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

Launched by DBV TECHNOLOGIES · May 27, 2025

Keywords

ClinConnect Summary

This clinical trial, called the COMFORT Toddlers study, is looking at the safety of a peanut allergy treatment called the Viaskin® Peanut Patch in young children aged 1 to 3 years old. Specifically, the study will monitor how safe a small dose of the patch is over a period of six months for children diagnosed with peanut allergies. To be eligible for this trial, children must have been diagnosed with a peanut allergy by a doctor, must be following a strict diet that avoids peanuts, and must meet certain test results that indicate their allergy severity.

If your child qualifies and participates in this study, they will be closely monitored by medical professionals for any side effects from the patch during the six-month period. It's important to note that children who have had severe allergic reactions to peanuts or who are currently receiving treatment for their allergies may not be eligible to join the trial. This study is not yet recruiting participants, but it aims to gather valuable information to help improve peanut allergy treatments for young children.

Gender

ALL

Eligibility criteria

• 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.