Additional Relevant Details
The Company’s 265 patient Phase 2b trial, called AURA (Aurinia Urine protein Reduction in Active Lupus with voclosporin) has recently completed enrollment and is currently underway in over 20 countries worldwide. It is a randomized, controlled, double-blind study comparing the efficacy of two doses of voclosporin plus mycophenolate mofetil (MMF) vs. MMF alone in patients with active LN. There will be a primary analysis to determine complete remission at week 24 and various secondary analyses at week 48 which include biomarkers and markers of non-renal SLE. The Company expects to analyse and review the AURA data with the FDA later in 2016 in order to reach agreement on further clinical development requirements.