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ARTICLE | Clinical News

Aurinia starts Phase III AURORA trial of voclosporin for lupus nephritis

June 16, 2017 7:11 PM UTC

Aurinia Pharmaceuticals Inc. (TSX:AUP; NASDAQ:AUPH) began the Phase III AURORA trial evaluating Luveniq voclosporin (LX211) to treat lupus nephritis. The double-blind, international trial will enroll about 320 patients to receive twice-daily 23.7 mg voclosporin plus standard of care (SOC) mycophenolate mofetil (MMF) or placebo plus SOC. Both arms will also receive low doses of corticosteroids as part of background therapy after a stringent taper.

The primary endpoint will measure the proportion of patients achieving a complete renal response at 52 weeks. Secondary endpoints will assess time to urine protein/creatinine ratio (UPCR) of ≤0.5 mg/mg, partial renal response, time to 50% reduction in UPCR from baseline, renal response at week 52, duration of renal response, change in laboratory parameters, renal response with low-dose steroids, quality of life (QOL) and SELENA-SLEDAI Index score...