Aurinia Renal Assessments 2: Aurinia Renal Response in Lupus With Voclosporin

NCT03597464 | Completed Phase 3 Results DMC FDA Drug

• 1 other identifier: AUR-VCS-2016-02
• Study Type: interventional
• Target: 216
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Lupus Nephritis

Keywords

lupus nephritis; calcineurin inhibitors; voclosporin

Outcome Measures

Primary Outcomes (1)

• Adverse Events (AE) Profile and Routine Biochemical and Hematological Assessments.

  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 Outcomes (8)

• Number (and Percent) of Subjects in Renal Response

  Months 12 (AURORA 2 Baseline), 18, 24, 30 and 36

• Number (and Percent) of Subjects in Partial Renal Response

  Months 12 (AURORA 2 baseline), 18, 24, 30 and 36

• Renal Flare as Adjudicated by the Clinical Endpoints Committee (CEC).

  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)

  Months 18, 24 and 36

• Change From AURORA 1 Baseline (i.e., Month 0) in Urine Protein to Creatinine Ratio (UPCR)

  Months 12 (AURORA 2 baseline), 18, 24, 30 and 36

Study Arms (2)

Voclosporin

EXPERIMENTAL

Voclosporin

Drug: Voclosporin

Placebo Oral Capsule

PLACEBO COMPARATOR

Placebo

Drug: Placebo Oral Capsule

Interventions

Voclosporin DRUG

Calcineurin inhibitor, oral, 23.7 mg twice daily (BID)

Also known as: ISA247

Voclosporin

Placebo Oral Capsule DRUG

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

Placebo Oral Capsule

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• Written informed consent before any study-specific procedures were performed.
• In the opinion of the investigator, subject required continued immunosuppressive therapy.
• Women of childbearing potential must continue to use effective contraception and have a negative urine pregnancy test at Month 12.
• Subject is willing to continue taking oral mycophenolate mofetil (MMF) for the duration of the study.

You may not qualify if:

• 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.
• Subjects currently requiring renal dialysis (hemodialysis or peritoneal dialysis) or expected to require dialysis during the study period.
• A planned kidney transplant within study treatment period.
• 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.
• Subjects who are pregnant, breast feeding or, if of childbearing potential, not using adequate contraceptive precautions.
• Vaccines using live organisms, virus or bacterial, while taking the study treatment.

Sponsors & Collaborators

• Aurinia Pharmaceuticals Inc.: lead

Study Sites (1)

AURORA Investigative Center

Oklahoma City, Oklahoma, 73104, United States

Location

Related Publications (7)

• Rovin BH, Parikh SV, Hebert LA, Chan TM, Mok CC, Ginzler EM, Hooi LS, Brunetta P, Maciuca R, Solomons N. Lupus nephritis: induction therapy in severe lupus nephritis--should MMF be considered the drug of choice? Clin J Am Soc Nephrol. 2013 Jan;8(1):147-53. doi: 10.2215/CJN.03290412. Epub 2012 Aug 9.

  PMID: 22879439 BACKGROUND

• Dooley MA, Jayne D, Ginzler EM, Isenberg D, Olsen NJ, Wofsy D, Eitner F, Appel GB, Contreras G, Lisk L, Solomons N; ALMS Group. Mycophenolate versus azathioprine as maintenance therapy for lupus nephritis. N Engl J Med. 2011 Nov 17;365(20):1886-95. doi: 10.1056/NEJMoa1014460.

  PMID: 22087680 BACKGROUND

• Ling SY, Huizinga RB, Mayo PR, Larouche R, Freitag DG, Aspeslet LJ, Foster RT. Cytochrome P450 3A and P-glycoprotein drug-drug interactions with voclosporin. Br J Clin Pharmacol. 2014 Jun;77(6):1039-50. doi: 10.1111/bcp.12309.

  PMID: 24330024 BACKGROUND

• Ling SY, Huizinga RB, Mayo PR, Freitag DG, Aspeslet LJ, Foster RT. Pharmacokinetics of voclosporin in renal impairment and hepatic impairment. J Clin Pharmacol. 2013 Dec;53(12):1303-12. doi: 10.1002/jcph.166. Epub 2013 Oct 8.

  PMID: 23996158 BACKGROUND

• Mayo PR, Huizinga RB, Ling SY, Freitag DG, Aspeslet LJ, Foster RT. Voclosporin food effect and single oral ascending dose pharmacokinetic and pharmacodynamic studies in healthy human subjects. J Clin Pharmacol. 2013 Aug;53(8):819-26. doi: 10.1002/jcph.114. Epub 2013 Jun 4.

  PMID: 23736966 BACKGROUND

• Busque S, Cantarovich M, Mulgaonkar S, Gaston R, Gaber AO, Mayo PR, Ling S, Huizinga RB, Meier-Kriesche HU; PROMISE Investigators. The PROMISE study: a phase 2b multicenter study of voclosporin (ISA247) versus tacrolimus in de novo kidney transplantation. Am J Transplant. 2011 Dec;11(12):2675-84. doi: 10.1111/j.1600-6143.2011.03763.x. Epub 2011 Sep 22.

  PMID: 21943027 BACKGROUND

• Avasare R, Drexler Y, Caster DJ, Mitrofanova A, Jefferson JA. Management of Lupus Nephritis: New Treatments and Updated Guidelines. Kidney360. 2023 Oct 1;4(10):1503-1511. doi: 10.34067/KID.0000000000000230.

  PMID: 37528520 DERIVED

MeSH Terms

Conditions

Lupus Nephritis

Interventions

voclosporin

Condition Hierarchy (Ancestors)

Glomerulonephritis; Nephritis; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lupus Erythematosus, Systemic; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Results Point of Contact

• Title: Clinical Trials Information
• Organization: Aurinia Pharmaceuticals

clinicaltrials@auriniapharma.com

1 (250) 744-2487

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 25, 2018
• First Posted: July 24, 2018
• Study Start: September 29, 2019
• Primary Completion: October 7, 2021
• Study Completion: October 7, 2021
• Last Updated: December 14, 2022
• Results First Posted: December 14, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)