Oral Immunotherapy for Wheat Allergy (Wheat OIT)
Primary Purpose
Wheat Allergy
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Wheat OIT
Sponsored by
About this trial
This is an interventional treatment trial for Wheat Allergy focused on measuring Food Allergy, Wheat Allergy, Oral Immunotherapy
Eligibility Criteria
Inclusion Criteria:
- Age 4-30 years either sex, any race, any ethnicity
- Positive Prick Skin Test to wheat greater than 3mm compared to control and/or a wheat specific IgE >= 0.35 kUA/L
- Positive baseline challenge to wheat (<= 1923 mg of vital wheat gluten)
- Written informed consent from subject and/or parent/guardian
- Written assent from all subjects as appropriate
- All females of child bearing age must be using appropriate birth control
Exclusion Criteria:
- History of anaphylaxis to wheat resulting in hypotension, neurological compromise or mechanical ventilation
- Known allergy to corn
- Known celiac disease
- Chronic disease (other than asthma, atopic dermatitis, rhinitis) requiring therapy (e.g., heart disease, diabetes)
- Active eosinophilic gastrointestinal disease in the past two years
- Participation in any interventional study for the treatment of food allergy in the past 6 months
- Subject is on "build-up phase" of immunotherapy (i.e., has not reached maintenance dosing). Subjects tolerating maintenance allergen immunotherapy can be enrolled.
- Severe asthma, uncontrolled mild or moderate asthma. More information on this criterion can be found in the protocol.
- A burst of oral, IM or IV steroids of more than 2 days for an indication other than asthma in the past 1 month
- Inability to discontinue antihistamines for initial day escalation, skin testing or OFC
- Use of omalizumab or other non-traditional forms of allergen immunotherapy or immunomodulator therapy (not including corticosteroids) or biologic therapy within the past year
- Use of beta-blockers (oral), angiotensin-converting enzyme (ACE) inhibitors, angiotensin-receptor blockers (ARB) or calcium channel blockers
- Use of investigational drug within 90 days or plan to use investigational drug during the study period
- Pregnancy or lactation
Sites / Locations
- Stanford University School of Medicine
- Ann & Robert H. Lurie Children's Hospital of Chicago
- Johns Hopkins University School of Medicine
- Icahn School of Medicine at Mount Sinai
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Wheat OIT
Placebo
Arm Description
Active treatment participants receive Vital Wheat Gluten, and have up to four oral food challenges as directed by the protocol.
Placebo for Vital Wheat Gluten followed by crossover to open-label active therapy (Vital Wheat Gluten), and up to three oral food challenges as directed by the protocol.
Outcomes
Primary Outcome Measures
The Percentage of Desensitized Participants as Measured by the Ability to Consume at Least 4443 mg of Wheat Protein During a 7443 mg Wheat Protein Oral Food Challenge (OFC) Performed 1 Year After Initiating Treatment.
Determine in wheat allergic children, whether relative to placebo, daily oral administration of Vital Wheat Gluten escalated to a maximum of 2035 mg/day of Vital Wheat Gluten increases desensitization as measured by consuming without dose limiting symptoms 4443 mg of wheat protein on a 7443 mg wheat protein OFC performed 1 year after initiating treatment.
Secondary Outcome Measures
Number of Subjects Who Successfully Consume a Wheat Protein Oral Food Challenge
The number of subjects who successfully consume a 7443 mg wheat protein oral food challenge (OFC) 8-10 weeks after therapy discontinuation and after passing the 7443 mg wheat protein OFC at the 2 year time point.This OFC will only be administered to subjects in the initial active treatment group.
Number of Subjects Who Achieve the Targeted Maintenance Dose of Wheat OIT
The number of subjects who achieve the targeted maintenance dose of wheat OIT during the desensitization phase of the study. For Wheat OIT group, reached target dose of 2035 mg wheat powder/1445 mg wheat protein. For placebo group, reached target dose of 2035 mg placebo powder.
Number of Subjects That Achieve Desensitization in the Placebo Cross Over Group
The number of subjects that achieve desensitization in the placebo cross over group after 1 year of dosing. Able to consume at least 4443 mg wheat protein on the Week 52 Crossover OFC (4443 mg wheat protein is the amount that was used for the primary endpoint).
Incidence of All Serious Adverse Events During the Study.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01980992
Brief Title
Oral Immunotherapy for Wheat Allergy
Acronym
Wheat OIT
Official Title
Oral Immunotherapy for Wheat Allergy
Study Type
Interventional
2. Study Status
Record Verification Date
August 2020
Overall Recruitment Status
Completed
Study Start Date
October 2013 (undefined)
Primary Completion Date
November 2015 (Actual)
Study Completion Date
April 13, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Hugh A Sampson, MD
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
This study is being done to learn about the medical effects, the safety, and the immunologic effects of Wheat Oral Immunotherapy (OIT) treatment. The goal of the study is to find out whether subjects can develop the ability to eat wheat (the food allergen) regularly without allergic symptoms after stopping the study treatment.
Detailed Description
Food allergy affects 6-8 percent of children in the United States. Wheat is one of the eight most common foods inducing allergic reactions in the US. Current treatment for food allergy is complete avoidance of the food and to carry antihistamines and self-injectable epinephrine if an accidental reaction occurs. However, accidental exposure to allergens in processed foods may be difficult to avoid. Currently, several therapeutic strategies are being investigated to prevent and treat food allergies. Since immunotherapy injections for food allergy are associated with a high rate of allergic reactions, alternate approaches to treatment are needed. Oral (by mouth) immunotherapy (OIT) is one approach that has been tried in some studies in the treatment of food allergies. The intent of the study is to examine the clinical effects and safety of wheat OIT. This study will last 2 years. All eligible subjects will receive a wheat oral food challenge (OFC). Those who react to 1923mg or less of vital wheat gluten will be randomized to Wheat OIT or a placebo. All eligible and enrolled subjects will have a 1-year and 2-year OFC. Placebo subjects will crossover to Wheat OIT at the 1-year time point. At selected visits, blood and urine collection, physical examination, prick skin tests, and atopic dermatitis and asthma evaluations will occur.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Wheat Allergy
Keywords
Food Allergy, Wheat Allergy, Oral Immunotherapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
46 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Wheat OIT
Arm Type
Active Comparator
Arm Description
Active treatment participants receive Vital Wheat Gluten, and have up to four oral food challenges as directed by the protocol.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo for Vital Wheat Gluten followed by crossover to open-label active therapy (Vital Wheat Gluten), and up to three oral food challenges as directed by the protocol.
Intervention Type
Drug
Intervention Name(s)
Wheat OIT
Other Intervention Name(s)
Vital Wheat Gluten
Intervention Description
Vital Wheat Gluten dispensed by the central manufacturer. Study product will be dispensed in vials for low doses, capsules for mid-range doses, and bulk powder with dosing scoops for the higher doses.
Primary Outcome Measure Information:
Title
The Percentage of Desensitized Participants as Measured by the Ability to Consume at Least 4443 mg of Wheat Protein During a 7443 mg Wheat Protein Oral Food Challenge (OFC) Performed 1 Year After Initiating Treatment.
Description
Determine in wheat allergic children, whether relative to placebo, daily oral administration of Vital Wheat Gluten escalated to a maximum of 2035 mg/day of Vital Wheat Gluten increases desensitization as measured by consuming without dose limiting symptoms 4443 mg of wheat protein on a 7443 mg wheat protein OFC performed 1 year after initiating treatment.
Time Frame
1 Year
Secondary Outcome Measure Information:
Title
Number of Subjects Who Successfully Consume a Wheat Protein Oral Food Challenge
Description
The number of subjects who successfully consume a 7443 mg wheat protein oral food challenge (OFC) 8-10 weeks after therapy discontinuation and after passing the 7443 mg wheat protein OFC at the 2 year time point.This OFC will only be administered to subjects in the initial active treatment group.
Time Frame
8 to 10 weeks after passing the 2 Year OFC
Title
Number of Subjects Who Achieve the Targeted Maintenance Dose of Wheat OIT
Description
The number of subjects who achieve the targeted maintenance dose of wheat OIT during the desensitization phase of the study. For Wheat OIT group, reached target dose of 2035 mg wheat powder/1445 mg wheat protein. For placebo group, reached target dose of 2035 mg placebo powder.
Time Frame
44 Weeks
Title
Number of Subjects That Achieve Desensitization in the Placebo Cross Over Group
Description
The number of subjects that achieve desensitization in the placebo cross over group after 1 year of dosing. Able to consume at least 4443 mg wheat protein on the Week 52 Crossover OFC (4443 mg wheat protein is the amount that was used for the primary endpoint).
Time Frame
2 Years
Title
Incidence of All Serious Adverse Events During the Study.
Time Frame
1 year and 2 Years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
4 Years
Maximum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age 4-30 years either sex, any race, any ethnicity
Positive Prick Skin Test to wheat greater than 3mm compared to control and/or a wheat specific IgE >= 0.35 kUA/L
Positive baseline challenge to wheat (<= 1923 mg of vital wheat gluten)
Written informed consent from subject and/or parent/guardian
Written assent from all subjects as appropriate
All females of child bearing age must be using appropriate birth control
Exclusion Criteria:
History of anaphylaxis to wheat resulting in hypotension, neurological compromise or mechanical ventilation
Known allergy to corn
Known celiac disease
Chronic disease (other than asthma, atopic dermatitis, rhinitis) requiring therapy (e.g., heart disease, diabetes)
Active eosinophilic gastrointestinal disease in the past two years
Participation in any interventional study for the treatment of food allergy in the past 6 months
Subject is on "build-up phase" of immunotherapy (i.e., has not reached maintenance dosing). Subjects tolerating maintenance allergen immunotherapy can be enrolled.
Severe asthma, uncontrolled mild or moderate asthma. More information on this criterion can be found in the protocol.
A burst of oral, IM or IV steroids of more than 2 days for an indication other than asthma in the past 1 month
Inability to discontinue antihistamines for initial day escalation, skin testing or OFC
Use of omalizumab or other non-traditional forms of allergen immunotherapy or immunomodulator therapy (not including corticosteroids) or biologic therapy within the past year
Use of beta-blockers (oral), angiotensin-converting enzyme (ACE) inhibitors, angiotensin-receptor blockers (ARB) or calcium channel blockers
Use of investigational drug within 90 days or plan to use investigational drug during the study period
Pregnancy or lactation
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hugh A Sampson, MD
Organizational Affiliation
Icahn School of Medicine at Mount Sinai
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Hugh A Sampson, MD
Organizational Affiliation
Icahn School of Medicine at Mount Sinai
Official's Role
Principal Investigator
Facility Information:
Facility Name
Stanford University School of Medicine
City
Stanford
State/Province
California
ZIP/Postal Code
94305
Country
United States
Facility Name
Ann & Robert H. Lurie Children's Hospital of Chicago
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
Johns Hopkins University School of Medicine
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287
Country
United States
Facility Name
Icahn School of Medicine at Mount Sinai
City
New York
State/Province
New York
ZIP/Postal Code
100029
Country
United States
12. IPD Sharing Statement
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Oral Immunotherapy for Wheat Allergy
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