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This is a multicenter, randomized, double-blind, placebo-controlled, phase III clinical study which is designed to determine the efficacy, safety, immunogenicity and pharmacokinetics, and pharmacodynamics of HB0017 Injection in the treatment of moderate to severe plaque psoriasis in adults.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HB0017 | Experimental | Participants will receive HB0017 at week 0,1,2,4,8 followed by once every four weeks (Q4W) or once every eight weeks (Q8W) at Week 12. |
|
| placebo | Placebo Comparator | Participants will receive placebo at week 0,1,2,4,8 followed by HB0017 once every four weeks (Q4W) at Week 12. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HB0017 Q4W | Biological | HB0017 at W0,1,2,4,8+HB0017Q4W |
| |
| HB0017 Q8W |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of subjects achieving PASI 75 response at Week 12 | The PASI75 response assessments are based on at least 75% improvement in PASI score from Baseline. | Week 12 |
| Proportion of subjects achieving sPGA 0/1 response at Week 12 | 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 90 response at Week 12 | The PASI90 response assessments are based on at least 90% improvement in PASI score from Baseline. | Week 12 |
| PASI 90 response maintainance at week 52 |
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Inclusion Criteria:
Key Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jianzhong Zhang, MD | Contact | 86-10-88326666 | rmzjz@126.com |
| Name | Affiliation | Role |
|---|---|---|
| Jianzhong Zhang, MD | Peking University People's Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Jiangmen Central Hospital | Not yet recruiting | Jiangmen | Guangdong | China |
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| Biological |
HB0017 at W0,1,2,4,8+HB0017Q8W |
|
| placebo | Biological | placebo at W0,1,2,4,8+HB0017Q4W |
|
Proportion of subjects maintaining PASI 90 response at Week 52 among those with PASI 90 response at Week 12
| Week12-52 |
| sPGA 0/1 response maintainance at week 52 | Proportion of subjects maintaining sPGA 0/1 response at Week 52 among those with sPGA 0/1 response at Week 12. | Week 12-52 |
| PASI 75 response maintainance at week 52 | Proportion of subjects maintaining PASI 75 response at Week 52 among those with PASI 75 response at Week 12. | Week12-52 |
| Nanyang First People's Hospital | Recruiting | Nanyang | Henan | China |
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| Beijing Friendship Hospital | Recruiting | Beijing | China |
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| China-Japan Friendship hospital | Recruiting | Beijing | China |
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| Peking University People's Hospital | Recruiting | Beijing | China |
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| The First Affiliated Hospital of Bengbu Medical College | Recruiting | Bengbu | China |
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| Jilin University Second Hospital | Recruiting | Changchun | China |
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| The first hospital of Jilin University | Recruiting | Changchun | China |
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| Xiangya Hospital of Central South University | Recruiting | Changsha | China |
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| Affiliated Hospital of Chengde Medical University | Recruiting | Chengde | China |
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| Sichuan Provincial People's Hospital | Not yet recruiting | Chengdu | China |
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| West China Hospital of Sichuan University | Not yet recruiting | Chengdu | China |
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| Chongqing Traditional Chinese Medicine Hospital | Not yet recruiting | Chongqing | China |
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| Dongguan People's Hospital | Recruiting | Dongguan | China |
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| The First Affiliated Hospital of Fujian Medical University | Recruiting | Fuzhou | China |
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| Dermatology Hospital of Southern Medical University | Recruiting | Guangzhou | China |
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| Guangdong Provincial People's Hospital | Recruiting | Guangzhou | China |
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| Hangzhou First People's Hospital | Recruiting | Hangzhou | China |
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| Hangzhou Third People's Hospital | Not yet recruiting | Hangzhou | China |
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| The First Affiliated Hospital of Zhejiang University School of Medicine | Not yet recruiting | Hangzhou | China |
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| The Second Affiliated Hospital of Harbin Medical University | Recruiting | Harbin | China |
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| The Second Affiliated Hospital of Anhui Medical University | Recruiting | Hefei | China |
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| Jiaxing First Hospital | Recruiting | Jiaxing | China |
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| Shandong Dermatology Hospital | Recruiting | Jinan | China |
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| Jining First People's Hospital | Not yet recruiting | Jining | China |
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| The First Affiliated Hospital of Kunming Medical University | Recruiting | Kunming | China |
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| The Second Affiliated Hospital of Kunming Medical University | Recruiting | Kunming | China |
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| The Second Affiliated Hospital of Henan University of Science and Technology | Recruiting | Luoyang | China |
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| Dermatology Hospital of Jiangxi Province | Recruiting | Nanchang | China |
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| The Second Affiliated Hospital of Nanchang University | Recruiting | Nanchang | China |
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| Jiangsu University Affiliated Hospital | Recruiting | Nanjing | China |
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| Ningbo Second Hospital | Recruiting | Ningbo | China |
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| Shanghai Dermatology Hospital | Recruiting | Shanghai | China |
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| People's Hospital of Liaoning Province | Recruiting | Shenyang | China |
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| Shenzhen People's Hospital | Recruiting | Shenzhen | China |
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| Shiyan People's Hospital | Recruiting | Shiyan | China |
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| The Second Hospital of Shanxi Medical University | Recruiting | Taiyuan | China |
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| Wenzhou Medical University Affiliated First Hospital | Recruiting | Wenzhou | China |
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| Wuhan University People's Hospital | Recruiting | Wuhan | China |
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| The First Affiliated Hospital of Wannan Medical College | Recruiting | Wuhu | China |
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| Wuxi Second People's Hospital | Recruiting | Wuxi | China |
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| The Second Affiliated Hospital of Xi'an Jiaotong University | Recruiting | Xi'an | China |
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| Xingtai People's Hospital | Recruiting | Xingtai | China |
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| Yangjiang People's Hospital | Not yet recruiting | Yangjiang | 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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