Voclosporin for Lupus Nephritis

(VOCAL Trial)

Overseen By Antonia Coeshall

Age: < 18

Sex: Any

Trial Phase: Phase 3

Sponsor: Aurinia Pharmaceuticals Inc.

Must not be taking: Biologics, Cyclophosphamide, CNIs, others

Disqualifiers: Immunodeficiency, Neoplasm, HIV, others

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

40 Participants Needed

Trial Summary

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 adolescents with active lupus nephritis (LN).

Eligibility Criteria

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.

Timeline

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

Treatment Details

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.

Participant Groups

Group I: Voclosporin treatment group 4 Experimental Treatment 1 Intervention

Maximum dose of 4 capsules (31.6 mg) BID of voclosporin.

Group II: Voclosporin treatment group 3 Experimental Treatment 1 Intervention

3 capsules (23.7 mg) BID of voclosporin

Group III: Voclosporin treatment group 1 Experimental Treatment 1 Intervention

2 capsules (15.8 mg) BID of voclosporin

Group IV: Placebo treatment group Placebo Group 1 Intervention

2 capsules BID of placebo

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+