A Study to Evaluate the Safety, Tolerability and Efficacy of Multiple Doses of JS002 in Patients With Hyperlipidemia..

A Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety, Tolerability and Efficacy, as Well as Immunogenecity, Pharmacokineticks and Pharmacodynamics of Multiple Doses of JS002 on Stable Statin Therapy in Patients With Hyperlipidemia.

JS002 is a recombinant humanized anti-PCSK9 monoclonal antibody.

Study Overview

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

• Study Type: Interventional
• Enrollment (Actual): 90
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• China
  • Beijing, China
    • Fuwai Hospital Chinese Academy of Medical Sciences

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Signed informed consent.
2. Age ≥18 and ≤65 years old;
3. Body mass index (BMI) ≥18 and ≤ 30 kg/m2;
4. Subjects who are receiving statin therapy at the time of screening or who are eligible for statin therapy can receive a stable dose of statin therapy for more than 28 days before randomization and are willing to maintain stable statin therapy during the study;
5. Low-density lipoprotein cholesterol (LDL-C) level ≥2.6mmol/L for subjects who are receiving statin and/or other lipid-lowering therapy at the time of screening, or LDL-C≥ 4.1mmol/L for subjects who didn't receive any-lowering therapy at the time of screening, and LDL-C still ≥2.6mmol/L before randomization;
6. Fasting triglycerides ≤4.5 mmol/L;

Exclusion Criteria:

1. Diagnosis of homozygous familial hypercholesterolemia;
2. History of New York heart association (NYHA) defined Ⅱ - Ⅳ heart failure;
3. History of uncontrolled arrhythmiast;
4. History of myocardial infarction, history of PTCA or PCI or CABG, history of unstable angina befor 90 days of randomization;
5. History of stroke or TIA；
6. Uncontrolled hypertension with SBP≥160mmHg and/or DBP≥100mmHg
7. Type 1 diabetes, or type 2 diabetes that is or poorly controlled（HbA1c> 8.0%);

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo; Participants received matching placebo dose regimens by subcutaneous injection.	Biological: Placebo; Administered by subcutaneous injection
Experimental: JS002; Participants received one of 3 dose regimens of JS002 administered as multiple subcutaneous doses.	Biological: Biological：JS002; Administered by subcutaneous injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Percent change from baseline in low-density lipoprotein cholesterol (LDL-C) to week 12	12 weeks after the first dose

Secondary Outcome Measures

Outcome Measure	Time Frame
Absolute value change from baseline in low-density lipoprotein cholesterol (LDL-C)	Twelve weeks after the last dose
Percent change from baseline in Total Cholesterol(TC、HDL-C、non-HDL-C、VLDL-C、Apo B、Apo A1、Lp(a) and TG )	Twelve weeks after the last dose
Percentage change from baseline TC/HDL-C ratio	Twelve weeks after the last dose
Percent change from baseline in Apolipoprotein B (Apo B)	Twelve weeks after the last dose
Percent change from baseline in Apolipoprotein A-I (ApoA-I)	Twelve weeks after the last dose

Other Outcome Measures

Outcome Measure	Time Frame
Number of subjects who develop detectable anti-drug antibodies (ADAs)	Twelve weeks after the last dose
Serum concentrations of JS002	Twelve weeks after the last dose
Change from baseline in proprotein convertase total / free pcsk9	Twelve weeks after the last dose

Collaborators and Investigators

• Sponsor: Shanghai Junshi Bioscience Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): May 23, 2019
• Primary Completion (Actual): May 3, 2020
• Study Completion (Actual): June 28, 2020

Study Registration Dates

• First Submitted: July 6, 2020
• First Submitted That Met QC Criteria: July 13, 2020
• First Posted (Actual): July 14, 2020

Study Record Updates

• Last Update Posted (Actual): July 14, 2020
• Last Update Submitted That Met QC Criteria: July 13, 2020
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Metabolic Diseases; Lipid Metabolism Disorders; Dyslipidemias; Hyperlipidemias; Hyperlipoproteinemias
• Other Study ID Numbers: JS002-002

Drug and device information, study documents

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