RecruitingPhase 3NCT07003919
Safety Study of Viaskin® Peanut Patch in Peanut-Allergic Children 1 Through 3 Years of Age (COMFORT Toddlers)
A Phase 3, Double-Blind, Placebo-Controlled, Randomized Study to Assess the Safety of Epicutaneous Immunotherapy With DBV712 250 mcg in 1-through 3-year-old Children With Peanut Allergy
Sponsor
DBV Technologies
Enrollment
480 participants
Start Date
Jun 24, 2025
Study Type
INTERVENTIONAL
Conditions
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.
Eligibility
Min Age: 1 YearMax Age: 3 Years
Inclusion Criteria5
- 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).
Exclusion Criteria6
- 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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Interventions
COMBINATION_PRODUCTDBV712 250 mcg
DBV712 250 mcg epicutaneous system.
COMBINATION_PRODUCTPlacebo
DBV712 matching placebo epicutaneous system.
Locations(90)
View Full Details on ClinicalTrials.gov
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NCT07003919
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