An Open Label Phase 1b Study of Felzartamab in Lupus Nephritis

Description

The goal of this clinical trial is to evaluate the safety and tolerability of felzartamab plus standard of care in participants with refractory Lupus Nephritis (LN).Study Sponsor, originally HI-Bio, Inc., is now HI-Bio, A Biogen Company.

Trial Eligibility

Inclusion Criteria: * 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) * 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 Exclusion Criteria: * 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 Other protocol-defined inclusion/exclusion criteria may apply

Study Info

Interventions

Locations Recruiting

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