A Safety and Efficacy Study of Xolair in Peanut Allergy

This study has been terminated.
Sponsor:
Information provided by (Responsible Party):
Genentech, Inc.
ClinicalTrials.gov Identifier:
NCT00086606
First received: July 6, 2004
Last updated: January 17, 2013
Last verified: January 2013
  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 2

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

Resource links provided by NLM:


Further study details as provided by Genentech, Inc.:

Estimated Enrollment: 150
Study Start Date: June 2004
Study Completion Date: April 2006
  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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, Inc.
Investigators
Study Director: Yamo Deniz, M.D. Genentech, Inc.
  More Information

No publications provided

Responsible Party: Genentech, Inc.
ClinicalTrials.gov Identifier: NCT00086606     History of Changes
Other Study ID Numbers: Q2788g
Study First Received: July 6, 2004
Last Updated: January 17, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Genentech, Inc.:
Peanut

Additional relevant MeSH terms:
Hypersensitivity
Peanut Hypersensitivity
Food Hypersensitivity
Hypersensitivity, Immediate
Immune System Diseases
Omalizumab
Anti-Allergic Agents
Anti-Asthmatic Agents
Pharmacologic Actions
Respiratory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 22, 2014