Peanut Allergy Long-Term Treatment with AR101 Oral Immunotherapy – Phase III

Long-term Safety Study of AR101 Characterized Oral Desensitization Immunotherapy in Subjects who Participated in a Prior AR101 Study

Protocol Description

Through this international multi-center study, researchers are collecting information about the safety of AR101 used as immunotherapy for peanut-allergic children and adults over an extended period. AR101 is a powder that contains peanut allergen in the form of peanut flour, which can be mixed with food and ingested. In the U.S., peanut hypersensitivity prevalence is growing, and among food allergies, peanut allergy is the most common cause of death.

Study Level: Phase III

Eligibility Criteria

This study is open to participants of both genders, who have a peanut allergy and were enrolled in an AR101 precursor study. It extends their participation for up to 3 years.
Males and Females: Ages 4 through 55 years

Requirements

In this study extension, participants will use AR101 at a 300 mg dosage level at the same frequency as the study in which they were originally enrolled. Clinic visits for physicals and various tests will occur every 3 months. The study will continue for up to 3 years from the time the first participant is enrolled or until the study drug becomes approved by the Food and Drug Administration, whichever comes first. The study also includes two optional challenges in which participants can consume peanut protein in powder form and as food, in a study setting, to measure tolerance and reaction.
Visits: Up to 13
Duration: Up to 3 years

Status: Active, Not Recruiting

Source(s) of Support

Aimmune Therapeutics

Primary Investigator

Hey Jin Chong, MD, PhD

Contact Information

For more information, please contact:
Clinical Research Coordinator Susan Richey, RN
412-692-6337