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

Hyperlipemia Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05532800
• Other study ID #: JS002-006
• Status: Completed
• Phase: Phase 3
• Start date: February 28, 2022
• Est. completion date: February 9, 2023

Study information

• Verified date: March 2023
• 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 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 255
• Est. completion date: February 9, 2023
• Est. primary completion date: February 9, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Hypercholesterolemia
• Hyperlipemia
• Hyperlipidemia, Familial Combined
• Hyperlipidemias
• Hyperlipoproteinemias

Intervention

Drug:
• JS002
JS002:150mg(1mL) Q2W PFS, Placebo: 1mL Q2W PFS.
• Placebo
JS002:150mg(1mL) Q2W AI, Placebo: 1mL Q2W AI.

Locations

Country	Name	City	State
China	Beijing Anzhen Hospital,Capital Medical University	Beijing	Beijing
China	China-Japan Friendship Hospital	Beijing	Beijing
China	Peking University Third Hospital	Beijing	Beijing
China	The First Hospital of Jilin University	Changchun	Jilin
China	The Second Xiangya Hospital Of Central South University	Changsha	Hunan
China	Changzhou Second People's Hospital	Changzhou	Jiangsu
China	Dalian Municipal Central Hospital	Dalian	Liaoning
China	Daqing People's Hospital	Daqing	Heilongjiang
China	The First Affiliated Hospital of Fujian Medical University	Fuzhou	Fujian
China	The Fourth Affiliated Hospital of Harbin Medical University	Harbin	Heilongjiang
China	Jingzhou Central Hospital	Jingzhou	Hubei
China	The First Affiliated Hospital of Jinzhou Medical University	Jinzhou	Liaoning
China	Nanchang First Hospital	Nanchang	Jiangxi
China	Nanchang Third Hospital	Nanchang	Jiangxi
China	The Second Affiliated Hospital of Nanchang University	Nanchang	Jiangxi
China	Taizhou Hospital Of Zhejiang Province	Taizhou	Zhejiang
China	Tianjin People's Hospital	Tianjin	Tianjin
China	The First Affiliated Hospital of Wenzhou Medical University	Wenzhou	Zhejiang
China	Xianyang Hospital of Yan'an University	Xianyang	Shanxi
China	Affiliated Hospital of Xuzhou Medical University	Xuzhou	Jiangsu
China	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	LDL-C with JS002 PFS	Percentage change in LDL-C relative to baseline at Week 12 with JS002 PFS	at week 12
Primary	LDL-C with JS002 AI	Percentage change in LDL-C relative to baseline at Week 12 with JS002 AI	at week 12
Secondary	LDL-C with JS002 PFS	The absolute change in LDL-C relative to baseline with JS002 PFS	at week 12
Secondary	LDL-C with JS002 AI	The absolute change in LDL-C relative to baseline with JS002 AI	at week 12
Secondary	lipid parameters	Percentages and absolute change in other lipid parameters to baseline with JS002 PFS and JS002 AI	at week 12
Secondary	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	at week 12
Secondary	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	at week 12
Secondary	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	at week 12
Secondary	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	at week 12
Secondary	full dose	Proportion of subjects receiving full dose of JS002 AI during treatment (weeks 0, 2, 4, 6, 8, 10)	at week 0, 2, 4, 6, 8, 10