The Phase 3 trial (NCT05288855) investigating voclosporin in adolescent and pediatric subjects with lupus nephritis was terminated as of 2025-07-03. The study aimed to assess the efficacy and safety of voclosporin compared to placebo in achieving renal response following 24 weeks of therapy in this population.
Background
Voclosporin was under investigation for the treatment of Adolescent Lupus Nephritis and Pediatric Lupus Nephritis. Lupus nephritis is a serious kidney inflammation that can occur in individuals with systemic lupus erythematosus, affecting both adolescents and children.
Trial design
The study, identified as NCT05288855, was a Phase 3 trial. It was designed to compare voclosporin against a placebo oral capsule in adolescent and pediatric subjects with active lupus nephritis. The trial had an enrollment of 9 participants and focused on conditions including Adolescent Lupus Nephritis and Pediatric Lupus Nephritis. The overall status of the trial is TERMINATED.
What this means
The termination of this Phase 3 trial for voclosporin in adolescent and pediatric lupus nephritis indicates that further development of the drug for this specific population has ceased. With only 9 participants enrolled, the trial concluded without reporting efficacy or safety data, which limits any conclusions regarding its potential as a treatment in this vulnerable patient group.
Source
Information regarding the termination of this trial was obtained from ClinicalTrials.gov, a public database of clinical studies. The update for study NCT05288855, titled "Voclosporin in Adolescent and Pediatric Subjects With Lupus Nephritis," was posted on 2025-07-03 on clinicaltrials.gov.