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The Safety and Efficacy of Multiple-dose of JS002 in Subject With 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

A limited list of criteria for selection of participants in the clinical study, provided in terms of inclusion and exclusion criteria and suitable for assisting potential participants in identifying clinical studies of interest. Use a bulleted list for each criterion below the headers "Inclusion Criteria" and "Exclusion Criteria". (Limit: 15,000 characters.)

Inclusion Criteria:

  1. Signed informed consent.
  2. Age 18~80 years old;
  3. Stable optimized LLT at least 4 weeks before randomization;

  4. At the time of screening, Low-density lipoprotein cholesterol (LDL-C) level according to ASCVD risks:

    • extra high risk patients: LDL-C≥1.4mmol/L(55mg/dL)
    • very high risk patients: LDL-C≥1.8mmol/L(70mg/dL)
    • high risk patients: LDL-C≥2.6mmol/L(100mg/dL)
    • moderate and low risk patients: LDL-C≥3.4mmol/L(130mg/dL)

4.Fasting triglycerides ≤4.5 mmol/L(400mg/dL);

Exclusion Criteria:

  1. History of NYHA class III-IV heart failure or EF<30%
  2. History of uncontrolled arrhythmia within 3 months
  3. History of MI,UA, PCI or CABG, stroke within 3 months.
  4. History of DVT or pulmonary embolism within 3 months.
  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

  • The First Affiliated Hospital of Bengbu Medical College
  • Beijing Anzhen Hospital, Capital Medical University
  • Beijing Chaoyang Hospital, Capital Medical University
  • Beijing Tongren Hospital Affiliated to Capital Medical University City:Beijing
  • China-Japan Friendship Hospital
  • Peking University Third Hospital
  • The Second Affiliated Hospital of Chongqing Medical University
  • The 900 Hospital of the Joint Service Support Force of the People's Liberation Army of China
  • The First Affiliated Hospital of Fujian Medical University
  • Lanzhou University Second Hospital
  • The First Hospital of Lanzhou University City:Lanzhou
  • Sun Yat-sen Memorial Hospital, Sun Yat-sen University
  • Guangdong General Hospital
  • The First Affiliated Hospital, Sun Yat-sen University
  • Peking University Shenzhen Hospital
  • The People's Hospital of Guangxi Zhuang Autonomous Region
  • Affiliated Hospital of Guizhou Medical University
  • Hainan General Hospital
  • The First Hospital of Hebei Medical University
  • The Second Hospital of Hebei Medical University
  • Daqingshi People's Hospital
  • The Fourth Affiliated Hospital of Harbin Medical University
  • The First Affiliated Hospital of Henan University of Science and Technology
  • The First Affiliated Hospital of Zhengzhou University
  • Jingzhou Central Hospital
  • Tongji Hospital Affiliated to Tongji Medical College of Huazhong University of Science and Technology
  • The Third Xiangya Hospital of Central South University
  • The Second Xiangya Hospital of Central South University
  • The Second People's Hospital of Changzhou
  • Zhongda Hospital Southeast Universty
  • Affiliated Hospital of Xuzhou Medical University
  • Northern Jiangsu People's Hospital
  • The First Hospital of Nanchang
  • The Second Affiliated Hospital of Nanchang University
  • First Hospital of Jilin University
  • China-Japan Union Hospital of Jilin University
  • The central hospital of Dalian
  • The First Affiliated Hospital of Jinzhou Medical University
  • The People's Hospital of Liaoning Provincial
  • General Hospital of the PLA Northern Theater Command
  • Jinan Central Hospital
  • Qilu Hospital of Shandong University
  • Huashan Hospital Affiliated to Fudan University
  • Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
  • Shanghai Changhai Hospital
  • Shanghai East Hospital
  • First Hospital of Shanxi Medical University
  • Shanxi Provincial People's Hospital
  • Xianyang Hospital of Yan 'an University
  • The First Affiliated Hospital of the Air Force Medical University
  • The Second Affiliated Hospital of Xi'an Jiaotong University
  • West China Hospital of Sichuan University
  • Teda International Cardiovascular Hospital
  • Tianjin First Central Hospital
  • 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

Cohort 1: 150 mg/1mL Q2W Subcutaneous(SC); Cohort 2: 300/2mL mg Q4W Subcutaneous(SC);

Cohort 1: 1mL Q2W Subcutaneous(SC); Cohort 2: 2mL Q4W Subcutaneous(SC);

Outcomes

Primary Outcome Measures

Change in LDL-C of JS002
Percentage change in LDL-C relative to baseline at Week 24

Secondary Outcome Measures

Change in LDL-C of JS002
Percentage change in LDL-C relative to baseline at Week 52
Other lipid parameters of JS002
Percentage change in LDL-C relative to baseline at Week 24 and Week 52
The occurrence of adverse events
Evaluate the change of clinically significant laboratory tests, vital signs, and electrocardiogram
The immunogenicity of JS002
To evaluate the production time, duration and proportion of anti JS002 antibody (ADA).ADA positive samples are tested for titer and for neutralizing antibody (Nab).
Pharmacokinetics (PK) of JS002
Evaluation of Serum concentration of JS002.Descriptive statistics include mean (arithmetic mean and geometric mean), standard deviation (SD), coefficient of variation CV% (arithmetic coefficient and geometric coefficient of variation), Median (Median), minimum (Min) and maximum (Max).
Pharmacokinetics (PD) of JS002
Evaluation of serum concentrations of free/total PCSK9 and changes from baseline.Descriptive statistics include mean (arithmetic mean and geometric mean), standard deviation (SD), coefficient of variation CV% (arithmetic coefficient and geometric coefficient of variation), Median (Median), minimum (Min) and maximum (Max).

Full Information

First Posted
February 24, 2021
Last Updated
April 14, 2023
Sponsor
Shanghai Junshi Bioscience Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT04781114
Brief Title
The Safety and Efficacy of Multiple-dose of JS002 in Subject With Hyperlipidemia
Official Title
A Phase III, Randomized, Double-blind, Placebo-controlled Clinical Study Evaluating the Efficacy and Safety of JS002 in Patients With Primary Hypercholesterolemia and Mixed Hyperlipidemia in China
Study Type
Interventional

2. Study Status

Record Verification Date
February 2021
Overall Recruitment Status
Completed
Study Start Date
December 23, 2020 (Actual)
Primary Completion Date
May 25, 2022 (Actual)
Study Completion Date
January 16, 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 safety and efficacy, as well as immunogenicity of JS002 treated repeatedly in patients with hyperlipidemia when combined with statin therapy. In this study, two dose group (150 mg, 300 mg) were set up in this study. 750 subjects are plan to be enrolled (the study drug will be assigned to a 2:1 ratio of JS002 or placebo). 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 3
Interventional Study Model
Sequential Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
806 (Actual)

8. Arms, Groups, and Interventions

Arm Title
JS002
Arm Type
Experimental
Arm Description
Cohort 1: 150 mg/1mL Q2W Subcutaneous(SC); Cohort 2: 300/2mL mg Q4W Subcutaneous(SC);
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Cohort 1: 1mL Q2W Subcutaneous(SC); Cohort 2: 2mL Q4W Subcutaneous(SC);
Intervention Type
Drug
Intervention Name(s)
JS002
Intervention Description
JS002: 150mg(1mL) Q2W; Placebo 1mL Q2W.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
JS002: 300mg(2mL) Q4W; Placebo 2mL Q4W.
Primary Outcome Measure Information:
Title
Change in LDL-C of JS002
Description
Percentage change in LDL-C relative to baseline at Week 24
Time Frame
Up to 24Weeks after dose administration
Secondary Outcome Measure Information:
Title
Change in LDL-C of JS002
Description
Percentage change in LDL-C relative to baseline at Week 52
Time Frame
Up to 52Weeks after dose administration
Title
Other lipid parameters of JS002
Description
Percentage change in LDL-C relative to baseline at Week 24 and Week 52
Time Frame
Up to Week 24 and 52Weeks after dose administration
Title
The occurrence of adverse events
Description
Evaluate the change of clinically significant laboratory tests, vital signs, and electrocardiogram
Time Frame
Up 60Weeks after dose administration
Title
The immunogenicity of JS002
Description
To evaluate the production time, duration and proportion of anti JS002 antibody (ADA).ADA positive samples are tested for titer and for neutralizing antibody (Nab).
Time Frame
Up 60Weeks after dose administration
Title
Pharmacokinetics (PK) of JS002
Description
Evaluation of Serum concentration of JS002.Descriptive statistics include mean (arithmetic mean and geometric mean), standard deviation (SD), coefficient of variation CV% (arithmetic coefficient and geometric coefficient of variation), Median (Median), minimum (Min) and maximum (Max).
Time Frame
Up 60Weeks after dose administration
Title
Pharmacokinetics (PD) of JS002
Description
Evaluation of serum concentrations of free/total PCSK9 and changes from baseline.Descriptive statistics include mean (arithmetic mean and geometric mean), standard deviation (SD), coefficient of variation CV% (arithmetic coefficient and geometric coefficient of variation), Median (Median), minimum (Min) and maximum (Max).
Time Frame
Up 60Weeks after dose administration

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
A limited list of criteria for selection of participants in the clinical study, provided in terms of inclusion and exclusion criteria and suitable for assisting potential participants in identifying clinical studies of interest. Use a bulleted list for each criterion below the headers "Inclusion Criteria" and "Exclusion Criteria". (Limit: 15,000 characters.) Inclusion criteria Males and females ≥ 18 and ≤ 80 years of age; LDL_C during screening period met the following conditions: super high risk: LDL - C ≥1.4mmol/L (55 mg/dL); extremely high risk: LDL - C ≥1.8 mmol/L (70 mg/dL); risk: LDL - C ≥2.6 mmol/L (100 mg/dL); low risk: LDL - C ≥ 3.4 /mmol/L (130 mg/dL) Fasting triglycerides ≤4.5 mmol/L; Exclusion criteria Known HoFH; History of NYHA class III-IV heart failure; History of uncontrolled arrhythmia, Unstable angina,MI, PCI,CABG, DVT or pulmonary embolism within 3 months. Uncontrolled hypertension. Uncontrolled diabetes mellitius (HbA1c>8.0%）. Other conditions that investigators considered inappropriate to participate in the study.
Facility Information:
Facility Name
The First Affiliated Hospital of Bengbu Medical College
City
Bengbu
State/Province
Anhui
ZIP/Postal Code
233000
Country
China
Facility Name
Beijing Anzhen Hospital, Capital Medical University
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100000
Country
China
Facility Name
Beijing Chaoyang Hospital, Capital Medical University
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100000
Country
China
Facility Name
Beijing Tongren Hospital Affiliated to Capital Medical University City:Beijing
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100000
Country
China
Facility Name
China-Japan Friendship Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100000
Country
China
Facility Name
Peking University Third Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100000
Country
China
Facility Name
The Second Affiliated Hospital of Chongqing Medical University
City
Chongqing
State/Province
Chongqing
ZIP/Postal Code
400000
Country
China
Facility Name
The 900 Hospital of the Joint Service Support Force of the People's Liberation Army of China
City
Fuzhou
State/Province
Fujian
ZIP/Postal Code
350000
Country
China
Facility Name
The First Affiliated Hospital of Fujian Medical University
City
Fuzhou
State/Province
Fujian
ZIP/Postal Code
350000
Country
China
Facility Name
Lanzhou University Second Hospital
City
Lanzhou
State/Province
Gansu
ZIP/Postal Code
730000
Country
China
Facility Name
The First Hospital of Lanzhou University City:Lanzhou
City
Lanzhou
State/Province
Gansu
ZIP/Postal Code
730000
Country
China
Facility Name
Sun Yat-sen Memorial Hospital, Sun Yat-sen University
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
5100000
Country
China
Facility Name
Guangdong General Hospital
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510000
Country
China
Facility Name
The First Affiliated Hospital, Sun Yat-sen University
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510000
Country
China
Facility Name
Peking University Shenzhen Hospital
City
Shenzhen
State/Province
Guangdong
ZIP/Postal Code
518000
Country
China
Facility Name
The People's Hospital of Guangxi Zhuang Autonomous Region
City
Nanning
State/Province
Guangxi
ZIP/Postal Code
530000
Country
China
Facility Name
Affiliated Hospital of Guizhou Medical University
City
Guiyang
State/Province
Guizhou
ZIP/Postal Code
550000
Country
China
Facility Name
Hainan General Hospital
City
Haikou
State/Province
Hainan
ZIP/Postal Code
570100
Country
China
Facility Name
The First Hospital of Hebei Medical University
City
Shijiazhuang
State/Province
Hebei
ZIP/Postal Code
050000
Country
China
Facility Name
The Second Hospital of Hebei Medical University
City
Shijiazhuang
State/Province
Hebei
ZIP/Postal Code
050000
Country
China
Facility Name
Daqingshi People's Hospital
City
Daqing
State/Province
Heilongjiang
ZIP/Postal Code
163316
Country
China
Facility Name
The Fourth Affiliated Hospital of Harbin Medical University
City
Haerbin
State/Province
Heilongjiang
ZIP/Postal Code
15000
Country
China
Facility Name
The First Affiliated Hospital of Henan University of Science and Technology
City
Luoyang
State/Province
Henan
ZIP/Postal Code
471000
Country
China
Facility Name
The First Affiliated Hospital of Zhengzhou University
City
Zhengzhou
State/Province
Henan
ZIP/Postal Code
450000
Country
China
Facility Name
Jingzhou Central Hospital
City
Jingzhou
State/Province
Hubei
ZIP/Postal Code
434000
Country
China
Facility Name
Tongji Hospital Affiliated to Tongji Medical College of Huazhong University of Science and Technology
City
Wuhan
State/Province
Hubei
ZIP/Postal Code
430000
Country
China
Facility Name
The Third Xiangya Hospital of Central South University
City
Changsha
State/Province
Hunan
ZIP/Postal Code
410000
Country
China
Facility Name
The Second Xiangya Hospital of Central South University
City
Changsha
State/Province
Hunan
ZIP/Postal Code
410100
Country
China
Facility Name
The Second People's Hospital of Changzhou
City
Changzhou
State/Province
Jiangsu
ZIP/Postal Code
213000
Country
China
Facility Name
Zhongda Hospital Southeast Universty
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
210009
Country
China
Facility Name
Affiliated Hospital of Xuzhou Medical University
City
Xuzhou
State/Province
Jiangsu
ZIP/Postal Code
221000
Country
China
Facility Name
Northern Jiangsu People's Hospital
City
Yangzhou
State/Province
Jiangsu
ZIP/Postal Code
225000
Country
China
Facility Name
The First Hospital of Nanchang
City
Nanchang
State/Province
Jiangxi
ZIP/Postal Code
330000
Country
China
Facility Name
The Second Affiliated Hospital of Nanchang University
City
Nanchang
State/Province
Jiangxi
ZIP/Postal Code
330000
Country
China
Facility Name
First Hospital of Jilin University
City
Changchun
State/Province
Jilin
ZIP/Postal Code
130000
Country
China
Facility Name
China-Japan Union Hospital of Jilin University
City
Changchun
State/Province
Jilin
ZIP/Postal Code
130033
Country
China
Facility Name
The central hospital of Dalian
City
Dalian
State/Province
Liaoning
ZIP/Postal Code
116000
Country
China
Facility Name
The First Affiliated Hospital of Jinzhou Medical University
City
Jinzhou
State/Province
Liaoning
ZIP/Postal Code
121000
Country
China
Facility Name
The People's Hospital of Liaoning Provincial
City
Shenyang
State/Province
Liaoning
ZIP/Postal Code
110000
Country
China
Facility Name
General Hospital of the PLA Northern Theater Command
City
Shenyang
State/Province
Liaoning
ZIP/Postal Code
110020
Country
China
Facility Name
Jinan Central Hospital
City
Jinan
State/Province
Shandong
ZIP/Postal Code
250000
Country
China
Facility Name
Qilu Hospital of Shandong University
City
Jinan
State/Province
Shandong
ZIP/Postal Code
250000
Country
China
Facility Name
Huashan Hospital Affiliated to Fudan University
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200000
Country
China
Facility Name
Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200000
Country
China
Facility Name
Shanghai Changhai Hospital
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200000
Country
China
Facility Name
Shanghai East Hospital
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200000
Country
China
Facility Name
First Hospital of Shanxi Medical University
City
Taiyuan
State/Province
Shanxi
ZIP/Postal Code
030000
Country
China
Facility Name
Shanxi Provincial People's Hospital
City
Taiyuan
State/Province
Shanxi
ZIP/Postal Code
030000
Country
China
Facility Name
Xianyang Hospital of Yan 'an University
City
Xianyang
State/Province
Shanxi
ZIP/Postal Code
712000
Country
China
Facility Name
The First Affiliated Hospital of the Air Force Medical University
City
Xian
State/Province
Shanxi
ZIP/Postal Code
710000
Country
China
Facility Name
The Second Affiliated Hospital of Xi'an Jiaotong University
City
Xian
State/Province
Shanxi
ZIP/Postal Code
710000
Country
China
Facility Name
West China Hospital of Sichuan University
City
Chengdu
State/Province
Sichuan
ZIP/Postal Code
610000
Country
China
Facility Name
Teda International Cardiovascular Hospital
City
Tianjin
State/Province
Tianjin
ZIP/Postal Code
300000
Country
China
Facility Name
Tianjin First Central Hospital
City
Tianjin
State/Province
Tianjin
ZIP/Postal Code
300000
Country
China
Facility Name
Tianjin People's Hospital
City
Tianjin
State/Province
Tianjin
ZIP/Postal Code
300000
Country
China
Facility Name
Taizhou Hospital of Zhejiang Province
City
Taizhou
State/Province
Zhejiang
ZIP/Postal Code
318000
Country
China
Facility Name
The First Affiliated Hospital of Wenzhou Medical University
City
Wenzhou
State/Province
Zhejiang
ZIP/Postal Code
325000
Country
China

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

The Safety and Efficacy of Multiple-dose of JS002 in Subject With Hyperlipidemia

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