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The Efficacy and Safety of JS002 PFS and AI in Patients With Primary Hypercholesterolemia and Mixed Hyperlipidemia

Primary Purpose

Hyperlipemia

Status
Completed
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
JS002
Placebo
Sponsored by
Shanghai Junshi Bioscience Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hyperlipemia

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Signed informed consent.
  2. Age 18~80 years old;
  3. Stable optimized LLT at least 4 weeks before randomization;
  4. Two times of Fasting triglycerides ≤4.5 mmol/L(400mg/dL)at the time of screening;

Exclusion Criteria:

  1. History of NYHA class III-IV heart failure or EF<30%;
  2. History of uncontrolled arrhythmia within 90 days;
  3. History of MI,UA, PCI or CABG, stroke within 90 days;
  4. Known hemorrhagic stroke disease;
  5. Planned cardiac surgery or revascularization.
  6. Uncontrolled hypertension.
  7. Uncontrolled diabetes mellitius (HbA1c>8.0%）.
  8. Other conditions that the researchers considered inappropriate to participate in the study.

Sites / Locations

  • Beijing Anzhen Hospital，Capital Medical University
  • Peking University Third Hospital
  • China-Japan Friendship Hospital
  • The First Affiliated Hospital of Fujian Medical University
  • Daqing People's Hospital
  • The Fourth Affiliated Hospital of Harbin Medical University
  • First Affiliated Hospital of Zhengzhou University
  • Jingzhou Central Hospital
  • The Second Xiangya Hospital Of Central South University
  • Changzhou Second People's Hospital
  • Affiliated Hospital of Xuzhou Medical University
  • Nanchang First Hospital
  • Nanchang Third Hospital
  • The Second Affiliated Hospital of Nanchang University
  • The First Hospital of Jilin University
  • Dalian Municipal Central Hospital
  • The First Affiliated Hospital of Jinzhou Medical University
  • Xianyang Hospital of Yan'an University
  • Tianjin People's Hospital
  • Taizhou Hospital Of Zhejiang Province
  • The First Affiliated Hospital of Wenzhou Medical University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

JS002

Placebo

Arm Description

Cobort 1:150 mg/1mL Q2W PFS,Cobort 2:150 mg/1mL Q2W AI

Cobort 1:/1mL Q2W PFS,Cobort 2:1mL Q2W AI

Outcomes

Primary Outcome Measures

LDL-C with JS002 PFS
Percentage change in LDL-C relative to baseline at Week 12 with JS002 PFS
LDL-C with JS002 AI
Percentage change in LDL-C relative to baseline at Week 12 with JS002 AI

Secondary Outcome Measures

LDL-C with JS002 PFS
The absolute change in LDL-C relative to baseline with JS002 PFS
LDL-C with JS002 AI
The absolute change in LDL-C relative to baseline with JS002 AI
lipid parameters
Percentages and absolute change in other lipid parameters to baseline with JS002 PFS and JS002 AI
LDL-C reduction≥50 with JS002 PFS
Proportion of subjects with a ≥50% reduction in serum LDL-C at 12 weeks after subcutaneous treatment with JS002 PFS from baseline
LDL-C reduction≥50 with JS002 AI
Proportion of subjects with a ≥50% reduction in serum LDL-C at 12 weeks after subcutaneous treatment with JS002 AI from baseline
LDL-C dropped to < 70 mg/dL with JS002 PFS
Proportion of subjects whose serum LDL-C dropped to < 70 mg/dL (1.8 mmol/L) at 12 weeks after subcutaneous injection of JS002 PFS
LDL-C dropped to < 70 mg/dL with JS002 AI
Proportion of subjects whose serum LDL-C dropped to < 70 mg/dL (1.8 mmol/L) at 12 weeks after subcutaneous injection of JS002 AI
full dose
Proportion of subjects receiving full dose of JS002 AI during treatment (weeks 0, 2, 4, 6, 8, 10)

Full Information

First Posted
September 5, 2022
Last Updated
March 14, 2023
Sponsor
Shanghai Junshi Bioscience Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT05532800
Brief Title
The Efficacy and Safety of JS002 PFS and AI in Patients With Primary Hypercholesterolemia and Mixed Hyperlipidemia
Official Title
A Randomized, Double-blind, Placebo-controlled Phase III Clinical Study Evaluating the Efficacy and Safety of JS002 Prefilled Syringes(PFS) and Prefilled Autosyringes(AI) in Patients With Primary Hypercholesterolemia and Mixed Hyperlipidemia
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Completed
Study Start Date
February 28, 2022 (Actual)
Primary Completion Date
February 9, 2023 (Actual)
Study Completion Date
February 9, 2023 (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. This is a randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of JS002 prefilled syringes and prefilled autosyringes in patients with primary hypercholesterolemia and mixed hyperlipidemia when combined with statin therapy. In this study, one dose group (150 mg) were set up in this study. 240 subjects are plan to be enrolled (the study drug will be assigned to a 2:1 :2:1ratio of JS002 PFS / placebo or JS002 AI / placebo ). Each subject required a maximum of 6 weeks of screening, 12 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 3
Interventional Study Model
Sequential Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
255 (Actual)

8. Arms, Groups, and Interventions

Arm Title
JS002
Arm Type
Experimental
Arm Description
Cobort 1:150 mg/1mL Q2W PFS,Cobort 2:150 mg/1mL Q2W AI
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Cobort 1:/1mL Q2W PFS,Cobort 2:1mL Q2W AI
Intervention Type
Drug
Intervention Name(s)
JS002
Intervention Description
JS002:150mg(1mL) Q2W PFS, Placebo: 1mL Q2W PFS.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
JS002:150mg(1mL) Q2W AI, Placebo: 1mL Q2W AI.
Primary Outcome Measure Information:
Title
LDL-C with JS002 PFS
Description
Percentage change in LDL-C relative to baseline at Week 12 with JS002 PFS
Time Frame
at week 12
Title
LDL-C with JS002 AI
Description
Percentage change in LDL-C relative to baseline at Week 12 with JS002 AI
Time Frame
at week 12
Secondary Outcome Measure Information:
Title
LDL-C with JS002 PFS
Description
The absolute change in LDL-C relative to baseline with JS002 PFS
Time Frame
at week 12
Title
LDL-C with JS002 AI
Description
The absolute change in LDL-C relative to baseline with JS002 AI
Time Frame
at week 12
Title
lipid parameters
Description
Percentages and absolute change in other lipid parameters to baseline with JS002 PFS and JS002 AI
Time Frame
at week 12
Title
LDL-C reduction≥50 with JS002 PFS
Description
Proportion of subjects with a ≥50% reduction in serum LDL-C at 12 weeks after subcutaneous treatment with JS002 PFS from baseline
Time Frame
at week 12
Title
LDL-C reduction≥50 with JS002 AI
Description
Proportion of subjects with a ≥50% reduction in serum LDL-C at 12 weeks after subcutaneous treatment with JS002 AI from baseline
Time Frame
at week 12
Title
LDL-C dropped to < 70 mg/dL with JS002 PFS
Description
Proportion of subjects whose serum LDL-C dropped to < 70 mg/dL (1.8 mmol/L) at 12 weeks after subcutaneous injection of JS002 PFS
Time Frame
at week 12
Title
LDL-C dropped to < 70 mg/dL with JS002 AI
Description
Proportion of subjects whose serum LDL-C dropped to < 70 mg/dL (1.8 mmol/L) at 12 weeks after subcutaneous injection of JS002 AI
Time Frame
at week 12
Title
full dose
Description
Proportion of subjects receiving full dose of JS002 AI during treatment (weeks 0, 2, 4, 6, 8, 10)
Time Frame
at week 0, 2, 4, 6, 8, 10

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; Stable optimized LLT at least 4 weeks before randomization; Two times of Fasting triglycerides ≤4.5 mmol/L(400mg/dL)at the time of screening; Exclusion Criteria: History of NYHA class III-IV heart failure or EF<30%; History of uncontrolled arrhythmia within 90 days; History of MI,UA, PCI or CABG, stroke within 90 days; Known hemorrhagic stroke disease; 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
ZIP/Postal Code
100029
Country
China
Facility Name
Peking University Third Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100191
Country
China
Facility Name
China-Japan Friendship Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100192
Country
China
Facility Name
The First Affiliated Hospital of Fujian Medical University
City
Fuzhou
State/Province
Fujian
ZIP/Postal Code
350005
Country
China
Facility Name
Daqing People's Hospital
City
Daqing
State/Province
Heilongjiang
ZIP/Postal Code
163711
Country
China
Facility Name
The Fourth Affiliated Hospital of Harbin Medical University
City
Harbin
State/Province
Heilongjiang
ZIP/Postal Code
150001
Country
China
Facility Name
First Affiliated Hospital of Zhengzhou University
City
Zhengzhou
State/Province
Henan
ZIP/Postal Code
450052
Country
China
Facility Name
Jingzhou Central Hospital
City
Jingzhou
State/Province
Hubei
ZIP/Postal Code
434020
Country
China
Facility Name
The Second Xiangya Hospital Of Central South University
City
Changsha
State/Province
Hunan
ZIP/Postal Code
410008
Country
China
Facility Name
Changzhou Second People's Hospital
City
Changzhou
State/Province
Jiangsu
ZIP/Postal Code
213004
Country
China
Facility Name
Affiliated Hospital of Xuzhou Medical University
City
Xuzhou
State/Province
Jiangsu
ZIP/Postal Code
221004
Country
China
Facility Name
Nanchang First Hospital
City
Nanchang
State/Province
Jiangxi
ZIP/Postal Code
330008
Country
China
Facility Name
Nanchang Third Hospital
City
Nanchang
State/Province
Jiangxi
ZIP/Postal Code
330008
Country
China
Facility Name
The Second Affiliated Hospital of Nanchang University
City
Nanchang
State/Province
Jiangxi
ZIP/Postal Code
330008
Country
China
Facility Name
The First Hospital of Jilin University
City
Changchun
State/Province
Jilin
ZIP/Postal Code
130061
Country
China
Facility Name
Dalian Municipal Central Hospital
City
Dalian
State/Province
Liaoning
ZIP/Postal Code
116089
Country
China
Facility Name
The First Affiliated Hospital of Jinzhou Medical University
City
Jinzhou
State/Province
Liaoning
ZIP/Postal Code
121011
Country
China
Facility Name
Xianyang Hospital of Yan'an University
City
Xianyang
State/Province
Shanxi
ZIP/Postal Code
716099
Country
China
Facility Name
Tianjin People's Hospital
City
Tianjin
State/Province
Tianjin
ZIP/Postal Code
300122
Country
China
Facility Name
Taizhou Hospital Of Zhejiang Province
City
Taizhou
State/Province
Zhejiang
ZIP/Postal Code
317000
Country
China
Facility Name
The First Affiliated Hospital of Wenzhou Medical University
City
Wenzhou
State/Province
Zhejiang
ZIP/Postal Code
325015
Country
China

12. IPD Sharing Statement

Plan to Share IPD
No

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The Efficacy and Safety of JS002 PFS and AI in Patients With Primary Hypercholesterolemia and Mixed Hyperlipidemia

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