Aurinia Renal Assessments 2: Aurinia Renal Response in Lupus With Voclosporin (AURORA 2)

November 17, 2022 updated by: Aurinia Pharmaceuticals Inc.

A Randomized, Controlled, Double-blind, Continuation Study Comparing the Long-term Safety and Efficacy of Voclosporin (23.7 mg Twice Daily) With Placebo in Subjects With Lupus Nephritis

The purpose of this study is assess the long-term safety and tolerability of voclosporin compared with placebo for up to an additional 24 months following completion of treatment in the AURORA 1 study in subjects with lupus nephritis (LN).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The aim of the Phase 3 continuation study (AURORA 2) is to assess the long-term safety and tolerability of voclosporin, added to the standard of care treatment in LN, for an additional 24 months, following a treatment period of 52 weeks in the AURORA 1 study (AUR-VCS-2016-01). All subjects will continue to receive background therapy of mycophenolate mofetil (MMF) and/or oral corticosteroids starting at the same dose as at the end of the AURORA 1 study. Subjects with LN, who have completed 52 weeks of treatment with study drug in the AURORA 1 study, will be eligible to enter the study. The long-term safety and tolerability of the drug combination will be assessed from its safety profile while demonstrating the continued ability to achieve and maintain long-term renal response.

Study Type

Interventional

Enrollment (Actual)

216

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73104
        • AURORA Investigative Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 71 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Subjects who have completed 52 weeks of treatment with study drug in the AURORA 1 study. Subjects who had a temporary interruption and successfully restarted study drug during the AURORA 1 study will be allowed with Medical Monitor approval.
  2. Written informed consent before any study-specific procedures were performed.
  3. In the opinion of the investigator, subject required continued immunosuppressive therapy.
  4. Women of childbearing potential must continue to use effective contraception and have a negative urine pregnancy test at Month 12.
  5. Subject is willing to continue taking oral mycophenolate mofetil (MMF) for the duration of the study.

Exclusion Criteria:

  1. Currently taking or known need for any of the medications or food items listed in Section 7.8, Prohibited Therapy and Concomitant Treatment during the study.
  2. Subjects currently requiring renal dialysis (hemodialysis or peritoneal dialysis) or expected to require dialysis during the study period.
  3. A planned kidney transplant within study treatment period.
  4. Subjects with any medical condition which, in the Investigator's judgment, may be associated with increased risk to the subject or may interfere with study assessments or outcomes.
  5. Subjects who are pregnant, breast feeding or, if of childbearing potential, not using adequate contraceptive precautions.
  6. Vaccines using live organisms, virus or bacterial, while taking the study treatment.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Voclosporin
Drug: Voclosporin
Calcineurin inhibitor, oral, 23.7 mg twice daily (BID)
Other Names:
  • ISA247
Placebo Comparator: Placebo Oral Capsule
Placebo
Drug: Placebo Oral Capsule
Voclosporin placebo, oral, 3 capsules twice daily (BID)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adverse Events (AE) Profile and Routine Biochemical and Hematological Assessments.
Time Frame: Month 12 (AURORA 2 baseline) to Month 36

Number (and percent) of adverse events experienced during the AURORA 2 treatment period.

To assess the long-term safety and tolerability of voclosporin compared with placebo for up to an additional 24 months following completion of treatment in the AURORA 1 study in subjects with LN.
Month 12 (AURORA 2 baseline) to Month 36

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number (and Percent) of Subjects in Renal Response
Time Frame: Months 12 (AURORA 2 Baseline), 18, 24, 30 and 36

Proportion of subjects in renal response defined as:

  • urine protein creatinine ratio (UPCR) of ≤0.5 mg/mg
  • estimated glomerular filtration rate (eGFR) ≥60 mL/min/1.73 m^2 or no confirmed decrease from baseline in eGFR of >20%
  • Received no rescue medication for LN
  • Did not receive more than 10 mg prednisone for ≥3 consecutive days or for ≥7 days in total during the 8 weeks prior to the renal response assessment.
Months 12 (AURORA 2 Baseline), 18, 24, 30 and 36
Number (and Percent) of Subjects in Partial Renal Response
Time Frame: Months 12 (AURORA 2 baseline), 18, 24, 30 and 36
Partial renal response defined as a 50% reduction from baseline in urine protein creatinine ratio (UPCR).
Months 12 (AURORA 2 baseline), 18, 24, 30 and 36
Renal Flare as Adjudicated by the Clinical Endpoints Committee (CEC).
Time Frame: Month 12 (AURORA 2 baseline) to Month 36

A patient could experience a flare from the point they achieved a response (or recovery). Renal flares were judged according to the following criteria:

  • A reproducible increase to UPCR >1 mg/mg from a post-response baseline of <0.2 mg/mg or
  • an increase to UPCR >2 mg/mg from a post-response baseline between 0.2 to 1.0 mg/mg or
  • a doubling of UPCR for baseline values of UPCR >1 mg/mg
Month 12 (AURORA 2 baseline) to Month 36
Change From AURORA 1 Baseline (i.e., Month 0) in Safety of Estrogens in Lupus Erythematosus National Assessment Systemic Lupus Erythematosus Disease Activity Index (SELENA-SLEDAI)
Time Frame: Months 18, 24 and 36

Participants analyzed included all subjects who were randomized treatment during AURORA 1 AND who consented to continue their treatment in AURORA 2. Baseline values were collected at the start of AURORA 1 but only for those subjects that continued in AURORA 2.

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.
Months 18, 24 and 36
Change From AURORA 1 Baseline (i.e., Month 0) in Urine Protein to Creatinine Ratio (UPCR)
Time Frame: Months 12 (AURORA 2 baseline), 18, 24, 30 and 36

Participants analyzed included all subjects who were randomized treatment during AURORA 1 AND who consented to continue their treatment in AURORA 2. Baseline values were collected at the start of AURORA 1 but only for those subjects that continued in AURORA 2.

Reductions in UPCR are indicative of better renal outcomes.
Months 12 (AURORA 2 baseline), 18, 24, 30 and 36
Change From AURORA 1 Baseline (i.e., Month 0) in Estimated Glomerular Filtration Rate (eGFR)
Time Frame: Months 12 (AURORA 2 baseline), 18, 24, 30 and 36

Participants analyzed included all subjects who were randomized treatment during AURORA 1 AND who consented to continue their treatment in AURORA 2. Baseline values were collected at the start of AURORA 1 but only for those subjects that continued in AURORA 2.

This endpoint incorporated Corrected eGFR values with a ceiling set to 90 mL/min/1.73 m^2

Increases in eGFR levels are indicative of better renal outcomes.
Months 12 (AURORA 2 baseline), 18, 24, 30 and 36
Change From AURORA 1 Baseline (i.e., Month 0) in Urine Protein
Time Frame: Months 12 (AURORA 2 baseline), 18, 24, 30 and 36

Participants analyzed included all subjects who were randomized treatment during AURORA 1 AND who consented to continue their treatment in AURORA 2. Baseline values were collected at the start of AURORA 1 but only for those subjects that continued in AURORA 2.

Reductions in Urine Protein levels are indicative of better renal outcomes.
Months 12 (AURORA 2 baseline), 18, 24, 30 and 36
Change From AURORA 1 Baseline (i.e., Month 0) in Serum Creatinine (SCr)
Time Frame: Months 12 (AURORA 2 baseline), 18, 24, 30 and 36

Participants analyzed included all subjects who were randomized treatment during AURORA 1 AND who consented to continue their treatment in AURORA 2. Baseline values were collected at the start of AURORA 1 but only for those subjects that continued in AURORA 2.

Decreases in SCr levels can be indicative of better renal outcomes.
Months 12 (AURORA 2 baseline), 18, 24, 30 and 36

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Aurinia Pharmaceuticals Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 29, 2019

Primary Completion (Actual)

October 7, 2021

Study Completion (Actual)

October 7, 2021

Study Registration Dates

First Submitted

June 25, 2018

First Submitted That Met QC Criteria

July 13, 2018

First Posted (Actual)

July 24, 2018

Study Record Updates

Last Update Posted (Estimate)

December 14, 2022

Last Update Submitted That Met QC Criteria

November 17, 2022

Last Verified

November 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AUR-VCS-2016-02

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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