Aurinia Renal Assessments 2: Aurinia Renal Response in Lupus With Voclosporin
| Status: | Recruiting |
|---|---|
| Conditions: | Lupus, Nephrology |
| Therapuetic Areas: | Immunology / Infectious Diseases, Nephrology / Urology |
| Healthy: | No |
| Age Range: | 18 - 75 |
| Updated: | 8/18/2018 |
| Start Date: | June 12, 2018 |
| End Date: | August 2021 |
| Contact: | Antonia Coeshall |
| Email: | acoeshall@auriniapharma.com |
| Phone: | 441962715493 |
AURORA 2: Aurinia Renal Response in Lupus With Voclosporin
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).
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).
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 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.
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 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.
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 judgment, 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.
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