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| Name | Class |
|---|---|
| Zhongqi Pharmaceutical Technology (Shijiazhuang) Co. Ltd. | UNKNOWN |
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A 52-Week Study of SYHX1901 tablet in Adults with non-segmental vitiligo.
SYHX1901 tablet is being evaluated for the treatment of non-segmental vitiligo. The study will enroll approximately 144 participants aged 18-65 with non-segmental vitiligo in 4 treatment arms. Participants will either receive study drug vs placebo oral tablets once daily (QD) for 24 weeks (Period A). In Period B (up to 52 weeks), participants who received placebo during the first 24 weeks will switch to study drug. Participants who received study drug during the first 24 weeks, will continue to receive study drug.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SYHX1901-A | Experimental | Participants in this group will receive dose A of SYHX1901 orally once daily (QD) for 52 weeks |
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| SYHX1901-B | Experimental | Participants in this group will receive dose B of SYHX1901 orally QD for 52 weeks |
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| SYHX1901-C | Experimental | articipants in this group will receive dose C of SYHX1901 orally QD for 52 weeks |
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| Placebo followed by dose C of SYHX1901 | Placebo Comparator | Participants in this group will receive placebo orally QD for 24 weeks followed by dose C of SYHX1901 orally QD for 28 weeks. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SYHX1901 | Drug | SYHX1901 tablet |
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| Measure | Description | Time Frame |
|---|---|---|
| Percent Change From Baseline in Facial-Vitiligo Area Scoring Index (F-VASI) | The vitiligo area scoring index (VASI) is a validated scoring method used to assess the areas of depigmentation due to vitiligo. The F-VASI includes contributions from the face, with a possible range from 0 to 3.5. | At 24 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Achieving F-VASI 50 (≥ 50% Improvement in F-VASI From Baseline) | The VASI is a validated scoring method used to assess the areas of depigmentation due to vitiligo. The F-VASI includes contributions from the face, with a possible range from 0 to 3.5. | At 4、8、12、16、20、24、28、32、36、40、44、48、52、56 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinical Trials Information Group | Recruiting | Shijiazhuang | China |
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Parallel assigned
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| placebo | Drug | Oral tablet |
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| Percentage of Participants Achieving F-VASI 75 (≥ 75% Improvement in F-VASI From Baseline) |
The VASI is a validated scoring method used to assess the areas of depigmentation due to vitiligo. The F-VASI includes contributions from the face, with a possible range from 0 to 3.5. |
| At 4、8、12、16、20、24、28、32、36、40、44、48、52、56 weeks |
| Percentage of Participants Achieving Total Vitiligo Area Scoring Index (T-VASI) 50 (≥ 50% Improvement in T-VASI From Baseline) | The VASI is a validated scoring method used to assess the areas of depigmentation due to vitiligo. It is based on a composite estimate of the overall area of vitiligo patches, measured by the number of hand units (palm plus 5 digits = 1% body surface area [BSA]) multiplied by the degree of depigmentation within each affected area (0%, 10%, 25%, 50%, 75%, 90%, or 100%). The T-VASI is calculated using a formula that includes contributions from all body regions, with a possible range from 0 to 100. | At 4、8、12、16、20、24、28、32、36、40、44、48、52、56 weeks |
| Percent Change From Baseline in F-VASI | The VASI is a validated scoring method used to assess the areas of depigmentation due to vitiligo. The T-VASI is calculated using a formula that includes contributions from all body regions, with a possible range from 0 to 100. | At 4、8、12、16、20、24、28、32、36、40、44、48、52、56 weeks |
| Percent Change From Baseline in BSA | The BSA is measured by the number of hand units (palm plus 5 digits = 1% body surface area). | At 4、8、12、16、20、24、28、32、36、40、44、48、52、56 weeks |
| Change from baseline in Overall Dermatology Life Quality Index (DLQI) score | The DLQI is a validated questionnaire used in dermatology clinical trials as patient reported outcome measure. The DLQI consists of 10 questions concerning patients' perception of the impact of skin diseases on different aspects of their health-related quality of life over the last week. | At 8、16、24、32、40、48、52、56 weeks |
| Change from baseline in Hospital Anxiety and Depression Scale (HADS) score | The HADS is a self-rating patient reported outcome measure (PROM) to assess depression and anxiety in patients. Fourteen items are equally divided in two subscales: anxiety (HADS-A) and depression (HADS-D). | At 8、16、24、32、40、48、52、56 weeks |