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RECRUITING

NCT06935357

PHASE3

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

Sponsor: Biogen

View on ClinicalTrials.gov

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.

Official title: A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study of Felzartamab in Adults With IgA Nephropathy (PREVAIL)

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

454

Start Date

2025-05-08

Completion Date

2029-06-05

Last Updated

2026-10-14

Healthy Volunteers

Conditions

Immunoglobulin A Nephropathy (IgAN)

Interventions

DRUG

Felzartamab

Administered IV

DRUG

Placebo

Administered IV

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.

Locations (265)

Applied Research Center of Arkansas

Little Rock, Arkansas, United States

Kidney & Hypertension Center - Apple Valley

Apple Valley, California, United States

Scripps Green Hospital

Carlsbad, California, United States

National Institute of clinical Research Administration Office

Garden Grove, California, United States

UCLA Health David Geffen School of Medicine

Los Angeles, California, United States

FOMAT Medical Research - FOMAT - PPDS

Oxnard, California, United States

North America Research Institute-San Dimas

San Dimas, California, United States

Nova Clinical Research, LLC

Bradenton, Florida, United States

University of Florida - Gainesville - 1600 SW Archer Rd

Gainesville, Florida, United States

Royal Research, Corp.

Hollywood, Florida, United States

Central Florida Kidney Specialists

Orlando, Florida, United States

CDC Research Institute, LLC

Port Saint Lucie, Florida, United States

American Clinical Trials LLC

Acworth, Georgia, United States

The Vasculitis and Glomerulonephritis Center at Massachusetts General Hospital

Boston, Massachusetts, United States

Brigham and Women's Hospital

Boston, Massachusetts, United States

UMass Memorial Medical Center

Worcester, Massachusetts, United States

Henry Ford Hospital

Detroit, Michigan, United States

Elixia Health - Michigan Kidney Consultants, LLC - Elixia - PPDS

Pontiac, Michigan, United States

Anointed Nephrology and HTN - SKYCRNG - PPDS

Brookhaven, Mississippi, United States

Midwest Nephrology Associates,Inc.

City of Saint Peters, Missouri, United States

Icahn School of Medicine at Mount Sinai

New York, New York, United States

James J Peters Veterans Administration Medical Center - NAVREF - PPDS

The Bronx, New York, United States

Penn Renal Electrolyte and Hypertension Perelman

Philadelphia, Pennsylvania, United States

Lifespan at Rhode Island Hospital

Providence, Rhode Island, United States

Knoxville Kidney Center, PLLC

Knoxville, Tennessee, United States

Texas Kidney Institute - Dallas

Dallas, Texas, United States

Provecta Research Network

Houston, Texas, United States

R & H Clinical Research

Katy, Texas, United States

Medical College of Wisconsin, Inc.

Milwaukee, Wisconsin, United States

Hospital General de Agudos Dr. Cosme Argerich

La Boca, Buenos Aires F.D., Argentina

Hospital Italiano de Buenos Aires

Almagro, Ciudad Autónoma de BuenosAires, Argentina

INECO Neurociencias Oroño

Rosario, Santa Fe Province, Argentina

CIMER-Centro Integral de Medicina Respiratoria

San Miguel de Tucumán, Tucumán Province, Argentina

Consultorios Médicos Dr. Doreski - Fundacion Respirar - PPDS

Buenos Aires, Argentina

DOM Centro de Reumatología

Buenos Aires, Argentina

Maffei Centro Médico

Buenos Aires, Argentina

Clínica de Nefrología Urología Y Enfermedades Cardiovasculares

Santa Fe, Argentina

John Hunter Hospital

New Lambton, New South Wales, Australia

Concord Repatriation General Hospital

New South Wales, New South Wales, Australia

Royal North Shore Hospital-Reserve Road

St Leonards, New South Wales, Australia

Westmead Hospital

Westmead, New South Wales, Australia

Townsville Hospital

Douglas, Queensland, Australia

Royal Brisbane & Women's Hospital

Herston, Queensland, Australia

Gold Coast University Hospital

Southport, Queensland, Australia

Griffith University

Southport, Queensland, Australia

Princess Alexandra Hospital

Woolloongabba, Queensland, Australia

Sunshine Hospital - Australia

St Albans, Victoria, Australia

Hôpital Erasme - PPDS

Anderlecht, Brussels Capital, Belgium

ZOL Genk - campus Sint-Jan

Genk, Limburg, Belgium

UZ Leuven - PPDS

Leuven, Vlaams Brabant, Belgium

Jan Yperman

Ieper, West-Vlaanderen, Belgium

AZ Groeninge

Kortrijk, West-Vlaanderen, Belgium

Cliniques Universitaires Saint-Luc

Brussels, Belgium

Freire Pesquisa Clínica

Belo Horizonte, Minas Gerais, Brazil

Irmandade da Santa Casa de Misericórdia de Belo Horizonte - PPDS

Belo Horizonte, Minas Gerais, Brazil

Centro Mineiro de Pesquisa - CMiP

Juiz de Fora, Minas Gerais, Brazil

Fundação Universidade de Caxias do Sul - Instituto de Pesquisas em Saúde

Caxias do Sul, Rio Grande do Sul, Brazil

Hospital de Clinicas de Porto Alegre (HCPA) - PPDS

Porto Alegre, Rio Grande do Sul, Brazil

Hospital Alemao Oswaldo Cruz- HAOC

São Paulo, Brazil

Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo

São Paulo, Brazil

Medical Center Medconsult Pleven - Lovech Branch

Lovech, Bulgaria

Medical Center Hera EOOD, Montana - Hera Clinics - PPDS

Montana, Bulgaria

Medical Center Medconsult Pleven OOD

Pleven, Bulgaria

University Multiprofile Hospital for Active Treatment Sv Ivan Rilski EAD-15 Acad. Ivan Geshov Blvd

Sofia, Bulgaria

St Paul's Hospital

Vancouver, British Columbia, Canada

McGill University Health Centre (MUHC)

Montreal, Quebec, Canada

Fu Yang People's Hospital - South Campus

Fuyang, Anhui, China

The First Affiliated Hospital of Anhui Medical University - Jixilu Campus

Hefei, Anhui, China

Peking University First Hospital - Changqiao Campus

Beijing, Beijing Municipality, China

Beijing Tsinghua Changgung Hospital

Beijing, Beijing Municipality, China

Fujian Medical University Union Hospital

Fuzhou, Fujian, China

Zhongshan Hospital Xiamen University

Xiamen, Fujian, China

Gansu Provincial Hospital

Lanzhou, Gansu, China

Sun Yat-sen Memorial Hospital, Sun Yat-sen University - North Campus

Guangzhou, Guangdong, China

The First Affiliated Hospital of Guangzhou Medical University - Yanjiang Campus

Guangzhou, Guangdong, China

Shenzhen Hospital of Southern Medical University

Shenzhen, Guangdong, China

Peking University Shenzhen Hospital

Shenzhen, Guangdong, China

Zhongshan Hospital of Traditional Chinese Medicine

Zhongshan, Guangdong, China

The First Affiliated Hospital of Guangxi Medical University

Nanning, Guangxi, China

The People's Hospital of Guangxi Zhuang Autonomous Region

Nanning, Guangxi, China

Guizhou Provincial People's Hospital

Guiyang, Guiyang, China

The Affiliated Hospital of Guizhou Medical University

Guiyang, Guizhou, China

Cangzhou Central Hospital

Cangzhou, Hebei, China

The Second Hospital of Hebei Medical University - Main

Shijiazhuang, Hebei, China

The Third Hospital of Hebei Medical University

Shijiazhuang, Hebei, China

Daqing Oilfield General Hospital

Daqing, Heilongjiang, China

The First Affiliated Hospital of Henan Science and Technology University - Jinghua Campus

Luoyang, Henan, China

Prince of Wales Hospital - Hong Kong

Hong Kong, Hong Kong, China

Queen Mary Hospital PPDS

Hong Kong, Hong Kong, China

Tung Wah Hospital

Hong Kong, Hong Kong, China

Renmin Hospital of Wuhan University - Main Campus

Wuhan, Hubei, China

Yichang Central People's Hospital - Wujiagang Campus

Yichang, Hubei, China

The Second Affiliated Hospital of Nanjing Medical University

Nanjing, Jiangsu, China

Affiliated Hospital of Nantong University

Nantong, Jiangsu, China

Wuxi Peoples Hospital

Wuxi, Jiangsu, China

Shengjing Hospital of China Medical University - Huaxiang Campus

Shenyang, Liaoning, China

Qilu Hospital of Shandong University

Jinan, Shandong, China

The Second Hospital of Shandong University

Jinan, Shandong, China

Yantai Yuhuangding Hospital

Yantai, Shandong, China

Zhongshan Hospital Fudan University

Shanghai, Shanghai Municipality, China

And 165 more locations on ClinicalTrials.gov

Clinical Research Directory

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

Summary

Key Details

Conditions

Interventions

Eligibility Criteria

Locations (265)