A Safety and Efficacy Study of Xolair in Peanut Allergy

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-06-30

Study Completion Date

2006-04-30

Brief Summary

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This is a 38-week, randomized, double-blind, placebo-controlled, parallel group trial of approximately 150 patients who have a history of immediate hypersensitivity reaction to peanut protein.

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Detailed Description

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Conditions

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Allergy

Study Design

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Primary Study Purpose

TREATMENT

Interventions

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Xolair (omalizumab)

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

6 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No