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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	5 Years - 17 Years
Gender	All

More Inclusion & Exclusion Criteria

Inclusion Criteria:

- Written informed consent from parent/guardian before any study-specific procedures are performed, if applicable per local regulations.

- Age-appropriate assent or informed consent from subject before any study-specific procedures are performed.

- Subjects who have completed 24 weeks of treatment with study drug (voclosporin/placebo) in the VOCAL study.

Subjects who had a temporary interruption and were able to successfully re-start study drug will be allowed to enroll after Medical Monitor approval.

- In the opinion of the Investigator subject requires continued immunosuppressive therapy.

- Subject is willing to continue to take oral MMF for the duration of the study.

Exclusion Criteria:

- Currently taking or known need for any of the following medications during the study: - Cholestyramine or other drugs that may interfere with enterohepatic recirculation of MMF.

- Calcineurin inhibitors (CNIs) (e.g., cyclosporin and tacrolimus) - Strong CYP3A4/5 inhibitors and inducers (e.g., ketoconazole, rifampin, itraconazole, clarithromycin) - Currently requiring renal dialysis (hemodialysis or peritoneal dialysis) or expected to require dialysis during the study period.

- A planned kidney transplant within study treatment period.

- Subjects with any medical condition which in the Investigator's judgement may be associated with increased risk to the subject or may interfere with study assessments or outcomes

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT05962788
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	Phase 3
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Aurinia Pharmaceuticals Inc.
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	N/A
Principal Investigator Affiliation	N/A
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Industry
Overall Status	Enrolling by invitation
Countries	Colombia, Japan, Mexico, Thailand, United States
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Adolescent Lupus Nephritis, Pediatric Lupus Nephritis

Additional Details

This is a 12 month, prospective, multi-center, long-term, open-label extension study of voclosporin in addition to background standard of care with mycophenolate mofetil (MMF) and oral steroids. Subjects completing participation and treatment with study drug (voclosporin/placebo) of the VOCAL Study (AUR-VCS-2020-03 ; NCT05288855) and meeting all eligibility criteria will receive open-label treatment with voclosporin for approximately 12 months giving a total study treatment duration of 18 months from the start of VOCAL. All subjects will continue to receive background therapy of MMF and oral corticosteroids starting at the same dose as at completion of the VOCAL study. When clinically indicated, subjects are permitted to be titrated off oral corticosteroids.

Arms & Interventions

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.

Interventions

Drug: - voclosporin

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.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

UNC-Chapel Hill, Chapel Hill, North Carolina

Status

Address

UNC-Chapel Hill

Chapel Hill, North Carolina, 27514

International Sites

Clinica de la Costa S.A.S, Barranquilla, Atlantico, Colombia

Status

Address

Clinica de la Costa S.A.S

Barranquilla, Atlantico, 76100

Yokohama City University Hospital, Yokohama, Kanagawa, Japan

Status

Address

Yokohama City University Hospital

Yokohama, Kanagawa,

Mérida, Yucatan, Mexico

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Address

Centro de Especialidades Medicas del Sureste

Mérida, Yucatan, 97000

Mexico City, Mexico

Status

Address

Hospital Infantil de México Federico Gómez

Mexico City, , 06720

Siriraj Hospital, Bangkok, Thailand

Status

Address

Siriraj Hospital

Bangkok, , 10700

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