A Study to Compare Elritercept to Placebo in Adults With Myelofibrosis and Anemia Who Are Taking Ruxolitinib
ELRISE MF
A Phase 3, Double-Blind, Randomized Trial Evaluating the Efficacy and Safety of Elritercept (TAK-226) Compared to Placebo in Participants With Myelofibrosis and Anemia on Concurrent Ruxolitinib Therapy
2 other identifiers
interventional
324
30 countries
201
Brief Summary
The main aim of this study is to find out how well elritercept works to improve anemia in participants with myelofibrosis (MF) who are taking ruxolitinib when compared to placebo. Other aims are to learn how elritercept improves anemia compared to placebo; to learn if elritercept reduces tiredness, improves symptoms related to MF, and helps participants do physical activities more easily. The study also aims to find out how elritercept affects the bone marrow, the spleen, and whether participants develop antibodies to the study drug. The study will also check how safe elritercept is compared to placebo, and if elritercept stays safe over a long period of time. Participants will receive study treatment for at least 9 months (36 weeks). After this period, participants who received placebo will have the option to switch to elritercept.
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 Aug 2026
Longer than P75 for phase_3
201 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
May 29, 2026
CompletedFirst Posted
Study publicly available on registry
June 3, 2026
CompletedStudy Start
First participant enrolled
August 25, 2026
ExpectedPrimary Completion
Last participant's last visit for primary outcome
December 7, 2029
Study Completion
Last participant's last visit for all outcomes
March 30, 2034
July 23, 2026
July 1, 2026
3.3 years
May 29, 2026
July 22, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Proportion of Participants Who Are Red Blood Cell-Transfusion Independent (RBC-TI) for Any Consecutive Greater Than or Equal to (≥) 12-Week Period During the 36-Week Double-Blinded Treatment Period
RBC-TI is defined as no RBC transfusions administered for the specified time period during study treatment.
From Cycle 1 Day 1 through Week 36 (each cycle is 28 days)
Secondary Outcomes (30)
Proportion of Participants Who Achieve ≥50 Percent (%) Reduction in RBC Transfusion Burden From Baseline Over Any Consecutive 12-Week Period
From Cycle 1 Day 1 through Week 36 (each cycle is 28 days)
Proportion of Participants Who Are RBC-TI for Any Consecutive ≥16-Week Period
From Cycle 1 Day 1 through Week 36 (each cycle is 28 days)
Proportion of Participants Who Are RBC-TI for Any Consecutive ≥12-Week Period With Concurrent Mean Hemoglobin (Hgb) Increase ≥1.5 Grams per Deciliter (g/dL) From Baseline
From Cycle 1 Day 1 through Week 36 (each cycle is 28 days)
Proportion of Participants Who Are RBC-TI for Any Consecutive ≥24-Week Period
From Cycle 1 Day 1 through Week 36 (each cycle is 28 days)
Proportion of Participants Who Are RBC-TI for Any Consecutive ≥12-Week Period With Concurrent Mean Hgb Increase of ≥1.0 g/dL and ≥2.0 g/dL From Baseline
From Cycle 1 Day 1 through Week 36 (each cycle is 28 days)
- +25 more secondary outcomes
Study Arms (2)
Elritercept
EXPERIMENTALParticipants will receive elritercept at a starting dose of 3.75 milligrams per kilogram (mg/kg) subcutaneously (SC) once every 4 weeks (Q4W) on Day 1 of each 28-day cycle for approximately 36 weeks during the double-blinded treatment period, with possible up-titration to 5.0 mg/kg from Cycle 3 Day 1 based on response and safety/tolerability. Participants may continue to receive elritercept during the extended open-label treatment period.
Placebo
PLACEBO COMPARATORParticipants will receive elritercept-matching placebo with equivalent volume to elritercept SC Q4W on Day 1 of each 28-day cycle for approximately 36 weeks during the double-blinded treatment period. Eligible participants may initiate elritercept at a starting dose of 3.75 mg/kg SC Q4W on Day 1 of each 28-day cycle during the extended open-label treatment period, with possible up-titration to 5.0 mg/kg after 2 cycles, based on response and safety/tolerability.
Interventions
Eligibility Criteria
You may qualify if:
- Aged ≥18 years at the time of signing the informed consent form (ICF).
- Able to understand the purpose and risks of the trial and voluntarily sign an ICF.
- Diagnosed with primary myelofibrosis (PMF), post-essential thrombocythemia (post-ET MF) or post-polycythemia vera (post-PV MF) according to the 2022 WHO criteria (WHO Classification of Tumours Editorial Board 2024), confirmed by local pathology report.
- Transfusion status as assessed in the 12 weeks immediately preceding randomization classified as Transfusion Dependent: 3 to 8 RBC units over 12 weeks.
- Receiving ruxolitinib (as approved in the country of the trial site) as the standard of care treatment for MF for at least 12 consecutive weeks, and on a stable daily dose for at least the 8 weeks immediately preceding the date of randomization.
- Eastern Cooperative Oncology Group score less than or equal to (≤) 2.
You may not qualify if:
- Prior treatment with luspatercept, sotatercept, or other transforming growth factor beta inhibitors or activin receptor ligand traps.
- Systemic treatment within 28 days before randomization with any of the following:
- Androgens (including danazol). Participants on stable androgen dosing for hypogonadism for ≥8 weeks are allowed.
- erythropoiesis-stimulating agents.
- granulocyte colony stimulating factor or granulocyte-macrophage colony stimulating factor.
- High dose corticosteroids. Participants on stable chronic steroid doses of prednisone ≤10 mg/day or corticosteroid equivalent for ≥4 weeks are allowed. Other treatments for autoimmune diseases may be allowed upon medical monitor review.
- Hydroxyurea.
- Immunomodulatory drugs (for example, thalidomide, pomalidomide, or lenalidomide).
- Interferon.
- Thrombopoietin receptor agonists.
- Initiation of new iron chelation therapy or dose adjustments to existing iron chelation therapy ≤8 weeks prior to randomization. Participants on stable doses of iron chelation therapy for ≥8 weeks are allowed.
- Clinically significant anemia that is due to causes other than MF or Janus kinase (JAK) inhibitor therapy (for example, thalassemia, iron deficiency, vitamin B12 and/or folate deficiencies, autoimmune or hemolytic anemia, infections, or any active clinically significant bleeding or sequestration).
- Receipt of RBC transfusion for any reason(s) other than underlying MF within 12 weeks before randomization.
- Life expectancy \<12 months per investigator's judgment.
- Clinically significant cardiovascular disease, defined as:
- +33 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Takedalead
Study Sites (207)
Los Angeles Cancer Network
Glendale, California, 91204, United States
Cancer and Blood Specialty Clinic
Whittier, California, 90603, United States
MedStar Georgetown University Hospital
Washington D.C., District of Columbia, 20007, United States
Advanced Research, LLC
Coral Springs, Florida, 33065, United States
Bioresearch Partners
Miami, Florida, 33143, United States
AdventHealth - Cancer Institute - Orlando
Orlando, Florida, 32804-4648, United States
Florida Clinical Trials Group
Tamarac, Florida, 33321, United States
Moffit Cancer Center
Tampa, Florida, 33612, United States
Emory University
Atlanta, Georgia, 30322, United States
Tufts Medical Center
Boston, Massachusetts, 02111, United States
University of Michigan
Ann Arbor, Michigan, 48109-5360, United States
Washington University School of Medicine
St Louis, Missouri, 63110, United States
St. Vincent Regional Hospital Cancer Centers
Billings, Montana, 59101, United States
University of New Mexico Comprehensive Cancer Center
Albuquerque, New Mexico, 87102, United States
Memorial Sloan Kettering Cancer Center
New York, New York, 10021, United States
Icahn School of Medicine at Mount Sinai
New York, New York, 10029, United States
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27514, United States
Novant Health
Winston-Salem, North Carolina, 27103, United States
Atrium Health Wake Forest Baptist
Winston-Salem, North Carolina, 27157-0001, United States
Cleveland Clinic
Cleveland, Ohio, 44195, United States
Oregon Health and Science University
Portland, Oregon, 97239, United States
Thomas Jefferson University
Philadelphia, Pennsylvania, 19107, United States
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15219, United States
Allegheny Health Network Cancer Institute - West Penn Hospital Location
Pittsburgh, Pennsylvania, 15224, United States
Medical University of South Carolina
Charleston, South Carolina, 29425, United States
Baptist Clinical Research Institute
Memphis, Tennessee, 38120, United States
Vanderbilt-Ingram Cancer Center (VICC)-Nashville
Nashville, Tennessee, 37232-0021, United States
Next Innovative Clinical Research
Baytown, Texas, 77521, United States
Baylor University Medical Center
Dallas, Texas, 75246, United States
MD Anderson Cancer Center
Houston, Texas, 77030, United States
The University of Utah-Huntsman Cancer Institute
Houston, Texas, 77030, United States
LUMI Research
Houston, Texas, 77090, United States
University of Washington
Seattle, Washington, 98109, United States
Hospital Universitario Austral
Pilar, Buenos Aires, B1629AHJ, Argentina
Swiss Medical Center Barrio Parque
Buenos Aires, Ciudad Autonoma de BuenosAires, 1405, Argentina
Instituto Medico de la Fundacion Estudios Clinicos
Rosario, Santa Fe Province, 2000, Argentina
Hospital Privado de Rosario
Rosario, Santa Fe Province, S2000GAP, Argentina
Hospital Aleman (HA) Deutsches Hospital
Buenos Aires, CPC1118AAT, Argentina
BRCR Global
Córdoba, 5000, Argentina
Flinders Medical Centre
Bedford Park, Adelaide, SA, 5042, Australia
The Canberra Hospital
Garran, Australian Capital Territory, 2605, Australia
Mid North Coast Cancer Institute (MNCCI)
Coffs Harbour, New South Wales, 2450, Australia
South Eastern Sydney Local Health District
Kogarah, New South Wales, 2217, Australia
St Vincents Hospital Melbourne
Fitzroy, Victoria, 3065, Australia
The Canberra Hospital
Heidelberg, 3084, Australia
Medizinische Universitat Innsbruck
Innsbruck, Tyrol, 6020, Austria
Klinikum Wels-Grieskirchen
Wels, Upper Austria, 4600, Austria
Ordensklinikum Linz Elisabethinen
Linz, 4020, Austria
Medizinische Universitat Wien (Medical University of Vienna - Austria)
Vienna, 1090, Austria
Centre Hospitalier Jolimont-Lobbes
La Louvière, Hainaut, 7100, Belgium
CHU Namur Site Mont Godinne
Yvoir, Namur, 5530, Belgium
UZ Leuven
Leuven, Vlaams-Brabant, 3000, Belgium
AZ Delta
Roeselare, West-Vlaanderen, 8800, Belgium
Ziekenhuis aan de Stroom-Cadix
Antwerp, 2030, Belgium
Centro de Ensino, Pesquisa e Inovacao do Hospital Sao Lucas (CEPIN HSL RJ / Rede Americas)
Rio de Janeiro, Rio de Janeiro, 22061080, Brazil
Porto Alegre Clinical Hospital (HCPA)
Porto Alegre, Rio Grande do Sul, 90035-903, Brazil
Hospital Mae De Deus - Integrated Oncology Center
Porto Alegre, Rio Grande do Sul, 90110-270, Brazil
Hospital Sao Lucas da PUCRS
Porto Alegre, Rio Grande do Sul, 90610-000, Brazil
Grupo Elora Pesquisa Clinica
Florianópolis, Santa Catarina, 88020-210, Brazil
Centro de Hematologia e Oncologia (CHO)
Joinville, Santa Catarina, 89201-260, Brazil
Hospital Amaral Carvalho (HAC)
Jaú, São Paulo, 17210-080, Brazil
Portuguese Charity of Sao Paulo
São Paulo, 01323-900, Brazil
UMHAT 'Dr. Georgi Stranski', EAD
Pleven, Pleven Province, 5800, Bulgaria
Dr. Pencho Georgiev - Outpatient Center
Plovdiv, 4002, Bulgaria
UMHAT Sv. Ivan Rilski
Sofia, 1431, Bulgaria
Specialized Hospital for Active Treatment of Haematological Diseases - Sofia
Sofia, 1797, Bulgaria
University Hospital Sveta Marina, Clinic of Clinical Hematology
Varna, 9010, Bulgaria
Arthur J.E. Child Comprehensive Cancer Centre
Calgary, Alberta, T2N 5G2, Canada
Juravinski Cancer Centre
Hamilton, Ontario, L8V 5C2, Canada
LHSC - Victoria Hospital
London, Ontario, N6A 5W9, Canada
Princess Margaret Cancer Centre
Toronto, Ontario, M5G 2M9, Canada
Hotel Dieu Hospital of Levis
Lévis, Quebec, G6V 3Z1, Canada
Jewish General Hospital
Montreal, Quebec, H3T1E2, Canada
McGill University Health Center
Montreal, Quebec, H4A 3J1, Canada
Hospital Cliniico Regional de Concepcion Dr
Concepción, Biobio, 4030000, Chile
IC La Serena Research
La Serena, Coquimbo Region, 01697, Chile
Icegclinic
Santiago, La Florida, 8241479, Chile
CECIM
Santiago, Region Metropolitana Santiago de Chile, 8320000, Chile
Immunocel
Las Condes, Santiago Metropolitan, 7560908, Chile
Centro de Oncologia de Precision
Santiago, Santiago Metropolitan, 7850000, Chile
Hospital Pablo Tobon Uribe
Medellín, Antioquia, 0000000, Colombia
Clinica General del Norte De Barranquilla
Barranquilla, Atlántico, 080002, Colombia
Los Cobos Medical Center
Bogotá, Bogota D.C., 110121, Colombia
Funcacion santa Fe De Bogota
Bogota, Cundinamarca, 11011, Colombia
Masaryk University Hospital Brno, Department of Internal Medicine, Hematology and Oncology
Brno, Czech Republic, 625 00, Czechia
Fakultni nemocnice Hradec Kralove
Hradec Králové, CZ, 50005, Czechia
Vseobecna fakultni nemocnice Praha
Prague, CZ, 12808, Czechia
Fakultni nemocnice Kralovske Vinohrady
Prague, Prague, 134 00, Czechia
CHU de Nice
Nice, Alpes Maritimes, 6002, France
Centre Hospitalier Lyon Sud
Pierre-Bénite, Auvergne-Rhône-Alpes, 69495, France
CHU de Strasbourg
Strasbourg, Bas Rhin, 67200, France
Institut Paoli Calmettes
Marseille, Bouches-du-Rhone, 13009, France
Centre Hospitalier Regional Universitaire Brest Hopital Morvan
Brest, Finistere, 29609, France
CHU de Bordeaux
Pessac, Gironde, 33600, France
Centre Hospitalier Regional Universitaire de Lille
Lille, Nord, 59037, France
Assistance Publique Hopitaux de Paris
Paris, Paris, 75015, France
CHU de Poitiers
Poitiers, Vienne, 86021, France
Universitaetsklinikum Freiburg
Freiburg im Breisgau, Baden-Wurttemberg, 79106, Germany
Kliniken Ostalb
Mutlangen, Baden-Wurttemberg, 73557, Germany
Muehlenkreiskliniken AoeR-Johannes Wesling Klinikum Minden - Universitaetsklinik fuer Neurologie und Neurogeriatrie
Minden, North Rhine-Westphalia, 32429, Germany
Institut fur Versorgungsforschung in der Onkologie GbR
Koblenz, Rhineland-Palatinate, 56068, Germany
Klinikum Chemnitz GmbH
Chemnitz, Saxony, 9116, Germany
University Hospital Halle (Saale)
Halle, Saxony-Anhalt, 06120, Germany
Universitaetsklinikum Jena
Jena, Thuringia, 7743, Germany
Praxis am Volkspark
Berlin, 10715, Germany
University General Hospital of Patras
Pátrai, Achaia, 26504, Greece
Olympion General Clinic & Rehabilitation Center
Pátrai, Ahaia, 264 43, Greece
Laiko General Hospital of Athens
Athens, Attica, 11526, Greece
General Hospital
Athens, Attica, 11527, Greece
Alexandra General Hospital of Athens
Athens, Attica, 11528, Greece
University of Crete
Heraklion, Crete, 70013, Greece
Ippokrateion Hospital of Thessaloniki
Thessaloniki, Macedonia, 54642, Greece
Debreceni Egyetem Klinikai Kozpont Belgyogyaszati Klinika
Debrecen, HB, 4032, Hungary
Komarom-Esztergom Varmegyei Szent Borbala Korhaz
Tatabánya, Komarom-Esztergom VArmegye, 2800, Hungary
Medanta- The Medicity- Gurugram
Gurgaon, Haryana, 122001, India
Amrita Institute of Medical Sciences
Kochi, Kerala, 682041, India
Sahyadri Super Speciality Hospital Deccan
Pune, Maharashtra, 411004, India
Rajiv Gandhi Cancer Institute and Research Centre
Rohini, NEW Delhi, 110085, India
Apollo Specialty Hospitals
Chennai, Tamil Nadu, 382424, India
Apollo Hospital Hyderabad
Hyderabad, Telangana, 500096, India
Tata Medical Center, Kolkata
Kolkata, West Bengal, 700 160, India
Max Super Specialty Hospital
Delhi, 201012, India
Cork University Hospital
Cork, T12 DC4A, Ireland
St James's Hospital
Dublin, D08 NHY1, Ireland
Mater Misericordiae University Hospital
Dublin, D15 W8Y7, Ireland
University Hospital Galway
Galway, H91YR71, Ireland
Rabin Medical Center
Petah Tikva, Central District, 4941492, Israel
Rambam Health Care Campus
Haifa, North, 3109601, Israel
The Tel Aviv Sourasky Medical Center
Tel Aviv, TLV, 64239, Israel
Carmel Medical Center
Haifa, 3436212, Israel
Hadassah Medical Organization, Hadassah Medical Center, Ein-
Jerusalem, 9112001, Israel
IRCCS - AOU di Bologna - Sant Orsola Malpighi
Bologna, BO, 40138, Italy
Universitaria di Ferrara Azienda Ospedaliero
Cona, Ferrara, 44124, Italy
Istituto Romagnolo per lo Studio dei Tumori Dino Amadori - IRST S.r.l
Meldola, Forli-Cesena, 47014, Italy
Universita degli Studi di Roma La Sapienza - Umberto I Policlinico di Roma
Rome, Lazio, 00161, Italy
Ospedale S Eugenio
Rome, Lazio, 144, Italy
Fondazione Irccs Ca' Granda Ospedale Maggioe Policlinico Di Milano
Milan, MI, 20122, Italy
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Rome, RM, 00168, Italy
Azienda Ospedaliero-Universitaria delle Marche; SOD Clinica Medica
Ancona, 60121, Italy
Policlinico Universitario di Catania
Catania, 95124, Italy
Azienda Ospedaliera Universitaria Careggi
Florence, 50134, Italy
AOU Citta della Salute e della Scienza di Torino
Torino, 10126, Italy
Azienda Sanitaria Universitaria Friuli Centrale
Udine, 33100, Italy
Chiba Cancer Center
Chiba, Chiba, 260-8717, Japan
Ehime University Hospital
Toon-shi, Ehime, 791-0295, Japan
Kobe City Medical Center General Hospital
Kobe, Hyōgo, 650-0047, Japan
Hitachi General Hospital
Hitachi, Ibaraki, 317-0077, Japan
Mie University Hospital
Tsu, Mie-ken, 514-8507, Japan
University of Miyazaki Hospital
Miyazaki, Miyazaki, 889-1692, Japan
Tokyo Metropolitan Komagome Hospital
Bunkyo-Ku, Tokyo, 113-8677, Japan
University of Yamanashi Hospital
Chuo-shi, Yamanashi, 409-3898, Japan
University Malaya Medical Centre
Kuala Lumpur, Kuala Lumpur, 59100, Malaysia
Hospital Pulau Pinang
George Town, Pulau Pinang, 10990, Malaysia
Hospital Queen Elizabeth
Kota Kinabalu, Sabah, 88586, Malaysia
Hospital Ampang
Ampang, Selangor, 68000, Malaysia
Hematologica Alta Especialidad S.C.
Huixquilucan, Mexico de Mexico, 52787, Mexico
Universidad Autonoma de Nuevo Leon
Monterrey, Mexic, 64710, Mexico
OSMO - Oaxaca Site Management Organization S.C
Oaxaca City, Oaxaca, 68000, Mexico
Pratia Poznan
Poznan, Greater Poland Voivodeship, 60-192, Poland
Wojewodzki Szpital Zespolony Im L Rydygiera
Torun, Kuyavian-Pomeranian Voivodeship, 87-100, Poland
Pratia MCM Krakow
Krakow, Lesser Poland Voivodeship, 30-727, Poland
MTZ Clinical Research Powered by PRATIA
Warsaw, Masovian Voivodeship, 02-172, Poland
Zespol Szpitali Miejskich w Chorzowie
Chorzów, Silesian Voivodeship, 41-500, Poland
Pratia Oncology Katowice
Katowice, Silesian Voivodeship, 40-519, Poland
Wojewodzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii im. M. Kopernika w Lodzi, Oddzial Hematologii
Lodz, Łódź Voivodeship, 93-513, Poland
Colentina Clinical Hospital
Bucharest, Bucharest, 20125, Romania
Institutul Oncologic Prof. Dr. Ion Chiricuta
Cluj-Napoca, CJ, 400124, Romania
Spitalul Municipal Filantropia Craiova
Craiova, Dolj, 200143, Romania
Spitalul Clinic Municipal de Urgenta Timisoara
Timișoara, 300700, Romania
King Abdulaziz University Hospital
Jeddah, Al Sharafiyyah District Jeddah, 21589, Saudi Arabia
King Faisal Specialist Hospital & Research Centre Riyadh
Riyadh, 11211, Saudi Arabia
King Khalid University Hospital
Riyadh, 12372, Saudi Arabia
Samsung Medical Center
Seoul, Gangnam-gu, South Korea
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, 13620, South Korea
Korea University Anam Hospital
Seoul, Seongbuk-gu, South Korea
Soon Chun Hyang University Hospital Seoul
Seoul, Seoul Teugbyeolsi, 04401, South Korea
Daegu Catholic University Medical Center
Daegu, 42472, South Korea
The Catholic University of Korea
Seoul, 137-701, South Korea
Seoul National University Hospital
Seoul, 3080, South Korea
Hospital Clinico Universitario de Santiago
Santiago de Compostela, A Coruna, 15706, Spain
Hospital Universitario Virgen de la Victoria
Málaga, Andalusia, 29003, Spain
Institut Catala d'Oncologia
Badalona, Barcelona, 8916, Spain
Institut Catala d'Oncologia Hospital Duran y Renals
L'Hospitalet de Llobregat, Barcelona, 08908, Spain
Hospital Universitario de Gran Canaria Doctor Negrin
Las Palmas de Gran Canaria, LAS Palmas, 35010, Spain
Hospital Universitari Vall d'Hebron
Barcelona, 08035, Spain
Hospital Ramon Y Cajal
Madrid, 28034, Spain
Universidad de Salamanca - Hospital Universitario de Salamanca
Salamanca, 37007, Spain
Hospital Universitari i Politecnic La Fe
Valencia, 46026, Spain
Skanes universitetssjukhus Lund-Dep. of hematology, oncology and radiation physics
Lund, 22185, Sweden
Orebro University Hospital
Örebro, 70185, Sweden
Karolinska University Hospital
Stockholm, 14186, Sweden
Taipei Veterans General Hospital
Taipei, Beitou, 11217, Taiwan
National Cheng Kung University Hospital
Tainan, Tainan City, 70403, Taiwan
National Taiwan University Hospital
Taipei, Taiwan (r.o.c.), 100, Taiwan
Kaohsiung Medical University Hospital
Kaohsiung City, Taiwan
Taichung Veterans General Hospital
Taichung, 40705, Taiwan
Ankara Bilkent City Hospital
Çankaya, Ankara, 06800, Turkey (Türkiye)
VM Medical Park Mersin Hospital
Mersin, Mezitli, 33000, Turkey (Türkiye)
Istanbul University-CerrahpaAYa, CerrahpaAYa Faculty of Medicine
Istanbul, 34303, Turkey (Türkiye)
Istanbul Florence Nightingale Hospital
Istanbul, 34381, Turkey (Türkiye)
United Lincolnshire Teaching Hospitals NHS Trust
Lincoln, East Midlands, LN2 5QY, United Kingdom
University Hospital of Leicester NHS
Leicester, Leicestershire, LE1 5WW, United Kingdom
Imperial College Healthcare NHS Trust
London, London, City of, W12 0HS, United Kingdom
Sunderland and South Tyneside NHS Foundation Trust
Sunderland, Tyne and Wear, SR4 7TP, United Kingdom
Birmingham Heartlands Hospital
Birmingham, W Mids, United Kingdom
UCL Cancer Institute - University College London Hospitals NHS Foundation Trust
London, NW1 2PG, United Kingdom
Guy's and St Thomas' NHS Foundation Trust - Guy's Hospital
London, SE1 9RT, United Kingdom
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Study Director
Takeda
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 29, 2026
First Posted
June 3, 2026
Study Start (Estimated)
August 25, 2026
Primary Completion (Estimated)
December 7, 2029
Study Completion (Estimated)
March 30, 2034
Last Updated
July 23, 2026
Record last verified: 2026-07
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF, CSR
- Access Criteria
- IPD from eligible studies will be shared with qualified researchers according to the criteria and process described on https://vivli.org/ourmember/takeda/. For approved requests, the researchers will be provided access to anonymized data (to respect patient privacy in line with applicable laws and regulations) and with information necessary to address the research objectives under the terms of a data sharing agreement.
Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.