Peanut Allergy Treatment Using Viaskin® Patch – Phase III

Trial to Assess Peanut Epicutaneous Immunotherapy Efficacy and Safety (PEPITES) with Viaskin Peanut in Peanut-Allergic Children

Protocol Description

This international multi-center study is investigating whether the Viaskin Peanut 250 microgram drug patch can help children with peanut hypersensitivity by desensitizing them against allergic reactions. The use of a patch to deliver a peanut protein antigen is called epicutaneous immunotherapy, or EPIT. The Peanut EPIT Efficacy and Safety study (PEPITES) builds on previous research that demonstrated the safety of using Viaskin Peanut with peanut-allergic children. 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


Following screening to determine each participant’s level of allergy, participants will be randomly assigned to receive either the study drug patch or a placebo patch. Patches are used for 6 hours a day during the first week, 12 hours during the second week and for 24 hours starting with the third week. Parents/guardians administering the patches will be required to maintain a diary to record usage, reactions, and related experiences. 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: 12
Duration: 61 weeks

Status: Open to Enrollment

Source(s) of Support

DBV Technologies

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
Linette Milkovich, RN