Peanut Allergy Long-Term Treatment Using Viaskin® Patch: The REALISE Study – Phase III

Long-Term Assessment of Safety and Therapeutic Benefit of Viaskin® Peanut Epicutaneous Treatment in Peanut-Allergic Children: A 6-Month Randomized, Double-Blind, Placebo-Controlled Phase III Study Followed by an Open Label Active Treatment

Protocol Description

This multi-center study is investigating the safety and therapeutic benefit of long-term treatment using the Viaskin Peanut 250 microgram drug patch to help children with peanut hypersensitivity. The use of a patch to deliver a peanut protein antigen to desensitize patients against allergic reactions is 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

Subject to certain exclusion criteria, the study is accepting participants of both genders, ages 4 through 11, who have been diagnosed with a peanut allergy.
Boys and girls: Ages 4 through 11 years

Requirements

Participants will use the Viaskin Peanut 250 microgram patch for 3 years. Following initial screening, participants will be randomly assigned to receive either the study drug patch or a placebo patch for the first 6 months. This will be done on a “blind” basis, meaning neither the family nor the research team will know if the participant is receiving a placebo patch or the Viaskin Peanut patch during this period. After 6 months, those who used the placebo patch will switch to the Viaskin Peanut patch for an additional 36 months. Those who used the Viaskin Peanut patch in the initial 6 months will continue to use the patch for another 30 months. Researchers will contact parents/guardians at specific intervals by telephone, and study visits will be required for physical exams and testing, including blood work, allergen skin tests, and pulmonary function tests.
Visits: 15 to 16
Duration: 37 to 43 months, depending on whether participant started with the Viaskin Peanut patch or the placebo patch

Status: Active, Not Recruiting

Source(s) of Support

DBV Technologies

Primary Investigator

Hey Jin Chong, MD, PhD

Contact Information

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