Summary

Eligibility
for people ages 18-75 (full criteria)
Location
at UCSF
Dates
study started
completion around

Description

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).

Official Title

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

Keywords

Lupus Nephritis, Felzartamab, LN, Systemic Lupus Erythematosus, Lupus, Refractory LN, Nephritis

Eligibility

You can join if…

Open to people ages 18-75

  • 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 m2) (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

You CAN'T join if...

  • 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

Locations

  • HI-Bio Investigational Site not yet accepting patients
    San Francisco California 94143 United States
  • HI-Bio Investigational Site accepting new patients
    La Jolla California 92037 United States
  • HI-Bio Investigational Site accepting new patients
    Stanford California 94305 United States

Details

Status
accepting new patients at some sites,
but this study is not currently recruiting here
Start Date
Completion Date
(estimated)
Sponsor
HI-Bio, A Biogen Company
ID
NCT06064929
Phase
Phase 1 Lupus Research Study
Study Type
Interventional
Participants
Expecting 20 study participants
Last Updated