Peanut Allergy Long-Term Study of Viaskin® Peanut Patch in Young Children: The EPOPEX Study – Phase III

EPITOPE Open-Label Extension Study to Evaluate the Long-term Clinical Benefit and Safety of Viaskin® Peanut in Peanut-allergic Children

Protocol Description

This multi-center study is investigating long-term effects of the Viaskin® Peanut patch for young children with peanut hypersensitivity. The research is designed specifically for children who were enrolled in a prior year-long protocol – the EPITOPE study. Through this extension study, participants will have used Viaskin Peanut for a total of three years. The patch contains a 250 microgram peanut protein antigen used to desensitize patients against allergic reactions through a process called epicutaneous immunotherapy. Researchers will test the theory that longer periods of treatment result in more efficient desensitization and greater tolerance of peanuts..

Study Level: Phase III

Eligibility Criteria

The study is enrolling children ages 2 through 4 who have been diagnosed with a peanut allergy and who participated in the EPITOPE study.
Boys and Girls: Ages 2 through 4

Requirements

Participants in the original EPITOPE study used either Viaskin Peanut or a placebo patch. Those who received Viaskin Peanut will continue to use the product for 2 more years. Those who received the placebo patch will use Viaskin Peanut for 3 years. After the initial study visit, participants will be seen about 4 times a year, during which they will receive physical examinations and be tested for peanut tolerance.
Visits: 9 to 12 depending on length of enrollment
Duration: 2 years and 1 month for those who received Viaskin Peanut, and 3 years and 1 month for those who received a placebo patch in the EPITOPE study

Status: Enrolling by Invitation

Source(s) of Support

DBV Technologies

Primary Investigator

Deborah Albright, MD

Contact Information

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