New phase III trial now enrolling lupus nephritis patients
Study Title: Aurinia Renal Response in Active Lupus with Voclosporin (Aurora)
Sponsor: Aurinia Pharmaceuticals Inc.
Purpose: The purpose of the Aurora study is to assess the benefits and risks of voclosporin when added to Cellcept® (mycophenolate mofetil) and steroids in achieving renal response after 52 weeks of therapy in subjects with active lupus nephritis.
What does the Aurora study involve?
Approximately 324 participants with biopsy confirmed lupus nephritis will be enrolled in this study at multiple sites around the world. Participants will be randomized to receive either voclosporin (23.7mg twice daily) or placebo as study drug. Neither participant nor the study doctor will know if you are taking voclosporin or placebo during the study.
All participants will also receive standard medication of mycophenolate mofetil (e.g., Cellcept®) and steroid medication in addition to the study drug or placebo 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. Patients may be eligible to participate in an extension study after the initial 12-month treatment period is over. Study assessment and procedures will be provided at no cost to participants.
To consider participation in this study you must:
- be 18 to 75 years of age
- not have had a kidney transplant
- not be on renal dialysis
- currently be taking corticosteroids
- have a diagnosis of systemic lupus erythematosus (SLE)
- be spilling protein in your urine
- have had a previous kidney biopsy
If you have any of the following, you may not be able to participate in the study:
- 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
To find out more about the Aurora study, visit auroraLNstudy.com or auriniapharma.com/for-patients-physicians/clinical-trials.
The Lupus Foundation of America works to educate and inform about clinical trial study options available to people with lupus and the importance of getting involved to help advance lupus research. The Lupus Foundation of America does not endorse specific trials.