Safety and Efficacy Study of Viaskin Peanut in Peanut-allergic Children 4-7 Years of Age

Key Inclusion Criteria:

• Aged 4 through 7 years at Visit 1 (screening).

• Physician-diagnosed peanut allergy or children with a well-documented medicalhistory of IgE-mediated reactions after ingestion of peanut and currently followinga strict peanut-free diet.

• Peanut-specific IgE of >0.7 kilo allergy unit per liter (kUA/L) and a positivepeanut SPT with the largest wheal diameter of ≥6 millimeter (mm) at Visit 1.

• An ED of ≤100 mg peanut protein at screening DBPCFC.

Participants may enter the Open-label Extension Period if they meet all of the following inclusion criteria:

• Signed ICF by the participant's parent(s)/caregiver(s). This consent should besigned after completion of the procedures in the randomized, DBPC Treatment Period,and before any procedure in Open-label Extension Period begins.

• Participants who perform the peanut DBPCFC at the end of Month 12 and have ≥80%compliance with investigational medicinal product (IMP).

• Parent(s)/caregiver(s) and participants willing to comply with all studyrequirements during the participant's participation in the study.

Key Exclusion Criteria:

• Severe generalized dermatologic disease involving the application area (interscapular region)

• Uncontrolled persistent asthma.

• Past or current immunotherapy for peanut allergy, including oral immunotherapy (OIT).

• Current immunotherapy for any allergen (including food allergy, allergic rhinitisand/or insect allergy), or treatment with any monoclonal antibody or biologicimmunomodulatory therapy within 6 months prior to Visit 1.

Participants may not enter the Open-label Extension Period if they meet any of the following exclusion criteria:

• Participants who develop a severe anaphylactic reaction during the DBPCFC at the endof Month 12 with the event requiring tracheal intubation or leading to a cardiacarrest and/or to coma. Participants with other reported cases of severe anaphylaxiswill be considered eligible to participate in the Open-label Extension Period, atthe judgement of the Investigator.

• Any clinically significant disease which in the judgment of the Investigator maypreclude safe participation or strict compliance with the protocol procedures.