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A Safety and Efficacy Study of Xolair in Peanut Allergy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00086606
Recruitment Status : Terminated
First Posted : July 9, 2004
Last Update Posted : January 21, 2013
Information provided by (Responsible Party):

July 6, 2004
July 9, 2004
January 21, 2013
June 2004
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Complete list of historical versions of study NCT00086606 on ClinicalTrials.gov Archive Site
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A Safety and Efficacy Study of Xolair in Peanut Allergy
A Phase II, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled, Oral Food Challenge Trial of Xolair (Omalizumab) in Peanut Allergy
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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Phase 2
Primary Purpose: Treatment
Drug: Xolair (omalizumab)
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
April 2006
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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
Sexes Eligible for Study: All
6 Years to 75 Years   (Child, Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
United States
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Genentech, Inc.
Genentech, Inc.
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Study Director: Yamo Deniz, M.D. Genentech, Inc.
Genentech, Inc.
January 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP