Safety Study of Viaskin® Peanut Patch in Peanut-Allergic Children 1 Through 3 Years of Age (COMFORT Toddlers)
← catalyst calendarNCT07003919 · readout ≤ 103 d
Sponsored by DBV Technologies (industry) · DBV.PA — their whole pipeline →.
Phase
Phase 3
Status
Active, not recruiting
Study type
Interventional
Design
Randomized · Triple · Treatment
Enrollment
480estimated
Sites
91
Countries
Australia, Canada, France +5
Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →
Source: ClinicalTrials.gov, retrieved 2026-08-19
Dates
each axis at the precision it was filed, with the registry's own basis| Date | Filed | Basis | What it is |
|---|---|---|---|
| Start | 2025-06-24 | actual | When the study began enrolling |
| Primary completion | Nov 2026 | estimated | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | May 2028 | estimated | The whole study's end, after follow-up |
| First posted | 2025-06-04 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2026-07-22 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Conditions
- Allergy
- Peanut Allergy
Interventions
- Combination product: DBV712 250 mcg — also filed as Viaskin® Peanut Patch
- Combination product: Placebo
Primary outcome
what the primary-completion date above is the date OFDBPC Treatment Period: Adverse Events (AEs), Treatment-Emergent Adverse Events (TEAEs), and Serious Adverse Events (SAEs)
measured Through DBPC Treatment Period, 6 months
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