A Double-blind, Randomized, Placebo-controlled, Multicenter Study to Evaluate Efficacy and Safety of JS002 as Monotherapy in Patients With Primary Hypercholesterolaemia and Mixed Dyslipidemia
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 582
- 试验地点
- 1
- 主要终点
- Percent Change From Baseline in LDL-C at Week 12
研究概览
简要总结
JS002 is a recombinant humanized anti-PCSK9 monoclonal antibody. This is a randomized, double-blind, placebo-controlled study to evaluate the efficacy, safety, PK/PD profile, immunogenicity as well as complete delivery of auto-injector by patients of JS002 as monotherapy in patients with primary hypercholesterolaemia and mixed dyslipidemia.
In this study, two dose cohorts(150 mg, 450 mg) are set up, and 582 subjects are planned to be enrolled (randomizedly assigned to JS002 or placebo 150/450 mg group in a 2:1:2:1 ratio).A screening period (≤6 weeks), a double-blind treatment period (12 weeks), an open-label treatment period (40 weeks), and a follow-up period (8 weeks) will be required.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Signed informed consent
- •Age 18~80 years old
- •Subject who has not achieve LDL-C goal as categorized by their CV risk at screening
- •Fasting TG≤4.5mmol/L by central laboratory at screening
- •Statin intolerance subject must have a history of statin intolerance as evidenced
排除标准
- •History of hemorrhagic stroke
- •NYHA III or IV heart failure, or known LVEF< 30% within 1 year before randomization
- •Uncontrolled serious cardiac arrhythmia defined as recurrent and highly symptomatic ventricular tachycardia, atrial fibrillation with rapid ventricular response, or supraventricular tachycardia that are not controlled by medications, within 90 days prior to randomization
- •Myocardial infarction, unstable angina, percutaneous coronary intervention (PCI), coronary artery bypass graft (CABG) or stroke, deep vein thrombosis or pulmonary embolism within 90 days prior to randomization
- •Planned cardiac surgery or revascularization
- •Uncontrolled hypertension defined as sitting systolic blood pressure(SBP) > 160 mmHg or diastolic BP (DBP) > 100 mmHg
- •Type 1 diabetes, poorly controlled type 2 diabetes (HbA1c > 8%), newly diagnosed type 2 diabetes (within 90 days of randomization)
- •Others factors not suitable for participation judged by PI
研究组 & 干预措施
JS002 150mg Q2W
JS002 150mg Q2W SC for 52 weeks
干预措施: JS002 (Drug)
JS002 450mg Q4W
JS002 450mg Q4W SC for 52 weeks
干预措施: JS002 (Drug)
Placebo Q2W
Placebo Q2W SC for 12 weeks, then switch to JS002 150mg Q2W SC for 40 weeks
干预措施: Placebo (Drug)
Placebo Q4W
Placebo Q4W SC for 12 weeks, then switch to JS002 450mg Q4W SC for 40 weeks
干预措施: Placebo (Drug)
结局指标
主要结局
Percent Change From Baseline in LDL-C at Week 12
时间窗: Baseline and week 12
Percent Change From Baseline in LDL-C at Week 12 in ITT subjects
次要结局
- Percent Change From Baseline in LDL-C at Week 24,52(Baseline and week 24,52)
- Percent Change From Baseline in other lipid parameters such as non-HDL-C, ApoB, TC, et al. at Week 12, 24, 52(Baseline and week 12, 24, 52)
- Percentage of Participants With LDL-C Less Than 1.8 mmol/L(70 mg/dL)(Baseline and week 12, 24, 52)
- Percentage of Participants With Full Administration of JS002(Baseline and week 12, 24, 52)
- Change From Baseline in LDL-C at Week 12(Baseline and week 12)
- Change From Baseline in LDL-C at Week 24,52(Baseline and week 24,52)