NCT04781114|CompletedPhase 3

The Safety and Efficacy of Multiple-dose of JS002 in Subject With Hyperlipidemia

A Phase III, Randomized, Double-blind, Placebo-controlled Clinical Study Evaluating the Efficacy and Safety of JS002 in Patients With Primary Hypercholesterolemia and Mixed Hyperlipidemia in China

Shanghai Junshi Bioscience Co., Ltd.ClinicalTrials.gov

Compare

1 other identifier

JS002-003

Study Type

interventional

Target

806

Locations

1 country

Sites

Timeline

RegisteredMar 2021

StartedDec 2020

CompletionJan 2023

Brief Summary

JS002 is a recombinant humanized anti-PCSK9 monoclonal antibody. This is a randomized, double-blind, placebo-controlled study to evaluate the safety and efficacy, as well as immunogenicity of JS002 treated repeatedly in patients with hyperlipidemia when combined with statin therapy. In this study, two dose group (150 mg, 300 mg) were set up in this study. 750 subjects are plan to be enrolled (the study drug will be assigned to a 2:1 ratio of JS002 or placebo). Each subject required a maximum of 6 weeks of screening, 52 weeks of treatment, and 8 weeks of follow-up.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

806

participants targeted

Target at P75+ for phase_3

Timeline

Completed

Started Dec 2020

Geographic Reach

1 country

57 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

2.1 years study duration

Study Start

First participant enrolled

December 23, 2020

Completed

2 months until next milestone

First Submitted

Initial submission to the registry

February 24, 2021

Completed

8 days until next milestone

First Posted

Study publicly available on registry

March 4, 2021

Completed

1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 25, 2022

Completed

8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 16, 2023

Completed

Last Updated

April 19, 2023

Status Verified

February 1, 2021

Enrollment Period

1.4 years

First QC Date

February 24, 2021

Last Update Submit

April 14, 2023

Conditions

Hyperlipemia

Outcome Measures

Primary Outcomes (1)

Change in LDL-C of JS002
Percentage change in LDL-C relative to baseline at Week 24
Up to 24Weeks after dose administration

Secondary Outcomes (6)

Change in LDL-C of JS002
Up to 52Weeks after dose administration
Other lipid parameters of JS002
Up to Week 24 and 52Weeks after dose administration
The occurrence of adverse events
Up 60Weeks after dose administration
The immunogenicity of JS002
Up 60Weeks after dose administration
Pharmacokinetics (PK) of JS002
Up 60Weeks after dose administration
+1 more secondary outcomes

Study Arms (2)

JS002

EXPERIMENTAL

Cohort 1: 150 mg/1mL Q2W Subcutaneous(SC); Cohort 2: 300/2mL mg Q4W Subcutaneous(SC);

Drug: JS002

Placebo

PLACEBO COMPARATOR

Cohort 1: 1mL Q2W Subcutaneous(SC); Cohort 2: 2mL Q4W Subcutaneous(SC);

Drug: Placebo

Interventions

JS002DRUG

JS002: 150mg(1mL) Q2W; Placebo 1mL Q2W.

JS002

PlaceboDRUG

JS002: 300mg(2mL) Q4W; Placebo 2mL Q4W.

Placebo

Eligibility Criteria

Age18 Years - 80 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may not qualify if:

Males and females ≥ 18 and ≤ 80 years of age;
LDL\_C during screening period met the following conditions: super high risk: LDL - C ≥1.4mmol/L (55 mg/dL); extremely high risk: LDL - C ≥1.8 mmol/L (70 mg/dL); risk: LDL - C ≥2.6 mmol/L (100 mg/dL); low risk: LDL - C ≥ 3.4 /mmol/L (130 mg/dL)
Fasting triglycerides ≤4.5 mmol/L;
Known HoFH;
History of NYHA class III-IV heart failure;
History of uncontrolled arrhythmia, Unstable angina,MI, PCI,CABG, DVT or pulmonary embolism within 3 months.
Uncontrolled hypertension.
Uncontrolled diabetes mellitius (HbA1c\>8.0%）.
Other conditions that investigators considered inappropriate to participate in the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Shanghai Junshi Bioscience Co., Ltd.lead

Study Sites (57)

The First Affiliated Hospital of Bengbu Medical College

Bengbu, Anhui, 233000, China

Location

Beijing Anzhen Hospital, Capital Medical University