Safety and Efficacy of Etrasimod (APD334) in Patients With Ulcerative Colitis

Summary

The purpose of this study is to determine whether etrasimod is a safe and effective treatment for ulcerative colitis.

Timeline

Start

2015-10-15

Primary completion

2018-02-14

Completion

2018-02-14

Outcome

Met primary endpoint

paper At week 12, the etrasimod 2 mg group met the primary and all secondary endpoints. PMID 31711921 ↗

registry analysis (superiority test); Etrasimod 2 mg vs Placebo; p = 0.0091; Difference in least square mean -0.99 (90% CI -1.68 to -0.30); NCT02447302 ↗

Publications

• 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.
• 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.
• Yarur AJ, Chiorean MV, Panes J, Jairath V, Zhang J, Rabbat CJ, Sandborn WJ, Vermeire S, Peyrin-Biroulet L. Achievement of Clinical, Endoscopic, and Histological Outcomes in Patients with Ulcerative Colitis Treated with Etrasimod, and Association with Faecal Calprotectin and C-reactive Protein: Results From the Phase 2 OASIS Trial. J Crohns Colitis. 2024 Jun 3;18(6):885-894. doi: 10.1093/ecco-jcc/jjae007.
• Sandborn WJ, Peyrin-Biroulet L, Zhang J, Chiorean M, Vermeire S, Lee SD, Kuhbacher T, Yacyshyn B, Cabell CH, Naik SU, Klassen P, Panes J. Efficacy and Safety of Etrasimod in a Phase 2 Randomized Trial of Patients With Ulcerative Colitis. Gastroenterology. 2020 Feb;158(3):550-561. doi: 10.1053/j.gastro.2019.10.035. Epub 2019 Nov 9.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Etrasimod	Small molecule	1 mg	Oral
Subject	Etrasimod	Small molecule	2 mg	Oral

Indications