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

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
DBV Technologies
Study ID
NCT07003919
Phase
PHASE3
Status
Recruiting
Apply to this trial

Conditions

  • Allergy
  • Peanut Allergy

Eligibility Criteria

Sex
ALL
Age
1 Year - 3 Years
Healthy Volunteers
Not accepted

Interventions

  • DBV712 250 mcg — COMBINATION_PRODUCT
    DBV712 250 mcg epicutaneous system.
  • Placebo — COMBINATION_PRODUCT
    DBV712 matching placebo epicutaneous system.

Study Details

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.

Key Dates

Start date
Jun 24, 2025
Status verified
Jan 2026
Primary completion
Nov 30, 2026
Completion
May 31, 2028

Study Design

Enrollment
480 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: DBPC Treatment Period: DBV712 250 mcg
    Participants will apply DBV712 250 mcg, epicutaneous system (or patch), daily for a period of 6 months.
  • Placebo Comparator: DBPC Treatment Period: Placebo
    Participants will apply DBV712 matching placebo epicutaneous system (or patch), daily for a period of 6 months.
  • Experimental: 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).

Primary Outcome Measure

DBPC Treatment Period: Adverse Events (AEs), Treatment-Emergent Adverse Events (TEAEs), and Serious Adverse Events (SAEs) [ Time Frame: Through DBPC Treatment Period, 6 months ]

Central Contacts

Locations (56)

FacilityCityStateZIPSite coordinators
AllerVie Clinical ResearchBirminghamAlabama35209-
University of Alabama at Birmingham Pediatric Primary Care ClinicBirminghamAlabama35233-
Modena Allergy & AsthmaScottsdaleArizona85254-
University of Arizona Asthma and Airway Disease Research CenterTucsonArizona85750-
Arkansas Children's HospitalLittle RockArkansas72202-
Modena Allergy & AsthmaLa JollaCalifornia92037-
Modena Allergy and AsthmaLong BeachCalifornia90808-
Children's Hospital of Los AngelesLos AngelesCalifornia90027-
UCLA Health Westwood PediatricsLos AngelesCalifornia90024-
Allergy & Asthma Associates of Southern CaliforniaMission ViejoCalifornia93691-
Lucile Packard Children's Hospital StanfordPalo AltoCalifornia94304-
Allergy & Asthma Medical Group and Research CenterSan DiegoCalifornia92123-
Rady Children's Hospital - San DiegoSan DiegoCalifornia92123-
Orso Health TorranceTorranceCalifornia90505-
Children's Hospital ColoradoAuroraColorado80045-
Asthma & Allergy AssociatesColorado SpringsColorado80907-
Children's National - Main HospitalWashington D.C.District of Columbia20016-
University of South Florida Children's Research InstituteSt. PetersburgFlorida33701-
Allergy, Asthma & Immunology Associates of Tampa BayTampaFlorida33613-
Emory University - Children's Healthcare of Atlanta, Inc.AtlantaGeorgia30329-
Ann & Robert H. Lurie Children's Hospital of ChicagoChicagoIllinois60611-
University of Chicago Medicine Comer Children's HospitalChicagoIllinois60637-
Sneeze, Wheeze and Itch Associated, LLCNormalIllinois61761-
Deaconess Clinic - Downtown EvansvilleEvansvilleIndiana47713-
Riley Hospital for Children at Indiana University HealthIndianapolisIndiana46202-
The University of Kansas Health System - Main Campus, Medical PavilionKansas CityKansas66160-
Johns Hopkins HospitalBaltimoreMaryland21287-
Allergy Asthma Specialists of Maryland - White MarshWhite MarshMaryland21162-
Boston Children's HospitalBostonMassachusetts02115-
MassGeneral Hospital for ChildrenBostonMassachusetts02114-
Allergy and Immunology Associates of Ann ArborAnn ArborMichigan48197-
Regents of the University of MichiganAnn ArborMichigan48106-
Allergy and Asthma Research Center of MinnesotaMaplewoodMinnesota55106-
Mayo ClinicRochesterMinnesota55905-
Children's Mercy HospitalKansas CityMissouri64108-
St. Louis Children's HospitalSt LouisMissouri63110-
Weiss MedicalRiverdaleNew Jersey07457-
Northwell Health Allergy and Immunology at the Irving Goldman Family Care CenterGreat NeckNew York11021-
Equity MedicalNew YorkNew York10023-
Icahn School of Medicine at Mount SinaiNew YorkNew York10029-
NYU Langone HealthNew YorkNew York10016-
University of Rochester Medical CenterRochesterNew York14642-
Children's Hospital at MontefioreThe BronxNew York10467-
UNC Hospitals Children's Specialty Clinics in Chapel Hill at Carolina Pointe IIChapel HillNorth Carolina27517-
Cincinnati Children's Hospital Medical CenterCincinnatiOhio45229-
Penn State Children's HospitalHersheyPennsylvania17036-
Children's Hospital of PhiladelphiaPhiladelphiaPennsylvania19104-
UPMC Children's Hospital of PittsburghPittsburghPennsylvania15224-
Medical University of South CarolinaCharlestonSouth Carolina29425-
Le Bonheur Children's HospitalMemphisTennessee38120-
Dell Children's Medical Center of Central TexasAustinTexas78723-
Children's Medical Center DallasDallasTexas75207-
Western Sky Medical ResearchEl PasoTexas79903-
Texas Children's HospitalHoustonTexas77030-
Gundersen Health System - La Crosse CampusLa CrosseWisconsin54601-
Children's Wisconsin, The Medical College of WisconsinMilwaukeeWisconsin53226-

Find similar trials in Birmingham, AL

By research site
AllerVie Clinical Research· Birmingham, ALUniversity of Alabama at Birmingham Pediatric Primary Care Clinic· Birmingham, ALModena Allergy & Asthma· Scottsdale, AZUniversity of Arizona Asthma and Airway Disease Research Center· Tucson, AZArkansas Children's Hospital· Little Rock, ARModena Allergy & Asthma· La Jolla, CA

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