The Safety and Efficacy of Multiple-dose of JS002 in Subject With Hyperlipidemia

Shanghai Junshi Bioscience Co., Ltd.806 enrolled

Overview

JS002 is a recombinant humanized anti-PCSK9 monoclonal antibody. This is a randomized, double-blind, placebo-controlled study to evaluate the safety and efficacy, as well as immunogenicity of JS002 treated repeatedly in patients with hyperlipidemia when combined with statin therapy. In this study, two dose group (150 mg, 300 mg) were set up in this study. 750 subjects are plan to be enrolled (the study drug will be assigned to a 2:1 ratio of JS002 or placebo). Each subject required a maximum of 6 weeks of screening, 52 weeks of treatment, and 8 weeks of follow-up.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

806

Conditions

Hyperlipemia

Interventions

JS002DRUG

JS002: 150mg(1mL) Q2W; Placebo 1mL Q2W.

PlaceboDRUG

JS002: 300mg(2mL) Q4W; Placebo 2mL Q4W.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

A limited list of criteria for selection of participants in the clinical study, provided in terms of inclusion and exclusion criteria and suitable for assisting potential participants in identifying clinical studies of interest. Use a bulleted list for each criterion below the headers "Inclusion Criteria" and "Exclusion Criteria". (Limit: 15,000 characters.) Inclusion criteria 1. Males and females ≥ 18 and ≤ 80 years of age; 2. LDL\_C during screening period met the following conditions: super high risk: LDL - C ≥1.4mmol/L (55 mg/dL); extremely high risk: LDL - C ≥1.8 mmol/L (70 mg/dL); risk: LDL - C ≥2.6 mmol/L (100 mg/dL); low risk: LDL - C ≥ 3.4 /mmol/L (130 mg/dL) 3. Fasting triglycerides ≤4.5 mmol/L; Exclusion criteria 1. Known HoFH; 2. History of NYHA class III-IV heart failure; 3. History of uncontrolled arrhythmia, Unstable angina,MI, PCI,CABG, DVT or pulmonary embolism within 3 months. 4. Uncontrolled hypertension. 5. Uncontrolled diabetes mellitius (HbA1c\>8.0%）. 6. Other conditions that investigators considered inappropriate to participate in the study.

Locations (57)

Outcomes

Primary Outcomes

Change in LDL-C of JS002

Percentage change in LDL-C relative to baseline at Week 24

Time frame: Up to 24Weeks after dose administration

Secondary Outcomes

Change in LDL-C of JS002

Percentage change in LDL-C relative to baseline at Week 52

Time frame: Up to 52Weeks after dose administration

Other lipid parameters of JS002

Percentage change in LDL-C relative to baseline at Week 24 and Week 52

Time frame: Up to Week 24 and 52Weeks after dose administration

The occurrence of adverse events

Evaluate the change of clinically significant laboratory tests, vital signs, and electrocardiogram

Time frame: Up 60Weeks after dose administration

The immunogenicity of JS002

To evaluate the production time, duration and proportion of anti JS002 antibody (ADA).ADA positive samples are tested for titer and for neutralizing antibody (Nab).

Time frame: Up 60Weeks after dose administration

Pharmacokinetics (PK) of JS002

Evaluation of Serum concentration of JS002.Descriptive statistics include mean (arithmetic mean and geometric mean), standard deviation (SD), coefficient of variation CV% (arithmetic coefficient and geometric coefficient of variation), Median (Median), minimum (Min) and maximum (Max).

Time frame: Up 60Weeks after dose administration

Pharmacokinetics (PD) of JS002

Evaluation of serum concentrations of free/total PCSK9 and changes from baseline.Descriptive statistics include mean (arithmetic mean and geometric mean), standard deviation (SD), coefficient of variation CV% (arithmetic coefficient and geometric coefficient of variation), Median (Median), minimum (Min) and maximum (Max).

Data from ClinicalTrials.gov

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The First Affiliated Hospital of Bengbu Medical College

Bengbu, Anhui, China

Beijing Anzhen Hospital, Capital Medical University