A Study to Evaluate the Efficacy and Safety of JS002 in Patients With Heterozygous Familial Hypercholesterolemia (HeFH).
NCT ID: NCT05325203
Last Updated: 2024-03-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE3
135 participants
INTERVENTIONAL
2021-12-31
2023-06-29
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Safety and Efficacy of IBI306 in HeFH Patients
NCT04179669
Liver Test Study of Using JKB-122 in Autoimmune Hepatitis (AIH) Patients Who Are Refractory or Intolerant to Current Therapies
NCT02556372
Trial of JYB1904 in Chronic Spontaneous Urticaria.
NCT06509334
Effect of JKB-122 on Prednisolone and Azathioprine Induced Remission in Autoimmune Hepatitis (AIH)
NCT04371718
Study of TJ003234 (Anti-GM-CSF Monoclonal Antibody) in Healthy Adult Subjects
NCT03794180
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
treatment cohorts: JS002 150mg Cohort:JS002 150mg or placebo treatment(JS002 :Placebo=2:1) Q2W JS002 450mg Cohort:JS002 450mg or placebo treatment(JS002 :Placebo=2:1)Q4W
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
JS002 150mg Q2W for 24 weeks
40 patients will be enrolled in this arm
Ongericimab
Administered by subcutaneous injection
placebo 150mg Q2W for 24 weeks
20 patients will be enrolled in this arm
Placebo
Administered by subcutaneous injection
JS002 450mg Q4W for 24 weeks
40 patients will be enrolled in this arm
Ongericimab
Administered by subcutaneous injection
placebo 450mg Q4W for 24 weeks
20 patients will be enrolled in this arm
Placebo
Administered by subcutaneous injection
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Ongericimab
Administered by subcutaneous injection
Placebo
Administered by subcutaneous injection
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
2. Males and females ≥ 18 to ≤ 80 years of age
3. DLCN\>8 in HeFH
4. Stable lipid-lowering therapies for at least 4 weeks
5. Patients with ASCVD LDL cholesterol≥1.4mmol/L at screening Patients without ASCVD LDL cholesterol≥2.6mmol/L at screening
6. Triglyceride≤4.5 mmol/L（400 mg/dL）;
Exclusion Criteria
2. New York Heart Association (NYHA) class III or IV or last known left ventricular ejection fraction \< 30%
3. History of uncontrolled arrhythmia within 90 days
4. Myocardial infarction, unstable angina, percutaneous coronary intervention (PCI), coronary artery bypass graft (CABG) or stroke within 90 days of randomization
5. Planned cardiac surgery or revascularization.
6. Uncontrolled diabetes mellitius (HbA1c\>8.0%）.
7. Uncontrolled hypertension.
8. Other conditions that the researchers considered inappropriate to participate in the study.
18 Years
80 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Shanghai Junshi Bioscience Co., Ltd.
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Beijing Anzhen Hospital Capital Medical University City:Beijing
Beijing, Beijing Municipality, China
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
JS002-005
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.