Lupus NephritisPhase 1NCT06064929
A Study to Learn More About the Safety and Effects of Felzartamab in Adults With Lupus Nephritis Aged 18 to 75 Years Old
A Phase 1 study testing Felzartamab in people with Lupus Nephritis, run by HI-Bio, A Biogen Company at 24 sites in 4 countries.
Trial 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. Antibodies are proteins in the blood used by the immune system to fight infection. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Lupus Nephritis
- What is being tested?
- Felzartamab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 24 sitesin 4 countries
- Study dates
- 1 Nov 2023to 8 Jul 2026
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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.
Who cannot join
- 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
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- 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.
Trial locations and contacts
24 sites in 4 countries.
24 sites in 4 countries
United States14 sites
University of Michigan
Ann Arbor, Michigan, 48109
Joseph S. and Diane H. Steinberg Ambulatory Care Center
Brooklyn, New York, 11201
SUNY Downstate Medical Center
Brooklyn, New York, 11203
University Hospitals Cleveland Medical Center
Cleveland, Ohio, 44106
ClinCept, LLC/River City Vascular Specialists LLC
Columbus, Georgia, 31904
The Ohio State University (OSU)
Columbus, Ohio, 43210
Precision Comprehensive Clinical Research Solutions - Grapevine
Grapevine, Texas, 76051
Prolato Clinical Research Center
Houston, Texas, 77054
Accurate Clinical Research - Katy
Katy, Texas, 77449
R & H Clinical Research
Katy, Texas, 77450
University of California, San Diego (UCSD)
La Jolla, California, 92037
Georgia Nephrology - Lawrenceville
Lawrenceville, Georgia, 30046
University of California, San Francisco (UCSF)
San Francisco, California, 94143
Stanford University Medical Center
Stanford, California, 94305
Australia4 sites
Monash Health
Melbourne, Victoria, 3168
Western Health
Saint Albans, Victoria, 3021
Westmead Hospital
Westmead, New South Wales, 2145
Princess Alexandra Hospital
Woolloongabba, Queensland, 4102
Argentina3 sites
Hospital Britanico de Buenos Aires
Caba, Buenos Aires F.D., C1280AEB
CEMIC
CABA, Buenos Aires F.D., C1431FWO
Clinica Priv Velez Sarsfield
Córdoba, Córdoba Province, X5016
Canada3 sites
Centre de Recherche du Centre Hospitalier de l'Université de Montréal (CRCHUM)
Montreal, Quebec, H2X 3J4
University Health Network - Toronto General Division
Toronto, Ontario, MST258
St. Paul's Hospital
Vancouver, British Columbia, V6Z1Y6
About this study
Official title: An Open Label Phase 1b Study of Felzartamab in Lupus Nephritis
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. Antibodies are proteins in the blood used by the immune system to fight infection. Glomeruli are small filters that remove waste and extra fluid from the blood. This buildup leads to inflammation and damage to the kidneys.
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.
Read more
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.
Read the detailed description
Study Sponsor, originally HI-Bio, Inc., is now HI-Bio, A Biogen Company.
- Conditions
- Lupus Nephritis
- Being tested
- Felzartamab
- Keywords
- Felzartamab, LN, Systemic Lupus Erythematosus, Lupus, Refractory LN
- Medical subject headings
- Lupus Nephritis, Lupus Erythematosus, Systemic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FelzartamabDrug
Also called HIB202, BIIB148, MOR202, MOR03087
Administered IV
| Study group | Role | What they receive |
|---|---|---|
| Felzartamab | Experimental | 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. Receives: Drug: Felzartamab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants with Adverse Events
Measured: Up to Week 104
Secondary outcomes (10)
Change from Baseline in Urine Protein:Creatinine Ratio (UPCR)
Measured: Baseline, Up to Week 104
Proportion of Participants Who Achieve a Complete Renal Response (CRR)
Measured: Week 24
Proportion of Participants Who Achieve Overall Complete and Partial Renal Response (PRR: CRR+PRR)
Measured: Week 24
Change from Baseline in Serum Creatinine
Measured: Baseline, Up to Week 104
Change from Baseline in Urine Protein
Measured: Baseline, Up to Week 104
Change from Baseline in Estimated Glomerular Filtration Rate (eGFR)
Measured: Baseline, Up to Week 104
Change from Baseline in eGFR Slope
Measured: Baseline, Up to Week 104
Change from Baseline in Lupus Serologic Markers
Measured: Baseline, Up to Week 104
Felzartamab Serum Concentrations
Measured: Up to Week 104
Number of Participants with Anti-drug Antibodies to Felzartamab
Measured: Baseline, Up to Week 104
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2023
- Study start1 Nov 2023
- Primary completion24 Jun 2026
- Study completion8 Jul 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lupus NephritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- HI-Bio, A Biogen Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, HI-Bio, A Biogen Company
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06064929
- Sponsor's protocol ID
- 299LE101
- Other IDs
- HIB-202-101
- Status last verified
- Jul 2026
- First submitted
- 26 Sep 2023
- Last updated
- 17 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: In accordance with Biogen's Clinical Trial Transparency and Data Sharing Policy on https://www.biogentrialtransparency.com/
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open Label Phase 1b Study of Felzartamab in Lupus Nephritis
- ClinicalTrials.gov ID
- NCT06064929
- Acronym / sponsor ID
- 299LE101
- Conditions
- Lupus Nephritis
- Keywords
- Felzartamab, LN, Systemic Lupus Erythematosus, Lupus, Refractory LN
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- HI-Bio, A Biogen CompanyIndustry (pharma, biotech, devices)
- Study start
- 1 Nov 2023 (actual)
- Primary completion
- 24 Jun 2026 (actual)
- Study completion
- 8 Jul 2026 (actual)
- First posted
- 3 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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. Antibodies are proteins in the blood used by the immune system to fight infection. Glomeruli are small filters that remove waste and extra fluid from the blood. This buildup leads to inflammation and damage to the kidneys.
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
Study Sponsor, originally HI-Bio, Inc., is now HI-Bio, A Biogen Company.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Felzartamab | Experimental | Drug: FelzartamabParticipants 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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)
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FelzartamabAlso: HIB202, BIIB148, MOR202, MOR03087Administered IV | Drug | Felzartamab |
Primary outcome
Number of Participants with Adverse Events
Time frame: Up to Week 104
10 secondary outcomes
Change from Baseline in Urine Protein:Creatinine Ratio (UPCR)
Time frame: Baseline, Up to Week 104
Proportion of Participants Who Achieve a Complete Renal Response (CRR)
Time frame: Week 24
Proportion of Participants Who Achieve Overall Complete and Partial Renal Response (PRR: CRR+PRR)
Time frame: Week 24
Change from Baseline in Serum Creatinine
Time frame: Baseline, Up to Week 104
Change from Baseline in Urine Protein
Time frame: Baseline, Up to Week 104
Change from Baseline in Estimated Glomerular Filtration Rate (eGFR)
Time frame: Baseline, Up to Week 104
Change from Baseline in eGFR Slope
Time frame: Baseline, Up to Week 104
Change from Baseline in Lupus Serologic Markers
Time frame: Baseline, Up to Week 104
Felzartamab Serum Concentrations
Time frame: Up to Week 104
Number of Participants with Anti-drug Antibodies to Felzartamab
Time frame: Baseline, Up to Week 104
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2026.
- Individual participant dataSharing planned: Yes. In accordance with Biogen's Clinical Trial Transparency and Data Sharing Policy on https://www.biogentrialtransparency.com/
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Medical Director study director
HI-Bio, A Biogen Company
24 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Felzartamab in people with Lupus Nephritis, run by HI-Bio, A Biogen Company at 24 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 24 sites in United States, Australia, Argentina, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants with Adverse Events (time frame: Up to Week 104). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jul 2026.