Peanut allergy is one of the most common food allergies and can cause severe, potentially fatal, allergic reactions, including anaphylaxis.
We have a comprehensive clinical research program in place for Viaskin Peanut. Two Phase III long-term studies in children ages four to 11 are ongoing, as well as a Phase III trial in patients one to three years of age. DBV’s Viaskin Peanut has obtained Fast Track and Breakthrough Therapy designation from the U.S. Food and Drug Administration (FDA) for the treatment of peanut allergy in children.
EPITOPE (EPIT in Toddlers with Peanut Allergy)
EPITOPE (EPIT in Toddlers with Peanut Allergy) is a global, Phase III clinical trial assessing the safety and efficacy of Viaskin Peanut for the treatment of peanut-allergic patients one to three years of age. EPITOPE is a two-part, pivotal, double-blind, placebo-controlled trial currently enrolling patients.
REALISE (Real Life Use and Safety of EPIT)
REALISE (Real Life Use and Safety of EPIT) is a multicenter, randomized, double-blind, placebo-controlled Phase III study designed to assess the use of Viaskin Peanut 250 μg in routine medical practice and generate safety data after six months of blinded treatment. The study enrolled 393 patients 4 to 11 years of age.
PEOPLE (PEPITES Open Label Extension Study)
PEOPLE (PEPITES Open Label Extension Study) is a global, Phase III extension trial of Viaskin Peanut that enrolled 300 patients. After patients completed the 12-month placebo-controlled period in PEPITES, they were eligible to enroll in PEOPLE to receive up to 36 months of open-label treatment with Viaskin Peanut 250 μg.
PEPITES (Peanut EPIT Efficacy and Safety Study)
PEPITES (Peanut EPIT Efficacy and Safety Study) was a global, pivotal, double-blinded, placebo-controlled Phase III trial designed to evaluate the safety and efficacy of Viaskin Peanut 250 μg in children ages four to 11 years. PEPITES enrolled 356 patients and was conducted in 31 centers across North America (Canada and the United States), Germany, Ireland and Australia.
OLFUS-VIPES (Open-Label Follow-Up Study-Viaskin Peanut’s Efficacy and Safety)
OLFUS-VIPES (Open-Label Follow-Up Study-Viaskin Peanut’s Efficacy and Safety) was an open-label follow-up Phase IIb clinical trial to VIPES. The study assessed the long-term efficacy and safety of Viaskin Peanut in patients with peanut allergy. The study enrolled 171 patients who had previously received either placebo or one of three 12-month dose regimens administered during VIPES.
VIPES (Viaskin™ Peanut’s Efficacy and Safety)
VIPES (Viaskin™ Peanut’s Efficacy and Safety) was a double-blind, placebo-controlled, multi-center clinical trial conducted at 22 sites in North America and Europe that enrolled 221 patients. Patients were randomized into four treatment arms to evaluate three doses of Viaskin Peanut, 50 micrograms, 100 micrograms and 250 micrograms, compared to placebo.
In July 2010, DBV Technologies initiated the first clinical trial of Viaskin Peanut in the United States, a Phase Ib trial to evaluate the safety and tolerability of repeated epicutaneous administration of Viaskin Peanut in patients allergic to peanuts.
CoFAR6 (Consortium for Food Allergy Research 6)
In October 2013, the Consortium for Food Allergy Research, or CoFAR, launched a multi-center, randomized, double-blind, placebo-controlled trial to evaluate Viaskin Peanut in children and adults. The study enrolled 75 patients from ages four to 25. This trial was sponsored and funded by The National Institute of Allergy and Infectious Diseases, or NIAID, an institute of the United States National Institutes of Health.
ARACHILD was a multi-center double blind placebo-controlled 18-month clinical trial designed to assess the efficacy and safety of Viaskin Peanut in 54 children, ages five – 17. The study was sponsored by Assistance Public-Hôpitaux de Paris (AP-HP).