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

INTRODUCTION

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.

METHODS

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.

RESULTS

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.

CONCLUSIONS

HS-20137 treatment was tolerable and effective in patients with psoriasis, supporting further investigation and development.

TRIAL REGISTRATION: ChiCTR2300075645.