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Due to the reconsideration of KHK4827's business in China, it. was decided to withdraw this clinical trial prior to enrollment of first participant.
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| Name | Class |
|---|---|
| Kyowa Kirin China Pharmaceutical Co., Ltd. | INDUSTRY |
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The objective of this study is assessing the efficacy and safety of brodalumab in Chinese subjects with moderate to severe plaque psoriasis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| KHK4827 210 mg SC (Subcutaneous) | Experimental | Single SC administration |
|
| Placebo SC | Placebo Comparator | Single SC administration |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| KHK4827-Active | Drug | Single SC administration |
| |
| Measure | Description | Time Frame |
|---|---|---|
| To evaluate the proportion of subjects achieving 75% improvement from baseline in Psoriasis Area and Severity Index (PASI; PASI 75) at Week 12 | Week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| To evaluate the proportion of subjects achieving 100% improvement from baseline in PASI (PASI 100) at Week 12 | Week 12 | |
| To evaluate static physician's global assessment (sPGA) of "clear or almost clear (0 or 1)" at Week 12 | Week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of patients with treatment-emergent adverse events (TEAEs) or drug-related TEAEs | after received an investigational product until last visit 1 year |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Site 01 | Beijing | China | ||||
| Site 03 |
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| KHK4827-Placebo |
| Drug |
Single SC administration |
|
| Beijing |
| China |
| Site 04 | Beijing | China |
| Site 10 | Beijing | China |
| Site 11 | Beijing | China |
| Site 12 | Beijing | China |
| Site 21 | Beijing | China |
| Site 07 | Changchun | China |
| Site 13 | Changchun | China |
| Site 14 | Chongqing | China |
| Site 09 | Hangzhou | China |
| Site 17 | Hangzhou | China |
| Site 24 | Hangzhou | China |
| Site 25 | Nanjing | China |
| Site 02 | Shanghai | China |
| Site 05 | Shanghai | China |
| Site 08 | Shanghai | China |
| Site 06 | Tianjin | China |
| Site 22 | Tianjin | China |
| Site 23 | Ürümqi | China |
| Site 16 | Wenzhou | China |
| Site 19 | Wuhan | China |
| Site 20 | Wuhan | China |
| Site 15 | Xi'an | China |
| Site 18 | Xi'an | China |