Aurinia Pharmaceuticals Inc. announced that it has fully enrolled the AURA (Aurinia Urine protein Reduction in Active Lupus nephritis or AURA) study at 265 patients (target 258 patients). This Phase 2B study, is a randomized, controlled, double-blind study comparing the efficacy of voclosporin as a component of multi-targeted therapy against placebo in achieving remission in patients with active lupus nephritis (LN). The AURA study has been designed to demonstrate that voclosporin can induce a rapid and sustained reduction of proteinuria with extremely low steroid exposure.

The placebo-controlled study assesses two doses of voclosporin, with all patients receiving background therapy of mycophenolate mofetil (MMF) coupled with an aggressive oral corticosteroid taper. There will be a primary analysis to determine complete remission at week 24 (confirmed at 26 weeks) and various secondary analyses at both 24 and 48 weeks which include biomarkers and markers of non-renal lupus. The company anticipates that the primary end-point results of the AURA study will be released in third quarter of this year.

The company also continues to recruit patients into its open label AURION study and expects to review data in the near future.