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. 2025 Sep 16:S0190-9622(25)02824-5.
doi: 10.1016/j.jaad.2025.09.036. Online ahead of print.

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

Jianzhong Zhang  1 , Cheng Zhou  2 , Guoying Miao  3 , Shoumin Zhang  4 , Xinsuo Duan  5 , Liming Wu  6 , Guoqiang Zhang  7 , Ningning Dang  8 , Yangfeng Ding  9 , Hongfang Han  10 , Aihua Wei  11 , Bin Yang  12 , Linfeng Li  13 , Shanshan Li  14 , Xunyi Dai  15 , Jianglin Zhang  16 , Tiechi Lei  17 , Wenjie Yan  18 , Lixia Zhang  19 , Zudong Meng  20 , Rixin Chen  21 , Qiuhe Song  22 , Liangchun Wang  23 , Wenhui Wang  24 , Xinglin Hu  25 , Ziyong Xiang  26 , Zhe Shi  26 , Ling Zhang  26
Affiliations

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

Jianzhong Zhang et al. J Am Acad Dermatol. .

Abstract

Background: D-2570, a TYK2 inhibitor, is currently being developed for autoimmune diseases including psoriasis and ulcerative colitis.

Objective: To evaluate the efficacy and safety of D-2570 in patients with moderate-to-severe plaque psoriasis.

Methods: 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.

Results: At week 12, significantly higher response rates for PASI 75 (85.0% to 90.0%, vs 12.5%, P < .001 for all), PASI 90 (70.7% to 77.5% vs 5.0%, P < .001), PASI 100 (39.0% to 50.0% vs 2.5%, P < .005) and sPGA 0/1 (80.5% to 87.5% vs 20.0%, P < .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.

Limitations: Small sample size, relatively short duration of treatment and follow-up.

Conclusion: D-2570 demonstrated a high efficacy with favorable safety profile in patients with moderate-to-severe plaque psoriasis.

Keywords: D-2570; TYK2 inhibitor; clinical trial; phase 2; plaque psoriasis.

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Conflict of interest statement

Conflicts of interest Dr Jianzhong Zhang has served as an advisor, speaker, or consultant and received honorarium for Pfizer Investment Co Ltd, Novartis Pharmaceuticals (China), Sanofi China, LEO Pharma (Shanghai) Co Ltd, GSK(China) Investment Co Ltd, Eli Lilly and Company (China), Xi'an Jassen Pharmaceutical Ltd, Bristol-Myers Squibb (China) Investment Co Ltd, Beijing Wenfeng Tianji Pharma Ltd, Keymed Biosciences (Chendu) Ltd, Akeso Biopharma Co Ltd, and Kintor Pharmaceutical Ltd. Dr Cheng Zhou has served as a speaker, or consultant and received honorarium for Pfizer Investment Co Ltd, Novartis Pharmaceuticals (China), and Eli Lilly and Company (China). Dr Guoqiang Zhang has received grants from Shanghai Jahwa. United Co, Ltd. Dr Hongfang Han has been a paid instructor and speaker for Novartis and Hengrui. Drs Zhe Shi, Ling Zhang and Ziyong Xiang are employees of InventisBio and report stocks in InventisBio. Other authors have no conflicts of interest to declare.

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