Clinical trial NCT05962788: Long-Term Voclosporin Treatment in Adolescent and Pediatric Subjects With Lupus Nephritis
Official title: An Open-Label Extension Study to Assess the Long-Term Safety and Efficacy of Voclosporin in Adolescent and Pediatric Subjects With Lupus Nephritis
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: PHASE3
Conditions: Adolescent Lupus Nephritis
Pediatric Lupus Nephritis
Keywords: voclosporin
lupus nephritis
calcineurin inhibitors
adolescents
pediatrics
Lead sponsor: Aurinia Pharmaceuticals Inc.
Sponsor class: INDUSTRY
First posted: 2023-07-27
Enrollment: 40
Sex: ALL
Minimum age (years): 5
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Incidence of Treatment Emergent Adverse Events (TEAE)
timeFrame: Per protocol from VOCAL-EXT Study Start to Study Completion plus a 30-day follow-up period
Secondary outcomes:
measure: Renal Response
timeFrame: Per protocol from Study Start to Study Completion plus a 30-day follow-up period
measure: Urine Protein Creatinine Ratio (UPCR)
timeFrame: Month 12 (VOCAL Study Completion/VOCAL-EXT Study Start) and Month 18 (VOCAL-EXT Study Completion)
measure: Partial Renal Response
timeFrame: Month 12 (VOCAL Study Completion/VOCAL-EXT Study Start) and Month 18 (VOCAL-EXT Study Completion)
Other outcomes:
Locations:
city: Chapel Hill
country: United States
facility: UNC-Chapel Hill
state: North Carolina
city: Barranquilla
country: Colombia
facility: Clinica de la Costa S.A.S
state: Atlantico
city: Yokohama
country: Japan
facility: Yokohama City University Hospital
state: Kanagawa
city: Mérida
country: Mexico
facility: Centro de Especialidades Medicas del Sureste
state: Yucatan
city: Mexico City
country: Mexico
facility: Hospital Infantil de México Federico Gómez
city: Bangkok
country: Thailand
facility: Siriraj Hospital
Study officials:
References: