Aurinia Renal Response in Active Lupus With Voclosporin

The aim of the current study is to investigate whether voclosporin, added to the standard of
care treatment in active lupus nephritis (LN), is able to reduce disease activity over a
treatment period of 52 weeks. The background therapy will be MMF and initial treatment with
IV methylprednisolone, followed by a reducing course of oral corticosteroids. Subjects with
active, flaring LN will be eligible to enter the study. They are required to have a diagnosis
of LN according to established diagnostic criteria and clinical and biopsy features
suggestive of active nephritis. Efficacy will be assessed by the ability of the drug
combination to reduce the level of proteinuria (as measured by urine protein/creatinine ratio
(UPCR)) while demonstrating an acceptable safety profile.

Key Inclusion Criteria:

- Subjects with evidence of active nephritis, defined as follows:

- Kidney biopsy result within 2 years prior to screening indicating Class III, IV-S,
IV-G (alone or in combination with Class V), or Class V LN with a doubling or greater
increase of UPCR within the last 6 months to a minimum of ≥1.5 mg/mg for Class III/IV
or to a minimum of ≥2 mg/mg for Class V at screening. Biopsy results over 6 months
prior to screening must be reviewed with a medical monitor to confirm eligibility.

OR

- Kidney biopsy result within 6 months prior to screening indicating Class III, IV-S or
IV-G (alone or in combination with Class V) LN with a UPCR of ≥1.5 mg/mg at screening.

OR

- Kidney biopsy result within 6 months prior to screening indicating Class V LN and a
UPCR of ≥2 mg/mg at screening.

- Women of childbearing potential must have a negative serum pregnancy test at
screening and a negative urine pregnancy test at baseline.

Exclusion Criteria:

- Estimated glomerular filtration rate (eGFR) of ≤45 mL/minute at screening.

- Current or medical history of:

- Congenital or acquired immunodeficiency.

- In the opinion of the Investigator, clinically significant drug or alcohol abuse
within 2 years prior to screening.

- Malignancy within 5 years of screening, with the exception of basal and squamous
cell carcinomas treated by complete excision.

- Lymphoproliferative disease or previous total lymphoid irradiation.

- Severe viral infection or known HIV infection.

- Active tuberculosis (TB), or known history of TB/evidence of old TB if not taking
prophylaxis with isoniazid.

- Other known clinically significant active medical conditions, such as:

- Severe cardiovascular disease, liver dysfunction or chronic obstructive pulmonary
disease or asthma requiring oral steroids or any other overlapping autoimmune
condition for which the condition or the treatment of the condition may affect
the study assessments or outcomes.