🇮🇪Ireland
16°C Partly Cloudy · Dublin
Live Updates
--:--:-- IST
Writer Login
Latest
Clinical Trials in the UK / NCT06935357
Recruiting Phase 3

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

NCT06935357 · tracked via the Priya Life Science UK tracker
Sponsor
Biogen
Phase
Phase 3
Started
2025-05-08
Last updated
2026-09-16

Condition(s) studied

Immunoglobulin A Nephropathy (IgAN)

Investigational drug(s) / intervention(s)

FelzartamabPlacebo

Felzartamab: Administered IV

Placebo: Administered IV

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. 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
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.

Primary outcome measure(s)

Trial sites (261)

FacilityCityRegionStatus
Applied Research Center of Arkansas Little Rock Arkansas Recruiting
Kidney & Hypertension Center - Apple Valley Apple Valley California Recruiting
Scripps Green Hospital Carlsbad California Recruiting
National Institute of clinical Research Administration Office Garden Grove California Withdrawn
UCLA Health David Geffen School of Medicine Los Angeles California Recruiting
FOMAT Medical Research - FOMAT - PPDS Oxnard California Recruiting
North America Research Institute-San Dimas San Dimas California Recruiting
Nova Clinical Research, LLC Bradenton Florida Recruiting
University of Florida - Gainesville - 1600 SW Archer Rd Gainesville Florida Recruiting
Royal Research, Corp. Hollywood Florida Recruiting
Central Florida Kidney Specialists Orlando Florida Recruiting
CDC Research Institute, LLC Port Saint Lucie Florida Recruiting
American Clinical Trials LLC Acworth Georgia Withdrawn
The Vasculitis and Glomerulonephritis Center at Massachusetts General Hospital Boston Massachusetts Recruiting
Brigham and Women's Hospital Boston Massachusetts Recruiting
UMass Memorial Medical Center Worcester Massachusetts Not Yet Recruiting
Henry Ford Hospital Detroit Michigan Recruiting
Elixia Health - Michigan Kidney Consultants, LLC - Elixia - PPDS Pontiac Michigan Withdrawn
Anointed Nephrology and HTN - SKYCRNG - PPDS Brookhaven Mississippi Recruiting
Midwest Nephrology Associates,Inc. City of Saint Peters Missouri Withdrawn
Icahn School of Medicine at Mount Sinai New York New York Not Yet Recruiting
James J Peters Veterans Administration Medical Center - NAVREF - PPDS The Bronx New York Recruiting
Penn Renal Electrolyte and Hypertension Perelman Philadelphia Pennsylvania Not Yet Recruiting
Lifespan at Rhode Island Hospital Providence Rhode Island Recruiting
Knoxville Kidney Center, PLLC Knoxville Tennessee Recruiting
Texas Kidney Institute - Dallas Dallas Texas Recruiting
Provecta Research Network Houston Texas Recruiting
R & H Clinical Research Katy Texas Recruiting
Hospital General de Agudos Dr. Cosme Argerich La Boca Buenos Aires F.D. Recruiting
Hospital Italiano de Buenos Aires Almagro Ciudad Autónoma de BuenosAires Recruiting
INECO Neurociencias Oroño Rosario Santa Fe Province Recruiting
CIMER-Centro Integral de Medicina Respiratoria San Miguel de Tucumán Tucumán Province Recruiting
Consultorios Médicos Dr. Doreski - Fundacion Respirar - PPDS Buenos Aires Argentina Recruiting
DOM Centro de Reumatología Buenos Aires Argentina Recruiting
Maffei Centro Médico Buenos Aires Argentina Not Yet Recruiting
Clínica de Nefrología Urología Y Enfermedades Cardiovasculares Santa Fe Argentina Recruiting
John Hunter Hospital New Lambton New South Wales Recruiting
Concord Repatriation General Hospital New South Wales New South Wales Recruiting
Royal North Shore Hospital-Reserve Road St Leonards New South Wales Recruiting
Westmead Hospital Westmead New South Wales Recruiting

+ 221 more sites — see the full list on the official registry below.

More Biogen trials in the UK

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06935357 on ClinicalTrials.gov ↗ ← All trials in the UK