To Evaluate the Efficacy and Safety of JS002 in HoFH Patients

Phase 2

Completed

• Conditions: Hyperlipemia
• Interventions: Drug: JS002

• Registration Number: NCT04515927
• Lead Sponsor: Shanghai Junshi Bioscience Co., Ltd.

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-08-11
• Study First Submitted QC: 2020-08-11
• Study Start: 2020-08-17
• Study First Posted: 2020-08-17
• Primary Completion: 2022-05-06
• Study Completion: 2022-07-29
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-23
• Last Update Posted: 2024-07-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 31

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
subcutaneous injection of JS002, 450mg, Q4W, 3/13 times.	JS002	-

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Beijing Anzhen Hospital Capital Medical University; 🇨🇳 Beijing, Beijing, China