Aurinia Renal Assessments 2: Aurinia Renal Response in Lupus With Voclosporin — AURORA 2  

Lupus Nephritis Clinical Trial

Official title: A Randomized, Controlled, Double-blind, Continuation Study Comparing the Long-term Safety and Efficacy of Voclosporin (23.7 mg Twice Daily) With Placebo in Subjects With Lupus Nephritis

Status Completed

Clinical Trial Summary

The purpose of this study is assess the long-term safety and tolerability of voclosporin compared with placebo for up to an additional 24 months following completion of treatment in the AURORA 1 study in subjects with lupus nephritis (LN).

Clinical Trial Description

The aim of the Phase 3 continuation study (AURORA 2) is to assess the long-term safety and tolerability of voclosporin, added to the standard of care treatment in LN, for an additional 24 months, following a treatment period of 52 weeks in the AURORA 1 study (AUR-VCS-2016-01). All subjects will continue to receive background therapy of mycophenolate mofetil (MMF) and/or oral corticosteroids starting at the same dose as at the end of the AURORA 1 study. Subjects with LN, who have completed 52 weeks of treatment with study drug in the AURORA 1 study, will be eligible to enter the study. The long-term safety and tolerability of the drug combination will be assessed from its safety profile while demonstrating the continued ability to achieve and maintain long-term renal response. ;

Related Conditions & MeSH terms

• Lupus Nephritis
• Nephritis

• NCT number: NCT03597464
• Study type: Interventional
• Source: Aurinia Pharmaceuticals Inc.
• Status: Completed
• Phase: Phase 3
• Start date: September 29, 2019
• Completion date: October 7, 2021