Evidence map›Paper›PMID 40145547›Full record

Trial reportJournal of the European Academy of Dermatology and Venereology : JEADV2025

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

B King, N Mesinkovska, M Senna, X Luo, J Minkiewicz, A Selfridge

Registry-linked trialAbstract readClinical Trial, Phase IIRandomized Controlled TrialMulticenter Study
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Journal of the European Academy of Dermatology and Venereology : JEADV, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04556734 (A Multicenter, Randomized, Double-Blind, Placebo-Controlled, 24-Week Study, With a 28-Week Open-Label Extension, to Assess the Safety and Efficacy of Etrasimod in Subjects With Moderate-to-Severe Alopecia Areata), which is not on this map. Cited by 6 papers.

0numbers the graph read from it
0cells of the map it votes in
6citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT04556734 phase2completednot on this map

A Multicenter, Randomized, Double-Blind, Placebo-Controlled, 24-Week Study, With a 28-Week Open-Label Extension, to Assess the Safety and Efficacy of Etrasimod in Subjects With Moderate-to-Severe Alopecia Areata

TypeinterventionalSponsorPfizerRan2020 to 2023Enrolled80ConditionsAlopecia AreataArmsEtrasimod, Placebo
3 · Its place in the literature

Who cites it

6 citing papers in PubMed.

  1. Trial
  2. Review
  3. Review
  4. Review
  5. Etrasimod for alopecia areata: The scenario for a less extensive and moderate form.Journal of the European Academy of Dermatology and Venereology : JEADV · 2025
    Article
  6. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

6 authors.

B KingDermatology Physicians of Connecticut, Fairfield, Connecticut, USA.ORCID https://orcid.org/0000-0002-4576-4616
N MesinkovskaDepartment of Dermatology and Dermatopathology, UCI School of Medicine, Irvine, California, USA.
M SennaLahey Hospital and Medical Center, Burlington, Massachusetts, USA.ORCID https://orcid.org/0000-0002-7813-520X
X LuoPfizer China R&D Center, Shanghai, China.
J MinkiewiczPfizer Inc, New York, New York, USA.
A SelfridgePfizer Inc, New York, New York, USA.

Funding

Pfizer Inc
6 · The paper itself

Abstract

backgroundEtrasimod, 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).

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

methodsThis 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. Patients completed a 24-week double-blind and 28-week open-label extension period. The primary endpoint was percent change from baseline (%CFB) in SALT score at Week 24. Safety was monitored throughout the trial.

resultsEighty patients were randomized to etrasimod 2 mg (n = 31), 3 mg (n = 25) or placebo (n = 24). At Week 24, least squares mean (SE) percent changes from baseline in SALT score for the etrasimod 2 mg, 3 mg and placebo groups were -13.8 (8.6), -21.4 (6.9) and 0.35 (8.9), respectively. The least squares mean difference (95% CI; P value) in SALT score %CFB of etrasimod 2 mg and 3 mg versus placebo was -14.1 (-38.9 to 10.6; p = 0.2579) and - 21.8 (-44.4 to 0.9; p = 0.0592), respectively; statistical superiority was not achieved. The proportions of patients achieving ≥30%, ≥50% or ≥75% improvement in baseline SALT score at Week 24 were generally numerically higher in etrasimod groups versus placebo. Treatment-emergent adverse events occurred in 67.7%, 80.0% and 78.3% of patients receiving etrasimod 2 mg, 3 mg and placebo, respectively, by Week 24.

conclusionsEtrasimod did not meet the primary and secondary efficacy endpoints, but efficacy was numerically higher with etrasimod than with placebo. The etrasimod clinical programme for AA has been discontinued. Etrasimod was well tolerated, and its safety profile was consistent with other etrasimod studies to date.

trial registrationClinicalTrials.gov: NCT04556734.

Indexed as

Alopecia AreataAcetatesAdultDouble-Blind MethodFemaleHumansIndolesMaleMiddle AgedTreatment OutcomeYoung AdultAcetatesetrasimodIndoles

Identifiers

PMID40145547
PMCPMC12105423

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.