A Study of Felzartamab in Participants With Lupus Nephritis

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Trial ID: NCT06064929

Purpose

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).

Official Title

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

Stanford Investigator(s)

Richard Lafayette
Richard Lafayette

Professor of Medicine (Nephrology)

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

Intervention(s):

drug: Felzartamab

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Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Elizabeth Chen
(650) 721-3848