Clinical Trial: Peanut Oral Immunotherapy and Anti-Immunoglobulin E (IgE) for Peanut Allergy

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Peanut OIT & Anti-IgE: Peanut Oral Immunotherapy and Anti-IgE Treatment for Peanut Allergy {NIH R21 Combined Peanut Oral Immunotherapy and Anti-IgE: Mechanistic Studie

Brief Summary: The purpose of this study is to determine whether the addition of anti-IgE treatment will make peanut oral immunotherapy safer, more tolerable, and more effective in treating peanut allergy.

Detailed Summary: The goal of this proposal is to produce a new treatment that would benefit subjects who have peanut allergy by lowering the risk of anaphylactic reactions (desensitization), and changing the peanut-specific immune response in subjects who have peanut allergy (tolerance). This project is designed to study if peanut oral immunotherapy (OIT) will desensitize subjects with peanut hypersensitivity by regulating their oral and systemic immune reactivity and cause long-term tolerance. This study will augment other ongoing studies by looking at whether anti-IgE therapy can reduce side effects and allow for an accelerated build up phase. Peanut allergic patients greater than 12 years old will undergo omalizumab (anti-IgE) treatment for 4 months prior to peanut OIT, and they will continue omalizumab until one month after maintenance therapy. Each subject will have an initial desensitization phase over 2 days to a goal of 950 mg of peanut powder followed by a build up phase over 4 months to goal maintenance dose of 8000 mg peanut powder. They will be randomized to continue maintenance for 12 or 24 months. They will then have an oral food challenge (OFC) immediately after stopping peanut OIT to test for desensitization. Four weeks later, off OIT, another food challenge will be done to assess tolerance. Outcome variables of interest include results of the OFCs, pre and post skin tests, CAP-FEIA values and basophil studies. These results will be compared between the starting point and the patient at the end of the study using appropriate statistical analysis.
Sponsor: University of North Carolina, Chapel Hill

Current Primary Outcome: The percentage of subjects who pass the 20gm peanut flour (~50% peanut protein) oral food challenge following the desensitization phase of the study [ Time Frame: 2 or 3 years ]

Original Primary Outcome: Same as current

Current Secondary Outcome: Incidence of side effects during initial escalation and build up phase [ Time Frame: Every 6 months ]

Original Secondary Outcome: Same as current

Information By: University of North Carolina, Chapel Hill

Dates:
Date Received: June 10, 2009
Date Started: July 2009
Date Completion:
Last Updated: October 6, 2015
Last Verified: October 2015