NCT06672393

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

A Multi-Center, Randomized, Double Blind, Placebo-Controlled, Phase 3 Study to Evaluate the Efficacy and Safety of HS-10374 in Adult Subjects With Moderate To Severe Plaque Psoriasis

• Status: Not Yet Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 375 (estimated)
• Sponsor: Hansoh BioMedical R&D Company · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study has been designed to confirm the clinical efficacy and safety of HS-10374 in the treatment of moderate to severe plaque psoriasis.

Detailed description

This is a 52-week, multi-center, randomized, double-blind, placebo-controlled, Phase 3 study. The study duration includes a 4-week screening period, a 16-week placebo-controlled treatment period, a 36-week study drug treatment period, and a 4-week follow-up period. All eligible subjects will be randomly assigned in a 2:1 ratio to receive HS-10374 or placebo QD. At Week 16, subjects receiving placebo will be switched to HS-10374 QD.

Conditions

• Psoriasis

Interventions

Type	Name	Description
DRUG	HS-10374 6mg tablets	Specified dose of HS-10374 tablets administered orally QD on specified days
DRUG	HS-10374-matched placebo tablets	Specified dose of HS-10374-matched placebo tablets administered orally QD on specified days

Timeline

• Start date: 2024-11-04
• Primary completion: 2025-10-22
• Completion: 2026-06-29
• First posted: 2024-11-04
• Last updated: 2024-11-04

Locations

1 site across 1 country: China