The Phase 3 study (NCT05962788) investigating voclosporin for long-term treatment in adolescent and pediatric subjects with lupus nephritis was terminated. This event was noted on 2025-07-04, as reported on ClinicalTrials.gov. The trial, which had an enrollment of 4 participants, was assessing the drug's long-term safety and tolerability.
Background
Voclosporin is being investigated for the treatment of lupus nephritis. This particular study aimed to assess the long-term safety and tolerability of the drug in adolescent and pediatric populations following prior treatment.
Trial design
The study, identified as NCT05962788 and titled "Long-Term Voclosporin Treatment in Adolescent and Pediatric Subjects With Lupus Nephritis," was a Phase 3 trial. It was designed to evaluate the long-term safety and tolerability of voclosporin for up to an additional 12 months in adolescent and pediatric subjects who had completed treatment in a prior study (AUR-VCS-2020-03, VOCAL). The trial had an enrollment of 4 participants and focused on individuals with adolescent lupus nephritis and pediatric lupus nephritis.
What this means
The termination of this Phase 3 study means that further long-term safety and tolerability data for voclosporin in adolescent and pediatric subjects with lupus nephritis will not be collected through this specific trial. While the reasons for termination are not provided in the available data, this decision impacts the ongoing assessment of the drug in these younger populations.
Source
Information regarding the termination of this trial was obtained from ClinicalTrials.gov, a public database of clinical studies. The status update for study NCT05962788, titled "Long-Term Voclosporin Treatment in Adolescent and Pediatric Subjects With Lupus Nephritis," was noted on 2025-07-04 on clinicaltrials.gov.