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

NCT07003919 | Active Not Recruiting Phase 3 DMC FDA Drug

• 1 other identifier: V712-308
• Study Type: interventional
• Target: 480
• Locations: 8 countries
• Sites: 91

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.

Conditions

Allergy; Peanut Allergy

Keywords

Peanut hypersensitivity; Epicutaneous Immunotherapy (EPIT); Epicutaneous; Immunotherapy; Viaskin; Nut and Peanut Hypersensitivity; Food Hypersensitivity; Peanut Allergy; Food Allergy; Nut and Peanut Allergy; Safety Study

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

EXPERIMENTAL

Participants will apply DBV712 250 mcg, epicutaneous system (or patch), daily for a period of 6 months.

Combination Product: DBV712 250 mcg

DBPC Treatment Period: Placebo

PLACEBO COMPARATOR

Participants will apply DBV712 matching placebo epicutaneous system (or patch), daily for a period of 6 months.

Combination Product: Placebo

Optional Open-Label Extension-Period: DBV712 250 mcg

EXPERIMENTAL

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).

Combination Product: DBV712 250 mcg

Interventions

Placebo COMBINATION_PRODUCT

DBV712 matching placebo epicutaneous system.

DBPC Treatment Period: Placebo

DBV712 250 mcg COMBINATION_PRODUCT

DBV712 250 mcg epicutaneous system.

Also known as: Viaskin® Peanut Patch

DBPC Treatment Period: DBV712 250 mcg; Optional Open-Label Extension-Period: DBV712 250 mcg

Eligibility Criteria

• Age: 1 Year - 3 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

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.

Sponsors & Collaborators

• DBV Technologies: lead

Study Sites (91)

AllerVie Clinical Research

Birmingham, Alabama, 35209, United States

Location

University of Alabama at Birmingham Pediatric Primary Care Clinic

Birmingham, Alabama, 35233, United States

Location

Modena Allergy & Asthma

Scottsdale, Arizona, 85254, United States

Location

University of Arizona Asthma and Airway Disease Research Center

Tucson, Arizona, 85750, United States

Location

Arkansas Children's Hospital

Little Rock, Arkansas, 72202, United States

Location

Modena Allergy & Asthma

La Jolla, California, 92037, United States

Location

Modena Allergy and Asthma

Long Beach, California, 90808, United States

Location

UCLA Health Westwood Pediatrics

Los Angeles, California, 90024, United States

Location

Children's Hospital of Los Angeles

Los Angeles, California, 90027, United States

Location

Allergy & Asthma Associates of Southern California

Mission Viejo, California, 93691, United States

Location

Lucile Packard Children's Hospital Stanford

Palo Alto, California, 94304, United States

Location

Allergy & Asthma Medical Group and Research Center

San Diego, California, 92123, United States

Location

Rady Children's Hospital - San Diego

San Diego, California, 92123, United States

Location

Orso Health Torrance

Torrance, California, 90505, United States

Location

Children's Hospital Colorado

Aurora, Colorado, 80045, United States

Location

Asthma & Allergy Associates

Colorado Springs, Colorado, 80907, United States

Location

Children's National - Main Hospital

Washington D.C., District of Columbia, 20016, United States

Location

University of South Florida Children's Research Institute

St. Petersburg, Florida, 33701, United States

Location

Allergy, Asthma & Immunology Associates of Tampa Bay

Tampa, Florida, 33613, United States

Location

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

Atlanta, Georgia, 30329, United States

Location

Ann & Robert H. Lurie Children's Hospital of Chicago

Chicago, Illinois, 60611, United States

Location

University of Chicago Medicine Comer Children's Hospital

Chicago, Illinois, 60637, United States

Location

Sneeze, Wheeze and Itch Associated, LLC

Normal, Illinois, 61761, United States

Location

Deaconess Clinic - Downtown Evansville

Evansville, Indiana, 47713, United States

Location

Riley Hospital for Children at Indiana University Health

Indianapolis, Indiana, 46202, United States

Location

The University of Kansas Health System - Main Campus, Medical Pavilion

Kansas City, Kansas, 66160, United States

Location

Johns Hopkins Hospital

Baltimore, Maryland, 21287, United States

Location

Allergy Asthma Specialists of Maryland - White Marsh

White Marsh, Maryland, 21162, United States

Location

MassGeneral Hospital for Children

Boston, Massachusetts, 02114, United States

Location

Boston Children's Hospital

Boston, Massachusetts, 02115, United States

Location

Regents of the University of Michigan

Ann Arbor, Michigan, 48106, United States

Location

Allergy and Immunology Associates of Ann Arbor

Ann Arbor, Michigan, 48197, United States

Location

Allergy and Asthma Research Center of Minnesota

Maplewood, Minnesota, 55106, United States

Location

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Children's Mercy Hospital

Kansas City, Missouri, 64108, United States

Location

St. Louis Children's Hospital

St Louis, Missouri, 63110, United States

Location

Weiss Medical

Riverdale, New Jersey, 07457, United States

Location

Northwell Health Allergy and Immunology at the Irving Goldman Family Care Center

Great Neck, New York, 11021, United States

Location

NYU Langone Health

New York, New York, 10016, United States

Location

Equity Medical

New York, New York, 10023, United States

Location

Icahn School of Medicine at Mount Sinai

New York, New York, 10029, United States

Location

University of Rochester Medical Center

Rochester, New York, 14642, United States

Location

Children's Hospital at Montefiore

The Bronx, New York, 10467, United States

Location

UNC Hospitals Children's Specialty Clinics in Chapel Hill at Carolina Pointe II

Chapel Hill, North Carolina, 27517, United States

Location

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, 45229, United States

Location

Penn State Children's Hospital

Hershey, Pennsylvania, 17036, United States

Location

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19104, United States

Location

UPMC Children's Hospital of Pittsburgh

Pittsburgh, Pennsylvania, 15224, United States

Location

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

Le Bonheur Children's Hospital

Memphis, Tennessee, 38120, United States

Location

Dell Children's Medical Center of Central Texas

Austin, Texas, 78723, United States

Location

Children's Medical Center Dallas

Dallas, Texas, 75207, United States

Location

Western Sky Medical Research

El Paso, Texas, 79903, United States

Location

Texas Children's Hospital

Houston, Texas, 77030, United States

Location

Gundersen Health System - La Crosse Campus

La Crosse, Wisconsin, 54601, United States

Location

Children's Wisconsin, The Medical College of Wisconsin

Milwaukee, Wisconsin, 53226, United States

Location

Westmead Childrens Hospital

Westmead, New South Wales, 2145, Australia

Location

Queensland Children's Hospital and Health Service

South Brisbane, Queensland, 4101, Australia

Location

Royal Children's Hospital Melbourne

Parkville, Victoria, 3052, Australia

Location

Epworth Healthcare Richmond

Richmond, Victoria, 3121, Australia

Location

Perth Children's Hospital

Nedlands, Western Australia, 6009, Australia

Location

Manitoba Allergy Research, Inc.

Winnipeg, Manitoba, R3J 0S9, Canada

Location

Halton Pediatric Allergy

Burlington, Ontario, L7L 6W6, Canada

Location

Hamilton Allergy

Hamilton, Ontario, L8S 1G5, Canada

Location

McMaster University Medical Center

Hamilton, Ontario, L8S 4L8, Canada

Location

Ottawa Allergy Research Corporation

Ottawa, Ontario, K1H 1E4, Canada

Location

Canadian Allergy Research and Education (CARE) Corporation

Ottawa, Ontario, K1H1E4, Canada

Location

Sick Kids, The Hospital for Sick Children

Toronto, Ontario, M5G 1X8, Canada

Location

Centre Hospitalier Universitaire Sainte-Justine

Montreal, Quebec, H3T 1C5, Canada

Location

Clinique Specialisee en Allergie de la Capitale

Québec, Quebec, G1V 4W2, Canada

Location

Centre Hospitalier Universitaire d'Angers

Angers, 49933, France

Location

Hospices Civils of Lyon, Hôpital Femme Mère Enfant

Bron, 69500, France

Location

Centre Hospitalier Régional Universitaire de Lille Hôpital Jeanne de Flandre

Lille, 59037, France

Location

Centre Hospitalier Universitaire Montpellier

Montpellier, 34090, France

Location

Centre Hospitalier Régional Universitaire de Nancy

Vandœuvre-lès-Nancy, 54511, France

Location

Cork University Hospital

Cork, T12DC4A, Ireland

Location

Royal College of Surgeons in Ireland. Children's Health Ireland (CHI) at Crumlin

Dublin, D01F772, Ireland

Location

Erasmus MC Sophia Children's Hospital

Rotterdam, 3015CN, Netherlands

Location

University Medical Center Utrecht (UMCU)

Utrecht, 3584CX, Netherlands

Location

Institut de Recerca Sant Joan de Déu.

Barcelona, 08950, Spain

Location

Hospital Infantil Universitario Niño Jesús

Madrid, 28009, Spain

Location

Hospital Universitario Ramón y Caja

Madrid, 28034, Spain

Location

Hospital Regional Universitario de Málaga, Hospital Materno Infantil

Málaga, 29011, Spain

Location

Hospital Clínico Universitario de Santiago de Compostela

Santiago de Compostela, 15706, Spain

Location

Royal Hospital for Children

Glasgow, G51 4TF, United Kingdom

Location

University Hospitals of Leicester NHS Trust

Leicester, LE1 5WW, United Kingdom

Location

Guy's and Saint Thomas' NHS Foundation Trust St Thomas' Hospital

London, SE1 7EH, United Kingdom

Location

Allergy Centre of Excellence

London, W1B 9AG, United Kingdom

Location

Royal Manchester Children's Hospital, Manchester University NHS Foundation Trust

Manchester, M13 PWL, United Kingdom

Location

Sheffield Children's NHS Foundation Trust Sheffield Children's Hospital

Sheffield, S10 2TH, United Kingdom

Location

University Hospital Southampton NHS Foundation Trust Southampton Children's Hospital

Southampton, S016 6YD, United Kingdom

Location

MeSH Terms

Conditions

Hypersensitivity; Peanut Hypersensitivity; Nut and Peanut Hypersensitivity; Food Hypersensitivity

Condition Hierarchy (Ancestors)

Immune System Diseases; Hypersensitivity, Immediate

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: July 22, 2026

Record last verified: 2026-07

Locations

AU (5); NL (2); ES (5); US (56); GB (7); FR (5); IE (2); CA (9)