A Phase 3 Study of Etrasimod in Subjects With Moderately to Severely Active Ulcerative Colitis

Conditions

Moderately to Severely Active Ulcerative Colitis

Brief 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

C Zheng, Q Cao, Y Ding, X Gao, J Zhong et al. (12 authors)

Journal of Crohn s and Colitis2026-01-01

10.1093/ecco-jcc/jjaf231.1046

P0717 Disease Clearance with Etrasimod in Asian Patients with Moderately to Severely Active Ulcerative Colitis: A Post Hoc Analysis of the Phase 3 ENLIGHT UC Trial

H Zhang, C Zheng, Q Cao, Y Ding, X Gao et al. (12 authors)

Journal of Crohn s and Colitis2026-01-01

10.1093/ecco-jcc/jjaf231.898

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.

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.

2025-09-301 citations

10.1016/s2468-1253(25)00198-0

Cardiovascular events observed among patients in the etrasimod clinical programme: an integrated safety analysis of patients with moderately to severely active ulcerative colitis

Séverine Vermeire, David T. Rubin, Laurent Peyrin-Biroulet, Marla C. Dubinsky, Miguel Regueiro et al. (16 authors)

BMJ Open Gastroenterology2025-01-019 citations

10.1136/bmjgast-2024-001516

DOP052 Etrasimod as induction and maintenance therapy in Asian patients with moderately to severely active Ulcerative Colitis: Results from the maintenance period of a randomised, double-blind, placebo-controlled, multi-centre Phase 3 study (ES101002)

Kaichun Wu, Chuansheng Zheng, Qian Cao, Xiang Gao, Yingying Ding et al. (32 authors)

Journal of Crohn s and Colitis2025-01-013 citations

10.1093/ecco-jcc/jjae190.0091

Low Incidence of Macular Edema and Other Ocular Events in the Etrasimod Development Program

Marla C. Dubinsky, Joseph Wu, Aoibhinn McDonnell, Krisztina Lazin, Martina Goetsch et al. (8 authors)

Journal of Crohn s and Colitis2024-11-224 citations

10.1093/ecco-jcc/jjae173

S905 Impact of Etrasimod on Blood Pressure and Hypertension: Data From the Etrasimod Ulcerative Colitis Clinical Program

Séverine Vermeire, David T. Rubin, Laurent Peyrin‐Biroulet, Marla C. Dubinsky, Miguel Regueiro et al. (14 authors)

The American Journal of Gastroenterology2023-10-011 citations

10.14309/01.ajg.0000953260.59351.c7

S1072 Hepatic Impact of Etrasimod for Treatment of Moderately to Severely Active Ulcerative Colitis: An Integrated Safety Summary From the Etrasimod Ulcerative Colitis Clinical Program

Miguel Regueiro, Séverine Vermeire, David T. Rubin, Marla C. Dubinsky, Ailsa Hart et al. (12 authors)

The American Journal of Gastroenterology2023-10-011 citations

10.14309/01.ajg.0000953928.95275.b5

P490 Etrasimod for the treatment of ulcerative colitis: up to 2.5 years of pooled safety data from global clinical trials

Séverine Vermeire, Laurent Peyrin‐Biroulet, Julián Panés, Miguel Regueiro, Paulo Gustavo Kotze et al. (12 authors)

Journal of Crohn s and Colitis2023-01-3011 citations

10.1093/ecco-jcc/jjac190.0620

Interventions

DRUGEtrasimod

Drug:Etrasimod Tablet other name:APD334

DRUGPlacebo

Drug:placebo Tablet

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

No

Inclusion criteria

1. A documented of diagnosis with UC at least 3 months prior to screening. 2. Have active UC confirmed by endoscopy with ≥ 10 cm rectal involved.

Exclusion criteria

1. Have severe extensive colitis 2. Diagnosis of Crohn's disease or indeterminate colitis or the presence or history of a fistula consistent with Crohn's disease 3. Diagnosis of microscopic colitis, ischemic colitis, infection colitis or colonic mucosal dysplasia

Design outcomes

Primary

Measure	Time frame	Description
Proportion of Subjects With Clinical Remission Assessed by modified Mayo score(mMS)	induction period week 12	Clinical remission per mMS(endoscopy, rectal bleeding, stool frequency), ranging from 0-9 (normal to severe)

Secondary

Measure	Time frame	Description
Proportion of Subjects Achieving Endoscopic Improvement Assessed by endoscopic subscore	induction period week 12	Endoscopic improvement per endoscopy subscore, ranging from 0 to 3 (normal to severe)
Proportion of Subjects with Clinical Response Assessed by modified Mayo score(mMS)	induction period Week 12	Clinical response per mMS, ranging from 0 to 9 (normal to severe).
Proportion of Subjects who achieve symptomatic response over time	Open label treatment period up to 40 Weeks	Symptomatic response per paritial Mayo score(rectal bleeding, stool frequency), ranging from 0-6(normal to severe)
Proportion of Subjects who achieve Symptomatic Remission over time	Open label treatment period up to 40 Weeks	Symptomatic remission per paritial Mayo score, ranging from 0-6(normal to severe)

Countries

China

Outcome results

None listed