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)

Peanut allergy

Primary endpoints: Percentage of treatment responders in the DBV712 250 μg group compared to the placebo group after 12 months of treatment in the target population. A subject is defined as a treatment responder if: - The initial ED was ≤ 30 mg peanut protein and the ED is ≥ 300 mg peanut protein at the post-treatment DBPCFC at Month 12; OR, - The initial ED was > 30 mg peanut protein and the ED is ≥ 600 mg peanut protein at the post-treatment DBPCFC at Month 12, Safety: The following safety criteria will be evaluated: - Adverse events and treatment-emergent AEs (TEAEs) - Assessment of pain and ease of removal of DBV712 - AESIs defined as: o Local AESIs: severe local site reactions (grade 4 with loss of skin barrier integrity), o Systemic AESIs: systemic allergic reactions, including those leading to epinephrine use, whatever the causal relationship to DBV712 250 μg o AEs leading to epinephrine use, irrespective of the causal relationship to DBV712 250 μg o AEs leading to inhaled or systemic corticosteroid use, irrespective of the causal relationship to DBV712 250 μg, - Systemic allergic reactions (Graded by CoFAR Grading Scale for Systemic Allergic Reactions V3.0 [APPENDIX 2]) - AE leading to topical corticosteroids use - Serious adverse events (SAEs) - Physical examinations (including grading any inflammation at system sites), SCORAD and vital signs

CRD of peanut protein after 12 months of treatment in the DBV712 250 μg group versus the placebo group. CRD will also be presented in each of the 2 screening ED subgroups;, ED of peanut protein after 12 months of treatment in the DBV712 250 μg group versus the placebo group. ED will also be presented in each of the 2 screening ED subgroups;, Percentage of subjects with an ED ≥ 600 mg and the percentage of subjects with an ED ≥ 1000 mg peanut protein at Month 12 in the DBV712 250 μg group versus the placebo group, overall, and in each of the 2 screening ED subgroups;, Maximum severity of allergic reaction at baseline and Month 12 Food Challenge in the DBV712 250 μg group versus the placebo group.

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