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Safety Study of Viaskin Peanut to Treat Peanut Allergy
Sponsor: DBV Technologies
Summary
This study evaluates the safety of Viaskin Peanut 250 µg in the treatment of peanut allergy in children from 4 to 11 years of age. Subjects will receive either Viaskin Peanut 250 µg or a placebo for a period of 6 months, after which all subjects will be receiving the active treatment up to a period of 3 years under active treatment.
Official title: Long-Term Assessment of Safety and Therapeutic Benefit of Viaskin® Peanut Epicutaneous Treatment in Peanut-Allergic Children: A 6-Month Randomized, Double-Blind, Placebo-Controlled Phase III Study Followed by an Open-Label Active Treatment (REALISE Study)
Key Details
Gender
All
Age Range
4 Years - 11 Years
Study Type
INTERVENTIONAL
Enrollment
393
Start Date
2016-10-25
Completion Date
2020-10-07
Last Updated
2026-10-08
Healthy Volunteers
No
Conditions
Interventions
Viaskin Peanut 250 µg
Placebo
Locations (32)
Arkansas Children's Hospital
Little Rock, Arkansas, United States
Allergy & Asthma Associates of Southern California
Mission Viejo, California, United States
Palos Verdes Medical Group
Rolling Hills Estates, California, United States
Stanford University School of Medicine
Stanford, California, United States
Children's Hospital Colorado
Aurora, Colorado, United States
National Jewish Health
Denver, Colorado, United States
Sarasota Clinical Research
Sarasota, Florida, United States
Atlanta Allergy & Asthma Clinic
Marietta, Georgia, United States
Ann & Robert H. Lurie Children's Hospital of CHicago
Chicago, Illinois, United States
Sneeze, Wheeze and Itch Associates,Clinical Research
Normal, Illinois, United States
Johns Hopkins Hospital
Baltimore, Maryland, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
Boston Children's Hospital
Boston, Massachusetts, United States
Clinical Research Institute
Plymouth, Minnesota, United States
Children's Mercy Hospital
Kansas City, Missouri, United States
The Asthma and Allergy Center
Bellevue, Nebraska, United States
Mount Sinai Medical Center
New York, New York, United States
The University of North Carolina - Chapell Hill
Chapel Hill, North Carolina, United States
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States
Children's Hospital of Pittsburgh
Pittsburgh, Pennsylvania, United States
National Allergy and Asthma Research
Charleston, South Carolina, United States
Children's Medical Center of Dallas
Dallas, Texas, United States
Baylor College of Medicine - Texas Children's Hospital
Houston, Texas, United States
Sylvana Research
San Antonio, Texas, United States
STAAMP Research
San Antonio, Texas, United States
ASTHMA, Inc. Clinical Research
Seattle, Washington, United States
Children's and Women's Health Centre of Brisith Columbia
Vancouver, British Columbia, Canada
Alpha Medical Research Inc.
Mississauga, Ontario, Canada
Ottawa Allergy Asthma Research Institute
Ottawa, Ontario, Canada
Gordon Sussman Clinical Research Inc.
Toronto, Ontario, Canada
Centre Hospitalier Universitaire Sainte Justine
Montreal, Quebec, Canada
Centre De Recherche Applique
Québec, Canada