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

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT07070739

Enrollment

120

Registered

2025-07-17

Start date

2025-07-31

Completion date

2027-07-31

Last updated

2025-07-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bechet's Disease

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.

Interventions

DRUGHSK44459 tablets

Orally, twice a day

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame
Incidence and severity of adverse events during the study	56 weeks

Secondary

Measure	Time frame
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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026