A Study to Learn More About the Safety and Effects of Felzartamab in Adults With Lupus Nephritis Aged 18 to 75 Years Old
NCT ID: NCT06064929
Last Updated: 2025-12-31
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
ACTIVE_NOT_RECRUITING
PHASE1
14 participants
INTERVENTIONAL
2023-11-01
2026-06-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Kidney damage can lead to too much protein and blood leaking into the urine. High levels of protein in the urine, called proteinuria, are common in people with LN. Symptoms of LN can include fever, swelling in the legs and body, and high blood pressure. If left untreated, LN can eventually lead to kidney failure.
In this study, researchers will learn more about how a study drug called felzartamab affects people with LN. Felzartamab is a monoclonal antibody, which means it is an antibody made in a laboratory. Felzartamab can target immune cells that produce antibodies, helping to lower their buildup in the kidneys. The main goal of this study is to learn more about the safety of felzartamab and how it works in the body of people with LN who are taking standard of care. This will help researchers decide if they should do more studies with felzartamab in people with LN. Standard of care is the usual treatment or care given to patients for a disease, as prescribed by their doctor.
The main question researchers want to answer in this study are:
• How many participants had adverse events during the study? An adverse event is a health problem that may or may not be caused by the study drug. It can happen during a clinical study or within a certain amount of time after the study has ended.
Researchers will also learn more about:
* How much felzartamab affects proteinuria and the level of creatinine in the urine. Creatinine is a protein that is released into the blood from normal muscle wear and tear. Its levels can help doctors understand how well your kidneys are working.
* How many participants have a complete response. A complete response means that their urine protein levels decrease to a low level, and their kidney function stays stable.
* How many participants have a 50% decrease in the level of protein and creatinine in their urine.
* How much felzartamab affects the participants' lupus-related blood tests.
* How the body processes felzartamab.
* How many participants develop antibodies against felzartamab in the blood.
This study will be done as follows:
* Participants will be screened to check if they can join the study. The screening period will be up to 42 days.
* Throughout the study, all participants will continue taking their standard of care, as prescribed by their doctor.
* There are 2 parts in this study. In both parts, participants will receive felzartamab through an intravenous infusion, also known as an IV. This means it is being given into a vein.
* In Part 1, participants will have up to 14 visits to their study research center. In Part 2, participants may have up to 15 visits.
* Each participant will be in the study for about 2 years.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Felzartamab
Participants will receive two courses of multiple intravenous (IV) doses of felzartamab, separated by a 28-week off-treatment period.
These courses are given in Part 1 and Part 2 of the trial.
Felzartamab
Administered IV
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Felzartamab
Administered IV
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
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)
1. 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
2. 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 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
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
18 Years
75 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
HI-Bio, A Biogen Company
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Medical Director
Role: STUDY_DIRECTOR
HI-Bio, A Biogen Company
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
University of California, San Diego (UCSD)
La Jolla, California, United States
University of California, San Francisco (UCSF)
San Francisco, California, United States
Stanford University Medical Center
Stanford, California, United States
ClinCept, LLC/River City Vascular Specialists LLC
Columbus, Georgia, United States
Georgia Nephrology - Lawrenceville
Lawrenceville, Georgia, United States
University of Michigan
Ann Arbor, Michigan, United States
Joseph S. and Diane H. Steinberg Ambulatory Care Center
Brooklyn, New York, United States
SUNY Downstate Medical Center
Brooklyn, New York, United States
University Hospitals Cleveland Medical Center
Cleveland, Ohio, United States
The Ohio State University (OSU)
Columbus, Ohio, United States
Precision Comprehensive Clinical Research Solutions - Grapevine
Grapevine, Texas, United States
Prolato Clinical Research Center
Houston, Texas, United States
Accurate Clinical Research - Katy
Katy, Texas, United States
R & H Clinical Research
Katy, Texas, United States
Hospital Britanico de Buenos Aires
Caba, Buenos Aires F.D., Argentina
CEMIC
CABA, Buenos Aires F.D., Argentina
Clinica Priv Velez Sarsfield
Córdoba, Córdoba Province, Argentina
Westmead Hospital
Westmead, New South Wales, Australia
Princess Alexandra Hospital
Woolloongabba, Queensland, Australia
Monash Health
Melbourne, Victoria, Australia
Western Health
Saint Albans, Victoria, Australia
St. Paul's Hospital
Vancouver, British Columbia, Canada
University Health Network - Toronto General Division
Toronto, Ontario, Canada
Centre de Recherche du Centre Hospitalier de l'Université de Montréal (CRCHUM)
Montreal, Quebec, Canada
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
HIB-202-101
Identifier Type: OTHER
Identifier Source: secondary_id
299LE101
Identifier Type: -
Identifier Source: org_study_id