NCT04781114

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 806 (actual)
• Sponsor: Shanghai Junshi Bioscience Co., Ltd. · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Hyperlipemia

Interventions

Type	Name	Description
DRUG	JS002	JS002: 150mg(1mL) Q2W; Placebo 1mL Q2W.
DRUG	Placebo	JS002: 300mg(2mL) Q4W; Placebo 2mL Q4W.

Timeline

• Start date: 2020-12-23
• Primary completion: 2022-05-25
• Completion: 2023-01-16
• First posted: 2021-03-04
• Last updated: 2023-04-19

Locations

57 sites across 1 country: China