A Safety and Efficacy Study of Xolair in Peanut Allergy - Full Text View

Sponsored by:	Genentech
Information provided by:	Genentech
ClinicalTrials.gov Identifier:	NCT00086606

Purpose

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.

Condition	Intervention	Phase
Allergy	Drug: Xolair (omalizumab)	Phase II

MedlinePlus related topics: Allergy

Drug Information available for: Omalizumab

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment
Official Title:	A Phase II, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled, Oral Food Challenge Trial of Xolair (Omalizumab) in Peanut Allergy

Further study details as provided by Genentech:

Estimated Enrollment:	150
Study Start Date:	June 2004

Eligibility

Ages Eligible for Study:	6 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00086606

Locations

United States, Colorado
Trial Information Support Line
Denver, Colorado, United States, 80012

Sponsors and Collaborators

Genentech

Investigators

Study Director:

Yamo Deniz, M.D.

Genentech

More Information

Study Results This link exits the ClinicalTrials.gov site

Study ID Numbers:	Q2788g
Study First Received:	July 6, 2004
Last Updated:	February 28, 2007
ClinicalTrials.gov Identifier:	NCT00086606
Health Authority:	United States: Food and Drug Administration

Keywords provided by Genentech:

Peanut

Study placed in the following topic categories:

Food Hypersensitivity
Hypersensitivity
Peanut Hypersensitivity
Hypersensitivity, Immediate
Omalizumab

Additional relevant MeSH terms:

Respiratory System Agents
Immune System Diseases
Therapeutic Uses

Anti-Asthmatic Agents
Anti-Allergic Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 15, 2009