics Allergy & Immunology

City

New York

State/Province

New York

ZIP/Postal Code

10029

Country

United States

Facility Name

North Carolina Children's Hospital: Department of Pediatrics, Division of Allergy, Immunology and Rheumatology

City

Chapel Hill

State/Province

North Carolina

ZIP/Postal Code

27599-7000

Country

United States

Facility Name

Children's Hospital of Philadelphia: Division of Allergy and Immunology

City

Philadelphia

State/Province

Pennsylvania

ZIP/Postal Code

19104

Country

United States

Facility Name

University of Texas Southwestern Medical Center: Division of Allergy and Immunology

City

Dallas

State/Province

Texas

ZIP/Postal Code

75390

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

30586557

Citation

Sampson HA, Berin MC, Plaut M, Sicherer SH, Jones S, Burks AW, Lindblad R, Leung DYM, Wood RA. The Consortium for Food Allergy Research (CoFAR): The first generation. J Allergy Clin Immunol. 2019 Feb;143(2):486-493. doi: 10.1016/j.jaci.2018.12.989. Epub 2018 Dec 23.

Results Reference

background

Links:

URL

http://www.niaid.nih.gov/about/dait

Description

Division of Allergy, Immunology, and Transplantation

URL

http://www.niaid.nih.gov/

Description

National Institute of Allergy and Infectious Diseases

Learn more about this trial

Omalizumab as Monotherapy and as Adjunct Therapy to Multi-Allergen OIT in Food Allergic Participants

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