The Phase IIb trial, called AURA–LV (Aurinia Urine protein Reduction in Active Lupus with voclosporin) or AURA, is planned to be carried out in about 20 countries.
The randomized, controlled, double-blind trial compares the efficacy of voclosporin against placebo in achieving remission in patients with active LN.
The trial is designed to show that voclosporin can induce a rapid and sustained reduction of proteinuria in the presence of extremely low steroid exposure and to fulfill specific regulatory requests.
The AURA trial will compare two dosage groups of voclosporin (23.7mg and 39.5mg) administered with mycophenolate mofetil (MMF) vs. MMF alone.
In the trial, all patients will also receive oral corticosteroids as background therapy.
The company said that there will be a primary analysis to determine complete remission at week 24 and several secondary analyses at week 48 which include biomarkers and markers of non-renal SLE.
The company expects patient recruitment to be completed within about 12 months.
Aurinia president and CEO Stephen Zaruby said the company intends to advance its development of voclosporin to treat lupus nephritis given the significant unmet need, lack of approved therapies and market opportunity.
"The immunology of LN, along with significant published data, support the use of a multi-targeted treatment approach for this debilitating and heterogeneous disease," Zaruby said.