Efficacy and Safety of JS002 as Monotherapy in Patients With Primary Hypercholesterolaemia and Mixed Dyslipidemia

Shanghai Junshi Biosciences

Status and phase: Enrolling; Phase 3

Conditions: Primary Hypercholesterolaemia and Mixed Dyslipidemia

Treatments: Drug: JS002; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT05621070

JS002-007

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 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.

Enrollment: 582 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Signed informed consent
2. Age 18~80 years old
3. Subject who has not achieve LDL-C goal as categorized by their CV risk at screening
4. Fasting TG≤4.5mmol/L by central laboratory at screening
5. Statin intolerance subject must have a history of statin intolerance as evidenced

Exclusion criteria

1. History of hemorrhagic stroke
2. NYHA III or IV heart failure, or known LVEF< 30% within 1 year before randomization
3. 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
4. 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
5. Planned cardiac surgery or revascularization
6. Uncontrolled hypertension defined as sitting systolic blood pressure(SBP) > 160 mmHg or diastolic BP (DBP) > 100 mmHg
7. Type 1 diabetes, poorly controlled type 2 diabetes (HbA1c > 8%), newly diagnosed type 2 diabetes (within 90 days of randomization)
8. Others factors not suitable for participation judged by PI

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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582 participants in 4 patient groups, including a placebo group

JS002 150mg Q2W

Experimental group

Description:

JS002 150mg Q2W SC for 52 weeks

Treatment:

Drug: JS002

Drug: JS002

JS002 450mg Q4W

Placebo Comparator group

Description:

JS002 450mg Q4W SC for 52 weeks

Treatment:

Drug: JS002

Drug: JS002

Placebo Q2W

Placebo Comparator group

Description:

Placebo Q2W SC for 12 weeks, then switch to JS002 150mg Q2W SC for 40 weeks

Treatment:

Drug: Placebo

Drug: Placebo

Placebo Q4W

Placebo Comparator group

Description:

Placebo Q4W SC for 12 weeks, then switch to JS002 450mg Q4W SC for 40 weeks

Treatment:

Drug: Placebo

Drug: Placebo