NCT07003919
Safety Study of Viaskin® Peanut Patch in Peanut-Allergic Children 1 Through 3 Years of Age (COMFORT Toddlers)
Active, Not Recruiting
PHASE3Ages 1–3InterventionalTreatmentDBV Technologies
~480 participants
Updated 2026-07-22 on ClinicalTrials.gov
What's tested:DBV712 250 mcgPlacebo
At a glance
Recruiting sites
0 of 91 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
DBPC Treatment Period: Adverse Events (AEs), Treatment-Emergent Adverse Events (TEAEs), and Serious Adverse Events (SAEs)
Measured over Through DBPC Treatment Period, 6 months
Conditions
Where it's being run
91 sites across 37 statesCalifornia9
United Kingdom7
New York6
Ontario6
France5
Spain5
Texas4
Illinois3
Who to contact
This trial hasn't published a contact. View it on ClinicalTrials.gov
Do you actually qualify for this trial?
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Eligibility criteria
Inclusion
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
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.
What this trial measures
- DBPC Treatment Period: Adverse Events (AEs), Treatment-Emergent Adverse Events (TEAEs), and Serious Adverse Events (SAEs)Through DBPC Treatment Period, 6 months