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JS002 is a recombinant humanized anti-PCSK9 monoclonal antibody. This is a randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of JS002 prefilled syringes and prefilled autosyringes in patients with primary hypercholesterolemia and mixed hyperlipidemia when combined with statin therapy.
In this study, one dose group (150 mg) were set up in this study. 240 subjects are plan to be enrolled (the study drug will be assigned to a 2:1 :2:1ratio of JS002 PFS / placebo or JS002 AI / placebo ).
Each subject required a maximum of 6 weeks of screening, 12 weeks of treatment, and 8 weeks of follow-up.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| JS002 | Experimental | Cobort 1:150 mg/1mL Q2W PFS,Cobort 2:150 mg/1mL Q2W AI |
|
| Placebo | Placebo Comparator | Cobort 1:/1mL Q2W PFS,Cobort 2:1mL Q2W AI |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| JS002 | Drug | JS002:150mg(1mL) Q2W PFS, Placebo: 1mL Q2W PFS. |
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| LDL-C with JS002 PFS | Percentage change in LDL-C relative to baseline at Week 12 with JS002 PFS | at week 12 |
| LDL-C with JS002 AI | Percentage change in LDL-C relative to baseline at Week 12 with JS002 AI | at week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| LDL-C with JS002 PFS | The absolute change in LDL-C relative to baseline with JS002 PFS | at week 12 |
| LDL-C with JS002 AI | The absolute change in LDL-C relative to baseline with JS002 AI |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Anzhen Hospital,Capital Medical University | Beijing | Beijing Municipality | 100029 | China | ||
| Peking University Third Hospital |
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| Drug |
JS002:150mg(1mL) Q2W AI, Placebo: 1mL Q2W AI. |
|
| at week 12 |
| lipid parameters | Percentages and absolute change in other lipid parameters to baseline with JS002 PFS and JS002 AI | at week 12 |
| LDL-C reduction≥50 with JS002 PFS | Proportion of subjects with a ≥50% reduction in serum LDL-C at 12 weeks after subcutaneous treatment with JS002 PFS from baseline | at week 12 |
| LDL-C reduction≥50 with JS002 AI | Proportion of subjects with a ≥50% reduction in serum LDL-C at 12 weeks after subcutaneous treatment with JS002 AI from baseline | at week 12 |
| LDL-C dropped to < 70 mg/dL with JS002 PFS | Proportion of subjects whose serum LDL-C dropped to < 70 mg/dL (1.8 mmol/L) at 12 weeks after subcutaneous injection of JS002 PFS | at week 12 |
| LDL-C dropped to < 70 mg/dL with JS002 AI | Proportion of subjects whose serum LDL-C dropped to < 70 mg/dL (1.8 mmol/L) at 12 weeks after subcutaneous injection of JS002 AI | at week 12 |
| full dose | Proportion of subjects receiving full dose of JS002 AI during treatment (weeks 0, 2, 4, 6, 8, 10) | at week 0, 2, 4, 6, 8, 10 |
| Beijing |
| Beijing Municipality |
| 100191 |
| China |
| China-Japan Friendship Hospital | Beijing | Beijing Municipality | 100192 | China |
| The First Affiliated Hospital of Fujian Medical University | Fuzhou | Fujian | 350005 | China |
| Daqing People's Hospital | Daqing | Heilongjiang | 163711 | China |
| The Fourth Affiliated Hospital of Harbin Medical University | Harbin | Heilongjiang | 150001 | China |
| First Affiliated Hospital of Zhengzhou University | Zhengzhou | Henan | 450052 | China |
| Jingzhou Central Hospital | Jingzhou | Hubei | 434020 | China |
| The Second Xiangya Hospital Of Central South University | Changsha | Hunan | 410008 | China |
| Changzhou Second People's Hospital | Changzhou | Jiangsu | 213004 | China |
| Affiliated Hospital of Xuzhou Medical University | Xuzhou | Jiangsu | 221004 | China |
| Nanchang First Hospital | Nanchang | Jiangxi | 330008 | China |
| Nanchang Third Hospital | Nanchang | Jiangxi | 330008 | China |
| The Second Affiliated Hospital of Nanchang University | Nanchang | Jiangxi | 330008 | China |
| The First Hospital of Jilin University | Changchun | Jilin | 130061 | China |
| Dalian Municipal Central Hospital | Dalian | Liaoning | 116089 | China |
| The First Affiliated Hospital of Jinzhou Medical University | Jinzhou | Liaoning | 121011 | China |
| Xianyang Hospital of Yan'an University | Xianyang | Shanxi | 716099 | China |
| Tianjin People's Hospital | Tianjin | Tianjin Municipality | 300122 | China |
| Taizhou Hospital Of Zhejiang Province | Taizhou | Zhejiang | 317000 | China |
| The First Affiliated Hospital of Wenzhou Medical University | Wenzhou | Zhejiang | 325015 | China |
| ID | Term |
|---|---|
| D006949 | Hyperlipidemias |
| ID | Term |
|---|---|
| D050171 | Dyslipidemias |
| D052439 | Lipid Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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