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The study is being conducted to evaluate the efficacy, and safety of SHR0302 tablets as single therapy or in combination with SHR0302 Base gel for patients with non-segmental vitiligo.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SHR0302 tablets in low dose group | Experimental |
| |
| SHR0302 tablets in high dose group | Experimental |
| |
| SHR0302 tablets + SHR0302 Base gel group | Experimental |
| |
| SHR0302 placebo tablets + SHR0302 Base placebo gel group | Placebo Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SHR0302 Tablets | Drug | SHR0302 tablets. |
|
| Measure | Description | Time Frame |
|---|---|---|
| The percentage change in the facial vitiligo area score index (F-VASI) from the baseline. | At Week 24. |
| Measure | Description | Time Frame |
|---|---|---|
| The percentage change in F-VASI compared to the baseline. | Except for Week 24. | Up to 48 weeks. |
| The percentage change in the total body vitiligo area score index (T-VASI) compared to the baseline. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Hui Wang | Contact | +86-0518-82342973 | hui.wang.hw119@hengrui.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dermatology Hospital affiliated to Shandong First Medical University | Recruiting | Jinan | Shandong | 250022 | China |
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| ID | Term |
|---|---|
| C000615713 | ivarmacitinib |
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| SHR0302 Base Gel | Drug | SHR0302 Base gel. |
|
| SHR0302 Placebo Tablets | Drug | SHR0302 placebo tablets. |
|
| SHR0302 Base Placebo Gel | Drug | SHR0302 Base placebo gel. |
|
| Up to 48 weeks. |
| The proportion of subjects who achieved an improvement of at least 50%/75%/90% compared to the baseline on the F-VASI (F-VASI 50/75/90 response). | Up to 48 weeks. |
| The proportion of subjects who achieved at least a 50%/75%/90% improvement in T-VASI compared to the baseline (T-VASI 50/75/90 response). | Up to 48 weeks. |
| The absolute change in facial vitiligo area (F-BSA) compared to the baseline. | Up to 48 weeks. |
| The percentage change in facial vitiligo area (F-BSA) compared to the baseline. | Up to 48 weeks. |
| The percentage change the total body vitiligo area (T-BSA) compared to the baseline. | Up to 48 weeks. |
| The absolute change the total body vitiligo area (T-BSA) compared to the baseline. | Up to 48 weeks. |
| The proportion of subjects who achieved a significant improvement (4) on the Vitiligo Visual Scale (VNS). | Up to 48 weeks. |
| The proportion of subjects who achieved a complete improvement (5) on the Vitiligo Visual Scale (VNS). | Up to 48 weeks. |
| The absolute values of the changes in the vitiligo-specific quality of life scale (VitiQoL) compared to the baseline. | Up to 48 weeks. |
| The percentages of the changes in the vitiligo-specific quality of life scale (VitiQoL) compared to the baseline. | Up to 48 weeks. |
| The proportion of subjects who achieved the facial - vitiligo physician global assessment (F-PhGVA) of no depigmentation (0). | Up to 48 weeks. |
| The proportion of subjects who achieved the facial - vitiligo physician global assessment (F-PhGVA) of almost no depigmentation (1). | Up to 48 weeks. |
| The proportion of subjects who achieved the overall assessment of vitiligo by dermatologists (T-PhGVA) as no depigmentation (0). | Up to 48 weeks. |
| The proportion of subjects who achieved the overall assessment of vitiligo by dermatologists (T-PhGVA) as almost no depigmentation (1). | Up to 48 weeks. |
| The proportion of subjects who achieved a significant improvement (1) in the facial vitiligo condition as perceived by the overall impression (F-PaGIC-V). | Up to 48 weeks. |
| The proportion of subjects who achieved a moderate improvement (2) in the facial vitiligo condition as perceived by the overall impression (F-PaGIC-V). | Up to 48 weeks. |
| The proportion of subjects who achieved a significant improvement (1) in the overall impression (T-PaGIC-V) of generalized vitiligo. | Up to 48 weeks. |
| The proportion of subjects who achieved a moderate improvement (2) in the overall impression (T-PaGIC-V) of generalized vitiligo. | Up to 48 weeks. |
| The plasma concentration of SHR0302. | Week 12 and Week 24. |
| The relative change in serum CXCL-9 level before administration compared to the baseline value. | At Week 4, 12, 24, 32, and 48. |
| The relative change in serum CXCL-10 level before administration compared to the baseline value. | At Week 4, 12, 24, 32, and 48. |