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
Status: Recruiting
Location: See all (7) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
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).
Eligibility
Participation Requirements
Sex: All
Minimum Age: 5
Maximum Age: 17
Healthy Volunteers: f
View:
• Previous diagnosis of systemic lupus erythematosus (SLE) as per the 2019 EULAR/ ACR classification criteria.
• Subjects with kidney biopsy confirmed active lupus nephritis.
Locations
United States
Florida
Nemours Children's Hospital, Orlando
RECRUITING
Orlando
North Carolina
UNC-Chapel Hill
WITHDRAWN
Chapel Hill
Other Locations
Colombia
Clinica de la Costa S.A.S
RECRUITING
Barranquilla
Japan
Yokohama City University Hospital
NOT_YET_RECRUITING
Yokohama
Mexico
Centro de Especialidades Medicas del Sureste
RECRUITING
Mérida
Hospital Infantil de México Federico Gómez
RECRUITING
Mexico City
Thailand
Siriraj Hospital
RECRUITING
Bangkok
Contact Information
Primary
Aurinia Clinical Trials Information
clinicaltrials@auriniapharma.com
833-672-0028
Time Frame
Start Date: 2023-10-10
Estimated Completion Date: 2028-06
Participants
Target number of participants: 40
Treatments
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.
Related Therapeutic Areas
Sponsors
Leads: Aurinia Pharmaceuticals Inc.