JS002 is a recombinant humanized anti-PCSK9 monoclonal antibody. This is a randomized, double-blind, placebo-controlled study to evaluate the efficacy, safety, PK/PD profile, immunogenicity as well as complete delivery of auto-injector by patients of JS002 as monotherapy in patients with primary hypercholesterolaemia and mixed dyslipidemia.
In this study, two dose cohorts(150 mg, 450 mg) are set up, and 582 subjects are planned to be enrolled (randomizedly assigned to JS002 or placebo 150/450 mg group in a 2:1:2:1 ratio).A screening period (≤6 weeks), a double-blind treatment period (12 weeks), an open-label treatment period (40 weeks), and a follow-up period (8 weeks) will be required.
Signed informed consent
Age 18~80 years old
Subject who has not achieve LDL-C goal as categorized by their CV risk at screening
Fasting TG≤4.5mmol/L by central laboratory at screening
History of hemorrhagic stroke
NYHA III or IV heart failure, or known LVEF< 30% within 1 year before randomization
Uncontrolled serious cardiac arrhythmia defined as recurrent and highly symptomatic ventricular tachycardia, atrial fibrillation with rapid ventricular response, or supraventricular tachycardia that are not controlled by medications, within 90 days prior to randomization
Myocardial infarction, unstable angina, percutaneous coronary intervention (PCI), coronary artery bypass graft (CABG) or stroke, deep vein thrombosis or pulmonary embolism within 90 days prior to randomization
Parallel
JS002
DrugJS002 will be administered per auto-injector. Participants will receive JS002 every 2 weeks subcutaneously.
JS002
DrugJS002 will be administered per auto-injector. Participants will receive JS002 every 4 weeks subcutaneously.
Placebo
DrugPlacebo will be administered per auto-injector. Participants will receive placebo every 2 weeks subcutaneously.
Placebo
DrugPlacebo will be administered per auto-injector. Participants will receive placebo every 4 weeks subcutaneously.
Percent Change From Baseline in LDL-C at Week 12
Percent Change From Baseline in LDL-C at Week 12 in statin intolerance subjects
Percent Change From Baseline in LDL-C at Week 12
Percent Change From Baseline in LDL-C at Week 12 in ITT subjects
Change From Baseline in LDL-C at Week 12
Change From Baseline in LDL-C at Week 12 in statin intolerance and ITT subjects
Percent Change From Baseline in LDL-C at Week 24,52
Percent Change From Baseline in LDL-C at Week 24,52 in statin intolerance and ITT subjects
Change From Baseline in LDL-C at Week 24,52
Change From Baseline in LDL-C at Week 24,52 in statin intolerance and ITT subjects
Percent Change From Baseline in other lipid parameters such as non-HDL-C, ApoB, TC, et al. at Week 12, 24, 52
Percent Change From Baseline in other lipid parameters at Week 12, 24, 52 in statin intolerance and ITT subjects
Number of Participants with anti-drug antibodies (ADAs)
Serum samples were analyzed for ADA. Positive samples were subsequently tested for neutralizing antibodies.
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