Clinical Trials

Date: 2017-08-02

Type of information: Recruitment of the first patient

phase: 3

Announcement: recruitment of the first patient

Company: DBV Technologies (France)

Product: Viaskin® Peanut

Action mechanism: immunotherapy product. Viaskin® is an electrostatic patch, based on Epicutaneous Immunotherapy, or EPIT®, which administers an allergen directly onto the superficial layers of the skin to activate the immune system by specifically targeting antigen-presenting cells without allowing passage of the antigen into the bloodstream. Viaskin® Peanut is currently being investigated in clinical trials for treatment of peanut allergy.

Disease: peanut allergy

Therapeutic area: Allergic diseases - Immunological diseases

Country: Australia, Canada, Ireland, USA

Trial details:

• The EPITOPE (EPIT in TOddlers with PEanut Allergy) trial is a two-part trial. Part A is designed to assess the safety of Viaskin Peanut 100 µg and 250 µg to determine the highest safe dose, and Part B is designed to assess the safety and efficacy of the highest safe dose selected in Part A.
• In Part A, patients are randomized 1:2:2 to receive either placebo or Viaskin Peanut 100 ?g or 250 ?g for three months. A safety analysis will be performed after three months to determine the highest safe dose to be studied in Part B. If there are no safety concerns with either of the two doses, patients will continue on their respective treatment and remain on the same active dose or placebo they received in Part A.
• In Part B, patients will be randomized 2:1 to receive the selected dose of Viaskin Peanut or placebo. The primary endpoint is based on a responder analysis after 12 months of treatment with the selected dose of Viaskin Peanut. Efficacy will be assessed using a double-blind, placebo controlled food challenge (DBPCFC). For patients with a baseline peanut protein eliciting dose (ED) equal to or less than 10 mg, a responder is defined as a patient with a peanut protein ED equal to or greater than 300 mg of peanut protein after 12 months of treatment. For patients with a baseline ED greater than 10 mg, a responder is defined as a patient with a peanut protein ED equal to or greater than 1,000 mg of peanut protein after 12 months of treatment. As a secondary efficacy endpoint, Cumulative Reactive Dose (CRD), will also be evaluated in EPITOPE to establish the total quantity of peanut protein that triggers patient reactions at month 12 of active treatment versus placebo. Serological markers will also be measured at baseline, 3, 6, and 12 months in order to characterize the immunological changes in patients. (NCT03211247)

Latest news:

• • On August 2, 2017, DBV Technologies announced that the first patient has been enrolled in EPITOPE (EPIT in TOddlers with PEanut Allergy), 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 the second Viaskin Peanut Phase III program. The study is expected to enroll approximately 331 patients (50 in Part A and 281 in Part B) in approximately 20 – 40 centers across North America (Canada and the United States), Ireland, and Australia.

Is general: Yes