Phase 3
N=877
An Extension Study of RPC1063 as Therapy for Moderate to Severe Ulcerative Colitis
Ulcerative Colitis
Bottom Line
View on ClinicalTrials.gov: NCT02531126 ↗Enrolled (actual)
877
Serious AEs
17.0%
Results posted
Dec 2025
Primary outcome: Primary: Number of Participants Experiencing Treatment-Emergent Adverse Event (TEAEs) — 139; 160; 342; 37 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- RPC1063 (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Celgene
- Primary completion
- Dec 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants Experiencing Treatment-Emergent Adverse Event (TEAEs) |
139; 160; 342; 37; 24; 41 | — |
| SECONDARY Percentage of Participants With Clinical Remission |
41.6; 62.9; 44.0; 57.8; 59.0; 50.5 | — |
| SECONDARY Percentage of Participants With Clinical Response |
81.8; 89.7; 77.0; 84.1; 92.9; 83.9 | — |
| SECONDARY Percentage of Participants With Endoscopic Improvement |
51.2; 72.0; 49.7; 41.4; 60.6; 66.9 | — |
| SECONDARY Percentage of Participants With Corticosteroid-free Remission |
40.7; 53.6; 38.0; 52.2; 49.6; 41.6 | — |
| SECONDARY Percentage of Participants With Histologic Remission |
19.4; 30.5; 25.4; 48.1; 22.6; 36.4 | — |
| SECONDARY Percentage of Participants With Mucosal Healing |
14.8; 27.0; 20.4; 25.9; 19.0; 34.5 | — |
| SECONDARY Change From Baseline in Complete Mayo Score |
-3.5; -2.9; -1.8; -3.7; -2.7; -2.2 | — |
| SECONDARY Change From Baseline in Partial Mayo Score |
-2.8; -2.2; -1.4; -2.9; -2.1; -1.8 | — |
| SECONDARY Change From Baseline in 9-Point Mayo Score |
-2.4; -2.1; -1.3; -2.5; -1.8; -1.5 | — |
| SECONDARY Percentage of Participants Who Had Previously Received Anti-TNF Therapy With Clinical Remission |
19.2; 44.4; 31.4; 46.7; 52.0; 43.8 | — |
| SECONDARY Percentage of Participants Who Had Previously Received Anti-TNF Therapy With Clinical Response |
64.0; 71.4; 74.1; 64.3; 95.8; 84.1 | — |
| SECONDARY Percentage of Participants Who Had Previously Received Anti-TNF Therapy With Endoscopic Improvement |
28.6; 55.3; 37.5; 50.0; 50.0; 66.7 | — |
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT02531126). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.