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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT03211247
Other study ID # EPITOPE
Secondary ID
Status Active, not recruiting
Phase Phase 3
First received
Last updated
Start date July 31, 2017
Est. completion date April 2022

Study information

Verified date April 2021
Source DBV Technologies
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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).


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 414
Est. completion date April 2022
Est. primary completion date April 2022
Accepts healthy volunteers No
Gender All
Age group 1 Year to 3 Years
Eligibility 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; 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


Related Conditions & MeSH terms


Intervention

Biological:
Viaskin Peanut 250 mcg
Viaskin Peanut 250 mcg, once daily
Viaskin Peanut 100 mcg
Viaskin Peanut 100 mcg, once daily
Placebo
Placebo patch, once daily

Locations

Country Name City State
Australia Perth Children's Hospital Nedlands Western Australia
Australia The Women's and children's hospital North Adelaide South Australia
Australia The Royal Children's Hospital Parkville Victoria
Australia Sydney Children's Hospital Randwick NWS
Australia Queensland Children's Hospital South Brisbane Queensland
Australia The Children's Hospital at Westmead Westmead New South Wales
Canada CHUM & CHU Sainte-Justine Montréal Quebec
Canada Hospital for Sick Children Toronto Ontario
Canada British Columbia Children's Hospital Vancouver British Columbia
France CHRU Lille Lille
France CHRU Metz-Thionville Metz
France Hopitaux Pediatriques de Nice Nice
France Hopital Necker Paris
France CHRU Nancy Vandoeuvre les nancy
Germany Universitatsklinikum Carl Gustav Carus Dresden
Germany Universitatsklinikum Frankfurt Frankfurt
Germany Universitatklinikum Giessen und Marburg Marburg
Ireland Cork University Hospital Cork
Netherlands Erasmus MC Sophia Children's Hospital Rotterdam
United Kingdom Guy's and Saint Thomas' NHS Foundation Trust London
United Kingdom St.Mary's Hospital London
United Kingdom ROyal Manchester Children's Hospital Manchester
United Kingdom Sheffield Children's Hospital Sheffield
United Kingdom University Hospital Southampton NHS Foundation Trust Southampton
United States University of Michigan Health System Ann Arbor Michigan
United States Emory University Atlanta Georgia
United States Children's Hospital Colorado Aurora Colorado
United States Dell Children's Medical Center Austin Texas
United States Johns Hopkins Hospital Baltimore Maryland
United States Boston Childrens' Hospital Boston Massachusetts
United States The University of North Carolina - Chapell Hill Chapel Hill North Carolina
United States Ann & Robert H. Lurie Children's Hospital of CHicago Chicago Illinois
United States The Universal of Chicago Medical Center Chicago Illinois
United States Cleveland Clinic Cleveland Ohio
United States Children's Medical Center of Dallas Dallas Texas
United States Baylor College of Medicine - Texas Children's Hospital Houston Texas
United States Riley Hospital for Children at Indiana University Indianapolis Indiana
United States Arkansas Children's Hospital Little Rock Arkansas
United States University of California School of Medicine Los Angeles California
United States Le Bonheur Children's Hospital Memphis Tennessee
United States Vanderbilt University Medical Center Nashville Tennessee
United States Mount Sinai Medical Center New York New York
United States Children's Hospital of Philadelphia Philadelphia Pennsylvania
United States Children's Hospital of Pittsburgh Pittsburgh Pennsylvania
United States University of Rochester Rochester New York
United States University of California, Rady Children's Hospital San Diego California
United States University of California San Francisco San Francisco California
United States ASTHMA, Inc. Seattle Washington
United States Stanford University School of Medicine Stanford California
United States University of Arizona Health Science Tucson Arizona
United States Children's national Health System Washington District of Columbia

Sponsors (1)

Lead Sponsor Collaborator
DBV Technologies

Countries where clinical trial is conducted

United States,  Australia,  Canada,  France,  Germany,  Ireland,  Netherlands,  United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Other Adverse Events (AEs), Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs) Throughout the study during 12 months
Primary Differences between the percentage of treatment responders in the selected active Viaskin Peanut group compared to the placebo group. Month 12
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