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ACTIVE NOT RECRUITING
NCT06642909
PHASE2

A Phase II Study of Zuberitamab Injection in Patients With Primary Membranous Nephropathy

Sponsor: BioRay Pharmaceutical Co., Ltd.

View on ClinicalTrials.gov

Summary

This study is a multicenter, randomized, open label, cyclosporine controlled Phase II trial aimed at evaluating the efficacy, safety, pharmacokinetics, and immunogenicity of Zuberitamab in patients with primary membranous nephropathy, and exploring the Phase III dosing regimen, sample size, and endpoint evaluation time

Official title: A Multicenter, Randomized, Open Label, Cyclosporine Controlled Phase II Clinical Study Evaluating the Efficacy and Safety of Zuberitamab Injection (HS006) in Patients With Primary Membranous Nephropathy

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

135

Start Date

2024-11-13

Completion Date

2027-05-10

Last Updated

2025-11-20

Healthy Volunteers

No

Interventions

DRUG

Zuberitamab 600mg

administered twice with a 2-week interval between each dose (i.e. D1, D15). One treatment cycle is 24 weeks

DRUG

Zuberitamab 1000mg

administered twice with a 2-week interval between each dose (i.e. D1, D15). One treatment cycle is 24 weeks

DRUG

cyclosporine

Initial dose of 3.5 mg/kg/d, oral administration, divided into two doses, taken 12 hours apart (Q12h)

Locations (1)

Zhongshan Hospital Fudan University

Shanghai, Shanghai Municipality, China