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RECRUITING

NCT06962800

PHASE3

A Study to Learn More About the Effects and Safety of Felzartamab Infusions in Adults With Primary Membranous Nephropathy (PMN)

Sponsor: Biogen

View on ClinicalTrials.gov

Summary

In this study, researchers will learn more about the use of felzartamab in participants with primary membranous nephropathy, also known as PMN. In people with PMN, autoantibodies build up in the glomeruli of the kidney. Antibodies are proteins that help the body fight off infection. An autoantibody is a type of antibody that mistakenly targets and attacks the body's own tissues. Glomeruli are the filters of the kidney that remove waste and extra fluid from the body. In PMN, the build-up of autoantibodies in the glomeruli causes damage to the kidneys. Kidney damage can lead to too much protein and blood leaking into the urine. High levels of protein in the urine, called proteinuria, are common in people with PMN. Symptoms of PMN can include swelling in the legs and body, tiredness, and high blood pressure. If left untreated, PMN can eventually lead to kidney failure. In this study, researchers will learn more about how a study drug called felzartamab affects people with PMN. Felzartamab is a monoclonal antibody, which means it is an antibody made in a laboratory. Felzartamab can target immune cells that produce autoantibodies, helping to lower their buildup in the kidneys. The main goal of this study is to compare how felzartamab works compared to a drug called tacrolimus. Tacrolimus is another drug given to people with PMN and kidney disease. The main question that researchers want to answer is: * How many participants achieve a complete response after 104 weeks of treatment? * A complete response means that their urine protein levels decrease to a low level and their kidney function remains stable. Researchers will also learn about: * How long it takes before the participants' disease gets worse * How long the participants' urine protein levels stay low * How many participants develop antibodies against felzartamab in the blood? * How many participants achieve a complete response after 76 weeks of treatment * How many participants have medical problems during the study * How felzartamab is processed by the body * How felzartamab affects participants' tiredness and overall physical health The study will be done as follows: * Participants will be screened to check if they can join the study. This may take up to 42 days. * Participants will be randomized to receive either felzartamab as intravenous (IV) infusions or tacrolimus, taken orally as tablets. * If participants have worsening kidney function or worsening proteinuria, or if their PMN relapses, or if they show no signs of improvement in their PMN, they will have a chance to receive rescue treatment. * If a participant stops treatment early, there will be follow-up visits every 12 weeks until they reach Week 104. * In total, participants will have up to 23 study visits. Participants who do not need rescue treatment will stay in the study for up to 104 weeks. Participants who need rescue treatment will stay in the study for up to 156 weeks.

Official title: An Open-Label, Multicenter, Randomized Phase 3 Study Evaluating the Efficacy and Safety of Felzartamab in Participants With Primary Membranous Nephropathy (PMN) [PROMINENT]

Key Details

Gender

All

Age Range

18 Years - 80 Years

Study Type

INTERVENTIONAL

Enrollment

180

Start Date

2025-05-22

Completion Date

2029-03-29

Last Updated

2026-04-02

Healthy Volunteers

Conditions

Primary Membranous Nephropathy

Interventions

DRUG

Felzartamab

Administered intravenously

DRUG

Tacrolimus

Administered orally

DRUG

Standard of Care IST

Administered intravenously and orally

Key Inclusion Criteria: * Diagnosed with PMN in need of IST according to the Investigator's clinical judgment. The diagnosis of PMN must be documented with the presence of nephrotic syndrome, and hypoalbuminemia, and confirmed with a kidney biopsy either during Screening or within 5 years of signing the informed consent form (ICF) \[see kidney biopsy exception below for participants positive for anti-PLA2R antibodies\]. For these participants, the biopsy report with redacted protected health information must be available to be reviewed by the Sponsor or an independent nephropathologist. If the participant requires a kidney biopsy during Screening, medical monitor approval must be obtained and all other eligibility criteria should be reviewed to ensure that the participant is otherwise eligible prior to performing the kidney biopsy. a. Kidney biopsy exception for anti-PLA2R antibody positive participants: Participants who are positive for anti-PLA2R antibodies and have not had a kidney biopsy performed within 5 years of signing the ICF, may be eligible for the study without undergoing a kidney biopsy based on medical monitor review confirming normal estimated glomerular filtration rate (eGFR), presence of nephrotic syndrome, hypoalbuminemia, positive anti-PLA2R antibody test (defined as an anti-PLA2R antibody titer \> 20 RU/mL), and documentation provided by the Investigator that the work-up for secondary causes of membranous nephropathy (MN) was negative with no identifiable secondary causes. * Meets one of the following: 1. Newly diagnosed PMN, defined as having never received IST for PMN in the past. 2. Relapsed PMN, defined as documented achievement of CR or partial remission (PR) after treatment with an IST for PMN followed by reappearance of nephrotic range proteinuria (urine protein to creatinine ratio \[UPCR\] ≥ 3.0 gram per gram \[g/g\] from a 24-hour urine collection or proteinuria ≥ 3.5 gram per 24 hour \[g/24 h\]). * Participants must be on the maximally approved dose or maximally tolerated dose of angiotensin-converting enzyme inhibitor (ACEI) or angiotensin receptor blocker (ARB) for at least 3 months prior to Screening. Participants not on the maximally approved dose of renin-angiotensin-aldosterone system (RAAS) inhibition may be enrolled provided there is documented intolerance to maximal RAAS inhibition (e.g., angioedema, development of postural hypotension, lightheadedness, hyperkalemia, etc). * A UPCR of ≥ 3.0 g/g (as determined by a 24-hour urine collection) or total proteinuria ≥ 3.5 g/24 h (as determined by a 24-hour urine collection) at Screening after best supportive care for at least 3 months prior to signing the ICF. Key Exclusion Criteria: * Secondary cause of MN (e.g., malignancies, medications, systemic lupus erythematosus \[SLE\], hepatitis B, hepatitis C, etc). * Severe renal impairment defined as an eGFR ≤ 30 mL/min/1.73m\^2 at Screening or including the need for dialysis or renal replacement therapy. Note: Other protocol-defined Inclusion/Exclusion criteria may apply.

Locations (85)

Apogee Clinical Research, LLC

Huntsville, Alabama, United States

The Nephrology Group, Inc. - Fresno

Fresno, California, United States

Academic Medical Research Institute

Los Angeles, California, United States

UCSF Medical Center

San Francisco, California, United States

Henry Ford Hospital- A-Basement Research Pharmacy

Detroit, Michigan, United States

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

Pontiac, Michigan, United States

James J Peters Veterans Administration Medical Center - NAVREF - PPDS

The Bronx, New York, United States

ECU Physicians Nephrology and Hypertension

Greenville, North Carolina, United States

Knoxville Kidney Center, PLLC

Knoxville, Tennessee, United States

Nephrotex Research Group

Dallas, Texas, United States

University of Texas Medical Branch

League City, Texas, United States

Organización Médica de Investigación

Buenos Aires, Argentina

CINME S.A. - Centro de Investigaciones Metabólicas

Buenos Aires, Argentina

Hospital Italiano de Buenos Aires

Buenos Aires, Argentina

Centro Medico Dra. Laura Maffei- Investigacion Clinica Aplicada

Buenos Aires, Argentina

Clínica Privada Vélez Sarsfield

Córdoba, Argentina

Concord Hospital

Concord, New South Wales, Australia

St George Hospital

Kogarah, New South Wales, Australia

Liverpool Hospital

Liverpool, New South Wales, Australia

Westmead Hospital

Westmead, New South Wales, Australia

Townsville Hospital

Douglas, Queensland, Australia

Gold Coast University Hospital

Southport, Queensland, Australia

Griffith University Clinical Trial Unit

Southport, Queensland, Australia

Monash Health

Clayton, Victoria, Australia

Santa Casa de Misericórdia de Belo Horizonte

Belo Horizonte, Minas Gerais, Brazil

Hospital de Clinicas de Porto Alegre

Porto Alegre, Rio Grande do Sul, Brazil

Hospital Sao Lucas Da Pontificia Universidade Catolica Do Rio Grande Do Sul (PUCRS)

Porto Alegre, Rio Grande do Sul, Brazil

Hospital das Clinicas da Faculdade de Medicina de Ribeirao Preto da Universidade de Sao Paulo

Ribeirão Preto, São Paulo, Brazil

Fundacao Faculdade Regional de Medicina de Sao Jose Do Rio Preto Hospital de Base - PPDS

São José do Rio Preto, São Paulo, Brazil

Centro de Pesquisa Clínica de Nefrologia do Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo

São Paulo, Brazil

Fu Yang People's Hospital - South Campus

Fuyang, Anhui, China

Beijing Tsinghua Changgung Hospital

Beijing, Beijing Municipality, China

Peking University First Hospital - Changqiao Campus

Xichengqu Beijing, Beijing Municipality, China

Zhongshan Hospital Xiamen University

Xiamen, Fujian, China

Gansu Provincial Hospital

Lanzhou, Gansu, China

Lanzhou University Second Hospital

Lanzhou, Gansu, China

Zhujiang Hospital of Southern Medical University

Guangzhou, Guangdong, China

The People's Hospital of Guangxi Zhuang Autonomous Region

Nanning, Guangxi, China

The Affiliated Hospital of Guizhou Medical University

Guiyang, Guizhou, China

The Second Hospital of Hebei Medical University - Main

Shijiazhuang, Hebei, China

The First 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

The Second Xiangya Hospital of Central South University

Changsha, Hunan, China

Yueyang People Hospital

Yueyang, Hunan, China

The First Affiliated Hospital of Xian Jiaotong University

Xi'an, Shaanxi, China

Qilu Hospital of Shandong University

Jinan, Shandong, China

The Second Hospital of Shandong University

Jinan, Shandong, China

The Affiliated Hospital of Qingdao University - Xihaian Campus

Qingdao, Shandong, China

Yantai Yuhuangding Hospital

Yantai, Shandong, China

The Second Affiliated Hospital, Zhejiang University School of Medicine

Hangzhou, Zhejiang, China

Osmania General Hospital

Hyderabad, Andhra Pradesh, India

Nizams Institute of Medical Sciences

Hyderabad, Andhra Pradesh, India

M.S. Ramaiah Medical College and Hospital

Bangalore, Karnataka, India

Noble Hospital

Pune, Maharashtra, India

Max Super Speciality Hospital - Saket

New Delhi, National Capital Territory of Delhi, India

Galaxy Hospital - Varanasi

Varanasi, Uttar Pradesh, India

National Hospital Organization Chiba Medical Center Chibahigashi National Hospital

Chia-shi, Chiba, Japan

Juntendo University Urayasu Hospital

Urayasu-Shi, Chiba, Japan

Hokkaido University Hospital

Sapporo, Hokkaidô, Japan

Kagawa University Hospital

Kita-Gun Uchiko-Cho, Kagawa-ken, Japan

The Kitasato Institute Kitasato University Hospital

Sagamihara-Shi Minami-Ku, Kanagawa, Japan

Yokohama City University Hospital

Yokohama, Kanagawa, Japan

University of Miyazaki Hospital

Miyazaki, Miyazaki, Japan

Niigata University Medical ＆ Dental Hospital

Niigata, Niigata, Japan

Social Medical Corporation Yuuaikai Yuuai Medical Center

Tomigusuku-Shi, Okinawa, Japan

Saitama Medical University Hospital

Iruma-Gun Moroyama-Machi, Saitama, Japan

Japanese Red Cross Musashino Hospital

Musashino-shi, Tokyo, Japan

Hospital Raja Permaisuri Bainun

Perak, Pahang, Malaysia

Hospital Canselor Tuanku Muhriz UKM

Cheras, WilayahPersekutuan KualaLumpur, Malaysia

Prince Court Medical Centre

Kuala Lumpur, Malaysia

Ajou University Hospital

Suwon, Gyeonggido, South Korea

Seoul National University Hospital

Seoul, Seoul Teugbyeolsi, South Korea

Inje University Haeundae Paik Hospital

Busan, South Korea

Hanyang University Seoul Hospital

Seoul, South Korea

Chung-Ang University Hospital

Seoul, South Korea

Hualien Tzu Chi Hospital

Hualien City, Hualien, Taiwan

Kaohsiung Medical University Chung-Ho Memorial Hospital

Kaohsiung City, Taiwan

China Medical University Hospital

Taichung, Taiwan

Taichung Veterans General Hospital

Taichung, Taiwan

National Cheng Kung University Hospital

Tainan, Taiwan

MacKay Memorial Hospital

Taipei, Taiwan

Taipei Medical University Hospital - PPDS

Taipei, Taiwan

Taipei Municipal Wanfang Hospital

Taipei, Taiwan

Chang Gung Memorial Hospital

Taoyuan District, Taiwan

Clinical Research Directory

A Study to Learn More About the Effects and Safety of Felzartamab Infusions in Adults With Primary Membranous Nephropathy (PMN)

Summary

Key Details

Conditions

Interventions

Eligibility Criteria

Locations (85)