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Efficacy and Safety of JS002 as Monotherapy in Patients With Primary Hypercholesterolaemia and Mixed Dyslipidemia

NCT05621070 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 582

Last updated 2024-09-19

No results posted yet for this study

Summary

JS002 is a recombinant humanized anti-PCSK9 monoclonal antibody. This is a randomized, double-blind, placebo-controlled study to evaluate the efficacy, safety, PK/PD profile, immunogenicity as well as complete delivery of auto-injector by patients of JS002 as monotherapy in patients with primary hypercholesterolaemia and mixed dyslipidemia.

In this study, two dose cohorts(150 mg, 450 mg) are set up, and 582 subjects are planned to be enrolled (randomizedly assigned to JS002 or placebo 150/450 mg group in a 2:1:2:1 ratio).A screening period (≤6 weeks), a double-blind treatment period (12 weeks), an open-label treatment period (40 weeks), and a follow-up period (8 weeks) will be required.

Conditions

  • Primary Hypercholesterolaemia and Mixed Dyslipidemia

Interventions

DRUG

JS002

JS002 will be administered per auto-injector. Participants will receive JS002 every 2 weeks subcutaneously.

DRUG

JS002

JS002 will be administered per auto-injector. Participants will receive JS002 every 4 weeks subcutaneously.

DRUG

Placebo

Placebo will be administered per auto-injector. Participants will receive placebo every 2 weeks subcutaneously.

DRUG

Placebo

Placebo will be administered per auto-injector. Participants will receive placebo every 4 weeks subcutaneously.

Sponsors & Collaborators

  • Shanghai Junshi Bioscience Co., Ltd.

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-02-03
Primary Completion
2024-09-23
Completion
2024-09-30

Countries

  • China

Study Locations

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05621070 on ClinicalTrials.gov