Peanut Reactivity Reduced by Oral Tolerance in an Anti-IgE Clinical Trial

Study Overview
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Brief Summary
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The investigators will perform a double blind, placebo controlled clinical trial with Xolair (omalizumab) at four centers to safely and rapidly desensitize patients with severe peanut allergy. The investigators will determine if pretreatment with anti-IgE mAb (Xolair/omalizumab) can greatly reduce allergic reactions and allow for faster and safer desensitization.

Detailed Description
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36 subjects will receive Xolair, and 8 subjects will receive placebo. The study will occur at 4 sites: Boston Children's Hospital, Children's Hospital of Philadelphia, Stanford University and Lurie Children's Hospital. Patients will be pre-treated with Xolair or placebo before rapid oral peanut desensitization. Patients will continue to receive Xolair during the 8 subsequent weeks of desensitization, receiving their final dose of Xolair one week after reaching the highest tolerated dose of peanut.

Official Title
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Phase 2 Study of Omalizumab in Oral Peanut Desensitization

Conditions
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Peanut Allergy, Food Allergy

Intervention / Treatment
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* Drug: Omalizumab
* Drug: placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Moderate to severe peanut allergy-sensitive subjects between the ages of 7 to 25 years old. Sensitivity to peanut allergen will be documented by a positive skin prick test result (6 mm diameter wheal or greater) ImmunoCAP IgE level to peanut > 10 kU/L. Sensitivity to peanut allergen based on a double-blind placebo-controlled oral food challenge (DBPCFC) at maximum of cumulative 175 mg of peanut protein dose. Exclusion Criteria: Subjects with a total IgE at screening of < 50 kU/L > 2,000 kU/L. Positive reaction to the placebo on DBPCFC. Previous reaction to omalizumab. Subjects having a history of severe anaphylaxis to peanut requiring intubation or admission to an ICU, frequent allergic or non-allergic urticaria, or history consistent with poorly controlled persistent asthma, or gastrointestinal or gastroesophageal disease.

Ages Eligible for Study
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Minimum Age: 7 Years
Maximum Age: 25 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: omalizumab group<br>Patients will receive omalizumab. | Drug: Omalizumab<br>* subcutaneous injection<br>* Other names: Xolair;|
| Placebo Comparator: placebo<br>Patients will receive placebo. | Drug: placebo<br>* subcutaneous injection<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tolerance of 2000 mg 6 Weeks After Last Dose of Omalizumab/Placebo |  | 6 weeks after last dose of omalizumab/placebo | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pass 4000 mg OFC 12 Weeks After Last Dose of Omalizumab/Placebo |  | 12 weeks after last dose of omalizumab/placebo | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Xolair, omalizumab, peanut, oral desensitization