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

Aurinia Pharmaceuticals Inc.216 enrolled

Overview

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).

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

216

Conditions

Lupus Nephritis

Interventions

VoclosporinDRUG

Calcineurin inhibitor, oral, 23.7 mg twice daily (BID)

Placebo Oral CapsuleDRUG

Voclosporin placebo, oral, 3 capsules twice daily (BID)

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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. Written informed consent before any study-specific procedures were performed. 3. In the opinion of the investigator, subject required continued immunosuppressive therapy. 4. Women of childbearing potential must continue to use effective contraception and have a negative urine pregnancy test at Month 12. 5. Subject is willing to continue taking oral mycophenolate mofetil (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.

Locations (1)

AURORA Investigative Center

Oklahoma City, Oklahoma, United States

Outcomes

Primary Outcomes

Adverse Events (AE) Profile and Routine Biochemical and Hematological Assessments.

Number (and percent) of adverse events experienced during the AURORA 2 treatment period. To 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 LN.

Time frame: Month 12 (AURORA 2 baseline) to Month 36

Secondary Outcomes

Number (and Percent) of Subjects in Renal Response

Proportion of subjects in renal response defined as: * urine protein creatinine ratio (UPCR) of ≤0.5 mg/mg * estimated glomerular filtration rate (eGFR) ≥60 mL/min/1.73 m\^2 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.

Time frame: Months 12 (AURORA 2 Baseline), 18, 24, 30 and 36

Number (and Percent) of Subjects in Partial Renal Response

Partial renal response defined as a 50% reduction from baseline in urine protein creatinine ratio (UPCR).

Time frame: Months 12 (AURORA 2 baseline), 18, 24, 30 and 36

Renal Flare as Adjudicated by the Clinical Endpoints Committee (CEC).

A patient could experience a flare from the point they achieved a response (or recovery). Renal flares were judged according to the following criteria: * A reproducible increase to UPCR \>1 mg/mg from a post-response baseline of \<0.2 mg/mg or * an increase to UPCR \>2 mg/mg from a post-response baseline between 0.2 to 1.0 mg/mg or * a doubling of UPCR for baseline values of UPCR \>1 mg/mg

Time frame: Month 12 (AURORA 2 baseline) to Month 36

Change From AURORA 1 Baseline (i.e., Month 0) in Safety of Estrogens in Lupus Erythematosus National Assessment Systemic Lupus Erythematosus Disease Activity Index (SELENA-SLEDAI)

Data from ClinicalTrials.gov

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