Voclosporin 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
  calcineurin inhibitor
• Placebo Oral Capsule — DRUG
  matching placebo capsule

Study Details

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).

Key Dates

Start date

Oct 10, 2023

Status verified

Feb 2026

Primary completion

Jul 3, 2025

Completion

Jul 3, 2025

Study Design

Enrollment

9 participants (actual)

Allocation

RANDOMIZED

Intervention model

SEQUENTIAL

Primary purpose

TREATMENT

Arms

• Experimental: Voclosporin treatment group 1
  2 capsules (15.8 mg) BID of voclosporin
• Placebo Comparator: Placebo treatment group 2
  2 capsules BID of placebo
• Experimental: Voclosporin treatment group 3
  3 capsules (23.7 mg) BID of voclosporin
• Experimental: Voclosporin treatment group 4
  Maximum dose of 2 capsules (15.8 mg) BID of voclosporin.

Primary Outcome Measure

Proportion of subjects with renal response [ Time Frame: Week 24 ]

Locations (1)

Related coverage on Hipa.ai

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

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