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A Safety and Efficacy Study of Xolair in Peanut Allergy

This study has been terminated.
Sponsor:
Information provided by (Responsible Party):
Genentech
ClinicalTrials.gov Identifier:
NCT00086606
First received: July 6, 2004
Last updated: January 17, 2013
Last verified: January 2013
History of Changes

July 6, 2004
January 17, 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.
Not Provided
Interventional
Phase 2
Primary Purpose: Treatment
Allergy
Drug: Xolair (omalizumab)
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
150
April 2006
Not Provided

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
Both
6 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00086606
Q2788g
Not Provided
Genentech
Genentech
Not Provided
Study Director: Yamo Deniz, M.D. Genentech
Genentech
January 2013

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