Actively Recruiting

Phase 3
Age: 1Year - 3Years
All Genders
NCT07003919

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

Led by DBV Technologies · Updated on 2026-03-24

480

Participants Needed

90

Research Sites

148 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 1Year - 3Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Aged 1 through 3 years at screening visit
  • Physician-diagnosed peanut allergy with a strict peanut-free diet
  • Peanut-specific IgE level greater than 0.7 kUA/L
  • Positive peanut skin prick test with wheal diameter of 6 mm or larger at screening
  • Eliciting dose of peanut protein 300 mg or less at screening food challenge
Not Eligible

You will not qualify if you...

  • History of severe anaphylaxis to peanut
  • Severe widespread skin disease affecting treatment area
  • Currently receiving immunotherapy for any allergen
  • Previous immunotherapy for peanut allergy including EPIT, OIT, or SLIT
  • Treatment with monoclonal antibody or biologic immunomodulator within 6 months before screening
  • Uncontrolled persistent asthma

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 90 locations

1

AllerVie Clinical Research

Birmingham, Alabama, United States, 35209

Actively Recruiting

2

University of Alabama at Birmingham Pediatric Primary Care Clinic

Birmingham, Alabama, United States, 35233

Actively Recruiting

3

Modena Allergy & Asthma

Scottsdale, Arizona, United States, 85254

Actively Recruiting

4

University of Arizona Asthma and Airway Disease Research Center

Tucson, Arizona, United States, 85750

Actively Recruiting

5

Arkansas Children's Hospital

Little Rock, Arkansas, United States, 72202

Actively Recruiting

6

Modena Allergy & Asthma

La Jolla, California, United States, 92037

Actively Recruiting

7

Modena Allergy and Asthma

Long Beach, California, United States, 90808

Actively Recruiting

8

UCLA Health Westwood Pediatrics

Los Angeles, California, United States, 90024

Actively Recruiting

9

Children's Hospital of Los Angeles

Los Angeles, California, United States, 90027

Actively Recruiting

10

Allergy & Asthma Associates of Southern California

Mission Viejo, California, United States, 93691

Actively Recruiting

11

Lucile Packard Children's Hospital Stanford

Palo Alto, California, United States, 94304

Actively Recruiting

12

Allergy & Asthma Medical Group and Research Center

San Diego, California, United States, 92123

Actively Recruiting

13

Rady Children's Hospital - San Diego

San Diego, California, United States, 92123

Actively Recruiting

14

Orso Health Torrance

Torrance, California, United States, 90505

Actively Recruiting

15

Children's Hospital Colorado

Aurora, Colorado, United States, 80045

Actively Recruiting

16

Asthma & Allergy Associates

Colorado Springs, Colorado, United States, 80907

Actively Recruiting

17

Children's National - Main Hospital

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

Actively Recruiting

18

University of South Florida Children's Research Institute

St. Petersburg, Florida, United States, 33701

Actively Recruiting

19

Allergy, Asthma & Immunology Associates of Tampa Bay

Tampa, Florida, United States, 33613

Actively Recruiting

20

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

Atlanta, Georgia, United States, 30329

Actively Recruiting

21

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

Chicago, Illinois, United States, 60611

Actively Recruiting

22

University of Chicago Medicine Comer Children's Hospital

Chicago, Illinois, United States, 60637

Actively Recruiting

23

Sneeze, Wheeze and Itch Associated, LLC

Normal, Illinois, United States, 61761

Actively Recruiting

24

Deaconess Clinic - Downtown Evansville

Evansville, Indiana, United States, 47713

Actively Recruiting

25

Riley Hospital for Children at Indiana University Health

Indianapolis, Indiana, United States, 46202

Actively Recruiting

26

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

Kansas City, Kansas, United States, 66160

Actively Recruiting

27

Johns Hopkins Hospital

Baltimore, Maryland, United States, 21287

Actively Recruiting

28

Allergy Asthma Specialists of Maryland - White Marsh

White Marsh, Maryland, United States, 21162

Actively Recruiting

29

MassGeneral Hospital for Children

Boston, Massachusetts, United States, 02114

Actively Recruiting

30

Boston Children's Hospital

Boston, Massachusetts, United States, 02115

Actively Recruiting

31

Regents of the University of Michigan

Ann Arbor, Michigan, United States, 48106

Actively Recruiting

32

Allergy and Immunology Associates of Ann Arbor

Ann Arbor, Michigan, United States, 48197

Actively Recruiting

33

Allergy and Asthma Research Center of Minnesota

Maplewood, Minnesota, United States, 55106

Actively Recruiting

34

Mayo Clinic

Rochester, Minnesota, United States, 55905

Actively Recruiting

35

Children's Mercy Hospital

Kansas City, Missouri, United States, 64108

Actively Recruiting

36

St. Louis Children's Hospital

St Louis, Missouri, United States, 63110

Actively Recruiting

37

Weiss Medical

Riverdale, New Jersey, United States, 07457

Actively Recruiting

38

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

Great Neck, New York, United States, 11021

Actively Recruiting

39

NYU Langone Health

New York, New York, United States, 10016

Actively Recruiting

40

Equity Medical

New York, New York, United States, 10023

Actively Recruiting

41

Icahn School of Medicine at Mount Sinai

New York, New York, United States, 10029

Actively Recruiting

42

University of Rochester Medical Center

Rochester, New York, United States, 14642

Actively Recruiting

43

Children's Hospital at Montefiore

The Bronx, New York, United States, 10467

Actively Recruiting

44

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

Chapel Hill, North Carolina, United States, 27517

Actively Recruiting

45

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, United States, 45229

Actively Recruiting

46

Penn State Children's Hospital

Hershey, Pennsylvania, United States, 17036

Actively Recruiting

47

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, United States, 19104

Actively Recruiting

48

UPMC Children's Hospital of Pittsburgh

Pittsburgh, Pennsylvania, United States, 15224

Actively Recruiting

49

Medical University of South Carolina

Charleston, South Carolina, United States, 29425

Actively Recruiting

50

Le Bonheur Children's Hospital

Memphis, Tennessee, United States, 38120

Actively Recruiting

51

Dell Children's Medical Center of Central Texas

Austin, Texas, United States, 78723

Actively Recruiting

52

Children's Medical Center Dallas

Dallas, Texas, United States, 75207

Actively Recruiting

53

Western Sky Medical Research

El Paso, Texas, United States, 79903

Actively Recruiting

54

Texas Children's Hospital

Houston, Texas, United States, 77030

Actively Recruiting

55

Gundersen Health System - La Crosse Campus

La Crosse, Wisconsin, United States, 54601

Actively Recruiting

56

Children's Wisconsin, The Medical College of Wisconsin

Milwaukee, Wisconsin, United States, 53226

Actively Recruiting

57

Westmead Childrens Hospital

Westmead, New South Wales, Australia, 2145

Actively Recruiting

58

Queensland Children's Hospital and Health Service

South Brisbane, Queensland, Australia, 4101

Actively Recruiting

59

Royal Children's Hospital Melbourne

Parkville, Victoria, Australia, 3052

Actively Recruiting

60

Epworth Healthcare Richmond

Richmond, Victoria, Australia, 3121

Actively Recruiting

61

Perth Children's Hospital

Nedlands, Western Australia, Australia, 6009

Actively Recruiting

62

Manitoba Allergy Research, Inc.

Winnipeg, Manitoba, Canada, R3J 0S9

Actively Recruiting

63

Halton Pediatric Allergy

Burlington, Ontario, Canada, L7L 6W6

Actively Recruiting

64

Hamilton Allergy

Hamilton, Ontario, Canada, L8S 1G5

Actively Recruiting

65

McMaster University Medical Center

Hamilton, Ontario, Canada, L8S 4L8

Not Yet Recruiting

66

Ottawa Allergy Research Corporation

Ottawa, Ontario, Canada, K1H 1E4

Actively Recruiting

67

Sick Kids, The Hospital for Sick Children

Toronto, Ontario, Canada, M5G 1X8

Actively Recruiting

68

Centre Hospitalier Universitaire Sainte-Justine

Montreal, Quebec, Canada, H3T 1C5

Actively Recruiting

69

Clinique Specialisee en Allergie de la Capitale

Québec, Quebec, Canada, G1V 4W2

Actively Recruiting

70

Centre Hospitalier Universitaire d'Angers

Angers, France, 49933

Actively Recruiting

71

Hospices Civils of Lyon, Hôpital Femme Mère Enfant

Bron, France, 69500

Actively Recruiting

72

Centre Hospitalier Régional Universitaire de Lille Hôpital Jeanne de Flandre

Lille, France, 59037

Actively Recruiting

73

Centre Hospitalier Universitaire Montpellier

Montpellier, France, 34090

Actively Recruiting

74

Centre Hospitalier Régional Universitaire de Nancy

Vandœuvre-lès-Nancy, France, 54511

Actively Recruiting

75

Cork University Hospital

Cork, Ireland, T12DC4A

Actively Recruiting

76

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

Dublin, Ireland, D01F772

Actively Recruiting

77

Erasmus MC Sophia Children's Hospital

Rotterdam, Netherlands, 3015CN

Actively Recruiting

78

University Medical Center Utrecht (UMCU)

Utrecht, Netherlands, 3584CX

Actively Recruiting

79

Institut de Recerca Sant Joan de Déu.

Barcelona, Spain, 08950

Actively Recruiting

80

Hospital Infantil Universitario Niño Jesús

Madrid, Spain, 28009

Actively Recruiting

81

Hospital Universitario Ramón y Caja

Madrid, Spain, 28034

Actively Recruiting

82

Hospital Regional Universitario de Málaga, Hospital Materno Infantil

Málaga, Spain, 29011

Actively Recruiting

83

Hospital Clínico Universitario de Santiago de Compostela

Santiago de Compostela, Spain, 15706

Actively Recruiting

84

Royal Hospital for Children

Glasgow, United Kingdom, G51 4TF

Actively Recruiting

85

University Hospitals of Leicester NHS Trust

Leicester, United Kingdom, LE1 5WW

Actively Recruiting

86

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

London, United Kingdom, SE1 7EH

Actively Recruiting

87

Allergy Centre of Excellence

London, United Kingdom, W1B 9AG

Actively Recruiting

88

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

Manchester, United Kingdom, M13 PWL

Actively Recruiting

89

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

Sheffield, United Kingdom, S10 2TH

Actively Recruiting

90

University Hospital Southampton NHS Foundation Trust Southampton Children's Hospital

Southampton, United Kingdom, S016 6YD

Actively Recruiting

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Research Team

D

DBV Technologies

CONTACT

D

DBV Technologies

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

TRIPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

3

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