A Study Investigating Oral Ozanimod (RPC1063) in Pediatric Participants With Moderate to Severe Active Ulcerative Colitis

Last updated: September 23, 2026
Sponsor: Bristol-Myers Squibb
Overall Status: Active - Recruiting

Phase

2/3

Condition

Inflammatory Bowel Disease

Crohn's Disease

Treatment

Ozanimod

Clinical Study ID

NCT05076175
IM047-001
2023
2023-509248-86
2021-002308-11
  • Ages 2-17
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria

  • Moderately to severely active Ulcerative Colitis (UC) diagnosed prior to the Screening Visit

  • 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

  • Diagnosis of Crohn's disease or indeterminate colitis

  • 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

  • Other protocol-defined inclusion/exclusion criteria apply

Study Design

Total Participants: 120
Treatment Group(s): 1
Primary Treatment: Ozanimod
Phase: 2/3
Study Start date:
May 30, 2022
Estimated Completion Date:
July 12, 2032

Connect with a study center

  • The Children's Hospital at Westmead

    Westmead, New South Wales 2145
    Australia

    Active - Recruiting

  • Local Institution - 0085

    Clayton, Victoria 3168
    Australia

    Site Not Available

  • Monash Health

    Clayton, Victoria 3168
    Australia

    Active - Recruiting

  • Local Institution - 0086

    Murdoch, Western Australia 6150
    Australia

    Site Not Available

  • Local Institution - 0106

    Nedlands, Western Australia 6009
    Australia

    Site Not Available

  • Local Institution - 0076

    Brussels, Bruxelles-Capitale, Région de 1090
    Belgium

    Site Not Available

  • Local Institution - 0059

    Leuven, Vlaams-Brabant 3000
    Belgium

    Active - Recruiting

  • UZ Leuven

    Leuven, Vlaams-Brabant 3000
    Belgium

    Active - Recruiting

  • Local Institution - 0056

    Brussels, 1090
    Belgium

    Completed

  • UZ Brussel

    Brussels, 1090
    Belgium

    Active - Recruiting

  • UZ Brussel

    Brussels 2800866, 1090
    Belgium

    Active - Recruiting

  • Local Institution - 0063

    Edegem, 2650
    Belgium

    Site Not Available

  • Centre Hospitalier Régional de la Citadelle

    Liège, 4000
    Belgium

    Active - Recruiting

  • Local Institution - 0061

    Liège, 4000
    Belgium

    Active - Recruiting

  • Local Institution - 0071

    Liège, 4000
    Belgium

    Site Not Available

  • Centre Hospitalier Régional de la Citadelle

    Liège 2792413, 4000
    Belgium

    Active - Recruiting

  • Local Institution - 0083

    Hamilton, Ontario L8N 3Z5
    Canada

    Site Not Available

  • Local Institution - 0082

    Toronto, Ontario M5G 1X8
    Canada

    Site Not Available

  • Local Institution - 0104

    Toronto, Ontario M3M 0B2
    Canada

    Site Not Available

  • Local Institution - 0082

    Toronto 6167865, Ontario 6093943 M5G 1X8
    Canada

    Site Not Available

  • CHU de Toulouse - Hôpital des Enfants

    Toulouse, Haute-Garonne 31059
    France

    Active - Recruiting

  • Hospices Civils de Lyon - Hôpital Femme Mère Enfant

    Bron, 69500
    France

    Active - Recruiting

  • Local Institution - 0022

    Bron, 69500
    France

    Completed

  • Centre Hospitalier Universitaire de Caen - Hôpital Côte de Nacre

    Caen, 14033
    France

    Active - Recruiting

  • Hôpital Universitaire Necker Enfants Malades

    Paris, 75015
    France

    Active - Recruiting

  • Local Institution - 0017

    Paris, 75015
    France

    Completed

  • Local Institution - 0073

    Paris, 75571
    France

    Site Not Available

  • Local Institution - 0073

    Paris 2988507, 75571
    France

    Site Not Available

  • Klinikum der Ludwig-Maximilians-Universitaet Muenchen

    München, Bavaria 80337
    Germany

    Active - Recruiting

  • Local Institution - 0032

    München, Bavaria 80337
    Germany

    Completed

  • Local Institution - 0097

    Leipzig, Sachsen 04103
    Germany

    Site Not Available

  • Universitätsklinikum Leipzig

    Leipzig, Saxony 04103
    Germany

    Active - Recruiting

  • Local Institution - 0031

    Dresden, 01307
    Germany

    Completed

  • Universitaetsklinikum Carl Gustav Carus Dresden

    Dresden, 01307
    Germany

    Active - Recruiting

  • Schneider Children's Medical Center

    Petah Tikva, Central District 49202
    Israel

    Active - Recruiting

  • Local Institution - 0020

    Petah-Tikva, HaMerkaz 49202
    Israel

    Active - Recruiting

  • Shaare Zedek Medical Center

    Jerusalem, Jerusalem 9013102
    Israel

    Active - Recruiting

  • Rambam Health Care Campus

    Haifa, Northern District 3109601
    Israel

    Active - Recruiting

  • Local Institution - 0019

    Jerusalem, Yerushalayim 9013102
    Israel

    Active - Recruiting

  • Local Institution

    Haifa, 3109601
    Israel

    Site Not Available

  • Local Institution

    Jerusalem, 9103102
    Israel

    Site Not Available

  • Local Institution

    Petah Tikva, 4920235
    Israel

    Site Not Available

  • Local Institution - 0025

    Obu, Aichi 474-8710
    Japan

    Active - Recruiting

  • Local Institution

    Obu-shi, Aichi
    Japan

    Site Not Available

  • Aichi Children's Health and Medical Center

    Ōbu, Aichi-ken 474-8710
    Japan

    Active - Recruiting

  • Kurume University Hospital

    Kurume-shi, Fukuoka 8300011
    Japan

    Active - Recruiting

  • Local Institution

    Kurume-shi, Fukuoka 830-0011
    Japan

    Site Not Available

  • Local Institution - 0011

    Kurume-shi, Fukuoka 8300011
    Japan

    Active - Recruiting

  • Local Institution - 0068

    Komatsu, Ishikawa 923-8560
    Japan

    Active - Recruiting

  • Komatsu Municipal Hospital

    Komatsu, Ishikawa-ken 923-8560
    Japan

    Active - Recruiting

  • Local Institution

    Yokohama, Kanagawa 230-0304
    Japan

    Site Not Available

  • Saiseikai Yokohamashi Tobu Hospital

    Yokohama, Kanagawa 2300012
    Japan

    Active - Recruiting

  • Local Institution - 0038

    Yokohama-shi, Kanagawa 2300012
    Japan

    Active - Recruiting

  • Local Institution

    Takatsuki, Osaka 569-8686
    Japan

    Site Not Available

  • Local Institution - 0021

    Takatsuki, Osaka 569-8686
    Japan

    Active - Recruiting

  • Osaka Medical and Pharmaceutical University Hospital

    Takatsuki, Osaka 569-8686
    Japan

    Active - Recruiting

  • Institute of Science Tokyo Hospital

    Bunkyo-Ku, Tokyo 113-8519
    Japan

    Active - Recruiting

  • Local Institution

    Bunkyo-ku, Tokyo 1138431
    Japan

    Site Not Available

  • Tokyo Medical and Dental University Hospital

    Bunkyo-ku, Tokyo 1138519
    Japan

    Active - Recruiting

  • Local Institution

    Setagaya-ku, Tokyo 1570074
    Japan

    Site Not Available

  • Local Institution - 0009

    Setagaya-ku, Tokyo 1578535
    Japan

    Active - Recruiting

  • National Center for Child Health and Development

    Setagaya-ku, Tokyo 1578535
    Japan

    Active - Recruiting

  • Local Institution

    Shinjuku-ku, Tokyo 1600023
    Japan

    Site Not Available

  • Local Institution - 0033

    Shinjuku-ku, Tokyo 160-0023
    Japan

    Active - Recruiting

  • Tokyo Medical University Hospital

    Shinjuku-ku, Tokyo 160-0023
    Japan

    Active - Recruiting

  • Hiroshima University Hospital

    Hiroshima, 734-8551
    Japan

    Active - Recruiting

  • Local Institution - 0069

    Hiroshima, 734-8551
    Japan

    Site Not Available

  • Juntendo University Hospital

    Tokyo, 113-8431
    Japan

    Active - Recruiting

  • Local Institution

    Tokyo, 113-8519
    Japan

    Site Not Available

  • Local Institution - 0010

    Tokyo, 113-8431
    Japan

    Active - Recruiting

  • Local Institution - 0012

    Wrocław, Dolnośląskie 50-369
    Poland

    Site Not Available

  • Local Institution - 0084

    Krakow, Lesser Poland Voivodeship 30-663
    Poland

    Site Not Available

  • Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego we Wrocławiu

    Wroclaw, Lower Silesian Voivodeship 50-369
    Poland

    Active - Recruiting

  • Centrum Zdrowia Dziecka w Warszawie

    Warsaw, Masovian Voivodeship 04-746
    Poland

    Active - Recruiting

  • WIP Warsaw IBD Point Profesor Kierkuś

    Warsaw, Masovian Voivodeship 00-728
    Poland

    Active - Recruiting

  • WIP Warsaw IBD Point Profesor Kierkuś

    Warsaw 756135, Masovian Voivodeship 858787 00-728
    Poland

    Active - Recruiting

  • Local Institution - 0014

    Warsaw, Mazowieckie 04-746
    Poland

    Active - Recruiting

  • Local Institution - 0043

    Warsaw, Mazowieckie 00-728
    Poland

    Active - Recruiting

  • Local Institution - 0015

    Rzeszów, Podkarpackie Voivodeship 35-302
    Poland

    Site Not Available

  • Local Institution - 0013

    Gdansk, Pomeranian Voivodeship 80-803
    Poland

    Site Not Available

  • Local Institution - 0079

    Gdansk, Pomeranian Voivodeship 80-803
    Poland

    Site Not Available

  • Local Institution - 0079

    Gdansk 3099434, Pomeranian Voivodeship 3337496 80-803
    Poland

    Site Not Available

  • Twoja Przychodnia SCM

    Szczecin, West Pomeranian Voivodeship 71-434
    Poland

    Active - Recruiting

  • Local Institution - 0092

    Lodz, Łódź Voivodeship 91-738
    Poland

    Completed

  • Local Institution

    Gdansk, 80-803
    Poland

    Site Not Available

  • Local Institution

    Rzeszow, 35-302
    Poland

    Site Not Available

  • Local Institution - 0088

    Szczecin, 71-434
    Poland

    Site Not Available

  • Local Institution

    Warszawa, 04-745
    Poland

    Site Not Available

  • Local Institution

    Wroclaw, 50-369
    Poland

    Site Not Available

  • Clinical Research Puerto Rico

    San Juan, 00909-1711
    Puerto Rico

    Active - Recruiting

  • Local Institution

    Moscow, 119991
    Russia

    Site Not Available

  • Local Institution

    Moskva, 119571
    Russia

    Site Not Available

  • Local Institution

    Moscow, 119991
    Russian Federation

    Site Not Available

  • Local Institution

    Moskva, 119571
    Russian Federation

    Site Not Available

  • Local Institution - 0048

    Badalona, Barcelona [Barcelona] 08916
    Spain

    Completed

  • Local Institution - 0051

    Esplugues de Llobregat, Barcelona [Barcelona] 08950
    Spain

    Completed

  • Local Institution - 0044

    Madrid, Madrid, Comunidad de 28009
    Spain

    Completed

  • Hospital General Universitario Gregorio Marañon

    Madrid, 28007
    Spain

    Active - Recruiting

  • Local Institution - 0050

    Madrid, 28046
    Spain

    Site Not Available

  • Local Institution - 0057

    Madrid, 28007
    Spain

    Completed

  • Local Institution - 0050

    Madrid 3117735, 28046
    Spain

    Site Not Available

  • Local Institution - 0057

    Madrid 3117735, 28007
    Spain

    Completed

  • Birmingham Children's Hospital

    Birmingham, England B4 6NH
    United Kingdom

    Active - Recruiting

  • Local Institution - 0054

    Birmingham, England B4 6NH
    United Kingdom

    Site Not Available

  • King's College Hospital

    London, Greater London SE5 9RS
    United Kingdom

    Active - Recruiting

  • Local Institution - 0105

    London, Greater London SW10 9NH
    United Kingdom

    Site Not Available

  • Local Institution - 0026

    London, London, City Of SE5 9RL
    United Kingdom

    Site Not Available

  • Local Institution - 0066

    London, London, City Of E1 1BB
    United Kingdom

    Active - Recruiting

  • Barts Health NHS Trust

    London, London, City of E1 1BB
    United Kingdom

    Active - Recruiting

  • Barts Health NHS Trust

    London 2643743, London, City of E1 1BB
    United Kingdom

    Active - Recruiting

  • Local Institution

    Phoenix, Arizona 85016
    United States

    Site Not Available

  • Local Institution - 0041

    Phoenix, Arizona 85016-7710
    United States

    Site Not Available

  • University of Arizona

    Tucson, Arizona 85724
    United States

    Site Not Available

  • Local Institution - 0052

    Garden Grove, California 92845
    United States

    Completed

  • Valley View Wellness Medical Center

    Garden Grove, California 92845
    United States

    Active - Recruiting

  • Loma Linda University Health System

    Loma Linda, California 92354
    United States

    Active - Recruiting

  • Cedars-Sinai Medical Center

    Los Angeles, California 90048
    United States

    Active - Recruiting

  • Local Institution

    Los Angeles, California 90048
    United States

    Site Not Available

  • Lucile Packard Children's Hospital

    Palo Alto, California 94304
    United States

    Site Not Available

  • Local Institution - 0096

    Sacramento, California 95817
    United States

    Site Not Available

  • University of California Davis Health

    Sacramento, California 95817
    United States

    Active - Recruiting

  • Local Institution - 0087

    Loma Linda 5367696, California 5332921 92354
    United States

    Site Not Available

  • Local Institution

    Hartford, Connecticut 06106
    United States

    Site Not Available

  • Local Institution - 0007

    Hartford, Connecticut 06106
    United States

    Completed

  • Children's National Medical Center

    Washington, District of Columbia 20010
    United States

    Active - Recruiting

  • Local Institution - 0064

    Washington D.C., District of Columbia 20010
    United States

    Completed

  • AdventHealth Orlando

    Orlando, Florida 32803
    United States

    Active - Recruiting

  • Local Institution - 0075

    Orlando, Florida 32803
    United States

    Completed

  • Local Institution

    Atlanta, Georgia 30342
    United States

    Site Not Available

  • Local Institution - 0016

    Atlanta, Georgia 30342
    United States

    Completed

  • Local Institution - 0101

    Park Ridge, Illinois 60068
    United States

    Site Not Available

  • Local Institution - 0100

    Indianapolis, Indiana 46202
    United States

    Site Not Available

  • Local Institution - 0049

    Iowa City, Iowa 52242
    United States

    Completed

  • University of Iowa

    Iowa City, Iowa 52242
    United States

    Active - Recruiting

  • Maine Medical Partners

    Portland, Maine 04102
    United States

    Site Not Available

  • Boston Children's Hospital

    Boston, Massachusetts 02115
    United States

    Active - Recruiting

  • Local Institution

    Boston, Massachusetts 02115
    United States

    Site Not Available

  • Local Institution - 0005

    Boston, Massachusetts 02115
    United States

    Site Not Available

  • Local Institution

    Springfield, Massachusetts 01107
    United States

    Site Not Available

  • Local Institution - 0042

    Springfield, Massachusetts 01199
    United States

    Completed

  • Local Institution - 0095

    Worcester, Massachusetts 01655
    United States

    Site Not Available

  • University of Massachusetts Chan Medical School

    Worcester, Massachusetts 01655
    United States

    Active - Recruiting

  • Children's Hospital of Michigan

    Detroit, Michigan 48201
    United States

    Active - Recruiting

  • Local Institution - 0093

    Detroit, Michigan 48201
    United States

    Completed

  • Mayo Clinic in Rochester, Minnesota

    Rochester, Minnesota 55905
    United States

    Active - Recruiting

  • Washington University

    Saint Louis, Missouri 63110
    United States

    Site Not Available

  • Washington University

    St Louis, Missouri 63110
    United States

    Active - Recruiting

  • Columbia University Medical Center

    New York, New York 10032
    United States

    Active - Recruiting

  • Local Institution

    New York, New York 10029
    United States

    Site Not Available

  • Local Institution - 0023

    New York, New York 10065
    United States

    Site Not Available

  • Local Institution - 0028

    New York, New York 10029
    United States

    Completed

  • Local Institution - 0040

    New York, New York 10032
    United States

    Active - Recruiting

  • Columbia University Medical Center

    New York 5128581, New York 5128638 10032
    United States

    Active - Recruiting

  • Local Institution - 0028

    New York 5128581, New York 5128638 10029
    United States

    Completed

  • University of North Carolina Medical Center

    Chapel Hill, North Carolina 27599
    United States

    Site Not Available

  • Atrium Health - Carolinas Medical Center

    Charlotte, North Carolina 28203
    United States

    Active - Recruiting

  • Local Institution - 0047

    Charlotte, North Carolina 28203
    United States

    Completed

  • Cleveland Clinic

    Cleveland, Ohio 44124
    United States

    Active - Recruiting

  • Local Institution

    Cleveland, Ohio 44195
    United States

    Site Not Available

  • Local Institution - 0036

    Cleveland, Ohio 44124
    United States

    Site Not Available

  • Local Institution - 0062

    Oklahoma City, Oklahoma 73112
    United States

    Site Not Available

  • Measurable Outcomes Research

    Oklahoma City, Oklahoma 73112
    United States

    Site Not Available

  • Local Institution - 0045

    Hershey, Pennsylvania 17033
    United States

    Completed

  • Penn State Milton S. Hershey Medical Center

    Hershey, Pennsylvania 17033
    United States

    Active - Recruiting

  • Local Institution

    Philadelphia, Pennsylvania 19134
    United States

    Site Not Available

  • Local Institution - 0099

    Charleston, South Carolina 29425
    United States

    Site Not Available

  • Local Institution - 0103

    Fort Worth, Texas 76104
    United States

    Site Not Available

  • Texas Children's Hospital

    Houston, Texas 77030
    United States

    Active - Recruiting

  • Local Institution - 0091

    Seattle, Washington 98122
    United States

    Completed

  • Seattle Children's Hospital

    Seattle, Washington 98105
    United States

    Active - Recruiting

  • Swedish Medical Center

    Seattle, Washington 98122
    United States

    Active - Recruiting

  • MultiCare Health System

    Tacoma, Washington 98405
    United States

    Active - Recruiting

  • Seattle Children's Hospital

    Seattle 5809844, Washington 5815135 98105
    United States

    Active - Recruiting

  • Children's Wisconsin

    Milwaukee, Wisconsin 53226
    United States

    Active - Recruiting

  • Local Institution - 0037

    Milwaukee, Wisconsin 53226
    United States

    Completed

  • Local Institution

    Wauwatosa, Wisconsin 53226
    United States

    Site Not Available

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