A Phase 3 Study of Etrasimod in Subjects With Moderately to Severely Active Ulcerative Colitis
NCT ID: NCT04176588
Last Updated: 2024-01-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE3
341 participants
INTERVENTIONAL
2019-09-10
2024-10-31
Brief Summary
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Condition or disease: Ulcerative Colitis Intervention/treatment: Drug: Etrasimod Drug: Placebo Phase: Phase 3
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Experimental: Etrasimod 2mg
2mg/tablet, administratered orally, once daily
Etrasimod
Drug:Etrasimod Tablet other name:APD334
Placebo Comparator: Placebo
matching tablet, administratered orally, once daily
Placebo
Drug:placebo Tablet
Etrasimod 2mg (optional open-label extension period)
2mg/tablet, administratered orally, once daily
Etrasimod
Drug:Etrasimod Tablet other name:APD334
Interventions
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Etrasimod
Drug:Etrasimod Tablet other name:APD334
Placebo
Drug:placebo Tablet
Eligibility Criteria
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Inclusion Criteria
2. Have active UC confirmed by endoscopy with ≥ 10 cm rectal involved.
Exclusion Criteria
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
18 Years
75 Years
ALL
No
Sponsors
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Everstar Therapeutics Limited
INDUSTRY
Responsible Party
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Principal Investigators
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Kaichun Wu
Role: PRINCIPAL_INVESTIGATOR
The First Affiliated Hospital of Fourth Military Medical University, PLA
Locations
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The First Affiliated Hospital of Fourth Military Medical University, PLA
Xi’an, Shanxi, China
Countries
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References
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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 Sep 30:S2468-1253(25)00198-0. doi: 10.1016/S2468-1253(25)00198-0. Online ahead of print.
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.
Other Identifiers
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ES101002
Identifier Type: -
Identifier Source: org_study_id
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