The Efficacy and Safety of JS002 PFS and AI in Patients With Primary Hypercholesterolemia and Mixed Hyperlipidemia

Shanghai Junshi Bioscience Co., Ltd.255 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

255

Conditions

Hyperlipemia

Interventions

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Signed informed consent. 2. Age 18\~80 years old; 3. Stable optimized LLT at least 4 weeks before randomization; 4. Two times of Fasting triglycerides ≤4.5 mmol/L(400mg/dL)at the time of screening; Exclusion Criteria: 1. History of NYHA class III-IV heart failure or EF\<30%; 2. History of uncontrolled arrhythmia within 90 days; 3. History of MI,UA, PCI or CABG, stroke within 90 days; 4. Known hemorrhagic stroke disease; 5. Planned cardiac surgery or revascularization. 6. Uncontrolled hypertension. 7. Uncontrolled diabetes mellitius (HbA1c\>8.0%）. 8. Other conditions that the researchers considered inappropriate to participate in the study.

Locations (21)

Beijing Anzhen Hospital，Capital Medical University

Beijing, Beijing Municipality, China

Peking University Third Hospital

Beijing, Beijing Municipality, China

China-Japan Friendship Hospital

Beijing, Beijing Municipality, China

The First Affiliated Hospital of Fujian Medical University

Fuzhou, Fujian, China

Daqing People's Hospital

Daqing, Heilongjiang, China

The Fourth Affiliated Hospital of Harbin Medical University

Harbin, Heilongjiang, China

First Affiliated Hospital of Zhengzhou University

Zhengzhou, Henan, China

Jingzhou Central Hospital

Jingzhou, Hubei, China

The Second Xiangya Hospital Of Central South University

Changsha, Hunan, China

Changzhou Second People's Hospital

Changzhou, Jiangsu, China

...and 11 more locations

Outcomes

Primary Outcomes

LDL-C with JS002 PFS

Percentage change in LDL-C relative to baseline at Week 12 with JS002 PFS

Time frame: at week 12

LDL-C with JS002 AI

Percentage change in LDL-C relative to baseline at Week 12 with JS002 AI

Time frame: at week 12

Secondary Outcomes

LDL-C with JS002 PFS

The absolute change in LDL-C relative to baseline with JS002 PFS

Time frame: at week 12

LDL-C with JS002 AI

The absolute change in LDL-C relative to baseline with JS002 AI

Time frame: at week 12

lipid parameters

Percentages and absolute change in other lipid parameters to baseline with JS002 PFS and JS002 AI

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: at week 12

full dose

Proportion of subjects receiving full dose of JS002 AI during treatment (weeks 0, 2, 4, 6, 8, 10)

Time frame: at week 0, 2, 4, 6, 8, 10