#1 Clinical Trials Search in Europe

Voclosporin

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.

Table of Contents

Clinical trial overview

These trials are studying Voclosporin in people with lupus-related disease, especially lupus nephritis, which is kidney disease caused by lupus.[1][2] 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.[1][2]

The trial data include one Phase 2 study and one Phase 3 study.[1][2] Both studies are listed as authorised and are designed to learn more about treatment effects in specific lupus groups.[1][2]

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.[1] Refractory means the disease is hard to treat or does not respond well to usual care.[1]

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.[1] The main results being measured are complete renal response at Week 52 and DORIS at Week 24 and Week 52.[1]

Complete renal response means the kidney disease has improved in a way defined by the study.[1] 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.[1]

Phase 3 study in lupus nephritis

The Phase 3 trial, 2025-522187-32-01, is studying lupus nephritis in 55 people.[2] 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.[2]

This trial focuses on people with lupus nephritis class III/IV with or without class V.[2] These classes describe the type of kidney damage seen on biopsy, which is a small sample of kidney tissue taken for study.[2]

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.[2] It also checks whether early tissue response is linked to clinical remission after two years and whether blood monocyte patterns may help predict response.[2]

Main outcomes being measured

In the Phase 2 study, the main outcomes are kidney response and remission at set time points.[1] The trial specifically measures complete renal response at Week 52 and DORIS at Week 24 and Week 52.[1]

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.[2] The study also looks at histological response, which means how the kidney tissue looks under the microscope after treatment.[2]

Another goal is to see whether early tissue improvement matches later clinical remission after two years.[2] This helps researchers understand whether early changes in the kidney can predict longer-term benefit.[2]

Who the trials are for

These studies are aimed at people with lupus-related disease, especially those with active and hard-to-treat illness.[1][2] The Phase 2 trial includes people with active, refractory systemic lupus erythematosus or active, refractory lupus nephritis.[1]

The Phase 3 trial includes people with lupus nephritis, especially class III/IV with or without class V disease.[2] Because the studies focus on specific lupus groups, not every person with lupus would match the trial criteria.[1][2]

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.[1][2] Histopathology means studying tissue under the microscope to see inflammation or damage.[2]

Single-cell RNA sequencing, written as scRNA-seq, is a lab method that looks at gene activity in individual cells.[2] In this study, it is used to compare macrophage changes in kidney tissue before and during treatment.[2]

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.[2] These kinds of measurements help researchers learn not only whether a treatment works, but also how early changes may relate to later results.[2]

Trial ID Phase Condition studied Status Enrollment
NCT06581198 Phase 2 Active, refractory systemic lupus erythematosus; active, refractory lupus nephritis Authorised 166
2025-522187-32-01 Phase 3 Lupus nephritis Authorised 55

FAQ

  • What conditions are being studied in Voclosporin trials? The trials are studying lupus nephritis, which is kidney disease caused by lupus, and active systemic lupus erythematosus. One study focuses on people with difficult-to-treat active disease.
  • Who can take part in these trials? The studies are looking at people with active, refractory systemic lupus erythematosus or active, refractory lupus nephritis. Another trial includes people with lupus nephritis class III/IV with or without class V.
  • What phases are the Voclosporin trials in? The trial data include a Phase 2 study and a Phase 3 study. These phases help researchers learn more about how the treatment performs and what effects it may have in the target groups.
  • What are the trials trying to measure? One study measures complete renal response, which means improvement in kidney disease, and DORIS, which is a remission standard for lupus. The other study looks at changes in kidney immune cells, tissue response, and links between early response and later remission.
  • How many people are planned for these studies? The Phase 2 study plans to include 166 people, and the Phase 3 study plans to include 55 people. These numbers help show the size of each trial.

Ongoing Clinical Trials on Voclosporin

  • A Study of Prednisolone, Mycophenolate Mofetil and Voclosporin Compared to Prednisolone and Mycophenolate Mofetil in Patients with Lupus Nephritis

    Recruiting

    1 1 1 1
    Investigated diseases:
    Investigated drugs:
    The Netherlands

  • Study on the Effects of Rapcabtagene Autoleucel in Patients with Systemic Lupus Erythematosus and Active, Refractory Lupus Nephritis

    Recruiting

    1 1 1
    Investigated diseases:
    Investigated drugs:
    Austria Czechia Denmark France Germany Hungary +7

Glossary

  • Systemic lupus erythematosus (SLE): A long-term disease where the immune system attacks the body’s own tissues and can affect many organs.
  • Lupus nephritis (LN): Kidney inflammation caused by lupus. It can damage the kidneys and affect how they work.
  • Active disease: A time when the disease is causing signs and symptoms and is not under good control.
  • Refractory: Hard to treat or not responding well to standard treatment.
  • Phase 2: A trial stage that looks more closely at how well a treatment works and what effects it has in a group of patients.
  • Phase 3: A later trial stage that studies a treatment in more people and compares outcomes between groups.
  • Complete renal response (CRR): A strong improvement in kidney disease. In this trial, it is one of the main results measured at Week 52.
  • DORIS: A remission standard in lupus. It means the disease is very quiet, with no active signs on the study measures used here.
  • Physician Global Assessment (PhGA): A doctor’s overall score of how active the disease is.
  • Clinical SLEDAI-2K: A score used to measure lupus activity. A score of 0 means no clinical disease activity on this scale.
  • Kidney biopsy: A small sample of kidney tissue taken to study inflammation and damage under a microscope.
  • Macrophages: Immune cells that help control inflammation and fight infection. In these trials, researchers are studying them in kidney tissue.

References