The study aims to assess the safety and efficacy of Viaskin Peanut to induce desensitization to peanut in peanut-allergic children 1 to 3 years of age after a 12-month treatment by EPicutaneous ImmunoTherapy (EPIT)
Study phase: III
Basic eligibility criteria:
Please contact the study coordinator for additional eligibility information.
- Male or female from 1-3 years of age at Visit
- Physician-diagnosed peanut allergy or high suspicion of peanut allergy as assessed by the physician:
- child presenting signs, symptoms and a medical and/or a family history putting him/her at high risk of having a peanut allergy
- and/or history of presence of peanut-specific IgE and/or positive SPT
- Subject currently following a strict peanut-free diet
- Peanut-specific IgE level (ImmunoCAP system) > 0.7 kU/L
- Positive peanut SPT with a largest wheal diameter ≥ 6 mm
Primary disease category: Allergy & Immunology
Sponsor: DBV Technologies
Protocol number: Epitope, V712-304
Projected enrollment dates: April 2018 to May 2020
Official study title: A Double-blind, Placebo-controlled, Randomized Phase III Trial to Assess the Safety and Efficacy of Viaskin Peanut in Peanut-allergic Young Children 1-3 Years of Age.