- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05962788
Long-Term Voclosporin Treatment in Adolescent Subjects With Lupus Nephritis (VOCAL-EXT)
An Open-Label Extension Study to Assess the Long-Term Safety and Efficacy of Voclosporin in Adolescent Subjects With Lupus Nephritis
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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 continue to receive open-label treatment with voclosporin for approximately 12 months giving a total study treatment duration of 18 months from the start of VOCAL. Subjects completing treatment in Group 2 of the VOCAL study who were receiving placebo will switch to receive open-label voclosporin initially at the same number of capsules as was being administered at the End of Study (EOS) Visit in 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.
Study Type
Enrollment (Estimated)
Phase
- Phase 3
Contacts and Locations
Study Contact
- Name: Antonia Coeshall
- Phone Number: +44-7968-836321
- Email: acoeshall@auriniapharma.com
Study Locations
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Florida
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Orlando, Florida, United States, 32827
- Nemours Children's Health, Lake Nona Medical City
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
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.
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Subjects will receive 2 capsules (15.8 mg) BID (twice daily), 3 capsules (23.7 mg) BID or 4 capsules (31.6 mg) BID of voclosporin in addition to standard of care with mycophenolate mofetil (MMF) and steroids.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Incidence of Treatment Emergent Adverse Events (TEAE)
Time Frame: Per protocol from VOCAL-EXT Study Start to Study Completion plus a 30-day follow-up period
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Incidence (subject counts and event counts) of TEAEs summarized by System Organ Class and Preferred Terms using MedDRA
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Per protocol from VOCAL-EXT Study Start to Study Completion plus a 30-day follow-up period
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Renal Response
Time Frame: Per protocol from Study Start to Study Completion plus a 30-day follow-up period
|
Proportion of subjects with renal response at Month 12 and 18, defined based on the following parameters:
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Per protocol from Study Start to Study Completion plus a 30-day follow-up period
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Urine Protein Creatinine Ratio (UPCR)
Time Frame: Month 12 (VOCAL Study Completion/VOCAL-EXT Study Start) and Month 18 (VOCAL-EXT Study Completion)
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Proportion of subjects with UPCR of ≤0.7 mg/mg
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Month 12 (VOCAL Study Completion/VOCAL-EXT Study Start) and Month 18 (VOCAL-EXT Study Completion)
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Partial Renal Response
Time Frame: Month 12 (VOCAL Study Completion/VOCAL-EXT Study Start) and Month 18 (VOCAL-EXT Study Completion)
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Proportion of subjects in partial renal response as defined by ≥50% reduction from VOCAL baseline in UPCR
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Month 12 (VOCAL Study Completion/VOCAL-EXT Study Start) and Month 18 (VOCAL-EXT Study Completion)
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Collaborators and Investigators
Sponsor
Collaborators
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Immune System Diseases
- Autoimmune Diseases
- Kidney Diseases
- Urologic Diseases
- Connective Tissue Diseases
- Glomerulonephritis
- Lupus Erythematosus, Systemic
- Female Urogenital Diseases
- Female Urogenital Diseases and Pregnancy Complications
- Urogenital Diseases
- Male Urogenital Diseases
- Nephritis
- Lupus Nephritis
Other Study ID Numbers
- AUR-VCS-2020-04
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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