Efficacy and safety of etrasimod in alopecia areata: A multicentre, randomized, double-blind, placebo-controlled, Phase 2 study.

ABSTRACT:

Background

Etrasimod, an oral, selective sphingosine 1-phosphate 1, 4 and 5 receptor modulator approved for the treatment of ulcerative colitis, has been studied in immune-mediated inflammatory diseases, including alopecia areata (AA).

Objectives

To evaluate the efficacy and safety of etrasimod in adults with moderate to severe AA.

Methods

This Phase 2, randomized, double-blind, placebo-controlled trial included patients (aged ≥18 years) with moderate to severe AA, defined as a Severity of Alopecia Tool (SALT) score of ≥25. Patients were sequentially enrolled into two cohorts. Cohort 1 included patients (SALT score of ≥50) randomized 2:1 to etrasimod 2 mg or placebo. Cohort 2 included patients (SALT score ≥25 to <95) randomized 4:1:2 to etrasimod 3 mg, 2 mg or placebo

SUBMITTER: King B 

PROVIDER: S-EPMC12105423 | biostudies-literature | 2025 Jun

REPOSITORIES: biostudies-literature