A Study to Learn More About the Safety and Effects of Felzartamab in Adults With Lupus Nephritis Aged 18 to 75 Years Old

Age

18–75

Sex

ALL

Healthy volunteers

Not accepted

You may be eligible if

Part 1
Diagnosis of Systemic Lupus Erythematosus (SLE) according to the 2019 European League Against Rheumatism (EULAR)/ American College of Rheumatology (ACR) criteria
Diagnosis of International Society of Nephrology/ Renal Pathology Society (ISN/RPS) 2003 Class III or IV LN as evidenced by renal biopsy performed within 1 year prior to or during screening, either with or without the presence of Class V LN
Proteinuria (urine protein to creatinine ratio) \> 1.0 gram per gram (g/g), based on 24-hour urine collection during screening
eGFR ≥ 45 milliliter/minute/1.73 square meters (mL/min/1.73 m\^2) (as calculated by the Chronic Kidney Disease Epidemiology Collaboration formula)
1. If eGFR is ≥35 to \<45 mL/min/1.73m\^2, renal biopsy must be within 6 months of screening and must not have \>50% of glomeruli with sclerosis. If the renal biopsy was performed more than 6 months prior to screening, a repeat biopsy must be done during screening after all the other eligibility criteria are met
2. If eGFR is ≥45 mL/min/1.73 m\^2, renal biopsy must be within 1 year prior to screening. If the renal biopsy was performed more than 1 year prior to screening, a repeat biopsy must be done during screening after all the other eligibility criteria are met
History of inadequate response, for lack of efficacy or intolerance, to at least a three-month course of one standard of care treatment for lupus nephritis, as determined by the treating physician
Part 2
Participants must complete Part 1 of the study to be eligible to participate in Part 2.

You may not be if

Part 1
Presence of rapidly progressive glomerulonephritis, as defined by at least one of the following: crescent formation in \> 50% of glomeruli on renal biopsy, sustained doubling of serum creatinine within 12 weeks of screening, or the investigator's opinion that the participant has rapidly progressive glomerulonephritis
Greater than 50% of glomeruli with sclerosis on renal biopsy
Currently requiring hemodialysis or peritoneal dialysis or expected to require dialysis during the study treatment period
A previous kidney transplant or other organ transplant, or planned transplant within study treatment period
Part 2
Did not complete Part 1 of the study
Received protocol-prohibited medications in Part 1 such as calcineurin inhibitors (e.g., cyclosporine, tacrolimus, or voclosporin), alkylating agents including cyclophosphamide, or biologic agents other than felzartamab
Progression of LN (as measured by worsening proteinuria and/or decreasing eGFR) has been observed such that in the opinion of the investigator the participant will not benefit from continuing in Part 2 of the study

A Study to Learn More About the Safety and Effects of Felzartamab in Adults With Lupus Nephritis Aged 18 to 75 Years Old

What this study is about

A Study to Learn More About the Safety and Effects of Felzartamab in Adults With Lupus Nephritis Aged 18 to 75 Years Old

What this study is about