Back to resultsA Study of Xolair in Peanut-Allergic Subjects Previously Enrolled in Study Q2788g
Primary Purpose
Peanut Hypersensitivity
Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
omalizumab
Sponsored by
About this trial
This is an interventional treatment trial for Peanut Hypersensitivity focused on measuring TOPS, Peanut allergy, Peanut-induced allergy, Allergy
Eligibility Criteria
Inclusion Criteria:
- Completion of last visit (or early termination visit, if applicable) for Study Q2788g
- Signed Informed Consent Form
- Use of an effective method of contraception for females of childbearing potential
- Body weight ≥ 20 kg and ≤ 150 kg
- IgE level ≤ 1300 IU/mL (Note: Subjects with an IgE < 30 IU/mL will be dosed at the lowest level on the dosing table [30 IU/mL], thus enabling better understanding of the role of Xolair in peanut allergic subjects who have low total IgE levels.)
Exclusion Criteria:
- Withdrawal from Study Q2788g prior to study closure or the final study visit (Week 36)
- Current participation in another investigational study
- Pregnancy or lactation
- History of brittle asthma
- Aspirin-sensitive asthma
- Known hypersensitivity to any ingredients of Xolair, including its excipients (sucrose, histidine, polysorbate 20)
- Have a polymorrphonuclear count <1500/uL
- Use of anti-coagulants, such as warfarin (Coumadin(R)), thrombolytic enzymes, or ticlopidine
- Current diagnosis of cancer, current investigation for possible cancer, or history of cancer (not including non-melanoma skin cancer)
- Thrombocytopenia as evidenced by a platelet count < 100,000/uL
- Any systemic condition requiring regular administration of an immunoglobulin
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
1
Arm Description
Outcomes
Primary Outcome Measures
Serious Adverse Events
All grades according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), v3.0. An SAE is defined as an adverse event that results in death, is life threatening, requires hospitalization, results in significant disability, results in birth defect, or is considered a significant medical event by the investigator
Secondary Outcome Measures
Food Allergen Exposure, Assessed on Patient-reported Questionnaire
Participants were asked to record every 4 weeks in the food-related allergic event questionnaire: "Whether you were exposed to peanut, tree nut (cashew, almond, etc.), shellfish (shrimp, crab, etc.), eggs, milk, or other (please specify)" and "Did you have a reaction? (Yes/No)."
Food-allergic Reactions As Assessed by the Ewan Scale
The Ewan scale has five ascending grades of severity from "Grade 1" to "Grade 5" (as well, there is a possible value of "Not Applicable"). Following a report of an allergic reaction to food on a patient-reported questionnaire, the reaction is graded by the study coordinator or Principle Investigator
Nonserious Food-related Adverse Events (AEs) and Other Nonserious AEs
All grades according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), v3.0. All AEs that do not meet any of the criteria for serious should be regarded as nonserious AEs.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00382148
Brief Title
A Study of Xolair in Peanut-Allergic Subjects Previously Enrolled in Study Q2788g
Official Title
A Phase IIb, Open-Label Study of Xolair (Omalizumab) in Peanut-Allergic Subjects Randomized to Study Drug in Study Q2788g (TOPS)
Study Type
Interventional
2. Study Status
Record Verification Date
November 2009
Overall Recruitment Status
Completed
Study Start Date
November 2006 (undefined)
Primary Completion Date
June 2008 (Actual)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Genentech, Inc.
4. Oversight
5. Study Description
Brief Summary
This is a Phase IIb, multicenter, open-label study available to active (Xolair) and control (placebo) subjects who have completed their final visit (or early termination visit, if applicable) for Study Q2788g, who meet the eligibility criteria of this study, and who provide consent to participate in this study.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Peanut Hypersensitivity
Keywords
TOPS, Peanut allergy, Peanut-induced allergy, Allergy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
omalizumab
Intervention Description
SC repeating dose
Primary Outcome Measure Information:
Title
Serious Adverse Events
Description
All grades according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), v3.0. An SAE is defined as an adverse event that results in death, is life threatening, requires hospitalization, results in significant disability, results in birth defect, or is considered a significant medical event by the investigator
Time Frame
Through Week 52
Secondary Outcome Measure Information:
Title
Food Allergen Exposure, Assessed on Patient-reported Questionnaire
Description
Participants were asked to record every 4 weeks in the food-related allergic event questionnaire: "Whether you were exposed to peanut, tree nut (cashew, almond, etc.), shellfish (shrimp, crab, etc.), eggs, milk, or other (please specify)" and "Did you have a reaction? (Yes/No)."
Time Frame
Every 4 weeks through Week 52
Title
Food-allergic Reactions As Assessed by the Ewan Scale
Description
The Ewan scale has five ascending grades of severity from "Grade 1" to "Grade 5" (as well, there is a possible value of "Not Applicable"). Following a report of an allergic reaction to food on a patient-reported questionnaire, the reaction is graded by the study coordinator or Principle Investigator
Time Frame
Through Week 52
Title
Nonserious Food-related Adverse Events (AEs) and Other Nonserious AEs
Description
All grades according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), v3.0. All AEs that do not meet any of the criteria for serious should be regarded as nonserious AEs.
Time Frame
Through Week 52
10. Eligibility
Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Completion of last visit (or early termination visit, if applicable) for Study Q2788g
Signed Informed Consent Form
Use of an effective method of contraception for females of childbearing potential
Body weight ≥ 20 kg and ≤ 150 kg
IgE level ≤ 1300 IU/mL (Note: Subjects with an IgE < 30 IU/mL will be dosed at the lowest level on the dosing table [30 IU/mL], thus enabling better understanding of the role of Xolair in peanut allergic subjects who have low total IgE levels.)
Exclusion Criteria:
Withdrawal from Study Q2788g prior to study closure or the final study visit (Week 36)
Current participation in another investigational study
Pregnancy or lactation
History of brittle asthma
Aspirin-sensitive asthma
Known hypersensitivity to any ingredients of Xolair, including its excipients (sucrose, histidine, polysorbate 20)
Have a polymorrphonuclear count <1500/uL
Use of anti-coagulants, such as warfarin (Coumadin(R)), thrombolytic enzymes, or ticlopidine
Current diagnosis of cancer, current investigation for possible cancer, or history of cancer (not including non-melanoma skin cancer)
Thrombocytopenia as evidenced by a platelet count < 100,000/uL
Any systemic condition requiring regular administration of an immunoglobulin
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dennis Wong, M.D.
Organizational Affiliation
Genentech, Inc.
Official's Role
Study Director
12. IPD Sharing Statement
Learn more about this trial
A Study of Xolair in Peanut-Allergic Subjects Previously Enrolled in Study Q2788g
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