Allergy, Peanut Clinical Trial
Official title:
A Phase 3, Double-blind, Placebo-controlled, Randomized Study to Assess the Efficacy and Safety of Epicutaneous Immunotherapy With DBV712 250 μg in 4-7-year-old Children With Peanut Allergy (VITESSE)
The primary purpose of this study is to assess the efficacy and safety of daily DBV712 250 micrograms (mcg) to induce desensitization to peanut in peanut-allergic children 4-7 years of age over a 12-month double-blind, placebo-controlled (DBPC) Treatment Period.
This study is consisting of a 4-week Screening Period, 12-month DBPC Treatment Period and an open-label extension of either 24 or 36-months duration so that each participant may have the opportunity to receive DBV712 for a total duration of 36 months. Following 36 months of treatment with DBV712 250 mcg, sustained unresponsiveness (SU) will be evaluated by subsequent open food challenge(s) [FC(s)] at 2-, 4-, and 6-months off treatment. Maximum participant participation will be either approximately 44 or 56 months, depending on the participant's randomized treatment assignment. During the 4-week Screening Period, participants are required to meet 2 sequential screening parameters to determine eligibility prior to randomization: - Assessment of peanut skin prick test (SPT) and serum peanut immunoglobulin-E (IgE) - Peanut double-blind placebo-controlled food challenge (DBPCFC) to confirm peanut allergy and establish an entry peanut eliciting dose (ED). Participants with a peanut protein ED less than or equal to (≤) 100 milligram (mg) will be eligible for randomization. The starting dose of the eligibility peanut DBPCFC will be 1 mg peanut protein and will escalate up to a highest single dose of 100 mg peanut protein (cumulative 144 mg) via the following schedule: 1, 3, 10, 30, 100 mg. Participants who react, with an eliciting dose (ED) (with dose-limiting symptoms) at or below the dose of 100 mg peanut protein will be considered eligible. Randomization of eligible participants will occur in a 2:1 ratio to DBV712 250 mcg (active treatment) or placebo, respectively. ;