A Study to Learn About the Effects of Felzartamab Infusions on Adults With Immunoglobulin A Nephropathy (IgAN)
PREVAIL
A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study of Felzartamab in Adults With IgA Nephropathy (PREVAIL)
2 other identifiers
interventional
454
28 countries
240
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started May 2025
Typical duration for phase_3
240 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 17, 2025
CompletedFirst Posted
Study publicly available on registry
April 20, 2025
CompletedStudy Start
First participant enrolled
May 8, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 31, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
June 5, 2029
June 10, 2026
June 1, 2026
2.1 years
April 17, 2025
June 9, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Percent Change From Baseline in Proteinuria as Measured by the Urine Protein: Creatinine Ratio (UPCR)
Baseline up to Week 36
Secondary Outcomes (12)
Change From Baseline in Estimated Glomerular Filtration Rate (eGFR) Values Calculated Using the Chronic Kidney Disease Epidemiology (CKD-EPI) Creatinine Equation
Baseline up to Week 104
Percentage of Participants Achieving Complete Response (CR)
Baseline up to Week 104
Percentage of Participants who Progressed to Kidney Malfunction
Baseline up to Week 104
Percentage of Participants Requiring Rescue Therapy
Baseline up to Week 104
Change From Baseline in eGFR Values Calculated Using the CKD-EPI Creatinine Equation
Baseline up to Week 52
- +7 more secondary outcomes
Study Arms (4)
Cohort 1
EXPERIMENTALParticipants will receive several intravenous (IV) doses of felzartamab.
Cohort 2
PLACEBO COMPARATORParticipants will receive several IV doses of placebo.
Cohort 3
EXPERIMENTALParticipants with an estimated glomerular filtration rate (eGFR) ≥ 20 and \<30 milliliter per minute per 1.73 square meter (mL/min/1.73m\^2) will receive several IV doses of felzartamab.
Cohort 4
PLACEBO COMPARATORParticipants with an eGFR ≥ 20 and \<30 mL/min/1.73m\^2 will receive several IV doses of placebo.
Interventions
Administered IV
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Biogenlead
Study Sites (240)
Applied Research Center of Arkansas
Little Rock, Arkansas, 72205, United States
Kidney & Hypertension Center - Apple Valley
Apple Valley, California, 92307, United States
Scripps Green Hospital
Carlsbad, California, 92009, United States
National Institute of clinical Research Administration Office
Garden Grove, California, 92844-2751, United States
UCLA Health David Geffen School of Medicine
Los Angeles, California, 90095, United States
FOMAT Medical Research - FOMAT - PPDS
Oxnard, California, 93030, United States
North America Research Institute-San Dimas
San Dimas, California, 91773, United States
Nova Clinical Research, LLC
Bradenton, Florida, 34209, United States
University of Florida - Gainesville - 1600 SW Archer Rd
Gainesville, Florida, 32610, United States
Royal Research, Corp.
Hollywood, Florida, 33024, United States
Central Florida Kidney Specialists
Orlando, Florida, 32806, United States
CDC Research Institute, LLC
Port Saint Lucie, Florida, 34952, United States
American Clinical Trials LLC
Acworth, Georgia, 30101, United States
The Vasculitis and Glomerulonephritis Center at Massachusetts General Hospital
Boston, Massachusetts, 02114-4724, United States
Brigham and Women's Hospital
Boston, Massachusetts, 02115-6110, United States
UMass Memorial Medical Center
Worcester, Massachusetts, 01655, United States
Henry Ford Hospital
Detroit, Michigan, 48202, United States
Elixia Health - Michigan Kidney Consultants, LLC - Elixia - PPDS
Pontiac, Michigan, 48341, United States
Anointed Nephrology and HTN - SKYCRNG - PPDS
Brookhaven, Mississippi, 39601, United States
Midwest Nephrology Associates,Inc.
City of Saint Peters, Missouri, 63376, United States
Icahn School of Medicine at Mount Sinai
New York, New York, 10029-6504, United States
James J Peters Veterans Administration Medical Center - NAVREF - PPDS
The Bronx, New York, 10468, United States
Penn Renal Electrolyte and Hypertension Perelman
Philadelphia, Pennsylvania, 19104, United States
Lifespan at Rhode Island Hospital
Providence, Rhode Island, 02903, United States
Knoxville Kidney Center, PLLC
Knoxville, Tennessee, 37923-3624, United States
Texas Kidney Institute - Dallas
Dallas, Texas, 95231, United States
Provecta Research Network
Houston, Texas, 77054, United States
R & H Clinical Research
Katy, Texas, 77974, United States
Hospital Italiano de Buenos Aires
Almagro, Ciudad Autónoma de BuenosAires, C1199ABB, Argentina
INECO Neurociencias Oroño
Rosario, Santa Fe Province, 2000, Argentina
CIMER-Centro Integral de Medicina Respiratoria
San Miguel de Tucumán, Tucumán Province, T4000CBC, Argentina
Consultorios Médicos Dr. Doreski - Fundacion Respirar - PPDS
Buenos Aires, B1605, Argentina
DOM Centro de Reumatología
Buenos Aires, C1111AAH, Argentina
Maffei Centro Médico
Buenos Aires, C1425, Argentina
Clínica de Nefrología Urología Y Enfermedades Cardiovasculares
Santa Fe, 3000, Argentina
John Hunter Hospital
New Lambton, New South Wales, 2305, Australia
Concord Repatriation General Hospital
New South Wales, New South Wales, 2060, Australia
Westmead Hospital
Westmead, New South Wales, 2145, Australia
Townsville Hospital
Douglas, Queensland, 4814, Australia
Royal Brisbane & Women's Hospital
Herston, Queensland, 4029, Australia
Gold Coast University Hospital
Southport, Queensland, 4215, Australia
Griffith University
Southport, Queensland, 4222, Australia
Sunshine Hospital - Australia
St Albans, Victoria, 3021, Australia
Hôpital Erasme - PPDS
Anderlecht, Brussels Capital, 1070, Belgium
ZOL Genk - campus Sint-Jan
Genk, Limburg, 3600, Belgium
UZ Leuven - PPDS
Leuven, Vlaams Brabant, 3000, Belgium
Jan Yperman
Ieper, West-Vlaanderen, 8900, Belgium
AZ Groeninge
Kortrijk, West-Vlaanderen, 8500, Belgium
Cliniques Universitaires Saint-Luc
Brussels, 1200, Belgium
Freire Pesquisa Clínica
Belo Horizonte, Minas Gerais, 30150-320, Brazil
Irmandade da Santa Casa de Misericórdia de Belo Horizonte - PPDS
Belo Horizonte, Minas Gerais, 30150221, Brazil
Centro Mineiro de Pesquisa - CMiP
Juiz de Fora, Minas Gerais, 36010, Brazil
Fundação Universidade de Caxias do Sul - Instituto de Pesquisas em Saúde
Caxias do Sul, Rio Grande do Sul, 95070-560, Brazil
Hospital de Clinicas de Porto Alegre (HCPA) - PPDS
Porto Alegre, Rio Grande do Sul, 90035-903, Brazil
Hospital Alemao Oswaldo Cruz- HAOC
São Paulo, 01323-903, Brazil
Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo
São Paulo, 05403-000, Brazil
Medical Center Medconsult Pleven - Lovech Branch
Lovech, 5500, Bulgaria
Medical Center Hera EOOD, Montana - Hera Clinics - PPDS
Montana, 3400, Bulgaria
Medical Center Medconsult Pleven OOD
Pleven, 5800, Bulgaria
University Multiprofile Hospital for Active Treatment Sv Ivan Rilski EAD-15 Acad. Ivan Geshov Blvd
Sofia, 1606, Bulgaria
St Paul's Hospital
Vancouver, British Columbia, V6Z 1Y6, Canada
McGill University Health Centre (MUHC)
Montreal, Quebec, H4A3J1, Canada
Fu Yang People's Hospital - South Campus
Fuyang, Anhui, 236000, China
The First Affiliated Hospital of Anhui Medical University - Jixilu Campus
Hefei, Anhui, 230022, China
Peking University First Hospital - Changqiao Campus
Beijing, Beijing Municipality, 100034, China
Beijing Tsinghua Changgung Hospital
Beijing, Beijing Municipality, 102218, China
Fujian Medical University Union Hospital
Fuzhou, Fujian, 350001, China
Zhongshan Hospital Xiamen University
Xiamen, Fujian, 361004, China
Gansu Provincial Hospital
Lanzhou, Gansu, 730000, China
The First Affiliated Hospital of Guangzhou Medical University - Yanjiang Campus
Guangzhou, Guangdong, 510120, China
Shenzhen Hospital of Southern Medical University
Shenzhen, Guangdong, 510086, China
Peking University Shenzhen Hospital
Shenzhen, Guangdong, 518036, China
Zhongshan Hospital of Traditional Chinese Medicine
Zhongshan, Guangdong, 528401, China
The First Affiliated Hospital of Guangxi Medical University
Nanning, Guangxi, 530021, China
The People's Hospital of Guangxi Zhuang Autonomous Region
Nanning, Guangxi, 530021, China
The Affiliated Hospital of Guizhou Medical University
Guiyang, Guizhou, 550000, China
Cangzhou Central Hospital
Cangzhou, Hebei, 61011, China
The Second Hospital of Hebei Medical University - Main
Shijiazhuang, Hebei, 50000, China
The Third Hospital of Hebei Medical University
Shijiazhuang, Hebei, 50000, China
Daqing Oilfield General Hospital
Daqing, Heilongjiang, 163001, China
The First Affiliated Hospital of Henan Science and Technology University - Jinghua Campus
Luoyang, Henan, 471003, China
Queen Mary Hospital PPDS
Hong Kong, Hong Kong, 999077, China
Yichang Central People's Hospital - Wujiagang Campus
Yichang, Hubei, 443003, China
The Second Affiliated Hospital of Nanjing Medical University
Nanjing, Jiangsu, 210011, China
Affiliated Hospital of Nantong University
Nantong, Jiangsu, 226001, China
Wuxi Peoples Hospital
Wuxi, Jiangsu, 214023, China
Qilu Hospital of Shandong University
Jinan, Shandong, 250012, China
The Second Hospital of Shandong University
Jinan, Shandong, 250033, China
Yantai Yuhuangding Hospital
Yantai, Shandong, 264000, China
Zhongshan Hospital Fudan University
Shanghai, Shanghai Municipality, 200023, China
Shanghai General Hospital - North Campus
Shanghai, Shanghai Municipality, 200080, China
Jiading Central Hospital
Shanghai, Shanghai Municipality, 201899, China
Sichuan Academy of Medical Sciences & Sichuan Provincial People's Hospital
Chengdu, Sichuan, 610072, China
Jinhua Municipal Central Hospital
Jinhua, Zhejiang, 321000, China
Taizhou Hospital of Zhejiang Province - Main
Taizhou, Zhejiang, 317000, China
Clinica de la Costa S.A.S. - PPDS
Barranquilla, Atlántico, 80020, Colombia
Hospital Universitario San Ignacio
Bogotá, Cundinamarca, 110231, Colombia
Healthy Medical Center S.A.S.
Zipaquirá, Cundinamarca, 250252, Colombia
Fundacion Valle Del Lili
Cali, Valle del Cauca Department, 760032, Colombia
Klinicki bolnicki centar Sestre Milosrdnice - Vinogradska cesta 29
Zagreb, City of Zagreb, 10000, Croatia
Polyclinic Bonifarm
Zagreb, City of Zagreb, 10000, Croatia
Clinical Hospital Center Rijeka
Rijeka, 51000, Croatia
Special Hospital Medico
Rijeka, 51000, Croatia
Institut klinicke a experimentalni mediciny
Prague, Praha, Hlavní Mesto, 140 21, Czechia
CHU de Strasbourg - Nouvel Hôpital Civil
Strasbourg, Bas-Rhin, 67091, France
CHU de Besançon
Besançon, Dobus, 25000, France
CHU de Bordeaux - Hôpital Pellegrin
Bordeaux, Gironde, 33076, France
CHU de Reims - Hôpital Maison Blanche
Reims, Grand Est, 51092, France
GHRMSA - Hôpital Emile Muller
Mulhouse, Haut-Rhin, 68100, France
Hopital Foch
Suresnes, Hauts-de-Seine, 92150, France
CHRU d'Orleans- Hôpital de La Source
Orléans, Loiret, 45067, France
CHU de Nîmes - Hopital Universitaire Caremeau
Nîmes Cédex 9, Occitanie, 30929, France
AP-HP - Hôpital Henri Mondor
Créteil, Val-de-Marne, 94000, France
Centre Hospitalier Departemental de Vendee
La Roche-sur-Yon, Vendée, 85925, France
CHU Amiens Picardie - Site Sud
Dreuil-lès-Amiens, 80470, France
AP-HP - Hôpital Saint-Louis
Paris, 75010, France
AP-HP - Hopital Tenon
Paris, 75020, France
Nephrologisches Zentrum Villingen-Schwenningen
Villingen-Schwenningen, Baden-Wurttemberg, 78052, Germany
Universitätsklinikum Frankfurt, Apotheke Haus 19
Frankfurt am Main, Hesse, 60596, Germany
Universitätsmedizin der Johannes Gutenberg-Universität Mainz
Mainz, Rhineland-Palatinate, 55131, Germany
Universitätsklinikum Carl Gustav Carus an der TU Dresden
Dresden, Saxony, 1307, Germany
Charité - Universitätsmedizin Berlin
Berlin, 10117, Germany
University General Hospital of Patras
Pátrai, Achaïa, 26500, Greece
General Hospital of Athens ''G. Gennimatas''
Athens, Attica, 115 27, Greece
General Hospital of Athens ''Hippokratio''
Athens, Attica, 115 27, Greece
Laiko General Hospital of Athens
Athens, Attica, 11527, Greece
University General Hospital ''ATTIKON'' - General Hospital of West Attica H AGIA VARVARA
Chaïdári, Attica, 12462, Greece
General Hospital of Heraklion Venizeleio
Heraklion, Irakleio, 714 09, Greece
PAGNI-University General Hospital of Heraklion
Heraklion, Irakleio, 715 00, Greece
University General Hospital of Ioannina
Ioannina, 34098, Greece
AHEPA University General Hospital of Thessaloniki
Thessaloniki, 54636, Greece
Osmania General Hospital
Hyderabad, Andhra Pradesh, 500012, India
Nizams Institute of Medical Sciences
Hyderabad, Andhra Pradesh, 500082, India
All India Institute of Medical Sciences ( AIIMS ) - Raipur
Raipur, Chhattisgarh, 492099, India
Zydus Hospital
Ahmedabad, Gujarat, 380081, India
Muljibhai Patel Society for Research in Nephro-Urology
Nadiād, Gujarat, 387001, India
Manipal Hospital Bangalore
Bangalore, Karnataka, 560017, India
M.S. Ramaiah Medical College and Hospital
Bangalore, Karnataka, 560054, India
Government Medical College, Kozhikode
Kozhikode, Kerala, 673008, India
Trivandrum Medical College Hospital
Trivandrum, Kerala, 695011, India
Seth G S Medical College and K E M Hospital
Mumbai, Maharashtra, 400012, India
Noble Hospital
Pune, Maharashtra, 411013, India
Max Super Speciality Hospital - Saket
New Delhi, National Capital Territory of Delhi, 110017, India
Sir Ganga Ram Hospital
New Delhi, National Capital Territory of Delhi, 110060, India
King George Medical University
Lucknow, Uttar Pradesh, 226003, India
Sanjay Gandhi Postgraduate Institute of Medical Sciences
Lucknow, Uttar Pradesh, 226014, India
Nil Ratan Sircar Medical College and Hospital
Kolkata, West Bengal, 700014, India
Postgraduate Institute of Medical Education & Research (PGIMER)
Chandigarh, 160012, India
Azienda Ospedaliero Universitaria di Parma
Fontevivo, Emilia-Romagna, 43010, Italy
AUSL Piacenza - Ospedale Guglielmo da Saliceto
Piacenza, Emilia-Romagna, 29121, Italy
Azienda Sanitaria Universitaria Giuliano Isontina (ASUGI) - Ospedale di Cattinara
Trieste, Friuli Venezia Giulia, 34149, Italy
IRCCS Azienda Ospedaliera Metropolitana - Ospedale Policlinico San Martino
Genoa, Liguria, 16132, Italy
ASST degli Spedali Civili di Brescia - Spedali Civili di Brescia
Brescia, Lombardy, 25123, Italy
Centro di Ricerche Cliniche per le Malattie Rare Aldo e Cele Daccò
Ranica, Lombardy, 24020, Italy
IRCCS Istituto Clinico Humanitas
Rozzano, Lombardy, 20089, Italy
Azienda Ospedaliero Universitaria Maggiore della Carità
Novara, Piedmont, 28100, Italy
ASL Città di Torino - Ospedale San Giovanni Bosco
Turin, Piedmont, 10154, Italy
Fujita Health University Hospital
Toyoake-shi, Aiti, 470-1192, Japan
Hirosaki University Hospital
Hirosaki-shi, Aomori, 036-8563, Japan
National Hospital Organization Chiba Medical Center Chibahigashi National Hospital
Chiba, Chiba, 260-8712, Japan
Juntendo University Urayasu Hospital
Urayasu-Shi, Chiba, 279-0021, Japan
Hokkaido University Hospital
Sapporo, Hokkaido, 060-8648, Japan
Hospital of the University of Occupational and Environmental Health, Japan
Kitakyushu-shi, Hukuoka, 807-8556, Japan
Fukushima Medical University Hospital
Fukushima, Hukusima, 960-1247, Japan
Toranomon Hospital Kajigaya
Kawasaki-shi, Kanagawa, 213-0015, Japan
Kitasato University Hospital
Sagamihara-shi, Kanagawa, 252-0375, Japan
Yokohama City University Hospital
Yokohama, Kanagawa, 236-0004, Japan
University Hospital, Kyoto Prefectural University of Medicine
Kyoto, Kyôto, 602-8566, Japan
Tohoku Medical and Pharmaceutical University Hospital
Sendai, Miyagi, 983-8512, Japan
Nara Medical University Hospital
Kashihara, Nara, 634-8522, Japan
Kawasaki Medical School Hospital
Kurashiki, Okayama-ken, 701-0192, Japan
Hamamatsu University Hospital
Hamamatsu, Sizouka, 431-3192, Japan
Tokushima University Hospital
Tokushima, Tokushima, 770-8503, Japan
The Jikei University West Medical Center
Ashikaga-Shi, Tokyo, 326-0843, Japan
Juntendo University Hospital
Bunkyo-Ku, Tokyo, 113-8431, Japan
Jikei University Hospital
Minato-ku, Tokyo, 105-8471, Japan
Showa Medical University Hospital
Shinagawa-ku, Tokyo, 142-86666, Japan
Ikeda Municipal Hospital
Ikeda-shi, Ôsaka, 563-8510, Japan
Osaka University Hospital
Suita-shi, Ôsaka, 565-0871, Japan
Hospital Tengku Ampuan Afzan
Kuantan, Pahang, 25100, Malaysia
Hospital Raja Permaisuri Bainun
Perak, Pahang, 30450, Malaysia
University Malaya Medical Centre
Lembah Pantai, WilayahPersekutuan KualaLumpur, 59100, Malaysia
Auckland City Hospital
Auckland, 1023, New Zealand
Aotearoa Clinical Trials Trust- Middlemore Hospital
Auckland, 2025, New Zealand
Wellington Hospital
Wellington, 6021, New Zealand
Norzel Medical and Diagnostic Clinic Foundation Corp.
Cebu City, Cebu, 6000, Philippines
MCM Krakow - PRATIA - PPDS
Krakow, Lesser Poland Voivodeship, 30727, Poland
SCM Clinic - Prywatny Szpital Specjalistyczny
Krakow, Lesser Poland Voivodeship, 31-559, Poland
SPZOZ Centralny Szpital Kliniczny UM w Lodzi - ul. Pomorska 251
Lodz, Lódzkie, 92-213, Poland
Uniwersyteckie Centrum Kliniczne w Gdansku - Debinki 7
Gdansk, Pomeranian Voivodeship, 80-952, Poland
Twoja Przychodnia - Szczecinskie Centrum Medyczne
Szczecin, West Pomeranian Voivodeship, 71-434, Poland
Uniwersytecki Szpital Kliniczny Nr 2 PUM w Szczecinie
Szczecin, 70-110, Poland
ULS de Lisboa Ocidental, EPE - Hospital Santa Cruz
Carnaxide, Lisbon District, 2790, Portugal
ULS de Gaia/Espinho, EPE - Unidade I
Vila Nova de Gaia, Lisbon District, 4434-502, Portugal
ULS da Região de Aveiro, EPE - Hospital Infante D. Pedro
Aveiro, 3814, Portugal
Centro Clínico Académico, Braga - Hospital de Braga
Braga, 4710-243, Portugal
ULS de Coimbra, EPE - Hospitais da Universidade de Coimbra
Coimbra, 3004-561, Portugal
ULS da Região de Leiria, EPE - Hospital de Santo André
Leiria, 2410-197, Portugal
ULS da Arrábida, EPE - Hospital de São Bernardo
Setúbal, 2910-446, Portugal
FDI Clinical Research
San Juan, 00927, Puerto Rico
Pusan National University Hospital
Busan, Gwangyeogsi, 49241, South Korea
Hallym University Sacred Heart Hospital
Anyang-si, Gyeonggido, 14068, South Korea
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggido, 13620, South Korea
Ajou University Hospital
Suwon, Gyeonggido, 16499, South Korea
Severance Hospital Yonsei University Health System
Seoul, Seoul Teugbyeolsi, 3722, South Korea
Hanyang University Seoul Hospital
Seoul, Seoul Teugbyeolsi, 4763, South Korea
Inje University Haeundae Paik Hospital
Busan, 48108, South Korea
Seoul National University Hospital
Seoul, 03080, South Korea
Samsung Medical Center
Seoul, 6351, South Korea
Fundacio Puigvert
Viladecans, Barcelona, 8840, Spain
Hospital del Mar
Barcelona, Catalonia, 8003, Spain
Hospital Universitario A Coruña
A Coruña, Galicia, 15006, Spain
Hospital Universitario Fundacion Alcorcon
Alcorcón, Madrid, 28922, Spain
Hospital Universitario de Getafe
Getafe, Madrid, 10400, Spain
Hospital Universitario Vall d'Hebron - PPDS
Barcelona, 8035, Spain
Hospital General San Pedro de Alcantara
Cáceres, 10003, Spain
Hospital Universitari de Girona Dr Josep Trueta
Girona, 17007, Spain
Hospital Universitario Fundacion Jimenez Diaz
Madrid, 28040, Spain
Hospital Universitario 12 de Octubre
Madrid, 28041, Spain
Hospital Universitario Virgen Macarena
Seville, 41009, Spain
Hospital Universitario Miguel Servet
Zaragoza, 50009, Spain
National Cheng Kung University Hospital
Dawan, Taiwan, Province of China, 70403, Taiwan
Far Eastern Memorial Hospital
New Taipei City, Taiwan, Province of China, 220216, Taiwan
China Medical University Hospital - PPDS
Taichung, Taiwan, Province of China, 40447, Taiwan
Mackay Memorial Hospital-Taipei branch
Taipei, Taiwan, Province of China, 104449, Taiwan
Taipei Municipal Wanfang Hospital
Taipei, Taiwan, Province of China, 116081, Taiwan
Chang Gung Memorial Hospital, Linkou
Taoyuan, Taiwan, Province of China, 33305, Taiwan
Kaohsiung Medical University - Chung-Ho Memorial Hospital
Kaohsiung City, 807, Taiwan
Taipei Medical University Shuang Ho Hospital
New Taipei City, 235041, Taiwan
Kocaeli Universitesi Arastirma ve Uygulama Hastanesi
İzmit, Kocaeli, 41380, Turkey (Türkiye)
Ankara Bilkent Sehir Hastanesi
Ankara, Turkey, 34899, Turkey (Türkiye)
Marmara Universitesi Pendik Egitim ve Arastirma Hastanesi
Istanbul, Turkey, 34899, Turkey (Türkiye)
Mehmet Akif Inan Egitim ve Arastirma Hastanesi
Sanliurfa, Turkey, 63040, Turkey (Türkiye)
Akdeniz University Medical Faculty
Antalya, 7070, Turkey (Türkiye)
Istanbul Universitesi - Cerrahpasa Cerrahpasa Tip Fakultesi Hastanesi
Istanbul, 34098, Turkey (Türkiye)
Erciyes Universitesi Tip Fakultesi Gevher Nesibe Hastanesi
Kayseri, 38039, Turkey (Türkiye)
Royal Preston Hospital - NWCRN- PPDS
Preston, Lancashire, PR2 9HT, United Kingdom
Leicester General Hospital
Leicester, Leicestershire, LE5 4PW, United Kingdom
Northern General Hospital
Sheffield, South Yorkshire, S5 7AU, United Kingdom
Royal Stoke University Hospital
Stoke-on-Trent, Staffordshire, ST4 6QG, United Kingdom
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Medical Director
Biogen
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 17, 2025
First Posted
April 20, 2025
Study Start
May 8, 2025
Primary Completion (Estimated)
May 31, 2027
Study Completion (Estimated)
June 5, 2029
Last Updated
June 10, 2026
Record last verified: 2026-06
Data Sharing
- IPD Sharing
- Will share
In accordance with Biogen's Clinical Trial Transparency and Data Sharing Policy on https://www.biogentrialtransparency.com/