Back to resultsEfficacy and Safety of JS002 as Monotherapy in Patients With Primary Hypercholesterolaemia and Mixed Dyslipidemia
Primary Purpose
Primary Hypercholesterolaemia and Mixed Dyslipidemia
Status
Not yet recruiting
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
JS002
JS002
Placebo
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Primary Hypercholesterolaemia and Mixed Dyslipidemia
Eligibility Criteria
Inclusion Criteria: Signed informed consent Age 18~80 years old Subject who has not achieve LDL-C goal as categorized by their CV risk at screening Fasting TG≤4.5mmol/L by central laboratory at screening Statin intolerance subject must have a history of statin intolerance as evidenced Exclusion Criteria: History of hemorrhagic stroke NYHA III or IV heart failure, or known LVEF< 30% within 1 year before randomization Uncontrolled serious cardiac arrhythmia defined as recurrent and highly symptomatic ventricular tachycardia, atrial fibrillation with rapid ventricular response, or supraventricular tachycardia that are not controlled by medications, within 90 days prior to randomization Myocardial infarction, unstable angina, percutaneous coronary intervention (PCI), coronary artery bypass graft (CABG) or stroke, deep vein thrombosis or pulmonary embolism within 90 days prior to randomization Planned cardiac surgery or revascularization Uncontrolled hypertension defined as sitting systolic blood pressure(SBP) > 160 mmHg or diastolic BP (DBP) > 100 mmHg Type 1 diabetes, poorly controlled type 2 diabetes (HbA1c > 8%), newly diagnosed type 2 diabetes (within 90 days of randomization) Others factors not suitable for participation judged by PI
Sites / Locations
- Peking University Third Hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Placebo Comparator
Placebo Comparator
Placebo Comparator
Arm Label
JS002 150mg Q2W
JS002 450mg Q4W
Placebo Q2W
Placebo Q4W
Arm Description
JS002 150mg Q2W SC for 52 weeks
JS002 450mg Q4W SC for 52 weeks
Placebo Q2W SC for 12 weeks, then switch to JS002 150mg Q2W SC for 40 weeks
Placebo Q4W SC for 12 weeks, then switch to JS002 450mg Q4W SC for 40 weeks
Outcomes
Primary Outcome Measures
Percent Change From Baseline in LDL-C at Week 12
Percent Change From Baseline in LDL-C at Week 12 in statin intolerance subjects
Percent Change From Baseline in LDL-C at Week 12
Percent Change From Baseline in LDL-C at Week 12 in ITT subjects
Secondary Outcome Measures
Change From Baseline in LDL-C at Week 12
Change From Baseline in LDL-C at Week 12 in statin intolerance and ITT subjects
Percent Change From Baseline in LDL-C at Week 24,52
Percent Change From Baseline in LDL-C at Week 24,52 in statin intolerance and ITT subjects
Change From Baseline in LDL-C at Week 24,52
Change From Baseline in LDL-C at Week 24,52 in statin intolerance and ITT subjects
Percent Change From Baseline in other lipid parameters such as non-HDL-C, ApoB, TC, et al. at Week 12, 24, 52
Percent Change From Baseline in other lipid parameters at Week 12, 24, 52 in statin intolerance and ITT subjects
Percentage of Participants With LDL-C Less Than 1.8 mmol/L(70 mg/dL)
Percentage of Participants With LDL-C Less Than 1.8 mmol/L(70 mg/dL) at Week 12, 24, 52 in statin intolerance and ITT subjects
Percentage of Participants With Full Administration of JS002
Percentage of Participants With Full Administration of JS002 at Weeks 12, 24, 52 in statin intolerance and ITT subjects
Full Information
NCT ID
NCT05621070
First Posted
November 14, 2022
Last Updated
November 17, 2022
Sponsor
Shanghai Junshi Bioscience Co., Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT05621070
Brief Title
Efficacy and Safety of JS002 as Monotherapy in Patients With Primary Hypercholesterolaemia and Mixed Dyslipidemia
Official Title
A Double-blind, Randomized, Placebo-controlled, Multicenter Study to Evaluate Efficacy and Safety of JS002 as Monotherapy in Patients With Primary Hypercholesterolaemia and Mixed Dyslipidemia
Study Type
Interventional
2. Study Status
Record Verification Date
November 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
December 2, 2022 (Anticipated)
Primary Completion Date
October 30, 2023 (Anticipated)
Study Completion Date
September 30, 2024 (Anticipated)
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. This is a randomized, double-blind, placebo-controlled study to evaluate the efficacy, safety, PK/PD profile, immunogenicity as well as complete delivery of auto-injector by patients of JS002 as monotherapy in patients with primary hypercholesterolaemia and mixed dyslipidemia.
In this study, two dose cohorts(150 mg, 450 mg) are set up, and 582 subjects are planned to be enrolled (randomizedly assigned to JS002 or placebo 150/450 mg group in a 2:1:2:1 ratio).A screening period (≤6 weeks), a double-blind treatment period (12 weeks), an open-label treatment period (40 weeks), and a follow-up period (8 weeks) will be required.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Primary Hypercholesterolaemia and Mixed Dyslipidemia
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
582 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
JS002 150mg Q2W
Arm Type
Experimental
Arm Description
JS002 150mg Q2W SC for 52 weeks
Arm Title
JS002 450mg Q4W
Arm Type
Placebo Comparator
Arm Description
JS002 450mg Q4W SC for 52 weeks
Arm Title
Placebo Q2W
Arm Type
Placebo Comparator
Arm Description
Placebo Q2W SC for 12 weeks, then switch to JS002 150mg Q2W SC for 40 weeks
Arm Title
Placebo Q4W
Arm Type
Placebo Comparator
Arm Description
Placebo Q4W SC for 12 weeks, then switch to JS002 450mg Q4W SC for 40 weeks
Intervention Type
Drug
Intervention Name(s)
JS002
Intervention Description
JS002 will be administered per auto-injector. Participants will receive JS002 every 2 weeks subcutaneously.
Intervention Type
Drug
Intervention Name(s)
JS002
Intervention Description
JS002 will be administered per auto-injector. Participants will receive JS002 every 4 weeks subcutaneously.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo will be administered per auto-injector. Participants will receive placebo every 2 weeks subcutaneously.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo will be administered per auto-injector. Participants will receive placebo every 4 weeks subcutaneously.
Primary Outcome Measure Information:
Title
Percent Change From Baseline in LDL-C at Week 12
Description
Percent Change From Baseline in LDL-C at Week 12 in statin intolerance subjects
Time Frame
Baseline and week 12
Title
Percent Change From Baseline in LDL-C at Week 12
Description
Percent Change From Baseline in LDL-C at Week 12 in ITT subjects
Time Frame
Baseline and week 12
Secondary Outcome Measure Information:
Title
Change From Baseline in LDL-C at Week 12
Description
Change From Baseline in LDL-C at Week 12 in statin intolerance and ITT subjects
Time Frame
Baseline and week 12
Title
Percent Change From Baseline in LDL-C at Week 24,52
Description
Percent Change From Baseline in LDL-C at Week 24,52 in statin intolerance and ITT subjects
Time Frame
Baseline and week 24,52
Title
Change From Baseline in LDL-C at Week 24,52
Description
Change From Baseline in LDL-C at Week 24,52 in statin intolerance and ITT subjects
Time Frame
Baseline and week 24,52
Title
Percent Change From Baseline in other lipid parameters such as non-HDL-C, ApoB, TC, et al. at Week 12, 24, 52
Description
Percent Change From Baseline in other lipid parameters at Week 12, 24, 52 in statin intolerance and ITT subjects
Time Frame
Baseline and week 12, 24, 52
Title
Percentage of Participants With LDL-C Less Than 1.8 mmol/L(70 mg/dL)
Description
Percentage of Participants With LDL-C Less Than 1.8 mmol/L(70 mg/dL) at Week 12, 24, 52 in statin intolerance and ITT subjects
Time Frame
Baseline and week 12, 24, 52
Title
Percentage of Participants With Full Administration of JS002
Description
Percentage of Participants With Full Administration of JS002 at Weeks 12, 24, 52 in statin intolerance and ITT subjects
Time Frame
Baseline and week 12, 24, 52
Other Pre-specified Outcome Measures:
Title
Number of Participants with anti-drug antibodies (ADAs)
Description
Serum samples were analyzed for ADA. Positive samples were subsequently tested for neutralizing antibodies.
Time Frame
From baseline to week 60
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Signed informed consent
Age 18~80 years old
Subject who has not achieve LDL-C goal as categorized by their CV risk at screening
Fasting TG≤4.5mmol/L by central laboratory at screening
Statin intolerance subject must have a history of statin intolerance as evidenced
Exclusion Criteria:
History of hemorrhagic stroke
NYHA III or IV heart failure, or known LVEF< 30% within 1 year before randomization
Uncontrolled serious cardiac arrhythmia defined as recurrent and highly symptomatic ventricular tachycardia, atrial fibrillation with rapid ventricular response, or supraventricular tachycardia that are not controlled by medications, within 90 days prior to randomization
Myocardial infarction, unstable angina, percutaneous coronary intervention (PCI), coronary artery bypass graft (CABG) or stroke, deep vein thrombosis or pulmonary embolism within 90 days prior to randomization
Planned cardiac surgery or revascularization
Uncontrolled hypertension defined as sitting systolic blood pressure(SBP) > 160 mmHg or diastolic BP (DBP) > 100 mmHg
Type 1 diabetes, poorly controlled type 2 diabetes (HbA1c > 8%), newly diagnosed type 2 diabetes (within 90 days of randomization)
Others factors not suitable for participation judged by PI
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Qiu'e Wan, PM
Phone
86 17710342522
Email
qiu.e_wan@junshipharma.com
Facility Information:
Facility Name
Peking University Third Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100191
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yida Tang, Doctor
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Efficacy and Safety of JS002 as Monotherapy in Patients With Primary Hypercholesterolaemia and Mixed Dyslipidemia
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