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

Launched by AURINIA PHARMACEUTICALS INC. · Jul 18, 2023

Keywords

ClinConnect Summary

This is a 12 month, prospective, multi-center, long-term, open-label extension study of voclosporin in addition to background standard of care with mycophenolate mofetil (MMF) and oral steroids.

Subjects completing participation and treatment with study drug (voclosporin/placebo) of the VOCAL Study (AUR-VCS-2020-03 ; NCT05288855) and meeting all eligibility criteria will receive open-label treatment with voclosporin for approximately 12 months giving a total study treatment duration of 18 months from the start of VOCAL.

All subjects will continue to receive background therapy of MMF and o...

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