NCT04515927已完成2 期
An Open-label, Single-arm Study Evaluated the Efficacy and Safety of JS002 in Patients With Homozygous Familial Hypercholesterolemia
Shanghai Junshi Bioscience Co., Ltd.1 个研究点 分布在 1 个国家目标入组 31 人开始时间: 2020年8月17日最近更新:
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 31
- 试验地点
- 1
- 主要终点
- The primary endpoint of effectiveness
研究概览
简要总结
JS002 is a recombinant human anti-PCSK9 monoclonal antibody. This phase II open-label, single-arm study aims to evaluate the efficacy and safety of JS002 in patients with homozygous familial hypercholesterolemia A dose group (450 mg) was set up in this study.Thirty subjects are planned to be enrolled.
Each subject required a maximum of 6 weeks of screening, 52 weeks of treatment, and 8 weeks of follow-up.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 12 Years 至 75 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Signed informed consent.
- •Age ≥12 and ≤75 years old;
- •Weight ≥40kg at the time of screening
- •Patients diagnosed with HoFH
- •Low-density lipoprotein cholesterol (LDL-C) level ≥3.4mmol/L at the time of screening
- •Fasting triglycerides ≤4.5 mmol/L;
排除标准
- •History of NYHA class III-IV heart failure or EF<30%
- •History of uncontrolled arrhythmia within 3 months
- •History of MI,UA, PCI or CABG, stroke within 3 months.
- •History of DVT or pulmonary embolism within 3 months.
- •Planned cardiac surgery or revascularization.
- •Uncontrolled hypertension.
- •Uncontrolled diabetes mellitius (HbA1c>8.0%）.
- •Other conditions that the researchers considered inappropriate to participate in the study.
研究组 & 干预措施
subcutaneous injection of JS002, 450mg, Q4W, 3/13 times.
Experimental
干预措施: JS002 (Drug)
结局指标
主要结局
The primary endpoint of effectiveness
时间窗: JS002 is administered subcutaneously every 4 weeks, from 12 or 52 weeks after initial administration
Percent Change From Baseline in Low-Density Lipoprotein Cholesterol (LDL-C) at Week 12
次要结局
未报告次要终点
研究者
研究点 (1)
Loading locations...
相似试验
已完成
1 期
A Single Dose Escalation Study of PCSK9 Inhibitor (JS002) in Health SubjectsHypercholesterolemiaNCT04197817Shanghai Junshi Bioscience Co., Ltd.84
已完成
3 期
A Study to Evaluate the Efficacy and Safety of JS002 in Patients With Heterozygous Familial Hypercholesterolemia (HeFH).Heterozygous Familial HypercholesterolemiaNCT05325203Shanghai Junshi Bioscience Co., Ltd.135
已完成
3 期
The Efficacy and Safety of JS002 PFS and AI in Patients With Primary Hypercholesterolemia and Mixed HyperlipidemiaHyperlipemiaNCT05532800Shanghai Junshi Bioscience Co., Ltd.255
已完成
1 期
A Study to Evaluate the Safety, Tolerability and Efficacy of Multiple Doses of JS002 in Patients With Hyperlipidemia..HyperlipemiaNCT04469673Shanghai Junshi Bioscience Co., Ltd.90
已完成
3 期
The Safety and Efficacy of Multiple-dose of JS002 in Subject With HyperlipidemiaHyperlipemiaNCT04781114Shanghai Junshi Bioscience Co., Ltd.806