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

NCT ID: NCT05962788

Last Updated: 2025-06-18

Basic Information

• Recruitment Status: ENROLLING_BY_INVITATION
• Clinical Phase: PHASE3
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-03-27
• Study Completion Date: 2029-06-30

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 adolescent and pediatric subjects with 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 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 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.

Conditions

Adolescent Lupus Nephritis; Pediatric Lupus Nephritis

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Open Label

All subjects will receive open label voclosporin initially at the same number of capsules as assigned at Week 24 (End of Study Visit) in AUR-VCS-2020-03 (VOCAL ; NCT05288855). At the Investigator's discretion and after consultation with the Medical Monitor, dose titration up or down in the study will be permitted up to the maximum dose that was studied in AUR-VCS-2020-03.

Group Type: EXPERIMENTAL

voclosporin

Intervention Type: DRUG

Subjects will receive 2 capsules (15.8 mg) BID (twice daily), 3 capsules (23.7 mg) BID of voclosporin in addition to standard of care with mycophenolate mofetil (MMF) and steroids.

Interventions

voclosporin

Subjects will receive 2 capsules (15.8 mg) BID (twice daily), 3 capsules (23.7 mg) BID of voclosporin in addition to standard of care with mycophenolate mofetil (MMF) and steroids.

Intervention Type: DRUG

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

• Minimum Eligible Age: 5 Years
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Aurinia Pharmaceuticals Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

UNC-Chapel Hill

Chapel Hill, North Carolina, United States

Clinica de la Costa S.A.S

Barranquilla, Atlántico, Colombia

Yokohama City University Hospital

Yokohama, Kanagawa, Japan

Hospital Infantil de México Federico Gómez

Mexico City, Mexico City, Mexico

Centro de Especialidades Medicas del Sureste

Mérida, Yucatán, Mexico

Siriraj Hospital

Bangkok, , Thailand

Countries

United States; Colombia; Japan; Mexico; Thailand

Other Identifiers

AUR-VCS-2020-04

Identifier Type: -

Identifier Source: org_study_id