Clinical trial NCT05288855: Voclosporin in Adolescent and Pediatric Subjects With Lupus Nephritis
Official title: A Double-Blind, Placebo-Controlled, Dose Escalation Study to Assess the Efficacy, Safety and Pharmacokinetics of Voclosporin in Adolescent and Pediatric Subjects With Lupus Nephritis
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Adolescent Lupus Nephritis
Pediatric Lupus Nephritis
Keywords: Lupus nephritis
calcineurin inhibitors
voclosporin
adolescents
pediatrics
Lead sponsor: Aurinia Pharmaceuticals Inc.
Sponsor class: INDUSTRY
First posted: 2022-03-21
Enrollment: 40
Sex: ALL
Minimum age (years): 5
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to assess the efficacy and safety of voclosporin compared to placebo in achieving renal response following 24 weeks of therapy in adolescent and pediatric subjects with active lupus nephritis (LN).

Detailed description: This is a 24 week, dose escalation study of voclosporin in addition to standard of care with mycophenolate mofetil (MMF) and steroids, consisting of 3 treatment periods: Period 1 is double-blind, placebo controlled receiving 15.8 mg twice daily, Period 2 is open-label receiving 23.7 mg twice daily, Period 3 is open-label receiving 15.8 mg twice daily.

Eligibility criteria: Key Inclusion Criteria:

* Previous diagnosis of systemic lupus erythematosus (SLE) as per the 2019 EULAR/ ACR classification criteria.
* Subjects with kidney biopsy confirmed active lupus nephritis.

Exclusion Criteria:

* Estimated glomerular filtration rate (eGFR) \<60 mL/minute/1.73 m2 at screening.
* Current or medical history of:

  * Congenital or acquired immunodeficiency.
  * Clinically significant drug or alcohol abuse prior to screening.
  * Malignant neoplasm.
  * Lymphoproliferative disease or previous total lymphoid irradiation.
  * Known severe viral infections within 3 months of screening; or known human immunodeficiency virus infection, or hepatitis B or C virus infection at any time prior to screening.
  * Active tuberculosis (TB) or known history of TB/evidence of old TB if not taking prophylaxis with isoniazid.
* Currently requiring renal dialysis (hemodialysis or peritoneal dialysis) or expected to require dialysis during the study period.
* Other known clinically significant active medical conditions, for which the condition or the treatment of the condition may affect the study assessments or outcomes.
* Currently taking or known need for any of the following medications:

  * Immunosuppression biologic agents within 12 weeks prior to randomization, cyclophosphamide, calcineurin inhibitors (CNIs) and live attenuated vaccines, initiation or dose change of ACE inhibitors/ARBs within 4 weeks prior to randomization, IV corticosteroids and IV immunoglobulin within 2 weeks prior to screening, strong CYP3A4/5 inhibitors and inducers within 2 weeks prior to randomization.

Primary outcomes:
measure: Proportion of subjects with renal response
timeFrame: Week 24
Secondary outcomes:
measure: Time to UPCR of ≤0.5 mg/mg.
timeFrame: Baseline to Week 24
measure: Proportion of subjects with partial renal response
timeFrame: Week 24
measure: Time to 50% Reduction in UPCR
timeFrame: Baseline to Week 24
measure: Number of treatment-emergent adverse events (TEAEs) will be summarized by treatment group
timeFrame: Baseline to Week 24
Other outcomes:
Locations:
city: Orlando
country: United States
facility: Nemours Children's Hospital, Orlando
state: Florida
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: Merida
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: