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

May 26, 2026 updated by: Bristol-Myers Squibb

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

120

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: First line of the email MUST contain NCT # and Site #.

Study Contact Backup

  • Name: BMS Clinical Trials Contact Center www.BMSClinicalTrials.com
  • Phone Number: 855-907-3286
  • Email: Clinical.Trials@bms.com

Study Locations

  • Australia
    • New South Wales
      • Westmead, New South Wales, Australia, 2145
        • Recruiting
        • The Children's Hospital at Westmead
        • Contact:
          • Shoma Dutt, Site 0094
          • Phone Number: 0298453999
    • Victoria
      • Clayton, Victoria, Australia, 3168
        • Recruiting
        • Monash Health
        • Contact:
          • Edward Giles, Site 0085
          • Phone Number: +61395943577
    • Western Australia
      • Murdoch, Western Australia, Australia, 6150
        • Withdrawn
        • Local Institution - 0086
  • Belgium
      • Brussels, Belgium, 1090
        • Completed
        • Local Institution - 0056
      • Edegem, Belgium, 2650
        • Not yet recruiting
        • Local Institution - 0063
        • Contact:
          • Site 0063
      • Liège, Belgium, 4000
        • Recruiting
        • Centre Hospitalier Régional de la Citadelle
        • Contact:
          • Emeline Bequet, Site 0061
          • Phone Number: 32 4321 54 67
      • Liège, Belgium, 4000
        • Withdrawn
        • Local Institution - 0071
    • Bruxelles-Capitale, Région de
      • Brussels, Bruxelles-Capitale, Région de, Belgium, 1090
        • Withdrawn
        • Local Institution - 0076
    • Vlaams-Brabant
      • Leuven, Vlaams-Brabant, Belgium, 3000
        • Recruiting
        • UZ Leuven
        • Contact:
          • Ilse Hoffman, Site 0059
          • Phone Number: 003216343343
  • Canada
    • Ontario
      • Hamilton, Ontario, Canada, L8N 3Z5
        • Withdrawn
        • Local Institution - 0083
      • Toronto, Ontario, Canada, M5G 1X8
        • Not yet recruiting
        • Local Institution - 0082
        • Contact:
          • Site 0082
      • Toronto, Ontario, Canada, M3M 0B2
        • Not yet recruiting
        • Local Institution - 0104
        • Contact:
          • Site 0104
  • France
      • Bron, France, 69500
        • Recruiting
        • Hospices Civils de Lyon - Hopital Femme Mère Enfant
        • Contact:
          • Remi Duclaux-Loras, Site 0022
          • Phone Number: 0472357050
      • Caen, France, 14033
        • Recruiting
        • Centre Hospitalier Universitaire de Caen - Hôpital Côte de Nacre
        • Contact:
          • Claire Dupont-Lucas, Site 0030
          • Phone Number: 33668354806
      • Paris, France, 75015
        • Recruiting
        • Hôpital Universitaire Necker Enfants Malades
        • Contact:
          • Frank Ruemmele, Site 0017
          • Phone Number: 0615781674
      • Paris, France, 75571
        • Withdrawn
        • Local Institution - 0073
    • Haute-Garonne
      • Toulouse, Haute-Garonne, France, 31059
        • Recruiting
        • CHU de Toulouse - Hôpital des Enfants
        • Contact:
          • EMMANUEL MAS, Site 0058
          • Phone Number: 0685946782
  • Germany
      • Dresden, Germany, 01307
        • Recruiting
        • Universitaetsklinikum Carl Gustav Carus Dresden
        • Contact:
          • Martin Laass, Site 0031
          • Phone Number: 00493514583449
    • Bavaria
      • München, Bavaria, Germany, 80337
        • Completed
        • Local Institution - 0032
    • Saxony
      • Leipzig, Saxony, Germany, 04103
        • Recruiting
        • Universitätsklinikum Leipzig
        • Contact:
          • Gunter Flemming, Site 0097
          • Phone Number: +49-341-9726111
  • Israel
    • Central District
      • Petah Tikva, Central District, Israel, 49202
        • Recruiting
        • Schneider Children's Medical Center
        • Contact:
          • Dror Shouval, Site 0020
          • Phone Number: 03-9253673
    • Jerusalem
      • Jerusalem, Jerusalem, Israel, 9013102
        • Recruiting
        • Shaare Zedek Medical Center
        • Contact:
          • Dan Turner, Site 0019
          • Phone Number: 02-6666482
    • Northern District
      • Haifa, Northern District, Israel, 3109601
        • Recruiting
        • Rambam Health Care Campus
        • Contact:
          • Ron Shaoul, Site 0018
          • Phone Number: 04-7774381
  • Japan
      • Hiroshima, Japan, 734-8551
        • Recruiting
        • Hiroshima University Hospital
        • Contact:
          • Shiro Oka, Site 0069
      • Tokyo, Japan, 113-8431
        • Recruiting
        • Juntendo University Hospital
        • Contact:
          • Takahiro Kudo, Site 0010
          • Phone Number: +81-3-3813-3111
    • Aichi-ken
      • Ōbu, Aichi-ken, Japan, 474-8710
        • Recruiting
        • Aichi Children's Health and Medical Center
        • Contact:
          • Naomi Iwata, Site 0025
          • Phone Number: 81562430500
    • Fukuoka
      • Kurume-shi, Fukuoka, Japan, 8300011
        • Recruiting
        • Kurume University Hospital
        • Contact:
          • Tatsuki Mizuochi, Site 0011
          • Phone Number: +81-942-35-3311
    • Ishikawa-ken
      • Komatsu, Ishikawa-ken, Japan, 923-8560
        • Recruiting
        • Komatsu Municipal Hospital
        • Contact:
          • HISASHI KANEDA, Site 0068
          • Phone Number: 81-761-22-7111
    • Kanagawa
      • Yokohama, Kanagawa, Japan, 2300012
        • Recruiting
        • Saiseikai Yokohamashi Tobu Hospital
        • Contact:
          • shuichiro umetsu, Site 0038
          • Phone Number: +81455763000
    • Osaka
      • Takatsuki, Osaka, Japan, 569-8686
        • Recruiting
        • Osaka Medical and Pharmaceutical University Hospital
        • Contact:
          • Emiri Kaji, Site 0021
          • Phone Number: 81-726-83-1221
    • Tokyo
      • Bunkyo-Ku, Tokyo, Japan, 113-8519
        • Recruiting
        • Institute of Science Tokyo Hospital
        • Contact:
          • Toshimitsu Fujii, Site 0024
          • Phone Number: +81-3-5803-5877
      • Setagaya-ku, Tokyo, Japan, 1578535
        • Recruiting
        • National Center for Child Health and Development
        • Contact:
          • Katsuhiro Arai, Site 0009
          • Phone Number: +81-3-3416-0181
      • Shinjuku-ku, Tokyo, Japan, 160-0023
        • Recruiting
        • Tokyo Medical University Hospital
        • Contact:
          • Shigeo Nishimata, Site 0033
          • Phone Number: 81333426111
  • Poland
    • Lesser Poland Voivodeship
      • Krakow, Lesser Poland Voivodeship, Poland, 30-663
        • Withdrawn
        • Local Institution - 0084
    • Lower Silesian Voivodeship
      • Wroclaw, Lower Silesian Voivodeship, Poland, 50-369
        • Recruiting
        • Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego we Wrocławiu
        • Contact:
          • Tomasz Pytrus, Site 0012
          • Phone Number: +48 71 7703045
    • Masovian Voivodeship
      • Warsaw, Masovian Voivodeship, Poland, 00-728
        • Recruiting
        • WIP Warsaw IBD Point Profesor Kierkus
        • Contact:
          • Monika Meglicka, Site 0043
          • Phone Number: +48603508908
      • Warsaw, Masovian Voivodeship, Poland, 04-746
        • Recruiting
        • Centrum Zdrowia Dziecka w Warszawie
        • Contact:
          • Jaroslaw Kierkus, Site 0014
          • Phone Number: +48500111648
    • Podkarpackie Voivodeship
      • Rzeszów, Podkarpackie Voivodeship, Poland, 35-302
        • Withdrawn
        • Local Institution - 0015
    • Pomeranian Voivodeship
      • Gdansk, Pomeranian Voivodeship, Poland, 80-803
        • Withdrawn
        • Local Institution - 0013
      • Gdansk, Pomeranian Voivodeship, Poland, 80-803
        • Withdrawn
        • Local Institution - 0079
    • West Pomeranian Voivodeship
      • Szczecin, West Pomeranian Voivodeship, Poland, 71-434
        • Recruiting
        • Twoja Przychodnia SCM
        • Contact:
          • Beata Gawdis-Wojnarska, Site 0088
          • Phone Number: +48664929399
    • Łódź Voivodeship
      • Lodz, Łódź Voivodeship, Poland, 91-738
        • Completed
        • Local Institution - 0092
  • Puerto Rico
      • San Juan, Puerto Rico, 00909-1711
        • Recruiting
        • Clinical Research Puerto Rico
        • Contact:
          • Antonio Del Valle-Segarra, Site 0098
          • Phone Number: 787-723-5945
  • Russia
      • Moscow, Russia, 119991
        • Withdrawn
        • Local Institution
      • Moskva, Russia, 119571
        • Withdrawn
        • Local Institution
  • Spain
      • Madrid, Spain, 28046
        • Withdrawn
        • Local Institution - 0050
      • Madrid, Spain, 28007
        • Completed
        • Local Institution - 0057
    • Barcelona [Barcelona]
      • Badalona, Barcelona [Barcelona], Spain, 08916
        • Completed
        • Local Institution - 0048
      • Esplugues de Llobregat, Barcelona [Barcelona], Spain, 08950
        • Completed
        • Local Institution - 0051
    • Madrid, Comunidad de
      • Madrid, Madrid, Comunidad de, Spain, 28009
        • Completed
        • Local Institution - 0044
  • United Kingdom
    • England
      • Birmingham, England, United Kingdom, B4 6NH
        • Recruiting
        • Birmingham Children's Hospital
        • Contact:
          • Rafeeq Muhammed, Site 0054
          • Phone Number: 07788861236
    • Greater London
      • London, Greater London, United Kingdom, SE5 9RS
        • Recruiting
        • King's College Hospital
        • Contact:
          • Babu Vadamalayan, Site 0026
          • Phone Number: 02032991674
      • London, Greater London, United Kingdom, SW10 9NH
        • Not yet recruiting
        • Local Institution - 0105
        • Contact:
          • Site 0105
    • London, City of
      • London, London, City of, United Kingdom, E1 1BB
        • Recruiting
        • Barts Health NHS Trust
        • Contact:
          • Protima Deb, Site 0066
          • Phone Number: 02035942473
  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85016-7710
        • Withdrawn
        • Local Institution - 0041
      • Tucson, Arizona, United States, 85724
        • Withdrawn
        • University of Arizona
    • California
      • Garden Grove, California, United States, 92845
        • Completed
        • Local Institution - 0052
      • Loma Linda, California, United States, 92354
        • Recruiting
        • Loma Linda University Health System
        • Contact:
          • Kalyan Ray Parashette, Site 0087
          • Phone Number: 505-274-0704
      • Los Angeles, California, United States, 90048
        • Recruiting
        • Cedars-Sinai Medical Center
        • Contact:
          • Shervin Rabizadeh, Site 0074
          • Phone Number: 310-423-7100
      • Palo Alto, California, United States, 94304
        • Not yet recruiting
        • Lucile Packard Children's Hospital
        • Contact:
          • Jonathan Moses, Site 0080
          • Phone Number: 650-721-2250
      • Sacramento, California, United States, 95817
        • Recruiting
        • University of California Davis Health
        • Contact:
          • Trinh Truong, Site 0096
          • Phone Number: 310-597-1251
    • Connecticut
      • Hartford, Connecticut, United States, 06106
        • Completed
        • Local Institution - 0007
    • District of Columbia
      • Washington D.C., District of Columbia, United States, 20010
        • Completed
        • Local Institution - 0064
    • Florida
      • Orlando, Florida, United States, 32803
        • Completed
        • Local Institution - 0075
    • Georgia
      • Atlanta, Georgia, United States, 30342
        • Completed
        • Local Institution - 0016
    • Illinois
      • Park Ridge, Illinois, United States, 60068
        • Not yet recruiting
        • Local Institution - 0101
        • Contact:
          • Site 0101
    • Indiana
      • Indianapolis, Indiana, United States, 46202
        • Not yet recruiting
        • Local Institution - 0100
        • Contact:
          • Site 0100
    • Iowa
      • Iowa City, Iowa, United States, 52242
        • Completed
        • Local Institution - 0049
    • Maine
      • Portland, Maine, United States, 04102
        • Not yet recruiting
        • Maine Medical Partners
        • Contact:
          • Noah Hoffman, Site 0090
          • Phone Number: 207-662-5522
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • Recruiting
        • Boston Children's Hospital
        • Contact:
          • Athos Bousvaros, Site 0005
          • Phone Number: 617-699-1021
      • Springfield, Massachusetts, United States, 01199
        • Completed
        • Local Institution - 0042
      • Worcester, Massachusetts, United States, 01655
        • Recruiting
        • University of Massachusetts Chan Medical School
        • Contact:
          • Basavaraj Kerur, Site 0095
          • Phone Number: 774-441-8082
    • Michigan
      • Detroit, Michigan, United States, 48201
        • Completed
        • Local Institution - 0093
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Recruiting
        • Mayo Clinic in Rochester, Minnesota
        • Contact:
          • Michael Stephens, Site 0070
          • Phone Number: 111111
    • Missouri
      • St Louis, Missouri, United States, 63110
        • Recruiting
        • Washington University
        • Contact:
          • Charles Samson, Site 0053
          • Phone Number: 513-518-8949
    • New York
      • New York, New York, United States, 10032
        • Recruiting
        • Columbia University Medical Center
        • Contact:
          • JOSEPH PICORARO, Site 0040
          • Phone Number: 212-305-5903
      • New York, New York, United States, 10065
        • Withdrawn
        • Local Institution - 0023
      • New York, New York, United States, 10029
        • Completed
        • Local Institution - 0028
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27599
        • Withdrawn
        • University of North Carolina Medical Center
      • Charlotte, North Carolina, United States, 28203
        • Completed
        • Local Institution - 0047
    • Ohio
      • Cleveland, Ohio, United States, 44124
        • Recruiting
        • Cleveland Clinic
        • Contact:
          • Jessica Barry, Site 0036
          • Phone Number: 216444231
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73112
        • Withdrawn
        • Local Institution - 0062
    • Pennsylvania
      • Hershey, Pennsylvania, United States, 17033
        • Completed
        • Local Institution - 0045
    • South Carolina
      • Charleston, South Carolina, United States, 29425
        • Not yet recruiting
        • Local Institution - 0099
        • Contact:
          • Site 0099
    • Texas
      • Fort Worth, Texas, United States, 76104
        • Not yet recruiting
        • Local Institution - 0103
        • Contact:
          • Site 0103
      • Houston, Texas, United States, 77030
        • Recruiting
        • Texas Children's Hospital
        • Contact:
          • Lina Karam, Site 0067
          • Phone Number: 832-822-3612
    • Washington
      • Seattle, Washington, United States, 98105
        • Recruiting
        • Seattle Children's Hospital
        • Contact:
          • Ghassan Wahbeh, Site 0060
          • Phone Number: 111111
      • Seattle, Washington, United States, 98122
        • Completed
        • Local Institution - 0091
      • Tacoma, Washington, United States, 98405
        • Recruiting
        • Multicare Health System
        • Contact:
          • Raghu Varier, Site 0046
          • Phone Number: 503-847-4748
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53226
        • Completed
        • Local Institution - 0037

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

2 years to 17 years (Child)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Ozanimod High Dose
Drug: Ozanimod
Specified dose on specified days
Other Names:
  • RPC1063
Experimental: Ozanimod Low Dose
Drug: Ozanimod
Specified dose on specified days
Other Names:
  • RPC1063

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Proportion of participants who achieve clinical remission
Time Frame: At Week 52
At Week 52

Secondary Outcome Measures

Outcome Measure
Time Frame
Proportion of participants who achieve clinical remission
Time Frame: At Week 10
At Week 10
Proportion of participants who achieve clinical response
Time Frame: At Week 52
At Week 52
Proportion of participants who achieve clinical response
Time Frame: At Week 10
At Week 10
Proportion of participants who achieve symptomatic remission
Time Frame: At Week 10 and Week 52
At Week 10 and Week 52
Time to achievement of symptomatic remission
Time Frame: Up to 6 years
Up to 6 years
Proportion of participants who achieve endoscopic improvement
Time Frame: At Week 10 and Week 52
At Week 10 and Week 52
Proportion of participants who achieve corticosteroid free remission
Time Frame: At Week 52
At Week 52
Incidence of Adverse Events (AEs)
Time Frame: Up to 6 years
Up to 6 years
Incidence of Serious Adverse Events
Time Frame: Up to 6 years
Up to 6 years
Incidence of AEs leading to discontinuation from treatment
Time Frame: Up to 6 years
Up to 6 years
Incidence of AEs of special interest (AESIs)
Time Frame: Up to 6 years
Up to 6 years
Steady state systemic exposure of ozanimod and CC112273
Time Frame: At Week 18 and throughout the study, up to 70 weeks
At Week 18 and throughout the study, up to 70 weeks
Absolute change from baseline in Absolute Lymphocyte Count (ALC)
Time Frame: Up to 6 years
Up to 6 years
Percent change from baseline in ALC
Time Frame: Up to 6 years
Up to 6 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bristol-Myers Squibb

Investigators

  • Study Director: Bristol-Myers Squibb, Bristol-Myers Squibb

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 30, 2022

Primary Completion (Estimated)

May 22, 2026

Study Completion (Estimated)

August 14, 2031

Study Registration Dates

First Submitted

October 4, 2021

First Submitted That Met QC Criteria

October 4, 2021

First Posted (Actual)

October 13, 2021

Study Record Updates

Last Update Posted (Actual)

May 27, 2026

Last Update Submitted That Met QC Criteria

May 26, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IM047-001
  • 2023-509248-86 (Other Identifier: EU CTR)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

BMS will provide access to individual anonymized participant data upon request from qualified researchers, and subject to certain criteria. Additional information regarding Bristol Myer Squibb's data sharing policy and process can be found at https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html

IPD Sharing Time Frame

See Plan Description

IPD Sharing Access Criteria

See Plan Description

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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