Etrasimod Versus Placebo for the Treatment of Moderately Active Ulcerative Colitis

Phase 2 Completed 234 enrolled Pfizer Arena is a wholly owned subsidiary of Pfizer · collab

RandomizedParallel-groupDouble-blindTreatment

Summary

The purpose of this study is to determine whether oral etrasimod is a safe and effective treatment for moderately active ulcerative colitis in adult participants.

Timeline

Start: 2021-04-12
Primary completion: 2024-06-19
Completion: 2024-06-19

Outcome

Missed primary endpoint

paper GLADIATOR's primary endpoint was not met PMID 42248437 ↗

registry Etrasimod vs Placebo; p = 0.2524; Risk Difference (RD) 7.35 (95% CI -5.24 to 19.94) NCT04607837 ↗

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.

Drugs

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