Voclosporin in Adolescent and Pediatric Subjects With Lupus Nephritis
Reason given: DSMB recommendation
Key facts
- Where
- Mérida and Mexico City, MexicoSee the 2 sites
- Phase
- Phase 3
Where in Mexico
- Centro de Especialidades Medicas del SuresteMérida, MexicoNo longer taking part
- Hospital Infantil de Mexico Federico GomezMexico City, MexicoNo longer taking part
Trial details
- Who runs it
- Aurinia Pharmaceuticals Inc.
- Trial code
- NCT05288855
- Record updated
- 10 February 2026
- Original 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).Read full original descriptionShow less
A Double-Blind, Placebo-Controlled, Dose Escalation Study to Assess the Efficacy, Safety and Pharmacokinetics of Voclosporin in Adolescent and Pediatric Subjects With Lupus Nephritis
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).
Inclusion: Previous diagnosis of systemic lupus erythematosus (SLE) as per the 2019 EULAR/ ACR classification criteria; Subjects with kidney biopsy confirmed active lupus nephritis.
Exclusion: 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 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; Other known clinically significant active medical conditions, for which the condition or the treatment of the condition may affect the study assessments or outcomes; Estimated glomerular filtration rate (eGFR) <60 mL/minute/1.73 m2 at screening; Currently requiring renal dialysis (hemodialysis or peritoneal dialysis) or expected to require dialysis during the study period.