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

Conditions

• Adolescent Lupus Nephritis
• Pediatric Lupus Nephritis

Eligibility Criteria

Sex

ALL

Age

5 Years - 17 Years

Healthy Volunteers

Not accepted

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.

Study Details

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.

Key Dates

Start date

Mar 28, 2024

Status verified

Feb 2026

Primary completion

Jul 4, 2025

Completion

Jul 4, 2025

Study Design

Enrollment

4 participants (actual)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• Experimental: Open Label
  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.

Primary Outcome Measure

Incidence of Treatment Emergent Adverse Events (TEAE) [ Time Frame: Per protocol from VOCAL-EXT Study Start to Study Completion plus a 30-day follow-up period ]

Locations (1)

Related coverage on Hipa.ai

• Voclosporin Phase 3 Trial for Pediatric Lupus Nephritis Terminated
  Voclosporin · Jul 4, 2025 · ClinicalTrials.gov

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