Bechet's DiseasePhase 2NCT07070739
A Long-term Study of HSK44459 Tablets in Participants With Bechet's Disease
A Phase 2 study testing HSK44459 tablets in people with Bechet's Disease, run by Haisco Pharmaceutical Group Co., Ltd..
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Bechet's Disease
- What is being tested?
- HSK44459 tablets
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- No sites listed yet
- Study dates
- Jul 2025to Jul 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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;
Who cannot join
- 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.
About this study
Official 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
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
- Being tested
- HSK44459 tablets
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HSK44459 tabletsDrug
Orally, twice a day
| Study group | Role | What they receive |
|---|---|---|
| Treatment group | Experimental | Not described Receives: Drug: HSK44459 tablets |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence and severity of adverse events during the study
Measured: 56 weeks
Secondary outcomes (4)
Complete remission rate of oral ulcers
Measured: 52 weeks
Changes in oral ulcer pain measured by VAS compared with baseline
Measured: 52 weeks
Changes in Bechet's Disease Quality of Life Score (BD-QoL) compared with baseline
Measured: 52 weeks
Changes in the Short Form Health Survey (SF-36) compared with baseline
Measured: 52 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2025
- Study startJul 2025 (estimated)
- Primary completionJul 2027 (estimated)
- Study completionJul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bechet's DiseaseStudies of the same condition, open and under way.
- More trials run by Haisco Pharmaceutical Group Co., Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Haisco Pharmaceutical Group Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07070739
- Sponsor's protocol ID
- HSK44459-205
- Status last verified
- Jul 2025
- First submitted
- 9 Jul 2025
- Last updated
- 17 Jul 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT07070739
- Acronym / sponsor ID
- HSK44459-205
- Conditions
- Bechet's Disease
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Haisco Pharmaceutical Group Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Jul 2025 (estimated)
- Primary completion
- Jul 2027 (estimated)
- Study completion
- Jul 2027 (estimated)
- First posted
- 17 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment group | Experimental | Drug: HSK44459 tablets |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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;
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HSK44459 tabletsOrally, twice a day | Drug | Treatment group |
Primary outcome
Incidence and severity of adverse events during the study
Time frame: 56 weeks
4 secondary outcomes
Complete remission rate of oral ulcers
Time frame: 52 weeks
Changes in oral ulcer pain measured by VAS compared with baseline
Time frame: 52 weeks
Changes in Bechet's Disease Quality of Life Score (BD-QoL) compared with baseline
Time frame: 52 weeks
Changes in the Short Form Health Survey (SF-36) compared with baseline
Time frame: 52 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2025.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing HSK44459 tablets in people with Bechet's Disease, run by Haisco Pharmaceutical Group Co., Ltd..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 17 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence and severity of adverse events during the study (time frame: 56 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jul 2025.