Status:
ACTIVE_NOT_RECRUITING
A Study to Learn More About the Safety and Effects of Felzartamab in Adults With Lupus Nephritis Aged 18 to 75 Years Old
Lead Sponsor:
HI-Bio, A Biogen Company
Conditions:
Lupus Nephritis
Eligibility:
All Genders
18-75 years
Phase:
PHASE1
Brief Summary
In this study, researchers will learn more about the use of felzartamab in people with active lupus nephritis, also known as LN. In people with LN, antibodies build up in the glomeruli of the kidneys....
Detailed Description
Study Sponsor, originally HI-Bio, Inc., is now HI-Bio, A Biogen Company.
Eligibility Criteria
Inclusion
- 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)
- 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
- 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
- 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.
Key Trial Info
Start Date :
November 1 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 30 2026
Estimated Enrollment :
14 Patients enrolled
Trial Details
Trial ID
NCT06064929
Start Date
November 1 2023
End Date
June 30 2026
Last Update
December 31 2025
Active Locations (24)
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1
University of California, San Diego (UCSD)
La Jolla, California, United States, 92037
2
University of California, San Francisco (UCSF)
San Francisco, California, United States, 94143
3
Stanford University Medical Center
Stanford, California, United States, 94305
4
ClinCept, LLC/River City Vascular Specialists LLC
Columbus, Georgia, United States, 31904