At a glance
ClinicalIndex Comparison Record- ✓Age 18 to 80 years old
- ✓Has not achieved LDL-C goal based on cardiovascular risk
- ✓Fasting triglycerides ≤4.5 mmol/L by central laboratory at screening
- ✓Statin-intolerant subjects must have documented history of statin intolerance
- ✕History of hemorrhagic stroke
- ✕NYHA class III or IV heart failure or LVEF <30% within 1 year before randomization
- ✕Uncontrolled serious cardiac arrhythmia (recurrent symptomatic ventricular tachycardia, atrial fibrillation with rapid ventricular response, or supraventricular tachycardia) within 90 days
- ✕Myocardial infarction, unstable angina, PCI, CABG, stroke, DVT, or PE within 90 days
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
NCT05621070Phase 3RecruitingUpdate OverdueUpdated 21mo ago · Completion was 21mo agoA Double-blind, Randomized, Placebo-controlled, Multicenter Study to Evaluate Efficacy and Safety of JS002 as Monotherapy in Patients With Primary Hypercholesterolaemia and Mixed Dyslipidemia
In Brief
A Phase 3 clinical trial evaluating JS002 and Placebo for Primary Hypercholesterolaemia and Mixed Dyslipidemia. Currently recruiting, targeting 582 participants across 1 site.
Signals
Detailed Summary
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 Details
Timeline
Interventions
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.