To Evaluate the Efficacy and Safety of JS002 in HoFH Patients

Hyperlipemia Clinical Trial

Official title:

An Open-label, Single-arm Study Evaluated the Efficacy and Safety of JS002 in Patients With Homozygous Familial Hypercholesterolemia

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04515927
• Other study ID #: JS002-004
• Status: Active, not recruiting
• Phase: Phase 2
• Start date: August 17, 2020
• Est. completion date: July 29, 2022

Study information

• Verified date: January 2022
• Source: Shanghai Junshi Bioscience Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 30
• Est. completion date: July 29, 2022
• Est. primary completion date: May 6, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Hyperlipemia
• Hyperlipidemias

Intervention

Drug:
• JS002
Biological: JS002 Administered by subcutaneous injection

Locations

Country	Name	City	State
China	Beijing Anzhen Hospital Capital Medical University	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai Junshi Bioscience Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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