NCT07225387

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

Safety and EfficacY of CombinatioN Belimumab and Voclosporin in the TrEatment of PRoliferative Forms of Lupus Glomerulopathy: Synergy Trial

• Status: Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: NephroNet, Inc. · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Lupus nephritis (LN) is the most serious common manifestation of systemic lupus erythematosus (SLE) and will ultimately affect about half of patients with SLE. LN increases the morbidity and mortality of patients with SLE, especially if Chronic Kidney Disease (CKD) and end-stage kidney disease (ESKD) develop. Morbidity and mortality are significantly mitigated if treatment-induced complete remission (CR) is achieved. While partial remission (PR) is better than no remission, its impact on renal survival is much less than CR. Within the last two years VCS and BEL have been approved for the treatment of LN, bescause each drug was shown to increase the number of patients having CR in well-conducted phase III trials. However, the overall proportion of patients achieving CR was below 50% in each trial, leaving a large unmet need for most patients with LN. Because VCS and BEL target different effector arms of the immune system relevant to kidney injury in LN, and individually have excellent safety profiles, investigators postulated that for the treatment of LN the combination of VCS and BEL with a significant reduction in mycophenolate-based immunosuppression may be complementary and safe, and would ultimately increase the proportion of patients who achieve a CR. In addition, both drugs offer different kidney-protective effects that favor long-term preservation of kidney function. Specifically, VCS protects podocytes and BEL reduces the LN flare rate and through unknown mechanisms, attenuates the decline in GFR seen in LN patients. Investigators further postulate that the combination of these targeted treatments will significantly reduce the need for non-specific immunosuppressives (cytotoxic agents and antimetabolites).

Conditions

• Lupus Nephritis

Interventions

Type	Name	Description
DRUG	Voclosporin	The trial is an open label, parallel, randomized study with patients randomized 1:1 the EARLY MMF TERMINATION (90 days) ARM or the EXTENDED MMF (360 days) ARM looking at the addition of Voclosporin in patients with Lupus Nephritis taking Belimumab, MMF, and Prednisone.

Timeline

• Start date: 2024-10-01
• Primary completion: 2027-01-01
• Completion: 2027-01-01
• First posted: 2025-11-06
• Last updated: 2025-11-06

Locations

7 sites across 1 country: United States

Regulatory

• FDA-regulated drug study