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

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

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.

Study Overview

• Status: Completed
• Conditions: Hyperlipemia
• Intervention / Treatment: Drug: JS002; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 255
• Phase: Phase 3

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100191
      • Peking University Third Hospital
    • Beijing, Beijing, China, 100029
      • Beijing Anzhen Hospital，Capital Medical University
    • Beijing, Beijing, China, 100192
      • China-Japan Friendship Hospital
  • Fujian
    • Fuzhou, Fujian, China, 350005
      • The First Affiliated Hospital of Fujian Medical University
  • Heilongjiang
    • Daqing, Heilongjiang, China, 163711
      • Daqing People's Hospital
    • Harbin, Heilongjiang, China, 150001
      • The Fourth Affiliated Hospital of Harbin Medical University
  • Henan
    • Zhengzhou, Henan, China, 450052
      • First Affiliated Hospital of Zhengzhou University
  • Hubei
    • Jingzhou, Hubei, China, 434020
      • Jingzhou Central Hospital
  • Hunan
    • Changsha, Hunan, China, 410008
      • The second Xiangya hospital of central south university
  • Jiangsu
    • Changzhou, Jiangsu, China, 213004
      • Changzhou Second People's Hospital
    • Xuzhou, Jiangsu, China, 221004
      • Affiliated Hospital of Xuzhou Medical University
  • Jiangxi
    • Nanchang, Jiangxi, China, 330008
      • The Second Affiliated Hospital of Nanchang University
    • Nanchang, Jiangxi, China, 330008
      • Nanchang First Hospital
    • Nanchang, Jiangxi, China, 330008
      • Nanchang Third Hospital
  • Jilin
    • Changchun, Jilin, China, 130061
      • The First Hospital of Jilin University
  • Liaoning
    • Dalian, Liaoning, China, 116089
      • Dalian Municipal Central Hospital
    • Jinzhou, Liaoning, China, 121011
      • The First Affiliated Hospital of Jinzhou Medical University
  • Shanxi
    • Xianyang, Shanxi, China, 716099
      • Xianyang Hospital of Yan'an University
  • Tianjin
    • Tianjin, Tianjin, China, 300122
      • Tianjin People's Hospital
  • Zhejiang
    • Taizhou, Zhejiang, China, 317000
      • Taizhou Hospital of Zhejiang Province
    • Wenzhou, Zhejiang, China, 325015
      • The First Affiliated Hospital of Wenzhou Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: JS002; Cobort 1:150 mg/1mL Q2W PFS,Cobort 2:150 mg/1mL Q2W AI	Drug: JS002; JS002:150mg(1mL) Q2W PFS, Placebo: 1mL Q2W PFS.
Placebo Comparator: Placebo; Cobort 1:/1mL Q2W PFS,Cobort 2:1mL Q2W AI	Drug: Placebo; JS002:150mg(1mL) Q2W AI, Placebo: 1mL Q2W AI.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
LDL-C with JS002 PFS	Percentage change in LDL-C relative to baseline at Week 12 with JS002 PFS	at week 12
LDL-C with JS002 AI	Percentage change in LDL-C relative to baseline at Week 12 with JS002 AI	at week 12

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
LDL-C with JS002 PFS	The absolute change in LDL-C relative to baseline with JS002 PFS	at week 12
LDL-C with JS002 AI	The absolute change in LDL-C relative to baseline with JS002 AI	at week 12
lipid parameters	Percentages and absolute change in other lipid parameters to baseline with JS002 PFS and JS002 AI	at week 12
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
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
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
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
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

Collaborators and Investigators

• Sponsor: Shanghai Junshi Bioscience Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): February 28, 2022
• Primary Completion (Actual): February 9, 2023
• Study Completion (Actual): February 9, 2023

Study Registration Dates

• First Submitted: September 5, 2022
• First Submitted That Met QC Criteria: September 5, 2022
• First Posted (Actual): September 8, 2022

Study Record Updates

• Last Update Posted (Actual): March 15, 2023
• Last Update Submitted That Met QC Criteria: March 14, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Metabolic Diseases; Genetic Diseases, Inborn; Metabolism, Inborn Errors; Lipid Metabolism Disorders; Dyslipidemias; Lipid Metabolism, Inborn Errors; Hypercholesterolemia; Hyperlipidemias; Hyperlipoproteinemias; Hyperlipidemia, Familial Combined
• Other Study ID Numbers: JS002-006

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No