40 Participants Needed

Voclosporin for Lupus Nephritis

(VOCAL-EXT Trial)

HL
AS
GK
KP
GC
AR
VB
EY
Overseen ByErnie Yap
Age: < 65
Sex: Any
Trial Phase: Phase 3
Sponsor: Aurinia Pharmaceuticals Inc.
Must be taking: MMF
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Pivotal Trial (Near Approval)This treatment is in the last trial phase before FDA approval
Prior Safety DataThis treatment has passed at least one previous human trial

Trial Summary

What is the purpose of this trial?

The purpose of this study is to assess the long-term safety and tolerability of voclosporin for up to an additional 12 months following completion of treatment in the AUR-VCS-2020-03 study (VOCAL) in adolescents with active lupus nephritis.

Will I have to stop taking my current medications?

You may need to stop taking certain medications, like cholestyramine, calcineurin inhibitors (such as cyclosporin and tacrolimus), and strong CYP3A4/5 inhibitors and inducers (like ketoconazole and rifampin), as they are not allowed during the study. However, you will need to continue taking oral MMF (mycophenolate mofetil) for the duration of the study.

What data supports the effectiveness of the drug Voclosporin for treating lupus nephritis?

Voclosporin, a new type of drug, has been shown to improve kidney function in people with lupus nephritis, as seen in clinical trials where it helped more patients achieve better kidney response compared to those who did not receive it.12345

Is voclosporin safe for humans?

Voclosporin has been evaluated for safety in clinical trials for lupus nephritis, showing it is generally safe when used with other medications like mycophenolate mofetil and glucocorticoids. It was approved by the FDA in 2021, indicating it met safety standards for this condition.34678

How is the drug voclosporin unique for treating lupus nephritis?

Voclosporin is unique because it is an oral medication that works as a calcineurin inhibitor, which helps suppress the immune system to reduce kidney inflammation in lupus nephritis. It has shown improved kidney response rates compared to standard treatments, and it allows for the reduction of steroid use, which can have significant side effects.12347

Research Team

AS

Aurinia Study Director

Principal Investigator

Aurinia Pharmaceuticals Inc.

Eligibility Criteria

This trial is for adolescents with active lupus nephritis who have completed a previous voclosporin study and need ongoing immunosuppressive therapy. They must be willing to take oral MMF throughout the study and not require dialysis or a kidney transplant during the trial.

Inclusion Criteria

I am willing to take oral MMF for the study duration.
Written informed consent from parent/guardian before any study-specific procedures are performed, if applicable per local regulations
I have given my consent to participate in this study.
See 2 more

Exclusion Criteria

Subjects with any medical condition which in the Investigator's judgement may be associated with increased risk to the subject or may interfere with study assessments or outcomes
I am on or expected to need kidney dialysis during the study.
I am not taking drugs that affect MMF absorption or strong CYP3A4/5 inhibitors.
See 1 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive open-label voclosporin in addition to background standard of care with MMF and oral steroids for 12 months

12 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Open-label extension

Continuation of voclosporin treatment for long-term safety and efficacy assessment

12 months

Treatment Details

Interventions

  • Voclosporin
Trial Overview The trial tests the long-term safety of voclosporin in treating lupus nephritis over an additional 12 months, following up on earlier treatment from the VOCAL study. Participants will continue their current medication regimen alongside voclosporin.
Participant Groups
1Treatment groups
Experimental Treatment
Group I: Open LabelExperimental Treatment1 Intervention
All subjects will receive open label voclosporin initially at the same number of capsules as assigned at Week 24 (End of Study Visit) in AUR-VCS-2020-03 (VOCAL ; NCT05288855). At the Investigator's discretion and after consultation with the Medical Monitor, dose titration up or down in the study will be permitted up to the maximum dose that was studied in AUR-VCS-2020-03.

Find a Clinic Near You

Who Is Running the Clinical Trial?

Aurinia Pharmaceuticals Inc.

Lead Sponsor

Trials
18
Recruited
3,700+

Labcorp Corporation of America Holdings, Inc

Industry Sponsor

Trials
22
Recruited
3,600+

Findings from Research

In a small study of four patients with lupus nephritis, the combination of voclosporin and belimumab showed promising results, allowing for a reduction in glucocorticoid use and decreased proteinuria.
None of the patients experienced serious infections during the treatment, suggesting a favorable safety profile for this combination therapy.
Treatment Using Both Voclosporin and Belimumab in Four Patients With Lupus Nephritis.Baum, R., Geetha, D., Fatola, A., et al.[2023]
Voclosporin, when combined with mycophenolate mofetil and glucocorticoids, significantly improved complete renal response in lupus nephritis patients, with 43.7% achieving this outcome compared to 23.3% in the control group, based on an integrated analysis of 534 patients from two clinical trials.
The safety profile of voclosporin was comparable to the control, with similar rates of adverse events, most of which were mild to moderate, indicating that voclosporin is a safe and effective treatment option for lupus nephritis.
Update on the Efficacy and Safety Profile of Voclosporin: An Integrated Analysis of Clinical Trials in Lupus Nephritis.Arriens, C., Teng, YKO., Ginzler, EM., et al.[2023]

References

Treatment Using Both Voclosporin and Belimumab in Four Patients With Lupus Nephritis. [2023]
Voclosporin: a novel calcineurin inhibitor for the treatment of lupus nephritis. [2022]
Journal Club: Efficacy and Safety of Voclosporin Versus Placebo for Lupus Nephritis (AURORA 1): A Double-Blind, Randomized, Multicenter, Placebo-Controlled, Phase 3 Trial. [2021]
Efficacy and safety of voclosporin versus placebo for lupus nephritis (AURORA 1): a double-blind, randomised, multicentre, placebo-controlled, phase 3 trial. [2022]
The efficacy of immunosuppressive drugs induction therapy for lupus nephritis: a systematic review and network meta-analysis. [2023]
Update on the Efficacy and Safety Profile of Voclosporin: An Integrated Analysis of Clinical Trials in Lupus Nephritis. [2023]
Voclosporin: First Approval. [2022]
Voclosporin: A Novel Calcineurin Inhibitor for the Treatment of Lupus Nephritis. [2022]