Clinical trial NCT05532800: 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
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hyperlipemia
Lead sponsor: Shanghai Junshi Bioscience Co., Ltd.
Sponsor class: OTHER
First posted: 2022-09-08
Enrollment: 255
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 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.


Eligibility criteria: 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.

Primary outcomes:
measure: LDL-C with JS002 PFS
timeFrame: at week 12
measure: LDL-C with JS002 AI
timeFrame: at week 12
Secondary outcomes:
measure: LDL-C with JS002 PFS
timeFrame: at week 12
measure: LDL-C with JS002 AI
timeFrame: at week 12
measure: lipid parameters
timeFrame: at week 12
measure: LDL-C reduction≥50 with JS002 PFS
timeFrame: at week 12
measure: LDL-C reduction≥50 with JS002 AI
timeFrame: at week 12
measure: LDL-C dropped to < 70 mg/dL with JS002 PFS
timeFrame: at week 12
measure: LDL-C dropped to < 70 mg/dL with JS002 AI
timeFrame: at week 12
measure: full dose
timeFrame: at week 0, 2, 4, 6, 8, 10
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Anzhen Hospital，Capital Medical University
state: Beijing
city: Beijing
country: China
facility: Peking University Third Hospital
state: Beijing
city: Beijing
country: China
facility: China-Japan Friendship Hospital
state: Beijing
city: Fuzhou
country: China
facility: The First Affiliated Hospital of Fujian Medical University
state: Fujian
city: Daqing
country: China
facility: Daqing People's Hospital
state: Heilongjiang
city: Harbin
country: China
facility: The Fourth Affiliated Hospital of Harbin Medical University
state: Heilongjiang
city: Zhengzhou
country: China
facility: First Affiliated Hospital of Zhengzhou University
state: Henan
city: Jingzhou
country: China
facility: Jingzhou Central Hospital
state: Hubei
city: Changsha
country: China
facility: The Second Xiangya Hospital Of Central South University
state: Hunan
city: Changzhou
country: China
facility: Changzhou Second People's Hospital
state: Jiangsu
city: Xuzhou
country: China
facility: Affiliated Hospital of Xuzhou Medical University
state: Jiangsu
city: Nanchang
country: China
facility: Nanchang First Hospital
state: Jiangxi
city: Nanchang
country: China
facility: Nanchang Third Hospital
state: Jiangxi
city: Nanchang
country: China
facility: The Second Affiliated Hospital of Nanchang University
state: Jiangxi
city: Changchun
country: China
facility: The First Hospital of Jilin University
state: Jilin
city: Dalian
country: China
facility: Dalian Municipal Central Hospital
state: Liaoning
city: Jinzhou
country: China
facility: The First Affiliated Hospital of Jinzhou Medical University
state: Liaoning
city: Xianyang
country: China
facility: Xianyang Hospital of Yan'an University
state: Shanxi
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: