drugset / Trial / NCT07225387

Safety and Efficacy of Combination Belimumab and Voclosporin in the Treatment of Proliferative Forms of Lupus Glomerulopathy: Synergy Trial

NCT07225387

Phase 4 Recruiting 30 enrolled NephroNet, Inc.
RandomizedParallel-groupOpen-labelTreatment

Summary

This is a Phase IV, open-label, randomized trial to determine whether the combination of Belimumab (BEL) and Voclosporin (VCS), plus background therapy with Mycophenolate Mofetil (MMF), improves the proportion of patients with proliferative lupus nephritis achieving complete renal response (CRR) compared to proportion of patients achieving CRR from recent clinical trials. This protocol will additionally determine whether combination therapy using Belimumab (BEL) and Voclosporin (VCS) facilitates rapid discontinuation of MMF.

Timeline

Start
2024-10-01
Primary completion
2027-01
Completion
2027-01

Drugs

EvaluationDrugModalityDoseRoute
Comparator Voclosporin Other / unclassified

Indications