Trial Information

Summary: A Safety and Efficacy Study of Xolair in Peanut Allergy

Purpose

The objectives of the study are to assess:

• The efficacy of Xolair in reducing the risk of peanut-induced allergic reactions in patients with chronic peanut allergy. The study will compare the peanut tolerability threshold in Xolair-treated patients versus placebo-treated patients; and
• The safety of Xolair in peanut allergy by determining the incidence and severity of all adverse events throughout the study.

This is a double-blind, 38-week study for patients with allergy to peanuts. Approximately 150 participants, aged six to 75, are expected to receive treatment in the study.

Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment

Official Title: A Phase II, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Oral Food Challenge trial of XolairŽ (Omalizumab) in Peanut Allergy

Eligibility

Ages Eligible for Study: 6 Years - 75 Years, Genders Eligible for Study: Both

Criteria

Inclusion Criteria:

• The patient has a diagnosis of acute peanut allergy
• The patient meets the Xolair dosing table eligibility criteria by having a serum baseline IgE level between 30 and 1300IU/mL, and a body weight between 20 and 150 kilograms
• The patient is six to 75 years of age
• The patient reacts to peanut flour but not wheat (placebo) flour during the first Oral Food Challenge (OFC)
• The patient has a positive skin prick test to peanut or detectable serum peanut-specific IgE level
• The patient is able to swallow capsules

Exclusion Criteria:

• Have FEV1 value <80% predicted or any clinical features of moderate persistent asthma, as defined by the NHLBI guidelines
• Have other significant medical conditions (e.g., liver, gastrointestinal, kidney, cardiovascular, pulmonary disease, or blood disorders), which, in the opinion of the Investigator, make the subject unsuitable for induction of food reactions
• Have a history of allergy to wheat protein
• Have previously been exposed to monoclonal antibody treatment

Study Protocol: Q2788G

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Trial listings updated: June 1, 2008 at 5:44:19 AM