Long-Term Voclosporin Treatment in Adolescent Subjects With Lupus Nephritis

Phase 3

Not yet recruiting

• Conditions: Adolescent Lupus Nephritis

• Registration Number: NCT05962788
• Lead Sponsor: Aurinia Pharmaceuticals Inc.

Brief Summary

The purpose of this study is to assess the long-term safety and tolerability of voclosporin for up to an additional 12 months following completion of treatment in the AUR-VCS-2020-03 study (VOCAL) in adolescents with active lupus nephritis.

Detailed Description

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 continue to receive open-label treatment with voclosporin for approximately 12 months giving a total study treatment duration of 18 months from the start of VOCAL. Subjects completing treatment in Group 2 of the VOCAL study who were receiving placebo will switch to receive open-label voclosporin initially at the same number of capsules as was being administered at the End of Study (EOS) Visit in VOCAL.

All subjects will continue to receive background therapy of MMF and oral corticosteroids starting at the same dose as at completion of the VOCAL study. When clinically indicated, subjects are permitted to be titrated off oral corticosteroids.

Study Timeline

• Study First Submitted: 2023-06-21
• Study First Submitted QC: 2023-07-18
• Study First Posted: 2023-07-27
• Status Verified: 2024-01
• Last Update Submitted: 2024-01-29
• Last Update Posted: 2024-01-30
• Study Start: 2024-03
• Primary Completion: 2026-06
• Study Completion: 2026-09

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Incidence of Treatment Emergent Adverse Events (TEAE)	Per protocol from VOCAL-EXT Study Start to Study Completion plus a 30-day follow-up period	Incidence (subject counts and event counts) of TEAEs summarized by System Organ Class and Preferred Terms using MedDRA

Secondary Outcome Measures

Name	Time	Method
Renal Response	Per protocol from Study Start to Study Completion plus a 30-day follow-up period	Proportion of subjects with renal response at Month 12 and 18, defined based on the following parameters: * urine protein creatinine ratio (UPCR) of ≤0.5 mg/mg, and; * estimated glomerular filtration rate (eGFR) ≥60 mL/min/1.73 m2 or no confirmed decrease from baseline in eGFR of \>20%, and; * Received no rescue medication for lupus nephritis, and; * Did not receive \>10 mg/day prednisone for ≥3 consecutive days or for ≥7 days in total prior to the renal response assessment
Partial Renal Response	Month 12 (VOCAL Study Completion/VOCAL-EXT Study Start) and Month 18 (VOCAL-EXT Study Completion)	Proportion of subjects in partial renal response as defined by ≥50% reduction from VOCAL baseline in UPCR
Urine Protein Creatinine Ratio (UPCR)	Month 12 (VOCAL Study Completion/VOCAL-EXT Study Start) and Month 18 (VOCAL-EXT Study Completion)	Proportion of subjects with UPCR of ≤0.7 mg/mg