Voclosporin Evidence: Trial Results and Peer-Reviewed Publications

Hipa.ai Research · Source: PubMed & ClinicalTrials.gov / AACT · Last updated:

The clinical evidence base for Voclosporin comprises 19 peer-reviewed publications across 14 journals, 4 pivotal-trial primary-outcome rows reported to ClinicalTrials.gov, spanning indications including Lupus Nephritis, Chronic Disease, Kidney Diseases, and Glomerulosclerosis, Focal Segmental. Most recent publication: The kidney injury biomarker profile of patients with lupus nephritis remains unchanged with the second-generation calcineurin inhibitor voclosporin., Front Nephrol, 2025.

Top peer-reviewed publications

Curated set of pivotal-trial result papers and recent publications in high-tier journals.

  1. Mycophenolate versus azathioprine as maintenance therapy for lupus nephritis.
    Dooley MA, Jayne D, Ginzler EM, et al. · N Engl J Med · 2011
    PubMed: PMID 22087680 · NCT03021499 (AURORA) · Lupus Nephritis
  2. The PROMISE study: a phase 2b multicenter study of voclosporin (ISA247) versus tacrolimus in de novo kidney transplantation.
    Busque S, Cantarovich M, Mulgaonkar S, et al. · Am J Transplant · 2012
    PubMed: PMID 21943027 · NCT03021499 (AURORA) · Lupus Nephritis
  3. Efficacy and safety of voclosporin versus placebo for lupus nephritis (AURORA 1): a double-blind, randomised, multicentre, placebo-controlled, phase 3 trial.
    Rovin BH, Teng YKO, Ginzler EM, et al. · Lancet · 2022
    PubMed: PMID 33971155 · NCT03021499 (AURORA) · Lupus Nephritis
  4. Efficacy of ISA247 in plaque psoriasis: a randomised, multicentre, double-blind, placebo-controlled phase III study.
    Papp K, Bissonnette R, Rosoph L, et al. · Lancet · 2008
    PubMed: PMID 18424323 · NCT00244842 (SPIRIT) · Chronic Disease
  5. The kidney injury biomarker profile of patients with lupus nephritis remains unchanged with the second-generation calcineurin inhibitor voclosporin.
    Palmer BF, Tumlin JA, Radhakrishnan J, et al. · Front Nephrol · 2025
    PubMed: PMID 40166657 · NCT03021499 (AURORA) · Lupus Nephritis
  6. Efficacy of Voclosporin in Proliferative Lupus Nephritis with High Levels of Proteinuria.
    Menn-Josephy H, Hodge LS, Birardi V, et al. · Clin J Am Soc Nephrol · 2024
    PubMed: PMID 38110196 · NCT03021499 (AURORA) · Lupus Nephritis
  7. Population PKPD of voclosporin in renal allograft patients.
    Mayo PR, Ling SY, Huizinga RB, et al. · J Clin Pharmacol · 2015
    PubMed: PMID 24243422 · NCT00270634 (PROMISE) · Kidney Diseases
  8. Management of Lupus Nephritis: New Treatments and Updated Guidelines.
    Avasare R, Drexler Y, Caster DJ, et al. · Kidney360 · 2023
    PubMed: PMID 37528520 · NCT03597464 (AURORA 2) · Lupus Nephritis

Primary-outcome results across pivotal trials

Per-arm reported values from Phase 2/3 and Phase 3 trials with results posted to ClinicalTrials.gov.

TrialIndicationPrimary endpointArmValue
NCT00244842
SPIRIT
Chronic DiseaseProportion of Subjects Achieving a PASI-75 at 12 Weeks at Each of the 3 Dose Levels of Voclosporin.
Twelve Weeks
Placebo4 Participants
Voclosporin 0.214 Participants
Voclosporin 0.326 Participants
Voclosporin 0.444 Participants
NCT03021499
AURORA
Lupus NephritisNumber of Participants With Adjudicated Renal Response at Week 52
52 Weeks
Placebo Oral Capsule40 Participants
Placebo Oral Capsule138 Participants
Voclosporin106 Participants
Voclosporin73 Participants
NCT03597464
AURORA 2
Lupus NephritisAdverse Events (AE) Profile and Routine Biochemical and Hematological Assessments.
Month 12 (AURORA 2 baseline) to Month 36
Placebo Oral Capsule17 Participants
Placebo Oral Capsule3 Participants
Placebo Oral Capsule0 Participants
Placebo Oral Capsule34 Participants
Placebo Oral Capsule11 Participants
Placebo Oral Capsule80 Participants
Placebo Oral Capsule21 Participants
Placebo Oral Capsule23 Participants
Voclosporin11 Participants
Voclosporin100 Participants
Voclosporin28 Participants
Voclosporin21 Participants
Voclosporin0 Participants
Voclosporin0 Participants
Voclosporin50 Participants
Voclosporin7 Participants
NCT04147650
AUDREY
Dry Eye SyndromesNumber of Subjects With a ≥10 mm Increase From Baseline in Schirmer Tear Test (STT)
4 Weeks
0.05% Voclosporin Ophthalmic Solution (VOS)12 participants
0.10% VOS10 participants
0.20% VOS13 participants
Vehicle Ophthalmic Solution6 participants

Publications by year

2004–2025: 19 publications.

2004
2
2005
1
2006
1
2008
1
2009
1
2011
2
2012
1
2013
1
2014
2
2015
2
2019
1
2022
1
2023
1
2024
1
2025
1

Publications by indication

Lupus Nephritis (9)

  • The kidney injury biomarker profile of patients with lupus nephritis remains unchanged with the second-generation calcineurin inhibitor voclosporin.
    Front Nephrol · 2025 · PMID 40166657 · NCT03021499
  • Efficacy of Voclosporin in Proliferative Lupus Nephritis with High Levels of Proteinuria.
    Clin J Am Soc Nephrol · 2024 · PMID 38110196 · NCT03021499
  • Management of Lupus Nephritis: New Treatments and Updated Guidelines.
    Kidney360 · 2023 · PMID 37528520 · NCT03597464
  • Efficacy and safety of voclosporin versus placebo for lupus nephritis (AURORA 1): a double-blind, randomised, multicentre, placebo-controlled, phase 3 trial.
    Lancet · 2022 · PMID 33971155 · NCT03021499
  • Pharmacokinetics of voclosporin in renal impairment and hepatic impairment.
    J Clin Pharmacol · 2014 · PMID 23996158 · NCT03597464

Chronic Disease (3)

  • ISATX247: a novel calcineurin inhibitor.
    J Heart Lung Transplant · 2019 · PMID 11250240 · NCT00408187
  • Efficacy of ISA247 in plaque psoriasis: a randomised, multicentre, double-blind, placebo-controlled phase III study.
    Lancet · 2008 · PMID 18424323 · NCT00244842
  • A randomized, multicenter, double-blind, placebo-controlled phase 2 trial of ISA247 in patients with chronic plaque psoriasis.
    J Am Acad Dermatol · 2006 · PMID 16488299 · NCT00408187

Kidney Diseases (3)

  • Population PKPD of voclosporin in renal allograft patients.
    J Clin Pharmacol · 2015 · PMID 24243422 · NCT00270634
  • In vivo evaluation of the novel calcineurin inhibitor ISATX247 in non-human primates.
    J Heart Lung Transplant · 2004 · PMID 14672749 · NCT00270634
  • Compared with cyclosporine, ISATX247 significantly prolongs renal-allograft survival in a nonhuman primate model.
    Transplantation · 2004 · PMID 15371668 · NCT00270634

Glomerulosclerosis, Focal Segmental (2)

  • Cytochrome P450 3A and P-glycoprotein drug-drug interactions with voclosporin.
    Br J Clin Pharmacol · 2015 · PMID 24330024 · NCT03598036
  • Voclosporin food effect and single oral ascending dose pharmacokinetic and pharmacodynamic studies in healthy human subjects.
    J Clin Pharmacol · 2014 · PMID 23736966 · NCT03598036

Publications by journal

Trial-results highlights

In the SPIRIT study, NCT00244842, which investigated chronic disease, the proportion of subjects achieving a PASI-75 at 12 weeks was measured. In the placebo arm, **4 participants** achieved this outcome. For the Voclosporin arms, **14 participants** in the 0.2 dose level, **26 participants** in the 0.3 dose level, and **44 participants** in the 0.4 dose level achieved a PASI-75 at 12 weeks.

For lupus nephritis, two studies provided data. In the AURORA study, NCT03021499, the number of participants with adjudicated renal response at Week 52 was reported. In the Placebo Oral Capsule arm, **40 participants** and **138 participants** achieved this response. For the **Voclosporin** arm, **106 participants** and **73 participants** achieved this response. The AURORA 2 study, NCT03597464, focused on the adverse events profile and routine biochemical and hematological assessments from Month 12 to Month 36. In the Placebo Oral Capsule arm, participant counts related to these assessments included:

  • 17 participants
  • 3 participants
  • 0 participants
  • 34 participants
  • 11 participants
  • 80 participants

In the AUDREY study, NCT04147650, for dry eye syndromes, the number of subjects with a ≥10 mm increase from baseline in Schirmer Tear Test (STT) at 4 weeks was evaluated. In the Vehicle Ophthalmic Solution arm, **6 participants** achieved this increase. For the **Voclosporin Ophthalmic Solution (VOS)** arms, **12 participants** in the 0.05% VOS arm, **10 participants** in the 0.10% VOS arm, and **13 participants** in the 0.20% VOS arm showed this increase. All values presented are sourced from primary registry reporting; individual papers should be consulted for clinical decisions.

All Voclosporin publications (19)

2025 (1 paper)

  1. The kidney injury biomarker profile of patients with lupus nephritis remains unchanged with the second-generation calcineurin inhibitor voclosporin.
    Palmer BF, Tumlin JA, Radhakrishnan J, et al. · Front Nephrol · 2025 · Derived
    PubMed: PMID 40166657 · NCT03021499 (AURORA) · Lupus Nephritis

2024 (1 paper)

  1. Efficacy of Voclosporin in Proliferative Lupus Nephritis with High Levels of Proteinuria.
    Menn-Josephy H, Hodge LS, Birardi V, et al. · Clin J Am Soc Nephrol · 2024 · Derived
    PubMed: PMID 38110196 · NCT03021499 (AURORA) · Lupus Nephritis

2023 (1 paper)

  1. Management of Lupus Nephritis: New Treatments and Updated Guidelines.
    Avasare R, Drexler Y, Caster DJ, et al. · Kidney360 · 2023 · Derived
    PubMed: PMID 37528520 · NCT03597464 (AURORA 2) · Lupus Nephritis

2022 (1 paper)

  1. Efficacy and safety of voclosporin versus placebo for lupus nephritis (AURORA 1): a double-blind, randomised, multicentre, placebo-controlled, phase 3 trial.
    Rovin BH, Teng YKO, Ginzler EM, et al. · Lancet · 2022 · Derived
    PubMed: PMID 33971155 · NCT03021499 (AURORA) · Lupus Nephritis

2019 (1 paper)

  1. ISATX247: a novel calcineurin inhibitor.
    Abel MD, Aspeslet LJ, Freitag DG, et al. · J Heart Lung Transplant · 2019 · Background
    PubMed: PMID 11250240 · NCT00408187 (ESSENCE) · Chronic Disease

2015 (2 papers)

  1. Population PKPD of voclosporin in renal allograft patients.
    Mayo PR, Ling SY, Huizinga RB, et al. · J Clin Pharmacol · 2015 · Derived
    PubMed: PMID 24243422 · NCT00270634 (PROMISE) · Kidney Diseases
  2. Cytochrome P450 3A and P-glycoprotein drug-drug interactions with voclosporin.
    Ling SY, Huizinga RB, Mayo PR, et al. · Br J Clin Pharmacol · 2015 · Background
    PubMed: PMID 24330024 · NCT03598036 (AURONA™) · Glomerulosclerosis, Focal Segmental

2014 (2 papers)

  1. Voclosporin food effect and single oral ascending dose pharmacokinetic and pharmacodynamic studies in healthy human subjects.
    Mayo PR, Huizinga RB, Ling SY, et al. · J Clin Pharmacol · 2014 · Background
    PubMed: PMID 23736966 · NCT03598036 (AURONA™) · Glomerulosclerosis, Focal Segmental
  2. Pharmacokinetics of voclosporin in renal impairment and hepatic impairment.
    Ling SY, Huizinga RB, Mayo PR, et al. · J Clin Pharmacol · 2014 · Background
    PubMed: PMID 23996158 · NCT03597464 (AURORA 2) · Lupus Nephritis

2013 (1 paper)

  1. Lupus nephritis: induction therapy in severe lupus nephritis--should MMF be considered the drug of choice?
    Rovin BH, Parikh SV, Hebert LA, et al. · Clin J Am Soc Nephrol · 2013 · Background
    PubMed: PMID 22879439 · NCT03597464 (AURORA 2) · Lupus Nephritis

2012 (1 paper)

  1. The PROMISE study: a phase 2b multicenter study of voclosporin (ISA247) versus tacrolimus in de novo kidney transplantation.
    Busque S, Cantarovich M, Mulgaonkar S, et al. · Am J Transplant · 2012 · Trial result
    PubMed: PMID 21943027 · NCT03021499 (AURORA) · Lupus Nephritis

2011 (2 papers)

  1. Mycophenolate versus azathioprine as maintenance therapy for lupus nephritis.
    Dooley MA, Jayne D, Ginzler EM, et al. · N Engl J Med · 2011 · Trial result
    PubMed: PMID 22087680 · NCT03021499 (AURORA) · Lupus Nephritis
  2. Structural basis for the cyclophilin A binding affinity and immunosuppressive potency of E-ISA247 (voclosporin).
    Kuglstatter A, Mueller F, Kusznir E, et al. · Acta Crystallogr D Biol Crystallogr · 2011 · Background
    PubMed: PMID 21245533 · NCT01586845 (INSPIRE)

2009 (1 paper)

  1. Mycophenolate mofetil versus cyclophosphamide for induction treatment of lupus nephritis.
    Appel GB, Contreras G, Dooley MA, et al. · J Am Soc Nephrol · 2009 · Background
    PubMed: PMID 19369404 · NCT02141672 (AURA-LV) · Lupus Nephritis

2008 (1 paper)

  1. Efficacy of ISA247 in plaque psoriasis: a randomised, multicentre, double-blind, placebo-controlled phase III study.
    Papp K, Bissonnette R, Rosoph L, et al. · Lancet · 2008 · Derived
    PubMed: PMID 18424323 · NCT00244842 (SPIRIT) · Chronic Disease

2006 (1 paper)

  1. A randomized, multicenter, double-blind, placebo-controlled phase 2 trial of ISA247 in patients with chronic plaque psoriasis.
    Bissonnette R, Papp K, Poulin Y, et al. · J Am Acad Dermatol · 2006 · Background
    PubMed: PMID 16488299 · NCT00408187 (ESSENCE) · Chronic Disease

2005 (1 paper)

  1. The novel calcineurin inhibitor ISA247: a more potent immunosuppressant than cyclosporine in vitro.
    Bîrsan T, Dambrin C, Freitag DG, et al. · Transpl Int · 2005 · Background
    PubMed: PMID 15827754 · NCT01586845 (INSPIRE)

2004 (2 papers)

  1. In vivo evaluation of the novel calcineurin inhibitor ISATX247 in non-human primates.
    Stalder M, Bîrsan T, Hubble RW, et al. · J Heart Lung Transplant · 2004 · Background
    PubMed: PMID 14672749 · NCT00270634 (PROMISE) · Kidney Diseases
  2. Compared with cyclosporine, ISATX247 significantly prolongs renal-allograft survival in a nonhuman primate model.
    Gregory CR, Kyles AE, Bernsteen L, et al. · Transplantation · 2004 · Background
    PubMed: PMID 15371668 · NCT00270634 (PROMISE) · Kidney Diseases

Sources and methodology

This page summarizes published evidence for general reference and does not constitute medical advice. For clinical decisions, consult the linked primary publications and your healthcare provider. Data sourced from PubMed and the ClinicalTrials.gov / AACT database maintained by the Clinical Trials Transformation Initiative (CTTI).