Phase 3 Clinical Trials
- PALISADE is the largest randomized clinical trial for peanut allergy to date, enrolling more than 550 participants ages 4-55 years in the US, Canada, and Europe.
- This clinical trial was designed to evaluate the efficacy and safety of AR101 to treat peanut allergy.
- Top-line results were announced in February 2018.
- The results from PALISADE were published in The New England Journal of Medicine in November 2018.
- RAMSES is designed to gain experience with AR101 in a real-world setting, without the use of a “food challenge”—a diagnostic test conducted by a physician to confirm that an individual has a food allergy or has successfully been desensitized to a food allergen.
- This clinical trial is designed to evaluate the safety of AR101 to treat peanut allergy.
Phase 2 Clinical Trials
As an oral biologic immunotherapy designed for use as a peanut allergy treatment, AR101—upon US Food and Drug Administration (FDA) approval—will meet the stringent manufacturing and quality requirements established by regulatory authorities.
The Biologics License Application for AR101 was accepted by the FDA and is currently undergoing review. Additionally, Aimmune has submitted a marketing authorization application for AR101 to the European Medicines Agency.
1. Bird JA, Spergel JM, Jones SM, et al. Efficacy and safety of AR101 in oral immunotherapy for peanut allergy: results of ARC001, a randomized, double-blind, placebo-controlled Phase 2 clinical trial. J Allergy Clin Immunol Pract. 2018;6(2):476-485.