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Safety Study of Viaskin® Peanut Patch in Peanut-Allergic Children 1 Through 3 Years of Age (COMFORT Toddlers)

NCT07003919 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 480

Last updated 2026-03-24

No results posted yet for this study

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.

Conditions

Interventions

COMBINATION_PRODUCT

DBV712 250 mcg

DBV712 250 mcg epicutaneous system.

COMBINATION_PRODUCT

Placebo

DBV712 matching placebo epicutaneous system.

Sponsors & Collaborators

  • DBV Technologies

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
1 Year
Max Age
3 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-06-24
Primary Completion
2026-11-30
Completion
2028-05-31
FDA Drug
Yes

Countries

  • United States
  • Australia
  • Canada
  • France
  • Ireland
  • Netherlands
  • Spain
  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07003919 on ClinicalTrials.gov