A Study of Bleximenib, Venetoclax and Azacitidine For Treatment of Participants With Newly Diagnosed Acute Myeloid Leukemia (AML)
cAMeLot-2
A Phase 3 Randomized, Double-Blind, Placebo-Controlled, Study of Bleximenib, Venetoclax and Azacitidine for the Treatment of Participants With Newly Diagnosed Acute Myeloid Leukemia Harboring KMT2A Rearrangements or NPM1 Mutations Who Are Ineligible for Intensive Chemotherapy
2 other identifiers
interventional
600
23 countries
233
Brief Summary
The purpose of this study is to assess how bleximenib and Venetoclax (VEN)+ Azacitidine (AZA) works as compared to placebo and VEN+AZA alone for the treatment of participants with newly diagnosed Acute Myeloid Leukemia (AML) with a mutation in the NPM1 or KMT2A gene.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Jun 2025
Typical duration for phase_3
233 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
February 25, 2025
CompletedFirst Posted
Study publicly available on registry
February 28, 2025
CompletedStudy Start
First participant enrolled
June 4, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 22, 2029
ExpectedStudy Completion
Last participant's last visit for all outcomes
August 15, 2029
April 13, 2026
April 1, 2026
4.1 years
February 25, 2025
April 9, 2026
Conditions
Outcome Measures
Primary Outcomes (2)
Percentage of Participants who Achieve Complete Remission (CR)
CR is defined as Bone marrow blasts less than (\<) 5 percent (%); Absence of circulating blasts; Absence of extramedullary disease; Absolute neutrophil count (ANC) greater than or equal to (\>=) 1.0 \* 10\^9/Liter (1,000/microliter \[mcL\]); Platelet count \>= 100 \* 10\^9/L (100,000/mcL).
Up to 4 years and 1 month
Overall Survival (OS)
Overall survival time is defined as the time duration from the date of randomization to death due to any cause.
Up to 4 years and 1 month
Secondary Outcomes (9)
Event-free survival (EFS)
Up to 4 years and 1 month
Duration of CR
Up to 4 years and 1 month
Time to CR
Up to 4 years and 1 month
Rate of CR Without Measurable Residual Disease (MRD-)
Up to 4 years and 1 month
Percentage of Participants who Achieved Transfusion Independence
Up to 4 years and 1 month
- +4 more secondary outcomes
Study Arms (2)
Arm A: Bleximenib and Venetoclax (VEN) + Azacitidine (AZA)
EXPERIMENTALParticipants with acute myeloid leukemia (AML) will receive bleximenib in combination with venetoclax (VEN) and azacitidine (AZA) for 28-days treatment cycles and treatment will continue until progression or unacceptable toxicity.
Arm B: Placebo and Venetoclax (VEN) + Azacitidine (AZA)
PLACEBO COMPARATORParticipants with AML will receive placebo in combination with VEN and AZA for 28-days treatment cycles, and treatment will continue until progression or unacceptable toxicity.
Interventions
Bleximenib will be administered orally.
VEN will be administered orally.
AZA will be administered intravenously or subcutaneously.
Placebo will be administered orally.
Eligibility Criteria
You may qualify if:
- Be 18 years of age or older at the time of informed consent
- Previously untreated lysine N-methyltransferase 2A gene rearranged (KMT2Ar) or nucleophosmin 1 gene mutated (NPM1m) acute myeloid leukemia (AML) with greater than or equal to (\> or =) 10% bone marrow blasts per 2022 international Consensus Classification criteria
- Ineligible for intensive chemotherapy based on the following criteria: a) \>= 75 years of age and ineligible per physician's discretion, with Eastern Cooperative Oncology Group (ECOG) performance status of 0-2, b) \>=18 to \<75 years of age with \>= 1 of the following comorbidities: i) ECOG performance status of 2, ii) Severe cardiac disorder, iii) Severe pulmonary disorder, iv) Renal impairment, v) Moderate hepatic impairment vi) Comorbidity that, in the investigator's opinion, makes the participant unsuitable for intensive chemotherapy, which must be documented before enrollment as defined in the protocol. Ineligibility for intensive chemotherapy should be explicitly approved by a multidisciplinary team in countries in which this process is standard of care
- Participants must have adequate hepatic and renal function
- A female participant must agree not to be pregnant, breast-feed, plan to become pregnant and use protocol-specified contraception while enrolled in this study and for 6 months after the last dose of study treatment
- A male participant must agree to use protocol-specified contraception while enrolled in this study for at least 90 days after the last dose of study treatment
- Must sign an informed consent form indicating that the participant understands the purpose of, and procedures required for, the study and is willing to participate in the study
You may not qualify if:
- Diagnosis of acute promyelocytic leukemia (APL)
- Known active leukemic involvement of the central nervous system (CNS)
- Recipient of solid organ transplant
- Any cardiac disorders such as heart attack, uncontrolled/unstable chest pain, congestive heart failure, uncontrolled or symptomatic irregular heartbeat, blockage of a blood vessel to brain, or transient ischemic (decreased oxygen in tissue) attack within 6 months of randomization
- Active infectious hepatitis
- Live, attenuated vaccine within 4 weeks of randomization
- Known allergies, hypersensitivity, or intolerance of bleximenib, azacitidine, or venetoclax excipients
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (239)
Cancer Treatment Center of America Phoenix
Goodyear, Arizona, 85338, United States
The University of Arizona Cancer Center
Tucson, Arizona, 85724, United States
University of Arkansas at Little Rock
Little Rock, Arkansas, 72204, United States
City of Hope
Duarte, California, 91010, United States
Jupiter Research
Jupiter, Florida, 33458, United States
Orlando Health Cancer Institute
Orlando, Florida, 32806, United States
Moffit Cancer center
Tampa, Florida, 33612, United States
Cleveland Clinic Florida
Weston, Florida, 33331, United States
University of Chicago Medicine
Chicago, Illinois, 60637, United States
University of Kentucky Markey Cancer Center
Lexington, Kentucky, 40536, United States
UofL Health Brown Cancer Center
Louisville, Kentucky, 40202, United States
Norton Cancer Institute
Louisville, Kentucky, 40207, United States
Mary Bird Perkins Cancer Center
Baton Rouge, Louisiana, 70809, United States
Dana Farber Cancer Institute
Boston, Massachusetts, 02115, United States
Henry Ford Health System
Detroit, Michigan, 48202, United States
Washington University in St Louis
St Louis, Missouri, 63130, United States
Dartmouth Hitchcock Medical Center
Lebanon, New Hampshire, 03756, United States
John Theurer Cancer Center at Hackensack University Medical Center
Hackensack, New Jersey, 07601, United States
Roswell Park Comprehensive Cancer Center
Buffalo, New York, 14263, United States
New York Presbyterian - Weill Cornell
New York, New York, 10065, United States
University of Rochester Medical Center
Rochester, New York, 14642, United States
Einstein-Montefiore Medical Center
The Bronx, New York, 10467, United States
Atrium Health
Charlotte, North Carolina, 28204, United States
Novant Health Charlotte
Charlotte, North Carolina, 28204, United States
Novant Health Winston Salem
Winston-Salem, North Carolina, 27106, United States
Atrium Health Wake Forest Baptist Comprehensive Cancer Center
Winston-Salem, North Carolina, 27157, United States
Gabrail Cancer Center
Canton, Ohio, 44718, United States
University Hospitals Cleveland Medical Center
Cleveland, Ohio, 44106, United States
Cleveland Clinic
Cleveland, Ohio, 44195, United States
Providence Portland Medical Center
Portland, Oregon, 97213, United States
Providence Oncology and Hematology Care Clinic Westside
Portland, Oregon, 97225, United States
Thomas Jefferson University
Philadelphia, Pennsylvania, 19107, United States
Fox Chase Cancer Center
Philadelphia, Pennsylvania, 19111, United States
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15260, United States
University of Tennessee
Knoxville, Tennessee, 37920, United States
Vanderbilt Ingram Cancer Center
Nashville, Tennessee, 37232, United States
Baylor University Medical Center
Dallas, Texas, 75246, United States
MD Anderson Cancer Center
Houston, Texas, 77030, United States
Virginia Commonwealth University - Massey Cancer Center
Richmond, Virginia, 23298, United States
Swedish Cancer Institute
Seattle, Washington, 98104, United States
Fred Hutchinson Cancer Center
Seattle, Washington, 98109, United States
Flinders Medical Centre
Bedford Park, 5042, Australia
Royal Prince Alfred Hospital
Camperdown, 2050, Australia
St Vincents Hospital Melbourne
Fitzroy, 3065, Australia
St George Hospital
Kogarah, 2217, Australia
Peter MacCallum Cancer Centre
Melbourne, 3000, Australia
Princess Alexandra Hospital
Woolloongabba, 4102, Australia
Kepler Universitatsklinikum GmbH
Linz, 4020, Austria
Ordensklinikum Linz GmbH Elisabethinen
Linz, 4020, Austria
Universitaetsklinikum Salzburg Landeskrankenhaus
Salzburg, 5020, Austria
Medical University of Vienna Universitatsklinik fur Innere Medizin I
Vienna, 1090, Austria
Wiener Gesundheitsverbund Klinik Hietzing
Vienna, 1130, Austria
Klinikum Wels Grieskirchen
Wels, 4600, Austria
AZ Sint-Jan
Bruges, 8000, Belgium
UZ Antwerpen
Edegem, 2650, Belgium
Ziekenhuis Oost-Limburg
Genk, 3600, Belgium
Ghent University Hospital
Ghent, 9000, Belgium
Chu Helora Hospital La Louviere Site Jolimont
La Louvière, 7100, Belgium
Universitair Ziekenhuis Leuven
Leuven, 3000, Belgium
Clinique Saint Pierre
Ottignies, 1340, Belgium
Algemeen Ziekenhuis Delta
Roeselare, 8800, Belgium
Fundacao Pio XII
Barretos, 14780 070, Brazil
DF Star Rede D or
Brasília, 70390 140, Brazil
Liga Paranaense de Combate ao Cancer
Curitiba, 81520 060, Brazil
Liga Norte Riograndense Contra O Cancer
Natal, 59062 000, Brazil
Ministerio da Saude Instituto Nacional do Cancer
Rio de Janeiro, 20230 130, Brazil
Instituto de Educacao, Pesquisa e Gestao em Saude Instituto Americas (COI)
Rio de Janeiro, 22775 001, Brazil
Real e Benemerita Associacao Portuguesa de Beneficencia
São Paulo, 01323 010, Brazil
Instituto D Or de Pesquisa e Ensino
São Paulo, 01401 002, Brazil
Sociedade Beneficente Israelita Brasileira Hospital Albert Einstein
São Paulo, 05652 900, Brazil
Arthur J E Child Comprehensive Cancer Centre
Calgary, Alberta, T2N 5G2, Canada
Vancouver General Hospital
Vancouver, British Columbia, V5Z 1N1, Canada
Cancercare Manitoba
Winnipeg, Manitoba, R3E 0V9, Canada
Queen Elizabeth II Health Sciences Centre
Halifax, Nova Scotia, B3H 2Y9, Canada
Juravinski Cancer Centre
Hamilton, Ontario, L8V 5C2, Canada
London Health Sciences Centre Victoria Hospital
London, Ontario, N6A 5W9, Canada
Princess Margaret Cancer Centre University Health Network
Toronto, Ontario, M5G 2M9, Canada
CIUSSS de l Est de l Ile de Montreal Installation Hopital Maisonneuve Rosemont
Montreal, Quebec, H1T 2M4, Canada
Peking University First Hospital
Beijing, 100020, China
Peking University People's Hospital
Beijing, 100044, China
Peking University Third Hospital
Beijing, 100191, China
The first Affiliated Hospital of Jilin University
Changchun, 130021, China
Sichuan Provincial Peoples Hospital
Chengdu, 610032, China
West China Hospital Si Chuan University
Chengdu, 610041, China
The First Affiliated Hospital of Chongqing Medical University
Chongqing, 401147, China
Sun Yat Sen University Cancer Center
Guangzhou, 510060, China
The First Affiliated Hospital Zhejiang University College of Medicine
Hangzhou, 310003, China
The First Affiliated Hospital of USTC Anhui Provincial Hospital
Hefei, 230001, China
Qilu Hospital of Shandong University
Jinan, 250012, China
The Second Hospital & Clinical Medical School Lanzhou University
Lanzhou, 730030, China
The First Affiliated Hospital of NanChang University
Nanchang, 330006, China
Zhongda Hospital Southeast University
Nanjing, 210009, China
The First Affiliated Hospital of Guangxi Medical University
Nanning, 530021, China
Shengjing Hospital Of China Medical University
Shenyang, 110055, China
The Second People's Hospital of Shenzhen
Shenzhen, 518035, China
First Affiliated Hospital SooChow University
Suzhou, 215005, China
Institute of Hematology and Blood Diseases Hospital Chinese Academy of Medical Sciences
Tijian, 3000200, China
The First Affiliated Hospital of Wenzhou Medical University
Wenzhou, 325000, China
Union Hospital Tongji Medical College of Huazhong University of Science and Technology
Wuhan, 430022, China
TongJi Hospital of TongJi Medical College of Huazhong University of Science & Technology
Wuhan, 430030, China
The Second Affiliated Hospital of Xi'an Jiaotong University
Xi'an, 710004, China
The first affiliated hospital of xiamen university
Xiamen, 361003, China
Henan Cancer Hospital
Zhengzhou, 450008, China
Fakultni nemocnice Brno, Interni hematologicka a onkologicka klinika
Brno, 625 00, Czechia
Fakultni nemocnice Hradec Kralove
Hradec Králové, 500 05, Czechia
Fakultni Nemocnice Ostrava
Ostrava - Poruba, 708 52, Czechia
Fakultni nemocnice Plzen
Pilsen, 304 60, Czechia
Fakultni nemocnice Kralovske Vinohrady
Prague, 100 00, Czechia
Ustav Hematologie A Krevni Transfuze
Prague, 128 00, Czechia
Vseobecna Fakultní Nemocnice
Prague, 128 08, Czechia
Aalborg University Hospital
Aalborg, 9000, Denmark
Odense University Hospital
Odense, 5000, Denmark
Zealand University Hospital
Roskilde, 4000, Denmark
CHU d'Angers
Angers, 49933, France
CHU de Clermont Ferrand - Site Estaing
Clermont-Ferrand, 63100, France
Hopital Saint Vincent de Paul
Lille, 59020, France
Institut Paoli Calmettes
Marseille, 13273, France
CHU de Montpellier Hopital Saint Eloi
Montpellier, 34295, France
CHU De Nice Hopital De l'Archet
Nice, 06202, France
Hopital Saint Louis
Paris, 75010, France
CHU Lyon Sud
Pierre-Bénite, 69310, France
CHU Reims Hopital Robert Debre
Reims, 51100, France
Chu Rennes Hopital Pontchaillou
Rennes, 35000, France
Institut Universitaire du Cancer Toulouse Oncopole
Toulouse, 31100, France
CHRU de Nancy - Hopitaux de Brabois
Vandœuvre Ies-Nancy, 54500, France
Institut Gustave Roussy
Villejuif, 94805, France
Klinikum Augsburg
Augsburg, 86156, Germany
Universitaetsklinikum Koeln
Cologne, 50937, Germany
Universitaetsklinikum Carl Gustav Carus TU Dresden
Dresden, 01307, Germany
Universitaetsklinikum Frankfurt
Frankfurt, 60590, Germany
Universitaetsklinikum Freiburg
Freiburg im Breisgau, 79106, Germany
Universitaetsklinikum Hamburg Eppendorf
Hamburg, 20246, Germany
Universitaetsklinikum Heidelberg
Heidelberg, 69120, Germany
Universitaetsklinikum Schleswig Holstein Campus Kiel
Kiel, 24105, Germany
Universitaetsklinikum Leipzig
Leipzig, 04103, Germany
Universitaetsklinikum Wuerzburg
Würzburg, 97080, Germany
University Hospital of Alexandroupolis
Alexandroupoli, 68100, Greece
Evaggelismos Hospital
Athens, 106 76, Greece
University General Hospital Attikon General Hospital Of West Attica H Agia Varvara
Chaïdári, 124 62, Greece
University General Hospital of Ioannina
Ioannina, 455 00Q, Greece
General University Hospital of Patras
Rio, 265 04, Greece
Ahepa University General Hospital of Thessaloniki
Thessaloniki, 54636, Greece
Geniko Nosokomeio Thessalonikis George Papanikolaou
Thessaloniki, 570 10, Greece
Queen Mary Hospital
Hong Kong, Hong Kong
Shamir Medical Center Assaf Harofeh
Beer Yaakov, 7033001, Israel
Rambam Medical Center
Haifa, 3109601, Israel
Carmel Medical Center
Haifa, 3436212, Israel
Shaare Zedek Medical Center
Jerusalem, 9103102, Israel
Hadassah University Hospita Ein Kerem
Jerusalem, 9112001, Israel
Rabin Medical Center
Petah Tikva, 4941492, Israel
Chaim Sheba Medical Center
Ramat Gan, 5262000, Israel
Tel Aviv Sourasky Medical Center
Tel Aviv, 6423906, Israel
ASST Papa Giovanni XXIII Bergamo
Bergamo, 24127, Italy
A O U Sant Orsola Malpighi
Bologna, 40138, Italy
Azienda Ospedaliera Spedali Civili di Brescia
Brescia, 25123, Italy
Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori
Meldola, 47014, Italy
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico
Milan, 20122, Italy
ASST Grande Ospedale Metropolitano Niguarda
Milan, 20162, Italy
Fondazione IRCCS Policlinico San Matteo
Pavia, 27100, Italy
Azienda Ospedaliera di Perugia Ospedale S.Maria della Misericordia
Perugia, 06132, Italy
AST Pesaro e Urbino Ospedale San Salvatore
Pesaro, 61121, Italy
Ospedale S. Maria Delle Croci
Ravenna, 48121, Italy
Grande Ospedale Metropolitano 'Bianchi-Melacrino-Morelli' Reggio Calabria
Reggio Calabria, 89124, Italy
IRCCS Istituto Clinico Humanitas
Rozzano, 20089, Italy
Casa Sollievo Della Sofferenza IRCCS
San Giovanni Rotondo, 71013, Italy
Azienda Ospedaliera Universitaria Citta della Salute e della Scienza di Torino
Torino, 10126, Italy
Tokyo Metropolitan Cancer and Infectious Diseases Center Komagome Hospital
Bunkyō City, 113 8677, Japan
Kyushu University Hospital
Fukuoka, 812 8582, Japan
Fukushima Medical University Hospital
Fukushima, 960 1295, Japan
Gifu Municipal Hospital
Gifu, 500-8513, Japan
Kanazawa University Hospital
Kanazawa, 920-8641, Japan
Kobe City Medical Center General Hospital
Kobe, 650 0047, Japan
National Hospital Organization Kumamoto Medical Center
Kumamoto, 860-0008, Japan
Gunmaken Saiseikai Maebashi Hospital
Maebashi, 371-0821, Japan
Nagoya University Hospital
Nagoya, 466 8560, Japan
Okayama University Hospital
Okayama, 700 8558, Japan
Japanese Red Cross Osaka Hospital
Osaka, 543 8555, Japan
Aiiku Hospital
Sapporo, 064 0804, Japan
Tohoku University Hospital
Sendai, 980 8574, Japan
Nippon Medical School Hospital
Tokyo, 113 8603, Japan
Yamagata University Hospital
Yamagata, 990 2331, Japan
University of Fukui Hospital
Yoshida, 910-1193, Japan
Centro de Investigacion Clinica Chapultepec
Mexico City, 04100, Mexico
Instituto Nacional de Cancerologia
Mexico City, 14080, Mexico
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
Mexico City, 14080, Mexico
Uniwersytecki Szpital Kliniczny w Bialymstoku
Bialystok, 15 276, Poland
Uniwersyteckie Centrum Kliniczne
Gdansk, 80 211, Poland
Swietokrzyskie Centrum Onkologii SPZOZ w Kielcach
Kielce, 25 734, Poland
Wojewodzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii im M Kopernika w Lodzi
Lodz, 93 513, Poland
Uniwersytecki Szpital Kliniczny im Jana Mikulicza Radeckiego we Wroclawiu
Wroclaw, 50 367, Poland
Uls Sao Jose - Hosp. Sto Antonio Dos Capuchos
Lisbon, 1169 050, Portugal
Uls Santa Maria Hosp. Santa Maria
Lisbon, 1649 028, Portugal
Uls Santo Antonio - Hosp. Santo Antonio
Porto, 4099 001, Portugal
Instituto Portugues de Oncologia Porto
Porto, 4200 072, Portugal
Uls Sao Joao - Hosp. Sao Joao
Porto, 4200 319, Portugal
Chungnam National University Hospital
Daejeon, 35015, South Korea
National Cancer Center
Goyang-si, 10408, South Korea
Seoul National University Bundang Hospital
Gyeonggi-do, 13620, South Korea
Seoul National University Hospital
Seoul, 03080, South Korea
Asan Medical Center
Seoul, 05505, South Korea
Samsung Medical Center
Seoul, 06351, South Korea
The Catholic University of Korea Seoul St Marys Hospital
Seoul, 137 701, South Korea
Hosp Univ A Coruna
A Coruña, 15006, Spain
Hosp Univ Vall D Hebron
Barcelona, 08035, Spain
Hosp. Clinic de Barcelona
Barcelona, 08036, Spain
Hosp. de La Santa Creu I Sant Pau
Barcelona, 08041, Spain
Hosp. San Pedro de Alcantara
Cáceres, 10003, Spain
Hosp. de Jerez de La Frontera
Jerez de la Frontera, 11407, Spain
Inst. Cat. Doncologia-H Duran I Reynals
L'Hospitalet de Llobregat, 08908, Spain
Clinica Univ. de Navarra Madrid
Madrid, 28027, Spain
Hosp. Univ. Ramon Y Cajal
Madrid, 28034, Spain
Hosp. Univ. 12 de Octubre
Madrid, 28041, Spain
Clinica Univ. de Navarra
Pamplona, 31008, Spain
Hosp. Quiron Madrid Pozuelo
Pozuelo de Alarcón, 28223, Spain
Hosp Clinico Univ de Salamanca
Salamanca, 37007, Spain
Hosp. Univ. Marques de Valdecilla
Santander, 39008, Spain
Hosp. Virgen Del Rocio
Seville, 41013, Spain
Hosp. Univ. I Politecni La Fe
Valencia, 46026, Spain
Kaohsiung Chang Gung Memorial Hospital
Kaohsiung City, 833, Taiwan
Chi Mei Medical Center Liouying Branch
Tainan, 736, Taiwan
National Taiwan University Hospital
Taipei, 100, Taiwan
Linkou Chang Gung Memorial Hospital
Taoyuan District, 333, Taiwan
Ankara Etlik Sehir Hastanesi
Ankara, 06170, Turkey (Türkiye)
Dr Abdurrahman Yurtaslan Oncology Training and Research Hospital
Ankara, 06200, Turkey (Türkiye)
Ankara University School of Medicine Cebeci Hospital
Ankara, 06590, Turkey (Türkiye)
Memorial Antalya Hospital
Antalya, 07025, Turkey (Türkiye)
Koc University Medical Faculty
Istanbul, 34010, Turkey (Türkiye)
VM Medical Park Mersin Hospital
Mersin, 33200, Turkey (Türkiye)
Sakarya University Training and Research Hospital
Sakarya, 54100, Turkey (Türkiye)
Ondokuz Mayis University
Samsun, 55139, Turkey (Türkiye)
Royal Sussex County Hospital
Brighton, BN2 5BE, United Kingdom
Addenbrookes Hospital
Cambridge, CB2 0QQ, United Kingdom
Kent and Canterbury Hospital
Canterbury, CT1 3NG, United Kingdom
Colchester Hospital University NHS
Colchester, CO4 5JL, United Kingdom
Western General Hospital
Edinburgh, EH4 2XU, United Kingdom
The Clatterbridge Cancer Centre
Liverpool, L7 8YA, United Kingdom
Guys' and St Thomas' NHS Trust
London, SE1 9RT, United Kingdom
Derriford Hospital
Plymouth, PL6 8DH, United Kingdom
Worthing Hospital
Worthing, BN11 2DH, United Kingdom
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Janssen Research & Development, LLC Clinical Trial
Janssen Research & Development, LLC
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 25, 2025
First Posted
February 28, 2025
Study Start
June 4, 2025
Primary Completion (Estimated)
June 22, 2029
Study Completion (Estimated)
August 15, 2029
Last Updated
April 13, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will share
The data sharing policy of Johnson \& Johnson Innovative Medicine is available at innovativemedicine.jnj.com/our-innovation/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu