Voclosporin in Adolescent and Pediatric Subjects With Lupus Nephritis
NCT05288855 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 9
Last updated 2026-02-10
Summary
The purpose of this study is to assess the efficacy and safety of voclosporin compared to placebo in achieving renal response following 24 weeks of therapy in adolescent and pediatric subjects with active lupus nephritis (LN).
Conditions
- Adolescent Lupus Nephritis
- Pediatric Lupus Nephritis
Interventions
- DRUG
-
Voclosporin
calcineurin inhibitor
- DRUG
-
Placebo Oral Capsule
matching placebo capsule
Sponsors & Collaborators
-
Aurinia Pharmaceuticals Inc.
lead INDUSTRY
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- QUADRUPLE
- Model
- SEQUENTIAL
Eligibility
- Min Age
- 5 Years
- Max Age
- 17 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2023-10-10
- Primary Completion
- 2025-07-03
- Completion
- 2025-07-03
- FDA Drug
- Yes
Countries
- United States
- Colombia
- Japan
- Mexico
- Thailand
Study Locations
More Related Trials
-
An Efficacy and Safety Study of Intravenous Anifrolumab to Treat Systemic Lupus Erythematosus in Pediatric Participants
NCT05835310 ·Status: RECRUITING ·Phase: PHASE3
-
AURA-LV: Aurinia Urinary Protein Reduction Active - Lupus With Voclosporin (AURA-LV)
NCT02141672 ·Status: COMPLETED ·Phase: PHASE2
-
Etanercept for the Treatment of Lupus Nephritis
NCT00447265 ·Status: TERMINATED ·Phase: PHASE2
-
A Study to Evaluate the Safety and Efficacy of Obinutuzumab Compared With Placebo in Participants With Lupus Nephritis (LN)
NCT02550652 ·Status: COMPLETED ·Phase: PHASE2
-
A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Obinutuzumab in Adolescents With Active Class III or IV Lupus Nephritis and the Safety and PK of Obinutuzumab in Pediatric Participants
NCT05039619 ·Status: RECRUITING ·Phase: PHASE2
-
Safety and Efficacy of Combination Belimumab and Voclosporin in the Treatment of Proliferative Forms of Lupus Glomerulopathy: Synergy Trial
NCT07225387 ·Status: RECRUITING ·Phase: PHASE4
-
The Pediatric Lupus Nephritis Mycophenolate Mofetil (PLUMM) Study
NCT05538208 ·Status: RECRUITING ·Phase: PHASE2
-
A Study to Evaluate the Efficacy and Safety of Obinutuzumab in Participants With ISN/RPS 2003 Class III or IV Lupus Nephritis
NCT04221477 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE3
-
A Study of QLG1074 Combined With Background Therapy in Subjects With Active Lupus Nephritis
NCT06406205 ·Status: RECRUITING ·Phase: PHASE3
-
Five-Year Actively Controlled Clinical Trial in New Onset Juvenile Systemic Lupus Erythematosus Nephritis
NCT00336414 ·Status: WITHDRAWN ·Phase: PHASE3
-
ALPN-101 (Acazicolcept) in Systemic Lupus Erythematosus
NCT04835441 ·Status: COMPLETED ·Phase: PHASE2
-
Phase 3 Study of Tacrolimus (FK506) for Lupus Nephritis: A Placebo Controlled, Double-Blind Multicenter, Comparative Study
NCT00429377 ·Status: COMPLETED ·Phase: PHASE3
-
Study of Efficacy and Safety of LNP023 in Participants With Active Lupus Nephritis Class III-IV, +/- V
NCT05268289 ·Status: RECRUITING ·Phase: PHASE2
-
Safety and Efficacy Study of LJP 394 (Abetimus Sodium) to Treat Lupus Kidney Disease
NCT00035308 ·Status: COMPLETED ·Phase: PHASE3
-
A Study of Laquinimod in Participants With Systemic Lupus Erythematosus (SLE) Active Lupus Nephritis
NCT01085097 ·Status: COMPLETED ·Phase: PHASE2
-
Clinical Trial Treatment in Lupus Nephritis
NCT01299922 ·Status: WITHDRAWN ·Phase: PHASE3
-
Dose Finding, Efficacy and Safety of BI 655064 in Patients With Active Lupus Nephritis
NCT02770170 ·Status: COMPLETED ·Phase: PHASE2
-
Efficacy and Safety of Enteric-coated Mycophenolate Sodium in Combination With Two Corticosteroid Regimens for the Treatment of Lupus Nephritis Flare
NCT00423098 ·Status: COMPLETED ·Phase: PHASE2
-
A Study to Compare the Efficacy and Safety of Tacrolimus Capsules With Leflunomide Tablets in Lupus Nephritis Patients
NCT01342016 ·Status: TERMINATED ·Phase: PHASE3
-
An Efficacy and Safety Study of CNTO 136 in Patients With Active Lupus Nephritis
NCT01273389 ·Status: COMPLETED ·Phase: PHASE2
-
A Study to Evaluate the Efficacy and Safety of CC-220 in Subjects With Active Systemic Lupus Erythematosus
NCT03161483 ·Status: COMPLETED ·Phase: PHASE2
-
A Study in Participants With Active Systemic Lupus Erythematosus With Inadequate Response to Glucocorticoids and ≥2 Immunosuppressants
NCT07175285 ·Status: RECRUITING
-
Safety, Efficacy and Tolerability of Ianalumab Versus Placebo, Combination With SoC Therapy, in Participants With Active Lupus Nephritis
NCT05126277 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE3
-
An Exploratory Maintenance Trial of BI 655064 in Patients With Lupus Nephritis
NCT03385564 ·Status: COMPLETED ·Phase: PHASE2
-
LUPKYNIS Drug-use Results Survey
NCT07053891 ·Status: RECRUITING