A Study of Felzartamab in Participants With Lupus Nephritis

• Status: Recruiting
• Trial end date: 2025-05-01
• Target enrollment: 0
• Participant gender: All

Summary

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).

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: HI-Bio
• Treatments: Felzartamab

Criteria

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