To Evaluate the Efficacy and Safety of JS002 in HoFH Patients

Shanghai Junshi Bioscience Co., Ltd.31 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Hyperlipemia

Interventions

JS002DRUG

Biological: JS002 Administered by subcutaneous injection

Eligibility

Sex: ALLMin age: 12 YearsMax age: 75 Years

Medical Language ↔ Plain English

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.

Locations (1)

Beijing Anzhen Hospital Capital Medical University

Beijing, Beijing Municipality, China

Outcomes

Primary Outcomes

The primary endpoint of effectiveness

Percent Change From Baseline in Low-Density Lipoprotein Cholesterol (LDL-C) at Week 12

Time frame: JS002 is administered subcutaneously every 4 weeks, from 12 or 52 weeks after initial administration

Data from ClinicalTrials.gov

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