Study on Felzartamab in Patients With Lupus Nephritis
The goal of this clinical trial is to assess the safety and tolerability of felzartamab plus standard of care in patients with refractory Lupus Nephritis (LN).
Conditions:
🦠 Lupus Nephritis
πŸ—“οΈ Study Start (Actual) 1 November 2023
πŸ—“οΈ Primary Completion (Estimated) May 2025
βœ… Study Completion (Estimated) May 2025
πŸ‘₯ Enrollment (Estimated) 20
πŸ”¬ Study Type INTERVENTIONAL
πŸ“Š Phase PHASE1
Locations:
πŸ“ La Jolla, California, United States
πŸ“ Stanford, California, United States
πŸ“ Columbus, Georgia, United States
πŸ“ Lawrenceville, Georgia, United States
πŸ“ Ann Arbor, Michigan, United States
πŸ“ Brooklyn, New York, United States
πŸ“ Cleveland, Ohio, United States
πŸ“ Columbus, Ohio, United States
πŸ“ Houston, Texas, United States
πŸ“ Caba, Argentina
πŸ“ Caba, Argentina
πŸ“ Westmead, New South Wales, Australia
πŸ“ Woolloongabba, Queensland, Australia
πŸ“ Clayton, Victoria, Australia
πŸ“ Saint Albans, Victoria, Australia
πŸ“ MontrΓ©al, Quebec, Canada

πŸ“‹ Eligibility Criteria

Description

    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 β‰₯ 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
Ages Eligible for Study: 18 Years to 75 Years (ADULT, OLDER_ADULT)
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: No

πŸ—“οΈ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

  • First Submitted 26 September 2023
  • First Submitted that Met QC Criteria 26 September 2023
  • First Posted 3 October 2023

Study Record Updates

  • Last Update Submitted that Met QC Criteria 1 July 2024
  • Last Update Posted 3 July 2024
  • Last Verified July 2024