NCT06642909

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

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

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 135 (estimated)
• Sponsor: BioRay Pharmaceutical Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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

Conditions

• Primary Membranous Nephropathy

Interventions

Type	Name	Description
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)

Timeline

• Start date: 2024-11-13
• Primary completion: 2027-03-31
• Completion: 2027-05-10
• First posted: 2024-10-15
• Last updated: 2025-11-20

Locations

1 site across 1 country: China