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

Open-Label Follow-up Study of the PEPITES Study to Evaluate the Long-Term Efficacy and Safety of the Viaskin® Peanut

Protocol Description

This multi-center study investigates 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, or EPIT. 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 were previously enrolled in a 12-month precursor investigation (the PEPITES study), and it extends their participation for a total of 3 years on the patch.
Boys and girls: Ages 5 through 12 years

Requirements

In this study, participants will use the Viaskin Peanut 250 microgram patch for 2 additional years, if they used the Viaskin patch in the PEPITES study, or for 3 years if they used a placebo patch. During this study, 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: 9 to 12, dependent on whether participants received a placebo in the prior study
Duration: 25 to 36 months

Status: Enrollment Limited to PEPITES Study Participants

Source(s) of Support

DBV Technologies

Primary Investigator

Hey Jin Chong, MD, PhD

Contact Information

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