Back to resultsA Study to Evaluate the Efficacy and Safety of JS002 in Patients With Heterozygous Familial Hypercholesterolemia (HeFH).
Primary Purpose
Heterozygous Familial Hypercholesterolemia
Status
Recruiting
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
Ongericimab
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Heterozygous Familial Hypercholesterolemia
Eligibility Criteria
Inclusion Criteria:
- 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 Criteria:
- 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.
Sites / Locations
- Beijing Anzhen Hospital Capital Medical University City:BeijingRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Placebo Comparator
Experimental
Placebo Comparator
Arm Label
JS002 150mg Q2W for 24 weeks
placebo 150mg Q2W for 24 weeks
JS002 450mg Q4W for 24 weeks
placebo 450mg Q4W for 24 weeks
Arm Description
40 patients will be enrolled in this arm
20 patients will be enrolled in this arm
40 patients will be enrolled in this arm
20 patients will be enrolled in this arm
Outcomes
Primary Outcome Measures
Percent Change From Baseline in Low-Density Lipoprotein Cholesterol (LDL-C) at Week 24
LDL-C was quantified using the enzymatic colorimetric assay
Secondary Outcome Measures
Absolute Change From Baseline in Low-Density Lipoprotein Cholesterol (LDL-C) at Week 24
LDL-C was quantified using the enzymatic colorimetric assay
Percentage changes From Baseline in the Total Cholesterol at week 24
TC was quantified using the enzymatic colorimetric assay
Absolute changes From Baseline in the Total Cholesterol at week 24
TC was quantified using the enzymatic colorimetric assay
Percentage changes From Baseline in Non-HDL-C at Week 24
Non-HDL-C was quantified using the Calculation,TC minus HDL-C
Absolute changes From Baseline in Non-HDL-C at Week 24
Non-HDL-C was quantified using the Calculation,TC minus HDL-C
Percentage changes From Baseline in Apo B at Week 24
Apo B was quantified using the turbidimetric immunoassay(TIA)
Absolute changes From Baseline in Apo B at Week 24
Apo B was quantified using the turbidimetric immunoassay(TIA)
Percentage changes From Baseline in Lp(a) at Week 24
Lp(a) was quantified using the turbidimetric immunoassay(TIA)
Absolute changes From Baseline in Lp(a) at Week 24
Lp(a) was quantified using the turbidimetric immunoassay(TIA)
Percentage changes From Baseline in HDL-C at Week 24
HDL-C was quantified using the enzymatic colorimetric assay
Absolute changes From Baseline in HDL-C at Week 24
HDL-C was quantified using the enzymatic colorimetric assay
Percentage changes From Baseline in Apo A1 at Week 24
Apo A1 was quantified using the turbidimetric immunoassay(TIA)
Absolute changes From Baseline in Apo A1 at Week 24
Apo A1 was quantified using the turbidimetric immunoassay(TIA)
Percentage changes From Baseline in TG at Week 24
TG was quantified using the enzymatic colorimetric assay
Absolute changes From Baseline in TG at Week 24
TG was quantified using the enzymatic colorimetric assay
The ratio of TC/HDL - C
Calculation
The ratio of Apo B/Apo A1
Calculation
Percentage of Participants With 50% or Greater Reduction in LDL-C From Baseline at Week 24
Calculation
Full Information
NCT ID
NCT05325203
First Posted
February 8, 2022
Last Updated
April 12, 2022
Sponsor
Shanghai Junshi Bioscience Co., Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT05325203
Brief Title
A Study to Evaluate the Efficacy and Safety of JS002 in Patients With Heterozygous Familial Hypercholesterolemia (HeFH).
Official Title
A Randomized, Double-blind, Placebo-controlled Phase III Clinical Study to Evaluate the Efficacy and Safety of Recombinant Humanized Anti-PCSK9 Monoclonal Antibody Injection in Subjects With Heterozygous Familial Hypercholesterolemia
Study Type
Interventional
2. Study Status
Record Verification Date
February 2022
Overall Recruitment Status
Recruiting
Study Start Date
December 31, 2021 (Actual)
Primary Completion Date
March 24, 2023 (Anticipated)
Study Completion Date
June 16, 2023 (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 human anti-PCSK9 monoclonal antibody.The study is a multicenter, randomized, double-blind, placebo-controlled Phase III clinical study in Chinese patients with heterozygous familial hypercholesterolemia (HeFH). Objective To evaluate the efficacy and safety of JS002 150 mg (Q2W) and 450 mg (Q4W) subcutaneous injection (SC).
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 planned to be enrolled. Each subject is required a maximum of 6 weeks of screening, 24 weeks of treatment, and 8 weeks of follow-up. To evaluate the lipid-lowering efficacy of subcutaneous injection of JS002 at 24 weeks compared with placebo in heterozygous familial hypercholesterolemia patients under optimized lipid lowing therapy . Subjects meeting the study inclusion criteria will be randomly assigned in a 2:1:2:1 ratio to JS002 150 mg Q2W or JS002 450 mg Q4W or matched placebo to receive the study drug (JS002) or placebo subcutaneously for 24 weeks.
treatment cohorts: JS002 150mg Cohort:JS002 150mg or placebo treatment(JS002 :Placebo=2:1) Q2W JS002 450mg Cohort:JS002 450mg or placebo treatment(JS002 :Placebo=2:1)Q4W
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heterozygous Familial Hypercholesterolemia
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
120 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
JS002 150mg Q2W for 24 weeks
Arm Type
Experimental
Arm Description
40 patients will be enrolled in this arm
Arm Title
placebo 150mg Q2W for 24 weeks
Arm Type
Placebo Comparator
Arm Description
20 patients will be enrolled in this arm
Arm Title
JS002 450mg Q4W for 24 weeks
Arm Type
Experimental
Arm Description
40 patients will be enrolled in this arm
Arm Title
placebo 450mg Q4W for 24 weeks
Arm Type
Placebo Comparator
Arm Description
20 patients will be enrolled in this arm
Intervention Type
Biological
Intervention Name(s)
Ongericimab
Other Intervention Name(s)
JS002
Intervention Description
Administered by subcutaneous injection
Intervention Type
Drug
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) at Week 24
Description
LDL-C was quantified using the enzymatic colorimetric assay
Time Frame
Baseline and week 24
Secondary Outcome Measure Information:
Title
Absolute Change From Baseline in Low-Density Lipoprotein Cholesterol (LDL-C) at Week 24
Description
LDL-C was quantified using the enzymatic colorimetric assay
Time Frame
Baseline and Week 24
Title
Percentage changes From Baseline in the Total Cholesterol at week 24
Description
TC was quantified using the enzymatic colorimetric assay
Time Frame
Baseline and Week 24
Title
Absolute changes From Baseline in the Total Cholesterol at week 24
Description
TC was quantified using the enzymatic colorimetric assay
Time Frame
Baseline and Week 24
Title
Percentage changes From Baseline in Non-HDL-C at Week 24
Description
Non-HDL-C was quantified using the Calculation,TC minus HDL-C
Time Frame
Baseline and Week 24
Title
Absolute changes From Baseline in Non-HDL-C at Week 24
Description
Non-HDL-C was quantified using the Calculation,TC minus HDL-C
Time Frame
Baseline and Week 24
Title
Percentage changes From Baseline in Apo B at Week 24
Description
Apo B was quantified using the turbidimetric immunoassay(TIA)
Time Frame
Baseline and Week 24
Title
Absolute changes From Baseline in Apo B at Week 24
Description
Apo B was quantified using the turbidimetric immunoassay(TIA)
Time Frame
Baseline and Week 24
Title
Percentage changes From Baseline in Lp(a) at Week 24
Description
Lp(a) was quantified using the turbidimetric immunoassay(TIA)
Time Frame
Baseline and Week 24
Title
Absolute changes From Baseline in Lp(a) at Week 24
Description
Lp(a) was quantified using the turbidimetric immunoassay(TIA)
Time Frame
Baseline and Week 24
Title
Percentage changes From Baseline in HDL-C at Week 24
Description
HDL-C was quantified using the enzymatic colorimetric assay
Time Frame
Baseline and Week 24
Title
Absolute changes From Baseline in HDL-C at Week 24
Description
HDL-C was quantified using the enzymatic colorimetric assay
Time Frame
Baseline and Week 24
Title
Percentage changes From Baseline in Apo A1 at Week 24
Description
Apo A1 was quantified using the turbidimetric immunoassay(TIA)
Time Frame
Baseline and Week 24
Title
Absolute changes From Baseline in Apo A1 at Week 24
Description
Apo A1 was quantified using the turbidimetric immunoassay(TIA)
Time Frame
Baseline and Week 24
Title
Percentage changes From Baseline in TG at Week 24
Description
TG was quantified using the enzymatic colorimetric assay
Time Frame
Baseline and Week 24
Title
Absolute changes From Baseline in TG at Week 24
Description
TG was quantified using the enzymatic colorimetric assay
Time Frame
Baseline and Week 24
Title
The ratio of TC/HDL - C
Description
Calculation
Time Frame
Baseline and Week 24
Title
The ratio of Apo B/Apo A1
Description
Calculation
Time Frame
Baseline and Week 24
Title
Percentage of Participants With 50% or Greater Reduction in LDL-C From Baseline at Week 24
Description
Calculation
Time Frame
Baseline and Week 24
Other Pre-specified Outcome Measures:
Title
Number of subjects who develop detectable anti-drug antibodies (ADAs)
Description
ADA was quantified using the Bridging-ECLIA
Time Frame
from baseline to 32 weeks
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.
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 Criteria:
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Xiuping Yang, Master
Phone
8613681039637
Email
xiuping_yang@junshipharma.com
Facility Information:
Facility Name
Beijing Anzhen Hospital Capital Medical University City:Beijing
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100020
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jie Lin, Doctor
Phone
861081028077
Email
linjie1998@126.com
12. IPD Sharing Statement
Learn more about this trial
A Study to Evaluate the Efficacy and Safety of JS002 in Patients With Heterozygous Familial Hypercholesterolemia (HeFH).
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