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NCT Number: NCT05621070

Efficacy and Safety of JS002 as Monotherapy in Patients With Primary Hypercholesterolaemia and Mixed Dyslipidemia

JS002 is a recombinant humanized anti-PCSK9 monoclonal antibody. This is a randomized, double-blind, placebo-controlled study to evaluate the efficacy, safety, PK/PD profile, immunogenicity as well as complete delivery of auto-injector by patients of JS002 as monotherapy in patients with primary hypercholesterolaemia and mixed dyslipidemia.

In this study, two dose cohorts(150 mg, 450 mg) are set up, and 582 subjects are planned to be enrolled (randomizedly assigned to JS002 or placebo 150/450 mg group in a 2:1:2:1 ratio).A screening period (≤6 weeks), a double-blind treatment period (12 weeks), an open-label treatment period (40 weeks), and a follow-up period (8 weeks) will be required.

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Key information

Conditions

Primary Hypercholesterolaemia and Mixed Dyslipidemia

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Peking University Third Hospital

Beijing, Beijing Municipality, 100191, China

Location status: Recruiting

Location contact

Yida Tang, Doctor

CONTACT

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Signed informed consent
  • Age 18~80 years old
  • Subject who has not achieve LDL-C goal as categorized by their CV risk at screening
  • Fasting TG≤4.5mmol/L by central laboratory at screening
  • Statin intolerance subject must have a history of statin intolerance as evidenced

Exclusion criteria

  • History of hemorrhagic stroke
  • NYHA III or IV heart failure, or known LVEF< 30% within 1 year before randomization
  • Uncontrolled serious cardiac arrhythmia defined as recurrent and highly symptomatic ventricular tachycardia, atrial fibrillation with rapid ventricular response, or supraventricular tachycardia that are not controlled by medications, within 90 days prior to randomization
  • Myocardial infarction, unstable angina, percutaneous coronary intervention (PCI), coronary artery bypass graft (CABG) or stroke, deep vein thrombosis or pulmonary embolism within 90 days prior to randomization
  • Planned cardiac surgery or revascularization
  • Uncontrolled hypertension defined as sitting systolic blood pressure(SBP) > 160 mmHg or diastolic BP (DBP) > 100 mmHg
  • Type 1 diabetes, poorly controlled type 2 diabetes (HbA1c > 8%), newly diagnosed type 2 diabetes (within 90 days of randomization)
  • Others factors not suitable for participation judged by PI

Treatment and study plan

JS002

Drug

JS002 will be administered per auto-injector. Participants will receive JS002 every 2 weeks subcutaneously.

Placebo

Drug

Placebo will be administered per auto-injector. Participants will receive placebo every 2 weeks subcutaneously.

Primary outcomes

  1. Percent Change From Baseline in LDL-C at Week 12

    Time frame: Baseline and week 12

    Percent Change From Baseline in LDL-C at Week 12 in statin intolerance subjects

  2. Percent Change From Baseline in LDL-C at Week 12

    Time frame: Baseline and week 12

    Percent Change From Baseline in LDL-C at Week 12 in ITT subjects

Secondary outcomes

  1. Change From Baseline in LDL-C at Week 12

    Time frame: Baseline and week 12

    Change From Baseline in LDL-C at Week 12 in statin intolerance and ITT subjects

  2. Percent Change From Baseline in LDL-C at Week 24,52

    Time frame: Baseline and week 24,52

    Percent Change From Baseline in LDL-C at Week 24,52 in statin intolerance and ITT subjects

  3. Change From Baseline in LDL-C at Week 24,52

    Time frame: Baseline and week 24,52

    Change From Baseline in LDL-C at Week 24,52 in statin intolerance and ITT subjects

  4. Percent Change From Baseline in other lipid parameters such as non-HDL-C, ApoB, TC, et al. at Week 12, 24, 52

    Time frame: Baseline and week 12, 24, 52

    Percent Change From Baseline in other lipid parameters at Week 12, 24, 52 in statin intolerance and ITT subjects

  5. Percentage of Participants With LDL-C Less Than 1.8 mmol/L(70 mg/dL)

    Time frame: Baseline and week 12, 24, 52

    Percentage of Participants With LDL-C Less Than 1.8 mmol/L(70 mg/dL) at Week 12, 24, 52 in statin intolerance and ITT subjects

  6. Percentage of Participants With Full Administration of JS002

    Time frame: Baseline and week 12, 24, 52

    Percentage of Participants With Full Administration of JS002 at Weeks 12, 24, 52 in statin intolerance and ITT subjects

Other outcomes

  1. Number of Participants with anti-drug antibodies (ADAs)

    Time frame: From baseline to week 60

    Serum samples were analyzed for ADA. Positive samples were subsequently tested for neutralizing antibodies.

Study contacts

Contact information is provided by the study sponsor or research team.

Qiu'e Wan, PM

CONTACT

[email protected]

86 17710342522

Sponsors and collaborators

Lead sponsor

Shanghai Junshi Bioscience Co., Ltd.

Other

Registry information

Official study title

A Double-blind, Randomized, Placebo-controlled, Multicenter Study to Evaluate Efficacy and Safety of JS002 as Monotherapy in Patients With Primary Hypercholesterolaemia and Mixed Dyslipidemia

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Nov 17, 2022
Registry last updated
Sep 19, 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.