{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,5]],"date-time":"2026-10-05T15:51:56Z","timestamp":1791215516840,"version":"4.1.0"},"reference-count":32,"publisher":"Oxford University Press (OUP)","issue":"2","license":[{"start":{"date-parts":[[2026,3,16]],"date-time":"2026-03-16T00:00:00Z","timestamp":1773619200000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/academic.oup.com\/pages\/standard-publication-reuse-rights"}],"funder":[{"name":"Hangzhou Highlight Pharmaceutical Co., Ltd."}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":[],"published-print":{"date-parts":[[2026,7,17]]},"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:sec>\n                    <jats:title>Background<\/jats:title>\n                    <jats:p>Chronic spontaneous urticaria (CSU) places a considerable burden on both patients and caregivers. Current treatments for CSU are inadequate for some patients. TLL-018, an oral tyrosine kinase 2\/Janus kinase 1 (TYK2\/JAK1) inhibitor, is currently being investigated as a potential treatment for CSU.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Objectives<\/jats:title>\n                    <jats:p>To evaluate the efficacy and safety of TLL-018 for treating moderate-to-severe CSU in patients with an inadequate response to antihistamines.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>In this multicentre, double-blind, randomized, placebo-controlled, parallel-group pilot study (NCT05373355), patients with CSU who showed an inadequate response to antihistamines were given (1: 1: 1) 10 or 30\u2005mg of TLL-018, or placebo, orally twice daily. After 4 weeks, patients on placebo were switched to TLL-018 20\u2005mg and continued treatment for a further 8 weeks. The primary endpoint was safety, while secondary endpoints included efficacy measures, such as weekly Urticaria Activity Score (UAS7) \u2264 6, UAS7 = 0, and a Dermatology Life Quality Index score of 0 or 1, at weeks 4 and 12.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>Overall, 41 patients were randomly assigned to TLL-018 10\u2005mg (n = 14), 30\u2005mg (n = 13) or placebo (n = 14). At week 4, the placebo-adjusted change from baseline (analysed using Ancova) in UAS7, weekly Itch Severity Score and weekly Hive Severity Score was \u201311.5, \u20138.0 and \u20133.8, respectively, in the 10-mg TLL-018 group, and \u201316.0, \u20139.0 and \u20137.0, respectively, in the 30-mg group. At week 12, the proportions of patients achieving UAS7 \u2264 6 and UAS7 = 0 were 54% and 39%, respectively, in the placebo-then-20-mg group, 71% and 64% in the 10-mg group, and 62% and 54% in the 30-mg group. Common treatment-emergent adverse events included elevated serum creatine kinase and blood lipid levels, hyperglycaemia and urinary occult blood.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions<\/jats:title>\n                    <jats:p>TLL-018 was well tolerated and effective in treating moderate-to-severe CSU in patients who had an inadequate response to antihistamines.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1093\/bjd\/ljag092","type":"journal-article","created":{"date-parts":[[2026,3,9]],"date-time":"2026-03-09T12:21:45Z","timestamp":1773058905000},"page":"222-231","source":"Crossref","is-referenced-by-count":2,"title":["Safety and efficacy of the selective tyrosine kinase 2\/Janus kinase 1 inhibitor TLL-018 in patients with moderate-to-severe chronic spontaneous urticaria with inadequate response to H1 antihistamines: a phase Ib, randomized, double-blind, placebo-controlled pilot study"],"prefix":"10.1093","volume":"195","author":[{"given":"Xu","family":"Yao","sequence":"first","affiliation":[{"name":"Department of Allergy and Rheumatology, Jiangsu Provincial Key Laboratory of Dermatology, Hospital for Skin Diseases, Institute of Dermatology, Chinese Academy of Medical Sciences and Peking Union Medical College , Nanjing ,","place":["China"]},{"name":"Key Laboratory of Basic and Translational Research on Immune-Mediated Skin Diseases, Chinese Academy of Medical Sciences , Nanjing ,","place":["China"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yi","family":"Liu","sequence":"additional","affiliation":[{"name":"Department of Allergy and Rheumatology, Jiangsu Provincial Key Laboratory of Dermatology, Hospital for Skin Diseases, Institute of Dermatology, Chinese Academy of Medical Sciences and Peking Union Medical College , Nanjing 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