Voclosporin for Lupus Nephritis
(VOCAL Trial)

Recruiting in Palo Alto (17 mi)

Age: < 18

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Recruiting

Sponsor: Aurinia Pharmaceuticals Inc.

Pivotal Trial (Near Approval)

Prior Safety Data

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.

+7 more

Participant Groups

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.

4Treatment groups

Experimental Treatment

Placebo Group

Group I: Voclosporin treatment group 4Experimental Treatment1 Intervention

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

Group II: Voclosporin treatment group 3Experimental Treatment1 Intervention

3 capsules (23.7 mg) BID of voclosporin

Group III: Voclosporin treatment group 1Experimental Treatment1 Intervention

2 capsules (15.8 mg) BID of voclosporin

Group IV: Placebo treatment groupPlacebo Group1 Intervention

2 capsules BID of placebo