A Study to Assess the Safety and Efficacy of Etrasimod in Subjects With Moderate-to-Severe Atopic Dermatitis

Summary

The purpose of this study is to determine whether etrasimod is a safe and effective treatment for moderate-to-severe atopic dermatitis (AD).

Timeline

Start

2019-10-04

Primary completion

2020-09-09

Completion

2021-10-11

Outcome

Missed primary endpoint

registry analysis (superiority test); Double-blind Treatment Period: Etrasimod 1 Milligrams (mg) vs Double-blind Treatment Period: Placebo; p =0.1198 NCT04162769 ↗

registry analysis (superiority test); Double-blind Treatment Period: Etrasimod 2 mg vs Double-blind Treatment Period: Placebo; p =0.1783 NCT04162769 ↗

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	1 mg	Oral
Subject	Etrasimod	Small molecule	2 mg	Oral

Indications