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

Phase 2

Completed

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.

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
1	omalizumab	-

Primary Outcome Measures

Name	Time	Method
Serious Adverse Events	Through Week 52	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

Name	Time	Method
Food Allergen Exposure, Assessed on Patient-reported Questionnaire	Every 4 weeks through Week 52	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	Through Week 52	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	Through Week 52	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.