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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment group | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HSK44459 tablets | Drug | Orally, twice a day |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence and severity of adverse events during the study | 56 weeks |
| Measure | Description | 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 |
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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:
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| 52 weeks |
| Changes in the Short Form Health Survey (SF-36) compared with baseline | 52 weeks |