Safety and Efficacy Study of Viaskin Peanut in Peanut-allergic Young Children 1-3 Years of Age

Last updated: December 11, 2024
Sponsor: DBV Technologies
Overall Status: Completed

Phase

3

Condition

Allergy (Peanut)

Treatment

Part A Placebo

Part A Viaskin Peanut 100 mcg

Part B Viaskin Peanut 250 mcg

Clinical Study ID

NCT03211247
EPITOPE
  • Ages 1-3
  • All Genders

Study Summary

The study aims to assess the safety and efficacy of Viaskin Peanut to induce desensitization to peanut in peanut-allergic children 1 to 3 years of age after a 12-month treatment by EPicutaneous ImmunoTherapy (EPIT).

Eligibility Criteria

Inclusion

Key Inclusion Criteria:

  • Male or female from 1-3 years of age;

  • Physician-diagnosed peanut allergy;

  • Peanut-specific IgE level > 0.7 kU/L;

  • Positive peanut SPT with a largest wheal diameter ≥ 6 mm;

  • Positive DBPCFC at ≤ 300 mg peanut protein;

Exclusion

Key Exclusion Criteria:

  • Uncontrolled asthma;

  • History of severe anaphylaxis to peanut;

  • Prior immunotherapy to any food or other immunotherapy;

  • Generalized severe dermatologic disease;

Study Design

Total Participants: 414
Treatment Group(s): 5
Primary Treatment: Part A Placebo
Phase: 3
Study Start date:
July 31, 2017
Estimated Completion Date:
April 27, 2022

Study Description

The study comprised of two parts:

  • In part A, subjects were randomized to receive either Viaskin Peanut 250 mcg, or Viaskin Peanut 100 mcg or the placebo in a 2:1 ratio, for 12 months. After 3 months of treatment, a data safety monitoring board had to determine the active dose to be applyed during the part B

  • In Part B, subjects were randomized to receive either Viaskin Peanut 250 mcg or the placebo in a 2:1 ratio, for 12 months

Connect with a study center

  • Sydney Children's Hospital

    Randwick, NWS 2031
    Australia

    Site Not Available

  • The Children's Hospital at Westmead

    Westmead, New South Wales 2145
    Australia

    Site Not Available

  • Queensland Children's Hospital

    South Brisbane, Queensland 4101
    Australia

    Site Not Available

  • The Women's and children's hospital

    North Adelaide, South Australia 5006
    Australia

    Site Not Available

  • The Royal Children's Hospital

    Parkville, Victoria 3052
    Australia

    Site Not Available

  • Perth Children's Hospital

    Nedlands, Western Australia 6009
    Australia

    Site Not Available

  • British Columbia Children's Hospital

    Vancouver, British Columbia V5H 3V4
    Canada

    Site Not Available

  • Hospital for Sick Children

    Toronto, Ontario M5G 1X8
    Canada

    Site Not Available

  • CHUM & CHU Sainte-Justine

    Montréal, Quebec H3T 1C4
    Canada

    Site Not Available

  • CHRU Lille

    Lille, 59037
    France

    Site Not Available

  • CHRU Metz-Thionville

    Metz, 57085
    France

    Site Not Available

  • Hopitaux Pediatriques de Nice

    Nice, 06200
    France

    Site Not Available

  • Hopital Necker

    Paris, 75015
    France

    Site Not Available

  • CHRU Nancy

    Vandoeuvre les nancy, 54511
    France

    Site Not Available

  • Universitatsklinikum Carl Gustav Carus

    Dresden, 01307
    Germany

    Site Not Available

  • Universitatsklinikum Frankfurt

    Frankfurt, 60590
    Germany

    Site Not Available

  • Universitatklinikum Giessen und Marburg

    Marburg, 35033
    Germany

    Site Not Available

  • Cork University Hospital

    Cork, T12YE02
    Ireland

    Site Not Available

  • Erasmus MC Sophia Children's Hospital

    Rotterdam, 3015
    Netherlands

    Site Not Available

  • Guy's and Saint Thomas' NHS Foundation Trust

    London, SE17EH
    United Kingdom

    Site Not Available

  • St.Mary's Hospital

    London, W21NY
    United Kingdom

    Site Not Available

  • ROyal Manchester Children's Hospital

    Manchester, M139WL
    United Kingdom

    Site Not Available

  • Sheffield Children's Hospital

    Sheffield, S102TH
    United Kingdom

    Site Not Available

  • University Hospital Southampton NHS Foundation Trust

    Southampton, SO166YD
    United Kingdom

    Site Not Available

  • University of Arizona Health Science

    Tucson, Arizona 85719
    United States

    Site Not Available

  • Arkansas Children's Hospital

    Little Rock, Arkansas 72202
    United States

    Site Not Available

  • University of California School of Medicine

    Los Angeles, California 10833
    United States

    Site Not Available

  • University of California, Rady Children's Hospital

    San Diego, California 92123
    United States

    Site Not Available

  • University of California San Francisco

    San Francisco, California 94158
    United States

    Site Not Available

  • Stanford University School of Medicine

    Stanford, California 94305
    United States

    Site Not Available

  • Children's Hospital Colorado

    Aurora, Colorado 80045
    United States

    Site Not Available

  • Children's national Health System

    Washington, District of Columbia 20010
    United States

    Site Not Available

  • Emory University

    Atlanta, Georgia 30329
    United States

    Site Not Available

  • Ann & Robert H. Lurie Children's Hospital of CHicago

    Chicago, Illinois 60611
    United States

    Site Not Available

  • The Universal of Chicago Medical Center

    Chicago, Illinois 60637
    United States

    Site Not Available

  • Riley Hospital for Children at Indiana University

    Indianapolis, Indiana 46202
    United States

    Site Not Available

  • Johns Hopkins Hospital

    Baltimore, Maryland 21205
    United States

    Site Not Available

  • Boston Childrens' Hospital

    Boston, Massachusetts 02115
    United States

    Site Not Available

  • University of Michigan Health System

    Ann Arbor, Michigan 48106
    United States

    Site Not Available

  • Mount Sinai Medical Center

    New York, New York 10029
    United States

    Site Not Available

  • University of Rochester

    Rochester, New York 14642
    United States

    Site Not Available

  • The University of North Carolina - Chapell Hill

    Chapel Hill, North Carolina 27599
    United States

    Site Not Available

  • Cleveland Clinic

    Cleveland, Ohio 44195
    United States

    Site Not Available

  • Children's Hospital of Philadelphia

    Philadelphia, Pennsylvania 19104
    United States

    Site Not Available

  • Children's Hospital of Pittsburgh

    Pittsburgh, Pennsylvania 15213
    United States

    Site Not Available

  • Le Bonheur Children's Hospital

    Memphis, Tennessee 38105
    United States

    Site Not Available

  • Vanderbilt University Medical Center

    Nashville, Tennessee 37232
    United States

    Site Not Available

  • Dell Children's Medical Center

    Austin, Texas 78723
    United States

    Site Not Available

  • Children's Medical Center of Dallas

    Dallas, Texas 75235
    United States

    Site Not Available

  • Baylor College of Medicine - Texas Children's Hospital

    Houston, Texas 77030
    United States

    Site Not Available

  • ASTHMA, Inc.

    Seattle, Washington 98115
    United States

    Site Not Available

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