drugset / Trial / NCT07830433
Evaluation of the Efficacy of Zuberitamab Injection in Patients With Primary Membranous Nephropathy
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Cyclosporine | Peptide | 3.5 mg/kg | Oral |
| Subject | Zuberitamab | Monoclonal antibody | 1000 mg | — |