Adolescent Lupus NephritisPhase 3VOCAL-EXTNCT05962788
Long-Term Voclosporin Treatment in Adolescent and Pediatric Subjects With Lupus Nephritis
A Phase 3 study testing voclosporin in people with Adolescent Lupus Nephritis and Pediatric Lupus Nephritis, run by Aurinia Pharmaceuticals Inc. at 6 sites in 5 countries.
Trial 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 adolescent and pediatric subjects with lupus nephritis. Read more about this study
- Who is it for?
- Ages 5 to 17 years
- Conditions the study is for
- Adolescent Lupus Nephritis, Pediatric Lupus Nephritis
- What is being tested?
- voclosporin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 6 sitesin 5 countries
- Study dates
- 28 Mar 2024to 4 Jul 2025
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
6 sites in 5 countries.
6 sites in 5 countries
Mexico2 sites
Centro de Especialidades Medicas del Sureste
Mérida, Yucatán, 97000
Hospital Infantil de México Federico Gómez
Mexico City, 06720
About this study
Official title: An Open-Label Extension Study to Assess the Long-Term Safety and Efficacy of Voclosporin in Adolescent and Pediatric Subjects With Lupus Nephritis
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.
Read the 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 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.
- Being tested
- voclosporin
- Keywords
- voclosporin, lupus nephritis, calcineurin inhibitors, adolescents, pediatrics
- Medical subject headings
- Lupus Nephritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
voclosporinDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Open Label | Experimental | 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. Receives: Drug: voclosporin |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Per protocol from VOCAL-EXT Study Start to Study Completion plus a 30-day follow-up period
Secondary outcomes (3)
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
Measured: Per protocol from Study Start to Study Completion plus a 30-day follow-up period
Urine Protein Creatinine Ratio (UPCR)
Proportion of subjects with UPCR of ≤0.7 mg/mg
Measured: Month 12 (VOCAL Study Completion/VOCAL-EXT Study Start) and Month 18 (VOCAL-EXT Study Completion)
Partial Renal Response
Proportion of subjects in partial renal response as defined by ≥50% reduction from VOCAL baseline in UPCR
Measured: Month 12 (VOCAL Study Completion/VOCAL-EXT Study Start) and Month 18 (VOCAL-EXT Study Completion)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2023
- Study start28 Mar 2024
- Primary completion4 Jul 2025
- Study completion4 Jul 2025
Why it stopped: DSMB recommendation
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adolescent Lupus NephritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aurinia Pharmaceuticals Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05962788
- Sponsor's protocol ID
- AUR-VCS-2020-04
- Acronym
- VOCAL-EXT
- Status last verified
- Feb 2026
- First submitted
- 21 Jun 2023
- Last updated
- 10 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label Extension Study to Assess the Long-Term Safety and Efficacy of Voclosporin in Adolescent and Pediatric Subjects With Lupus Nephritis
- ClinicalTrials.gov ID
- NCT05962788
- Acronym / sponsor ID
- VOCAL-EXT / AUR-VCS-2020-04
- Keywords
- voclosporin, lupus nephritis, calcineurin inhibitors, adolescents, pediatrics
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: DSMB recommendation
- Enrolment
- 4 participants (actual)
- Lead sponsor
- Aurinia Pharmaceuticals Inc.Industry (pharma, biotech, devices)
- Study start
- 28 Mar 2024 (actual)
- Primary completion
- 4 Jul 2025 (actual)
- Study completion
- 4 Jul 2025 (actual)
- First posted
- 27 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Open Label | Experimental | Drug: voclosporinAll 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. |
Who may qualify
- Ages
- 5 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (7 listed)
- Currently taking or known need for any of the following medications during the study:
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| voclosporinSubjects 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. | Drug | Open Label |
Primary outcome
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
Incidence (subject counts and event counts) of TEAEs summarized by System Organ Class and Preferred Terms using MedDRA
3 secondary outcomes
Renal Response
Time frame: Per protocol from Study Start to Study Completion plus a 30-day follow-up period
Urine Protein Creatinine Ratio (UPCR)
Time frame: Month 12 (VOCAL Study Completion/VOCAL-EXT Study Start) and Month 18 (VOCAL-EXT Study Completion)
Partial Renal Response
Time frame: Month 12 (VOCAL Study Completion/VOCAL-EXT Study Start) and Month 18 (VOCAL-EXT Study Completion)
Results and safety
The study was stopped early (reason given: DSMB recommendation). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
6 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing voclosporin in people with Adolescent Lupus Nephritis and Pediatric Lupus Nephritis, run by Aurinia Pharmaceuticals Inc. at 6 sites in 5 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 10 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Mexico, United States, Colombia, Japan, Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: DSMB recommendation). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Feb 2026.