Clinical Trial: Peanut Allergy Oral Immunotherapy Study of AR101 for Desensitization in Children and Adults (PALISADE)

Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional

Official Title: Peanut Allergy Oral Immunotherapy Study of AR101 for Desensitization in Children and Adults (PALISADE)

Brief Summary: The purpose of this study is to demonstrate the efficacy and safety of AR101 through reduction in clinical reactivity to peanut allergen in peanut-allergic children and adults.

Detailed Summary: This is an international, multicenter, randomized, double-blind, placebo-controlled study of the efficacy and safety of AR101 in a characterized desensitization oral immunotherapy regimen in peanut-allergic individuals.
Sponsor: Aimmune Therapeutics, Inc.

Current Primary Outcome: Peanut allergy desensitization [ Time Frame: 12 months ]

The proportion of subjects who tolerate at least 1043 mg cumulative of peanut protein with no more than mild symptoms at the Exit Double Blind Placebo Controlled Food Challenge (DBPCFC)


Original Primary Outcome: Same as current

Current Secondary Outcome:

Original Secondary Outcome:

Information By: Aimmune Therapeutics, Inc.

Dates:
Date Received: December 17, 2015
Date Started: December 2015
Date Completion: November 2017
Last Updated: March 1, 2017
Last Verified: March 2017