To Evaluate the Efficacy and Safety of JS002 in HoFH Patients

NCT04515927 | Completed Phase 2

• 1 other identifier: JS002-004
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 1

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.

Conditions

Hyperlipemia

Outcome Measures

Primary Outcomes (1)

• The primary endpoint of effectiveness

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

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

Study Arms (1)

subcutaneous injection of JS002, 450mg, Q4W, 3/13 times.

EXPERIMENTAL

Drug: JS002

Interventions

JS002 DRUG

Biological: JS002 Administered by subcutaneous injection

subcutaneous injection of JS002, 450mg, Q4W, 3/13 times.

Eligibility Criteria

• Age: 12 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Signed informed consent.
• Age ≥12 and ≤75 years old;
• Weight ≥40kg at the time of screening
• Patients diagnosed with HoFH
• Low-density lipoprotein cholesterol (LDL-C) level ≥3.4mmol/L at the time of screening
• Fasting triglycerides ≤4.5 mmol/L;

You may not qualify if:

• History of NYHA class III-IV heart failure or EF\<30%
• History of uncontrolled arrhythmia within 3 months
• History of MI,UA, PCI or CABG, stroke within 3 months.
• History of DVT or pulmonary embolism within 3 months.
• Planned cardiac surgery or revascularization.
• Uncontrolled hypertension.
• Uncontrolled diabetes mellitius (HbA1c\>8.0%）.
• Other conditions that the researchers considered inappropriate to participate in the study.

Sponsors & Collaborators

• Shanghai Junshi Bioscience Co., Ltd.: lead

Study Sites (1)

Beijing Anzhen Hospital Capital Medical University

Beijing, Beijing Municipality, China

Location

MeSH Terms

Conditions

Hyperlipidemias

Condition Hierarchy (Ancestors)

Dyslipidemias; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 11, 2020
• First Posted: August 17, 2020
• Study Start: August 17, 2020
• Primary Completion: May 6, 2022
• Study Completion: July 29, 2022
• Last Updated: July 24, 2024

Record last verified: 2024-07

Locations

CN (1)