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Voclosporin in Adolescent and Pediatric Subjects With Lupus Nephritis | Clinical Trials | Clareo Health

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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

NCT05288855•Aurinia Pharmaceuticals Inc.

View on ClinicalTrials.gov

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.

Eligibility

Age

5 - 17 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

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

Exclusion Criteria

•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.
+2 more criteria

Locations (6)

Nemours Children's Hospital, Orlando

Orlando, Florida, United States

Clinica de la Costa S.A.S

Barranquilla, Atlántico, Colombia

Yokohama City University Hospital

Yokohama, Kanagawa, Japan

Centro de Especialidades Medicas del Sureste

Mérida, Yucatán, Mexico

Hospital Infantil de México Federico Gómez

Mexico City, Mexico

Siriraj Hospital

Bangkok, Thailand

Key Dates

Start Date

October 10, 2023

Primary Completion Date

July 3, 2025

Completion Date

July 3, 2025

Last Updated

February 10, 2026

Enrollment

ACTUAL participants

Conditions

Adolescent Lupus NephritisPediatric Lupus Nephritis

Interventions

Voclosporin

DRUG

Placebo Oral Capsule

DRUG