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Immunosuppressant

Voclosporin for Lupus Nephritis (VOCAL-EXT Trial)

Phase 3

Waitlist Available

Research Sponsored by Aurinia Pharmaceuticals Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Subject is willing to continue to take oral MMF for the duration of the study

Be younger than 65 years old

Must not have

Currently requiring renal dialysis (hemodialysis or peritoneal dialysis) or expected to require dialysis during the study period

Currently taking or known need for any of the following medications during the study: Cholestyramine or other drugs that may interfere with enterohepatic recirculation of MMF, Calcineurin inhibitors (CNIs) (e.g., cyclosporin and tacrolimus), Strong CYP3A4/5 inhibitors and inducers (e.g., ketoconazole, rifampin, itraconazole, clarithromycin)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up month 12 (vocal study completion/vocal-ext study start) and month 18 (vocal-ext study completion)

Awards & highlights

No Placebo-Only Group

Pivotal Trial

Summary

This trial tests the long-term safety of a drug used to treat active lupus nephritis in teens.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

While specific side effects are not listed here, typical ones associated with immunosuppressants like voclosporin may include increased risk of infections, headaches, high blood pressure, nausea, and possible kidney function impairment.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am willing to take oral MMF for the study duration.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am on or expected to need kidney dialysis during the study.

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I am not taking drugs that affect MMF absorption or strong CYP3A4/5 inhibitors.

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I am scheduled for a kidney transplant during the study.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ month 12 (vocal study completion/vocal-ext study start) and month 18 (vocal-ext study completion)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~month 12 (vocal study completion/vocal-ext study start) and month 18 (vocal-ext study completion)

This trial's timeline: 3 weeks for screening, Varies for treatment, and month 12 (vocal study completion/vocal-ext study start) and month 18 (vocal-ext study completion) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Incidence of Treatment Emergent Adverse Events (TEAE)

Secondary study objectives

Partial Renal Response

Renal Response

Urine Protein Creatinine Ratio (UPCR)

Side effects data

From 2005 Phase 3 trial • 451 Patients • NCT00244842

25%

Nasopharyngitis

17%

Headache

11%

Upper respiratory tract infection

Hypertension

Back pain

Blood pressure increased

Vomiting

Arthralgia

Diarrhoea

Convulsion

Basal Cell Carcinoma

100%

80%

60%

40%

20%

Study treatment Arm

Placebo

Voclosporin 0.2

Voclosporin 0.3

Voclosporin 0.4

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

voclosporin

2006

Completed Phase 3

~1420

0 / 4Eligibility criteria met