drugset / Trial / NCT06642909

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

NCT06642909

Phase 2 Active not recruiting 135 enrolled BioRay Pharmaceutical Co., Ltd.
RandomizedParallel-groupOpen-labelTreatment

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

Timeline

Start
2024-11-13
Primary completion
2027-03-31
Completion
2027-05-10

Drugs

EvaluationDrugModalityDoseRoute
Comparator Cyclosporine Peptide 3.5 mg/kg Oral
Subject Zuberitamab Monoclonal antibody 600 mg
Subject Zuberitamab Monoclonal antibody 1000 mg