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NCT Number: NCT07070739

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

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.

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Key information

Conditions

Bechet's Disease

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

HSK44459 tablets

Drug

Orally, twice a day

Primary outcomes

  1. Incidence and severity of adverse events during the study

    Time frame: 56 weeks

Secondary outcomes

  1. Complete remission rate of oral ulcers

    Time frame: 52 weeks

  2. Changes in oral ulcer pain measured by VAS compared with baseline

    Time frame: 52 weeks

  3. Changes in Bechet's Disease Quality of Life Score (BD-QoL) compared with baseline

    Time frame: 52 weeks

  4. Changes in the Short Form Health Survey (SF-36) compared with baseline

    Time frame: 52 weeks

Sponsors and collaborators

Lead sponsor

Haisco Pharmaceutical Group Co., Ltd.

Industry

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Jul 17, 2025
Registry last updated
Jul 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.