AURORA 2: Aurinia Renal Response in Lupus Nephritis with Orelvo (voclosporin)

Phase 3

Completed

Conditions: upus Nephritis

Registration Number: JPRN-jRCT2080224051

Lead Sponsor: Aurinia Pharmaceuticals Inc./ CMIC Co., Ltd

Brief Summary: Across 3 years of observation, the addition of voclosporin to MMF and low dose corticosteroids demonstrated an acceptable long-term safety profile with sustained efficacy, resulting in a favorable risk/ benefit profile. The efficacy benefit in this continuation study, as measured by UPCR and 50% reduction in UPCR, confirms the treatment effect of voclosporin 23.7 mg BID compared with placebo in the AURORA 1 study when combined with background standard of care.

Detailed Description: Not available

Recruitment & Eligibility

Status: completed

Sex: All

Target Recruitment: 216

Inclusion Criteria

1. Subjects who have completed 52 weeks of treatment with study drug in the AURORA 1 study. Subjects who had a temporary interruption and successfully restarted study drug during the AURORA 1 study will be allowed with Medical Monitor approval.
2. Women of childbearing potential must continue to use effective contraception and have a negative urine pregnancy test at Month 12.
3. Subject is willing to continue taking oral MMF for the duration of the study.

Exclusion Criteria

1. Currently taking or known need for any of the medications or food items listed in Section 7.8, Prohibited therapy and concomitant treatment during the study.
2. Subjects currently requiring renal dialysis (hemodialysis or peritoneal dialysis) or expected to require dialysis during the study period.
3. A planned kidney transplant within study treatment period.
4. Subjects with any medical condition which, in the investigator's judgement, may be associated with increased risk to the subject or may interfere with study assessments or outcomes.
5. Subjects who are pregnant, breast feeding or, if of childbearing potential, not using adequate contraceptive precautions.
6. Vaccines using live organisms, virus or bacterial, while taking the study treatment.