A Study Evaluating the Efficacy and Safety of Oral Etrasimod in the Treatment of Adult Participants With Moderately to Severely Active Crohn's Disease

Summary

This is a Phase 2/3 study that comprises 5 substudies designed to evaluate the efficacy, safety, and tolerability of oral etrasimod as therapy in adult participants with moderately to severely active Crohn's disease (CD) who are refractory or intolerant to at least 1 of the current therapies for CD (ie, corticosteroids, immunosuppressants, or biologics). The overall duration of this study is up to 282 weeks, inclusive of the Screening Period, Treatment Period of up to 274 weeks (Induction, Extension or Maintenance, and Long-term Extension Periods), and the 4-Week Follow-Up Period for safety assessment.

Timeline

Start

2020-01-06

Primary completion

2025-04-23

Completion

2025-06-09

Outcome

Missed primary endpoint

Stopped: “The study was prematurely discontinued due to a lack of efficacy in sub-study 1”

registry SS1: Placebo in Induction Period vs SS1: Etrasimod 2 mg in Induction Period; p =0.3147; Percentage Difference 2.5 (90% CI -6.1 to 11.1) NCT04173273 ↗

registry SS1: Placebo in Induction Period vs SS1: Etrasimod 3 mg in Induction Period; p =0.4857; Percentage Difference 0.2 (90% CI -8.3 to 8.7) NCT04173273 ↗

Publications

• Dubinsky MC, Wu J, McDonnell A, Lazin K, Goetsch M, Branquinho D, Modesto I, Armuzzi A. Low Incidence of Macular Edema and Other Ocular Events in the Etrasimod Development Program. J Crohns Colitis. 2025 May 8;19(5):jjae173. doi: 10.1093/ecco-jcc/jjae173.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Etrasimod	Small molecule	—	Oral

Indications