Colitis, UlcerativePhase 2/3NCT05076175
A Study Investigating Oral Ozanimod (RPC1063) in Pediatric Participants With Moderate to Severe Active Ulcerative Colitis
A Phase 2/3 study testing Ozanimod in people with Colitis, Ulcerative, run by Bristol-Myers Squibb at 91 sites in 13 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 2 to 17 years
- Conditions the study is for
- Colitis, Ulcerative
- What is being tested?
- Ozanimod
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 91 sitesin 13 countries
- Study dates
- 30 May 2022to 12 Jul 2032
- Phase
- Phase 2/3
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
91 sites in 13 countries. Contact the study team or a site near you to ask about taking part.
BMS Clinical Trials Contact Center www.BMSClinicalTrials.com contact
First line of the email MUST contain NCT # and Site #. contact
91 sites in 13 countries
United States36 sites, 18 recruiting
- Completed
Local Institution - 0016
Atlanta, Georgia, 30342
- Recruiting
Boston Children's Hospital
Boston, Massachusetts, 02115
Athos Bousvaros, Site 0005, 617-699-1021
- Withdrawn
University of North Carolina Medical Center
Chapel Hill, North Carolina, 27599
- Not yet recruiting
Local Institution - 0099
Charleston, South Carolina, 29425
Site 0099
- Completed
Local Institution - 0047
Charlotte, North Carolina, 28203
- Recruiting
Cleveland Clinic
Cleveland, Ohio, 44124
Jessica Barry, Site 0036, 216444231
- Completed
Local Institution - 0093
Detroit, Michigan, 48201
- Not yet recruiting
Local Institution - 0103
Fort Worth, Texas, 76104
Site 0103
- Completed
Local Institution - 0052
Garden Grove, California, 92845
- Completed
Local Institution - 0007
Hartford, Connecticut, 06106
- Completed
Local Institution - 0045
Hershey, Pennsylvania, 17033
- Recruiting
Texas Children's Hospital
Houston, Texas, 77030
Lina Karam, Site 0067, 832-822-3612
- Not yet recruiting
Local Institution - 0100
Indianapolis, Indiana, 46202
Site 0100
- Completed
Local Institution - 0049
Iowa City, Iowa, 52242
- Recruiting
Loma Linda University Health System
Loma Linda, California, 92354
Kalyan Ray Parashette, Site 0087, 505-274-0704
- Recruiting
Cedars-Sinai Medical Center
Los Angeles, California, 90048
Shervin Rabizadeh, Site 0074, 310-423-7100
- Completed
Local Institution - 0037
Milwaukee, Wisconsin, 53226
- Completed
Local Institution - 0028
New York, New York, 10029
- Recruiting
Columbia University Medical Center
New York, New York, 10032
JOSEPH PICORARO, Site 0040, 212-305-5903
- Withdrawn
Local Institution - 0023
New York, New York, 10065
- Withdrawn
Local Institution - 0062
Oklahoma City, Oklahoma, 73112
- Completed
Local Institution - 0075
Orlando, Florida, 32803
- Not yet recruiting
Lucile Packard Children's Hospital
Palo Alto, California, 94304
Jonathan Moses, Site 0080, 650-721-2250
- Not yet recruiting
Local Institution - 0101
Park Ridge, Illinois, 60068
Site 0101
- Withdrawn
Local Institution - 0041
Phoenix, Arizona, 85016-7710
- Not yet recruiting
Maine Medical Partners
Portland, Maine, 04102
Noah Hoffman, Site 0090, 207-662-5522
- Recruiting
Mayo Clinic in Rochester, Minnesota
Rochester, Minnesota, 55905
Michael Stephens, Site 0070, 111111
- Recruiting
University of California Davis Health
Sacramento, California, 95817
Trinh Truong, Site 0096, 310-597-1251
- Recruiting
Seattle Children's Hospital
Seattle, Washington, 98105
Ghassan Wahbeh, Site 0060, 111111
- Completed
Local Institution - 0091
Seattle, Washington, 98122
- Completed
Local Institution - 0042
Springfield, Massachusetts, 01199
- Recruiting
Washington University
St Louis, Missouri, 63110
Charles Samson, Site 0053, 513-518-8949
- Recruiting
MultiCare Health System
Tacoma, Washington, 98405
Raghu Varier, Site 0046, 503-847-4748
- Withdrawn
University of Arizona
Tucson, Arizona, 85724
- Completed
Local Institution - 0064
Washington D.C., District of Columbia, 20010
- Recruiting
University of Massachusetts Chan Medical School
Worcester, Massachusetts, 01655
Basavaraj Kerur, Site 0095, 774-441-8082
Japan10 sites, 10 recruiting
- Recruiting
Institute of Science Tokyo Hospital
Bunkyo-Ku, Tokyo, 113-8519
Toshimitsu Fujii, Site 0024, +81-3-5803-5877
- Recruiting
Hiroshima University Hospital
Hiroshima, 734-8551
Shiro Oka, Site 0069
- Recruiting
Komatsu Municipal Hospital
Komatsu, Ishikawa-ken, 923-8560
HISASHI KANEDA, Site 0068, 81-761-22-7111
- Recruiting
Kurume University Hospital
Kurume-shi, Fukuoka, 8300011
Tatsuki Mizuochi, Site 0011, +81-942-35-3311
- Recruiting
Aichi Children's Health and Medical Center
Ōbu, Aichi-ken, 474-8710
Naomi Iwata, Site 0025, 81562430500
- Recruiting
National Center for Child Health and Development
Setagaya-ku, Tokyo, 1578535
Katsuhiro Arai, Site 0009, +81-3-3416-0181
- Recruiting
Tokyo Medical University Hospital
Shinjuku-ku, Tokyo, 160-0023
Shigeo Nishimata, Site 0033, 81333426111
- Recruiting
Osaka Medical and Pharmaceutical University Hospital
Takatsuki, Osaka, 569-8686
Emiri Kaji, Site 0021, 81-726-83-1221
- Recruiting
Juntendo University Hospital
Tokyo, 113-8431
Takahiro Kudo, Site 0010, +81-3-3813-3111
- Recruiting
Saiseikai Yokohamashi Tobu Hospital
Yokohama, Kanagawa, 2300012
shuichiro umetsu, Site 0038, +81455763000
Poland9 sites, 4 recruiting
- Withdrawn
Local Institution - 0013
Gdansk, Pomeranian Voivodeship, 80-803
- Withdrawn
Local Institution - 0079
Gdansk, Pomeranian Voivodeship, 80-803
- Withdrawn
Local Institution - 0084
Krakow, Lesser Poland Voivodeship, 30-663
- Completed
Local Institution - 0092
Lodz, Łódź Voivodeship, 91-738
- Withdrawn
Local Institution - 0015
Rzeszów, Podkarpackie Voivodeship, 35-302
- Recruiting
Twoja Przychodnia SCM
Szczecin, West Pomeranian Voivodeship, 71-434
Beata Gawdis-Wojnarska, Site 0088, +48664929399
- Recruiting
WIP Warsaw IBD Point Profesor Kierkuś
Warsaw, Masovian Voivodeship, 00-728
Monika Meglicka, Site 0043, +48603508908
- Recruiting
Centrum Zdrowia Dziecka w Warszawie
Warsaw, Masovian Voivodeship, 04-746
Jaroslaw Kierkus, Site 0014, +48500111648
- Recruiting
Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego we Wrocławiu
Wroclaw, Lower Silesian Voivodeship, 50-369
Tomasz Pytrus, Site 0012, +48 71 7703045
Belgium6 sites, 3 recruiting
- Withdrawn
Local Institution - 0076
Brussels, Bruxelles-Capitale, Région de, 1090
- Completed
Local Institution - 0056
Brussels, 1090
- Not yet recruiting
Local Institution - 0063
Edegem, 2650
Site 0063
- Recruiting
UZ Leuven
Leuven, Vlaams-Brabant, 3000
Ilse Hoffman, Site 0059, 003216343343
- Recruiting
Centre Hospitalier Régional de la Citadelle
Liège, 4000
Emeline Bequet, Site 0061, 32 4321 54 67
- Withdrawn
Local Institution - 0071
Liège, 4000
France5 sites, 2 recruiting
- Completed
Local Institution - 0022
Bron, 69500
- Recruiting
Centre Hospitalier Universitaire de Caen - Hôpital Côte de Nacre
Caen, 14033
Claire Dupont-Lucas, Site 0030, 33668354806
- Completed
Local Institution - 0017
Paris, 75015
- Withdrawn
Local Institution - 0073
Paris, 75571
- Recruiting
CHU de Toulouse - Hôpital des Enfants
Toulouse, Haute-Garonne, 31059
EMMANUEL MAS, Site 0058, 0685946782
Spain5 sites
- Completed
Local Institution - 0048
Badalona, Barcelona [Barcelona], 08916
- Completed
Local Institution - 0051
Esplugues de Llobregat, Barcelona [Barcelona], 08950
- Completed
Local Institution - 0044
Madrid, Madrid, Comunidad de, 28009
- Completed
Local Institution - 0057
Madrid, 28007
- Withdrawn
Local Institution - 0050
Madrid, 28046
Australia4 sites, 3 recruiting
- Recruiting
Monash Health
Clayton, Victoria, 3168
Edward Giles, Site 0085, +61395943577
- Withdrawn
Local Institution - 0086
Murdoch, Western Australia, 6150
- Not yet recruiting
Local Institution - 0106
Nedlands, Western Australia, 6009
Site 0106
- Recruiting
The Children's Hospital at Westmead
Westmead, New South Wales, 2145
Shoma Dutt, Site 0094, 0298453999
United Kingdom4 sites, 4 recruiting
- Recruiting
Birmingham Children's Hospital
Birmingham, England, B4 6NH
Rafeeq Muhammed, Site 0054, +44 121 333 9999
- Recruiting
King's College Hospital
London, Greater London, SE5 9RS
Babu Vadamalayan, Site 0026, +44 20 3299 9000
- Not yet recruiting
Local Institution - 0105
London, Greater London, SW10 9NH
Site 0105
- Recruiting
Barts Health NHS Trust
London, London, City of, E1 1BB
Protima Deb, Site 0066, 02035941551
Canada3 sites, 1 recruiting
- Withdrawn
Local Institution - 0083
Hamilton, Ontario, L8N 3Z5
- Withdrawn
Local Institution - 0104
Toronto, Ontario, M3M 0B2
- Recruiting
The Hospital for Sick Children
Toronto, Ontario, M5G 1X8
Thomas Walters, Site 0082, 416-813-7734
Germany3 sites, 1 recruiting
- Completed
Local Institution - 0031
Dresden, 01307
- Recruiting
Universitätsklinikum Leipzig
Leipzig, Saxony, 04103
Gunter Flemming, Site 0097, +49-341-9726111
- Completed
Local Institution - 0032
München, Bavaria, 80337
Israel3 sites, 3 recruiting
- Recruiting
Rambam Health Care Campus
Haifa, Northern District, 3109601
Ron Shaoul, Site 0018, 04-7774381
- Recruiting
Shaare Zedek Medical Center
Jerusalem, Jerusalem, 9013102
Dan Turner, Site 0019, 02-6666482
- Recruiting
Schneider Children's Medical Center
Petah Tikva, Central District, 49202
Dror Shouval, Site 0020, 03-9253673
Russia2 sites
- Withdrawn
Local Institution
Moscow, 119991
- Withdrawn
Local Institution
Moskva, 119571
Puerto Rico1 site, 1 recruiting
- Recruiting
Clinical Research Puerto Rico
San Juan, 00909-1711
Antonio Del Valle-Segarra, Site 0098, 787-723-5945
About this study
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
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.
- Conditions
- Colitis, Ulcerative
- Being tested
- Ozanimod
- Keywords
- Ulcerative Colitis, Ozanimod, Pediatric
- Medical subject headings
- Colitis, Ulcerative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OzanimodDrug
Also called RPC1063
Specified dose on specified days
| Study group | Role | What they receive |
|---|---|---|
| Ozanimod High Dose | Experimental | Not described Receives: Drug: Ozanimod |
| Ozanimod Low Dose | Experimental | Not described Receives: Drug: Ozanimod |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of participants who achieve clinical remission
Measured: At Week 52
Secondary outcomes (14)
Proportion of participants who achieve clinical remission
Measured: At Week 10
Proportion of participants who achieve clinical response
Measured: At Week 52
Proportion of participants who achieve clinical response
Measured: At Week 10
Proportion of participants who achieve symptomatic remission
Measured: At Week 10 and Week 52
Time to achievement of symptomatic remission
Measured: Up to 6 years
Proportion of participants who achieve endoscopic improvement
Measured: At Week 10 and Week 52
Proportion of participants who achieve corticosteroid free remission
Measured: At Week 52
Incidence of Adverse Events (AEs)
Measured: Up to 6 years
Incidence of Serious Adverse Events
Measured: Up to 6 years
Incidence of AEs leading to discontinuation from treatment
Measured: Up to 6 years
Incidence of AEs of special interest (AESIs)
Measured: Up to 6 years
Steady state systemic exposure of ozanimod and CC112273
Measured: At Week 18 and throughout the study, up to 70 weeks
Absolute change from baseline in Absolute Lymphocyte Count (ALC)
Measured: Up to 6 years
Percent change from baseline in ALC
Measured: Up to 6 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2021
- Study start30 May 2022
- Primary completion12 Jul 2032 (estimated)
- Study completion12 Jul 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colitis, UlcerativeStudies of the same condition, open and under way.
- More trials run by Bristol-Myers SquibbThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bristol-Myers Squibb
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bristol-Myers Squibb, Study director, Bristol-Myers Squibb
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05076175
- Sponsor's protocol ID
- IM047-001
- Other IDs
- 2023-509248-86, 2023
- Status last verified
- Oct 2026
- First submitted
- 4 Oct 2021
- Last updated
- 20 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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