NCT05288855

Voclosporin in Adolescent and Pediatric Subjects With Lupus Nephritis

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

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 9 (actual)
• Sponsor: Aurinia Pharmaceuticals Inc. · Industry
• Sex: All
• Age: 5 Years – 17 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Adolescent Lupus Nephritis
• Pediatric Lupus Nephritis

Interventions

Type	Name	Description
DRUG	Voclosporin	calcineurin inhibitor
DRUG	Placebo Oral Capsule	matching placebo capsule

Timeline

• Start date: 2023-10-10
• Primary completion: 2025-07-03
• Completion: 2025-07-03
• First posted: 2022-03-21
• Last updated: 2026-02-10

Locations

6 sites across 5 countries: United States, Colombia, Japan, Mexico, Thailand

Regulatory

• FDA-regulated drug study