COMFORT Toddlers
Research type
Research Study
Full title
A Phase 3, Double-Blind, Placebo-Controlled, Randomized Study to Assess the Safety of Epicutaneous Immunotherapy with DBV712 250 µg in 1-through 3-year-old Children with Peanut Allergy (COMFORT Toddlers)
IRAS ID
1012196
Contact name
Roxane Castan Castan
Contact email
Sponsor organisation
DBV Technologies S.A
Clinicaltrials.gov Identifier
Research summary
The study will measure the safety of young children who are treated for their peanut allergy by wearing the DBV712 peanut patch. The DBV712 peanut patch has already been shown to be effective and safe in other research studies, including studies in peanut-allergic toddlers aged 1-3 years (one study) and children aged 4-11.
The DBV712 patch contains 250 µg of peanut protein. It is applied to the back and worn by the child for a whole day, before being swapped for a new one. Previous studies show that wearing this patch enables children to eat more peanut without showing any sign of a reaction, which protects them from the unsafe consequences of accidentally eating peanut. In this study, all participants undergo a peanut challenge in hospital, when we offer children increasing steps of peanut to eat, so we can measure at what dose they show a reaction to peanut. Participants who show a reaction to peanut will then be randomly assigned (like flipping a coin) to receive either the DBV712 250 µg patch or the placebo patch which contains no peanut. Participants will not know which treatment they are assigned to.
An initial 6-month treatment period which is followed by an additional optional 18-month extension treatment period. The optional extension period is open label which means all participants will receive the DBV712 250 µg patch. Participation in the initial 6-month period of the study will last approximately 34 weeks. The study is planned to involve 480 children with peanut allergy aged 1 through 3 years at approximately 90 sites worldwide.REC name
West Midlands - Coventry & Warwickshire Research Ethics Committee
REC reference
25/WM/0146
Date of REC Opinion
14 Aug 2025
REC opinion
Further Information Favourable Opinion