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A Study Investigating Oral Ozanimod (RPC1063) in Pediatric Participants With Moderate to Severe Active Ulcerative Colitis
Sponsor: Bristol-Myers Squibb
Summary
The purpose of this study is to evaluate the effectiveness and safety of ozanimod (RPC1063) in achieving and maintaining clinical remission. Ozanimod will be administered orally to pediatric participants with moderate to severe active ulcerative colitis (UC) who have had an inadequate response to conventional therapy.
Official title: A Phase 2/3, Multicenter, Randomized, Double-Blind Study to Evaluate the Efficacy, Safety, Pharmacokinetics and Pharmacodynamics of Oral Ozanimod (RPC1063) in Pediatric Subjects With Moderately to Severely Active Ulcerative Colitis With an Inadequate Response to Conventional Therapy
Key Details
Gender
All
Age Range
2 Years - 17 Years
Study Type
INTERVENTIONAL
Enrollment
120
Start Date
2022-05-30
Completion Date
2031-08-14
Last Updated
2026-04-07
Healthy Volunteers
No
Conditions
Interventions
Ozanimod
Specified dose on specified days
Locations (90)
Local Institution - 0041
Phoenix, Arizona, United States
University of Arizona
Tucson, Arizona, United States
Local Institution - 0052
Garden Grove, California, United States
Loma Linda University Health System
Loma Linda, California, United States
Cedars-Sinai Medical Center
Los Angeles, California, United States
Lucile Packard Children's Hospital
Palo Alto, California, United States
Local Institution - 0096
Sacramento, California, United States
Local Institution - 0007
Hartford, Connecticut, United States
Local Institution - 0064
Washington D.C., District of Columbia, United States
Local Institution - 0075
Orlando, Florida, United States
Local Institution - 0016
Atlanta, Georgia, United States
Local Institution - 0101
Park Ridge, Illinois, United States
Local Institution - 0100
Indianapolis, Indiana, United States
University of Iowa
Iowa City, Iowa, United States
Maine Medical Partners
Portland, Maine, United States
Boston Children's Hospital
Boston, Massachusetts, United States
Local Institution - 0042
Springfield, Massachusetts, United States
University of Massachusetts Chan Medical School
Worcester, Massachusetts, United States
Children's Hospital of Michigan
Detroit, Michigan, United States
Mayo Clinic in Rochester, Minnesota
Rochester, Minnesota, United States
Washington University
St Louis, Missouri, United States
Local Institution - 0028
New York, New York, United States
Columbia University Medical Center
New York, New York, United States
Local Institution - 0023
New York, New York, United States
University of North Carolina Medical Center
Chapel Hill, North Carolina, United States
Local Institution - 0047
Charlotte, North Carolina, United States
Cleveland Clinic
Cleveland, Ohio, United States
Local Institution - 0062
Oklahoma City, Oklahoma, United States
Penn State Milton S. Hershey Medical Center
Hershey, Pennsylvania, United States
Local Institution - 0099
Charleston, South Carolina, United States
Local Institution - 0103
Fort Worth, Texas, United States
Texas Children's Hospital
Houston, Texas, United States
Seattle Children's Hospital
Seattle, Washington, United States
Local Institution - 0091
Seattle, Washington, United States
MultiCare Health System
Tacoma, Washington, United States
Children's Wisconsin
Milwaukee, Wisconsin, United States
The Children's Hospital at Westmead
Westmead, New South Wales, Australia
Monash Health
Clayton, Victoria, Australia
Local Institution - 0086
Murdoch, Western Australia, Australia
Local Institution - 0076
Brussels, Bruxelles-Capitale, Région de, Belgium
UZ Leuven
Leuven, Vlaams-Brabant, Belgium
Local Institution - 0056
Brussels, Belgium
Local Institution - 0063
Edegem, Belgium
Centre Hospitalier Régional de la Citadelle
Liège, Belgium
Local Institution - 0071
Liège, Belgium
Local Institution - 0083
Hamilton, Ontario, Canada
Local Institution - 0104
Toronto, Ontario, Canada
Local Institution - 0082
Toronto, Ontario, Canada
CHU de Toulouse - Hôpital des Enfants
Toulouse, Haute-Garonne, France
Hospices Civils de Lyon - Hôpital Femme Mère Enfant
Bron, France
Centre Hospitalier Universitaire de Caen - Hôpital Côte de Nacre
Caen, France
Hôpital Universitaire Necker Enfants Malades
Paris, France
Local Institution - 0073
Paris, France
Local Institution - 0032
München, Bavaria, Germany
Universitätsklinikum Leipzig
Leipzig, Saxony, Germany
Universitaetsklinikum Carl Gustav Carus Dresden
Dresden, Germany
Schneider Children's Medical Center
Petah Tikva, Central District, Israel
Shaare Zedek Medical Center
Jerusalem, Jerusalem, Israel
Rambam Health Care Campus
Haifa, Northern District, Israel
Aichi Children's Health and Medical Center
Ōbu, Aichi-ken, Japan
Kurume University Hospital
Kurume-shi, Fukuoka, Japan
Komatsu Municipal Hospital
Komatsu, Ishikawa-ken, Japan
Saiseikai Yokohamashi Tobu Hospital
Yokohama, Kanagawa, Japan
Osaka Medical and Pharmaceutical University Hospital
Takatsuki, Osaka, Japan
Institute of Science Tokyo Hospital
Bunkyo-Ku, Tokyo, Japan
National Center for Child Health and Development
Setagaya-ku, Tokyo, Japan
Tokyo Medical University Hospital
Shinjuku-ku, Tokyo, Japan
Hiroshima University Hospital
Hiroshima, Japan
Juntendo University Hospital
Tokyo, Japan
Local Institution - 0084
Krakow, Lesser Poland Voivodeship, Poland
Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego we Wrocławiu
Wroclaw, Lower Silesian Voivodeship, Poland
WIP Warsaw IBD Point Profesor Kierkuś
Warsaw, Masovian Voivodeship, Poland
Centrum Zdrowia Dziecka w Warszawie
Warsaw, Masovian Voivodeship, Poland
Local Institution - 0015
Rzeszów, Podkarpackie Voivodeship, Poland
Local Institution - 0013
Gdansk, Pomeranian Voivodeship, Poland
Local Institution - 0079
Gdansk, Pomeranian Voivodeship, Poland
Twoja Przychodnia SCM
Szczecin, West Pomeranian Voivodeship, Poland
Local Institution - 0092
Lodz, Łódź Voivodeship, Poland
Clinical Research Puerto Rico
San Juan, Puerto Rico
Local Institution
Moscow, Russia
Local Institution
Moskva, Russia
Local Institution - 0048
Badalona, Barcelona [Barcelona], Spain
Local Institution - 0051
Esplugues de Llobregat, Barcelona [Barcelona], Spain
Local Institution - 0044
Madrid, Madrid, Comunidad de, Spain
Local Institution - 0057
Madrid, Spain
Local Institution - 0050
Madrid, Spain
Birmingham Children's Hospital
Birmingham, England, United Kingdom
King's College Hospital
London, Greater London, United Kingdom
Local Institution - 0105
London, Greater London, United Kingdom
Barts Health NHS Trust
London, London, City of, United Kingdom