Lupus Nephritis

Primary Objective: • To assess the long-term safety and tolerability of Orelvo 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). Secondary Objective: • To assess the long-term efficacy of Orelvo compared with placebo for up to an additional 24 months following completion of treatment in the AURORA 1 study in subjects with LN

Orelvo (voclosporin)

Voclosporin

capsule

7.9

Primary Endpoint:
• Adverse events (AE) profile and routine biochemical and hematological assessments.

Secondary Endpoints:
Proportion of subjects in renal response defined as:
− UPCR of ≤0.5 mg/mg
− estimated glomerular filtration rate (eGFR) ≥60 mL/min/1.73 m2 or no confirmed decrease from baseline in eGFR of >20%
− Received no rescue medication for LN
− Did not receive more than 10 mg prednisone for ≥3 consecutive days or for ≥7 days in total during the 8 weeks prior to the renal response assessment.
• Subjects who withdraw from the study prior to the response assessment will be defined as non-responders.
• Proportion of subjects in partial renal response defined as a 50% reduction from baseline in UPCR.
• Renal flare as adjudicated by the Clinical Endpoints Committee (CEC).
• Extra-renal flare as adjudicated by the CEC.
• SELENA-SLEDAI scores by visit.
• Change in UPCR, eGFR, urine protein, and serum creatinine from AURORA 1 baseline.
• Change in immunology parameters (complement 3 (C3), complement 4 (C4), and anti-double-stranded deoxyribonucleic acid (DNA)) from AURORA 1 baseline.
• Change in health-related quality of life (HRQoL) (SF-36) from AURORA 1 baseline.
• Healthcare Resource Utilization (HRU).

1. Written informed consent before any study-specific procedures are performed.
2. Male or female 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.
3. In the opinion of the Investigator, subject requires continued immunosuppressive
therapy.
4. Women of childbearing potential must continue to use effective contraception
and have a negative urine pregnancy test at Month 12. Two effective forms of
contraception must be used simultaneously unless abstinence is the chosen
method. Subjects must use effective contraception during the study (see
Section 5.4, Adequate/Effective Contraception).
5. Subject is willing to continue taking oral MMF for the duration of the study.

1. Subjects unable or unwilling to give written informed consent and/or to comply
with study procedures.
2. 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.
3. Subjects currently requiring renal dialysis (hemodialysis or peritoneal dialysis)
or expected to require dialysis during the study period.
4. A planned kidney transplant within study treatment period.
5. Subjects with any medical condition which, in the Investigator’s judgment, may
be associated with increased risk to the subject or may interfere with study
assessments or outcomes.
6. Subjects who are pregnant, breast feeding or, if of childbearing potential, not
using adequate contraceptive precautions.
7. Vaccines using live organisms, virus or bacterial, while taking the study
treatment.