A Phase 2/3 interventional study of Ozanimod in Colitis, Ulcerative, sponsored by Bristol-Myers Squibb. Recruiting at 91 sites in 13 countries. Open to participants aged 2 Years to 17 Years. Per ClinicalTrials.gov, last updated 2026-10-20.
Sponsored by Bristol-Myers Squibb · Phase 2/3, Interventional, and Treatment
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.
1,853 studies on the registry are indexed under Colitis, Ulcerative; 472 are open to participants now.
This study's planned enrollment of 120 is above the median of 70 across 1,236 interventional studies indexed under Colitis, Ulcerative.
Browse Colitis, Ulcerative studies →Bristol-Myers Squibb is the lead sponsor of 1,561 studies on the registry; 117 are open to participants now.
Of its 436 completed or terminated interventional studies of FDA-regulated products, 228 (52%) have results posted.
Counted across the registry records on this site, refreshed daily.
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Exclusion Criteria
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Drug: Ozanimod
Drug: Ozanimod
Specified dose on specified days
Also known as: RPC1063
Proportion of participants who achieve clinical remission
Time frame: At Week 52
Proportion of participants who achieve clinical remission
Time frame: At Week 10
Proportion of participants who achieve clinical response
Time frame: At Week 52
Proportion of participants who achieve clinical response
Time frame: At Week 10
Proportion of participants who achieve symptomatic remission
Time frame: At Week 10 and Week 52
Time to achievement of symptomatic remission
Time frame: Up to 6 years
Proportion of participants who achieve endoscopic improvement
Time frame: At Week 10 and Week 52
Proportion of participants who achieve corticosteroid free remission
Time frame: At Week 52
Incidence of Adverse Events (AEs)
Time frame: Up to 6 years
Incidence of Serious Adverse Events
Time frame: Up to 6 years
Incidence of AEs leading to discontinuation from treatment
Time frame: Up to 6 years
Incidence of AEs of special interest (AESIs)
Time frame: 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
Absolute change from baseline in Absolute Lymphocyte Count (ALC)
Time frame: Up to 6 years
Percent change from baseline in ALC
Time frame: Up to 6 years
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Plan to share: 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
Supporting information: Study protocol, Statistical analysis plan, Clinical study report
Time frame: See Plan Description
Access criteria: See Plan Description
Data sharing details ↗ · www.bms.com
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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Studies of the drug tested here: Ozanimod