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

HIB-202-101

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).

2023-11-01

2025-05-01

2025-05-01

Recruiting

Early phase I

20

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

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE1'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 20, 'type': 'ESTIMATED'}}

2024-06-11