Suspended

A Phase II, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled, Oral Food Challenge Trial of Xolair (Omalizumab) in Peanut Allergy

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What is being tested

Data Collection

Who is being recruted

Nut and Peanut Hypersensitivity+3

+ Food Hypersensitivity

+ Hypersensitivity

From 6 to 75 Years
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 2
Interventional
Study Start: June 2004
See protocol details

Summary

Principal SponsorGenentech, Inc.
Last updated: January 14, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: June 1, 2004

Actual date on which the first participant was enrolled.

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.

Official TitleA Phase II, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled, Oral Food Challenge Trial of Xolair (Omalizumab) in Peanut Allergy 
Principal SponsorGenentech, Inc.
Last updated: January 14, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

150 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 6 to 75 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Nut and Peanut HypersensitivityFood HypersensitivityHypersensitivityHypersensitivity, ImmediateImmune System DiseasesPeanut Hypersensitivity

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 Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Suspended

Trial Information Support Line

Denver, United StatesSee the location
SuspendedOne Study Center