In short
Clinical trials are studying Voclosporin in people with lupus nephritis and systemic lupus erythematosus. These studies are looking at how well it works, what changes it may cause in the kidneys and immune system, and whether it helps people reach remission. The trials include patients with active, hard-to-treat disease.
Key points
- Clinical trials investigating Voclosporin are focused on lupus nephritis and systemic lupus erythematosus. One Phase 2 study is in people with active, hard-to-treat disease and measures kidney response and remission at Week 52. A Phase 3 study looks at people with lupus nephritis, including class III/IV with or without class V, and studies kidney immune cells, tissue changes, and early response after treatment. The trial data show that researchers are interested in both clinical improvement and changes seen in kidney biopsy samples. These studies are designed to learn more about how Voclosporin is being used in lupus-related kidney disease.
Clinical trial overview
These trials are studying Voclosporin in people with lupus-related disease, especially lupus nephritis, which is kidney disease caused by lupus. The studies are looking at how well it works, what changes it may cause in the kidneys, and whether it helps people reach remission, which means the disease becomes very quiet.
The trial data include one Phase 2 study and one Phase 3 study. Both studies are listed as authorised and are designed to learn more about treatment effects in specific lupus groups.
Phase 2 study in active, hard-to-treat lupus
The Phase 2 trial, NCT06581198, is studying people with active, refractory systemic lupus erythematosus and active, refractory lupus nephritis. Refractory means the disease is hard to treat or does not respond well to usual care.
This study plans to include 166 people and is testing a treatment approach that includes Voclosporin among several other medicines listed in the trial record. The main results being measured are complete renal response at Week 52 and DORIS at Week 24 and Week 52.
Complete renal response means the kidney disease has improved in a way defined by the study. DORIS is a remission standard for lupus, and in this trial it requires a clinical SLEDAI-2K score of 0, a Physician Global Assessment below 0.5, and stable immunomodulatory or immunosuppressive treatment.
Phase 3 study in lupus nephritis
The Phase 3 trial, 2025-522187-32-01, is studying lupus nephritis in 55 people. The study compares triple therapy, which includes Voclosporin on top of mycophenolate mofetil and prednisolone, with dual therapy, which uses mycophenolate mofetil and prednisolone without Voclosporin.
This trial focuses on people with lupus nephritis class III/IV with or without class V. These classes describe the type of kidney damage seen on biopsy, which is a small sample of kidney tissue taken for study.
The study is looking at early immune changes in the kidney, including differences in macrophage clusters, which are groups of immune cells that help drive inflammation. It also checks whether early tissue response is linked to clinical remission after two years and whether blood monocyte patterns may help predict response.
Main outcomes being measured
In the Phase 2 study, the main outcomes are kidney response and remission at set time points. The trial specifically measures complete renal response at Week 52 and DORIS at Week 24 and Week 52.
In the Phase 3 study, the main outcome is a change in macrophage patterns in kidney tissue between the first biopsy and a biopsy after 3 months of treatment. The study also looks at histological response, which means how the kidney tissue looks under the microscope after treatment.
Another goal is to see whether early tissue improvement matches later clinical remission after two years. This helps researchers understand whether early changes in the kidney can predict longer-term benefit.
Who the trials are for
These studies are aimed at people with lupus-related disease, especially those with active and hard-to-treat illness. The Phase 2 trial includes people with active, refractory systemic lupus erythematosus or active, refractory lupus nephritis.
The Phase 3 trial includes people with lupus nephritis, especially class III/IV with or without class V disease. Because the studies focus on specific lupus groups, not every person with lupus would match the trial criteria.
Important study terms
Clinical remission means the disease is under strong control and signs of active illness are low or absent on the study measures used here. Histopathology means studying tissue under the microscope to see inflammation or damage.
Single-cell RNA sequencing, written as scRNA-seq, is a lab method that looks at gene activity in individual cells. In this study, it is used to compare macrophage changes in kidney tissue before and during treatment.
Monocytes are a type of blood immune cell, and the study is exploring whether their patterns in blood may help explain or predict treatment response. These kinds of measurements help researchers learn not only whether a treatment works, but also how early changes may relate to later results.