Clinical trial NCT04781114: 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
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hyperlipemia
Lead sponsor: Shanghai Junshi Bioscience Co., Ltd.
Sponsor class: OTHER
First posted: 2021-03-04
Enrollment: 806
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

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.


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

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.

Primary outcomes:
measure: Change in LDL-C of JS002
timeFrame: Up to 24Weeks after dose administration
Secondary outcomes:
measure: Change in LDL-C of JS002
timeFrame: Up to 52Weeks after dose administration
measure: Other lipid parameters of JS002
timeFrame: Up to Week 24 and 52Weeks after dose administration
measure: The occurrence of adverse events
timeFrame: Up 60Weeks after dose administration
measure: The immunogenicity of JS002
timeFrame: Up 60Weeks after dose administration
measure: Pharmacokinetics (PK) of JS002
timeFrame: Up 60Weeks after dose administration
measure: Pharmacokinetics (PD) of JS002
timeFrame: Up 60Weeks after dose administration
Other outcomes:
Locations:
city: Bengbu
country: China
facility: The First Affiliated Hospital of Bengbu Medical College
state: Anhui
city: Beijing
country: China
facility: Beijing Anzhen Hospital, Capital Medical University
state: Beijing
city: Beijing
country: China
facility: Beijing Chaoyang Hospital, Capital Medical University
state: Beijing
city: Beijing
country: China
facility: Beijing Tongren Hospital Affiliated to Capital Medical University City:Beijing
state: Beijing
city: Beijing
country: China
facility: China-Japan Friendship Hospital
state: Beijing
city: Beijing
country: China
facility: Peking University Third Hospital
state: Beijing
city: Chongqing
country: China
facility: The Second Affiliated Hospital of Chongqing Medical University
state: Chongqing
city: Fuzhou
country: China
facility: The 900 Hospital of the Joint Service Support Force of the People's Liberation Army of China
state: Fujian
city: Fuzhou
country: China
facility: The First Affiliated Hospital of Fujian Medical University
state: Fujian
city: Lanzhou
country: China
facility: Lanzhou University Second Hospital
state: Gansu
city: Lanzhou
country: China
facility: The First Hospital of Lanzhou University City:Lanzhou
state: Gansu
city: Guangzhou
country: China
facility: Sun Yat-sen Memorial Hospital, Sun Yat-sen University
state: Guangdong
city: Guangzhou
country: China
facility: Guangdong General Hospital
state: Guangdong
city: Guangzhou
country: China
facility: The First Affiliated Hospital, Sun Yat-sen University
state: Guangdong
city: Shenzhen
country: China
facility: Peking University Shenzhen Hospital
state: Guangdong
city: Nanning
country: China
facility: The People's Hospital of Guangxi Zhuang Autonomous Region
state: Guangxi
city: Guiyang
country: China
facility: Affiliated Hospital of Guizhou Medical University
state: Guizhou
city: Haikou
country: China
facility: Hainan General Hospital
state: Hainan
city: Shijiazhuang
country: China
facility: The First Hospital of Hebei Medical University
state: Hebei
city: Shijiazhuang
country: China
facility: The Second Hospital of Hebei Medical University
state: Hebei
city: Daqing
country: China
facility: Daqingshi People's Hospital
state: Heilongjiang
city: Haerbin
country: China
facility: The Fourth Affiliated Hospital of Harbin Medical University
state: Heilongjiang
city: Luoyang
country: China
facility: The First Affiliated Hospital of Henan University of Science and Technology
state: Henan
city: Zhengzhou
country: China
facility: The First Affiliated Hospital of Zhengzhou University
state: Henan
city: Jingzhou
country: China
facility: Jingzhou Central Hospital
state: Hubei
city: Wuhan
country: China
facility: Tongji Hospital Affiliated to Tongji Medical College of Huazhong University of Science and Technology
state: Hubei
city: Changsha
country: China
facility: The Third Xiangya Hospital of Central South University
state: Hunan
city: Changsha
country: China
facility: The Second Xiangya Hospital of Central South University
state: Hunan
city: Changzhou
country: China
facility: The Second People's Hospital of Changzhou
state: Jiangsu
city: Nanjing
country: China
facility: Zhongda Hospital Southeast Universty
state: Jiangsu
city: Xuzhou
country: China
facility: Affiliated Hospital of Xuzhou Medical University
state: Jiangsu
city: Yangzhou
country: China
facility: Northern Jiangsu People's Hospital
state: Jiangsu
city: Nanchang
country: China
facility: The First Hospital of Nanchang
state: Jiangxi
city: Nanchang
country: China
facility: The Second Affiliated Hospital of Nanchang University
state: Jiangxi
city: Changchun
country: China
facility: First Hospital of Jilin University
state: Jilin
city: Changchun
country: China
facility: China-Japan Union Hospital of Jilin University
state: Jilin
city: Dalian
country: China
facility: The central hospital of Dalian
state: Liaoning
city: Jinzhou
country: China
facility: The First Affiliated Hospital of Jinzhou Medical University
state: Liaoning
city: Shenyang
country: China
facility: The People's Hospital of Liaoning Provincial
state: Liaoning
city: Shenyang
country: China
facility: General Hospital of the PLA Northern Theater Command
state: Liaoning
city: Jinan
country: China
facility: Jinan Central Hospital
state: Shandong
city: Jinan
country: China
facility: Qilu Hospital of Shandong University
state: Shandong
city: Shanghai
country: China
facility: Huashan Hospital Affiliated to Fudan University
state: Shanghai
city: Shanghai
country: China
facility: Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
state: Shanghai
city: Shanghai
country: China
facility: Shanghai Changhai Hospital
state: Shanghai
city: Shanghai
country: China
facility: Shanghai East Hospital
state: Shanghai
city: Taiyuan
country: China
facility: First Hospital of Shanxi Medical University
state: Shanxi
city: Taiyuan
country: China
facility: Shanxi Provincial People's Hospital
state: Shanxi
city: Xianyang
country: China
facility: Xianyang Hospital of Yan 'an University
state: Shanxi
city: Xian
country: China
facility: The First Affiliated Hospital of the Air Force Medical University
state: Shanxi
city: Xian
country: China
facility: The Second Affiliated Hospital of Xi'an Jiaotong University
state: Shanxi
city: Chengdu
country: China
facility: West China Hospital of Sichuan University
state: Sichuan
city: Tianjin
country: China
facility: Teda International Cardiovascular Hospital
state: Tianjin
city: Tianjin
country: China
facility: Tianjin First Central Hospital
state: Tianjin
city: Tianjin
country: China
facility: Tianjin People's Hospital
state: Tianjin
city: Taizhou
country: China
facility: Taizhou Hospital of Zhejiang Province
state: Zhejiang
city: Wenzhou
country: China
facility: The First Affiliated Hospital of Wenzhou Medical University
state: Zhejiang
Study officials:
References: