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Looking for participantsPhase3

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

Sponsor: Biogen

NCT ID: NCT06935357

View on ClinicalTrials.gov ↗

At a glance

What the study gets you
Access to the study treatment being tested
Type of study
Interventional (receives a drug or procedure)
Time in hospital
In-person visits at study sites — visit count not specified by the sponsor
Drug or intervention
Felzartamab (drug), Placebo (drug)
How long the study runs
Study runs about 49 months (dates as stated)
About the drug or intervention
Felzartamab — drug: Administered IV · Placebo — drug: Administered IV
Patient visit burden
"* In total, participants will have 17 study visits." (as stated by sponsor)
Type of study
Testing a treatment
Ages
18 Years and over
Who
All
Number of participants
454
Started
2025-05-08
Last checked
2026-09

Plain English Summary

What is this study?

  • • Testing a new treatment for immunoglobulin a nephropathy (igan)
  • • Phase3 - 454 participants
  • • In this study, researchers will learn more about the use of felzartamab in participants with immunoglobulin A nephropathy (IgAN)

Who can take part?

  • • Ages 18 Years and over
  • • Diagnosed with immunoglobulin a nephropathy (igan)

Where?

  • • London - St Pancras Clinical Research
  • • Preston - Royal Preston Hospital - NWCRN- PPDS
  • • Leicester - Leicester General Hospital
  • • Sheffield - Northern General Hospital
  • • +1 more UK sites

This is a simplified summary. Always discuss with your doctor before making any decisions.

About This Trial

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. This study will focus on participants who have protein in their urine (proteinuria) as a result of damaged kidneys. The main goal of the study is to learn about the effect felzartamab has on proteinuria. The main question that researchers want to answer is: • How much does the amount of protein in the urine change from the start of the study to Week 36? Researchers will learn about the effect felzartamab has on the kidneys' ability to filter blood. They will also learn more about the safety of felzartamab and how it is processed by the body. The study will be done as follows: * Participants will be screened to check if they can join the study. * Participants will be randomized to receive either felzartamab or a placebo. A placebo looks like the study drug but contains no real medicine. * Neither the researchers nor the participants will know what the participants will receive. * Participants will receive felzartamab or placebo as intravenous (IV) infusions. The treatment period will last 24 weeks. * Afterwards, participants will enter a follow-up period which will last 80 weeks. * In total, participants will have 17 study visits. Participants will stay in the study for about 2 years.

More detail

The primary objective of the study is to evaluate the efficacy of felzartamab compared to placebo on proteinuria in participants with Immunoglobulin A nephropathy (IgAN). The main secondary objective of the study is to evaluate the efficacy of felzartamab compared to placebo on kidney functions in participants with IgAN. The additional secondary objectives are to evaluate the efficacy of felzartamab compared to placebo on additional clinical endpoints and to assess the pharmacokinetics (PK) and immunogenicity of felzartamab.

Immunoglobulin A Nephropathy (IgAN)

How this trial compares with your answers

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What we know so far

Condition· Matched your search
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Still need:

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Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.

Eligibility at a Glance

Key info

  • Age: 18 Years and over
  • Who can join: All genders

Biomarkers mentioned

eGFR

What the study is looking for

  • ✓Proteinuria of ≥ 1.0 gram per day (g/day) or UPCR ≥0.8 gram per gram (g/g) as assessed by an adequate 24-hour urine...

Who cannot take part

  • ✗Any history of secondary forms of IgAN, indicated by the presence of any other systemic disease potentially leading...
  • ✗History of rapidly progressive variant of IgAN, defined as eGFR loss by \> 50% per 3 months and not explained by...
  • ✗IgAN-(MCD) variant.
  • ✗Concomitant other progressive glomerulonephritis or non-immunologic glomerular disease such as diabetic nephropathy.
  • ✗Participants currently treated with oral budesonide. Participants who have stopped this therapy ≥ 4 months prior to...
See the full criteria
Key Inclusion Criteria: * Biopsy-confirmed diagnosis of IgAN within the past 10 years prior to signature of the informed consent form (ICF). For participants with diabetes mellitus type 2, an IgAN diagnostic biopsy within the past 24 months prior to signing the ICF. * An eGFR ≥ 30 mL/min/1.73 m\^2 at Screening as calculated using the 2021 chronic kidney disease epidemiology (CKD-EPI) creatinine formula. An eGFR of ≥ 20 and \< 30 mL/min/1.73 m\^2 is acceptable for the cohorts 3 and 4. * Proteinuria of ≥ 1.0 gram per day (g/day) or UPCR ≥0.8 gram per gram (g/g) as assessed by an adequate 24-hour urine collection. * Clinically stable on a maximally tolerated dose or maximally approved dose of angiotensin-converting enzyme inhibitors (ACEI) or angiotensin receptor blockers (ARB) for at least 12 weeks prior to Screening. Participants may also be using sodium-glucose cotransporter-2 inhibitors (SGLT2is); endothelin receptor antagonists (ERAs) or dual endothelin angiotensin receptor antagonist (DEARAs) approved for the treatment of IgAN; and/or mineralocorticoid receptor antagonists (MRAs) as long as the dose is stable for at least 12 weeks prior to Screening. Participants should remain on stable doses of these background medications for the duration of the study. Once the ICF is signed and thereafter, the doses cannot be changed during the study nor the drugs discontinued except if deemed related to an AE. Participants using a DEARA (e.g., sparsentan) will not be permitted to use simultaneous ACEI or ARB medication. Key Exclusion Criteria: * Any history of secondary forms of IgAN, indicated by the presence of any other systemic disease potentially leading to IgA deposits as determined by the Investigator. * History of rapidly progressive variant of IgAN, defined as eGFR loss by \> 50% per 3 months and not explained by changes in renin-angiotensin system (RAS) blockade or other factors. * IgAN-(MCD) variant. * Concomitant other progressive glomerulonephritis or non-immunologic glomerular disease such as diabetic nephropathy. * Type 2 diabetes mellitus with Hemoglobin A1c (HbA1c) \> 8% at Screening, or evidence of diabetic nephropathy on biopsy, history of diabetic microvascular or macrovascular disease (eg, diabetic retinopathy, peripheral neuropathy). * Any diagnosed or suspected immunosuppressed or immunodeficient state such as asplenia, human immunodeficiency virus (HIV), primary immunodeficiencies, organ or bone marrow transplantation, with the exception of corneal transplants. * Previously treated with immunosuppressive or other immunomodulatory agents such as but not limited to cyclophosphamide, rituximab, infliximab, eculizumab, canakinumab, mycophenolate mofetil (MMF) or mycophenolate sodium (MPS), cyclosporine, tacrolimus, sirolimus, everolimus, or systemic glucocorticoid exposure (\> 7.5 milligrams per day \[mg/d\] prednisone-equivalent for indications other than IgAN or any dose if given for the treatment of IgAN) within 4 months prior to Screening. Use of hydroxychloroquine in Mainland China is allowed if the candidate has been on this for at least 6 months prior to Screening with a stable dose for at least 12 weeks prior to Screening. If a potential participant requires systemic glucocorticoids at any dose for IgAN during Screening, this will result in a screen fail. If a potential participant requires systemic glucocorticoids \> 7.5 mg/day prednisone-equivalent for indications other than IgAN during Screening, this will result in a screen fail. * Participants currently treated with oral budesonide. Participants who have stopped this therapy ≥ 4 months prior to Screening may be eligible. * Active clinically significant infections, known history of recurrent clinically significant infection, or Screening laboratory evidence consistent with an active infection, or non-prophylactic treatment with IV anti-infectives (antibacterials, antiviral or antifungals). Participants with a history of opportunistic infections are excluded. * Hypogammaglobulinemia: serum Immunoglobin G (IgG) \< 6.0 gram per litre (g/L), at Screening. Note: Other protocol-defined Inclusion/Exclusion criteria may apply.

Where Is This Study? (5 UK sites)

St Pancras Clinical Research

London EC2Y 8EA, United Kingdom

Recruiting
Site contact (verified)
Muhammad Magdi YaqoobPrincipal Investigator

Royal Preston Hospital - NWCRN- PPDS

Preston PR2 9HT, United Kingdom

Recruiting
Site contact (verified)
Arvind PonnusamyPrincipal Investigator

Leicester General Hospital

Leicester LE5 4PW, United Kingdom

Recruiting
Site contact (verified)
Chee Kay CheungPrincipal Investigator

Northern General Hospital

Sheffield S5 7AU, United Kingdom

Recruiting
Site contact (verified)
Salim Arif KhwajaPrincipal Investigator

Royal Stoke University Hospital

Stoke-on-Trent ST4 6QG, United Kingdom

Recruiting
Site contact (verified)
Diane (Julie) WesselsPrincipal Investigator

How to Get in Touch

US Biogen Clinical Trial Center

Sponsor contact

CONTACT

866-633-4636 clinicaltrials@biogen.com

Global Biogen Clinical Trial Center

Sponsor contact

CONTACT

clinicaltrials@biogen.com
Data sourced from ClinicalTrials.gov · Last verified: 2026-09