NCT05325203

Brief Summary

JS002 is a recombinant human anti-PCSK9 monoclonal antibody.The study is a multicenter, randomized, double-blind, placebo-controlled Phase III clinical study in Chinese patients with heterozygous familial hypercholesterolemia (HeFH). Objective To evaluate the efficacy and safety of JS002 150 mg (Q2W) and 450 mg (Q4W) subcutaneous injection (SC).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
135

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Dec 2021

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 31, 2021

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

February 8, 2022

Completed
2 months until next milestone

First Posted

Study publicly available on registry

April 13, 2022

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 8, 2023

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 29, 2023

Completed
Last Updated

March 18, 2024

Status Verified

February 1, 2022

Enrollment Period

1.4 years

First QC Date

February 8, 2022

Last Update Submit

March 14, 2024

Conditions

Heterozygous Familial Hypercholesterolemia

Outcome Measures

Primary Outcomes (1)

  • Percent Change From Baseline in Low-Density Lipoprotein Cholesterol (LDL-C) at Week 24

    LDL-C was quantified using the enzymatic colorimetric assay

    Baseline and week 24

Secondary Outcomes (18)

  • Absolute Change From Baseline in Low-Density Lipoprotein Cholesterol (LDL-C) at Week 24

    Baseline and Week 24

  • Percentage changes From Baseline in the Total Cholesterol at week 24

    Baseline and Week 24

  • Absolute changes From Baseline in the Total Cholesterol at week 24

    Baseline and Week 24

  • Percentage changes From Baseline in Non-HDL-C at Week 24

    Baseline and Week 24

  • Absolute changes From Baseline in Non-HDL-C at Week 24

    Baseline and Week 24

  • +13 more secondary outcomes

Other Outcomes (1)

  • Number of subjects who develop detectable anti-drug antibodies (ADAs)

    from baseline to 32 weeks

Study Arms (4)

JS002 150mg Q2W for 24 weeks

EXPERIMENTAL

40 patients will be enrolled in this arm

Biological: Ongericimab

placebo 150mg Q2W for 24 weeks

PLACEBO COMPARATOR

20 patients will be enrolled in this arm

Drug: Placebo

JS002 450mg Q4W for 24 weeks

EXPERIMENTAL

40 patients will be enrolled in this arm

Biological: Ongericimab

placebo 450mg Q4W for 24 weeks

PLACEBO COMPARATOR

20 patients will be enrolled in this arm

Drug: Placebo

Interventions

OngericimabBIOLOGICAL

Administered by subcutaneous injection

Also known as: JS002
JS002 150mg Q2W for 24 weeksJS002 450mg Q4W for 24 weeks
PlaceboDRUG

Administered by subcutaneous injection

placebo 150mg Q2W for 24 weeksplacebo 450mg Q4W for 24 weeks

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Signed informed consent.
  • Males and females ≥ 18 to ≤ 80 years of age
  • DLCN\>8 in HeFH
  • Stable lipid-lowering therapies for at least 4 weeks
  • Patients with ASCVD LDL cholesterol≥1.4mmol/L at screening Patients without ASCVD LDL cholesterol≥2.6mmol/L at screening
  • Triglyceride≤4.5 mmol/L（400 mg/dL）;

You may not qualify if:

  • HoFH or meet the diagnostic criteria of HoFH
  • New York Heart Association (NYHA) class III or IV or last known left ventricular ejection fraction \< 30%
  • History of uncontrolled arrhythmia within 90 days
  • Myocardial infarction, unstable angina, percutaneous coronary intervention (PCI), coronary artery bypass graft (CABG) or stroke within 90 days of randomization
  • Planned cardiac surgery or revascularization.
  • Uncontrolled diabetes mellitius (HbA1c\>8.0%）.
  • Uncontrolled hypertension.
  • Other conditions that the researchers considered inappropriate to participate in the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Beijing Anzhen Hospital Capital Medical University City:Beijing

Beijing, Beijing Municipality, 100020, China

Location

Related Publications (1)

  • Lin J, Ji Y, Wang G, Ma X, Yao Z, Han X, Chen J, Chen J, Huang W, Xu G, Peng D, Yan P, Qiao P, He Y, Tang Y, Wang M, Zhang M, Yu J, Hao Y, Ma C. Efficacy and safety of ongericimab in Chinese patients with heterozygous familial hypercholesterolemia: A randomized, double-blind, placebo-controlled phase 3 trial. Atherosclerosis. 2025 Apr;403:119120. doi: 10.1016/j.atherosclerosis.2025.119120. Epub 2025 Jan 29.

    PMID: 39999660DERIVED

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 8, 2022

First Posted

April 13, 2022

Study Start

December 31, 2021

Primary Completion

May 8, 2023

Study Completion

June 29, 2023

Last Updated

March 18, 2024

Record last verified: 2022-02

Locations

CN(1)