NCT07003919

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

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 480 (estimated)
• Sponsor: DBV Technologies · Industry
• Sex: All
• Age: 1 Year – 3 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This is a Phase 3 randomized double-blind, placebo-controlled (DBPC) study of 6-months duration to assess the safety of DBV712 250 mcg in subjects 1 through 3 years of age with peanut allergy. Participants who complete the 6-month DBPC period will be eligible to enter an optional 18-month open-label extension (OLE). The overall maximum study duration for each participant will be approximately 112 weeks: Screening Period of 6-weeks, DBPC Treatment Period of 26-weeks, Open-label Period of 78-weeks and Follow-up Period of 2-weeks. For participation eligibility, please refer to eligibility criteria section. Randomization of eligible participants will occur in a 3:1 ratio to DBV712 250 mcg (active treatment) or placebo, respectively.

Conditions

• Allergy
• Peanut Allergy

Interventions

Type	Name	Description
COMBINATION_PRODUCT	DBV712 250 mcg	DBV712 250 mcg epicutaneous system.
COMBINATION_PRODUCT	Placebo	DBV712 matching placebo epicutaneous system.

Timeline

• Start date: 2025-06-24
• Primary completion: 2026-11-01
• Completion: 2028-05-01
• First posted: 2025-06-04
• Last updated: 2026-03-24

Locations

90 sites across 8 countries: United States, Australia, Canada, France, Ireland, Netherlands, Spain, United Kingdom

Regulatory

• FDA-regulated drug study