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Completed

NCT Number: NCT04781114

The Safety and Efficacy of Multiple-dose of JS002 in Subject With Hyperlipidemia

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.

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

The First Affiliated Hospital of Bengbu Medical College, Bengbu, Anhui, China

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

  • Males and females ≥ 18 and ≤ 80 years of age;
  • 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)
  • Fasting triglycerides ≤4.5 mmol/L;

Exclusion criteria

  • Known HoFH;
  • History of NYHA class III-IV heart failure;
  • History of uncontrolled arrhythmia, Unstable angina,MI, PCI,CABG, DVT or pulmonary embolism within 3 months.
  • Uncontrolled hypertension.
  • Uncontrolled diabetes mellitius (HbA1c>8.0%).
  • Other conditions that investigators considered inappropriate to participate in the study.

Treatment and study plan

JS002

Drug

JS002: 150mg(1mL) Q2W; Placebo 1mL Q2W.

Placebo

Drug

JS002: 300mg(2mL) Q4W; Placebo 2mL Q4W.

Primary outcomes

  1. Change in LDL-C of JS002

    Time frame: Up to 24Weeks after dose administration

    Percentage change in LDL-C relative to baseline at Week 24

Secondary outcomes

  1. Change in LDL-C of JS002

    Time frame: Up to 52Weeks after dose administration

    Percentage change in LDL-C relative to baseline at Week 52

  2. Other lipid parameters of JS002

    Time frame: Up to Week 24 and 52Weeks after dose administration

    Percentage change in LDL-C relative to baseline at Week 24 and Week 52

  3. The occurrence of adverse events

    Time frame: Up 60Weeks after dose administration

    Evaluate the change of clinically significant laboratory tests, vital signs, and electrocardiogram

  4. The immunogenicity of JS002

    Time frame: Up 60Weeks after dose administration

    To evaluate the production time, duration and proportion of anti JS002 antibody (ADA).ADA positive samples are tested for titer and for neutralizing antibody (Nab).

  5. Pharmacokinetics (PK) of JS002

    Time frame: Up 60Weeks after dose administration

    Evaluation of Serum concentration of JS002.Descriptive statistics include mean (arithmetic mean and geometric mean), standard deviation (SD), coefficient of variation CV% (arithmetic coefficient and geometric coefficient of variation), Median (Median), minimum (Min) and maximum (Max).

  6. Pharmacokinetics (PD) of JS002

    Time frame: Up 60Weeks after dose administration

    Evaluation of serum concentrations of free/total PCSK9 and changes from baseline.Descriptive statistics include mean (arithmetic mean and geometric mean), standard deviation (SD), coefficient of variation CV% (arithmetic coefficient and geometric coefficient of variation), Median (Median), minimum (Min) and maximum (Max).

Sponsors and collaborators

Lead sponsor

Shanghai Junshi Bioscience Co., Ltd.

Other

Registry information

Official study 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

Important dates

Study start
2020
Primary completion
2022
Study completion
2023
First posted
Mar 4, 2021
Registry last updated
Apr 19, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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