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

About

Brief Summary

The primary objective of this study is to assess the 6-month safety of DBV712 250 micrograms (mcg) in subjects 1 through 3 years of age with peanut allergy.

Primary Purpose

Treatment

Study Type

Interventional

Phase

Phase 3

Eligibility

Gender

All

Healthy Volunteers

No

Minimum Age

1 Year

Maximum Age

3 Years

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.

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