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This study is a randomized, double-blind phase 2 clinical trial aimed at exploring the efficacy, safety, and immunogenicity of HB0017 injection with different dosing regimens in the treatment of moderate to severe plaque psoriasis in subjects
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental Group 1 | Experimental | HB0017 higer dose plus longer dose regimen |
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| Experimental Group 2 | Experimental | HB0017 higer dose plus shorter dose regimen |
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| Experimental Group 3 | Experimental | HB0017 low dose plus shortest dose regimen |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HB0017 | Biological | 300mg Q12W |
| |
| HB0017 |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of subjects achieving PASI 90 response | The PASI75 response assessments are based on at least 90% improvement in PASI score from Baseline. | Week 12 |
| Proportion of subjects achieving sPGA 0/1 | The sPGA is a physician's determination of the participant's psoriasis lesions overall at a given time point categorized by descriptions for induration, erythema, and scaling. For the analysis of responses, the participant's psoriasis is assessed as clear (0), Almost clear (1), mild (2), moderate (3), severe (4). An sPGA 0/1 response was defined as a post-baseline sPGA score of 0 or 1. | Week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of subjects achieving PASI 75 response | The PASI75 response assessments are based on at least 75% improvement in PASI score from Baseline. | Week 12 |
| Proportion of subjects achieving PASI 100 response |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Affiliated Hospital of Bengbu Medical College | Recruiting | Bengbu | Anhui | China |
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| ID | Term |
|---|---|
| D011565 | Psoriasis |
| ID | Term |
|---|---|
| D017444 | Skin Diseases, Papulosquamous |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| Biological |
300mg Q8W |
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| HB0017 | Biological | 150mg Q4W |
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The PASI100 response assessments are based on 100% improvement in PASI score from Baseline
| Week 12 |
| PASI 90 response maintainance at week 48 | Proportion of subjects maintaining PASI 90 response at Week 48 among those with PASI 90 response at Week 12 | Week12-48 |
| sPGA 0/1 response maintainance at week 48 | Proportion of subjects maintaining sPGA 0/1 response at Week 48 among those with sPGA 0/1 response at Week 12. | Week12-48 |
| Southern Medical University Dermatology Hospital | Recruiting | Guangzhou | Guangdong | China |
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| Xiangya Hospital of Central South University | Recruiting | Changsha | Hunan | China |
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| Wuxi Second People's Hospital | Recruiting | Wuxi | Jiangsu | China |
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| Jiangsu University Affiliated Hospital | Recruiting | Zhenjiang | Jiangsu | China |
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| Jilin University Second Hospital | Recruiting | Changchun | Jilin | China |
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| Shandong First Medical University Affiliated Dermatology Hospital | Not yet recruiting | Jinan | Shandong | 0531 | China |
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| Jining First People's Hospital | Recruiting | Jining | Shandong | 0531 | China |
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| Xingtai People's Hospital | Recruiting | Xingtai | Shandong | 0531 | China |
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| Shanxi Medical University Second Hospital | Recruiting | Taiyuan | Shanxi | China |
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| Sichuan Provincial People's Hospital | Recruiting | Chengdu | Sichuan | China |
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| Chongqing Traditional Chinese Medicine Hospital | Recruiting | Chongqing | Sichuan | China |
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| Hangzhou First People's Hospital | Recruiting | Hangzhou | Zhejiang | China |
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| The First Affiliated Hospital of Zhejiang University School of Medicine | Recruiting | Hangzhou | Zhejiang | China |
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| Jiaxing First Hospital | Recruiting | Jiaxing | Zhejiang | China |
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| Wenzhou Medical University Affiliated First Hospital | Recruiting | Wenzhou | Zhejiang | China |
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| Guangdong Provincial People's Hospital | Recruiting | Guangzhou | China |
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| Ningbo Second Hospital | Recruiting | Ningbo | China |
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