drugset / Trial / NCT07830433

Evaluation of the Efficacy of Zuberitamab Injection in Patients With Primary Membranous Nephropathy

NCT07830433 ↗

Phase 3 Not yet recruiting 150 enrolled BioRay Pharmaceutical Co., Ltd.
RandomizedParallel-groupOpen-labelTreatment

Summary

This is a randomized, open-label, cyclosporine-controlled, multicenter Phase III study. It aims to evaluate the efficacy, safety, pharmacokinetics and immunogenicity of zuberitamab versus cyclosporine in patients with primary membranous nephropathy, and provide evidence to support the expansion of zuberitamab's indication for primary membranous nephropathy. Approximately 150 study participants are expected to be enrolled in this trial and randomized in a 1:1 ratio to the HS006 1000 mg group (treatment group) and the cyclosporine group (control group), with 75 participants in each arm.

Timeline

Start
2026-10
Primary completion
2029-12
Completion
2029-12

Drugs

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