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terminated by sponsor
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The purpose of this study is to assess the efficacy and safety of SHR0302 ointment in adult patients with Vitiligo.
This study is a phase II/â…¢ seamless adaptive clinical trial to evaluate the efficacy and safety of SHR0302 ointment in adult patients with non-segmental vitiligo.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SHR0302 Low Dose | Active Comparator | Drug: SHR0302 SHR0302 Ointment BID Low Dose |
|
| SHR0302 High Dose | Active Comparator | Drug: SHR0302 SHR0302 Ointment BID High Dose |
|
| Placebo Comparator: Vehicle | Placebo Comparator | Drug: vehicle Vehicle BID Placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Low Dose SHR0302 Ointment BID | Drug | Low Dose SHR0302 Ointment BID |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Phase 2 | Phase 2: Percentage of change in face and neck vitiligo area scoring index (F-VASI) compared with baseline at week 24. | 24 weeks |
| Phase 3 | Phase 3: Percentage of subjects whose face and neck vitiligo area scoring index improved by at least 75% (F-VASI75) compared with the baseline at week 24. | 24 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Affiliated Hospital of Fujian Medical University | Fuzhou | Fujian | China | |||
| Dermatology Hospital of Southern Medical University |
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| High Dose SHR0302 Ointment BID |
| Drug |
High Dose SHR0302 Ointment BID |
|
| Placebo Comparator: Vehicle | Other | Placebo |
|
| Guangzhou |
| Guangdong |
| China |
| Wuhan No.1 Hospital | Wuhan | Hubei | China |
| The First Affiliated Hospital of Dalian Medical University | Dalian | Liaoning | China |
| Xijing Hospital, Air Force Medical University | Xi'an | Shaanxi | China |
| Shanghai Skin Disease Hospital | Shanghai | Shanghai Municipality | 200071 | China |
| West China School of Medicine | Chengdu | Sichuan | China |
| Tianjin Academy of Traditional Chinese Medicine Affiliated Hospital | Tianjin | Tianjin Municipality | 300120 | China |
| Hangzhou Third Hospital | Hangzhou | Zhejiang | China |
| Zhejiang University School of Medicine | Hangzhou | Zhejiang | China |
| Ningbo No.2 Hospital | Ningbo | Zhejiang | China |
| The First Hospital of Jillin University | Changchun | 130021 | China |
| Sun. Yai- Sen Memorial Hospital, Sun. Yai- Sen University | Guangzhou | 51000 | China |
| Zhejiang Provincial People's Hospital | Hangzhou | 310014 | China |
| Jiangsu Province Hospital | Nanjing | 210006 | China |
| Huashan Hospital Affiliated To Fudan University | Shanghai | China |
| ID | Term |
|---|---|
| D014820 | Vitiligo |
| ID | Term |
|---|---|
| D017496 | Hypopigmentation |
| D010859 | Pigmentation Disorders |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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