Lupus Nephritis
Conditions
Keywords
voclosporin, calcineurin inhibitor
Brief summary
The goal of this clinical study is to assess the efficacy and safety of LUPKYNIS® in combination with belimumab, obinutuzumab or anifrolumab at inducing rapid renal response in patients with lupus nephritis (LN).
Detailed description
Patients with LN will be administered LUPKYNIS in combination with belimumab, obinutuzumab or anifrolumab. Additionally, patients will receive treatment with a mycophenolic acid analog (MPAA), specifically mycophenolate mofetil (MMF) or mycophenolic acid (MPA), and oral prednisone (or equivalent).
Interventions
DRUGLUPKYNIS
voclosporin
BIOLOGICALbelimumab, obinutuzumab or anifrolumab
BENLYSTA (belimumab), GAZYVA (obinutuzumab) or SAPHNELO (anifrolumab)
DRUGmycophenolic acid analog (MPAA)
CELLCEPT (mycophenolate mofetil \[MMF\]) or MYFORTIC (mycophenolic acid \[MPA\])
DRUGcorticosteroid
prednisone (or equivalent)
Sponsors
Aurinia Pharmaceuticals Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
Key Inclusion Criteria: * Adults 18-75 years old * Diagnosed with biopsy-proven lupus nephritis (LN) according to the 2003 International Society of Nephrology (ISN) / Renal Pathology Society (RPS) (class III, class IV, class III/V or class IV/V) * Urine protein-to-creatine ratio (UPCR) ≥0.5 g/g and \<5.0 g/g from a first morning void (FMV) urine sample * Estimated glomerular filtration rate (eGFR) of ≥45 mL/min/1.73 m2 * Concomitant biologic: * Patients on the belimumab or anifrolumab treatment regimens are receiving belimumab or anifrolumab (as applicable) prior to Screening or will initiate belimumab or anifrolumab (as applicable) on or before Day 1. * Patients on the obinutuzumab treatment regimen must have received at least 2 administrations of obinutuzumab prior to Screening. * Willing to take mycophenolic acid analog (MPAA), either by continuing current MPAA therapy or by initiating it on or before Day 1 * Willing to take corticosteroids, either by continuing current corticosteroids (prednisone \[or equivalent\]) or by initiating on or before Day 1 Key
Exclusion criteria
* Any B cell targeted therapy except for the concomitant biologics (belimumab and obinutuzumab) within 1 year prior to Screening unless demonstration of B cell count within the normal range * Cyclophosphamide or any calcineurin inhibitor other than voclosporin (eg, cyclosporine and tacrolimus) within 3 months prior to Screening * Any other immunosuppressive therapy except for the concomitant drugs (anifrolumab, MPAAs and oral prednisone \[or equivalent\]) and immunosuppressive agents used to treat a patient's underlying systemic lupus erythematosus (SLE), including, but not limited to, the examples below, within 30 days or 5 half-lives, whichever is longer, prior to Screening: * Anti-tumor necrosis factor (TNF) therapy (eg, adalimumab, etanercept, infliximab) * Anti-interleukin therapy (eg, risankizumab, secukinumab, ixekizumab, ustekinumab, guselkumab, tocilizumab, dupilumab) * T cell costimulation modulator (eg, abatacept) * Intravenous immunoglobulin (IVIg) * Janus kinase (JAK) inhibitors (eg, upadacitinib) * Pregnant, breastfeeding or intending to become pregnant during the Study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To assess the efficacy of LUPKYNIS in combination with belimumab, obinutuzumab or anifrolumab at inducing rapid renal response: Proportion of patients with complete renal response at 24 weeks | 24 weeks |
Secondary
| Measure | Time frame |
|---|---|
| To assess the safety of LUPKYNIS in combination with belimumab, obinutuzumab or anifrolumab: Incidence of treatment-emergent adverse events | From baseline to study completion, up to 28 weeks |
| To assess the efficacy of LUPKYNIS in combination with belimumab, obinutuzumab or anifrolumab at inducing rapid renal response: Proportion of patients with partial renal response at 24 weeks | 24 weeks |
| To assess the efficacy of LUPKYNIS in combination with belimumab, obinutuzumab or anifrolumab at inducing rapid renal response: Proportion of patients with deep renal response rate at 24 weeks | 24 weeks |
| To assess the time to reach efficacy endpoints of LUPKYNIS in combination with belimumab, obinutuzumab or anifrolumab: Time to complete renal response | From baseline to complete renal response, up to 24 weeks |
| To assess the time to reach efficacy endpoints of LUPKYNIS in combination with belimumab, obinutuzumab or anifrolumab: Time to partial renal response | From baseline to partial renal response, up to 24 weeks |
| To investigate the pharmacodynamics of LUPKYNIS in combination with belimumab, obinutuzumab or anifrolumab: Change from baseline in levels of anti-double-stranded deoxyribonucleic acid (dsDNA) autoantibodies at 12 weeks and at 24 weeks | Baseline, 12 weeks, and 24 weeks |
| To investigate the pharmacodynamics of LUPKYNIS in combination with belimumab, obinutuzumab or anifrolumab: Change from baseline in levels of complement 3 (C3) at 12 weeks and at 24 weeks | Baseline, 12 weeks, and 24 weeks |
| To investigate the pharmacodynamics of LUPKYNIS in combination with belimumab, obinutuzumab or anifrolumab: Change from baseline in levels of complement 4 (C4) at 12 weeks and at 24 weeks | Baseline, 12 weeks, and 24 weeks |
Countries
United States
Contacts
CONTACTAurinia Clinical Trials Information
Outcome results
None listed