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

Phase 2 Completed 54 enrolled Pfizer Arena is a wholly owned subsidiary of Pfizer · collab

RandomizedParallel-groupDouble-blindTreatment

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.

Timeline

Start: 2021-09-10
Primary completion: 2023-10-06
Completion: 2023-10-06

Outcome

Met primary endpoint

registry Placebo vs Etrasimod 2 mg; Difference in percentage 26.3 (95% CI 6.52 to 46.12) NCT05061446 ↗

Publications

Takeuchi K, Nakase H, Hisamatsu T, Matsuoka K, Arai S, Yuasa H, Oe M, Ono R, Keating M, Gu G, Lazin K, McDonnell A, Fukuta K, Hibi T. Efficacy and safety of etrasimod in Japanese patients with ulcerative colitis: results from a phase 2 dose-ranging study. Intest Res. 2026 Apr;24(2):352-365. doi: 10.5217/ir.2024.00213. Epub 2025 Apr 25.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Etrasimod	Small molecule	1 mg	Oral
Subject	Etrasimod	Small molecule	2 mg	Oral