The double-blind, placebo-controlled AURORA trial (NCT03021499) will include about 320 patients. It will determine if a combination of voclosporin and a standard of care therapy known as mycophenolate mofetil increases kidney function, compared with a placebo. During the study, patients will be tapered off the oral corticosteroids they have been treated with.
The trial’s primary objective is to stop kidney deterioration after 52 weeks of treatment.
Results are expected in 2020. The company hopes they will support voclosporin’s approval as a lupus nephritis treatment in the United States and other countries.
Voclosporin stopped or slowed kidney deterioration in many of the 265 patients in the Phase 2b AURA-LV clinical trial (NCT02141672).
The study randomly assigned patients either to 23.7 mg of voclosporin twice a day, along with mycophenolate mofetil and steroids; 39.5 mg of voclosprin and the other therapies; or a placebo.
At week 48, kidney deterioration had stopped in 48 percent of patients in the low-dose group and 40 percent in the high-dose group, compared with 24 percent in the placebo group. The percentage of patients who achieved either a full or partial response to treatment included 70 percent in the low-dose group and 66 percent in the high-dose group, versus 49 percent in the placebo group.
The treatment was well-tolerated, with no reports of unexpected side effects.
“Lupus nephritis is a devastating disease which if not managed, can be life-threatening,” Dr. Mary Anne Dooley, the trial’s principal investigator, said in a news release. “There is no approved medication to treat the condition, which mostly affects women in their childbearing years. “The AURA Phase II results showed great promise, and if replicated in Phase 3, voclosporin has the potential to change the current treatment paradigm” for lupus nephritis.
Voclosporin prevents kidney inflammation by inhibiting a protein called calcineurin that activates immune T-cells against the kidneys. The treatment has a dual mechanism of action that, along with standard of care therapies, improves both near- and long-term lupus nephritis outcomes.