To Evaluate the Efficacy and Safety of JS002 in HoFH Patients
Primary Purpose
Hyperlipemia
Status
Active
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
JS002
Sponsored by
About this trial
This is an interventional treatment trial for Hyperlipemia
Eligibility Criteria
Inclusion Criteria:
- Signed informed consent.
- Age ≥12 and ≤75 years old;
- Weight ≥40kg at the time of screening
- Patients diagnosed with HoFH
- Low-density lipoprotein cholesterol (LDL-C) level ≥3.4mmol/L at the time of screening
- Fasting triglycerides ≤4.5 mmol/L;
Exclusion Criteria:
- History of NYHA class III-IV heart failure or EF<30%
- History of uncontrolled arrhythmia within 3 months
- History of MI,UA, PCI or CABG, stroke within 3 months.
- History of DVT or pulmonary embolism within 3 months.
- 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.
Sites / Locations
- Beijing Anzhen Hospital Capital Medical University
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
subcutaneous injection of JS002, 450mg, Q4W, 3/13 times.
Arm Description
Outcomes
Primary Outcome Measures
The primary endpoint of effectiveness
Percent Change From Baseline in Low-Density Lipoprotein Cholesterol (LDL-C) at Week 12
Secondary Outcome Measures
Full Information
NCT ID
NCT04515927
First Posted
August 11, 2020
Last Updated
January 24, 2022
Sponsor
Shanghai Junshi Bioscience Co., Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT04515927
Brief Title
To Evaluate the Efficacy and Safety of JS002 in HoFH Patients
Official Title
An Open-label, Single-arm Study Evaluated the Efficacy and Safety of JS002 in Patients With Homozygous Familial Hypercholesterolemia
Study Type
Interventional
2. Study Status
Record Verification Date
January 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
August 17, 2020 (Actual)
Primary Completion Date
May 6, 2022 (Anticipated)
Study Completion Date
July 29, 2022 (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. This phase II open-label, single-arm study aims to evaluate the efficacy and safety of JS002 in patients with homozygous familial hypercholesterolemia A dose group (450 mg) was set up in this study.Thirty subjects are planned to be enrolled.
Each subject required a maximum of 6 weeks of screening, 52 weeks of treatment, and 8 weeks of follow-up.
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 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
subcutaneous injection of JS002, 450mg, Q4W, 3/13 times.
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
JS002
Intervention Description
Biological: JS002 Administered by subcutaneous injection
Primary Outcome Measure Information:
Title
The primary endpoint of effectiveness
Description
Percent Change From Baseline in Low-Density Lipoprotein Cholesterol (LDL-C) at Week 12
Time Frame
JS002 is administered subcutaneously every 4 weeks, from 12 or 52 weeks after initial administration
10. Eligibility
Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Signed informed consent.
Age ≥12 and ≤75 years old;
Weight ≥40kg at the time of screening
Patients diagnosed with HoFH
Low-density lipoprotein cholesterol (LDL-C) level ≥3.4mmol/L at the time of screening
Fasting triglycerides ≤4.5 mmol/L;
Exclusion Criteria:
History of NYHA class III-IV heart failure or EF<30%
History of uncontrolled arrhythmia within 3 months
History of MI,UA, PCI or CABG, stroke within 3 months.
History of DVT or pulmonary embolism within 3 months.
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.
Facility Information:
Facility Name
Beijing Anzhen Hospital Capital Medical University
City
Beijing
State/Province
Beijing
Country
China
12. IPD Sharing Statement
Learn more about this trial
To Evaluate the Efficacy and Safety of JS002 in HoFH Patients
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