Hyperlipemia
Conditions
Brief summary
JS002 is a recombinant human anti-PCSK9 monoclonal antibody. This phase II open-label, single-arm study aims to evaluate the efficacy and safety of JS002 in patients with homozygous familial hypercholesterolemia A dose group (450 mg) was set up in this study.Thirty subjects are planned to be enrolled. Each subject required a maximum of 6 weeks of screening, 52 weeks of treatment, and 8 weeks of follow-up.
Interventions
DRUGJS002
Biological: JS002 Administered by subcutaneous injection
Sponsors
Shanghai Junshi Bioscience Co., Ltd.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
12 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. Signed informed consent. 2. Age ≥12 and ≤75 years old; 3. Weight ≥40kg at the time of screening 4. Patients diagnosed with HoFH 5. Low-density lipoprotein cholesterol (LDL-C) level ≥3.4mmol/L at the time of screening 6. Fasting triglycerides ≤4.5 mmol/L;
Exclusion criteria
1. History of NYHA class III-IV heart failure or EF\<30% 2. History of uncontrolled arrhythmia within 3 months 3. History of MI,UA, PCI or CABG, stroke within 3 months. 4. History of DVT or pulmonary embolism within 3 months. 5. Planned cardiac surgery or revascularization. 6. Uncontrolled hypertension. 7. Uncontrolled diabetes mellitius (HbA1c\>8.0%）. 8. Other conditions that the researchers considered inappropriate to participate in the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The primary endpoint of effectiveness | JS002 is administered subcutaneously every 4 weeks, from 12 or 52 weeks after initial administration | Percent Change From Baseline in Low-Density Lipoprotein Cholesterol (LDL-C) at Week 12 |
Countries
China
Outcome results
None listed