Voclosporin

DRUG18 trials

Sponsors

Novartis Pharma AG, Aurinia Pharmaceuticals Inc., Weill Medical College of Cornell University, Leiden University Medical Center, National Institute of Allergy and Infectious Diseases (NIAID)

Conditions

Adolescent Lupus NephritisCovid19Drug-drug InteractionFocal Segmental GlomerulosclerosisImmunosuppressionKidney DiseasesKidney Transplant InfectionLupus Nephritis

Phase 1

Voclosporin in Healthy Japanese Volunteers

CompletedNCT02949999

Aurinia Pharmaceuticals Inc.Volunteers

Start: 2016-10-31End: 2016-12-31Target: 40Updated: 2018-01-17

Drug-Drug Interaction Study to Investigate Effects of Voclosporin on Pharmacokinetics of Simvastatin

CompletedNCT05306379

Aurinia Pharmaceuticals Inc.Drug-drug Interaction

Start: 2022-01-24End: 2022-04-05Updated: 2022-04-20

Phase 2

Study of ISA247 (Voclosporin) in De Novo Renal Transplantation

CompletedNCT00270634

Aurinia Pharmaceuticals Inc.Kidney Diseases

Start: 2006-01-31End: 2009-07-31Updated: 2013-02-12

Aurinia Early Urinary Protein Reduction Predicts Response

CompletedNCT02949973

Aurinia Pharmaceuticals Inc.Lupus Nephritis

Start: 2015-06-30End: 2017-02-17Updated: 2021-03-19

Dose-Exploration Evaluating the Efficacy and Safety of Voclosporin in Subjects With Focal Segmental Glomerulosclerosis

TerminatedNCT03598036

Aurinia Pharmaceuticals Inc.Focal Segmental Glomerulosclerosis

Start: 2018-06-21End: 2020-05-19Updated: 2021-09-16

Anti-Viral Effects of Voclosporin in COVID-19 Positive Kidney Transplant Recipients

CompletedNCT04701528

Leiden University Medical CenterCovid19, Kidney Transplant Infection

Start: 2020-11-15End: 2022-10-25Updated: 2024-10-17

Examining Distinct Immunophenotypes to Validate and Enhance Rational Treatment in Systemic Lupus

TerminatedNCT05306873

National Institute of Allergy and Infectious Diseases (NIAID)Systemic Lupus Erythematosus

Start: 2022-11-30End: 2024-07-11Updated: 2025-09-09

A Phase 2, adaptive, randomized, open-label, assessor-blinded active-controlled study to evaluate the efficacy and safety of rapcabtagene autoleucel versus Standard of Care in patients suffering from systemic lupus erythematosus (SLE) with active, refractory lupus nephritis (LN).

RecruitingCTIS2023-510150-17-00

Novartis Pharma AGrefractory lupus nephritis (LN), systemic lupus erythematosus (SLE) with active

Start: 2024-12-11Target: 69Updated: 2025-08-04

Phase 3

Randomized Placebo-controlled Study of ISA247 in Plaque Psoriasis

CompletedNCT00244842

Aurinia Pharmaceuticals Inc.Psoriasis

Start: 2004-12-31End: 2005-10-31Updated: 2023-03-27

A 36-Week Extension to Protocol ISA04-03

CompletedNCT00258713

Aurinia Pharmaceuticals Inc.Psoriasis

Start: 2005-09-30End: 2006-07-31Updated: 2008-09-29

Randomized, Placebo and Ciclosporin Controlled Study of ISA247 in Plaque Psoriasis Patients

CompletedNCT00408187

Aurinia Pharmaceuticals Inc.Psoriasis

Start: 2006-12-31End: 2008-12-31Updated: 2009-07-30

Safety and Efficacy Study of Voclosporin and Tacrolimus in Transplantation

WithdrawnNCT01586845

Aurinia Pharmaceuticals Inc.Renal Transplantation

Start: 2013-03-31End: 2015-12-31Updated: 2014-01-20

Aurinia Renal Response in Active Lupus With Voclosporin

CompletedNCT03021499

Aurinia Pharmaceuticals Inc.Lupus Nephritis

Start: 2017-05-17End: 2019-10-10Updated: 2023-03-27

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

CompletedNCT03597464

Aurinia Pharmaceuticals Inc.Lupus Nephritis

Start: 2019-09-29End: 2021-10-07Updated: 2022-12-14

Voclosporin in Adolescent and Pediatric Subjects With Lupus Nephritis

TerminatedNCT05288855

Aurinia Pharmaceuticals Inc.Adolescent Lupus Nephritis, Pediatric Lupus Nephritis

Start: 2023-10-10End: 2025-07-03Updated: 2026-02-10

Long-Term Voclosporin Treatment in Adolescent and Pediatric Subjects With Lupus Nephritis

TerminatedNCT05962788

Aurinia Pharmaceuticals Inc.Adolescent Lupus Nephritis, Pediatric Lupus Nephritis

Start: 2024-03-28End: 2025-07-04Updated: 2026-02-10

Phase 4

Safety and Efficacy of Combination Belimumab and Voclosporin in the Treatment of Proliferative Forms of Lupus Glomerulopathy: Synergy Trial

RecruitingNCT07225387

NephroNet, Inc.Lupus Nephritis

Start: 2024-10-01End: 2027-01-31Target: 30Updated: 2025-11-06

Unknown Phase

Special Access for the Use of Voclosporin for Kidney Transplantation

Weill Medical College of Cornell UniversityImmunosuppression, Transplantation, Kidney

Updated: 2025-01-29

Related Papers

#1672 Cost-effectiveness analysis of voclosporin vs mycophenolate or belimumab in the treatment of patients with lupus nephritis from the Spanish National Healthcare System perspective

Nephrology Dialysis Transplantation2025-10-01

The kidney injury biomarker profile of patients with lupus nephritis remains unchanged with the second-generation calcineurin inhibitor voclosporin

Frontiers in Nephrology2025-03-173 citations

514 Voclosporin for lupus nephritis: interim analysis of the AURORA 2 extension study

Abstracts2021-11-012 citations

Efficacy and safety of voclosporin versus placebo for lupus nephritis (AURORA 1): a double-blind, randomised, multicentre, placebo-controlled, phase 3 trial.

2021-05-07358 citations

Comparison of standard of care treatment with a low steroid and mycophenolate mofetil regimen for lupus nephritis in the ALMS and AURA studies

Lupus2019-04-0125 citations

Efficacy of ISA247 in plaque psoriasis: a randomised, multicentre, double-blind, placebo-controlled phase III study.

2008-04-0153 citations