NCT05621070 Efficacy and Safety of JS002 as Monotherapy in Patients With Primary Hypercholesterolaemia and Mixed Dyslipidemia
| NCT ID | NCT05621070 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Shanghai Junshi Bioscience Co., Ltd. |
| Condition | Primary Hypercholesterolaemia and Mixed Dyslipidemia |
| Study Type | INTERVENTIONAL |
| Enrollment | 582 participants |
| Start Date | 2023-02-03 |
| Primary Completion | 2024-09-23 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 582 participants in total. It began in 2023-02-03 with a primary completion date of 2024-09-23.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
Inclusion Criteria: 1. Signed informed consent 2. Age 18\~80 years old 3. Subject who has not achieve LDL-C goal as categorized by their CV risk at screening 4. Fasting TG≤4.5mmol/L by central laboratory at screening 5. Statin intolerance subject must have a history of statin intolerance as evidenced Exclusion Criteria: 1. History of hemorrhagic stroke 2. NYHA III or IV heart failure, or known LVEF\< 30% within 1 year before randomization 3. 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 4. 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 5. Planned cardiac surgery or revascularization 6. Uncontrolled hypertension defined as sitting systolic blood pressure(SBP) \> 160 mmHg or diastolic BP (DBP) \> 100 mmHg 7. Type 1 diabetes, poorly controlled type 2 diabetes (HbA1c \> 8%), newly diagnosed type 2 diabetes (within 90 days of randomization) 8. Others factors not suitable for participation judged by PI
Contact & Investigator
Frequently Asked Questions
Who can join the NCT05621070 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 80 Years, studying Primary Hypercholesterolaemia and Mixed Dyslipidemia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05621070 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 582 participants.
Is NCT05621070 currently recruiting?
Yes, NCT05621070 is actively recruiting participants. Contact the research team at qiu.e_wan@junshipharma.com for enrollment information.
Where is the NCT05621070 trial being conducted?
This trial is being conducted at Beijing, China.
Who is sponsoring the NCT05621070 clinical trial?
NCT05621070 is sponsored by Shanghai Junshi Bioscience Co., Ltd.. The trial plans to enroll 582 participants.