This website uses cookies to enhance your browsing experience, improve site performance, and gather analytics. By selecting 'Accept,' you consent to these cookies as described in our Privacy Policy.

Logo

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

V712-308

Status

Recruiting

Type

Interventional

Phase

Phase 3

Placebo

Yes

Accepting

1 to 3 Years
All Sexes

Trial Timing

Started 10 months ago

What is this trial about?

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.

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.