Long-Term Voclosporin Treatment in Adolescent and Pediatric Subjects With Lupus Nephritis
NCT05962788 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 4
Last updated 2026-02-10
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
Interventions
- DRUG
-
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.
Sponsors & Collaborators
-
Aurinia Pharmaceuticals Inc.
lead INDUSTRY
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 5 Years
- Max Age
- 17 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2024-03-28
- Primary Completion
- 2025-07-04
- Completion
- 2025-07-04
- FDA Drug
- Yes
Countries
- United States
- Colombia
- Japan
- Mexico
- Thailand
Study Locations
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