Lupus Nephritis

Voclosporin

Voclosporin placebo, oral, 3 capsules BID

Placebo Oral Capsule

AURORA Investigative Center

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

AURORA 2: Aurinia Renal Response in Lupus With Voclosporin

Adverse events (AE) profile and routine biochemical and hematological assessments.

Assessment of Systemic Lupus Erythematosus (SLE) Disease Activity within the last 10 days. It scores 24 disease descriptors across 9 organ systems which are summed to a minimum of <2 (considered indicative of no activity) and maximum of 105 points. Scores are weighted and a score of 6 is considered clinically significant. Higher scores indicate worse disease activity.

Change from Aurinia Renal Response in Active Lupus With Voclosporin (AURORA) 1 baseline.

A set of 36 generic questions assessing quality of life and health status across 8 health concepts (physical functioning, bodily pain, role limitations due to physical health problems, role limitations due to personal or emotional problems, emotional well-being, social functioning, energy/fatigue, and general health perceptions) and is reliant upon patient self-reporting.

Qualitative information gathered form the subjects via interview related to utilisation of healthcare resources e.g visits to health care practitioners

Aurinia Pharmaceuticals Inc.

AURORA

AURORA Investigative Cener

Aurinia Renal Response in Active Lupus With Voclosporin

A Randomized, Controlled Double-blind Study Comparing the Efficacy and Safety of Voclosporin (23.7 mg Twice Daily) With Placebo in Achieving Renal Response in Subjects With Active Lupus Nephritis

The number of subjects achieving renal response

Time to 50% reduction in UPCR from baseline.

Change from baseline in laboratory parameters at each time point

Change from baseline in the SELENA-SLEDAI Index score

voclosporin

AURION Site

Aurinia Early Urinary Protein Reduction Predicts Response

An Exploratory Study Assessing the Short Term Predictors of Remission of Voclosporin 23.7mg BID in Combination With Standard of Care in Patients With Active Lupus Nephritis

Complete remission is defined as Protein/creatinine ratio of ≤0.5 mg/mg in the presence of stable renal function

Voclosporin, oral 23.7 mg BID until Week 2, then voclosporin, oral, 39.5 mg BID

Low dose: Voclosporin placebo, oral, 3 capsules BID
High dose: Voclosporin placebo, oral, 3 capsules BID until Week 2 then voclosporin placebo, oral, 5 capsules BID

Voclosporin High Dose

Voclosporin Low Dose

Placebo

AURA-LV Site

AURA-L Site

AURA -LV Site

AURA-LV

AUR-LV Site

AURA-LV: Aurinia Urinary Protein Reduction Active - Lupus With Voclosporin (AURA-LV)

A Randomized, Controlled Double-blind Study Comparing the Efficacy and Safety of Voclosporin (23.7 mg BID, or 39.5 mg BID) With Placebo in Achieving Remission in Patients With Active Lupus Nephritis

Complete remission is defined as:
Confirmed protein/creatinine ratio of ≤0.5 mg/mg and
eGFR ≥60 mL/min/1.73m2 or no confirmed decrease from baseline in eGFR of ≥20%. Subjects who receive rescue medication for lupus or ≥10 mg prednisone for >3 consecutive days or >7 days total from Weeks 16-26 will not be considered as achieving complete remission.

Complete remission in the presence of low dose steroids at Week 24 (defined as confirmed complete remission and ≤5 mg prednisone for ≥8 weeks) and Week 48 (defined as confirmed complete remission and ≤5 mg prednisone for ≥12 weeks).

defined as complete remission which occurs on or before Week 24 which is sustained through Week 48.

Defined as the first occurrence of partial remission which is sustained through Week 48

Defined by 50% reduction in protein/creatinine ratio from baseline at Weeks 24 and 48.

Partial remission which occurs on or before Week 24 which is sustained through Week 48).

Defined as the first occurrence of partial remission which is sustained through Week 48.

Defined by >10 red blood cells per high powered field (RBC/hpf) with dysmorphic red blood cells (RBC) and/or RBC casts on urinalysis of a urine sample which has a minimum volume of 50 mL

aurinia saxatilis/nefritida

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

Aurinia Renal Response in Active Lupus With Voclosporin

Aurinia Early Urinary Protein Reduction Predicts Response

AURA-LV: Aurinia Urinary Protein Reduction Active - Lupus With Voclosporin (AURA-LV)

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