Long-Term Voclosporin Treatment in Adolescent and Pediatric Subjects With Lupus Nephritis

Launched by AURINIA PHARMACEUTICALS INC. · Jul 18, 2023

Keywords

ClinConnect Summary

This study is a long-term, open-label extension of voclosporin for lupus nephritis in children and teens. It looks at safety and how well the drug is tolerated when given for about 12 more months after completing the prior VOCAL study, in addition to standard treatments like mycophenolate mofetil (MMF) and steroids. It is a phase 3 trial with a single group (no placebo), and results aren’t available yet.

Who may be eligible? Kids and adolescents aged roughly 5 to 17 who have lupus nephritis and who completed at least 24 weeks of the prior VOCAL study. They must stay on immunosuppressive therapy and MMF, and be willing to continue follow-up care. People are excluded if they need dialysis, are planning a kidney transplant, or are taking certain medicines that could interfere with the study drugs. Participants enrolled by invitation will receive open-label voclosporin, with dose adjustments allowed, and they’ll be followed for safety and kidney-related outcomes, such as changes in urine protein and kidney function, over the 12-month extension (with ongoing standard care).

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Written informed consent from parent/guardian before any study-specific procedures are performed, if applicable per local regulations.
• • Age-appropriate assent or informed consent from subject before any study-specific procedures are performed.
• • Subjects who have completed 24 weeks of treatment with study drug (voclosporin/placebo) in the VOCAL study. Subjects who had a temporary interruption and were able to successfully re-start study drug will be allowed to enroll after Medical Monitor approval.
• • In the opinion of the Investigator subject requires continued immunosuppressive therapy.
• • Subject is willing to continue to take oral MMF for the duration of the study.
• Exclusion Criteria:
• * Currently taking or known need for any of the following medications during the study:
• • Cholestyramine or other drugs that may interfere with enterohepatic recirculation of MMF
• • Calcineurin inhibitors (CNIs) (e.g., cyclosporin and tacrolimus)
• • Strong CYP3A4/5 inhibitors and inducers (e.g., ketoconazole, rifampin, itraconazole, clarithromycin)
• • Currently requiring renal dialysis (hemodialysis or peritoneal dialysis) or expected to require dialysis during the study period.
• • A planned kidney transplant within study treatment period.
• • Subjects with any medical condition which in the Investigator's judgement may be associated with increased risk to the subject or may interfere with study assessments or outcomes