Clinical Trial

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

Recruiting Phase 3
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Record status
This record was last updated September 19, 2024 (before its estimated September 23, 2024 completion). Its status may not reflect the trial's current state.
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.
Protocol Amendment History 2 amendments
This ClinicalTrials.gov record has been amended 2 times since 2022-11-14; most recent amendment 2024-09-09.
Status change: Not Yet Recruiting → Recruiting 2024-09-09
Trial Details
NCT Number NCT05621070
Lead Sponsor Shanghai Junshi Bioscience Co., Ltd.
Conditions Primary Hypercholesterolaemia and Mixed Dyslipidemia
Enrollment 582 participants
Start Date 2023-02-03
Primary Completion 2024-09-23 (estimated)
Study Completion 2024-09-30 (estimated)
Updated on ClinicalTrials.gov 2024-09-19