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

Shanghai Junshi Biosciences

Status and phase: Completed; Phase 3

Conditions: Hyperlipemia

Treatments: Drug: Placebo; Drug: JS002

Study type: Interventional

Funder types: Other

Identifiers

NCT04781114

JS002-003

Details and patient eligibility

About

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.

Enrollment: 806 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Quadruple Blind

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806 participants in 2 patient groups, including a placebo group

JS002

Experimental group

Description:

Cohort 1: 150 mg/1mL Q2W Subcutaneous(SC); Cohort 2: 300/2mL mg Q4W Subcutaneous(SC);

Treatment:

Drug: JS002

Placebo

Placebo Comparator group

Description:

Cohort 1: 1mL Q2W Subcutaneous(SC); Cohort 2: 2mL Q4W Subcutaneous(SC);

Treatment:

Drug: Placebo