Safety Study of Viaskin® Peanut Patch in Peanut-Allergic Children 1 Through 3 Years of Age (COMFORT Toddlers)
Study Phase: Phase 3
Recruitment Status: Recruiting
Start Date: June 24, 2025
End Date: May 01, 2028
DBV Technologies
908-679-5200
908-679-5200
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.