Work

HS-20137 for Chinese Moderate-to-Severe Psoriasis: A Randomized, Double-Blinded, Phase 2 Study

Year: 2026

Type: article

Study designs: Randomized Controlled Trial, Clinical Trial

Abstract: HS-20137 is a novel interleukin-23 inhibitor and is suggested to be effective for the treatment of psoriasis in a phase 1b study. Our study aimed to evaluate the efficacy and safety of HS-20137 in patients with moderate-to-severe plaque psoriasis in a larger and longer phase 2 study. This was a randomized, double-blind, placebo-controlled phase 2 study up to 52 weeks. The study was conducted from September 2023 to February 2025 at 22 sites across mainland China and enrolled male and female adults with moderate-to-severe psoriasis. Dosing was scheduled at weeks 0 and 4, and subsequently every 8 weeks (Q8W) or Q12W. Eligible patients were randomized 1:1:1:1 to subcutaneously receive HS-20137 at doses of 100 mg Q8W, 200 mg Q8W, 200 mg Q12W, or placebo. Patients switched to receive HS-20137 200 mg Q8W at week 16 or week 28. The primary endpoint was the percentage of patients achieving at least 90% improvement in the Psoriasis Area and Severity Index (PASI 90) at week 16. In total, 159 participants were enrolled, with a mean (SD) PASI score of 25.8 (10.9). More patients treated with HS-20137 achieved PASI 90 compared to placebo (65.0%–76.9% in HS-20137 groups vs. 7.5% in placebo group, P < 0.001) at week 16, as well as PASI 100, investigator global assessment (IGA) score of 0/1, and IGA 0. The PASI score significantly decreased in all treatment groups (41.4%–46.2%) after the first injection by week 4 and was maintained through week 52. During the placebo-controlled period, treatment-emergent adverse event (TEAE) rates were similar among groups (77.5%–67.5%). Throughout the study, most TEAEs were mild; only one serious treatment-related AE occurred, and it resolved after treatment. HS-20137 treatment was tolerable and effective in patients with psoriasis, supporting further investigation and development. ChiCTR2300075645. Psoriasis is a chronic, immune-mediated inflammatory disease that affects 0.14%–1.99% of the global population and nearly 6.5 million people in China. This randomized, double-blind, placebo-controlled, 52-week phase 2 study was conducted to further evaluate the efficacy and safety of HS-20137 in patients with moderate-to-severe plaque psoriasis at 22 sites across mainland China from September 2023 to February 2025. In total, 159 adult participants with moderate-to-severe psoriasis were enrolled and randomized 1:1:1:1 to take HS-20137 at doses of 100 mg every 8 weeks (Q8W), 200 mg Q8W, 200 mg Q12W, or placebo (without treatment). Switching to HS-20137 200 mg Q8W happened at week 16 or week 28. Psoriatic lesions improved significantly and for a long time in the HS-20137-treated population compared with the untreated population. After 16 weeks’ treatment, the impact of psoriasis on patients’ quality of life had reduced to a mild level. The adverse event rate during the placebo-controlled period was similar between the treated and untreated population. In conclusion, HS-20137 treatment was tolerable and effective, and it may offer a promising alternative therapy for Chinese patients with psoriasis.

Source: Dermatology and Therapy

DOI: 10.1007/s13555-026-01694-1