An Extension Study of RPC1063 as Therapy for Moderate to Severe Ulcerative Colitis

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the long-term safety and efficacy of RPC1063 in participants with moderately to severely active ulcerative colitis. Only those participants who have previously participated in a trial of RPC1063, being either RPC01-3101 or completed at least 1 year of the open-label period of RPC01-202 will be eligible.

Detailed Description
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This is an extension study trial. Eligible participants from the RPC01-3101 and RPC01-202 trials were able to roll-over in this trial to receive study medication until March 2023 or until the Sponsor discontinues the development program, whichever comes first.

Official Title
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A Phase 3, Multicenter, Open-Label Extension Trial of Oral RPC1063 as Therapy for Moderate to Severe Ulcerative Colitis

Conditions
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Ulcerative Colitis

Intervention / Treatment
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* Drug: RPC1063


Participation Criteria
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Eligibility Criteria
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For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit: www.BMSStudyConnect.com Inclusion Criteria: • Previously participated in a trial of RPC1063 and meets the criteria for participation in the open-label extension as outlined in the prior trial Exclusion Criteria: Receiving treatment with breast cancer resistance protein inhibitors Clinically relevant cardiovascular conditions Liver function impairment Other protocol-defined inclusion/exclusion criteria apply

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: RPC0163 (Ozanimod)<br> | Drug: RPC1063<br> <br> * Other names: Ozanimod;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants with Treatment Emergent Adverse Events (TEAEs) |  | From enrollment until at least 90 days after completion of study treatment | 
| Number of Participants with Adverse Events (AEs) |  | From enrollment until at least 90 days after completion of study treatment | 
| Number of Participants with Serious Adverse Events (SAEs) |  | From enrollment until at least 90 days after completion of study treatment | 
| Number of Participants with TEAEs Leading to Discontinuation of Investigational Drug |  | From enrollment until at least 90 days after completion of study treatment | 
| Number of Participants with Adverse Events of Special Interest |  | From enrollment until at least 90 days after completion of study treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of participants with clinical remission |  | Up to 6 years | 
| Proportion of participants with a clinical response |  | Up to 6 years | 
| Proportion of participants with endoscopic improvement |  | Up to 6 years | 
| Proportion of participants with mucosal healing |  | Up to 6 years | 
| Proportion of participants with corticosteroid-free remission |  | Up to 6 years | 
| Change from Baseline in complete Mayo score |  | Up to 6 years | 
| Change from Baseline in partial Mayo score |  | Up to 6 years | 
| Change from Baseline in 9-point Mayo score |  | Up to 6 years | 
| Proportion of participants with histologic remission |  | Up to 6 years | 
| Proportion of participants with clinical response in participants who had previously received anti-TNF therapy |  | Up to 6 years | 
| Proportion of participants with clinical remission in participants who had previously received anti-TNF therapy |  | Up to 6 years | 
| Proportion of participants with endoscopic improvement in participants who had previously received anti-TNF therapy |  | Up to 6 years |