Back to resultsLong-Term Voclosporin Treatment in Adolescent Subjects With Lupus Nephritis (VOCAL-EXT)
Primary Purpose
Adolescent Lupus Nephritis
Status
Not yet recruiting
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
voclosporin
Sponsored by
About this trial
This is an interventional treatment trial for Adolescent Lupus Nephritis focused on measuring voclosporin, lupus nephritis, calcineurin inhibitors, adolescents
Eligibility 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
Sites / Locations
- Nemours Children's Health, Lake Nona Medical City
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Open Label
Arm Description
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.
Outcomes
Primary Outcome Measures
Incidence of Treatment Emergent Adverse Events (TEAE)
Incidence (subject counts and event counts) of TEAEs summarized by System Organ Class and Preferred Terms using MedDRA
Secondary Outcome Measures
Renal Response
Proportion of subjects with renal response at Month 12 and 18, defined based on the following parameters:
urine protein creatinine ratio (UPCR) of ≤0.5 mg/mg, and
estimated glomerular filtration rate (eGFR) ≥60 mL/min/1.73 m2 or no confirmed decrease from baseline in eGFR of >20%, and
Received no rescue medication for lupus nephritis, and
Did not receive >10 mg/day prednisone for ≥3 consecutive days or for ≥7 days in total prior to the renal response assessment
Urine Protein Creatinine Ratio (UPCR)
Proportion of subjects with UPCR of ≤0.7 mg/mg
Partial Renal Response
Proportion of subjects in partial renal response as defined by ≥50% reduction from VOCAL baseline in UPCR
Full Information
NCT ID
NCT05962788
First Posted
June 21, 2023
Last Updated
July 18, 2023
Sponsor
Aurinia Pharmaceuticals Inc.
Collaborators
Labcorp Corporation of America Holdings, Inc
1. Study Identification
Unique Protocol Identification Number
NCT05962788
Brief Title
Long-Term Voclosporin Treatment in Adolescent Subjects With Lupus Nephritis
Acronym
VOCAL-EXT
Official Title
An Open-Label Extension Study to Assess the Long-Term Safety and Efficacy of Voclosporin in Adolescent Subjects With Lupus Nephritis
Study Type
Interventional
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
December 2023 (Anticipated)
Primary Completion Date
June 2026 (Anticipated)
Study Completion Date
September 2026 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Aurinia Pharmaceuticals Inc.
Collaborators
Labcorp Corporation of America Holdings, Inc
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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 adolescents with active lupus nephritis.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Adolescent Lupus Nephritis
Keywords
voclosporin, lupus nephritis, calcineurin inhibitors, adolescents
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Open Label
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
voclosporin
Intervention Description
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.
Primary Outcome Measure Information:
Title
Incidence of Treatment Emergent Adverse Events (TEAE)
Description
Incidence (subject counts and event counts) of TEAEs summarized by System Organ Class and Preferred Terms using MedDRA
Time Frame
Per protocol from VOCAL-EXT Study Start to Study Completion plus a 30-day follow-up period
Secondary Outcome Measure Information:
Title
Renal Response
Description
Proportion of subjects with renal response at Month 12 and 18, defined based on the following parameters:
urine protein creatinine ratio (UPCR) of ≤0.5 mg/mg, and
estimated glomerular filtration rate (eGFR) ≥60 mL/min/1.73 m2 or no confirmed decrease from baseline in eGFR of >20%, and
Received no rescue medication for lupus nephritis, and
Did not receive >10 mg/day prednisone for ≥3 consecutive days or for ≥7 days in total prior to the renal response assessment
Time Frame
Per protocol from Study Start to Study Completion plus a 30-day follow-up period
Title
Urine Protein Creatinine Ratio (UPCR)
Description
Proportion of subjects with UPCR of ≤0.7 mg/mg
Time Frame
Month 12 (VOCAL Study Completion/VOCAL-EXT Study Start) and Month 18 (VOCAL-EXT Study Completion)
Title
Partial Renal Response
Description
Proportion of subjects in partial renal response as defined by ≥50% reduction from VOCAL baseline in UPCR
Time Frame
Month 12 (VOCAL Study Completion/VOCAL-EXT Study Start) and Month 18 (VOCAL-EXT Study Completion)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Antonia Coeshall
Phone
+44-7968-836321
Email
acoeshall@auriniapharma.com
Facility Information:
Facility Name
Nemours Children's Health, Lake Nona Medical City
City
Orlando
State/Province
Florida
ZIP/Postal Code
32827
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Long-Term Voclosporin Treatment in Adolescent Subjects With Lupus Nephritis
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