Safety and Efficacy of Oral Etrasimod in Adult Participants With Moderate-to-Severe Alopecia Areata

Phase 2 Completed 80 enrolled Pfizer Arena is a wholly owned subsidiary of Pfizer · collab

RandomizedParallel-groupTriple-blindTreatment

Summary

The purpose of this study is to evaluate the safety and efficacy of etrasimod monotherapy (2 milligrams \[mg\] and 3 mg) in participants with moderate-to-severe alopecia areata (AA).

Timeline

Start: 2020-07-29
Primary completion: 2023-06-07
Completion: 2023-06-07

Outcome

Missed primary endpoint

paper statistical superiority was not achieved. PMID 40145547 ↗

paper Etrasimod did not meet the primary and secondary efficacy endpoints PMID 40145547 ↗

Publications

King B, Mesinkovska N, Senna M, Luo X, Minkiewicz J, Selfridge A. Efficacy and safety of etrasimod in alopecia areata: A multicentre, randomized, double-blind, placebo-controlled, Phase 2 study. J Eur Acad Dermatol Venereol. 2025 Jun;39(6):1174-1184. doi: 10.1111/jdv.20605. Epub 2025 Mar 27.
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	2 mg	Oral
Subject	Etrasimod	Small molecule	3 mg	Oral