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

Hyperlipemia Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04781114
• Other study ID #: JS002-003
• Status: Completed
• Phase: Phase 3
• Start date: December 23, 2020
• Est. completion date: January 16, 2023

Study information

• Verified date: February 2021
• Source: Shanghai Junshi Bioscience Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 806
• Est. completion date: January 16, 2023
• Est. primary completion date: May 25, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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. Males and females = 18 and = 80 years of age;

2. 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)

3. Fasting triglycerides =4.5 mmol/L; Exclusion criteria

1. Known HoFH;

2. History of NYHA class III-IV heart failure;

3. History of uncontrolled arrhythmia, Unstable angina,MI, PCI,CABG, DVT or pulmonary embolism within 3 months.

4. Uncontrolled hypertension.

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

6. Other conditions that investigators considered inappropriate to participate in the study.

Related Conditions & MeSH terms

• Hyperlipemia
• Hyperlipidemias
• Hyperlipoproteinemias

Intervention

Drug:
• JS002
JS002: 150mg(1mL) Q2W; Placebo 1mL Q2W.
• Placebo
JS002: 300mg(2mL) Q4W; Placebo 2mL Q4W.

Locations

Country	Name	City	State
China	Beijing Anzhen Hospital, Capital Medical University	Beijing	Beijing
China	Beijing Chaoyang Hospital, Capital Medical University	Beijing	Beijing
China	Beijing Tongren Hospital Affiliated to Capital Medical University City:Beijing	Beijing	Beijing
China	China-Japan Friendship Hospital	Beijing	Beijing
China	Peking University Third Hospital	Beijing	Beijing
China	The First Affiliated Hospital of Bengbu Medical College	Bengbu	Anhui
China	China-Japan Union Hospital of Jilin University	Changchun	Jilin
China	First Hospital of Jilin University	Changchun	Jilin
China	The Second Xiangya Hospital of Central South University	Changsha	Hunan
China	The Third Xiangya Hospital of Central South University	Changsha	Hunan
China	The Second People's Hospital of Changzhou	Changzhou	Jiangsu
China	West China Hospital of Sichuan University	Chengdu	Sichuan
China	The Second Affiliated Hospital of Chongqing Medical University	Chongqing	Chongqing
China	The central hospital of Dalian	Dalian	Liaoning
China	Daqingshi People's Hospital	Daqing	Heilongjiang
China	The 900 Hospital of the Joint Service Support Force of the People's Liberation Army of China	Fuzhou	Fujian
China	The First Affiliated Hospital of Fujian Medical University	Fuzhou	Fujian
China	Guangdong General Hospital	Guangzhou	Guangdong
China	Sun Yat-sen Memorial Hospital, Sun Yat-sen University	Guangzhou	Guangdong
China	The First Affiliated Hospital, Sun Yat-sen University	Guangzhou	Guangdong
China	Affiliated Hospital of Guizhou Medical University	Guiyang	Guizhou
China	The Fourth Affiliated Hospital of Harbin Medical University	Haerbin	Heilongjiang
China	Hainan General Hospital	Haikou	Hainan
China	Jinan Central Hospital	Jinan	Shandong
China	Qilu Hospital of Shandong University	Jinan	Shandong
China	Jingzhou Central Hospital	Jingzhou	Hubei
China	The First Affiliated Hospital of Jinzhou Medical University	Jinzhou	Liaoning
China	Lanzhou University Second Hospital	Lanzhou	Gansu
China	The First Hospital of Lanzhou University City:Lanzhou	Lanzhou	Gansu
China	The First Affiliated Hospital of Henan University of Science and Technology	Luoyang	Henan
China	The First Hospital of Nanchang	Nanchang	Jiangxi
China	The Second Affiliated Hospital of Nanchang University	Nanchang	Jiangxi
China	Zhongda Hospital Southeast Universty	Nanjing	Jiangsu
China	The People's Hospital of Guangxi Zhuang Autonomous Region	Nanning	Guangxi
China	Huashan Hospital Affiliated to Fudan University	Shanghai	Shanghai
China	Ruijin Hospital, Shanghai Jiao Tong University School of Medicine	Shanghai	Shanghai
China	Shanghai Changhai Hospital	Shanghai	Shanghai
China	Shanghai East Hospital	Shanghai	Shanghai
China	General Hospital of the PLA Northern Theater Command	Shenyang	Liaoning
China	The People's Hospital of Liaoning Provincial	Shenyang	Liaoning
China	Peking University Shenzhen Hospital	Shenzhen	Guangdong
China	The First Hospital of Hebei Medical University	Shijiazhuang	Hebei
China	The Second Hospital of Hebei Medical University	Shijiazhuang	Hebei
China	First Hospital of Shanxi Medical University	Taiyuan	Shanxi
China	Shanxi Provincial People's Hospital	Taiyuan	Shanxi
China	Taizhou Hospital of Zhejiang Province	Taizhou	Zhejiang
China	Teda International Cardiovascular Hospital	Tianjin	Tianjin
China	Tianjin First Central Hospital	Tianjin	Tianjin
China	Tianjin People's Hospital	Tianjin	Tianjin
China	The First Affiliated Hospital of Wenzhou Medical University	Wenzhou	Zhejiang
China	Tongji Hospital Affiliated to Tongji Medical College of Huazhong University of Science and Technology	Wuhan	Hubei
China	The First Affiliated Hospital of the Air Force Medical University	Xian	Shanxi
China	The Second Affiliated Hospital of Xi'an Jiaotong University	Xian	Shanxi
China	Xianyang Hospital of Yan 'an University	Xianyang	Shanxi
China	Affiliated Hospital of Xuzhou Medical University	Xuzhou	Jiangsu
China	Northern Jiangsu People's Hospital	Yangzhou	Jiangsu
China	The First Affiliated Hospital of Zhengzhou University	Zhengzhou	Henan

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
Primary	Change in LDL-C of JS002	Percentage change in LDL-C relative to baseline at Week 24	Up to 24Weeks after dose administration
Secondary	Change in LDL-C of JS002	Percentage change in LDL-C relative to baseline at Week 52	Up to 52Weeks after dose administration
Secondary	Other lipid parameters of JS002	Percentage change in LDL-C relative to baseline at Week 24 and Week 52	Up to Week 24 and 52Weeks after dose administration
Secondary	The occurrence of adverse events	Evaluate the change of clinically significant laboratory tests, vital signs, and electrocardiogram	Up 60Weeks after dose administration
Secondary	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).	Up 60Weeks after dose administration
Secondary	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).	Up 60Weeks after dose administration
Secondary	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).	Up 60Weeks after dose administration