{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,5,4]],"date-time":"2026-05-04T21:07:28Z","timestamp":1777928848708,"version":"3.51.4"},"reference-count":32,"publisher":"SAGE Publications","issue":"14","license":[{"start":{"date-parts":[[2020,10,28]],"date-time":"2020-10-28T00:00:00Z","timestamp":1603843200000},"content-version":"unspecified","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"}],"content-domain":{"domain":["journals.sagepub.com"],"crossmark-restriction":true},"short-container-title":["Lupus"],"published-print":{"date-parts":[[2020,12]]},"abstract":"<jats:sec>\n                    <jats:title>Objective<\/jats:title>\n                    <jats:p>To evaluate the safety, pharmacokinetics, pharmacodynamics, and exploratory efficacy of amiselimod, an oral selective sphingosine 1-phosphate receptor-1 modulator, in patients with systemic lupus erythematosus (SLE).<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>A multicenter, open-label phase Ib trial was conducted in Japan. Patients in Part 1 and Part 2-B received 0.2\u2009mg amiselimod while those in Part 2-A received 0.4\u2009mg amiselimod for 24\u2009weeks.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>Seventeen subjects received 0.2 or 0.4\u2009mg amiselimod. Amiselimod and amiselimod-P plasma concentrations increased dose-dependently. Peripheral blood lymphocyte count decreased in all patients after amiselimod treatment, with no clear dose response. There were no serious\/severe adverse events (AEs) or clinically meaningful cardiac effects. Five subjects were withdrawn from amiselimod treatment following a decrease in lymphocyte count to &lt;200\/\u03bcl. Anti-double stranded-DNA antibody decreased from baseline to Week 24\/end of treatment (EOT), with those in 2 subjects (22.2%) decreasing to within the normal range. Total SLE disease activity index 2000 score decreased by \u22654 at EOT in 7 of 17 subjects.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions<\/jats:title>\n                    <jats:p>Amiselimod was generally well tolerated. While no serious AEs or infectious AEs led to discontinuation, low lymphocyte counts of &lt;200\/\u03bcl were observed as a laboratory abnormality. Our findings suggest the potential efficacy of amiselimod for patients with SLE. Trial registration: ClinicalTrials.gov identifier: NCT02307643.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1177\/0961203320966385","type":"journal-article","created":{"date-parts":[[2020,10,29]],"date-time":"2020-10-29T02:22:01Z","timestamp":1603938121000},"page":"1902-1913","update-policy":"https:\/\/doi.org\/10.1177\/sage-journals-update-policy","source":"Crossref","is-referenced-by-count":20,"title":["Amiselimod, a sphingosine 1-phosphate receptor-1 modulator, for systemic lupus erythematosus: A multicenter, open-label exploratory study"],"prefix":"10.1177","volume":"29","author":[{"given":"Yoshiya","family":"Tanaka","sequence":"first","affiliation":[{"name":"The First Department of Internal Medicine, School of Medicine, University of Occupational and Environmental Health, Japan, Kitakyushu, Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Kazuoki","family":"Kondo","sequence":"additional","affiliation":[{"name":"Ikuyaku, Integrated Value Development 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