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To Evaluate the Efficacy and Safety of JS002 in HoFH Patients

Primary Purpose

Hyperlipemia

Status
Active
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
JS002
Sponsored by
Shanghai Junshi Bioscience Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hyperlipemia

Eligibility Criteria

12 Years - 75 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Beijing Anzhen Hospital Capital Medical University

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

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

Arm Description

Outcomes

Primary Outcome Measures

The primary endpoint of effectiveness
Percent Change From Baseline in Low-Density Lipoprotein Cholesterol (LDL-C) at Week 12

Secondary Outcome Measures

Full Information

First Posted
August 11, 2020
Last Updated
January 24, 2022
Sponsor
Shanghai Junshi Bioscience Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT04515927
Brief Title
To Evaluate the Efficacy and Safety of JS002 in HoFH Patients
Official Title
An Open-label, Single-arm Study Evaluated the Efficacy and Safety of JS002 in Patients With Homozygous Familial Hypercholesterolemia
Study Type
Interventional

2. Study Status

Record Verification Date
January 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
August 17, 2020 (Actual)
Primary Completion Date
May 6, 2022 (Anticipated)
Study Completion Date
July 29, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Shanghai Junshi Bioscience Co., Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hyperlipemia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
subcutaneous injection of JS002, 450mg, Q4W, 3/13 times.
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
JS002
Intervention Description
Biological: JS002 Administered by subcutaneous injection
Primary Outcome Measure Information:
Title
The primary endpoint of effectiveness
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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; Exclusion Criteria: 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.
Facility Information:
Facility Name
Beijing Anzhen Hospital Capital Medical University
City
Beijing
State/Province
Beijing
Country
China

12. IPD Sharing Statement

Learn more about this trial

To Evaluate the Efficacy and Safety of JS002 in HoFH Patients

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