Worldwide Clinical Trials has been chosen to conduct Aurinia Pharmaceuticals’ Phase 3 trial, called AURORA, evaluating voclosporin as a potential treatment for active lupus nephritis (LN). The trial is expected to begin by mid-year.
The company plans to use the study’s results to support a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA).
“We are thrilled to partner with Worldwide to support the AURORA Phase 3 clinical trial,” Charles Rowland, Aurinia’s chief executive officer, said in a press release. “We are rapidly moving forward with our plans to bring this important therapy to market for patients living with this devastating disease, and Worldwide’s deep expertise and capabilities in managing pivotal trials will be a tremendous asset to us.”
The randomized, placebo-controlled, double-blind, 52-week clinical trial (NCT03021499) will enroll nearly 320 patients. It is not yet open for recruitment.
Researchers will assess voclosporin’s efficacy, compared to placebo, in achieving renal response (complete remission) in patients with active lupus nephritis when added to standard-of-care mycophenolate mofetil (U.S. brand name CellCept).
Voclosporin is an immunosuppressant with a synergistic dual mechanism of action. It is a calcineurin inhibitor (CNI) that blocks IL-2 expression and T-cell mediated immune responses.
Both the active and placebo arms will receive a reducing course of oral corticosteroids as part of background therapy.
The study’s design is consistent with that of the ongoing Phase 2b AURA trial (NCT02141672), which is assessing the efficacy of two doses of voclosporin, compared to placebo, in LN patients.
The primary endpoint of AURORA, like in AURA, is renal response at 24 weeks. In addition, the trial will examine the duration of proteinuria improvement. (Proteinuria is the presence of excess proteins in the urine.) A secondary endpoint will be the length of renal response at 52 weeks (48 weeks in the AURA trial).
“Our entire Worldwide team is delighted to have been selected as Aurinia’s (clinical research organization) partner to advance voclosporin, which has the potential to become the first FDA-approved treatment for LN,” said Peter Benton, president and chief operating officer at Worldwide. “We’re looking forward to working closely with Aurinia’s clinical development team on this new therapy, which could significantly improve the lives and long-term outcomes of patients suffering from LN.”