A Phase 3, Multicenter, Open-Label Extension Trial of Oral RPC1063 as Therapy for Moderate to Severe Ulcerative Colitis
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Celgene
- Enrollment
- 877
- Locations
- 41
- Primary Endpoint
- Number of Participants Experiencing Treatment-Emergent Adverse Event (TEAEs)
Study Overview
Brief Summary
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
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
RPC0163 (Ozanimod)
Intervention: RPC1063 (Drug)
Outcomes
Primary Outcomes
Number of Participants Experiencing Treatment-Emergent Adverse Event (TEAEs)
Time Frame: From first dose to 90 days post last dose (Up to approximately 92 months)
Number of participants experiencing TEAEs, Serious TEAEs, TEAEs leading to discontinuation and TEAEs of special interest. TEAE is defined as any event with an onset date on or after the first dose date, or any ongoing event on the first dose date that worsens in severity on or after the first dose date, and until 90 days following the last dose of treatment with the study drug.
Secondary Outcomes
- Percentage of Participants With Clinical Remission(Week 46, 94, 142, 190, 238)
- Percentage of Participants With Clinical Response(Week 46, 94, 142, 190, 238)
- Percentage of Participants With Endoscopic Improvement(Week 46, 94, 142, 190, 238)
- Percentage of Participants With Corticosteroid-free Remission(Week 46, 94, 142, 190, 238)
- Percentage of Participants With Histologic Remission(Week 46, 94, 142, 190, 238)
- Change From Baseline in Partial Mayo Score(Baseline, week 46, 94, 142, 190, 238, 286, 334, 382)
- Percentage of Participants With Mucosal Healing(Week 46, 94, 142, 190, 238)
- Percentage of Participants Who Had Previously Received Anti-TNF Therapy With Clinical Response(Week 46, 94, 142, 190, 238)
- Change From Baseline in Complete Mayo Score(Baseline, week 46, 94, 142, 190, 238, 286, 334, 382)
- Change From Baseline in 9-Point Mayo Score(Baseline, week 46, 94, 142, 190, 238, 286, 334, 382)
- Percentage of Participants Who Had Previously Received Anti-TNF Therapy With Clinical Remission(Week 46, 94, 142, 190, 238)
- Percentage of Participants Who Had Previously Received Anti-TNF Therapy With Endoscopic Improvement(Week 46, 94, 142, 190, 238)