Peanut Allergy Treatment with AR101 Oral Immunotherapy – Phase III

Peanut Allergy Oral Immunotherapy Study of AR101 for Desensitation in Children and Adults (PALISADE)

Protocol Description

Through this international multi-center study, researchers are collecting information about the effectiveness and safety of AR101 as immunotherapy for peanut-allergic children and adults. AR101 is a powder that contains peanut allergen in the form of peanut flour, which can be mixed with food and ingested. The PALISADE study builds on previous research that demonstrated the safety of using AR101 with peanut-allergic children and adults. 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

Subject to certain exclusion criteria, the study is accepting participants of both genders, ages 4 through 55, who have been diagnosed with a peanut allergy.
Males and females: Ages 4 through 55 years

Requirements

Following screening to determine each participant’s level of allergy, participants will be randomly assigned to receive either the study drug or a placebo, which will be administered daily throughout the course of the study period. Over the course of the first 6 months of the study, the dosage of AR101 will be gradually increased up to a maximum of 300 mg, with return visits to the study clinic at specific intervals. This will be followed by a 6-month maintenance period at the 300 mg dosage level, with clinic visits for physicals and various tests every 4 weeks.
Visits: Approximately 20-25
Duration: 12 months

Status: Open to Enrollment

Source(s) of Support

Aimmune Therapeutics, Inc.

Primary Investigator

Todd D. Green, MD

Contact Information

For more information about the study or enrollment, please contact:
Clinical Research Coordinators
Susan M. Richey, RN
412-692-6337
or
Linette Milkovich, RN
412-692-5383