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RECRUITING Phase 3

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

NCT07003919 · View on ClinicalTrials.gov ↗

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 Studied

Interventions

  • COMBINATION_PRODUCT Placebo
  • COMBINATION_PRODUCT DBV712 250 mcg

Study Locations (20)

California

  • Modena Allergy & Asthma — La Jolla
  • Modena Allergy and Asthma — Long Beach
  • UCLA Health Westwood Pediatrics — Los Angeles
  • Children's Hospital of Los Angeles — Los Angeles
  • Allergy & Asthma Associates of Southern California — Mission Viejo
  • Lucile Packard Children's Hospital Stanford — Palo Alto
  • Allergy & Asthma Medical Group and Research Center — San Diego
  • Rady Children's Hospital - San Diego — San Diego
  • Orso Health Torrance — Torrance

Alabama

  • AllerVie Clinical Research — Birmingham
  • University of Alabama at Birmingham Pediatric Primary Care Clinic — Birmingham

Arizona

  • Modena Allergy & Asthma — Scottsdale
  • University of Arizona Asthma and Airway Disease Research Center — Tucson

Colorado

  • Children's Hospital Colorado — Aurora
  • Asthma & Allergy Associates — Colorado Springs

Florida

  • University of South Florida Children's Research Institute — St. Petersburg
  • Allergy, Asthma & Immunology Associates of Tampa Bay — Tampa

Arkansas

  • Arkansas Children's Hospital — Little Rock

District of Columbia

  • Children's National - Main Hospital — Washington D.C.

Georgia

  • Emory University - Children's Healthcare of Atlanta, Inc. — Atlanta

Trial Details

FieldValue
Enrollment Target 480 participants
Start Date 2025-06-24
Est. Completion 2028-05
Phase Phase 3

Sponsor

DBV Technologies

3 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT07003919

The ClinicalTrials.gov registry entry for NCT07003919 describes a study currently listed as recruiting. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 480 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is DBV Technologies, which has 3 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 2 conditions, with Allergy appearing as the primary indexed condition, and to 2 interventions — of which Placebo is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT07003919 reports 20 study locations spanning 8 distinct geographic areas — top geographies include California, Alabama, Arizona. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT07003919 about?

NCT07003919 is a clinical study titled "Safety Study of Viaskin® Peanut Patch in Peanut-Allergic Children 1 Through 3 Years of Age (COMFORT Toddlers)". 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.

What is the current status of trial NCT07003919?

This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 480 participants. The study started on 2025-06-24. Estimated completion is 2028-05.

What conditions does trial NCT07003919 study?

This clinical trial studies the following conditions: Allergy, Peanut Allergy. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT07003919?

The interventions under investigation include: Placebo (COMBINATION_PRODUCT), DBV712 250 mcg (COMBINATION_PRODUCT). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT07003919?

This trial is sponsored by DBV Technologies, which has 3 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT07003919 being conducted?

This trial has 20 study locations across Alabama, Arizona, Arkansas, California, Colorado. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial