NCT05621070

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

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

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 582 (estimated)
• 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 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

Type	Name	Description
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.

Timeline

• Start date: 2023-02-03
• Primary completion: 2024-09-23
• Completion: 2024-09-30
• First posted: 2022-11-17
• Last updated: 2024-09-19

Locations

1 site across 1 country: China