Status:
COMPLETED
The Safety and Efficacy of Multiple-dose of JS002 in Subject With Hyperlipidemia
Lead Sponsor:
Shanghai Junshi Bioscience Co., Ltd.
Conditions:
Hyperlipemia
Eligibility:
All Genders
18-80 years
Phase:
PHASE3
Brief Summary
JS002 is a recombinant humanized anti-PCSK9 monoclonal antibody. This is a randomized, double-blind, placebo-controlled study to evaluate the safety and efficacy, as well as immunogenicity of JS002 tr...
Eligibility Criteria
Inclusion
- A limited list of criteria for selection of participants in the clinical study, provided in terms of inclusion and exclusion criteria and suitable for assisting potential participants in identifying clinical studies of interest. Use a bulleted list for each criterion below the headers "Inclusion Criteria" and "Exclusion Criteria". (Limit: 15,000 characters.) Inclusion criteria
- Males and females ≥ 18 and ≤ 80 years of age;
- LDL\_C during screening period met the following conditions: super high risk: LDL - C ≥1.4mmol/L (55 mg/dL); extremely high risk: LDL - C ≥1.8 mmol/L (70 mg/dL); risk: LDL - C ≥2.6 mmol/L (100 mg/dL); low risk: LDL - C ≥ 3.4 /mmol/L (130 mg/dL)
- Fasting triglycerides ≤4.5 mmol/L;
- Exclusion criteria
- Known HoFH;
- History of NYHA class III-IV heart failure;
- History of uncontrolled arrhythmia, Unstable angina,MI, PCI,CABG, DVT or pulmonary embolism within 3 months.
- Uncontrolled hypertension.
- Uncontrolled diabetes mellitius (HbA1c\>8.0%）.
- Other conditions that investigators considered inappropriate to participate in the study.
Exclusion
Key Trial Info
Start Date :
December 23 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 16 2023
Estimated Enrollment :
806 Patients enrolled
Trial Details
Trial ID
NCT04781114
Start Date
December 23 2020
End Date
January 16 2023
Last Update
April 19 2023
Active Locations (57)
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1
The First Affiliated Hospital of Bengbu Medical College
Bengbu, Anhui, China, 233000
2
Beijing Anzhen Hospital, Capital Medical University
Beijing, Beijing Municipality, China, 100000
3
Beijing Chaoyang Hospital, Capital Medical University
Beijing, Beijing Municipality, China, 100000
4
Beijing Tongren Hospital Affiliated to Capital Medical University City:Beijing
Beijing, Beijing Municipality, China, 100000