40 Participants Needed

Voclosporin for Lupus Nephritis

(VOCAL Trial)

Recruiting at 5 trial locations
RG
AC
AC
Overseen ByAurinia Clinical Trials Information
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

What You Need to Know Before You Apply

What is the purpose of this trial?

The purpose of this study is to assess the efficacy and safety of voclosporin compared to placebo in achieving renal response following 24 weeks of therapy in adolescent and pediatric subjects with active lupus nephritis (LN).

Are You a Good Fit for This Trial?

Adolescents previously diagnosed with systemic lupus erythematosus and confirmed active lupus nephritis can join. They must have a kidney function above a certain level (eGFR >60) and not be immunocompromised or have significant drug/alcohol abuse, cancer, severe infections like HIV or hepatitis, TB without prophylaxis, or require dialysis.

Inclusion Criteria

I have been diagnosed with lupus according to the 2019 criteria.
My kidney biopsy confirmed I have active lupus nephritis.

Exclusion Criteria

Clinically significant drug or alcohol abuse prior to screening
I do not have active TB nor a history of TB without taking TB prevention medication.
I have been diagnosed with cancer.
See 7 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment Period 1

Double-blind, placebo-controlled treatment with voclosporin or placebo

8 weeks

Treatment Period 2

Open-label treatment with increasing doses of voclosporin

8 weeks

Treatment Period 3

Continuation of open-label treatment with maximum dose of voclosporin

8 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Placebo Oral Capsule
  • Voclosporin
Trial Overview The trial is testing the effectiveness of voclosporin against a placebo in treating lupus nephritis over 24 weeks. Participants will either receive voclosporin capsules or placebo to see if there's an improvement in their kidney condition.
How Is the Trial Designed?
4Treatment groups
Experimental Treatment
Placebo Group
Group I: Voclosporin treatment group 4Experimental Treatment1 Intervention
Group II: Voclosporin treatment group 3Experimental Treatment1 Intervention
Group III: Voclosporin treatment group 1Experimental Treatment1 Intervention
Group IV: Placebo treatment group 2Placebo Group1 Intervention

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+

Labcorp Drug Development, Inc.

Industry Sponsor

Trials
11
Recruited
540+

Labcorp Drug Development Inc

Industry Sponsor

Trials
17
Recruited
2,100+
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