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

NCT05962788 | Terminated Phase 3 DMC FDA Drug

• 1 other identifier: AUR-VCS-2020-04
• Study Type: interventional
• Target: 4
• Locations: 5 countries
• Sites: 6

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.

Conditions

Adolescent Lupus Nephritis; Pediatric Lupus Nephritis

Keywords

voclosporin; lupus nephritis; calcineurin inhibitors; adolescents; pediatrics

Outcome Measures

Primary Outcomes (1)

• Incidence of Treatment Emergent Adverse Events (TEAE)

  Incidence (subject counts and event counts) of TEAEs summarized by System Organ Class and Preferred Terms using MedDRA

  Per protocol from VOCAL-EXT Study Start to Study Completion plus a 30-day follow-up period

Secondary Outcomes (3)

• Renal Response

  Per protocol from Study Start to Study Completion plus a 30-day follow-up period

• Urine Protein Creatinine Ratio (UPCR)

  Month 12 (VOCAL Study Completion/VOCAL-EXT Study Start) and Month 18 (VOCAL-EXT Study Completion)

• Partial Renal Response

  Month 12 (VOCAL Study Completion/VOCAL-EXT Study Start) and Month 18 (VOCAL-EXT Study Completion)

Study Arms (1)

Open Label

EXPERIMENTAL

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.

Drug: voclosporin

Interventions

voclosporin 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.

Open Label

Eligibility Criteria

• Age: 5 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Aurinia Pharmaceuticals Inc.: lead

Study Sites (6)

UNC-Chapel Hill

Chapel Hill, North Carolina, 27514, United States

Location

Clinica de la Costa S.A.S

Barranquilla, Atlántico, 76100, Colombia

Location

Yokohama City University Hospital

Yokohama, Kanagawa, Japan

Location

Centro de Especialidades Medicas del Sureste

Mérida, Yucatán, 97000, Mexico

Location

Hospital Infantil de México Federico Gómez

Mexico City, 06720, Mexico

Location

Siriraj Hospital

Bangkok, 10700, Thailand

Location

MeSH Terms

Conditions

Lupus Nephritis

Interventions

voclosporin

Condition Hierarchy (Ancestors)

Glomerulonephritis; Nephritis; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lupus Erythematosus, Systemic; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 21, 2023
• First Posted: July 27, 2023
• Study Start: March 28, 2024
• Primary Completion: July 4, 2025
• Study Completion: July 4, 2025
• Last Updated: February 10, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

TH (1); ME (2); CO (1); JP (1); US (1)