Aurinia Renal Response in Active Lupus With Voclosporin (AURORA)

Aurinia Pharmaceuticals

Status and phase: Completed; Phase 3

Conditions: Lupus Nephritis

Treatments: Drug: Placebo Oral Capsule; Drug: Voclosporin

Study type: Interventional

Funder types: Industry

Identifiers

NCT03021499

AUR-VCS-2016-01

Details and patient eligibility

About

The purpose of this study is to assess the efficacy of voclosporin compared with placebo in achieving renal response after 52 weeks of therapy in subjects with active lupus nephritis.

Full description

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 mycophenolate mofetil (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.

Enrollment: 358 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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358 participants in 2 patient groups, including a placebo group

Voclosporin

Experimental group

Description:

oral, 23.7 mg twice daily (BID)

Treatment:

Drug: Voclosporin

Placebo Oral Capsule

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebo Oral Capsule