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The purpose of this study is to assess efficacy, safety of subcutaneous SHR-1314 in pediatric patients of age 6 to <18 years with moderate-to-Severe plaque psoriasis
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SHR-1314 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SHR-1314 | Drug | SHR-1314: dose 1 SHR-1314:dose 2 SHR-1314:dose 3 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Safety assessment including adverse events at Week 16 | Week 16 | |
| PK parameters: Cmax at Week 12 | Week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of subjects who achieve at least 75% improvement in PASI score (PASI 75) at Week 12 | Week 12 | |
| sPGA of 0 or 1 response at Week 12 | Week 12 | |
| Percentage of subjects who achieve at least 90% improvement in PASI score (PASI 90)at Week 12 |
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Inclusion Criteria:
PASI score of 12 or greater, and sPGA score of 3 or greater (based on a static scale of 0 - 5), and Body Surface Area (BSA) affected by plaque psoriasis of 10% or greater.
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| xiaoyan bai | Contact | +0518-81220121 | xiaoyan.bai@hengrui.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Capital Medical University Affiliated Children's Hospital | Beijing | Beijing Municipality | 100045 | China |
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| Week 12 |
| Shanghai Huashan Hospital | Shanghai | Shanghai Municipality | 200040 | China |
|