A Study to Evaluate the Efficacy and Safety of JS002 in Patients With Heterozygous Familial Hypercholesterolemia (HeFH).

Heterozygous Familial Hypercholesterolemia Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05325203
• Other study ID #: JS002-005
• Status: Completed
• Phase: Phase 3
• Start date: December 31, 2021
• Est. completion date: June 29, 2023

Study information

• Verified date: February 2022
• Source: Shanghai Junshi Bioscience Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 135
• Est. completion date: June 29, 2023
• Est. primary completion date: May 8, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

1. Signed informed consent.

2. Males and females = 18 to = 80 years of age

3. DLCN>8 in HeFH

4. Stable lipid-lowering therapies for at least 4 weeks

5. Patients with ASCVD LDL cholesterol=1.4mmol/L at screening Patients without ASCVD LDL cholesterol=2.6mmol/L at screening

6. Triglyceride=4.5 mmol/L(400 mg/dL);

Exclusion Criteria:

1. HoFH or meet the diagnostic criteria of HoFH

2. New York Heart Association (NYHA) class III or IV or last known left ventricular ejection fraction < 30%

3. History of uncontrolled arrhythmia within 90 days

4. Myocardial infarction, unstable angina, percutaneous coronary intervention (PCI), coronary artery bypass graft (CABG) or stroke within 90 days of randomization

5. Planned cardiac surgery or revascularization.

6. Uncontrolled diabetes mellitius (HbA1c>8.0%).

7. Uncontrolled hypertension.

8. Other conditions that the researchers considered inappropriate to participate in the study.

Related Conditions & MeSH terms

• Heterozygous Familial Hypercholesterolemia
• Hypercholesterolemia
• Hyperlipoproteinemia Type II

Intervention

Biological:
• Ongericimab
Administered by subcutaneous injection

Drug:
• Placebo
Administered by subcutaneous injection

Locations

Country	Name	City	State
China	Beijing Anzhen Hospital Capital Medical University City:Beijing	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai Junshi Bioscience Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Number of subjects who develop detectable anti-drug antibodies (ADAs)	ADA was quantified using the Bridging-ECLIA	from baseline to 32 weeks
Primary	Percent Change From Baseline in Low-Density Lipoprotein Cholesterol (LDL-C) at Week 24	LDL-C was quantified using the enzymatic colorimetric assay	Baseline and week 24
Secondary	Absolute Change From Baseline in Low-Density Lipoprotein Cholesterol (LDL-C) at Week 24	LDL-C was quantified using the enzymatic colorimetric assay	Baseline and Week 24
Secondary	Percentage changes From Baseline in the Total Cholesterol at week 24	TC was quantified using the enzymatic colorimetric assay	Baseline and Week 24
Secondary	Absolute changes From Baseline in the Total Cholesterol at week 24	TC was quantified using the enzymatic colorimetric assay	Baseline and Week 24
Secondary	Percentage changes From Baseline in Non-HDL-C at Week 24	Non-HDL-C was quantified using the Calculation,TC minus HDL-C	Baseline and Week 24
Secondary	Absolute changes From Baseline in Non-HDL-C at Week 24	Non-HDL-C was quantified using the Calculation,TC minus HDL-C	Baseline and Week 24
Secondary	Percentage changes From Baseline in Apo B at Week 24	Apo B was quantified using the turbidimetric immunoassay(TIA)	Baseline and Week 24
Secondary	Absolute changes From Baseline in Apo B at Week 24	Apo B was quantified using the turbidimetric immunoassay(TIA)	Baseline and Week 24
Secondary	Percentage changes From Baseline in Lp(a) at Week 24	Lp(a) was quantified using the turbidimetric immunoassay(TIA)	Baseline and Week 24
Secondary	Absolute changes From Baseline in Lp(a) at Week 24	Lp(a) was quantified using the turbidimetric immunoassay(TIA)	Baseline and Week 24
Secondary	Percentage changes From Baseline in HDL-C at Week 24	HDL-C was quantified using the enzymatic colorimetric assay	Baseline and Week 24
Secondary	Absolute changes From Baseline in HDL-C at Week 24	HDL-C was quantified using the enzymatic colorimetric assay	Baseline and Week 24
Secondary	Percentage changes From Baseline in Apo A1 at Week 24	Apo A1 was quantified using the turbidimetric immunoassay(TIA)	Baseline and Week 24
Secondary	Absolute changes From Baseline in Apo A1 at Week 24	Apo A1 was quantified using the turbidimetric immunoassay(TIA)	Baseline and Week 24
Secondary	Percentage changes From Baseline in TG at Week 24	TG was quantified using the enzymatic colorimetric assay	Baseline and Week 24
Secondary	Absolute changes From Baseline in TG at Week 24	TG was quantified using the enzymatic colorimetric assay	Baseline and Week 24
Secondary	The ratio of TC/HDL - C	Calculation	Baseline and Week 24
Secondary	The ratio of Apo B/Apo A1	Calculation	Baseline and Week 24
Secondary	Percentage of Participants With 50% or Greater Reduction in LDL-C From Baseline at Week 24	Calculation	Baseline and Week 24