drugset / Trial / NCT03945188
Etrasimod Versus Placebo for the Treatment of Moderately to Severely Active Ulcerative Colitis
RandomizedParallel-groupDouble-blindTreatment
Summary
The purpose of this study is to determine whether oral etrasimod is a safe and effective treatment for moderately to severely active ulcerative colitis.
Timeline
- Start
- 2019-06-13
- Primary completion
- 2022-02-08
- Completion
- 2022-02-16
Outcome
Met primary endpoint
registry analysis (superiority test); Etrasimod 2 mg vs Placebo; p <0.001; Risk Difference (RD) 19.75 (95% CI 12.88 to 26.63); Cochran-Mantel-Haenszel NCT03945188 ↗
registry analysis (superiority test); Etrasimod 2 mg vs Placebo; p <0.001; Risk Difference (RD) 25.39 (95% CI 18.42 to 32.36); Cochran-Mantel-Haenszel NCT03945188 ↗
release “ELEVATE UC 52 met the co-primary endpoints of clinical remission at both weeks 12 and 52 and all key secondary endpoints” pfizer.com ↗
Publications
- Danese S, Goetsch M, Peyrin-Biroulet L, Yarur AJ, Dubinsky M, Rubin DT, Feagan BG, D'Haens G, Baert F, Lazin K, Gu G, Yu J, Lawendy N, Zang C, Wang W, Menon S, Law EH, Modesto I, Wosik K, Sidhu S, Niezychowski W, Vermeire S. The Efficacy and Safety of Etrasimod in Mildly to Moderately Active Ulcerative Colitis: Results From the Phase II GLADIATOR Trial. Clin Gastroenterol Hepatol. 2026 Jun 4:S1542-3565(26)00405-2. doi: 10.1016/j.cgh.2026.05.024. Online ahead of print.
- Dubinsky MC, Chaparro M, Irving PM, Hur P, Sidhu S, Woolcott JC, Wang W, Goetsch M, Torres J, Panaccione R. Rapid symptomatic improvement with etrasimod in ulcerative colitis: a post-hoc analysis of the ELEVATE UC program. Inflamm Bowel Dis. 2026 Jun 1;32(6):1075-1085. doi: 10.1093/ibd/izaf333.
- Chaparro M, Panaccione R, Sands BE, Irving PM, Goetsch M, Kunina E, Wang W, Wu J, Woolcott JC, Bartolome L, Cognata C, Wosik K, Dubinsky MC. Etrasimod for the symptomatic relief of ulcerative colitis: a post-hoc analysis from the ELEVATE UC clinical programme. BMJ Open Gastroenterol. 2025 Aug 31;12(1):e001838. doi: 10.1136/bmjgast-2025-001838.
- Yarur AJ, Reinisch W, Chang S, Gecse KB, Green J, Abbatemarco AM, Wu J, Goetsch M, Lazin K, Pradeep G, Sands BE. Efficacy of Etrasimod in Ulcerative Colitis: Analysis of ELEVATE UC 52 and ELEVATE UC 12 by Baseline Endoscopic Severity. Clin Gastroenterol Hepatol. 2026 Jan;24(1):210-220.e3. doi: 10.1016/j.cgh.2025.06.020. Epub 2025 Jul 4.
- Lichtenstein GR, Allegretti JR, Loftus EV Jr, Irving PM, Banerjee R, Charabaty A, Kuehbacher T, Bananis E, Woolcott JC, Dalam AB, Lazin K, Keating M, McDonnell A, Danese S. Assessment and Impact of Age on the Safety and Efficacy of Etrasimod in Patients With Ulcerative Colitis: A Post Hoc Analysis of Data From the ELEVATE UC Clinical Program. Inflamm Bowel Dis. 2025 Sep 1;31(9):2352-2362. doi: 10.1093/ibd/izae308.
- Sands BE, Dubinsky MC, Kotze PG, Vermeire S, Panaccione R, Long MD, Woolcott JC, Wu J, McDonnell A, Goetsch M, Bananis E, Yarur AJ. Efficacy and Safety of Etrasimod in Patients With Moderately to Severely Active Ulcerative Colitis Stratified by Baseline Modified Mayo Score: A Post Hoc Analysis From the Phase 3 ELEVATE UC Clinical Program. Inflamm Bowel Dis. 2025 Oct 1;31(10):2681-2692. doi: 10.1093/ibd/izaf036.
- Afzali A, Regueiro M, Yarur AJ, Zabana Y, Ng SC, Menon S, McDonnell A, Lazin K, Keating M, Bhattacharjee A, Branquinho D, Bananis E, Peyrin-Biroulet L. Concomitant Use of Etrasimod With Opioids or Antidepressants in Patients With Ulcerative Colitis-A Safety Analysis. United European Gastroenterol J. 2025 Jun;13(5):719-727. doi: 10.1002/ueg2.12745. Epub 2025 Feb 1.
- Yarur AJ, Long MD, Torres J, Nandi N, Cross RK, Abbatemarco AM, Blanco D, Niezychowski W, Crosby C, Wu J, Pradeep G, Goetsch M, Panaccione R. Body Mass Index Did Not Affect Efficacy and Safety of Etrasimod: A Post Hoc Analysis of the ELEVATE Ulcerative Colitis Clinical Program. Am J Gastroenterol. 2025 Nov 1;120(11):2611-2622. doi: 10.14309/ajg.0000000000003330. Epub 2025 Jan 29.
- 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.
- Yarur AJ, Chiorean MV, Allegretti JR, Cross RK, Ha C, Goetsch M, McDonnell A, Dalam AB, Wu J, Blanco DA, Abbatemarco AM, Panes J. Etrasimod as a Monotherapy or With Concomitant Use of Corticosteroids and/or Aminosalicylates: Results From the ELEVATE UC Clinical Program. Inflamm Bowel Dis. 2025 Aug 1;31(8):2144-2153. doi: 10.1093/ibd/izae288.
- Lees CW, Torres J, Leung Y, Vermeire S, Fellmann M, Modesto I, McDonnell A, Lazin K, Keating M, Goetsch M, Wu J, Loftus EV Jr. Non-serious adverse events in patients with ulcerative colitis receiving etrasimod: an analysis of the phase II OASIS and phase III ELEVATE UC 52 and ELEVATE UC 12 clinical trials. Ther Adv Gastroenterol. 2024 Nov 7;17:17562848241293643. doi: 10.1177/17562848241293643. eCollection 2024.
- Armuzzi A, Rubin DT, Schreiber S, Panes J, Fellmann M, Bartolome L, Gruben D, Goetsch M, Bhattacharjee A, Chaparro M, Dubinsky MC. Health-Related Quality of Life Outcomes With Etrasimod Treatment in Patients With Ulcerative Colitis: A Post Hoc Analysis of Data From ELEVATE UC 52 and ELEVATE UC 12. Inflamm Bowel Dis. 2025 Jun 13;31(6):1583-1594. doi: 10.1093/ibd/izae229.
- Sands BE, Leung Y, Rubin DT, Gecse KB, Panes J, Goetsch M, Wang W, Woolcott JC, Smith CC, Wosik K, Schreiber S. Etrasimod Corticosteroid-Free Efficacy, Impact of Concomitant Corticosteroids on Efficacy and Safety, and Corticosteroid-Sparing Effect in Ulcerative Colitis: Analyses of the ELEVATE UC Clinical Program. J Crohns Colitis. 2025 Mar 5;19(3):jjae150. doi: 10.1093/ecco-jcc/jjae150.
- Magro F, Peyrin-Biroulet L, Sands BE, Danese S, Jairath V, Goetsch M, Bhattacharjee A, Wu J, Branquinho D, Modesto I, Feagan BG. Endoscopic, Histologic, and Composite Endpoints in Patients With Ulcerative Colitis Treated With Etrasimod. Clin Gastroenterol Hepatol. 2025 Feb;23(2):341-350.e6. doi: 10.1016/j.cgh.2024.07.010. Epub 2024 Jul 31.
- Vermeire S, Sands BE, Peyrin-Biroulet L, D'Haens GR, Panes J, Yarur AJ, Wolf DC, Ritter T, Schreiber S, Woolcott JC, Modesto I, Keating M, Shan K, Wu J, Chiorean MV, Baert F, Dubinsky MC, Goetsch M, Danese S, Feagan BG. Impact of Prior Biologic or Janus Kinase Inhibitor Therapy on Efficacy and Safety of Etrasimod in the ELEVATE UC 52 and ELEVATE UC 12 Trials. J Crohns Colitis. 2024 Nov 4;18(11):1780-1794. doi: 10.1093/ecco-jcc/jjae079.
- Regueiro M, Siegmund B, Yarur AJ, Steinwurz F, Gecse KB, Goetsch M, Bhattacharjee A, Wu J, Green J, McDonnell A, Crosby C, Lazin K, Branquinho D, Modesto I, Abreu MT. Etrasimod for the Treatment of Ulcerative Colitis: Analysis of Infection Events from the ELEVATE UC Clinical Programme. J Crohns Colitis. 2024 Oct 15;18(10):1596-1605. doi: 10.1093/ecco-jcc/jjae060.
- Peyrin-Biroulet L, Dubinsky MC, Sands BE, Panes J, Schreiber S, Reinisch W, Feagan BG, Danese S, Yarur AJ, D'Haens GR, Goetsch M, Wosik K, Keating M, Lazin K, Wu J, Modesto I, McDonnell A, Bartolome L, Vermeire S. Efficacy and Safety of Etrasimod in Patients with Moderately to Severely Active Isolated Proctitis: Results From the Phase 3 ELEVATE UC Clinical Programme. J Crohns Colitis. 2024 Aug 14;18(8):1270-1282. doi: 10.1093/ecco-jcc/jjae038.
- Sandborn WJ, Vermeire S, Peyrin-Biroulet L, Dubinsky MC, Panes J, Yarur A, Ritter T, Baert F, Schreiber S, Sloan S, Cataldi F, Shan K, Rabbat CJ, Chiorean M, Wolf DC, Sands BE, D'Haens G, Danese S, Goetsch M, Feagan BG. Etrasimod as induction and maintenance therapy for ulcerative colitis (ELEVATE): two randomised, double-blind, placebo-controlled, phase 3 studies. Lancet. 2023 Apr 8;401(10383):1159-1171. doi: 10.1016/S0140-6736(23)00061-2. Epub 2023 Mar 2.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Etrasimod | Small molecule | 2 mg | Oral |