A Study to Evaluate the Efficacy and Safety of JS002 in Patients With Heterozygous Familial Hypercholesterolemia (HeFH).

• Status: Recruiting
• Trial end date: 2023-06-16
• Target enrollment: 0
• Participant gender: All

Summary

JS002 is a recombinant human anti-PCSK9 monoclonal antibody.The study is a multicenter, randomized, double-blind, placebo-controlled Phase III clinical study in Chinese patients with heterozygous familial hypercholesterolemia (HeFH). Objective To evaluate the efficacy and safety of JS002 150 mg (Q2W) and 450 mg (Q4W) subcutaneous injection (SC).

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Shanghai Junshi Bioscience Co., Ltd.

Criteria

Inclusion Criteria:

1. Signed informed consent.

2. Males and females ≥ 18 to ≤ 80 years of age

3. DLCN>8 in HeFH

4. Stable lipid-lowering therapies for at least 4 weeks

5. Patients with ASCVD LDL cholesterol≥1.4mmol/L at screening Patients without ASCVD LDL cholesterol≥2.6mmol/L at screening

6. Triglyceride≤4.5 mmol/L（400 mg/dL）;

Exclusion Criteria:

1. HoFH or meet the diagnostic criteria of HoFH

2. New York Heart Association (NYHA) class III or IV or last known left ventricular ejection fraction < 30%

3. History of uncontrolled arrhythmia within 90 days

4. Myocardial infarction, unstable angina, percutaneous coronary intervention (PCI), coronary artery bypass graft (CABG) or stroke within 90 days of randomization

5. Planned cardiac surgery or revascularization.

6. Uncontrolled diabetes mellitius (HbA1c>8.0%）.

7. Uncontrolled hypertension.

8. Other conditions that the researchers considered inappropriate to participate in the study.