LUPKYNISbelimumab, obinutuzumab or anifrolumabmycophenolic acid analog (MPAA)corticosteroid
LUPKYNIS: voclosporin
belimumab, obinutuzumab or anifrolumab: BENLYSTA (belimumab), GAZYVA (obinutuzumab) or SAPHNELO (anifrolumab)
mycophenolic acid analog (MPAA): CELLCEPT (mycophenolate mofetil \[MMF\]) or MYFORTIC (mycophenolic acid \[MPA\])
corticosteroid: prednisone (or equivalent)
Study 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).
Eligibility
Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
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
Primary outcome measure(s)
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
Trial sites (27)
Facility
City
Region
Status
Purushotham & Akther Kotha MD, Inc.
La Mesa
California
Recruiting
Valerius Medical Group & Research Center of Greater Long Beach, Inc.
Los Alamitos
California
Recruiting
Western Nephrology & Metabolic Bone Disease, PC
Arvada
Colorado
Recruiting
Swati Shah MD Rheumatology, LLC
Jacksonville
Florida
Recruiting
Vida Clinical Research
Kissimmee
Florida
Recruiting
Life Clinical Trials
Margate
Florida
Recruiting
CTR Oakwater
Orlando
Florida
Recruiting
Parris and Associates Rheumatology
Lawrenceville
Georgia
Recruiting
Accurate Clinical Research, Inc.
Lake Charles
Louisiana
Recruiting
Arthritis and Rheumatism Associates
Rockville
Maryland
Recruiting
Kansas City Physician Partners
Kansas City
Missouri
Recruiting
University of Nevada Las Vegas
Las Vegas
Nevada
Recruiting
Sahni Rheumatology & Therapy
West Long Branch
New Jersey
Recruiting
Buffalo Rheumatology and Medicine, PLLC
Orchard Park
New York
Recruiting
Arthritis and Osteoporosis Consultants of the Carolinas
Charlotte
North Carolina
Recruiting
Joint and Muscle Research Institute
Charlotte
North Carolina
Recruiting
Rheumatic Disease Associates, Ltd.
Willow Grove
Pennsylvania
Recruiting
Dunes Clinical Research
Dakota Dunes
South Dakota
Recruiting
West Tennessee Research Institute
Jackson
Tennessee
Recruiting
Novel Research LLC
Bellaire
Texas
Recruiting
Liberty Research Center
Dallas
Texas
Recruiting
Texas Arthritis Center
El Paso
Texas
Recruiting
Integrative Rheumatology of South Texas
Harlingen
Texas
Recruiting
Northwest Houston Arthritis Center
Houston
Texas
Recruiting
Texas Tech University Health Science Center
Lubbock
Texas
Recruiting
Texas Rheumatology Research Institute, LLC
Plano
Texas
Recruiting
Nephrology Leaders and Associates, PLLC
Van Vleck
Texas
Recruiting
More Aurinia Pharmaceuticals Inc. trials in the USA
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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