LUPUS NEPHRITIS CLINICAL STUDY

AURINIA PHARMACEUTICALS

About the AURORA Clinical Study

What to expect during study visits

If you agree to take part in AURORA

www.auriniapharma.com

You may qualify for the AURORA study if you... (select any that apply)

Have not had a kidney transplant

Are not on renal dialysis

Are currently taking corticosteroids

Have a diagnosis of Systemic Lupus Erythematosus (SLE)

Are spilling protein in your urine

Have had a previous Kidney biopsy

About Voclosporin

About Lupus Nephritis

About Aurinia

Voclosporin, an investigational drug, is being developed by Aurinia Pharmaceuticals Inc. for the potential treatment of lupus nephritis.  Voclosporin is not commercially available and is not approved for use by any national or foreign drug regulatory authority as safe or effective for any treatment, including Lupus Nephritis.  Voclosporin belongs to a class of medications called immunosuppressants.  Studies in people and animals have shown voclosporin has the potential to work in a similar manner as other approved immunosuppressants, but at possibly a lower dose with fewer side effects.  Approximately 2,400 people have taken voclosporin or other investigational products containing voclosporin in clinical trials.

 

A phase 2 clinical trial to examine the use of voclosporin in achieving complete remission in patients with active lupus nephritis was recently completed. In the trial, 49% of the patients receiving low dose (23.7 mg twice daily) voclosporin achieved complete clinical remission after 48 weeks of treatment.

Lupus nephritis is kidney inflammation caused by systemic lupus erythematosus (SLE or lupus). SLE is an autoimmune disease—a disorder in which the body’s immune system attacks its own tissues causing damage. Up to 60 percent of people with SLE are diagnosed with lupus nephritis, which can lead to significant illness and even death.*

Aurinia is a clinical stage biopharmaceutical company focused on developing and commercializing therapies to treat targeted patient populations that are suffering from serious diseases with a high unmet medical need. The company is currently developing voclosporin, an investigational drug, for the treatment of LN.  The company is headquartered in Victoria, BC and focuses its development efforts globally.

*Lee YH, Woo JH, Choi SJ, Ji JD, Song GG. Induction and maintenance therapy for lupus nephritis: a systematic review and meta-analysis. Lupus. 2010;19:703–710

Learn More

Participants will be randomized to receive either the investigational drug voclosporin (23.7 mg twice daily) or placebo as a study drug. Neither participant nor the study doctor will know if you are taking voclosporin or placebo during the study. Participants will also receive standard medication mycophenolate mofetil (e.g. Cellcept®) and steroids in addition to the study drug for the duration of the study.

Participants will receive study medication for approximately 12 months and participants are expected to attend about 16 clinic visits over the course of the study period. Study assessments, study drugs and procedures will be provided at no cost to participants.

Approximately 324 participants with biopsy confirmed lupus nephritis will be enrolled in this study at multiple sites around the world.

© Aurinia Pharmaceuticals Inc.