Phase
Condition
Lupus Nephritis
Lupus
Cutaneous Lupus Erythematosus
Treatment
Felzartamab
Clinical Study ID
Ages 18-75 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Part 1
Diagnosis of Systemic Lupus Erythematosus (SLE) according to the 2019 EuropeanLeague 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 priorto 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 bythe Chronic Kidney Disease Epidemiology Collaboration formula)
If eGFR is ≥35 to <45 mL/min/1.73m^2, renal biopsy must be within 6 months ofscreening and must not have >50% of glomeruli with sclerosis. If the renalbiopsy was performed more than 6 months prior to screening, a repeat biopsymust 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 toscreening. If the renal biopsy was performed more than 1 year prior toscreening, a repeat biopsy must be done during screening after all the othereligibility criteria are met
- History of inadequate response, for lack of efficacy or intolerance, to at least athree-month course of one standard of care treatment for lupus nephritis, asdetermined by the treating physician
Part 2
- Participants must complete Part 1 of the study to be eligible to participate in Part
Exclusion
Exclusion Criteria:
Part 1
Presence of rapidly progressive glomerulonephritis, as defined by at least one ofthe following: crescent formation in > 50% of glomeruli on renal biopsy, sustaineddoubling of serum creatinine within 12 weeks of screening, or the investigator'sopinion 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 requiredialysis during the study treatment period
A previous kidney transplant or other organ transplant, or planned transplant withinstudy 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 includingcyclophosphamide, or biologic agents other than felzartamab
Progression of LN (as measured by worsening proteinuria and/or decreasing eGFR) hasbeen observed such that in the opinion of the investigator the participant will notbenefit from continuing in Part 2 of the study
Other protocol-defined inclusion/exclusion criteria may apply.
Study Design
Study Description
Connect with a study center
CEMIC
CABA, Buenos Aires F.D. C1431FWO
ArgentinaSite Not Available
Hospital Britanico de Buenos Aires
Caba, Buenos Aires F.D. C1280AEB
ArgentinaSite Not Available
Clinica Priv Velez Sarsfield
Córdoba, Córdoba Province X5016
ArgentinaSite Not Available
Westmead Hospital
Westmead, New South Wales 2145
AustraliaSite Not Available
Princess Alexandra Hospital
Woolloongabba, Queensland 4102
AustraliaSite Not Available
Monash Health
Melbourne, Victoria 3168
AustraliaSite Not Available
Western Health
Saint Albans, Victoria 3021
AustraliaSite Not Available
St. Paul's Hospital
Vancouver, British Columbia V6Z1Y6
CanadaSite Not Available
University Health Network - Toronto General Division
Toronto, Ontario MST258
CanadaSite Not Available
Centre de Recherche du Centre Hospitalier de l'Université de Montréal (CRCHUM)
Montreal, Quebec H2X 3J4
CanadaSite Not Available
University of California, San Diego (UCSD)
La Jolla, California 92037
United StatesSite Not Available
University of California, San Francisco (UCSF)
San Francisco, California 94143
United StatesSite Not Available
Stanford University Medical Center
Stanford, California 94305
United StatesSite Not Available
ClinCept, LLC/River City Vascular Specialists LLC
Columbus, Georgia 31904
United StatesSite Not Available
Georgia Nephrology - Lawrenceville
Lawrenceville, Georgia 30046
United StatesSite Not Available
University of Michigan
Ann Arbor, Michigan 48109
United StatesSite Not Available
Joseph S. and Diane H. Steinberg Ambulatory Care Center
Brooklyn, New York 11201
United StatesSite Not Available
SUNY Downstate Medical Center
Brooklyn, New York 11203
United StatesSite Not Available
University Hospitals Cleveland Medical Center
Cleveland, Ohio 44106
United StatesSite Not Available
The Ohio State University (OSU)
Columbus, Ohio 43210
United StatesSite Not Available
Precision Comprehensive Clinical Research Solutions - Grapevine
Grapevine, Texas 76051
United StatesSite Not Available
Prolato Clinical Research Center
Houston, Texas 77054
United StatesSite Not Available
Accurate Clinical Research - Katy
Katy, Texas 77449
United StatesSite Not Available
R & H Clinical Research
Katy, Texas 77450
United StatesSite Not Available

Not the study for you?
Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.