Abstract: INFO17-FR
Voclosporin Treatment in Adolescents with Lupus Nephritis (VOCAL™)
Session Information
- Informational Posters - II
November 03, 2023 | Location: Exhibit Hall, Pennsylvania Convention Center
Abstract Time: 10:00 AM - 12:00 PM
Category: Glomerular Diseases
- No subcategory defined
Authors
- Waddingham, Nicola C., Aurinia Pharmaceuticals Inc, Edmonton, Alberta, Canada
- Rosales, Amber, Aurinia Pharmaceuticals Inc, Edmonton, Alberta, Canada
- Cheung, Gigi, Aurinia Pharmaceuticals Inc, Edmonton, Alberta, Canada
- Potter, Steven Blake, Aurinia Pharmaceuticals Inc, Edmonton, Alberta, Canada
- Palmen, Mary, Aurinia Pharmaceuticals Inc, Edmonton, Alberta, Canada
Description
Renal involvement is common in pediatric patients with systemic lupus erythematosus (SLE), with more than 50% of patients developing renal manifestations, typically within the first two years of diagnosis.1 While renal outcomes have improved in recent years, renal disease remains a significant cause of morbidity and mortality in pediatric patients with SLE.
Voclosporin was approved by the FDA in 2021 and by the European Medicine Agency in 2022 for the treatment of adult patients with active lupus nephritis in combination with background immunosuppressive therapy. The Phase 3 AURORA 1 study showed that the addition of voclosporin to mycophenolate mofetil (MMF) and low-dose glucocorticoids in adult patients ≥18 years of age yielded significant reductions in proteinuria; efficacy was maintained for an additional 24 months in patients who continued treatment in the AURORA 2 study.
Here we describe a Phase 3, dose-escalation study of voclosporin used in combination with MMF and low-dose steroids in an adolescent population with lupus nephritis.
The Voclosporin in Adolescents with Lupus Nephritis (VOCAL) study (NCT05288855) is a global Phase 3, 24-week, dose-escalation study of voclosporin consisting of three treatment periods; period 1 is double-blind and placebo-controlled, and periods 2 and 3 are open-label, with increasing doses of voclosporin administered in each period (15.8 mg BID, 23.7 mg BID, and 31.6 mg BID) in addition to MMF and low-dose steroids. Patients aged 12 to <18 years old at the time of screening with biopsy-confirmed lupus nephritis and estimated glomerular filtration rate (eGFR) ≥60 mL/min/1.73 m2 are eligible to participate. The primary efficacy endpoint is complete renal response (defined as urine protein creatinine ratio [UPCR] ≤0.5 g/g, eGFR ≥60 mL/min/1.73 m2 or no decrease from baseline of >20%, no rescue medication and no steroid use >10 mg/day for ≥3 consecutive days or for ≥7 days in total between Week 16 to 24) at Week 24. Secondary endpoints include time to UPCR ≤0.5 g/g, partial renal response (≥50% reduction in UPCR from baseline), time to partial renal response, and safety outcomes.
1. Levy DM, et al. Pediatr Clin North Am 2012;59(2):345-64.
Funding
- Aurinia Pharmaceuticals Inc. provided funding for this study.