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Efficacy and Safety of JS002 as Monotherapy in Patients With Primary Hypercholesterolaemia and Mixed Dyslipidemia
Sponsor: Shanghai Junshi Bioscience Co., Ltd.
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.
Official title: A Double-blind, Randomized, Placebo-controlled, Multicenter Study to Evaluate Efficacy and Safety of JS002 as Monotherapy in Patients With Primary Hypercholesterolaemia and Mixed Dyslipidemia
Key Details
Gender
All
Age Range
18 Years - 80 Years
Study Type
INTERVENTIONAL
Enrollment
582
Start Date
2023-02-03
Completion Date
2024-09-30
Last Updated
2024-09-19
Healthy Volunteers
No
Interventions
JS002
JS002 will be administered per auto-injector. Participants will receive JS002 every 2 weeks subcutaneously.
JS002
JS002 will be administered per auto-injector. Participants will receive JS002 every 4 weeks subcutaneously.
Placebo
Placebo will be administered per auto-injector. Participants will receive placebo every 2 weeks subcutaneously.
Placebo
Placebo will be administered per auto-injector. Participants will receive placebo every 4 weeks subcutaneously.
Locations (1)
Peking University Third Hospital
Beijing, Beijing Municipality, China