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NCT05288855: VOCAL
Voclosporin in Adolescent and Pediatric Subjects With Lupus Nephritis
Phase 3 trial testing Voclosporin in Adolescent Lupus Nephritis in 9 participants. Terminated before completion.
3 July 2025
Quick facts
| Lead sponsor | Aurinia Pharmaceuticals Inc. |
|---|---|
| Phase | Phase 3 |
| Status | Terminated |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | sequential |
| Masking | quadruple |
| Primary purpose | treatment |
| Enrollment | 9 |
| Start date | 10 October 2023 |
| Primary completion | 3 July 2025 |
| Estimated completion | 3 July 2025 |
| Sites | 6 locations across Colombia, Japan, Mexico, Thailand, United States |
Drugs / interventions tested
- Voclosporin — full drug profile →
- Placebo Oral Capsule
Conditions studied
- Adolescent Lupus Nephritis — all drugs for Adolescent Lupus Nephritis →
- Pediatric Lupus Nephritis — all drugs for Pediatric Lupus Nephritis →
Sponsor
Aurinia Pharmaceuticals Inc. — full company profile →
Who can join
Adults 5 to 17, any sex, with Adolescent Lupus Nephritis or Pediatric Lupus Nephritis. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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).
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
-
Systemic lupus erythematosus: updated insights on the pathogenesis, diagnosis, prevention and therapeutics.
Dai X, Fan Y, Zhao X. · · 2025 · cited 78× · PMID 40097390 · DOI 10.1038/s41392-025-02168-0 -
Systemic lupus erythematosus: pathogenesis and targeted therapy.
Su X, Yu H, Lei Q, Chen X, et al · · 2024 · cited 33× · PMID 39472388 · DOI 10.1186/s43556-024-00217-8 -
Juvenile-onset Systemic Lupus Erythematosus: Recent Advances in Pathogenesis and Treatment.
Natoli V, Charras A, Smith EM, Hedrich CM. · · 2025 · cited 1× · PMID 41410901 · DOI 10.1007/s11926-025-01207-7 -
Renal disease in pediatric rheumatology.
Cody E, Brunner HI. · · 2024 · cited 1× · PMID 38752864 · DOI 10.1097/bor.0000000000001027 -
Global perspectives on lupus nephritis: a review of clinical trials and therapeutic innovations.
Xu J, Zhang Y, Huang H, Cao Y. · · 2026 · PMID 42233033 · DOI 10.3389/fimmu.2026.1762892 -
Single-center experience of voclosporin use for pediatric lupus nephritis: a case series.
Hazan R, Tang Civilibal N, Baszis K, Bigley TM. · · 2026 · PMID 41834110 · DOI 10.1093/rheumatology/keag125 -
Pathogenesis, Treatment Advances, and Renal Outcomes in Childhood-Onset Lupus Nephritis.
Safdar A. · · 2026 · PMID 41709467 · DOI 10.1177/00099228261422294 -
The evolving landscape of rheumatic drugs and their indications in paediatric and adolescent care.
Ciurtin C, Sparchez M, Elephtheriou D, Brogan P. · · 2025 · PMID 40845184 · DOI 10.1093/rheumatology/keaf455
Verify or expand the search:
- PubMed search for NCT05288855
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Voclosporin
Trials testing the same drug.
- NCT05306873 — Examining Distinct Immunophenotypes to Validate and Enhance Rational Treatment in Systemic Lupus · Phase 2 · terminated
- NCT05306379 — Drug-Drug Interaction Study to Investigate Effects of Voclosporin on Pharmacokinetics of Simvastatin · Phase 1 · completed
- NCT04701528 — Anti-Viral Effects of Voclosporin in COVID-19 Positive Kidney Transplant Recipients · Phase 2 · completed
- NCT03597464 — Aurinia Renal Assessments 2: Aurinia Renal Response in Lupus With Voclosporin · Phase 3 · completed
- NCT03598036 — Dose-Exploration Evaluating the Efficacy and Safety of Voclosporin in Subjects With Focal Segmental Glomerulosclerosis · Phase 2 · terminated
Other Aurinia Pharmaceuticals Inc. trials
Trials by the same sponsor.
- NCT05962788 — Long-Term Voclosporin Treatment in Adolescent and Pediatric Subjects With Lupus Nephritis · Phase 3 · terminated
- NCT05337124 — A Prospective Observational Registry of Patients Treated With LUPKYNIS® (Voclosporin) in the US · completed
- NCT05306379 — Drug-Drug Interaction Study to Investigate Effects of Voclosporin on Pharmacokinetics of Simvastatin · Phase 1 · completed
- NCT04147650 — Dose Ranging Study to Assess the Efficacy and Safety of Voclosporin Ophthalmic Solution in Subjects With Dry Eye Syndrom · Phase 2, PHASE3 · completed
- NCT03597464 — Aurinia Renal Assessments 2: Aurinia Renal Response in Lupus With Voclosporin · Phase 3 · completed
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05288855 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Aurinia Pharmaceuticals Inc.
- Last refreshed: 10 February 2026
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05288855.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing