Status:
COMPLETED
A Study to Evaluate the Efficacy and Safety of JS002 in Patients With Heterozygous Familial Hypercholesterolemia (HeFH).
Lead Sponsor:
Shanghai Junshi Bioscience Co., Ltd.
Conditions:
Heterozygous Familial Hypercholesterolemia
Eligibility:
All Genders
18-80 years
Phase:
PHASE3
Brief 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 fami...
Detailed Description
A randomized, double-blind, placebo-controlled Phase III clinical study evaluating the efficacy and safety of JS002 in patients with heterozygous familial hypercholesterolemia. 120 subjects are planne...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
December 31 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 29 2023
Estimated Enrollment :
135 Patients enrolled
Trial Details
Trial ID
NCT05325203
Start Date
December 31 2021
End Date
June 29 2023
Last Update
March 18 2024
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Beijing Anzhen Hospital Capital Medical University City:Beijing
Beijing, Beijing Municipality, China, 100020