Peanut Allergy Treatment for Toddlers: The EPITOPE Study – Phase III

Trial to Assess the Safety and Efficacy of Viaskin® Peanut in Peanut-allergic Young Children 1-3 Years of Age

Protocol Description

This multi-center study is investigating the safety and therapeutic benefit of the Viaskin® Peanut patch to help very young children with peanut hypersensitivity. The patch contains a 250 microgram peanut protein antigen used to desensitize patients against allergic reactions through a process called epicutaneous immunotherapy. 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

The study is accepting participants ages 1 through 3 who have been diagnosed with a peanut allergy.
Boys and Girls: Ages 1 through 3

Requirements

Participants will be randomly assigned to a group that will either use the Viaskin Peanut 250 microgram patch or a Viaskin placebo patch. The chances of being in the placebo group are 1 in 3. Parents/guardians will be provided with a supply of patches that are to be applied daily for progressively longer periods over the first 5 weeks, as prescribed by the study team. In the first week, patches will be applied for only 2 hours a day, and by the fifth week, the patch will be applied for 24 hours. An electronic device will be provided to help parents journal the use of the patch.
Visits: 12 for physical examinations and testing
Duration: 62 weeks (1 year, 2.5 months)

Status: Active, Not Recruiting

Source(s) of Support

DBV Technologies

Primary Investigator

Deborah Albright, MD

Contact Information

For more information about the study or enrollment, please contact:
Clinical Research Coordinator Susan Richey, RN
412-692-6337