A Phase 3 Study of Etrasimod in Subjects With Moderately to Severely Active Ulcerative Colitis
Summary
The purpose of this study is to determine whether etrasimod is a safe and effective treatment for moderately to severely active ulcerative colitis. Condition or disease: Ulcerative Colitis Intervention/treatment: Drug: Etrasimod Drug: Placebo Phase: Phase 3
Timeline
- Start
- 2019-09-10
- Primary completion
- 2024-07
- Completion
- 2024-10
Outcome
Met primary endpoint
paper A significantly greater proportion of patients treated with etrasimod than those treated with placebo, showed clinical remission at induction week 12 PMID 41043449 ↗
paper clinical remission at induction week 12 (57 [25·0%] of 228 patients vs six [5·4%] of 112 patients; adjusted difference 20·4%; 95% CI 13·4%-27·4%; p<0·0001) PMID 41043449 ↗
paper maintenance period week 40 (37 [48·1%] of 77 patients vs 10 [12·5%] of 80 patients; adjusted difference 35·9%; 95% CI 22·5%-49·2%; p<0·0001) PMID 41043449 ↗
Publications
- Wu K, Zheng C, Cao Q, Ding Y, Gao X, Zhong J, Chiu CT, Zhang H, Wang X, Wang B, Liang J, Liu X, Zhou Y, Xu B, Kim TO, Shen X, Chen D, Chen W, Liu Y, Shen J, Liu F, Ding X, Zhan Q, Chou JW, Zeng S, Lin Y, Ying L, Chen X; ENLIGHT UC Study Group. Etrasimod as induction and maintenance treatment for patients with moderately to severely active ulcerative colitis in East Asia (ENLIGHT UC): a randomised, double-blind, placebo-controlled, multicentre, phase 3 study. Lancet Gastroenterol Hepatol. 2025 Dec;10(12):1089-1103. doi: 10.1016/S2468-1253(25)00198-0. Epub 2025 Sep 30.
- Vermeire S, Rubin DT, Peyrin-Biroulet L, Dubinsky MC, Regueiro M, Irving PM, Goetsch M, Lazin K, Gu G, Wu J, Modesto I, McDonnell A, Guo X, Green J, Dalam AB, Yarur AJ. Cardiovascular events observed among patients in the etrasimod clinical programme: an integrated safety analysis of patients with moderately to severely active ulcerative colitis. BMJ Open Gastroenterol. 2025 Jan 8;12(1):e001516. doi: 10.1136/bmjgast-2024-001516.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Etrasimod | Small molecule | 2 mg | — |