A Randomized, Double-blind, Placebo-controlled Phase III Clinical Study to Evaluate the Efficacy and Safety of Recombinant Humanized Anti-PCSK9 Monoclonal Antibody Injection in Subjects With Heterozygous Familial Hypercholesterolemia
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 135
- 试验地点
- 1
- 主要终点
- Percent Change From Baseline in Low-Density Lipoprotein Cholesterol (LDL-C) at Week 24
研究概览
简要总结
JS002 is a recombinant human anti-PCSK9 monoclonal antibody.The study is a multicenter, randomized, double-blind, placebo-controlled Phase III clinical study in Chinese patients with heterozygous familial hypercholesterolemia (HeFH). Objective To evaluate the efficacy and safety of JS002 150 mg (Q2W) and 450 mg (Q4W) subcutaneous injection (SC).
详细描述
A randomized, double-blind, placebo-controlled Phase III clinical study evaluating the efficacy and safety of JS002 in patients with heterozygous familial hypercholesterolemia. 120 subjects are planned to be enrolled. Each subject is required a maximum of 6 weeks of screening, 24 weeks of treatment, and 8 weeks of follow-up. To evaluate the lipid-lowering efficacy of subcutaneous injection of JS002 at 24 weeks compared with placebo in heterozygous familial hypercholesterolemia patients under optimized lipid lowing therapy . Subjects meeting the study inclusion criteria will be randomly assigned in a 2:1:2:1 ratio to JS002 150 mg Q2W or JS002 450 mg Q4W or matched placebo to receive the study drug (JS002) or placebo subcutaneously for 24 weeks.
treatment cohorts: JS002 150mg Cohort:JS002 150mg or placebo treatment(JS002 :Placebo=2:1) Q2W JS002 450mg Cohort:JS002 450mg or placebo treatment(JS002 :Placebo=2:1)Q4W
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.
- •Males and females ≥ 18 to ≤ 80 years of age
- •DLCN>8 in HeFH
- •Stable lipid-lowering therapies for at least 4 weeks
- •Patients with ASCVD LDL cholesterol≥1.4mmol/L at screening Patients without ASCVD LDL cholesterol≥2.6mmol/L at screening
- •Triglyceride≤4.5 mmol/L（400 mg/dL）;
排除标准
- •HoFH or meet the diagnostic criteria of HoFH
- •New York Heart Association (NYHA) class III or IV or last known left ventricular ejection fraction < 30%
- •History of uncontrolled arrhythmia within 90 days
- •Myocardial infarction, unstable angina, percutaneous coronary intervention (PCI), coronary artery bypass graft (CABG) or stroke within 90 days of randomization
- •Planned cardiac surgery or revascularization.
- •Uncontrolled diabetes mellitius (HbA1c>8.0%）.
- •Uncontrolled hypertension.
- •Other conditions that the researchers considered inappropriate to participate in the study.
研究组 & 干预措施
JS002 150mg Q2W for 24 weeks
40 patients will be enrolled in this arm
干预措施: Ongericimab (Biological)
placebo 150mg Q2W for 24 weeks
20 patients will be enrolled in this arm
干预措施: Placebo (Drug)
JS002 450mg Q4W for 24 weeks
40 patients will be enrolled in this arm
干预措施: Ongericimab (Biological)
placebo 450mg Q4W for 24 weeks
20 patients will be enrolled in this arm
干预措施: Placebo (Drug)
结局指标
主要结局
Percent Change From Baseline in Low-Density Lipoprotein Cholesterol (LDL-C) at Week 24
时间窗: Baseline and week 24
LDL-C was quantified using the enzymatic colorimetric assay
次要结局
- Absolute changes From Baseline in Non-HDL-C at Week 24(Baseline and Week 24)
- Absolute changes From Baseline in Lp(a) at Week 24(Baseline and Week 24)
- Absolute changes From Baseline in HDL-C at Week 24(Baseline and Week 24)
- Percentage changes From Baseline in Apo A1 at Week 24(Baseline and Week 24)
- Absolute changes From Baseline in Apo A1 at Week 24(Baseline and Week 24)
- Percentage changes From Baseline in TG at Week 24(Baseline and Week 24)
- The ratio of TC/HDL - C(Baseline and Week 24)
- Absolute Change From Baseline in Low-Density Lipoprotein Cholesterol (LDL-C) at Week 24(Baseline and Week 24)
- Absolute changes From Baseline in the Total Cholesterol at week 24(Baseline and Week 24)
- Percentage changes From Baseline in Apo B at Week 24(Baseline and Week 24)
- Absolute changes From Baseline in TG at Week 24(Baseline and Week 24)
- Percentage changes From Baseline in the Total Cholesterol at week 24(Baseline and Week 24)
- Percentage changes From Baseline in Non-HDL-C at Week 24(Baseline and Week 24)
- Percentage changes From Baseline in Lp(a) at Week 24(Baseline and Week 24)
- Absolute changes From Baseline in Apo B at Week 24(Baseline and Week 24)
- Percentage changes From Baseline in HDL-C at Week 24(Baseline and Week 24)
- The ratio of Apo B/Apo A1(Baseline and Week 24)
- Percentage of Participants With 50% or Greater Reduction in LDL-C From Baseline at Week 24(Baseline and Week 24)