Phase 2
Completed N=54
Etrasimod Dose-Ranging Versus Placebo as Induction Therapy Study in Adult Japanese Subjects With Moderately to Severely Active Ulcerative Colitis
Source: ClinicalTrials.gov NCT05061446 ↗Enrolled (actual)
54
Serious AEs
0.0%
Results posted
Oct 2024
Primary outcomePrimary: Percentage of Participants Who Achieved Clinical Remission at Week 12 — 0; 6.7; 26.3 Percentage of participants
Summary
The purpose of this Japan-only study is to assess the safety and efficacy of etrasimod at 2 doses in Japanese subjects with moderately to severely active ulcerative colitis (UC) when administered for 12 weeks.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants Who Achieved Clinical Remission at Week 12 |
0; 6.7; 26.3 | — |
| SECONDARY Percentage of Participants Who Achieved Endoscopic Improvement at Week 12 |
0; 6.7; 26.3 | — |
| SECONDARY Percentage of Participants Who Achieved Symptomatic Remission at Week 12 |
0; 20.0; 31.6 | — |
| SECONDARY Percentage of Participants Who Achieved Mucosal Healing at Week 12 |
0; 6.7; 5.3 | — |
| SECONDARY Percentage of Participants Who Achieved Clinical Response at Week 12 |
7.1; 33.3; 52.6 | — |
| SECONDARY Percentage of Participants Who Achieved Endoscopic Normalization at Week 12 |
0; 0; 0 | — |
Eligibility Criteria
Inclusion Criteria
- Japanese ancestry
- Diagnosed with ulcerative colitis (UC) ≥ 3 months prior to screening
- Having active UC confirmed by endoscopy
- Moderately to severely active UC
Exclusion Criteria
- Severe extensive colitis
- Diagnosis of Crohn's disease (CD) or indeterminate colitis or the presence, history of a fistula consistent with CD
- Diagnosis of microscopic colitis, ischemic colitis, or infectious colitis
Data sourced from ClinicalTrials.gov (NCT05061446). 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.