Development Program:
Viaskin™ Peanut

Viaskin Peanut Development Pipeline

Peanut allergy is one of the most common food allergies and can cause severe, potentially fatal, allergic reactions, as well as anaphylaxis.

We have a comprehensive clinical research program in place for Viaskin Peanut. One Phase 3 long-term study in children ages 4 to 11 is ongoing, as well as a Phase 3 trial in patients one to three years of age.

Current Clinical Trials

VITESSE

This study is evaluating an investigational drug patch called DBV712 for 4 to 7 year old children with peanut allergy. The main purpose of this study is to learn how well the study drug patch (DBV712) works and how safe it is compared with a placebo patch in children with peanut allergy. The small amount of peanut protein in the study drug patch is designed to potentially desensitise (or make less sensitive) a peanut-allergic person by repeated exposures to very small amounts of peanut via the skin.

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Completed Clinical Trials

EPITOPE (EPIT™ in Toddlers with Peanut Allergy)

EPITOPE is a global, Phase 3 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.

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REALISE (Real Life Use and Safety of EPIT)

REALISE is a multicenter, randomized, double-blind, placebo-controlled Phase 3 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, followed by up to 36 months of open-label treatment. The study enrolled 393 patients 4 to 11 years of age.

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PEOPLE (PEPITES Open Label Extension Study)

PEOPLE is a global, Phase 3 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 60 months of open-label treatment with Viaskin Peanut 250 µg.

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PEPITES (Peanut EPIT Efficacy and Safety Study)

PEPITES is a global, pivotal, double-blinded, placebo-controlled Phase 3 trial designed to evaluate the safety and efficacy of Viaskin Peanut 250 µg in children. The study enrolled 356 patients 4 to 11 years of age.

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OLFUS-VIPES (Open-Label Follow-Up Study-Viaskin Peanut’s Efficacy and Safety)

OLFUS-VIPES is an open-label follow-up Phase 2b clinical trial to VIPES. The study assessed the long-term efficacy and safety of Viaskin Peanut. The study enrolled 171 patients who had previously received either placebo or one of three dose regimens administered during VIPES.

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VIPES (Viaskin™ Peanut’s Efficacy and Safety)

VIPES is a double-blind, placebo-controlled, multicenter clinical trial designed to study the safety and efficacy of three doses of Viaskin Peanut (50 µg, 100 µg, 250 µg). The study enrolled 221 patients 6 to 55 years of age.

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Phase Ib Clinical Trial

The safety and tolerability of Viaskin Peanut was evaluated in a Phase 1b trial. The study enrolled 100 patients 6 to 50 years of age.

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External Collaborations: Viaskin Peanut Trials

CoFAR6 (Consortium for Food Allergy Research 6)

In October 2013, the Consortium for Food Allergy Research, or CoFAR, launched a multicenter, randomized, double-blind, placebo-controlled trial to evaluate Viaskin Peanut in children and adults. The initial 52-week study enrolled 75 patients from ages 4 to 25, with 59 patients continuing in the long-term study extension for a total active treatment period of 30 months (130 weeks). This trial was sponsored and funded by The National Institute of Allergy and Infectious Diseases (NIAID), an institute of the United States National Institutes of Health (NIH).

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ARACHILD

ARACHILD was a multicenter, double-blind, placebo-controlled 18-month clinical trial designed to assess the efficacy and safety of Viaskin Peanut in 54 children ages 5 to 17. The study was sponsored by Assistance Public-Hôpitaux de Paris (AP-HP).

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* Viaskin Peanut is an investigational product and has not been approved for any use in any country.

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