Back to resultsA Study to Evaluate the Safety, Tolerability and Efficacy of Multiple Doses of JS002 in Patients With Hyperlipidemia..
Primary Purpose
Hyperlipemia
Status
Completed
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
Biological：JS002
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Hyperlipemia
Eligibility Criteria
Inclusion Criteria:
- Signed informed consent.
- Age ≥18 and ≤65 years old;
- Body mass index (BMI) ≥18 and ≤ 30 kg/m2;
- Subjects who are receiving statin therapy at the time of screening or who are eligible for statin therapy can receive a stable dose of statin therapy for more than 28 days before randomization and are willing to maintain stable statin therapy during the study;
- Low-density lipoprotein cholesterol (LDL-C) level ≥2.6mmol/L for subjects who are receiving statin and/or other lipid-lowering therapy at the time of screening, or LDL-C≥ 4.1mmol/L for subjects who didn't receive any-lowering therapy at the time of screening, and LDL-C still ≥2.6mmol/L before randomization;
- Fasting triglycerides ≤4.5 mmol/L;
Exclusion Criteria:
- Diagnosis of homozygous familial hypercholesterolemia;
- History of New York heart association (NYHA) defined Ⅱ - Ⅳ heart failure;
- History of uncontrolled arrhythmiast;
- History of myocardial infarction, history of PTCA or PCI or CABG, history of unstable angina befor 90 days of randomization;
- History of stroke or TIA；
- Uncontrolled hypertension with SBP≥160mmHg and/or DBP≥100mmHg
- Type 1 diabetes, or type 2 diabetes that is or poorly controlled（HbA1c> 8.0%);
Sites / Locations
- Fuwai Hospital Chinese Academy of Medical Sciences
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
JS002
Placebo
Arm Description
Participants received one of 3 dose regimens of JS002 administered as multiple subcutaneous doses.
Participants received matching placebo dose regimens by subcutaneous injection.
Outcomes
Primary Outcome Measures
Percent change from baseline in low-density lipoprotein cholesterol (LDL-C) to week 12
Secondary Outcome Measures
Absolute value change from baseline in low-density lipoprotein cholesterol (LDL-C)
Percent change from baseline in Total Cholesterol(TC、HDL-C、non-HDL-C、VLDL-C、Apo B、Apo A1、Lp(a) and TG )
Percentage change from baseline TC/HDL-C ratio
Percent change from baseline in Apolipoprotein B (Apo B)
Percent change from baseline in Apolipoprotein A-I (ApoA-I)
Full Information
NCT ID
NCT04469673
First Posted
July 6, 2020
Last Updated
July 13, 2020
Sponsor
Shanghai Junshi Bioscience Co., Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT04469673
Brief Title
A Study to Evaluate the Safety, Tolerability and Efficacy of Multiple Doses of JS002 in Patients With Hyperlipidemia..
Official Title
A Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety, Tolerability and Efficacy, as Well as Immunogenecity, Pharmacokineticks and Pharmacodynamics of Multiple Doses of JS002 on Stable Statin Therapy in Patients With Hyperlipidemia.
Study Type
Interventional
2. Study Status
Record Verification Date
July 2020
Overall Recruitment Status
Completed
Study Start Date
May 23, 2019 (Actual)
Primary Completion Date
May 3, 2020 (Actual)
Study Completion Date
June 28, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Shanghai Junshi Bioscience Co., Ltd.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
JS002 is a recombinant humanized anti-PCSK9 monoclonal antibody.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hyperlipemia
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Sequential Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
90 (Actual)
8. Arms, Groups, and Interventions
Arm Title
JS002
Arm Type
Experimental
Arm Description
Participants received one of 3 dose regimens of JS002 administered as multiple subcutaneous doses.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Participants received matching placebo dose regimens by subcutaneous injection.
Intervention Type
Biological
Intervention Name(s)
Biological：JS002
Intervention Description
Administered by subcutaneous injection
Intervention Type
Biological
Intervention Name(s)
Placebo
Intervention Description
Administered by subcutaneous injection
Primary Outcome Measure Information:
Title
Percent change from baseline in low-density lipoprotein cholesterol (LDL-C) to week 12
Time Frame
12 weeks after the first dose
Secondary Outcome Measure Information:
Title
Absolute value change from baseline in low-density lipoprotein cholesterol (LDL-C)
Time Frame
Twelve weeks after the last dose
Title
Percent change from baseline in Total Cholesterol(TC、HDL-C、non-HDL-C、VLDL-C、Apo B、Apo A1、Lp(a) and TG )
Time Frame
Twelve weeks after the last dose
Title
Percentage change from baseline TC/HDL-C ratio
Time Frame
Twelve weeks after the last dose
Title
Percent change from baseline in Apolipoprotein B (Apo B)
Time Frame
Twelve weeks after the last dose
Title
Percent change from baseline in Apolipoprotein A-I (ApoA-I)
Time Frame
Twelve weeks after the last dose
Other Pre-specified Outcome Measures:
Title
Number of subjects who develop detectable anti-drug antibodies (ADAs)
Time Frame
Twelve weeks after the last dose
Title
Serum concentrations of JS002
Time Frame
Twelve weeks after the last dose
Title
Change from baseline in proprotein convertase total / free pcsk9
Time Frame
Twelve weeks after the last dose
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Signed informed consent.
Age ≥18 and ≤65 years old;
Body mass index (BMI) ≥18 and ≤ 30 kg/m2;
Subjects who are receiving statin therapy at the time of screening or who are eligible for statin therapy can receive a stable dose of statin therapy for more than 28 days before randomization and are willing to maintain stable statin therapy during the study;
Low-density lipoprotein cholesterol (LDL-C) level ≥2.6mmol/L for subjects who are receiving statin and/or other lipid-lowering therapy at the time of screening, or LDL-C≥ 4.1mmol/L for subjects who didn't receive any-lowering therapy at the time of screening, and LDL-C still ≥2.6mmol/L before randomization;
Fasting triglycerides ≤4.5 mmol/L;
Exclusion Criteria:
Diagnosis of homozygous familial hypercholesterolemia;
History of New York heart association (NYHA) defined Ⅱ - Ⅳ heart failure;
History of uncontrolled arrhythmiast;
History of myocardial infarction, history of PTCA or PCI or CABG, history of unstable angina befor 90 days of randomization;
History of stroke or TIA；
Uncontrolled hypertension with SBP≥160mmHg and/or DBP≥100mmHg
Type 1 diabetes, or type 2 diabetes that is or poorly controlled（HbA1c> 8.0%);
Facility Information:
Facility Name
Fuwai Hospital Chinese Academy of Medical Sciences
City
Beijing
Country
China
12. IPD Sharing Statement
Learn more about this trial
A Study to Evaluate the Safety, Tolerability and Efficacy of Multiple Doses of JS002 in Patients With Hyperlipidemia..
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