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Novel TYK2 inhibitor D-2570 in moderate to severe plaque psoriasis: a randomized, double-blind, placebo-controlled, phase 2 trial

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机构: [1]Department of Dermatology, Peking University People's Hospital, Beijing, China. Electronic address: rmzjz@126.com. [2]Department of Dermatology, Peking University People's Hospital, Beijing, China. [3]Department of Dermatology, Affiliated Hospital of Hebei University of Engineering, Handan, China. [4]Department of Dermatology, Henan Provincial People's Hospital, Zhengzhou, China. [5]Department of Dermatology, Affiliated Hospital of Chengde Medical University, Chengde, China. [6]Department of Dermatology, Hangzhou First People's Hospital, Hangzhou, China. [7]Department of Dermatology, The First Hospital of Hebei Medical University, Shijiazhuang, China. [8]Department of Dermatology, Shandong Provincial Hospital, Jinan, China. [9]Department of Dermatology, Shanghai Skin Disease Hospital, Shanghai, China. [10]Department of Dermatology, The First Affiliated Hospital of Bengbu Medical University, Bengbu, China. [11]Department of Dermatology, Beijing Tongren Hospital Affiliated to Capital Medical University, Beijing, China. [12]Department of Dermatology, Dermatology Hospital of Southern Medical University, Guangzhou, China. [13]Department of Dermatology, Beijing Friendship Hospital, Capital Medical University, Beijing, China. [14]Department of Dermatology, First Hospital of Jilin University, Changchun, China. [15]Department of Dermatology, Wuxi Second People's Hospital, Wuxi, China. [16]Department of Dermatology, Shenzhen People's Hospital, Shenzhen, China. [17]Department of Dermatology, RenMin Hospital of Wuhan University, Wuhan, China. [18]Department of Dermatology, The Affiliated Hospital of Guilin Medical University, Guilin, China. [19]Department of Dermatology, Sichuan Provincial People's Hospital, Chengdu, China. [20]Department of Dermatology, Shiyan Renmin Hospital, Shiyan, China. [21]Department of Dermatology, Nanyang First People's Hospital, Nanyang, China. [22]Department of Dermatology, Jiujiang University Affiliated Hospital, Jiujiang, China. [23]Department of Dermatology, Sun Yat-sen Memorial Hospital, Sun Yat-sen University, Guangzhou, China. [24]Department of Dermatology, Peking University Third Hospital, Beijing, China. [25]Department of Dermatology, The First People's Hospital of Chenzhou, Chenzhou, China. [26]InventisBio Co., Ltd, Shanghai, China.
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D-2570, a TYK2 inhibitor, is currently being developed for autoimmune diseases including psoriasis and ulcerative colitis.To evaluate the efficacy and safety of D-2570 in patients with moderate-to-severe plaque psoriasis.In the randomized, double-blind, phase 2 study (NCT06278350), patients were randomized 1:1:1:1 to receive D-2570 at 18/27/36 mg, or placebo once daily for 12 weeks. The primary endpoint was the proportion of patients achieving psoriasis area severity index (PASI) 75 at week 12. Secondary endpoints included PASI 75/90/100 and static Physician Global Assessment (sPGA) score of 0/1, safety, and pharmacokinetic/pharmacodynamic characteristics.At week 12, significantly higher response rates for PASI 75 (85.0%-90.0%, vs 12.5%, p<0.001 for all), PASI 90 (70.7%-77.5% vs 5.0%, p<0.001), PASI 100 (39.0%-50.0% vs 2.5%, p<0.005) and sPGA 0/1 (80.5%-87.5% vs 20.0%, p<0.001) were achieved in patients receiving D-2570 at 18/27/36 mg versus placebo. D-2570 was well tolerated, and most treatment-emergent adverse events were mild/moderate. D-2570 exhibited favorable pharmacokinetic properties and effectively suppressed IL-17A levels in patients.small sample size, relatively short duration of treatment and follow-up.D-2570 demonstrated a high efficacy with favorable safety profile in patients with moderate to severe plaque psoriasis.Copyright © 2025. Published by Elsevier Inc.

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大类 | 1 区 医学
小类 | 1 区 皮肤病学
最新[2025]版:
大类 | 1 区 医学
小类 | 1 区 皮肤病学
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第一作者机构: [1]Department of Dermatology, Peking University People's Hospital, Beijing, China. Electronic address: rmzjz@126.com. [*1]Department of Dermatology, Peking University People’s Hospital, No.11 Xizhimen South St, Beijing, China
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通讯机构: [1]Department of Dermatology, Peking University People's Hospital, Beijing, China. Electronic address: rmzjz@126.com. [*1]Department of Dermatology, Peking University People’s Hospital, No.11 Xizhimen South St, Beijing, China
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