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)

This is a 12-month, Phase 3, double-blind, placebo-controlled, randomized study to assess the efficacy and safety of daily DBV712 250 μg in peanut-allergic children aged 4-7 years. The overall maximum study duration for each subject is approximately 58 weeks: 4-week Screening Period, 12-month Treatment Period and 2-week Follow-up Period. Randomization of eligible subjects will occur in a 2:1 ratio with DBV712 250 μg (active treatment) or placebo, respectively. Participants will undergo other assessments at Months 3, 6 and 12. After completion of the study, all participants, including the placebo subjects, will be offered the opportunity to participate in an open- label extension study/Expanded Access Program to receive DBV712 250 μg.