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ACTIVE NOT RECRUITING

NCT05741476

PHASE3

Safety and Efficacy Study of Viaskin Peanut in Peanut-allergic Children 4-7 Years of Age

Sponsor: DBV Technologies

View on ClinicalTrials.gov

Summary

The primary purpose of this study is to assess the efficacy and safety of daily DBV712 250 micrograms (mcg) to induce desensitization to peanut in peanut-allergic children 4-7 years of age over a 12-month double-blind, placebo-controlled (DBPC) Treatment Period.

Official title: A Phase 3, Double-blind, Placebo-controlled, Randomized Study to Assess the Efficacy and Safety of Epicutaneous Immunotherapy With DBV712 250 μg in 4-7-year-old Children With Peanut Allergy (VITESSE)

Key Details

Gender

All

Age Range

4 Years - 7 Years

Study Type

INTERVENTIONAL

Enrollment

600

Start Date

2023-02-21

Completion Date

2029-10

Last Updated

2026-01-22

Healthy Volunteers

Conditions

Allergy, Peanut

Interventions

DRUG

DBV712

DBV712 250 mcg epicutaneous system.

OTHER

Placebo

DBV712 matching placebo epicutaneous system.

DRUG

DBV712

DBV712 250 mcg epicutaneous system.

Key Inclusion Criteria: * Aged 4 through 7 years at Visit 1 (screening). * Physician-diagnosed peanut allergy or children with a well-documented medical history of IgE-mediated reactions after ingestion of peanut and currently following a strict peanut-free diet. * Peanut-specific IgE of \>0.7 kilo allergy unit per liter (kUA/L) and a positive peanut SPT with the largest wheal diameter of ≥6 millimeter (mm) at Visit 1. * An ED of ≤100 mg peanut protein at screening DBPCFC. Participants may enter the Open-label Extension Period if they meet all of the following inclusion criteria: * Signed ICF by the participant's parent(s)/caregiver(s). This consent should be signed after completion of the procedures in the randomized, DBPC Treatment Period, and before any procedure in Open-label Extension Period begins. * Participants who perform the peanut DBPCFC at the end of Month 12 and have ≥80% compliance with investigational medicinal product (IMP). * Parent(s)/caregiver(s) and participants willing to comply with all study requirements during the participant's participation in the study. Key Exclusion Criteria: * Severe generalized dermatologic disease involving the application area (interscapular region) * Uncontrolled persistent asthma. * Past or current immunotherapy for peanut allergy, including oral immunotherapy (OIT). * Current immunotherapy for any allergen (including food allergy, allergic rhinitis and/or insect allergy), or treatment with any monoclonal antibody or biologic immunomodulatory therapy within 6 months prior to Visit 1. Participants may not enter the Open-label Extension Period if they meet any of the following exclusion criteria: * Participants who develop a severe anaphylactic reaction during the DBPCFC at the end of Month 12 with the event requiring tracheal intubation or leading to a cardiac arrest and/or to coma. Participants with other reported cases of severe anaphylaxis will be considered eligible to participate in the Open-label Extension Period, at the judgement of the Investigator. * Any clinically significant disease which in the judgment of the Investigator may preclude safe participation or strict compliance with the protocol procedures.

Locations (87)

DBV Investigative Site

Birmingham, Alabama, United States

DBV Investigative Site

Tucson, Arizona, United States

DBV Investigative Site

Little Rock, Arkansas, United States

DBV Investigative Site

Los Angeles, California, United States

DBV Investigative Site

Los Angeles, California, United States

DBV Investigative site

Mission Viejo, California, United States

DBV Investigative Site

San Diego, California, United States

DBV Investigative Site

San Francisco, California, United States

DBV Investigative Site

San Jose, California, United States

DBV Investigative Site

Aurora, Colorado, United States

DBV Investigative Site

Colorado Springs, Colorado, United States

DBV Investigative Site

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

DBV Investigative Site

Hollywood, Florida, United States

DBV Investigative Site

Miami, Florida, United States

DBV Investigative Site

St. Petersburg, Florida, United States

DBV Investigative Site

Tampa, Florida, United States

DBV Investigative site

Atlanta, Georgia, United States

DBV Investigative Site

Marietta, Georgia, United States

DBV Investigative Site

Chicago, Illinois, United States

DBV Investigative Site

Normal, Illinois, United States

DBV Investigative Site

Indianapolis, Indiana, United States

DBV Investigative Site

Louisville, Kentucky, United States

DBV Investigative Site

Baltimore, Maryland, United States

DBV Investigative Site

Chevy Chase, Maryland, United States

DBV Investigative Site

Boston, Massachusetts, United States

DBV Investigative Site

Boston, Massachusetts, United States

DBV Investigative Site

Taunton, Massachusetts, United States

DBV Investigative Site

Ann Arbor, Michigan, United States

DBV Investigative Site

Ypsilanti, Michigan, United States

DBV Investigative Site

Maplewood, Minnesota, United States

DBV Investigative Site

Kansas City, Missouri, United States

DBV Investigative Site

Great Neck, New York, United States

DBV Investigative Site

New York, New York, United States

DBV Investigative Site

New York, New York, United States

DBV Investigative Site

Rochester, New York, United States

DBV Investigative Site

Chapel Hill, North Carolina, United States

DBV Investigative Site

Cincinnati, Ohio, United States

DBV Investigative Site

Cleveland, Ohio, United States

DBV Investigative Site

Cleveland, Ohio, United States

DBV Investigative Site

Columbus, Ohio, United States

DBV Investigative Site

Philadelphia, Pennsylvania, United States

DBV Investigative Site

Pittsburgh, Pennsylvania, United States

DBV Investigative Site

Memphis, Tennessee, United States

DBV Investigative Site

Nashville, Tennessee, United States

DBV Investigative Site

Austin, Texas, United States

DBV Investigative Site

Dallas, Texas, United States

DBV Investigative Site

Houston, Texas, United States

DBV Investigative Site

Seattle, Washington, United States

DBV Investigative Site

Seattle, Washington, United States

DBV Investigative Site

Milwaukee, Wisconsin, United States

DBV Investigative Site

Adelaide, Australia

DBV Investigative Site

Nedlands, Australia

DBV Investigative Site

Parkville, Australia

DBV Investigative Site

Richmond, Australia

DBV Investigative Site

South Brisbane, Australia

DBV Investigative Site

Westmead, Australia

DBV Investigative Site

Vancouver, British Columbia, Canada

DBV Investigative Site

Winnipeg, Manitoba, Canada

DBV Investigative Site

Burlington, Ontario, Canada

DBV Investigative Site

North York, Ontario, Canada

DBV Investigative Site

Ottawa, Ontario, Canada

DBV Investigative Site

Toronto, Ontario, Canada

DBV Investigative Site

Montreal, Quebec, Canada

DBV Investigative Site

Montreal, Quebec, Canada

DBV Investigative Site

Québec, Quebec, Canada

DBV Investigative Site

Hamilton, Canada

DBV Investigative Site

Angers, France

DBV Investigative Site

Brest, France

DBV Investigative Site

Bron, France

DBV Investigative Site

Nice, France

DBV Investigative Site

Strasbourg, France

DBV Investigative Site

Vandœuvre-lès-Nancy, France

DBV Investigative Site

Düsseldorf, Germany

DBV Investigative Site

Frankfurt, Germany

DBV Investigative Site

Ulm, Germany

DBV Investigative Site

Cork, Ireland

DBV Investigative Site

Dublin, Ireland

DBV Investigative Site

Rotterdam, Netherlands

DBV Investigative Site

Utrecht, Netherlands

DBV Investigative Site

Madrid, Spain

DBV Investigative Site

Madrid, Spain

DBV Investigative Site

Málaga, Spain

DBV Investigative Site

London, United Kingdom

DBV Investigative Site

London, United Kingdom

DBV Investigative Site

Manchester, United Kingdom

DBV Investigative Site

Sheffield, United Kingdom

DBV Investigative Site

Southampton, United Kingdom

Clinical Research Directory

Safety and Efficacy Study of Viaskin Peanut in Peanut-allergic Children 4-7 Years of Age

Summary

Key Details

Conditions

Interventions

Eligibility Criteria

Locations (87)