Phase 2
Completed N=199
Efficacy and Safety Study of Ozanimod in Ulcerative Colitis
Source: ClinicalTrials.gov NCT01647516 ↗Enrolled (actual)
199
Serious AEs
8.5%
Results posted
Oct 2020
Primary outcomePrimary: Percentage of Participants Who Achieved Clinical Remission Based on the Central Read of the Mayo Score (MS), at Week 8 — 6.2; 13.8; 16.4 Percentage of Participants — p=0.0482
Summary
The purpose of this study is to determine whether RPC1063 is effective in the treatment of ulcerative colitis (UC).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants Who Achieved Clinical Remission Based on the Central Read of the Mayo Score (MS), at Week 8 |
6.2; 13.8; 16.4 | 0.0482 sig |
| SECONDARY Percentage of Participants Who Achieved a Clinical Response in the Mayo Score (MS) at Week 8 |
36.9; 53.8; 56.7 | 0.0207 sig |
| SECONDARY Change From Baseline in Mayo Score at Week 8 |
-2.0; -2.6; -3.4 | 0.0042 sig |
| SECONDARY Percentage of Participants With Mucosal Healing at Week 8 |
12.3; 27.7; 34.3 | 0.0023 sig |
| SECONDARY Percentage of Participants Who Achieved Clinical Remission in the Mayo Score at Week 32 |
6.2; 26.2; 20.9 | 0.0108 sig |
| SECONDARY Percentage of Participants Who Achieved Clinical Response at Week 32 |
20.0; 35.4; 50.7 | 0.0002 sig |
| SECONDARY Percentage of Participants With Mucosal Healing at Week 32 |
12.3; 32.3; 32.8 | 0.0046 sig |
| SECONDARY Number of Participants With Treatment Emergent Adverse Events (TEAE) During the Induction Period |
21; 24; 17; 7; 12; 6 | — |
| SECONDARY Number of Participants With Treatment Emergent Adverse Events (TEAE) During the Maintenance Period |
8; 4; 11; 4; 1; 5 | — |
| SECONDARY Number of Participants With TEAE During the Open-Label Treatment Period (OLP) |
101; 63; 17; 27; 2; 27 | — |
Eligibility Criteria
Inclusion Criteria
- Ulcerative colitis (UC) confirmed on endoscopy
- Moderately to severely active UC (Mayo score 6-12)
Exclusion Criteria
- Current use of anti-TNF agents
Data sourced from ClinicalTrials.gov (NCT01647516). 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. Informational only — not medical advice.