Safety Study of Viaskin® Peanut Patch in Peanut-Allergic Children 1 Through 3 Years of Age (COMFORT Toddlers)

This is a Phase 3 randomized double-blind, placebo-controlled (DBPC) study of 6-months duration to assess the safety of DBV712 250 mcg in subjects 1 through 3 years of age with peanut allergy. Participants who complete the 6-month DBPC period will be eligible to enter an optional 18-month open-label extension (OLE).

The overall maximum study duration for each participant will be approximately 112 weeks: Screening Period of 6-weeks, DBPC Treatment Period of 26-weeks, Open-label Period of 78-weeks and Follow-up Period of 2-weeks.

For participation eligibility, please refer to eligibility criteria section.

Randomization of eligible participants will occur in a 3:1 ratio to DBV712 250 mcg (active treatment) or placebo, respectively.

Key Inclusion Criteria:

• Aged 1 through 3 years at Visit 1 (screening).
• Physician-diagnosed peanut allergy and following a strict peanut-free diet
• Peanut-specific IgE > 0.7 kUA/L.
• A positive peanut SPT with the largest wheal diameter of ≥ 6 mm at Visit 1 (screening).
• An ED ≤ 300 mg peanut protein at screening double-blind placebo-controlled food challenge (DBPCFC).

Key Exclusion Criteria:

• Peanut allergic subjects presenting a medical history of severe anaphylaxis to peanut.
• Severe generalized dermatologic disease involving the proposed treatment application area (interscapular region).
• Current immunotherapy for any allergen (including food allergy, allergic rhinitis and/or insect allergy).
• History of any immunotherapy for peanut allergy, including Epicutaneous immunotherapy (EPIT), oral immunotherapy (OIT), sublingual immunotherapy (SLIT).
• Treatment with any monoclonal antibody or biologic immunomodulatory therapy within 6 months prior to Visit 1.
• Uncontrolled persistent asthma.