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
1 other identifier
interventional
480
8 countries
90
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Jun 2025
Typical duration for phase_3
90 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 27, 2025
CompletedFirst Posted
Study publicly available on registry
June 4, 2025
CompletedStudy Start
First participant enrolled
June 24, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
May 1, 2028
March 24, 2026
January 1, 2026
1.4 years
May 27, 2025
March 20, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
DBPC Treatment Period: Adverse Events (AEs), Treatment-Emergent Adverse Events (TEAEs), and Serious Adverse Events (SAEs)
Through DBPC Treatment Period, 6 months
Other Outcomes (3)
Concentration of peanut-specific IgE (kUA/L) at baseline and month 6.
Month 6
Concentration of peanut-specific IgG4 (mg/L) at baseline and month 6.
Month 6
DBPC Treatment Period: Change from baseline in peanut Skin Prick Test (SPT) mean wheal diameters
Month 6
Study Arms (3)
DBPC Treatment Period: DBV712 250 mcg
EXPERIMENTALParticipants will apply DBV712 250 mcg, epicutaneous system (or patch), daily for a period of 6 months.
DBPC Treatment Period: Placebo
PLACEBO COMPARATORParticipants will apply DBV712 matching placebo epicutaneous system (or patch), daily for a period of 6 months.
Optional Open-Label Extension-Period: DBV712 250 mcg
EXPERIMENTALThe 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).
Interventions
DBV712 250 mcg epicutaneous system.
DBV712 matching placebo epicutaneous system.
Eligibility Criteria
You may qualify if:
- 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).
You may not qualify if:
- 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 the study team to confirm eligibility.
Sponsors & Collaborators
- DBV Technologieslead
Study Sites (90)
AllerVie Clinical Research
Birmingham, Alabama, 35209, United States
University of Alabama at Birmingham Pediatric Primary Care Clinic
Birmingham, Alabama, 35233, United States
Modena Allergy & Asthma
Scottsdale, Arizona, 85254, United States
University of Arizona Asthma and Airway Disease Research Center
Tucson, Arizona, 85750, United States
Arkansas Children's Hospital
Little Rock, Arkansas, 72202, United States
Modena Allergy & Asthma
La Jolla, California, 92037, United States
Modena Allergy and Asthma
Long Beach, California, 90808, United States
UCLA Health Westwood Pediatrics
Los Angeles, California, 90024, United States
Children's Hospital of Los Angeles
Los Angeles, California, 90027, United States
Allergy & Asthma Associates of Southern California
Mission Viejo, California, 93691, United States
Lucile Packard Children's Hospital Stanford
Palo Alto, California, 94304, United States
Allergy & Asthma Medical Group and Research Center
San Diego, California, 92123, United States
Rady Children's Hospital - San Diego
San Diego, California, 92123, United States
Orso Health Torrance
Torrance, California, 90505, United States
Children's Hospital Colorado
Aurora, Colorado, 80045, United States
Asthma & Allergy Associates
Colorado Springs, Colorado, 80907, United States
Children's National - Main Hospital
Washington D.C., District of Columbia, 20016, United States
University of South Florida Children's Research Institute
St. Petersburg, Florida, 33701, United States
Allergy, Asthma & Immunology Associates of Tampa Bay
Tampa, Florida, 33613, United States
Emory University - Children's Healthcare of Atlanta, Inc.
Atlanta, Georgia, 30329, United States
Ann & Robert H. Lurie Children's Hospital of Chicago
Chicago, Illinois, 60611, United States
University of Chicago Medicine Comer Children's Hospital
Chicago, Illinois, 60637, United States
Sneeze, Wheeze and Itch Associated, LLC
Normal, Illinois, 61761, United States
Deaconess Clinic - Downtown Evansville
Evansville, Indiana, 47713, United States
Riley Hospital for Children at Indiana University Health
Indianapolis, Indiana, 46202, United States
The University of Kansas Health System - Main Campus, Medical Pavilion
Kansas City, Kansas, 66160, United States
Johns Hopkins Hospital
Baltimore, Maryland, 21287, United States
Allergy Asthma Specialists of Maryland - White Marsh
White Marsh, Maryland, 21162, United States
MassGeneral Hospital for Children
Boston, Massachusetts, 02114, United States
Boston Children's Hospital
Boston, Massachusetts, 02115, United States
Regents of the University of Michigan
Ann Arbor, Michigan, 48106, United States
Allergy and Immunology Associates of Ann Arbor
Ann Arbor, Michigan, 48197, United States
Allergy and Asthma Research Center of Minnesota
Maplewood, Minnesota, 55106, United States
Mayo Clinic
Rochester, Minnesota, 55905, United States
Children's Mercy Hospital
Kansas City, Missouri, 64108, United States
St. Louis Children's Hospital
St Louis, Missouri, 63110, United States
Weiss Medical
Riverdale, New Jersey, 07457, United States
Northwell Health Allergy and Immunology at the Irving Goldman Family Care Center
Great Neck, New York, 11021, United States
NYU Langone Health
New York, New York, 10016, United States
Equity Medical
New York, New York, 10023, United States
Icahn School of Medicine at Mount Sinai
New York, New York, 10029, United States
University of Rochester Medical Center
Rochester, New York, 14642, United States
Children's Hospital at Montefiore
The Bronx, New York, 10467, United States
UNC Hospitals Children's Specialty Clinics in Chapel Hill at Carolina Pointe II
Chapel Hill, North Carolina, 27517, United States
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229, United States
Penn State Children's Hospital
Hershey, Pennsylvania, 17036, United States
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104, United States
UPMC Children's Hospital of Pittsburgh
Pittsburgh, Pennsylvania, 15224, United States
Medical University of South Carolina
Charleston, South Carolina, 29425, United States
Le Bonheur Children's Hospital
Memphis, Tennessee, 38120, United States
Dell Children's Medical Center of Central Texas
Austin, Texas, 78723, United States
Children's Medical Center Dallas
Dallas, Texas, 75207, United States
Western Sky Medical Research
El Paso, Texas, 79903, United States
Texas Children's Hospital
Houston, Texas, 77030, United States
Gundersen Health System - La Crosse Campus
La Crosse, Wisconsin, 54601, United States
Children's Wisconsin, The Medical College of Wisconsin
Milwaukee, Wisconsin, 53226, United States
Westmead Childrens Hospital
Westmead, New South Wales, 2145, Australia
Queensland Children's Hospital and Health Service
South Brisbane, Queensland, 4101, Australia
Royal Children's Hospital Melbourne
Parkville, Victoria, 3052, Australia
Epworth Healthcare Richmond
Richmond, Victoria, 3121, Australia
Perth Children's Hospital
Nedlands, Western Australia, 6009, Australia
Manitoba Allergy Research, Inc.
Winnipeg, Manitoba, R3J 0S9, Canada
Halton Pediatric Allergy
Burlington, Ontario, L7L 6W6, Canada
Hamilton Allergy
Hamilton, Ontario, L8S 1G5, Canada
McMaster University Medical Center
Hamilton, Ontario, L8S 4L8, Canada
Ottawa Allergy Research Corporation
Ottawa, Ontario, K1H 1E4, Canada
Sick Kids, The Hospital for Sick Children
Toronto, Ontario, M5G 1X8, Canada
Centre Hospitalier Universitaire Sainte-Justine
Montreal, Quebec, H3T 1C5, Canada
Clinique Specialisee en Allergie de la Capitale
Québec, Quebec, G1V 4W2, Canada
Centre Hospitalier Universitaire d'Angers
Angers, 49933, France
Hospices Civils of Lyon, Hôpital Femme Mère Enfant
Bron, 69500, France
Centre Hospitalier Régional Universitaire de Lille Hôpital Jeanne de Flandre
Lille, 59037, France
Centre Hospitalier Universitaire Montpellier
Montpellier, 34090, France
Centre Hospitalier Régional Universitaire de Nancy
Vandœuvre-lès-Nancy, 54511, France
Cork University Hospital
Cork, T12DC4A, Ireland
Royal College of Surgeons in Ireland. Children's Health Ireland (CHI) at Crumlin
Dublin, D01F772, Ireland
Erasmus MC Sophia Children's Hospital
Rotterdam, 3015CN, Netherlands
University Medical Center Utrecht (UMCU)
Utrecht, 3584CX, Netherlands
Institut de Recerca Sant Joan de Déu.
Barcelona, 08950, Spain
Hospital Infantil Universitario Niño Jesús
Madrid, 28009, Spain
Hospital Universitario Ramón y Caja
Madrid, 28034, Spain
Hospital Regional Universitario de Málaga, Hospital Materno Infantil
Málaga, 29011, Spain
Hospital Clínico Universitario de Santiago de Compostela
Santiago de Compostela, 15706, Spain
Royal Hospital for Children
Glasgow, G51 4TF, United Kingdom
University Hospitals of Leicester NHS Trust
Leicester, LE1 5WW, United Kingdom
Guy's and Saint Thomas' NHS Foundation Trust St Thomas' Hospital
London, SE1 7EH, United Kingdom
Allergy Centre of Excellence
London, W1B 9AG, United Kingdom
Royal Manchester Children's Hospital, Manchester University NHS Foundation Trust
Manchester, M13 PWL, United Kingdom
Sheffield Children's NHS Foundation Trust Sheffield Children's Hospital
Sheffield, S10 2TH, United Kingdom
University Hospital Southampton NHS Foundation Trust Southampton Children's Hospital
Southampton, S016 6YD, United Kingdom
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 27, 2025
First Posted
June 4, 2025
Study Start
June 24, 2025
Primary Completion (Estimated)
November 1, 2026
Study Completion (Estimated)
May 1, 2028
Last Updated
March 24, 2026
Record last verified: 2026-01