The Efficacy and Safety of JS002 PFS and AI in Patients With Primary Hypercholesterolemia and Mixed Hyperlipidemia
A Randomized, Double-blind, Placebo-controlled Phase III Clinical Study Evaluating the Efficacy and Safety of JS002 Prefilled Syringes(PFS) and Prefilled Autosyringes(AI) in Patients With Primary Hypercholesterolemia and Mixed Hyperlipidemia
1 other identifier
interventional
255
1 country
21
Brief Summary
JS002 is a recombinant humanized anti-PCSK9 monoclonal antibody. This is a randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of JS002 prefilled syringes and prefilled autosyringes in patients with primary hypercholesterolemia and mixed hyperlipidemia when combined with statin therapy. In this study, one dose group (150 mg) were set up in this study. 240 subjects are plan to be enrolled (the study drug will be assigned to a 2:1 :2:1ratio of JS002 PFS / placebo or JS002 AI / placebo ). Each subject required a maximum of 6 weeks of screening, 12 weeks of treatment, and 8 weeks of follow-up.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Feb 2022
Shorter than P25 for phase_3
21 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 28, 2022
CompletedFirst Submitted
Initial submission to the registry
September 5, 2022
CompletedFirst Posted
Study publicly available on registry
September 8, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 9, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
February 9, 2023
CompletedMarch 15, 2023
March 1, 2023
12 months
September 5, 2022
March 14, 2023
Conditions
Outcome Measures
Primary Outcomes (2)
LDL-C with JS002 PFS
Percentage change in LDL-C relative to baseline at Week 12 with JS002 PFS
at week 12
LDL-C with JS002 AI
Percentage change in LDL-C relative to baseline at Week 12 with JS002 AI
at week 12
Secondary Outcomes (8)
LDL-C with JS002 PFS
at week 12
LDL-C with JS002 AI
at week 12
lipid parameters
at week 12
LDL-C reduction≥50 with JS002 PFS
at week 12
LDL-C reduction≥50 with JS002 AI
at week 12
- +3 more secondary outcomes
Study Arms (2)
JS002
EXPERIMENTALCobort 1:150 mg/1mL Q2W PFS,Cobort 2:150 mg/1mL Q2W AI
Placebo
PLACEBO COMPARATORCobort 1:/1mL Q2W PFS,Cobort 2:1mL Q2W AI
Interventions
Eligibility Criteria
You may qualify if:
- Signed informed consent.
- Age 18\~80 years old;
- Stable optimized LLT at least 4 weeks before randomization;
- Two times of Fasting triglycerides ≤4.5 mmol/L(400mg/dL)at the time of screening;
You may not qualify if:
- History of NYHA class III-IV heart failure or EF\<30%;
- History of uncontrolled arrhythmia within 90 days;
- History of MI,UA, PCI or CABG, stroke within 90 days;
- Known hemorrhagic stroke disease;
- Planned cardiac surgery or revascularization.
- Uncontrolled hypertension.
- Uncontrolled diabetes mellitius (HbA1c\>8.0%）.
- Other conditions that the researchers considered inappropriate to participate in the study.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (21)
Beijing Anzhen Hospital，Capital Medical University
Beijing, Beijing Municipality, 100029, China
Peking University Third Hospital
Beijing, Beijing Municipality, 100191, China
China-Japan Friendship Hospital
Beijing, Beijing Municipality, 100192, China
The First Affiliated Hospital of Fujian Medical University
Fuzhou, Fujian, 350005, China
Daqing People's Hospital
Daqing, Heilongjiang, 163711, China
The Fourth Affiliated Hospital of Harbin Medical University
Harbin, Heilongjiang, 150001, China
First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, 450052, China
Jingzhou Central Hospital
Jingzhou, Hubei, 434020, China
The Second Xiangya Hospital Of Central South University
Changsha, Hunan, 410008, China
Changzhou Second People's Hospital
Changzhou, Jiangsu, 213004, China
Affiliated Hospital of Xuzhou Medical University
Xuzhou, Jiangsu, 221004, China
Nanchang First Hospital
Nanchang, Jiangxi, 330008, China
Nanchang Third Hospital
Nanchang, Jiangxi, 330008, China
The Second Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, 330008, China
The First Hospital of Jilin University
Changchun, Jilin, 130061, China
Dalian Municipal Central Hospital
Dalian, Liaoning, 116089, China
The First Affiliated Hospital of Jinzhou Medical University
Jinzhou, Liaoning, 121011, China
Xianyang Hospital of Yan'an University
Xianyang, Shanxi, 716099, China
Tianjin People's Hospital
Tianjin, Tianjin Municipality, 300122, China
Taizhou Hospital Of Zhejiang Province
Taizhou, Zhejiang, 317000, China
The First Affiliated Hospital of Wenzhou Medical University
Wenzhou, Zhejiang, 325015, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 5, 2022
First Posted
September 8, 2022
Study Start
February 28, 2022
Primary Completion
February 9, 2023
Study Completion
February 9, 2023
Last Updated
March 15, 2023
Record last verified: 2023-03
Data Sharing
- IPD Sharing
- Will not share