NCT06077331

A Study to Evaluate Efficacy and Safety of HS-10374 for Moderate to Severe Plaque Psoriasis

A Multi-Center, Randomized, Double Blind, Placebo-Controlled, Phase 2 Study to Evaluate the Efficacy and Safety of HS-10374 in Adult Subjects With Moderate To Severe Plaque Psoriasis

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 120 (estimated)
• Sponsor: Hansoh BioMedical R&D Company · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

This study has been designed to explore the clinical efficacy and safety of HS-10374 in the treatment of moderate to severe plaque psoriasis. Additionally, this study is to find the optimal dosing for the future clinical development of HS-10374.

Detailed description

This is a 12-week, multi-center, randomized, double blind, placebo-controlled, Phase 2 study. The study duration includes a 4-week screening period, a 12-week treatment period, and a 4-week follow-up period. All eligible subjects will be randomly assigned to 1 of 3 treatment arms (HS-10374 Dose 1, HS-10374 Dose 2, and placebo) in an equal ratio.

Conditions

• Psoriasis

Interventions

Type	Name	Description
DRUG	HS-10374 tablets 1mg	Administered orally QD for 12 weeks
DRUG	HS-10374 tablets 5mg	Administered orally QD for 12 weeks
DRUG	HS-10374-matched placebo tablets	Administered orally QD for 12 weeks

Timeline

• Start date: 2023-09-28
• Primary completion: 2024-07-31
• Completion: 2024-08-31
• First posted: 2023-10-11
• Last updated: 2023-12-06

Locations

1 site across 1 country: China