CompletedPhase 3

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

China135 participantsStarted 2021-12-31

Plain-language 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).

Who can participate

Age range18 Years – 80 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Signed informed consent.
✓. Males and females ≥ 18 to ≤ 80 years of age
✓. DLCN\>8 in HeFH
✓. Stable lipid-lowering therapies for at least 4 weeks
✓. Patients with ASCVD LDL cholesterol≥1.4mmol/L at screening Patients without ASCVD LDL cholesterol≥2.6mmol/L at screening
✓. Triglyceride≤4.5 mmol/L（400 mg/dL）;

Exclusion criteria

✕. HoFH or meet the diagnostic criteria of HoFH
✕. New York Heart Association (NYHA) class III or IV or last known left ventricular ejection fraction \< 30%
✕. History of uncontrolled arrhythmia within 90 days
✕. Myocardial infarction, unstable angina, percutaneous coronary intervention (PCI), coronary artery bypass graft (CABG) or stroke within 90 days of randomization
✕. Planned cardiac surgery or revascularization.
✕. Uncontrolled diabetes mellitius (HbA1c\>8.0%）.
✕. Uncontrolled hypertension.
✕. Other conditions that the researchers considered inappropriate to participate in the study.

What they're measuring

Percent Change From Baseline in Low-Density Lipoprotein Cholesterol (LDL-C) at Week 24

Timeframe: Baseline and week 24

Trial details

NCT IDNCT05325203

SponsorShanghai Junshi Bioscience Co., Ltd.

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-05-08

View on ClinicalTrials.gov More Heterozygous Familial Hypercholesterolemia trials