NCT03597464

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

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
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 216 (actual)
• Sponsor: Aurinia Pharmaceuticals Inc. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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).

Detailed 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.

Conditions

• Lupus Nephritis

Interventions

Type	Name	Description
DRUG	Voclosporin	Calcineurin inhibitor, oral, 23.7 mg twice daily (BID)
DRUG	Placebo Oral Capsule	Voclosporin placebo, oral, 3 capsules twice daily (BID)

Timeline

• Start date: 2019-09-29
• Primary completion: 2021-10-07
• Completion: 2021-10-07
• First posted: 2018-07-24
• Last updated: 2022-12-14
• Results posted: 2022-12-14

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study