Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
HI-Bio, A Biogen Company
Study Sponsor, originally HI-Bio, Inc., is now HI-Bio, A Biogen Company.
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
