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

Not Applicable

Not yet recruiting

• Conditions: Bechet's Disease
• Interventions: Drug: HSK44459 tablets

• Registration Number: NCT07070739
• Lead Sponsor: Haisco Pharmaceutical Group Co., Ltd.

Brief 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-07
• Study Start: 2025-07-01
• Study First Submitted: 2025-07-09
• Study First Submitted QC: 2025-07-09
• Last Update Submitted: 2025-07-09
• Study First Posted: 2025-07-17
• Last Update Posted: 2025-07-17
• Primary Completion: 2027-07
• Study Completion: 2027-07-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

• Have previously participated in clinical studies on the treatment of Bechet's disease with HSK44459 tablets and completed the specified treatment in accordance with the protocol;

Exclusion Criteria

1. Active involvement of major organs related to Behçet's disease - pulmonary (eg, pulmonary artery aneurysms), vascular (eg, thrombophlebitis), gastrointestinal (eg, gastrointestinal ulcers), and central nervous system (eg, meningoencephalitis) manifestations, and ocular lesions (eg, uveitis) requiring immunosuppressive treatment.
2. Subjects who experienced treatment-emergent serious adverse events (SAEs) related to the investigational product in previous HSK44459 studies, and in the investigator's judgment, are not suitable for continuing treatment with HSK44459 tablets.
3. Currently has hepatitis B surface antigen (HBsAg) or hepatitis C antibody (anti-HCV) positive, or has other clinically active liver disease, or tests positive for HBsAg or anti-HCV
4. Subjects whom the investigator deems to have any other factors that make them unsuitable for participating in this clinical study.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Treatment group	HSK44459 tablets	-

Primary Outcome Measures

Name	Time	Method
Incidence and severity of adverse events during the study	56 weeks

Secondary Outcome Measures

Name	Time	Method
Complete remission rate of oral ulcers	52 weeks
Changes in oral ulcer pain measured by VAS compared with baseline	52 weeks
Changes in Bechet's Disease Quality of Life Score (BD-QoL) compared with baseline	52 weeks
Changes in the Short Form Health Survey (SF-36) compared with baseline	52 weeks