A Study of Xolair in Peanut-Allergic Subjects Previously Enrolled in Study Q2788g

Study Overview
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Brief Summary
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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.

Official Title
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A Phase IIb, Open-Label Study of Xolair (Omalizumab) in Peanut-Allergic Subjects Randomized to Study Drug in Study Q2788g (TOPS)

Conditions
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Peanut Hypersensitivity

Intervention / Treatment
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* Drug: omalizumab


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 6 Years
Maximum Age: 75 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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Drug: omalizumab<br>* SC repeating dose<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | Through Week 52 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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). | Every 4 weeks through Week 52 | 
| 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 | Through Week 52 | 
| 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. | Through Week 52 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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TOPS, Peanut allergy, Peanut-induced allergy, Allergy