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

Peanut Allergy Clinical Trial

— EPITOPE  

Official title:

A Double-blind, Placebo-controlled, Randomized Phase III Trial to Assess the Safety and Efficacy of Viaskin Peanut in Peanut-allergic Young Children 1-3 Years of Age.

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03211247
• Other study ID #: EPITOPE
• Status: Active, not recruiting
• Phase: Phase 3
• 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
• 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;

Related Conditions & MeSH terms

• Peanut Allergy
• Peanut Hypersensitivity

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