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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

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:

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.

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

NCT ID

NCT04515927

First Posted

August 11, 2020

Last Updated

January 24, 2022

Sponsor

Shanghai Junshi Bioscience Co., Ltd.

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

Studies a U.S. FDA-regulated Device Product

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

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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