Voclosporin in Adolescent and Pediatric Subjects With Lupus Nephritis

Stopped early · Phase 3 · Has a placebo group

Conditions studied: Adolescent Lupus Nephritis, Pediatric Lupus Nephritis

In brief

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).

Key facts

Study ID

NCT05288855

Run by

Aurinia Pharmaceuticals Inc.

People needed

9

Starts

2023-10-10

Expected to finish

2025-07-03

Last updated by the study team

2026-02-10

Who can join

Age: 5 and older, up to 17. Sex: any. Healthy volunteers: not accepted.

You may not qualify if…

• Estimated glomerular filtration rate (eGFR) <60 mL/minute/1.73 m2 at screening.
• Current or medical history of:
• Congenital or acquired immunodeficiency.
• Clinically significant drug or alcohol abuse prior to screening.
• Malignant neoplasm.
• Lymphoproliferative disease or previous total lymphoid irradiation.
• Known severe viral infections within 3 months of screening; or known human immunodeficiency virus infection, or hepatitis B or C virus infection at any time prior to screening.
• Active tuberculosis (TB) or known history of TB/evidence of old TB if not taking prophylaxis with isoniazid.
• Currently requiring renal dialysis (hemodialysis or peritoneal dialysis) or expected to require dialysis during the study period.
• Other known clinically significant active medical conditions, for which the condition or the treatment of the condition may affect the study assessments or outcomes.
• Currently taking or known need for any of the following medications:
• Immunosuppression biologic agents within 12 weeks prior to randomization, cyclophosphamide, calcineurin inhibitors (CNIs) and live attenuated vaccines, initiation or dose change of ACE inhibitors/ARBs within 4 weeks prior to randomization, IV corticosteroids and IV immunoglobulin within 2 weeks prior to screening, strong CYP3A4/5 inhibitors and inducers within 2 weeks prior to randomization.

Where it is running

• Nemours Children's Hospital, Orlando — Orlando, Florida, United States
• Clinica de la Costa S.A.S — Barranquilla, Atlántico, Colombia
• Yokohama City University Hospital — Yokohama, Kanagawa, Japan
• Centro de Especialidades Medicas del Sureste — Mérida, Yucatán, Mexico
• Hospital Infantil de México Federico Gómez — Mexico City, Mexico
• Siriraj Hospital — Bangkok, Thailand

Full record on ClinicalTrials.gov

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