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OpenTrials
Completed

NCT Number: NCT04515927

To Evaluate the Efficacy and Safety of JS002 in HoFH Patients

JS002 is a recombinant human anti-PCSK9 monoclonal antibody. This phase II open-label, single-arm study aims to evaluate the efficacy and safety of JS002 in patients with homozygous familial hypercholesterolemia A dose group (450 mg) was set up in this study.Thirty subjects are planned to be enrolled.

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

Conditions

Hyperlipemia Dyslipidemias Hyperlipidemias Lipid Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

12 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Beijing Anzhen Hospital Capital Medical University

Beijing, Beijing Municipality, China

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Signed informed consent.
  • Age ≥12 and ≤75 years old;
  • Weight ≥40kg at the time of screening
  • Patients diagnosed with HoFH
  • Low-density lipoprotein cholesterol (LDL-C) level ≥3.4mmol/L at the time of screening
  • Fasting triglycerides ≤4.5 mmol/L;

Exclusion criteria

  • History of NYHA class III-IV heart failure or EF<30%
  • History of uncontrolled arrhythmia within 3 months
  • History of MI,UA, PCI or CABG, stroke within 3 months.
  • History of DVT or pulmonary embolism within 3 months.
  • Planned cardiac surgery or revascularization.
  • Uncontrolled hypertension.
  • Uncontrolled diabetes mellitius (HbA1c>8.0%）.
  • Other conditions that the researchers considered inappropriate to participate in the study.

Treatment and study plan

JS002

Drug

Biological: JS002 Administered by subcutaneous injection

Primary outcomes

  1. The primary endpoint of effectiveness

    Time frame: JS002 is administered subcutaneously every 4 weeks, from 12 or 52 weeks after initial administration

    Percent Change From Baseline in Low-Density Lipoprotein Cholesterol (LDL-C) at Week 12

Sponsors and collaborators

Lead sponsor

Shanghai Junshi Bioscience Co., Ltd.

Other

Registry information

Official study title

An Open-label, Single-arm Study Evaluated the Efficacy and Safety of JS002 in Patients With Homozygous Familial Hypercholesterolemia

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Aug 17, 2020
Registry last updated
Jul 24, 2024

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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