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

Area of Science:

• Dermatology
• Immunology
• Clinical Pharmacology

Background:

• HS-20137 is a novel interleukin-23 inhibitor.
• Previous phase 1b studies suggested efficacy for psoriasis treatment.
• A phase 2 study was designed to further evaluate HS-20137 in a larger patient cohort.

Purpose of the Study:

• To evaluate the efficacy and safety of HS-20137 in adult patients with moderate-to-severe plaque psoriasis.
• To compare different dosing regimens of HS-20137 against a placebo.
• To assess long-term efficacy and safety up to 52 weeks.

Main Methods:

• A randomized, double-blind, placebo-controlled phase 2 study.
• 159 adult patients with moderate-to-severe psoriasis were enrolled across 22 sites in China.
• Patients received subcutaneous HS-20137 (100mg Q8W, 200mg Q8W, 200mg Q12W) or placebo, with crossover to active treatment.

Main Results:

• Significantly higher PASI 90 response rates were observed with HS-20137 compared to placebo at week 16 (65.0%-76.9% vs. 7.5%, P < 0.001).
• HS-20137 also led to superior PASI 100, IGA 0/1, and IGA 0 scores.
• Sustained PASI score reduction was observed through week 52, with comparable and mild treatment-emergent adverse event rates across groups.

Conclusions:

• HS-20137 demonstrated significant efficacy in achieving PASI 90 and other key endpoints in patients with moderate-to-severe plaque psoriasis.
• The treatment was found to be tolerable with a favorable safety profile.
• These findings support the further investigation and development of HS-20137 for psoriasis treatment.