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This is a randomized, double-blind, placebo-controlled, multi-center Phase 2 study to evaluate the efficacy and safety of HB0017 in subjects with moderate to severe plaque psoriasis.
This is a randomized, double-blind, placebo-controlled, multi-center Phase 2 study to evaluate the efficacy and safety of HB0017 in subjects with moderate to severe plaque psoriasis. The study will consist of 3 periods: up to 5 weeks screening period, 28 weeks treatment period, 8 weeks Safety Follow-Up period.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental: HB0017 dosing regimen 1 | Experimental | HB0017 low dose short intervals of subcutaneous injection |
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| Experimental: HB0017 dosing regimen 2 | Experimental | HB0017 low dose long intervals of subcutaneous injection |
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| Experimental: HB0017 dosing regimen 3 | Experimental | HB0017 high dose long intervals of subcutaneous injection |
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| Placebo Comparator: placebo group | Placebo Comparator | Placebo was subcutaneously injected into the 12 weeks turnover HB0017 subcutaneous injection |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo | Other | Subjects will receive several injections of Placebo |
| |
| Measure | Description | Time Frame |
|---|---|---|
| PASI 90 response | Proportion of subjects who achieve Psoriasis Area and Severity Index (PASI) 90 response or higher at week 12 | Week 12 |
| sPGA 0/1 response | Proportion of subjects who achieve static Physician Global Assessment (sPGA) 0 or 1 | Week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| PASI 75 response | Proportion of subjects who achieve PASI 75 response or higher | Week 12 |
| Adverse events | Treatment Related Adverse events (TEAEs)/serious adverse events (SAEs) |
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Inclusion Criteria:
Key Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jianzhong zhang | Peking University People's Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Affiliated Hospital of Bengbu Medical College | Bengbu | Anhui | China | |||
| The First Affiliated Hospital of Anhui Medical University |
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| HB0017 |
| Drug |
Subjects will receive HB0017 in different dosing regimens |
|
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| From baseline through 36 weeks |
| Immunity | Number and proportion of subjects who developed anti-drug antibodies (ADAs) Following Study Treatment | From baseline through 36 weeks |
| PK characteristics | Population pharmacokinetics (PK), Apparent Total Clearance (CL/F), Apparent Volume of Distribution (V/F) of HB0017 | From Baseline through 36 weeks |
| PASI responses up to 36 Weeks | Proportion of subjects who achieve PASI 50, PASI 75, PASI 90 , PASI 100 response up to 36 weeks | From Baseline through 36 weeks |
| sPGA 0/1 up to 36 Weeks | Proportion of subjects who achieve | From Baseline through 36 weeks |
| PD characterestics | HB0017 concentrations in serum at different time points | From Baseline through 36 weeks |
| PASI score change | change in PASI From Baseline to Week 36 | From Baseline through 36 weeks |
| Percent change in PASI | Percent change in PASI From Baseline to Week 36 | From Baseline through 36 weeks |
| Hefei |
| Anhui |
| China |
| The Second Hospital of Anhui Medical University | Hefei | Anhui | China |
| The First Affiliated Hospital of Wannan Medical College | Wuhu | Anhui | China |
| Dermatology Hospital of Southern Medical University | Guangzhou | Guangdong | China |
| Guangdong Provincial People's Hospital | Guangzhou | Guangdong | China |
| The first hospital of Hebei Medical University | Shijiazhuang | Hebei | China |
| The Second Xiangya Hospital of Central South University | Changsha | Hunan | China |
| The Third Xiangya Hospital of Central South University | Changsha | Hunan | China |
| Xiangya Hospital of Central South University | Changsha | Hunan | China |
| Affiliated Hospital of Jiangsu University | Zhenjiang | Jiangsu | China |
| Dermatology Hospital of Jiangxi Province | Nanchang | Jiangxi | China |
| Shandong Provincial Hospital Affiliated to Shandong First Medical University | Jinan | Shandong | China |
| Skin Disease Hospital of Shandong First Medical University | Jinan | Shandong | China |
| Yantai Yuhuangding hospital | Yantai | Shandong | China |
| Affiliated Hangzhou First People's Hospital, Zhejiang University School of Medicine | Hangzhou | Zhejiang | China |
| The First Affiliated Hospital, Zhejiang University School of Medicine | Hangzhou | Zhejiang | China |
| The Third People's Hospital of Hangzhou | Hangzhou | Zhejiang | China |
| Peking University People's Hospital | Beijing | China |
| Peking University Third Hospital | Beijing | China |
| Shanghai Skin Disease Hospital | Shanghai | China |