NCT06844799

A Study of HS-20137 in Participants with Moderate-to-severe Plaque Psoriasis

A Randomized, Double-blind, Placebo-controlled, Phase 3 Study to Evaluate Efficacy and Safety of HS-20137, an Anti-IL-23 Monoclonal Antibody, in Participants with Moderate-to-severe Plaque Psoriasis

• Status: Not Yet Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 720 (estimated)
• Sponsor: Hansoh BioMedical R&D Company · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The primary objective of this study is to evaluate the efficacy and safety of HS-20137 in the treatment of participants with moderate to severe plaque psoriasis.

Detailed description

HS-20137 is an antibody targeting IL-23, which were recommended biologic agents for the treatment of patients with moderate-to-severe psoriasis. This is a randomized, double-blinded, placebo-controlled phase 3 study, including a 4 weeks screening period, a 52 weeks double-blinded period (placebo-control period in the first 16 weeks) and a 8 weeks follow-up period (total 60 weeks). The hypothesis is that HS-20137 will be more effective in treatment of psoriasis than placebo and well tolerated. Participants with moderate-to-severe plaque psoriasis will be included in this study and received HS-20137 200mg or placebo in week 0, 4, 8 in placebo-control period and then HS-20137 200mg every 8 or 12 weeks thereafter.

Conditions

• Moderate-to-severe Plaque Psoriasis

Interventions

Type	Name	Description
DRUG	HS-20137	HS-20137 200mg injection at week 0, 4, 8 and then every 8 or 12 weeks.
DRUG	Placebo&HS-20137	Placebo injection at week 0, 4, 8, and then HS-20137 200mg injection at week 16, 20, 24, and every 8 or 12 weeks thereafter

Timeline

• Start date: 2025-06-10
• Primary completion: 2027-03-31
• Completion: 2027-06-30
• First posted: 2025-02-25
• Last updated: 2025-02-25