Voclosporin in Adolescent and Pediatric Subjects With Lupus Nephritis

NCT05288855 | Terminated Phase 3 DMC FDA Drug

• 1 other identifier: AUR-VCS-2020-03
• Study Type: interventional
• Target: 9
• Locations: 5 countries
• Sites: 6

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).

Conditions

Adolescent Lupus Nephritis; Pediatric Lupus Nephritis

Keywords

Lupus nephritis; calcineurin inhibitors; voclosporin; adolescents; pediatrics

Outcome Measures

Primary Outcomes (1)

• Proportion of subjects with renal response

  Renal response defined as UPCR ≤0.5 mg/mg, eGFR ≥60 mL/min/1.73 m2 or no decrease from baseline of \>20%, no rescue medication and no steroid use \>10 mg/day for ≥3 consecutive days or for ≥7 days in total between week 16 to 24

  Week 24

Secondary Outcomes (4)

• Time to UPCR of ≤0.5 mg/mg.

  Baseline to Week 24

• Proportion of subjects with partial renal response

  Week 24

• Time to 50% Reduction in UPCR

  Baseline to Week 24

• Number of treatment-emergent adverse events (TEAEs) will be summarized by treatment group

  Baseline to Week 24

Study Arms (4)

Voclosporin treatment group 1

EXPERIMENTAL

2 capsules (15.8 mg) BID of voclosporin

Drug: Voclosporin

Placebo treatment group 2

PLACEBO COMPARATOR

2 capsules BID of placebo

Drug: Placebo Oral Capsule

Voclosporin treatment group 3

EXPERIMENTAL

3 capsules (23.7 mg) BID of voclosporin

Drug: Voclosporin

Voclosporin treatment group 4

EXPERIMENTAL

Maximum dose of 2 capsules (15.8 mg) BID of voclosporin.

Drug: Voclosporin

Interventions

Voclosporin DRUG

calcineurin inhibitor

Voclosporin treatment group 1; Voclosporin treatment group 3; Voclosporin treatment group 4

Placebo Oral Capsule DRUG

matching placebo capsule

Placebo treatment group 2

Eligibility Criteria

• Age: 5 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Aurinia Pharmaceuticals Inc.: lead

Study Sites (6)

Nemours Children's Hospital, Orlando

Orlando, Florida, 13535, United States

Location

Clinica de la Costa S.A.S

Barranquilla, Atlántico, 76100, Colombia

Location

Yokohama City University Hospital

Yokohama, Kanagawa, Japan

Location

Centro de Especialidades Medicas del Sureste

Mérida, Yucatán, 97000, Mexico

Location

Hospital Infantil de México Federico Gómez

Mexico City, Mexico

Location

Siriraj Hospital

Bangkok, 10700, Thailand

Location

MeSH Terms

Conditions

Lupus Nephritis

Interventions

voclosporin

Condition Hierarchy (Ancestors)

Glomerulonephritis; Nephritis; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lupus Erythematosus, Systemic; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Double blind (participant, care provider, investigator and outcome assessor) for period 1 and Open-label for period 2 and period 3
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 11, 2022
• First Posted: March 21, 2022
• Study Start: October 10, 2023
• Primary Completion: July 3, 2025
• Study Completion: July 3, 2025
• Last Updated: February 10, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

JP (1); CO (1); ME (2); TH (1); US (1)