Clinical trial NCT05621070: Efficacy and Safety of JS002 as Monotherapy in Patients With Primary Hypercholesterolaemia and Mixed Dyslipidemia
Official 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Primary Hypercholesterolaemia and Mixed Dyslipidemia
Lead sponsor: Shanghai Junshi Bioscience Co., Ltd.
Sponsor class: OTHER
First posted: 2022-11-17
Enrollment: 582
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Primary outcomes:
measure: Percent Change From Baseline in LDL-C at Week 12
timeFrame: Baseline and week 12
measure: Percent Change From Baseline in LDL-C at Week 12
timeFrame: Baseline and week 12
Secondary outcomes:
measure: Change From Baseline in LDL-C at Week 12
timeFrame: Baseline and week 12
measure: Percent Change From Baseline in LDL-C at Week 24,52
timeFrame: Baseline and week 24,52
measure: Change From Baseline in LDL-C at Week 24,52
timeFrame: Baseline and week 24,52
measure: Percent Change From Baseline in other lipid parameters such as non-HDL-C, ApoB, TC, et al. at Week 12, 24, 52
timeFrame: Baseline and week 12, 24, 52
measure: Percentage of Participants With LDL-C Less Than 1.8 mmol/L(70 mg/dL)
timeFrame: Baseline and week 12, 24, 52
measure: Percentage of Participants With Full Administration of JS002
timeFrame: Baseline and week 12, 24, 52
Other outcomes:
measure: Number of Participants with anti-drug antibodies (ADAs)
timeFrame: From baseline to week 60
Locations:
city: Beijing
country: China
facility: Peking University Third Hospital
state: Beijing
Study officials:
References: