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RecruitingPhase 3

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

Biogen · NCT06935357

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Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Ages 18+ · All sexes
Healthy volunteers
Not accepted (a condition is required)
Study type
Interventional · Phase 3
Target enrollment
454
US sites recruiting
24
Study start
May 8, 2025
Record last updated
October 14, 2026

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study is about

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.

Being studied: Felzartamab; Placebo

Conditions: Immunoglobulin A Nephropathy (IgAN)

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show 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.

Recruiting US locations

  • Applied Research Center of Arkansas

    Little Rock, AR 72205

    Site contact: 501-804-5939

  • Kidney & Hypertension Center - Apple Valley

    Apple Valley, CA 92307

    Site contact: 760-780-4179

  • Scripps Green Hospital

    Carlsbad, CA 92009

    Site contact: 617-956-2587

  • UCLA Health David Geffen School of Medicine

    Los Angeles, CA 90095

    Site contact: 310-206-8478

  • FOMAT Medical Research - FOMAT - PPDS

    Oxnard, CA 93030

    Site contact: 805-483-1185

  • North America Research Institute-San Dimas

    San Dimas, CA 91773

    Site contact: 800-797-1695

  • Nova Clinical Research, LLC

    Bradenton, FL 34209

    Site contact: 941-792-6564

  • University of Florida - Gainesville - 1600 SW Archer Rd

    Gainesville, FL 32610

    Site contact: 352-294-5068

  • Royal Research, Corp.

    Hollywood, FL 33024

    Site contact: 954-940-0208

  • Central Florida Kidney Specialists

    Orlando, FL 32806

    Site contact: 407-472-5120

  • CDC Research Institute, LLC

    Port Saint Lucie, FL 34952

    Site contact: 772-807-1636

  • The Vasculitis and Glomerulonephritis Center at Massachusetts General Hospital

    Boston, MA 02114-4724

    Site contact: 617-726-4132

  • Brigham and Women's Hospital

    Boston, MA 02115-6110

    Site contact: 617-732-8327

  • UMass Memorial Medical Center

    Worcester, MA 01655

    Site contact: 413-324-8626

  • Henry Ford Hospital

    Detroit, MI 48202

    Site contact: 313-916-0026

  • Anointed Nephrology and HTN - SKYCRNG - PPDS

    Brookhaven, MS 39601

    Site contact: 601-833-4111

  • Icahn School of Medicine at Mount Sinai

    New York, NY 10029-6504

    Site contact: 646-286-0194

  • James J Peters Veterans Administration Medical Center - NAVREF - PPDS

    The Bronx, NY 10468

    Site contact: 71858490006099

  • Lifespan at Rhode Island Hospital

    Providence, RI 02903

    Site contact: 401-444-6844

  • Knoxville Kidney Center, PLLC

    Knoxville, TN 37923-3624

    Site contact: 692-3462

  • Texas Kidney Institute - Dallas

    Dallas, TX 95231

    Site contact: 214-396-4950

  • Provecta Research Network

    Houston, TX 77054

    Site contact: 832-338-9118

  • R & H Clinical Research

    Katy, TX 77974

    Site contact: 713-367-2791

  • Medical College of Wisconsin, Inc.

    Milwaukee, WI 53226

    Site contact: 414-805-3100

Study contacts (from the official record)

  • US Biogen Clinical Trial Center · 866-633-4636 · clinicaltrials@biogen.com
  • Global Biogen Clinical Trial Center · clinicaltrials@biogen.com
A Study to Learn About the Effects of Felzartamab Infusions on… (NCT06935357) | Bored Studies