Safety Study of Viaskin® Peanut Patch in Peanut-Allergic Children 1 Through 3 Years of Age (COMFORT Toddlers)
Sponsored by DBV Technologies
About this trial
Last updated a month ago
Study ID
Status
Type
Phase
Placebo
Accepting
Trial Timing
Started 10 months ago
What is this trial about?
What are the Participation Requirements?
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.
