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

Launched by HI-BIO, A BIOGEN COMPANY · Sep 26, 2023

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called felzartamab for people with lupus nephritis, a kidney condition caused by lupus that can be difficult to manage. The main goal is to find out if felzartamab is safe and how well it works when given alongside standard treatments for lupus nephritis, especially for those who have not responded well to previous therapies. The trial is currently looking for participants aged between 18 and 75 who have been diagnosed with systemic lupus erythematosus (SLE) and have specific kidney issues confirmed by a recent kidney biopsy.

If you or a family member are interested in participating, you should have a history of lupus nephritis and have tried at least one standard treatment without success. Participants can expect regular check-ups and monitoring throughout the study to ensure their safety and to see how well the treatment works. It's important to note that certain kidney conditions or past surgeries may prevent someone from joining the trial, so potential participants should discuss their medical history with the study team.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 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.
• Exclusion Criteria:
• • 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
• • Other protocol-defined inclusion/exclusion criteria may apply.