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).
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).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
150
voclosporin
BENLYSTA (belimumab), GAZYVA (obinutuzumab) or SAPHNELO (anifrolumab)
CELLCEPT (mycophenolate mofetil \[MMF\]) or MYFORTIC (mycophenolic acid \[MPA\])
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
Time frame: 24 weeks
To assess the safety of LUPKYNIS in combination with belimumab, obinutuzumab or anifrolumab: Incidence of treatment-emergent adverse events
Time frame: 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
Time frame: 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
Time frame: 24 weeks
To assess the time to reach efficacy endpoints of LUPKYNIS in combination with belimumab, obinutuzumab or anifrolumab: Time to complete renal response
Time frame: 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
Time frame: 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
Time frame: Baseline, 12 weeks, and 24 weeks
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
prednisone (or equivalent)
Purushotham & Akther Kotha MD, Inc.
La Mesa, California, United States
RECRUITINGValerius Medical Group & Research Center of Greater Long Beach, Inc.
Los Alamitos, California, United States
RECRUITINGWestern Nephrology & Metabolic Bone Disease, PC
Arvada, Colorado, United States
RECRUITINGSwati Shah MD Rheumatology, LLC
Jacksonville, Florida, United States
RECRUITINGVida Clinical Research
Kissimmee, Florida, United States
RECRUITINGLife Clinical Trials
Margate, Florida, United States
RECRUITINGCTR Oakwater
Orlando, Florida, United States
RECRUITINGParris and Associates Rheumatology
Lawrenceville, Georgia, United States
RECRUITINGAccurate Clinical Research, Inc.
Lake Charles, Louisiana, United States
RECRUITINGArthritis and Rheumatism Associates
Rockville, Maryland, United States
RECRUITING...and 17 more locations
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
Time frame: 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
Time frame: Baseline, 12 weeks, and 24 weeks