Safety Study of Viaskin® Peanut Patch in Peanut-Allergic Children 1 Through 3 Years of Age (COMFORT Toddlers)
NCT ID: NCT07003919
Last Updated: 2025-11-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
480 participants
INTERVENTIONAL
2025-06-24
2028-05-31
Brief Summary
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Detailed Description
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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
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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DBPC Treatment Period: DBV712 250 mcg
Participants will apply DBV712 250 mcg, epicutaneous system (or patch), daily for a period of 6 months.
DBV712 250 mcg
DBV712 250 mcg epicutaneous system.
DBPC Treatment Period: Placebo
Participants will apply DBV712 matching placebo epicutaneous system (or patch), daily for a period of 6 months.
Placebo
DBV712 matching placebo epicutaneous system.
Optional Open-Label Extension-Period: DBV712 250 mcg
The 6-month DBPC period will be followed by an optional open-label extension (OLE) period during which eligible participants will receive DBV712 250 mcg for a duration of 18 months (representing 24 months of active treatment for those participants initially randomized to DBV712 250 mcg and 18 months of active treatment for those participants that were initially randomized to placebo).
DBV712 250 mcg
DBV712 250 mcg epicutaneous system.
Interventions
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DBV712 250 mcg
DBV712 250 mcg epicutaneous system.
Placebo
DBV712 matching placebo epicutaneous system.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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).
Exclusion Criteria
* 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.
1 Year
3 Years
ALL
No
Sponsors
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DBV Technologies
INDUSTRY
Responsible Party
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Locations
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AllerVie Clinical Research
Birmingham, Alabama, United States
University of Alabama at Birmingham Pediatric Primary Care Clinic
Birmingham, Alabama, United States
Modena Allergy & Asthma
Scottsdale, Arizona, United States
University of Arizona Asthma and Airway Disease Research Center
Tucson, Arizona, United States
Arkansas Children's Hospital
Little Rock, Arkansas, United States
Modena Allergy & Asthma
La Jolla, California, United States
UCLA Health Westwood Pediatrics
Los Angeles, California, United States
Children's Hospital of Los Angeles
Los Angeles, California, United States
Allergy & Asthma Associates of Southern California
Mission Viejo, California, United States
Lucile Packard Children's Hospital Stanford
Palo Alto, California, United States
Allergy & Asthma Medical Group and Research Center
San Diego, California, United States
Rady Children's Hospital - San Diego
San Diego, California, United States
Children's Hospital Colorado
Aurora, Colorado, United States
Asthma & Allergy Associates
Colorado Springs, Colorado, United States
Children's National - Main Hospital
Washington D.C., District of Columbia, United States
University of South Florida Children's Research Institute
St. Petersburg, Florida, United States
Allergy, Asthma & Immunology Associates of Tampa Bay
Tampa, Florida, United States
Emory University - Children's Healthcare of Atlanta, Inc.
Atlanta, Georgia, United States
Ann & Robert H. Lurie Children's Hospital of Chicago
Chicago, Illinois, United States
University of Chicago Medicine Comer Children's Hospital
Chicago, Illinois, United States
Sneeze, Wheeze and Itch Associated, LLC
Normal, Illinois, United States
Deaconess Clinic - Downtown Evansville
Evansville, Indiana, United States
Riley Hospital for Children at Indiana University Health
Indianapolis, Indiana, United States
The University of Kansas Health System - Main Campus, Medical Pavilion
Kansas City, Kansas, United States
Johns Hopkins Hospital
Baltimore, Maryland, United States
MassGeneral Hospital for Children
Boston, Massachusetts, United States
Boston Children's Hospital
Boston, Massachusetts, United States
Regents of the University of Michigan
Ann Arbor, Michigan, United States
Allergy and Immunology Associates of Ann Arbor
Ann Arbor, Michigan, United States
Allergy and Asthma Research Center of Minnesota
Maplewood, Minnesota, United States
Mayo Clinic
Rochester, Minnesota, United States
Children's Mercy Hospital
Kansas City, Missouri, United States
St. Louis Children's Hospital
St Louis, Missouri, United States
Weiss Medical
Riverdale, New Jersey, United States
Northwell Health Allergy and Immunology at the Irving Goldman Family Care Center
Great Neck, New York, United States
NYU Grossman School of Medicine
New York, New York, United States
Equity Medical
New York, New York, United States
Icahn School of Medicine at Mount Sinai
New York, New York, United States
University of Rochester Medical Center
Rochester, New York, United States
Children's Hospital at Montefiore
The Bronx, New York, United States
UNC Hospitals Children's Specialty Clinics in Chapel Hill at Carolina Pointe II
Chapel Hill, North Carolina, United States
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States
Penn State Children's Hospital
Hershey, Pennsylvania, United States
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States
UPMC Children's Hospital of Pittsburgh
Pittsburgh, Pennsylvania, United States
Medical University of South Carolina
Charleston, South Carolina, United States
Le Bonheur Children's Hospital
Memphis, Tennessee, United States
Dell Children's Medical Center of Central Texas
Austin, Texas, United States
Children's Medical Center Dallas
Dallas, Texas, United States
Texas Children's Hospital
Houston, Texas, United States
Gundersen Health System - La Crosse Campus
La Crosse, Wisconsin, United States
Children's Wisconsin, The Medical College of Wisconsin
Milwaukee, Wisconsin, United States
Westmead Childrens Hospital
Westmead, New South Wales, Australia
Queensland Children's Hospital and Health Service
South Brisbane, Queensland, Australia
Royal Children's Hospital Melbourne
Parkville, Victoria, Australia
Epworth Healthcare Richmond
Richmond, Victoria, Australia
Perth Children's Hospital
Nedlands, Western Australia, Australia
Manitoba Allergy Research, Inc.
Winnipeg, Manitoba, Canada
Halton Pediatric Allergy
Burlington, Ontario, Canada
Hamilton Allergy
Hamilton, Ontario, Canada
McMaster University Medical Center
Hamilton, Ontario, Canada
Ottawa Allergy Research Corporation
Ottawa, Ontario, Canada
Sick Kids, The Hospital for Sick Children
Toronto, Ontario, Canada
Centre Hospitalier Universitaire Sainte-Justine
Montreal, Quebec, Canada
Clinique Specialisee en Allergie de la Capitale
Québec, Quebec, Canada
Royal Hospital for Children
Glasgow, , United Kingdom
University Hospitals of Leicester NHS Trust
Leicester, , United Kingdom
Guy's and Saint Thomas' NHS Foundation Trust St Thomas' Hospital
London, , United Kingdom
Allergy Centre of Excellence
London, , United Kingdom
Royal Manchester Children's Hospital, Manchester University NHS Foundation Trust
Manchester, , United Kingdom
Sheffield Children's NHS Foundation Trust Sheffield Children's Hospital
Sheffield, , United Kingdom
University Hospital Southampton NHS Foundation Trust Southampton Children's Hospital
Southampton, , United Kingdom
Countries
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Central Contacts
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DBV Technologies
Role: CONTACT
Phone: 908-679-5200
Other Identifiers
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V712-308
Identifier Type: -
Identifier Source: org_study_id