Voclosporin - VOCAL
Voclosporin is a calcineurin inhibitor which forms a heterodimeric complex with cyclophilin A, which binds to and inhibits calcineurin, a calcium-dependent phosphatase involved in cytokine production and activation of T-cells.
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How is Voclosporin being studied in Lupus nephritis?
The efficacy, pharmacokinetics and safety of Voclosporin compared to placebo in achieving renal response following 24 weeks of therapy in adolescents with active lupus nephritis was studied in this Double-Blind, Placebo-Controlled, Dose Escalation Study. This is a 24-week, dose-escalation study of Voclosporin in addition to standard of care with mycophenolate mofetil and steroids, consisting of 3 treatment periods, in which period 1 is double-blind, placebo-controlled, and period 2 and period 3 are open-label, with increasing doses of Voclosporin in a pediatric population.
Group 1 - 2 capsules (15.8 mg) BID of voclosporin
Group 2- 2 capsules BID of placebo
Group 3- 3 capsules (23.7 mg) BID of voclosporin
Group 4- Maximum dose of 4 capsules (31.6 mg) BID of voclosporin.
The primary outcome is the proportion of subjects with renal response.
Eligibility Criteria
Aged 12-17 years
Previous diagnosis of systemic lupus erythematosus (SLE) as per the 2019 EULAR/ ACR classification criteria.
Subjects with kidney biopsy confirmed active lupus nephritis.