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

Genentech, Inc.10 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Peanut Hypersensitivity

Interventions

omalizumabDRUG

SC repeating dose

Eligibility

Sex: ALLMin age: 6 YearsMax age: 75 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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

Time frame: Through Week 52

Secondary Outcomes

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)."

Time frame: 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

Time frame: 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.

Time frame: Through Week 52

Data from ClinicalTrials.gov

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