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

June 11, 2026 updated by: Biogen

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

The primary objective of the study is to assess the efficacy of felzartamab compared to tacrolimus in participants with PMN in achieving complete remission (CR) of proteinuria. The secondary objectives of the study are to evaluate the efficacy of felzartamab through additional clinical endpoints and timepoints, to assess the impact of felzartamab on serum anti-phospholipase A2 receptor (PLA2R) antibodies and patient-reported outcomes, and to assess the safety, pharmacokinetics (PK) and immunogenicity of felzartamab.

Study Type

Interventional

Enrollment (Estimated)

180

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Argentina
      • Buenos Aires, Argentina, C1199ABB
        • Recruiting
        • Hospital Italiano de Buenos Aires
        • Contact:
          • Phone Number: 541150000000
        • Principal Investigator:
          • Carlos Varela
      • Buenos Aires, Argentina, C1015ABO
        • Recruiting
        • Organizacion Medica de Investigacion
        • Contact:
        • Principal Investigator:
          • Ana Malvar Perrin
      • Buenos Aires, Argentina, C1056ABI
        • Recruiting
        • CINME S.A. - Centro de Investigaciones Metabólicas
        • Contact:
          • Phone Number: 548889000000
        • Principal Investigator:
          • Fernando Halac
      • Buenos Aires, Argentina, C1425
        • Recruiting
        • Centro Medico Dra. Laura Maffei- Investigacion Clinica Aplicada
        • Contact:
          • Phone Number: 541134723300
        • Principal Investigator:
          • Mria Smuclir Quevedo
      • Córdoba, Argentina, X5016KET
        • Recruiting
        • Clínica Privada Vélez Sarsfield
        • Principal Investigator:
          • Rafael Maldonado
        • Contact:
          • Phone Number: 5403514432121
  • Australia
    • New South Wales
      • Concord, New South Wales, Australia, 2138
        • Recruiting
        • Concord Hospital
      • Kogarah, New South Wales, Australia, 2217
        • Recruiting
        • St George Hospital
      • Liverpool, New South Wales, Australia, 2170
        • Recruiting
        • Liverpool Hospital
      • Westmead, New South Wales, Australia, 2145
        • Recruiting
        • Westmead Hospital
    • Queensland
      • Douglas, Queensland, Australia, 4814
        • Recruiting
        • Townsville Hospital
      • Herston, Queensland, Australia, 4006
        • Recruiting
        • Royal Brisbane and Women s Hospital
      • Southport, Queensland, Australia, 4215
        • Recruiting
        • Gold Coast University Hospital
      • Southport, Queensland, Australia, 4215
        • Recruiting
        • Griffith University Clinical Trial Unit
    • Victoria
      • Clayton, Victoria, Australia, 3168
        • Recruiting
        • Monash Health
      • St Albans, Victoria, Australia, 3021
        • Recruiting
        • Sunshine Hospital - Australia
  • Brazil
      • São Paulo, Brazil, 05304-000
        • Recruiting
        • Centro de Pesquisa Clínica de Nefrologia do Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo
        • Principal Investigator:
          • Irene Noronha
        • Contact:
          • Phone Number: 551127000000
    • Minas Gerais
      • Belo Horizonte, Minas Gerais, Brazil, 30150-221
        • Recruiting
        • Santa Casa de Misericordia de Belo Horizonte
        • Contact:
          • Phone Number: 55319422796
        • Principal Investigator:
          • Pedro Augusto Macedo de Souza
    • Rio Grande do Sul
      • Porto Alegre, Rio Grande do Sul, Brazil, 90610-001
        • Recruiting
        • Hospital Sao Lucas Da Pontificia Universidade Catolica Do Rio Grande Do Sul (PUCRS)
        • Contact:
        • Principal Investigator:
          • Giovani Gadonski
      • Porto Alegre, Rio Grande do Sul, Brazil, 90560-030
        • Recruiting
        • Hospital de Clínicas de Porto Alegre
        • Principal Investigator:
          • Cristina Karohl
        • Contact:
          • Phone Number: 555134000000
    • São Paulo
      • Ribeirão Preto, São Paulo, Brazil, 14051-140
        • Recruiting
        • Hospital das Clinicas da Faculdade de Medicina de Ribeirao Preto da Universidade de Sao Paulo
        • Contact:
          • Phone Number: 551640000000
        • Principal Investigator:
          • Gustavo Misiara
      • São José do Rio Preto, São Paulo, Brazil, 15090-000
        • Recruiting
        • Fundacao Faculdade Regional de Medicina de Sao Jose Do Rio Preto Hospital de Base - PPDS
        • Contact:
          • Phone Number: 551732000000
        • Principal Investigator:
          • Fernanda Cristina Camelo Sanches
  • Canada
    • Ontario
      • London, Ontario, Canada, N6A 5W9
        • Recruiting
        • London Health Sciences Centre - Victoria Hospital
        • Contact:
        • Principal Investigator:
          • Huang, Susan (Shih-Han)
  • China
    • Anhui
      • Fuyang, Anhui, China, 236006
        • Recruiting
        • Fu Yang People's Hospital - South Campus
    • Beijing Municipality
      • Beijing, Beijing Municipality, China, 102218
        • Recruiting
        • Beijing Tsinghua Changgung Hospital
      • Xichengqu Beijing, Beijing Municipality, China, 100034
        • Recruiting
        • Peking University First Hospital - Changqiao Campus
    • Fujian
      • Xiamen, Fujian, China, 361004
        • Recruiting
        • Zhongshan Hospital Xiamen University
    • Gansu
      • Lanzhou, Gansu, China, 730030
        • Recruiting
        • Lanzhou university second hospital
      • Lanzhou, Gansu, China, 730000
        • Recruiting
        • Gansu Provincial Hospital
    • Guangdong
      • Guangzhou, Guangdong, China, 510280
        • Recruiting
        • ZhuJiang Hospital of Southern Medical University
      • Shenzhen, Guangdong, China, 518036
        • Recruiting
        • Peking University Shenzhen Hospital
    • Guangxi
      • Nanning, Guangxi, China, 530021
        • Recruiting
        • The First Affiliated Hospital of Guangxi Medical University
      • Nanning, Guangxi, China, 530021
        • Recruiting
        • The People's Hospital of Guangxi Zhuang Autonomous Region
    • Guizhou
      • Guiyang, Guizhou, China, 550004
        • Recruiting
        • The Affiliated Hospital of Guizhou Medical University
    • Hebei
      • Shijiazhuang, Hebei, China, 50031
        • Recruiting
        • The First Hospital of Hebei Medical University
      • Shijiazhuang, Hebei, China, 50000
        • Recruiting
        • The Second Hospital of Hebei Medical University - Main
    • Heilongjiang
      • Daqing, Heilongjiang, China, 163001
        • Recruiting
        • Daqing Oilfield General hospital
    • Henan
      • Luoyang, Henan, China, 471003
        • Recruiting
        • The First Affiliated Hospital of Henan Science and Technology University - Jinghua Campus
    • Hunan
      • Changsha, Hunan, China, 410011
        • Recruiting
        • The Second Xiangya Hospital of Central South University
      • Yueyang, Hunan, China, 414000
        • Recruiting
        • Yueyang People Hospital
    • Shaanxi
      • Xi'an, Shaanxi, China, 710061
        • Recruiting
        • The First Affiliated Hospital of Xian Jiaotong University
      • Xi'an, Shaanxi, China, 710004
        • Recruiting
        • The Second Affiliated Hospital of Xian Jiaotong University
    • Shandong
      • Jinan, Shandong, China, 250012
        • Recruiting
        • Qilu Hospital of Shandong University
      • Jinan, Shandong, China, 250033
        • Recruiting
        • The Second Hospital of Shandong University
      • Qingdao, Shandong, China, 266555
        • Recruiting
        • The Affiliated Hospital of Qingdao University - Xihaian Campus
      • Yantai, Shandong, China, 264000
        • Recruiting
        • Yantai Yuhuangding Hospital
    • Zhejiang
      • Hangzhou, Zhejiang, China, 310009
        • Recruiting
        • the second Affiliated Hospital, Zhejiang University School of Medicine
      • Hangzhou, Zhejiang, China, 310016
        • Recruiting
        • Sir Run Run Shaw Hospital Zhejiang University School of Medicine - Qingchun Campus
  • India
      • Chandigarh, India, 160012
        • Recruiting
        • Postgraduate Institute of Medical Education & Research (PGIMER)
    • Andhra Pradesh
      • Hyderabad, Andhra Pradesh, India, 500012
        • Recruiting
        • Osmania General Hospital
      • Hyderabad, Andhra Pradesh, India, 500082
        • Recruiting
        • Nizams Institute of Medical Sciences
    • Karnataka
      • Bangalore, Karnataka, India, 560054
        • Recruiting
        • M.S. Ramaiah Medical College and Hospital
      • Bangalore, Karnataka, India, 560017
        • Recruiting
        • Manipal Hospital Bangalore
    • Maharashtra
      • Pune, Maharashtra, India, 411013
        • Recruiting
        • Noble Hospital
    • National Capital Territory of Delhi
      • New Delhi, National Capital Territory of Delhi, India, 110060
        • Recruiting
        • Sir Ganga Ram Hospital
      • New Delhi, National Capital Territory of Delhi, India, 110017
        • Recruiting
        • Max Super Speciality Hospital - Saket
    • Uttar Pradesh
      • Lucknow, Uttar Pradesh, India, 226022
        • Recruiting
        • Regency Health Super Specialty Hospital - Lucknow
      • Varanasi, Uttar Pradesh, India, 221010
        • Recruiting
        • Galaxy Hospital - Varanasi
    • West Bengal
      • Kolkata, West Bengal, India, 700014
        • Recruiting
        • Nil Ratan Sircar Medical College and Hospital
  • Japan
    • Chiba
      • Chia-shi, Chiba, Japan, 260-8712
        • Recruiting
        • National Hospital Organization Chiba Medical Center Chibahigashi National Hospital
      • Urayasu-Shi, Chiba, Japan, 279-0021
        • Recruiting
        • Juntendo University Urayasu Hospital
    • Hokkaidô
      • Sapporo, Hokkaidô, Japan, 060-8648
        • Recruiting
        • Hokkaido University Hospital
    • Kagawa-ken
      • Kita-Gun Uchiko-Cho, Kagawa-ken, Japan, 761-0793
        • Recruiting
        • Kagawa University Hospital
    • Kanagawa
      • Sagamihara-Shi Minami-Ku, Kanagawa, Japan, 252-0375
        • Recruiting
        • The Kitasato Institute Kitasato University Hospital
      • Yokohama, Kanagawa, Japan, 236-0004
        • Recruiting
        • Yokohama City University Hospital
    • Miyazaki
      • Miyazaki, Miyazaki, Japan, 889-1692
        • Recruiting
        • University of Miyazaki Hospital
    • Niigata
      • Niigata, Niigata, Japan, 951-8520
        • Recruiting
        • Niigata University Medical & Dental Hospital
    • Okinawa
      • Tomigusuku-Shi, Okinawa, Japan, 901-0224
        • Recruiting
        • Social Medical Corporation Yuuaikai Yuuai Medical Center
    • Saitama
      • Iruma-Gun Moroyama-Machi, Saitama, Japan, 350-0451
        • Recruiting
        • Saitama Medical University Hospital
    • Tokyo
      • Musashino-shi, Tokyo, Japan, 180-8610
        • Recruiting
        • Japanese Red Cross Musashino Hospital
  • Malaysia
      • Kuala Lumpur, Malaysia, 50450
        • Recruiting
        • Prince Court Medical Centre
    • Pahang
      • Perak, Pahang, Malaysia, 30450
        • Recruiting
        • Hospital Raja Permaisuri Bainun
    • WilayahPersekutuan KualaLumpur
      • Cheras, WilayahPersekutuan KualaLumpur, Malaysia, 56000
        • Recruiting
        • Hospital Canselor Tuanku Muhriz UKM
  • South Korea
      • Busan, South Korea, 48108
        • Recruiting
        • Inje University Haeundae Paik Hospital
      • Seoul, South Korea, 4763
        • Recruiting
        • Hanyang University Seoul Hospital
      • Seoul, South Korea, 6973
        • Recruiting
        • Chung-Ang University Hospital
    • Gyeonggido
      • Suwon, Gyeonggido, South Korea, 16499
        • Recruiting
        • Ajou University Hospital
    • Seoul Teugbyeolsi
      • Seoul, Seoul Teugbyeolsi, South Korea, 3080
        • Recruiting
        • Seoul National University Hospital
  • Taiwan
      • Kaohsiung City, Taiwan, 83301
        • Recruiting
        • Kaohsiung Chang Gung Memorial Hospital
      • Kaohsiung City, Taiwan, 80756
        • Recruiting
        • Kaohsiung Medical University Chung-Ho Memorial Hospital
      • Taichung, Taiwan, 40705
        • Recruiting
        • Taichung Veterans General Hospital
      • Taichung, Taiwan, 40447
        • Recruiting
        • China Medical University Hospital
      • Tainan, Taiwan, 70403
        • Recruiting
        • National Cheng Kung University Hospital
      • Taipei, Taiwan, 104
        • Recruiting
        • Mackay Memorial Hospital
      • Taipei, Taiwan, 116
        • Recruiting
        • Taipei Municipal Wanfang Hospital
      • Taipei, Taiwan, 11031
        • Recruiting
        • Taipei Medical University Hospital - PPDS
      • Taoyuan, Taiwan, 33305
        • Recruiting
        • Chang Gung Memorial Hospital
    • Hualien
      • Hualien City, Hualien, Taiwan, 970
        • Recruiting
        • Hualien Tzu Chi Hospital
  • United States
    • Alabama
      • Huntsville, Alabama, United States, 35805-4104
        • Recruiting
        • Apogee Clinical Research, LLC
        • Principal Investigator:
          • Michael Quadrini
        • Contact:
          • Phone Number: 256-533-4626
    • California
      • Fresno, California, United States, 93720-2989
        • Recruiting
        • The Nephrology Group, Inc. - Fresno
        • Contact:
          • Phone Number: 8706 559-228-6600
        • Principal Investigator:
          • Yangming Cao
      • Los Angeles, California, United States, 90022
        • Recruiting
        • Academic Medical Research Institute
        • Principal Investigator:
          • Mohamed El-Shahawy
        • Contact:
          • Phone Number: 323-725-0051
      • San Francisco, California, United States, 94143-2205
        • Recruiting
        • UCSF Medical Center
        • Principal Investigator:
          • Christopher Carlos
        • Contact:
          • Phone Number: 415-353-7900
      • Stanford, California, United States, 94305-2200
        • Recruiting
        • Stanford University
        • Principal Investigator:
          • Fahmeedah Kamal
        • Contact:
          • Phone Number: 650-721-4011
    • Michigan
      • Detroit, Michigan, United States, 48202-2608
        • Recruiting
        • Henry Ford Hospital- A-Basement Research Pharmacy
        • Contact:
          • Phone Number: 313-900-2298
        • Principal Investigator:
          • Douglas Atchison
      • Pontiac, Michigan, United States, 48341
        • Completed
        • Elixia Health - Michigan Kidney Consultants, LLC - Elixia - PPDS
    • New York
      • The Bronx, New York, United States, 10468
        • Recruiting
        • James J Peters Veterans Administration Medical Center - NAVREF - PPDS
        • Principal Investigator:
          • Chang Xu
        • Contact:
          • Phone Number: 2158 718-584-9000
    • North Carolina
      • Greenville, North Carolina, United States, 27834
        • Recruiting
        • ECU Physicians Nephrology and Hypertension
        • Contact:
        • Principal Investigator:
          • Reginald Obi
    • Ohio
      • Cleveland, Ohio, United States, 44106-1716
        • Recruiting
        • University Hospitals Cleveland Medical Center
        • Contact:
        • Principal Investigator:
          • Lazar, Andrew
    • Tennessee
      • Knoxville, Tennessee, United States, 37923-3624
        • Recruiting
        • Knoxville Kidney Center, PLLC
        • Principal Investigator:
          • George Newman
        • Contact:
          • Phone Number: 865-692-3462
      • Nashville, Tennessee, United States, 37204-3609
        • Recruiting
        • Vanderbilt University Medical Center
        • Contact:
          • Phone Number: 615-936-1179
        • Principal Investigator:
          • Neil Sanghani
    • Texas
      • Dallas, Texas, United States, 75231-0929
        • Recruiting
        • Nephrotex Research Group
        • Contact:
          • Phone Number: 214-396-4950
        • Principal Investigator:
          • Sumit Kumar
      • League City, Texas, United States, 77573
        • Recruiting
        • University of Texas Medical Branch
        • Contact:
          • Phone Number: 409-772-2473
        • Principal Investigator:
          • Shikha Wadhwani
    • Wisconsin
      • Madison, Wisconsin, United States, 53792-0001
        • Recruiting
        • University of Wisconsin School of Medicine and Public Health
        • Contact:
          • Phone Number: 608-265-0631
        • Principal Investigator:
          • Sarah Panzer

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Open-Label Treatment Phase
Participants will receive several intravenous (IV) doses of felzartamab or oral tacrolimus in the Open-Label Treatment Phase.
Drug: Felzartamab
Administered intravenously
Other Names:
  • MOR202, MOR03087, TJ202, BIIB148, HIB202
Drug: Tacrolimus
Administered orally
Experimental: Non-Responder Treatment Phase
Participants initially randomized to felzartamab or tacrolimus who meet rescue criteria may receive regional standard of care immunosuppressive therapy (IST) per Investigator discretion or several IV doses of felzartamab, respectively, in the Non-Responder Treatment Phase.
Drug: Felzartamab
Administered intravenously
Other Names:
  • MOR202, MOR03087, TJ202, BIIB148, HIB202
Drug: Standard of Care IST
Administered intravenously and orally

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Percentage of Participants who Achieve Complete Remission (CR) at Week 104
Time Frame: Week 104
Week 104

Secondary Outcome Measures

Outcome Measure
Time Frame
Percentage of Participants who Achieve CR at Week 76
Time Frame: Week 76
Week 76
Percentage of Participants who Achieve Overall Remission (OR), Defined as CR or Partial Remission (PR) at Week 104
Time Frame: Week 104
Week 104
Percentage of Participants With a Baseline Anti-Phospholipase A2 Receptor (PLA2R) Autoantibody Titer Greater Than 50 Relative Unit per Milliliter (RU/mL) who Achieve an OR at Week 76 and at Week 104
Time Frame: Weeks 76 and 104
Weeks 76 and 104
Time to Disease Worsening
Time Frame: Baseline up to week 156
Baseline up to week 156
Time to a Sustained Reduction in eGFR of ≥ 30% From Baseline
Time Frame: Baseline up to week 104
Baseline up to week 104
Absolute Change in Anti-PLA2R Autoantibody Titer in Participants Positive for Anti-PLA2R at Baseline
Time Frame: Baseline up to week 156
Baseline up to week 156
Change From Baseline in the Patient Reported Outcome Measurement Information System (PROMIS) Fatigue Scale at Week 104
Time Frame: Week 104
Week 104
Change From Baseline in PROMIS Global Assessment of Physical Health Scale at Week 104
Time Frame: Week 104
Week 104
Number of Participants With Treatment Emergent Adverse Event (TEAE), Serious Adverse Event (SAE) and Adverse Events of Special Interest (AESIs)
Time Frame: From first dose of study drug up to end of follow-up (up to week 156)
From first dose of study drug up to end of follow-up (up to week 156)
Felzartamab Serum Concentrations Over Time
Time Frame: Predose and at multiple timepoints post dose up to week 156
Predose and at multiple timepoints post dose up to week 156
Number of Participants With Anti-Drug Antibodies (ADAs) Against Felzartamab
Time Frame: Predose and at multiple timepoints post dose up to week 156
Predose and at multiple timepoints post dose up to week 156
Duration of CR
Time Frame: Baseline up to week 156
Baseline up to week 156

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Biogen

Investigators

  • Study Director: Medical Director, Biogen

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 22, 2025

Primary Completion (Estimated)

December 29, 2028

Study Completion (Estimated)

March 29, 2029

Study Registration Dates

First Submitted

April 30, 2025

First Submitted That Met QC Criteria

April 30, 2025

First Posted (Actual)

May 8, 2025

Study Record Updates

Last Update Posted (Actual)

June 12, 2026

Last Update Submitted That Met QC Criteria

June 11, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 299PN301
  • 2024-519232-16-00 (Other Identifier: EU CT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

In accordance with Biogen's Clinical Trial Transparency and Data Sharing Policy on https://www.biogentrialtransparency.com/

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Primary Membranous Nephropathy

Clinical Trials on Felzartamab

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Suriname

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe