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

NCT07070739 | Not Yet Recruiting Phase 2

• 1 other identifier: HSK44459-205
• Study Type: interventional
• Target: 120
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Bechet's Disease

Outcome Measures

Primary Outcomes (1)

• Incidence and severity of adverse events during the study

  56 weeks

Secondary Outcomes (4)

• 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

Study Arms (1)

Treatment group

EXPERIMENTAL

Drug: HSK44459 tablets

Interventions

HSK44459 tablets DRUG

Orally, twice a day

Treatment group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \- 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;

You may not qualify if:

• 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.

Sponsors & Collaborators

• Haisco Pharmaceutical Group Co., Ltd.: lead

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 9, 2025
• First Posted: July 17, 2025
• Study Start: July 1, 2025
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): July 1, 2027
• Last Updated: July 17, 2025

Record last verified: 2025-07