Adolescent Lupus NephritisPhase 3VOCALNCT05288855
Voclosporin 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 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). 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?
- Yes, some participants may receive a placebo
- How many people
- 9 participants
- Where
- 6 sitesin 5 countries
- Study dates
- 10 Oct 2023to 3 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
- Previous diagnosis of systemic lupus erythematosus (SLE) as per the 2019 EULAR/ ACR classification criteria.
- Subjects with kidney biopsy confirmed active lupus nephritis.
Who cannot join
- Estimated glomerular filtration rate (eGFR) <60 mL/minute/1.73 m2 at screening.
- Current or medical history of:
- Congenital or acquired immunodeficiency.
- Clinically significant drug or alcohol abuse prior to screening.
- Malignant neoplasm.
- Lymphoproliferative disease or previous total lymphoid irradiation.
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- Known severe viral infections within 3 months of screening; or known human immunodeficiency virus infection, or hepatitis B or C virus infection at any time prior to screening.
- Active tuberculosis (TB) or known history of TB/evidence of old TB if not taking prophylaxis with isoniazid.
- Currently requiring renal dialysis (hemodialysis or peritoneal dialysis) or expected to require dialysis during the study period.
- Other known clinically significant active medical conditions, for which the condition or the treatment of the condition may affect the study assessments or outcomes.
- Currently taking or known need for any of the following medications:
- Immunosuppression biologic agents within 12 weeks prior to randomization, cyclophosphamide, calcineurin inhibitors (CNIs) and live attenuated vaccines, initiation or dose change of ACE inhibitors/ARBs within 4 weeks prior to randomization, IV corticosteroids and IV immunoglobulin within 2 weeks prior to screening, strong CYP3A4/5 inhibitors and inducers within 2 weeks prior to randomization.
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
United States1 site
Nemours Children's Hospital, Orlando
Orlando, Florida, 13535
About this study
Official title: 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
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).
Read the detailed description
This is a 24 week, dose escalation study of voclosporin in addition to standard of care with mycophenolate mofetil (MMF) and steroids, consisting of 3 treatment periods: Period 1 is double-blind, placebo controlled receiving 15.8 mg twice daily, Period 2 is open-label receiving 23.7 mg twice daily, Period 3 is open-label receiving 15.8 mg twice daily.
- Being tested
- Voclosporin, Placebo Oral Capsule
- Keywords
- Lupus nephritis, calcineurin inhibitors, voclosporin, 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
calcineurin inhibitor
Placebo Oral CapsuleDrug
matching placebo capsule
| Study group | Role | What they receive |
|---|---|---|
| Voclosporin treatment group 1 | Experimental | 2 capsules (15.8 mg) BID of voclosporin Receives: Drug: Voclosporin |
| Placebo treatment group 2 | Placebo comparator | 2 capsules BID of placebo Receives: Drug: Placebo Oral Capsule |
| Voclosporin treatment group 3 | Experimental | 3 capsules (23.7 mg) BID of voclosporin Receives: Drug: Voclosporin |
| Voclosporin treatment group 4 | Experimental | Maximum dose of 2 capsules (15.8 mg) BID of voclosporin. Receives: Drug: Voclosporin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of subjects with renal response
Renal response defined as UPCR ≤0.5 mg/mg, eGFR ≥60 mL/min/1.73 m2 or no decrease from baseline of >20%, no rescue medication and no steroid use >10 mg/day for ≥3 consecutive days or for ≥7 days in total between week 16 to 24
Measured: Week 24
Secondary outcomes (4)
Time to UPCR of ≤0.5 mg/mg.
Time in days to reduction in UPCR to ≤ 0.5 mg/mg
Measured: Baseline to Week 24
Proportion of subjects with partial renal response
defined as ≥50% reduction from baseline in UPCR
Measured: Week 24
Time to 50% Reduction in UPCR
Time in days to reduction from baseline UPCR of at least 50% Organ Class, and preferred term.
Measured: Baseline to Week 24
Number of treatment-emergent adverse events (TEAEs) will be summarized by treatment group
Treatment-emergent adverse events will be summarized by treatment group, System Organ Class, and preferred term
Measured: Baseline to Week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2022
- Study start10 Oct 2023
- Primary completion3 Jul 2025
- Study completion3 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
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 9 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
- NCT05288855
- Sponsor's protocol ID
- AUR-VCS-2020-03
- Acronym
- VOCAL
- Status last verified
- Feb 2026
- First submitted
- 11 Mar 2022
- 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
- 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
- ClinicalTrials.gov ID
- NCT05288855
- Acronym / sponsor ID
- VOCAL / AUR-VCS-2020-03
- Keywords
- Lupus nephritis, calcineurin inhibitors, voclosporin, adolescents, pediatrics
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: DSMB recommendation
- Enrolment
- 9 participants (actual)
- Lead sponsor
- Aurinia Pharmaceuticals Inc.Industry (pharma, biotech, devices)
- Study start
- 10 Oct 2023 (actual)
- Primary completion
- 3 Jul 2025 (actual)
- Study completion
- 3 Jul 2025 (actual)
- First posted
- 21 Mar 2022 (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 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).
Detailed description
This is a 24 week, dose escalation study of voclosporin in addition to standard of care with mycophenolate mofetil (MMF) and steroids, consisting of 3 treatment periods: Period 1 is double-blind, placebo controlled receiving 15.8 mg twice daily, Period 2 is open-label receiving 23.7 mg twice daily, Period 3 is open-label receiving 15.8 mg twice daily.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Voclosporin treatment group 1 | Experimental | Drug: Voclosporin2 capsules (15.8 mg) BID of voclosporin |
| Placebo treatment group 2 | Placebo comparator | Drug: Placebo Oral Capsule2 capsules BID of placebo |
| Voclosporin treatment group 3 | Experimental | Drug: Voclosporin3 capsules (23.7 mg) BID of voclosporin |
| Voclosporin treatment group 4 | Experimental | Drug: VoclosporinMaximum dose of 2 capsules (15.8 mg) BID of voclosporin. |
Who may qualify
- Ages
- 5 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Previous diagnosis of systemic lupus erythematosus (SLE) as per the 2019 EULAR/ ACR classification criteria.
- Subjects with kidney biopsy confirmed active lupus nephritis.
Key exclusion criteria (12 listed)
- Estimated glomerular filtration rate (eGFR) <60 mL/minute/1.73 m2 at screening.
- Current or medical history of:
- Currently requiring renal dialysis (hemodialysis or peritoneal dialysis) or expected to require dialysis during the study period.
- Other known clinically significant active medical conditions, for which the condition or the treatment of the condition may affect the study assessments or outcomes.
- Currently taking or known need for any of the following medications:
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 |
|---|---|---|
| Voclosporincalcineurin inhibitor | Drug | Voclosporin treatment group 1, Voclosporin treatment group 3, Voclosporin treatment group 4 |
| Placebo Oral Capsulematching placebo capsule | Drug | Placebo treatment group 2 |
Primary outcome
Proportion of subjects with renal response
Time frame: Week 24
Renal response defined as UPCR ≤0.5 mg/mg, eGFR ≥60 mL/min/1.73 m2 or no decrease from baseline of >20%, no rescue medication and no steroid use >10 mg/day for ≥3 consecutive days or for ≥7 days in total between week 16 to 24
4 secondary outcomes
Time to UPCR of ≤0.5 mg/mg.
Time frame: Baseline to Week 24
Proportion of subjects with partial renal response
Time frame: Week 24
Time to 50% Reduction in UPCR
Time frame: Baseline to Week 24
Number of treatment-emergent adverse events (TEAEs) will be summarized by treatment group
Time frame: Baseline to Week 24
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
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 2 inclusion and 12 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. Some participants in this study may receive a placebo. 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?
Proportion of subjects with renal response (time frame: Week 24). 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.