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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental: Etrasimod 2mg | Experimental | 2mg/tablet, administratered orally, once daily |
|
| Placebo Comparator: Placebo | Placebo Comparator | matching tablet, administratered orally, once daily |
|
| Etrasimod 2mg (optional open-label extension period) | Experimental | 2mg/tablet, administratered orally, once daily |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Etrasimod | Drug | Drug:Etrasimod Tablet other name:APD334 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of Subjects With Clinical Remission Assessed by modified Mayo score(mMS) | Clinical remission per mMS(endoscopy, rectal bleeding, stool frequency), ranging from 0-9 (normal to severe) | induction period week 12 |
| Proportion of Subjects With Clinical Remission Assessed by modified Mayo score(mMS) | Clinical remission per mMS, ranging from 0-9 (normal to severe) | Maintenance period week 40 |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of Subjects Achieving Endoscopic Improvement Assessed by endoscopic subscore | Endoscopic improvement per endoscopy subscore, ranging from 0 to 3 (normal to severe) | induction period week 12 |
| Proportion of Subjects with Clinical Response Assessed by modified Mayo score(mMS) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kaichun Wu | The First Affiliated Hospital of Fourth Military Medical University, PLA | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Affiliated Hospital of Fourth Military Medical University, PLA | Xi’an | Shanxi | 710032 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41043449 | Derived | 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. | |
| 39778975 |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Jul 8, 2025 | |
| Unrelease | Jul 8, 2025 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Jul 8, 2025 | Jul 8, 2025 |
| ID | Term |
|---|---|
| C000656249 | etrasimod |
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| Placebo | Drug | Drug:placebo Tablet |
|
Clinical response per mMS, ranging from 0 to 9 (normal to severe). |
| induction period Week 12 |
| Proportion of Subjects Achieving Endoscopic Improvement Assessed by endoscopic subscore | Endoscopic improvement per endoscopy subscore, ranging from 0 to 3 (normal to severe) | Maintenance period Week 40 |
| Proportion of Subjects with Clinical Response Assessed by modified Mayo score(mMS) | Clinical response per mMS, ranging from 0 to 9 (normal to severe) | Maintenance period Week 40 |
| Proportion of Subjects who achieve symptomatic response over time | Symptomatic response per paritial Mayo score(rectal bleeding, stool frequency), ranging from 0-6(normal to severe) | Open label treatment period up to 40 Weeks |
| Proportion of Subjects who achieve Symptomatic Remission over time | Symptomatic remission per paritial Mayo score, ranging from 0-6(normal to severe) | Open label treatment period up to 40 Weeks |
| Derived |
| 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. |