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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
582
JS002 will be administered per auto-injector. Participants will receive JS002 every 2 weeks subcutaneously.
JS002 will be administered per auto-injector. Participants will receive JS002 every 4 weeks subcutaneously.
Placebo will be administered per auto-injector. Participants will receive placebo every 2 weeks subcutaneously.
Placebo will be administered per auto-injector. Participants will receive placebo every 4 weeks subcutaneously.
Peking University Third Hospital
Beijing, Beijing Municipality, China
RECRUITINGPercent Change From Baseline in LDL-C at Week 12
Percent Change From Baseline in LDL-C at Week 12 in statin intolerance subjects
Time frame: Baseline and week 12
Percent Change From Baseline in LDL-C at Week 12
Percent Change From Baseline in LDL-C at Week 12 in ITT subjects
Time frame: Baseline and week 12
Change From Baseline in LDL-C at Week 12
Change From Baseline in LDL-C at Week 12 in statin intolerance and ITT subjects
Time frame: Baseline and week 12
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
Time frame: Baseline and week 24,52
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
Time frame: Baseline and week 24,52
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
Time frame: Baseline and week 12, 24, 52
Percentage of Participants With LDL-C Less Than 1.8 mmol/L(70 mg/dL)
Percentage of Participants With LDL-C Less Than 1.8 mmol/L(70 mg/dL) at Week 12, 24, 52 in statin intolerance and ITT subjects
Time frame: Baseline and week 12, 24, 52
Percentage of Participants With Full Administration of JS002
Percentage of Participants With Full Administration of JS002 at Weeks 12, 24, 52 in statin intolerance and ITT subjects
Time frame: Baseline and week 12, 24, 52
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