NCT07070739

A Long-term Study of HSK44459 Tablets in Participants With Bechet's Disease

A Multicenter, Open-label Study to Evaluate the Long-term Safety and Efficacy of HSK44459 Tablets for the Treatment of Patients With Bechet'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 long-term extension study of HSK44459-202 in eligible participants who have completed the Week 12 visit of the originating Study HSK44459-202. The total duration of this study will be up to 56 weeks which will include a 52-week treatment period, and a 4-week safety follow-up period after the last study intervention administration. Safety will be assessed by the incidence and severity of adverse events during the study.

Conditions

• Bechet's Disease

Interventions

Type	Name	Description
DRUG	HSK44459 tablets	Orally, twice a day

Timeline

• Start date: 2025-07-01
• Primary completion: 2027-07-01
• Completion: 2027-07-01
• First posted: 2025-07-17
• Last updated: 2025-07-17