NCT07150988

A Phase II Efficacy and Safety Study of HSK44459 in Subjects With Moderate to Severe Plaque Psoriasis

A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase II Clinical Study to Evaluate the Efficacy and Safety of HSK44459 in Subjects With Moderate to Severe Plaque Psoriasis

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 150 (estimated)
• Sponsor: Haisco Pharmaceutical Group Co., Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to assess the efficacy and safety of HSK44459 administered orally for moderate to severe plaque psoriasis in adults.

Detailed description

Patients with moderate to severe plaque psoriasis will be randomized into 3 cohorts (dose level 1, dose level 2 and placebo). Approximately 150 subjects will be enrolled. This study includes an 16-week treatment Period, then a 4-week safety visit period.

Conditions

• Psoriasis

Interventions

Type	Name	Description
DRUG	HSK44459 dose level 1	HSK44459 dose level 1 oral administration
DRUG	HSK44459 dose level 2	HSK44459 dose level 2 orally administration
DRUG	placebo	placebo oral adminisitration

Timeline

• Start date: 2025-09-26
• Primary completion: 2026-11-06
• Completion: 2026-11-06
• First posted: 2025-09-02
• Last updated: 2025-09-02

Locations

1 site across 1 country: China