To Evaluate the Efficacy and Safety of JS002 in HoFH Patients

• Status: Recruiting
• Trial end date: 2022-07-29
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Shanghai Junshi Bioscience Co., Ltd.

Criteria

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.