{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,8,20]],"date-time":"2026-08-20T14:50:40Z","timestamp":1787237440625,"version":"build-2736575974"},"reference-count":28,"publisher":"Wiley","issue":"6","license":[{"start":{"date-parts":[[2025,3,27]],"date-time":"2025-03-27T00:00:00Z","timestamp":1743033600000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"}],"funder":[{"DOI":"10.13039\/100004319","name":"Pfizer","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100004319","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Acad Dermatol Venereol"],"published-print":{"date-parts":[[2025,6]]},"abstract":"Abstract<\/jats:title>\n \n Background<\/jats:title>\n Etrasimod, an oral, selective sphingosine 1\u2010phosphate 1, 4 and 5 receptor modulator approved for the treatment of ulcerative colitis, has been studied in immune\u2010mediated inflammatory diseases, including alopecia areata (AA).<\/jats:p>\n <\/jats:sec>\n \n Objectives<\/jats:title>\n To evaluate the efficacy and safety of etrasimod in adults with moderate to severe AA.<\/jats:p>\n <\/jats:sec>\n \n Methods<\/jats:title>\n This Phase 2, randomized, double\u2010blind, placebo\u2010controlled trial included patients (aged \u226518\u2009years) with moderate to severe AA, defined as a Severity of Alopecia Tool (SALT) score of \u226525. Patients were sequentially enrolled into two cohorts. Cohort 1 included patients (SALT score of \u226550) randomized 2:1 to etrasimod 2\u2009mg or placebo. Cohort 2 included patients (SALT score \u226525 to <95) randomized 4:1:2 to etrasimod 3\u2009mg, 2\u2009mg or placebo. Patients completed a 24\u2010week double\u2010blind and 28\u2010week open\u2010label extension period. The primary endpoint was percent change from baseline (%CFB) in SALT score at Week 24. Safety was monitored throughout the trial.<\/jats:p>\n <\/jats:sec>\n \n Results<\/jats:title>\n \n Eighty patients were randomized to etrasimod 2\u2009mg (\n n<\/jats:italic>\n \u2009=\u200931), 3\u2009mg (\n n<\/jats:italic>\n \u2009=\u200925) or placebo (\n n<\/jats:italic>\n \u2009=\u200924). At Week 24, least squares mean (SE) percent changes from baseline in SALT score for the etrasimod 2\u2009mg, 3\u2009mg and placebo groups were \u221213.8 (8.6), \u221221.4 (6.9) and 0.35 (8.9), respectively. The least squares mean difference (95% CI;\n P<\/jats:italic>\n value) in SALT score %CFB of etrasimod 2\u2009mg and 3\u2009mg versus placebo was \u221214.1 (\u221238.9 to 10.6;\n p<\/jats:italic>\n \u2009=\u20090.2579) and\u2009\u2212\u200921.8 (\u221244.4 to 0.9;\n p<\/jats:italic>\n \u2009=\u20090.0592), respectively; statistical superiority was not achieved. The proportions of patients achieving \u226530%, \u226550% or\u2009\u226575% improvement in baseline SALT score at Week 24 were generally numerically higher in etrasimod groups versus placebo. Treatment\u2010emergent adverse events occurred in 67.7%, 80.0% and 78.3% of patients receiving etrasimod 2\u2009mg, 3\u2009mg and placebo, respectively, by Week 24.\n <\/jats:p>\n <\/jats:sec>\n \n Conclusions<\/jats:title>\n Etrasimod 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.<\/jats:p>\n <\/jats:sec>\n \n Trial Registration<\/jats:title>\n \n ClinicalTrials.gov<\/jats:ext-link>\n : NCT04556734.\n <\/jats:p>\n <\/jats:sec>","DOI":"10.1111\/jdv.20605","type":"journal-article","created":{"date-parts":[[2025,3,30]],"date-time":"2025-03-30T02:54:56Z","timestamp":1743303296000},"page":"1174-1184","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":6,"title":["Efficacy and safety of etrasimod in alopecia areata: A multicentre, randomized, double\u2010blind, placebo\u2010controlled, Phase 2 study"],"prefix":"10.1111","volume":"39","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-4576-4616","authenticated-orcid":false,"given":"B.","family":"King","sequence":"first","affiliation":[{"name":"Dermatology Physicians of Connecticut Fairfield Connecticut USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"N.","family":"Mesinkovska","sequence":"additional","affiliation":[{"name":"Department of Dermatology and Dermatopathology UCI School of Medicine Irvine California USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-7813-520X","authenticated-orcid":false,"given":"M.","family":"Senna","sequence":"additional","affiliation":[{"name":"Lahey Hospital and Medical Center Burlington Massachusetts USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"X.","family":"Luo","sequence":"additional","affiliation":[{"name":"Pfizer China R&D Center Shanghai China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"J.","family":"Minkiewicz","sequence":"additional","affiliation":[{"name":"Pfizer Inc New York New York USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"A.","family":"Selfridge","sequence":"additional","affiliation":[{"name":"Pfizer Inc New York New York USA"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2025,3,27]]},"reference":[{"key":"e_1_2_14_2_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.jaad.2003.09.032"},{"key":"e_1_2_14_3_1","doi-asserted-by":"publisher","DOI":"10.1111\/bjd.18883"},{"key":"e_1_2_14_4_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.jaad.2016.09.007"},{"key":"e_1_2_14_5_1","doi-asserted-by":"publisher","DOI":"10.1093\/bjd\/ljad253"},{"key":"e_1_2_14_6_1","doi-asserted-by":"publisher","DOI":"10.1007\/s13555-023-01033-8"},{"key":"e_1_2_14_7_1","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa2110343"},{"key":"e_1_2_14_8_1","doi-asserted-by":"publisher","DOI":"10.1016\/S0140\u20106736(23)00222\u20102"},{"key":"e_1_2_14_9_1","doi-asserted-by":"publisher","DOI":"10.3389\/fimmu.2023.1111547"},{"key":"e_1_2_14_10_1","doi-asserted-by":"publisher","DOI":"10.1111\/exd.14129"},{"key":"e_1_2_14_11_1","doi-asserted-by":"publisher","DOI":"10.14309\/01.ajg.0000722976.59079.27"},{"key":"e_1_2_14_12_1","doi-asserted-by":"publisher","DOI":"10.14309\/01.ajg.0000860352.29232.aa"},{"key":"e_1_2_14_13_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.jid.2022.05.866"},{"key":"e_1_2_14_14_1","doi-asserted-by":"publisher","DOI":"10.1016\/S0140\u20106736(23)00061\u20102"},{"key":"e_1_2_14_15_1","doi-asserted-by":"publisher","DOI":"10.1093\/ecco-jcc\/jjab016"},{"key":"e_1_2_14_16_1","doi-asserted-by":"publisher","DOI":"10.1111\/jdv.18914"},{"key":"e_1_2_14_17_1","doi-asserted-by":"publisher","DOI":"10.3390\/ijms20133232"},{"key":"e_1_2_14_18_1","doi-asserted-by":"publisher","DOI":"10.1002\/jcph.887"},{"key":"e_1_2_14_19_1","volume-title":"Velsipity [prescribing information]","year":"2023"},{"key":"e_1_2_14_20_1","doi-asserted-by":"publisher","DOI":"10.1016\/S1474-4422(14)70049-3"},{"key":"e_1_2_14_21_1","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa2033617"},{"key":"e_1_2_14_22_1","doi-asserted-by":"publisher","DOI":"10.1093\/ecco-jcc\/jjac190.0762"},{"key":"e_1_2_14_23_1","unstructured":"Gilenya (fingolimod) [package insert]. Novartis Pharmaceuticals Corporation2019."},{"key":"e_1_2_14_24_1","unstructured":"Mayzent (siponimod) [package insert]. Novartis Pharmaceuticals Corporation2021."},{"key":"e_1_2_14_25_1","unstructured":"Ponvory (ponesimod) [package insert]. Janssen Pharmaceuticals Inc2021."},{"key":"e_1_2_14_26_1","unstructured":"Zeposia (ozanimod) [package insert]. Celgene Corporation2021."},{"key":"e_1_2_14_27_1","doi-asserted-by":"publisher","DOI":"10.1007\/s11481\u2010013\u20109465\u20105"},{"key":"e_1_2_14_28_1","doi-asserted-by":"publisher","DOI":"10.1172\/jci.insight.134251"},{"key":"e_1_2_14_29_1","doi-asserted-by":"publisher","DOI":"10.1212\/NXI.0000000000000839"}],"container-title":["Journal of the European Academy of Dermatology and Venereology"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/pdf\/10.1111\/jdv.20605","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2025,5,26]],"date-time":"2025-05-26T07:48:07Z","timestamp":1748245687000},"score":1,"resource":{"primary":{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/10.1111\/jdv.20605"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2025,3,27]]},"references-count":28,"journal-issue":{"issue":"6","published-print":{"date-parts":[[2025,6]]}},"alternative-id":["10.1111\/jdv.20605"],"URL":"https:\/\/doi.org\/10.1111\/jdv.20605","archive":["Portico"],"relation":{},"ISSN":["0926-9959","1468-3083"],"issn-type":[{"value":"0926-9959","type":"print"},{"value":"1468-3083","type":"electronic"}],"subject":[],"published":{"date-parts":[[2025,3,27]]},"assertion":[{"value":"2024-08-06","order":0,"name":"received","label":"Received","group":{"name":"publication_history","label":"Publication History"}},{"value":"2025-01-21","order":2,"name":"accepted","label":"Accepted","group":{"name":"publication_history","label":"Publication History"}},{"value":"2025-03-27","order":3,"name":"published","label":"Published","group":{"name":"publication_history","label":"Publication History"}}]}}