NCT07070739Not yet recruitingPhase 2
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
Haisco Pharmaceutical Group Co., Ltd.0 sites120 target enrollmentStarted: July 1, 2025Last updated:
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 2
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 120
- Primary Endpoint
- Incidence and severity of adverse events during the study
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
- •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.
- •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.
- •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
- •Subjects whom the investigator deems to have any other factors that make them unsuitable for participating in this clinical study.
Arms & Interventions
Treatment group
Experimental
Intervention: HSK44459 tablets (Drug)
Outcomes
Primary Outcomes
Incidence and severity of adverse events during the study
Time Frame: 56 weeks
Secondary Outcomes
- 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)
Investigators
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