A Study Investigating Oral Ozanimod (RPC1063) in Pediatric Participants With Moderate to Severe Active Ulcerative Colitis
NCT ID: NCT05076175
Last Updated: 2025-12-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2/PHASE3
120 participants
INTERVENTIONAL
2022-05-30
2031-08-14
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Ozanimod High Dose
Ozanimod
Specified dose on specified days
Ozanimod Low Dose
Ozanimod
Specified dose on specified days
Interventions
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Ozanimod
Specified dose on specified days
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Evidence of UC extending beyond the rectum, as determined by baseline endoscopy
* Has had an inadequate response, loss of response to, or is intolerant to at least 1 of the following treatments for UC: oral aminosalicylates, systemic corticosteroids, immunomodulators, biologic therapy
Exclusion Criteria
* Has documentation of positive test for toxin producing Clostridium difficile, or polymerase chain reaction examination of the stool
* Apheresis within 2 weeks of randomization
* History of or currently active primary or secondary immunodeficiency, or participants with known genetic disorders as a cause for colitis
2 Years
17 Years
ALL
No
Sponsors
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Bristol-Myers Squibb
INDUSTRY
Responsible Party
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Principal Investigators
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Bristol-Myers Squibb
Role: STUDY_DIRECTOR
Bristol-Myers Squibb
Locations
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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
UZ Brussel
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
Klinikum der Ludwig-Maximilians-Universitaet Muenchen
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
Local Institution - 0098
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
Barts Health NHS Trust
London, London, City of, United Kingdom
Countries
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Central Contacts
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BMS Study Connect Contact Center www.BMSStudyConnect.com
Role: CONTACT
First line of the email MUST contain the NCT# and Site #.
Role: CONTACT
Facility Contacts
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Kalyan Ray Parashette, Site 0087
Role: primary
Shervin Rabizadeh, Site 0074
Role: primary
Jonathan Moses, Site 0080
Role: primary
Site 0096
Role: primary
Site 0101
Role: primary
Site 0100
Role: primary
Dawn Ebach, Site 0049
Role: primary
Noah Hoffman, Site 0090
Role: primary
Athos Bousvaros, Site 0005
Role: primary
Basavaraj Kerur, Site 0095
Role: primary
Kristen Cares, Site 0093
Role: primary
Michael Stephens, Site 0070
Role: primary
Charles Samson, Site 0053
Role: primary
JOSEPH PICORARO, Site 0040
Role: primary
Jessica Barry, Site 0036
Role: primary
Stefany Garrity, Site 0045
Role: primary
Site 0099
Role: primary
Site 0103
Role: primary
Lina Karam, Site 0067
Role: primary
Ghassan Wahbeh, Site 0060
Role: primary
Raghu Varier, Site 0046
Role: primary
Abdul Elkadri, Site 0037
Role: primary
Shoma Dutt, Site 0094
Role: primary
Edward Giles, Site 0085
Role: primary
Ilse Hoffman, Site 0059
Role: primary
Elisabeth De Greef, Site 0056
Role: primary
Site 0063
Role: primary
Emeline Bequet, Site 0061
Role: primary
Site 0104
Role: primary
Site 0082
Role: primary
EMMANUEL MAS, Site 0058
Role: primary
Remi Duclaux-Loras, Site 0022
Role: primary
Claire Dupont-Lucas, Site 0030
Role: primary
Frank Ruemmele, Site 0017
Role: primary
Tobias Schwerd, Site 0032
Role: primary
Gunter Flemming, Site 0097
Role: primary
Martin Laass, Site 0031
Role: primary
Dror Shouval, Site 0020
Role: primary
Dan Turner, Site 0019
Role: primary
Ron Shaoul, Site 0018
Role: primary
Naomi Iwata, Site 0025
Role: primary
Tatsuki Mizuochi, Site 0011
Role: primary
HISASHI KANEDA, Site 0068
Role: primary
shuichiro umetsu, Site 0038
Role: primary
Emiri Kaji, Site 0021
Role: primary
Toshimitsu Fujii, Site 0024
Role: primary
Katsuhiro Arai, Site 0009
Role: primary
Norito Tsutsumi, Site 0033
Role: primary
Shiro Oka, Site 0069
Role: primary
Takahiro Kudo, Site 0010
Role: primary
Tomasz Pytrus, Site 0012
Role: primary
Monika Meglicka, Site 0043
Role: primary
Jaroslaw Kierkus, Site 0014
Role: primary
Beata Gawdis-Wojnarska, Site 0088
Role: primary
Site 0098
Role: primary
Rafeeq Muhammed, Site 0054
Role: primary
Babu Vadamalayan, Site 0026
Role: primary
Protima Deb, Site 0066
Role: primary
Related Links
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BMS Clinical Trial Information
BMS Clinical Trial Patient Recruiting
Other Identifiers
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IM047-001
Identifier Type: -
Identifier Source: org_study_id
2023-509248-86
Identifier Type: OTHER
Identifier Source: secondary_id