NCT05076175RecruitingPhase 2/3
A Study Investigating Oral Ozanimod (RPC1063) in Pediatric Participants With Moderate to Severe Active Ulcerative Colitis
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
Source: ClinicalTrials.gov · Last updated 20 Oct 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2/3
- Study type
- Interventional
- Enrollment
- 120 (estimated)
- First submitted
- 4 Oct 2021
- Start date
- 30 May 2022
- Primary completion date
- 12 Jul 2032
- Lead sponsor
- Bristol-Myers Squibb
- Diseases
- Ulcerative colitis
- NCT number
- NCT05076175
- EudraCT number
- 2023-509248-86
What you commit to
- Study type: Interventional · Phase 2/3
- Planned participants: 120
- From 30 May 2022 to the primary completion date, 12 Jul 2032
- 91 sites in 13 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Diagnosis of Crohn's disease or indeterminate colitis
- History of or currently active primary or secondary immunodeficiency, or participants with known genetic disorders as a cause for colitis
Other
- Has documentation of positive test for toxin producing Clostridium difficile, or polymerase chain reaction examination of the stool
- Apheresis within 2 weeks of randomization
- Other protocol-defined inclusion/exclusion criteria apply
Who the study is looking for
- 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
Age in the registry: 2 years to 17 years · Sex: All · Does not accept healthy volunteers
Sites (91)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Monash Health Coordinator of this site? Confirm its status | Clayton | Australia | Recruiting |
| Local Institution - 0086 Coordinator of this site? Confirm its status | Murdoch | Australia | Withdrawn |
| Local Institution - 0106 Coordinator of this site? Confirm its status | Nedlands | Australia | Not yet recruiting |
| The Children's Hospital at Westmead Coordinator of this site? Confirm its status | Westmead | Australia | Recruiting |
| Local Institution - 0056 Coordinator of this site? Confirm its status | Brussels | Belgium | Completed |
| Local Institution - 0076 Coordinator of this site? Confirm its status | Brussels | Belgium | Withdrawn |
| Local Institution - 0063 Coordinator of this site? Confirm its status | Edegem | Belgium | Not yet recruiting |
| UZ Leuven Coordinator of this site? Confirm its status | Leuven | Belgium | Recruiting |
| Local Institution - 0071 Coordinator of this site? Confirm its status | Liège | Belgium | Withdrawn |
| Centre Hospitalier Regional de la Citadelle Coordinator of this site? Confirm its status | Liège | Belgium | Recruiting |
| Local Institution - 0083 Coordinator of this site? Confirm its status | Hamilton | Canada | Withdrawn |
| The Hospital for Sick Children Coordinator of this site? Confirm its status | Toronto | Canada | Recruiting |
| Local Institution - 0104 Coordinator of this site? Confirm its status | Toronto | Canada | Withdrawn |
| Local Institution - 0031 Coordinator of this site? Confirm its status | Dresden | Germany | Completed |
| Universitatsklinikum Leipzig Coordinator of this site? Confirm its status | Leipzig | Germany | Recruiting |
| Local Institution - 0032 Coordinator of this site? Confirm its status | München | Germany | Completed |
| Local Institution - 0048 Coordinator of this site? Confirm its status | Badalona | Spain | Completed |
| Local Institution - 0051 Coordinator of this site? Confirm its status | Esplugues de Llobregat | Spain | Completed |
| Local Institution - 0057 Coordinator of this site? Confirm its status | Madrid | Spain | Completed |
| Local Institution - 0050 Coordinator of this site? Confirm its status | Madrid | Spain | Withdrawn |
| Local Institution - 0044 Coordinator of this site? Confirm its status | Madrid | Spain | Completed |
| Local Institution - 0022 Coordinator of this site? Confirm its status | Bron | France | Completed |
| Centre Hospitalier Universitaire de Caen - Hôpital Côte de Nacre Coordinator of this site? Confirm its status | Caen | France | Recruiting |
| Local Institution - 0073 Coordinator of this site? Confirm its status | Paris | France | Withdrawn |
| Local Institution - 0017 Coordinator of this site? Confirm its status | Paris | France | Completed |
| CHU de Toulouse - Hôpital des Enfants Coordinator of this site? Confirm its status | Toulouse | France | Recruiting |
| Birmingham Children's Hospital Coordinator of this site? Confirm its status | Birmingham | United Kingdom | Recruiting |
| Barts Health NHS Trust Coordinator of this site? Confirm its status | London | United Kingdom | Recruiting |
| Local Institution - 0105 Coordinator of this site? Confirm its status | London | United Kingdom | Not yet recruiting |
| King's College Hospital Coordinator of this site? Confirm its status | London | United Kingdom | Recruiting |
| Rambam Health Care Campus Coordinator of this site? Confirm its status | Haifa | Israel | Recruiting |
| Shaare Zedek Medical Center Coordinator of this site? Confirm its status | Jerusalem | Israel | Recruiting |
| Schneider Children's Medical Center Coordinator of this site? Confirm its status | Petah Tikva | Israel | Recruiting |
| Institute of Science Tokyo Hospital Coordinator of this site? Confirm its status | Bunkyo-ku | Japan | Recruiting |
| Hiroshima University Hospital Coordinator of this site? Confirm its status | Hiroshima | Japan | Recruiting |
| Komatsu Municipal Hospital Coordinator of this site? Confirm its status | Komatsu | Japan | Recruiting |
| Kurume University Hospital Coordinator of this site? Confirm its status | Kurume-shi | Japan | Recruiting |
| Aichi Children's Health and Medical Center Coordinator of this site? Confirm its status | Ōbu | Japan | Recruiting |
| National Center for Child Health and Development Coordinator of this site? Confirm its status | Setagaya-Ku | Japan | Recruiting |
| Tokyo Medical University Hospital Coordinator of this site? Confirm its status | Shinjuku-ku | Japan | Recruiting |
| Osaka Medical and Pharmaceutical University Hospital Coordinator of this site? Confirm its status | Takatsuki | Japan | Recruiting |
| Juntendo University Hospital Coordinator of this site? Confirm its status | Tokyo | Japan | Recruiting |
| Saiseikai Yokohamashi Tobu Hospital Coordinator of this site? Confirm its status | Yokohama | Japan | Recruiting |
| Local Institution - 0079 Coordinator of this site? Confirm its status | Gdansk | Poland | Withdrawn |
| Local Institution - 0013 Coordinator of this site? Confirm its status | Gdansk | Poland | Withdrawn |
| Local Institution - 0084 Coordinator of this site? Confirm its status | Krakow | Poland | Withdrawn |
| Local Institution - 0092 Coordinator of this site? Confirm its status | Lodz | Poland | Completed |
| Local Institution - 0015 Coordinator of this site? Confirm its status | Rzeszów | Poland | Withdrawn |
| Twoja Przychodnia SCM Coordinator of this site? Confirm its status | Szczecin | Poland | Recruiting |
| WIP Warsaw IBD Point Profesor Kierkus Coordinator of this site? Confirm its status | Warsaw | Poland | Recruiting |
| Centrum Zdrowia Dziecka w Warszawie Coordinator of this site? Confirm its status | Warsaw | Poland | Recruiting |
| Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego we Wrocławiu Coordinator of this site? Confirm its status | Wroclaw | Poland | Recruiting |
| Clinical Research Puerto Rico Coordinator of this site? Confirm its status | San Juan | Puerto Rico | Recruiting |
| Local Institution Coordinator of this site? Confirm its status | Moscow | Russia | Withdrawn |
| Local Institution Coordinator of this site? Confirm its status | Moskva | Russia | Withdrawn |
| Local Institution - 0016 Coordinator of this site? Confirm its status | Atlanta | United States | Completed |
| Boston Children's Hospital Coordinator of this site? Confirm its status | Boston | United States | Recruiting |
| University of North Carolina Medical Center Coordinator of this site? Confirm its status | Chapel Hill | United States | Withdrawn |
| Local Institution - 0099 Coordinator of this site? Confirm its status | Charleston | United States | Not yet recruiting |
| Local Institution - 0047 Coordinator of this site? Confirm its status | Charlotte | United States | Completed |
| Cleveland Clinic Coordinator of this site? Confirm its status | Cleveland | United States | Recruiting |
| Local Institution - 0093 Coordinator of this site? Confirm its status | Detroit | United States | Completed |
| Local Institution - 0103 Coordinator of this site? Confirm its status | Fort Worth | United States | Not yet recruiting |
| Local Institution - 0052 Coordinator of this site? Confirm its status | Garden Grove | United States | Completed |
| Local Institution - 0007 Coordinator of this site? Confirm its status | Hartford | United States | Completed |
| Local Institution - 0045 Coordinator of this site? Confirm its status | Hershey | United States | Completed |
| Texas Children's Hospital Coordinator of this site? Confirm its status | Houston | United States | Recruiting |
| Local Institution - 0100 Coordinator of this site? Confirm its status | Indianapolis | United States | Not yet recruiting |
| Local Institution - 0049 Coordinator of this site? Confirm its status | Iowa City | United States | Completed |
| Loma Linda University Health System Coordinator of this site? Confirm its status | Loma Linda | United States | Recruiting |
| Cedars-Sinai Medical Center Coordinator of this site? Confirm its status | Los Angeles | United States | Recruiting |
| Local Institution - 0037 Coordinator of this site? Confirm its status | Milwaukee | United States | Completed |
| Columbia University Medical Center Coordinator of this site? Confirm its status | New York | United States | Recruiting |
| Local Institution - 0028 Coordinator of this site? Confirm its status | New York | United States | Completed |
| Local Institution - 0023 Coordinator of this site? Confirm its status | New York | United States | Withdrawn |
| Local Institution - 0062 Coordinator of this site? Confirm its status | Oklahoma City | United States | Withdrawn |
| Local Institution - 0075 Coordinator of this site? Confirm its status | Orlando | United States | Completed |
| Lucile Packard Children's Hospital Coordinator of this site? Confirm its status | Palo Alto | United States | Not yet recruiting |
| Local Institution - 0101 Coordinator of this site? Confirm its status | Park Ridge | United States | Not yet recruiting |
| Local Institution - 0041 Coordinator of this site? Confirm its status | Phoenix | United States | Withdrawn |
| Maine Medical Partners Coordinator of this site? Confirm its status | Portland | United States | Not yet recruiting |
| Mayo Clinic in Rochester, Minnesota Coordinator of this site? Confirm its status | Rochester | United States | Recruiting |
| University of California Davis Health Coordinator of this site? Confirm its status | Sacramento | United States | Recruiting |
| Local Institution - 0091 Coordinator of this site? Confirm its status | Seattle | United States | Completed |
| Seattle Children's Hospital Coordinator of this site? Confirm its status | Seattle | United States | Recruiting |
| Local Institution - 0042 Coordinator of this site? Confirm its status | Springfield | United States | Completed |
| Washington University Coordinator of this site? Confirm its status | St Louis | United States | Recruiting |
| MultiCare Health System Coordinator of this site? Confirm its status | Tacoma | United States | Recruiting |
| University of Arizona Coordinator of this site? Confirm its status | Tucson | United States | Withdrawn |
| Local Institution - 0064 Coordinator of this site? Confirm its status | Washington D.C. | United States | Completed |
| University of Massachusetts Chan Medical School Coordinator of this site? Confirm its status | Worcester | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.