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

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 foodchallenge (DBPCFC).

Key Exclusion Criteria:

• Peanut allergic subjects presenting a medical history of severe anaphylaxis topeanut.

• Severe generalized dermatologic disease involving the proposed treatment applicationarea (interscapular region).

• Current immunotherapy for any allergen (including food allergy, allergic rhinitisand/or insect allergy).

• History of any immunotherapy for peanut allergy, including Epicutaneousimmunotherapy (EPIT), oral immunotherapy (OIT), sublingual immunotherapy (SLIT).

• Treatment with any monoclonal antibody or biologic immunomodulatory therapy within 6months prior to Visit 1.

• Uncontrolled persistent asthma.