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Not yet recruitingNCT07889362Updated Oct 22, 2026

A Study to Learn About the Effects of Felzartamab on the Kidneys of Adults With Immunoglobulin A Nephropathy (IgAN)

A Phase 2 interventional study of Felzartamab in Immunoglobulin A Nephropathy, sponsored by Biogen. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-22.

Sponsored by Biogen · Phase 2, Interventional, and Treatment

Updated Oct 22, 2026Newly registeredGo to Updates ↓
Phase
Phase 2
Study type
Interventional
Enrollment
25
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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. 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).
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.

02

Conditions studied

  • Immunoglobulin A Nephropathy

Keywords

  • Felzartamab
  • Biopsy
03

In context

Glomerulonephritis, IGA

262 studies on the registry are indexed under Glomerulonephritis, IGA; 102 are open to participants now.

This study's planned enrollment of 25 is below the median of 68 across 212 interventional studies indexed under Glomerulonephritis, IGA.

Browse Glomerulonephritis, IGA studies →

Lead sponsor

Biogen is the lead sponsor of 511 studies on the registry; 24 are open to participants now.

Of its 100 completed or terminated interventional studies of FDA-regulated products, 49 (49%) have results posted.

Browse Biogen studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility criteria

Key Inclusion Criteria:

  • Biopsy-confirmed diagnosis of IgAN.

Key Exclusion Criteria:

  • 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.
  • 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.

05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
25 participants (estimated)

Study arms

  • Experimental
    Felzartamab

    Participants will receive a single dose of felzartamab at each dosing visit.

    Drug: Felzartamab

Interventions

  • DrugFelzartamab

    Administered IV

    Also known as: BIIB148, MOR202, MOR03087, TJ202

06

What researchers measure

Primary outcomes

  1. Change From Baseline in Mesangial Immunoglobulin A (IgA) Deposition by Immunofluorescence (IF)

    Time frame: Baseline, Week 36

Secondary outcomes

  1. Change From Baseline in Mesangial IgA Deposition by IF

    Time frame: Baseline, Week 104

  2. Percent Change From Baseline in Proteinuria

    Time frame: Baseline up to Week 36

  3. Annualized Rate of Change (slope) in the Estimated Glomerular Filtration Rate (eGFR)

    Time frame: Baseline up to Week 104

  4. Change From Baseline in eGFR

    Time frame: Baseline up to Week 104

  5. Percentage of Participants Achieving Complete Response (CR)

    Time frame: Baseline up to Week 104

  6. Percentage of Participants who Progressed to Kidney Failure

    Time frame: Baseline up to Week 104

  7. Percentage of Participants With Treatment Emergent Adverse Event (TEAE) and Treatment Emergent Serious Adverse Event (TESAE)

    Time frame: Baseline up to Week 104

  8. Number of Participants with Clinically Significant Laboratory, Physical Examination, Vital Signs and Electrocardiograms (ECGs) Abnormalities

    Time frame: Baseline up to Week 104

  9. Felzartamab Serum Concentrations Over Time

    Time frame: Predose and at multiple timepoints postdose up to Week 36

  10. Number of Participants with Anti-Drug Antibodies (ADAs) Against Felzartamab

    Time frame: Baseline up to Week 104

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: Yes — In accordance with Biogen's Clinical Trial Transparency and Data Sharing Policy on https://www.biogentrialtransparency.com/

Data sharing details ↗ · vivli.org

No publications or documents are linked to this record.

09

Updates

1 registry update since Sep 25, 2026
Registered
First appeared on the registry. No changes since
Oct 22, 2026
Show all 1 update
  1. Oct 22, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07889362
Lead sponsor
Biogen
Responsible party
Sponsor
First posted
Oct 22, 2026
Start date
Nov 16, 2026 (estimated)
Primary completion
Aug 13, 2028 (estimated)
Completion
Dec 2, 2029 (estimated)
Last update
Oct 22, 2026

Study contacts

US Biogen Clinical Trial Center
Contact
clinicaltrials@biogen.com
866-633-4636
Global Biogen Clinical Trial Center
Contact
clinicaltrials@biogen.com
Medical Director
study director · Biogen

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.

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