NCT06902428

Evaluating the Efficacy and Safety of of HSK44459 in Patients With Behçet's Disease

A Multi-center, Randomised, Double-blind, Placebo-controlled Phase II Clinical Study Evaluating the Efficacy and Safety of HSK44459 Tablets in Patients With Behçet's Disease

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 120 (estimated)
• Sponsor: Haisco Pharmaceutical Group Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This is a phase 2, multi-center, randomised, double-blind, placebo-controlled study with an equal randomization among the HSK44459 dose 1, dose 2 and placebo treatment groups. The main objective is to evaluate of the efficacy and the secondary objective is to evaluate the safety and pharmacokinetic.

Detailed description

This study is a phase 2, multi-center, randomized, double - blind, placebo - controlled study designed to evaluate the efficacy and safety of HSK44459 in the treatment of patients with Behçet Disease (BD). Approximately 120 subjects will be randomized into this study. The entire study will consist of 3 phases: a screening phase, a 12-week treatment phase, and a 4-week follow-up phase. Screening: All subjects will undergo a screening period of up to 6 weeks before the first dose (Visit 3, Day 1). Treatment phase: Eligible BD patients will be randomly assigned to the HSK44459 dose 1 group, the HSK44459 dose 2 group, or the placebo group. During the treatment period, HSK44459 or placebo will be administered twice daily for 12 weeks. Follow-up phase: Subjects in the study (including those who withdraw from treatment for any reason) will have an additional 4 - week follow-up after the end of the last administration.

Conditions

• Behcet's Disease

Interventions

Type	Name	Description
DRUG	HSK44459	HSK44459, bid p.o.
DRUG	Placebo	Placebo, bid p.o.

Timeline

• Start date: 2025-03-24
• Primary completion: 2026-06-05
• Completion: 2026-07-03
• First posted: 2025-03-30
• Last updated: 2025-03-30