A Safety and Efficacy Study of Xolair in Peanut Allergy

Allergy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00086606
• Other study ID #: Q2788g
• Status: Terminated
• Phase: Phase 2
• First received: July 6, 2004
• Last updated: January 17, 2013
• Start date: June 2004
• Est. completion date: April 2006

Study information

• Verified date: January 2013
• Source: Genentech, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 150
• Est. completion date: April 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 6 Years to 75 Years

Eligibility

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 Design

Primary Purpose: Treatment

Related Conditions & MeSH terms

• Allergy
• Hypersensitivity
• Peanut Hypersensitivity

Intervention

Drug:
• Xolair (omalizumab)

Locations

Country	Name	City	State
United States	Trial Information Support Line	Denver	Colorado

Sponsors (1)

Lead Sponsor	Collaborator
Genentech, Inc.

Country where clinical trial is conducted

United States,