Immunoglobulin A NephropathyPhase 2NCT07889362
A Study to Learn About the Effects of Felzartamab on the Kidneys of Adults With Immunoglobulin A Nephropathy (IgAN)
A Phase 2 study testing Felzartamab in people with Immunoglobulin A Nephropathy, run by Biogen.
Trial summary
In this study, researchers will learn more about the use of felzartamab in participants with immunoglobulin A nephropathy (IgAN). IgAN is a kidney disease caused by the buildup of an antibody called IgA in the kidneys over time. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Immunoglobulin A Nephropathy
- 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
- 25 participants
- Where
- No sites listed yet
- Study dates
- 16 Nov 2026to 2 Dec 2029
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Biopsy-confirmed diagnosis of IgAN.
Who cannot join
- Conditions that may predispose to an increased bleeding risk, as determined by the Investigator.
- History of diabetes mellitus.
- Any diagnosed or suspected immunosuppressed or immunodeficient state.
- Any history of malignancy within 5 years prior to Screening with the exception of adequately treated in situ carcinoma of the uterine cervix, basal or squamous cell carcinoma or other non-melanomatous skin cancer.
- Any clinically significant underlying illness that, in the opinion of the Investigator, medical monitor, and/or Sponsor may compromise study participation, present a safety risk to the participant, or may confound the interpretation of the study results, including general non-adherence to study medication therapy.
- Active clinically significant infections; known history of recurrent clinically significant infection.
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- Hematologic and hepatic abnormalities.
- History of major surgery, severe trauma, or bone fracture within 3 months prior to first dose of felzartamab or planned major surgery any time from Screening until 1 month after the end of study.
- Note: Other protocol-defined Inclusion/Exclusion criteria may apply.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
Global Biogen Clinical Trial Center contact
About this study
Official title: A Phase 2 Open Label Study to Evaluate the Effects of Felzartamab on the Kidney in Individuals With IgA Nephropathy
In this study, researchers will learn more about the use of felzartamab in participants with immunoglobulin A nephropathy (IgAN). IgAN is a kidney disease caused by the buildup of an antibody called IgA in the kidneys over time. In people with IgAN, abnormal IgA and other antibodies form clusters that build up in the small filters of the kidneys, which leads to inflammation and damage. Felzartamab is designed to target certain immune cells that produce these abnormal antibodies.
The main goal of the study is to learn about the effect felzartamab has on the buildup of IgA clusters in the kidneys. The main question that researchers want to answer is:
Read more
- How much does the buildup of IgA in the kidney change from the start of the study to Week 36? Researchers will also learn about the effect felzartamab has on kidney health by measuring protein levels in the urine and the kidneys' ability to filter blood. They will also learn more about the safety of felzartamab and how the body processes the drug.
The study will be done as follows:
- Participants will be screened to check if they can join the study.
- This is an open-label study, which means both the researchers and the participants will know that all participants are receiving felzartamab.
- Participants will receive felzartamab as intravenous (IV) infusions.
- Participants will have kidney biopsies done over the course of the study to help measure changes in the health of the kidneys.
- Participants will have multiple scheduled study visits over about 104 weeks. An extra study visit may be needed if a participant decides to leave the study early.
- In total, participants will stay in the study for about 2 years (up to 112 weeks).
Read the detailed description
The primary objective of the study is to evaluate the effects of felzartamab on immunoglobulin A (IgA) deposition by immunofluorescence (IF). The secondary objectives are to evaluate the effects of felzartamab on histological and efficacy endpoints, and to evaluate the safety, pharmacokinetics (PK), and immunogenicity of felzartamab.
- Conditions
- Immunoglobulin A Nephropathy
- Being tested
- Felzartamab
- Keywords
- Felzartamab, Biopsy
- Medical subject headings
- Glomerulonephritis, IGA
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FelzartamabDrug
Also called BIIB148, MOR202, MOR03087, TJ202
Administered IV
| Study group | Role | What they receive |
|---|---|---|
| Felzartamab | Experimental | Participants will receive a single dose of felzartamab at each dosing visit. Receives: Drug: Felzartamab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in Mesangial Immunoglobulin A (IgA) Deposition by Immunofluorescence (IF)
Measured: Baseline, Week 36
Secondary outcomes (10)
Change From Baseline in Mesangial IgA Deposition by IF
Measured: Baseline, Week 104
Percent Change From Baseline in Proteinuria
Measured: Baseline up to Week 36
Annualized Rate of Change (slope) in the Estimated Glomerular Filtration Rate (eGFR)
Measured: Baseline up to Week 104
Change From Baseline in eGFR
Measured: Baseline up to Week 104
Percentage of Participants Achieving Complete Response (CR)
Measured: Baseline up to Week 104
Percentage of Participants who Progressed to Kidney Failure
Measured: Baseline up to Week 104
Percentage of Participants With Treatment Emergent Adverse Event (TEAE) and Treatment Emergent Serious Adverse Event (TESAE)
Measured: Baseline up to Week 104
Number of Participants with Clinically Significant Laboratory, Physical Examination, Vital Signs and Electrocardiograms (ECGs) Abnormalities
Measured: Baseline up to Week 104
Felzartamab Serum Concentrations Over Time
Measured: Predose and at multiple timepoints postdose up to Week 36
Number of Participants with Anti-Drug Antibodies (ADAs) Against 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 posted22 Oct 2026
- Study start16 Nov 2026 (estimated)
- Primary completion13 Aug 2028 (estimated)
- Study completion2 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Immunoglobulin A NephropathyStudies of the same condition, open and under way.
- More trials run by BiogenThe sponsor's other registered studies.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Biogen
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Biogen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07889362
- Sponsor's protocol ID
- 299GN201-IgAN
- Status last verified
- Oct 2026
- First submitted
- 16 Oct 2026
- Last updated
- 22 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- 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 22 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2 Open Label Study to Evaluate the Effects of Felzartamab on the Kidney in Individuals With IgA Nephropathy
- ClinicalTrials.gov ID
- NCT07889362
- Acronym / sponsor ID
- 299GN201-IgAN
- Conditions
- Immunoglobulin A Nephropathy
- Keywords
- Felzartamab, Biopsy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- BiogenIndustry (pharma, biotech, devices)
- Study start
- 16 Nov 2026 (estimated)
- Primary completion
- 13 Aug 2028 (estimated)
- Study completion
- 2 Dec 2029 (estimated)
- First posted
- 22 Oct 2026 (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 participants with immunoglobulin A nephropathy (IgAN). IgAN is a kidney disease caused by the buildup of an antibody called IgA in the kidneys over time. In people with IgAN, abnormal IgA and other antibodies form clusters that build up in the small filters of the kidneys, which leads to inflammation and damage. Felzartamab is designed to target certain immune cells that produce these abnormal antibodies.
The main goal of the study is to learn about the effect felzartamab has on the buildup of IgA clusters in the kidneys. The main question that researchers want to answer is:
- How much does the buildup of IgA in the kidney change from the start of the study to Week 36? Researchers will also learn about the effect felzartamab has on kidney health by measuring protein levels in the urine and the kidneys' ability to filter blood. They will also learn more about the safety of felzartamab and how the body processes the drug.
The study will be done as follows:
- Participants will be screened to check if they can join the study.
- This is an open-label study, which means both the researchers and the participants will know that all participants are receiving felzartamab.
- Participants will receive felzartamab as intravenous (IV) infusions.
- Participants will have kidney biopsies done over the course of the study to help measure changes in the health of the kidneys.
- Participants will have multiple scheduled study visits over about 104 weeks. An extra study visit may be needed if a participant decides to leave the study early.
- In total, participants will stay in the study for about 2 years (up to 112 weeks).
Detailed description
The primary objective of the study is to evaluate the effects of felzartamab on immunoglobulin A (IgA) deposition by immunofluorescence (IF). The secondary objectives are to evaluate the effects of felzartamab on histological and efficacy endpoints, and to evaluate the safety, pharmacokinetics (PK), and immunogenicity of felzartamab.
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 a single dose of felzartamab at each dosing visit. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Biopsy-confirmed diagnosis of IgAN.
Key exclusion criteria (9 listed)
- Conditions that may predispose to an increased bleeding risk, as determined by the Investigator.
- History of diabetes mellitus.
- Any diagnosed or suspected immunosuppressed or immunodeficient state.
- Any history of malignancy within 5 years prior to Screening with the exception of adequately treated in situ carcinoma of the uterine cervix, basal or squamous cell carcinoma or other non-melanomatous skin cancer.
- Any clinically significant underlying illness that, in the opinion of the Investigator, medical monitor, and/or Sponsor may compromise study participation, present a safety risk to the participant, or may confound the interpretation of the study results, including general non-adherence to study medication therapy.
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: BIIB148, MOR202, MOR03087, TJ202Administered IV | Drug | Felzartamab |
Primary outcome
Change From Baseline in Mesangial Immunoglobulin A (IgA) Deposition by Immunofluorescence (IF)
Time frame: Baseline, Week 36
10 secondary outcomes
Change From Baseline in Mesangial IgA Deposition by IF
Time frame: Baseline, Week 104
Percent Change From Baseline in Proteinuria
Time frame: Baseline up to Week 36
Annualized Rate of Change (slope) in the Estimated Glomerular Filtration Rate (eGFR)
Time frame: Baseline up to Week 104
Change From Baseline in eGFR
Time frame: Baseline up to Week 104
Percentage of Participants Achieving Complete Response (CR)
Time frame: Baseline up to Week 104
Percentage of Participants who Progressed to Kidney Failure
Time frame: Baseline up to Week 104
Percentage of Participants With Treatment Emergent Adverse Event (TEAE) and Treatment Emergent Serious Adverse Event (TESAE)
Time frame: Baseline up to Week 104
Number of Participants with Clinically Significant Laboratory, Physical Examination, Vital Signs and Electrocardiograms (ECGs) Abnormalities
Time frame: Baseline up to Week 104
Felzartamab Serum Concentrations Over Time
Time frame: Predose and at multiple timepoints postdose up to Week 36
Number of Participants with Anti-Drug Antibodies (ADAs) Against Felzartamab
Time frame: Baseline up to Week 104
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 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.
Global Biogen Clinical Trial Center contact
Medical Director study director
Biogen
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Felzartamab in people with Immunoglobulin A Nephropathy, run by Biogen.
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 1 inclusion and 9 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: opening soon, as of the sponsor's last update on 22 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact US Biogen Clinical Trial Center (866-633-4636, clinicaltrials@biogen.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change From Baseline in Mesangial Immunoglobulin A (IgA) Deposition by Immunofluorescence (IF) (time frame: Baseline, Week 36). 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 22 Oct 2026.