NCT07003919 Safety Study of Viaskin® Peanut Patch in Peanut-Allergic Children 1 Through 3 Years of Age (COMFORT Toddlers)
| NCT ID | NCT07003919 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | DBV Technologies |
| Condition | Allergy |
| Study Type | INTERVENTIONAL |
| Enrollment | 480 participants |
| Start Date | 2025-06-24 |
| Primary Completion | 2026-11 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 480 participants in total. It began in 2025-06-24 with a primary completion date of 2026-11.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
Key Inclusion Criteria: * 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). Key Exclusion Criteria: * 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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07003919 clinical trial?
This trial is open to participants of all sexes, aged 1 Year or older, up to 3 Years, studying Allergy. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07003919 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 480 participants.
Is NCT07003919 currently recruiting?
Yes, NCT07003919 is actively recruiting participants. Contact the research team at clinicaltrials@dbv-technologies.com for enrollment information.
Where is the NCT07003919 trial being conducted?
This trial is being conducted at Birmingham, United States, Birmingham, United States, Scottsdale, United States, Tucson, United States and 11 additional locations.
Who is sponsoring the NCT07003919 clinical trial?
NCT07003919 is sponsored by DBV Technologies. The trial plans to enroll 480 participants.