Overview

Etrasimod Dose-Ranging Versus Placebo as Induction Therapy Study in Adult Japanese Subjects With Moderately to Severely Active Ulcerative Colitis

Status:
Not yet recruiting
Trial end date:
2023-12-01
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Arena Pharmaceuticals
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