A Study of Bomedemstat (IMG-7289/MK-3543) Compared to Best Available Therapy (BAT) in Participants With Essential Thrombocythemia and an Inadequate Response or Intolerance of Hydroxyurea (MK-3543-006)
A Phase 3, Randomized, Open-label, Active-Comparator-Controlled Clinical Study to Evaluate the Safety and Efficacy of Bomedemstat (MK-3543/IMG-7289) Versus Best Available Therapy (BAT) in Participants With Essential Thrombocythemia Who Have an Inadequate Response to or Are Intolerant of Hydroxyurea
6 other identifiers
interventional
340
24 countries
163
Brief Summary
This is a study evaluating the safety and efficacy of bomedemstat (MK-3543) compared with the best available therapy (BAT) in participants with essential thrombocythemia (ET) who have an inadequate response to or are intolerant of hydroxyurea. The primary study hypothesis is that bomedemstat is superior to the best available therapy with respect to durable clinicohematologic response (DCHR).
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 Dec 2023
Longer than P75 for phase_3
163 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 6, 2023
CompletedFirst Posted
Study publicly available on registry
October 12, 2023
CompletedStudy Start
First participant enrolled
December 31, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 30, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
August 18, 2028
June 12, 2026
June 1, 2026
3.6 years
October 6, 2023
June 11, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Durable Clinicohematologic Response (DCHR) Rate
DCHR rate is the percentage of participants with DCHR, defined as a confirmed reduction of platelet count to ≤400 × 10\^9/L, absence of white blood cell (WBC) count elevation to \>10 × 10\^9/L locally assessed to be due to ET, and the absence of any thrombotic or major hemorrhagic events or disease progression to myelofibrosis (MF), myelodysplastic syndrome (MDS) or acute myeloid leukemia (AML) by Week 52.
Up to approximately 52 weeks
Secondary Outcomes (10)
Change From Baseline in Myelofibrosis Symptom Assessment Form (MFSAF) v4.0 Individual Fatigue Symptom Item Score
Baseline and pre-specified timepoints through Week 156
Change From Baseline in Patient-reported Outcomes Measurement Information System (PROMIS) Fatigue SF-7a Total Fatigue Score
Baseline and pre-specified timepoints through Week 156
Change From Baseline in Total Symptom Score as Measured on the MFSAF v4.0
Baseline and pre-specified timepoints through Week 156
Duration of Clinicohematologic Response (DOCHR)
Up to approximately 52 weeks
Duration of Hematologic Remission (DOHR)
Up to approximately 52 weeks
- +5 more secondary outcomes
Study Arms (2)
Bomedemstat
EXPERIMENTALParticipants will begin treatment at a dose of 50 mg of bomedemstat daily. Dosage will be adjusted either up or down within specified time parameters for each participant to the dose that provides sufficient exposure to safely inhibit thrombopoiesis to decrease platelet counts to the target range. All participants will be treated daily for up to 52 weeks, and are eligible for an extended treatment phase up to 156 weeks.
Best Available Therapy
ACTIVE COMPARATOREach participant will receive either anagrelide, busulfan, interferon alfa/pegylated interferon alfa 2a/pegylated interferon alfa 2b, or ruxolitinib as determined by investigator. All participants will be treated per respective approved product labels for up to 52 weeks. Participants receiving BAT for 52 weeks who stop responding to BAT are eligible to switch to bomedemstat and receive this for up to 156 weeks at the investigators discretion.
Interventions
Subcutaneous Solution
Eligibility Criteria
You may qualify if:
- Has a diagnosis of ET per WHO 2016 diagnostic criteria for myeloproliferative neoplasms (confirmed by a central pathologist)
- Has a centrally assessed bone marrow fibrosis score of Grade 0 or Grade 1, as per a modified version of the European Consensus Criteria for Grading Myelofibrosis
- Has a history of inadequate response to or intolerance of hydroxyurea based on modified European LeukemiaNet (ELN) criteria for hydroxyurea resistance or intolerance
- Has an inadequate or loss of response to their most recent prior ET therapy, requiring a change of cytoreductive therapy
- Has a platelet count \> 450 × 10\^9/L (450k /μL) assessed up to 72 hours before first dose of study intervention
- Has an absolute neutrophil count (ANC) ≥0.75 × 10\^9/L assessed up to 72 hours before first dose of study intervention
- Participants may have received up to 3 prior ET-directed cytoreductive agents including hydroxyurea
You may not qualify if:
- Known immediate or delayed hypersensitivity reaction or idiosyncrasy to drugs chemically related to bomedemstat or lysine demethylase or monoamine oxidase inhibitor (LSDi or MAOi) or the chosen best available therapy (including anagrelide, interferon alfa/pegylated interferon, ruxolitinib, or busulfan) that contraindicates participation
- History of any illness/impairment of GI function that might interfere with drug absorption (eg, chronic diarrhea or history of gastric bypass surgical procedure), confound the study results or pose an additional risk to the individual by participation in the study
- Evidence at the time of Screening of increased risk of bleeding
- History of a malignancy, unless potentially curative treatment has been completed with no evidence of malignancy for 2 years. Note: The time requirement does not apply to participants who underwent successful definitive resection of basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or carcinoma in situ, excluding carcinoma in situ of the bladder
- Human immunodeficiency virus (HIV)-infected participants with a history of Kaposi's sarcoma and/or Multicentric Castleman's Disease
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (163)
Palo Verde Hematology/ Oncology Center, Ltd. ( Site 3496)
Glendale, Arizona, 85304, United States
Los Angeles Cancer Network ( Site 3491)
Glendale, California, 91206, United States
Stanford Cancer Institute ( Site 0107)
Stanford, California, 94305-5826, United States
The Lundquist Institute ( Site 3423)
Torrance, California, 90502, United States
University of Colorado Anschutz Medical Campus ( Site 3425)
Aurora, Colorado, 80045, United States
Tufts Medical Center ( Site 3408)
Boston, Massachusetts, 02111, United States
University of Michigan ( Site 0008)
Ann Arbor, Michigan, 48109, United States
Henry Ford Hospital ( Site 3413)
Detroit, Michigan, 48202, United States
Optum Care Cancer Center ( Site 3497)
Las Vegas, Nevada, 89102, United States
Roswell Park Cancer Institute ( Site 3421)
Buffalo, New York, 14263, United States
Duke University Health System (DUHS) ( Site 0016)
Durham, North Carolina, 27710, United States
Wake Forest Baptist Health-Internal Medicine, Section on Hematology & Oncology ( Site 3400)
Winston-Salem, North Carolina, 27157, United States
Oncology Associates of Oregon, P.C.(Willamette Valley Cancer Institute) (WVCI) ( Site 8000)
Eugene, Oregon, 97401, United States
Medical University of South Carolina-Hollings Cancer Center ( Site 3426)
Charleston, South Carolina, 29425, United States
University of Virginia ( Site 3422)
Charlottesville, Virginia, 22908, United States
VCU Health Adult Outpatient Pavillion ( Site 3416)
Richmond, Virginia, 23219, United States
Hospital Universitario Austral ( Site 0104)
Pilar, Buenos Aires, B1629AHJ, Argentina
Hospital Italiano de Buenos Aires ( Site 0105)
ABB, Buenos Aires F.D., C1199ABB, Argentina
C.I.C.E. 9 de Julio ( Site 1001)
San Miguel de Tucumán, Tucumán Province, T4000IKO, Argentina
Royal Prince Alfred Hospital ( Site 1100)
Camperdown, New South Wales, 2050, Australia
Liverpool Hospital-Haematology ( Site 0501)
Liverpool, New South Wales, 2170, Australia
Royal North Shore Hospital ( Site 0003)
St Leonards, New South Wales, 2065, Australia
Calvary Mater Newcastle ( Site 0505)
Waratah, New South Wales, 2298, Australia
Royal Adelaide Hospital-Haematology Clinical Trials Unit ( Site 0001)
Adelaide, South Australia, 5000, Australia
Monash Health-Haematology Research ( Site 0006)
Clayton, Victoria, 3168, Australia
Western Health-Sunshine & Footscray Hospitals-Cancer Services-Cancer Research ( Site 0502)
Melbourne, Victoria, 3021, Australia
Royal Perth Hospital-Haematology ( Site 0504)
Perth, Western Australia, 6000, Australia
ZAS Cadix ( Site 1200)
Antwerp, 2030, Belgium
University Of Alberta Hospital ( Site 1504)
Edmonton, Alberta, T6G 2B7, Canada
The Moncton Hospital-Oncology ( Site 1500)
Moncton, New Brunswick, E1C 6Z8, Canada
The First Afflilated Hospital of Bengbu Medical College ( Site 3509)
Bengbu, Anhui, 233004, China
Anhui Provincial Hospital ( Site 3513)
Hefei, Anhui, 230071, China
Peking University Third Hospital-Hematology ( Site 3502)
Beijing, Beijing Municipality, 100191, China
Peking Union Medical College Hospital ( Site 3531)
Beijing, Beijing Municipality, 100730, China
The Second Affiliated Hospital Of Fujian Medical University ( Site 3525)
Quanzhou, Fujian, 362000, China
The First Affiliated hospital of Xiamen University ( Site 3515)
Xiamen, Fujian, 361003, China
Sun Yat-sen Memorial Hospital of Sun Yat-sen University ( Site 3524)
Guangzhou, Guangdong, 510120, China
Southern Medical University Nanfang Hospital-Department of Hematopathology ( Site 3511)
Guangzhou, Guangdong, 510515, China
The First Hospital of Hebei Medical University ( Site 3510)
Shijiazhuang, Hebei, 050031, China
Henan Cancer Hospital-hematology department ( Site 3504)
Zhengzhou, Henan, 450008, China
Wuhan Union Hospital ( Site 3500)
Wuhan, Hubei, 430022, China
Jiangsu Province Hospital ( Site 3507)
Nanjing, Jiangsu, 210029, China
Affiliated Hospital of Nantong University ( Site 3527)
Nantong, Jiangsu, 226001, China
The First affiliated hospital of Nanchang University (Xianghu campus) ( Site 3505)
Nanchang, Jiangxi, 330209, China
The First Hospital of Jilin University-Hematology ( Site 3526)
Changchun, Jilin, 130021, China
Shaanxi provincial people's hospital ( Site 3516)
Xi'an, Shaanxi, 710068, China
Jinan Central Hospital ( Site 3523)
Jinan, Shandong, 250013, China
Zhongshan Hospital,Fudan University-Hematology ( Site 3530)
Shanghai, Shanghai Municipality, 200032, China
Huashan Hospital, Fudan University ( Site 3529)
Shanghai, Shanghai Municipality, 200040, China
West China Hospital, Sichuan University ( Site 3518)
Chengdu, Sichuan, 610041, China
Institute of hematology&blood disease hospital ( Site 3501)
Tianjin, Tianjin Municipality, 300020, China
The first Affiliated Hospital, Zhejiang University School of Medicine ( Site 3508)
Hangzhou, Zhejiang, 310006, China
Zhejiang University School of Medicine-The Fourth Affiliated Hospital ( Site 3517)
Yiwu, Zhejiang, 322000, China
Fundacion Colombiana de Cancerología Clinica Vida ( Site 1403)
Medellín, Antioquia, 050030, Colombia
Los Cobos Medical Center ( Site 1404)
Bogotá, Bogota D.C., 110121, Colombia
IMAT S.A.S ( Site 1401)
Montería, Departamento de Córdoba, 230002, Colombia
Centre Hospitalier Universitaire de Rennes - Hôpital Pontchaillou ( Site 0417)
Rennes, Brittany Region, 35000, France
Centre Hospitalier Régional Universitaire de Tours - Hôpital-Hématologie et Thérapie Cellulaire ( Site 0413)
Tours, Indre-et-Loire, 37000, France
Centre Hospitalier Universitaire de Limoges - Hôpital Dupuyt-Hématologie Clinique et Thérapie Cellu ( Site 1701)
Limoges, Limousin, 87042, France
Centre Hospitalier Régional Universitaire de Nancy - Hôpitaux de Brabois-HEMATOLOGY ( Site 0407)
Vandœuvre-lès-Nancy, Lorraine, 54511, France
Centre Hospitalier de Roubaix ( Site 1703)
Roubaix, Nord, 59100, France
centre hospitalier lyon sud ( Site 0406)
Pierre-Bénite, Rhone, 69310, France
Hôpital Saint-Louis-Centre d'Investigations Cliniques ( Site 0405)
Paris, 75010, France
Hôpital Saint Antoine-Service d'Hématologie et de Thérapie Cellulaire ( Site 1702)
Paris, Île-de-France Region, 75571, France
Universitätsklinikum Aachen ( Site 1801)
Aachen, North Rhine-Westphalia, 52074, Germany
Universitaetsklinikum Carl Gustav Carus Dresden-Medical Dept I - Medical Oncology ( Site 0402)
Dresden, Saxony, 01307, Germany
Universitätsklinikum Halle ( Site 0401)
Halle, Saxony-Anhalt, 06120, Germany
Queen Mary Hospital ( Site 1901)
Hksar, Hong Kong
Petz Aladar Egyetemi Oktato Korhaz ( Site 2000)
Győr, Győr-Moson-Sopron, Hungary
Szabolcs-Szatmár-Bereg Megyei Kórházak és Egyetemi Oktatókór-Haematológia osztály ( Site 0706)
Nyíregyháza, Szabolcs-Szatmár-Bereg, 4400, Hungary
Semmelweis Egyetem-Belgyógyászati és Hematológiai Klinika ( Site 0708)
Budapest, 1088, Hungary
Debreceni Egyetem Klinikai Kozpont-Belgyógyászati Klinika (Haematologia) ( Site 0707)
Debrecen, 4032, Hungary
Soroka Medical Center ( Site 2100)
Beersheba, 8410101, Israel
Rambam Health Care Campus ( Site 2102)
Haifa, 3109601, Israel
Carmel Hospital ( Site 0906)
Haifa, 3436212, Israel
Hadassah Medical Center ( Site 0904)
Jerusalem, 9112001, Israel
Rabin Medical Center ( Site 0905)
Petah Tikva, 4941492, Israel
Sheba Medical Center ( Site 2101)
Ramat Gan, 5265601, Israel
Sourasky Medical Center ( Site 0902)
Tel Aviv, 6423906, Israel
Yitzhak Shamir Medical Center. ( Site 0901)
Ẕerifin, 7033001, Israel
Azienda Ospedaliero Universitaria di Ferrara ( Site 0304)
Cona, Ferrara, 44124, Italy
IRCCS - Istituto Romagnolo per lo Studio dei Tumori (IRST) "Dino Amadori" ( Site 0308)
Meldola, Forli-Cesena, 47014, Italy
Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico ( Site 2201)
Milan, Lombardy, 20122, Italy
Azienda Ospedaliera Universitaria Careggi ( Site 0030)
Florence, Tuscany, 50134, Italy
Azienda Ospedaliero Universitaria Pisana-UO Ematologia UNIV ( Site 0309)
Pisa, Tuscany, 56126, Italy
Istituto Oncologico Veneto IRCCS-Oncoematologia ( Site 0306)
Castelfranco Veneto, Veneto, 31033, Italy
Azienda Ospedaliero-Universitaria SS. Antonio e Biagio e Cesare Arrigo ( Site 0034)
Alessandria, 15121, Italy
Azienda Ospedaliero Universitaria delle Marche ( Site 0302)
Ancona, 60126, Italy
Arcispedale Santa Maria Nuova ( Site 0301)
Reggio Emilia, 42123, Italy
Ospedale Mauriziano ( Site 0305)
Torino, 10128, Italy
Ospedale di Circolo e Fondazione Macchi Varese ( Site 2200)
Varese, 21100, Italy
Fujita Health University Hospital ( Site 3613)
Toyoake, Aichi-ken, 470-1192, Japan
National Cancer Center Hospital East ( Site 3610)
Kashiwa, Chiba, 277-8577, Japan
Ehime University Hospital ( Site 3612)
Tōon, Ehime, 791-0295, Japan
Hokkaido University Hospital ( Site 3601)
Sapporo, Hokkaido, 060-8648, Japan
Kobe City Medical Center General Hospital ( Site 3603)
Kobe, Hyōgo, 650-0047, Japan
Kanazawa University Hospital ( Site 3614)
Kanazawa, Ishikawa-ken, 920-8641, Japan
Mie University Hospital ( Site 3615)
Tsu, Mie-ken, 514-8507, Japan
National Hospital Organization Sendai Medical Center ( Site 3617)
Sendai, Miyagi, 983-8520, Japan
Kansai Medical University Hospital ( Site 3607)
Hirakata, Osaka, 573-1191, Japan
Kindai University Hospital ( Site 3600)
Sakai, Osaka, 590-0197, Japan
Juntendo University Hospital ( Site 3611)
Bunkyo-ku, Tokyo, 113-8431, Japan
Nippon Medical School Hospital ( Site 3608)
Bunkyo-ku, Tokyo, 113-8603, Japan
University of Yamanashi Hospital ( Site 3606)
Chūō, Yamanashi, 409-3898, Japan
Kyushu University Hospital ( Site 3605)
Fukuoka, 812-8582, Japan
Fukushima Medical University Hospital ( Site 3616)
Fukushima, 960-1295, Japan
University of Miyazaki Hospital ( Site 3609)
Miyazaki, 889-1692, Japan
Okayama University Hospital ( Site 3604)
Okayama, 700-8558, Japan
Spaarne Gasthuis - Hoofddorp-Oncology ( Site 2301)
Hoofddorp, North Holland, 2134 TM, Netherlands
Albert Schweitzer Ziekenhuis, locatie Dordwijk-Internal Medicine ( Site 2302)
Dordrecht, South Holland, 3318 AT, Netherlands
University Medical Center Groningen ( Site 2304)
Groningen, 9713 GZ, Netherlands
Martini Ziekenhuis ( Site 2300)
Groningen, 9728 NT, Netherlands
North Shore Hospital-Department of Haematology ( Site 0051)
Auckland, 0622, New Zealand
Aotearoa Clinical Trials ( Site 0050)
Auckland, 2025, New Zealand
Pratia Onkologia Katowice ( Site 0702)
Katowice, Silesian Voivodeship, 40-519, Poland
Swietokrzyskie Centrum Onkologii, Samodzielny Publiczny Zakl-Klinika Hematologii i Transplantacji S ( Site 2504)
Kielce, Świętokrzyskie Voivodeship, 25-734, Poland
Unidade Local de Saude de Braga - Hospital de Braga ( Site 0415)
Braga, 4710-243, Portugal
Unidade Local de Saude Lisboa Ocidental - Hospital de São Francisco Xavier ( Site 2600)
Lisbon, 1449-005, Portugal
Instituto Português de Oncologia do Porto Francisco Gentil, EPE ( Site 0414)
Porto, 4200-072, Portugal
Seoul National University Bundang Hospital-Hematology ( Site 0605)
Seongnam, Kyonggi-do, 13620, South Korea
Korea University Anam Hospital ( Site 0604)
Seoul, 02841, South Korea
Asan Medical Center ( Site 0603)
Seoul, 05505, South Korea
The Catholic Univ. of Korea Seoul St. Mary's Hospital ( Site 0606)
Seoul, 06591, South Korea
Hospital Germans Trias i Pujol-Instituto Catalán de Oncología de Badalona ( Site 0409)
Badalona, Barcelona, 08916, Spain
Institut Català d'Oncologia - L'Hospitalet-Haematology Department ( Site 2801)
L'Hospitalet Del Llobregat, Barcelona, 08908, Spain
Hospital del Mar ( Site 2807)
Barcelona, Catalonia, 08003, Spain
HOSPITAL CLÍNIC DE BARCELONA ( Site 2800)
Barcelona, Catalonia, 08036, Spain
CHUS - Hospital Clinico Universitario ( Site 0421)
Santiago de Compostela, La Coruna, 19706, Spain
Hospital Universitario Ramón y Cajal-Hematology ( Site 2803)
Madrid, Madrid, Comunidad de, 28034, Spain
Hospital Costa del Sol-Hematology Service ( Site 0412)
Marbella, Malaga, 29603, Spain
Hospital General Universitario de Albacete ( Site 0408)
Albacete, 02006, Spain
Hospital Universitari Vall d'Hebron-Departamento de Oncologia- VHIO ( Site 0404)
Barcelona, 08035, Spain
Hospital Universitario 12 de Octubre ( Site 2806)
Madrid, 28041, Spain
Hospital Universitario Virgen de la Victoria ( Site 0418)
Málaga, 29010, Spain
Hospital Universitario de Salamanca - Complejo Asistencial U-Servicio de Hematologia ( Site 0419)
Salamanca, 37007, Spain
Hospital Universitario Doctor Peset ( Site 0411)
Valencia, 46017, Spain
Karolinska Universitetssjukhuset Huddinge ( Site 2900)
Huddinge, Stockholm County, 141 86, Sweden
Universitetssjukhuset Örebro ( Site 0403)
Örebro, Örebro County, 701 85, Sweden
Chang Gung Memorial Hospital- Chiayi ( Site 3102)
Chiayi City, Chiayi, 613, Taiwan
Chang Gung Memorial Hospital at Kaohsiung-Division of Hematology and Oncology ( Site 3104)
Kaohsiung City, 83301, Taiwan
National Cheng Kung University Hospital-Clinical Trial Center ( Site 3105)
Tainan, 704, Taiwan
National Taiwan University Hospital ( Site 3101)
Taipei, 10048, Taiwan
Chang Gung Medical Foundation-Linkou Branch ( Site 3103)
Taoyuan, 33305, Taiwan
Ege Universitesi Hastanesi ( Site 3202)
Bornova, İzmir, 35100, Turkey (Türkiye)
Hacettepe Universite Hastaneleri-Department of Hematology ( Site 3204)
Ankara, 06230, Turkey (Türkiye)
Ankara UTF Cebeci Arastırma ve Uygulama Hastanesi ( Site 3210)
Ankara, 06620, Turkey (Türkiye)
Ankara Bilkent Şehir Hastanesi ( Site 3201)
Ankara, 06800, Turkey (Türkiye)
Antalya Egitim ve Arastırma Hastanesi ( Site 3207)
Antalya, 07100, Turkey (Türkiye)
Trakya University Medical Faculty Hospital-Hematology ( Site 3200)
Edirne, 22030, Turkey (Türkiye)
Medipol Mega Universite Hastanesi-oncology ( Site 3203)
Istanbul, 34214, Turkey (Türkiye)
Kocaeli Üniversitesi-Hematology ( Site 3205)
Kocaeli, 41380, Turkey (Türkiye)
VM Medical Park Mersin Hastanesi ( Site 3208)
Mersin, 33440, Turkey (Türkiye)
Ondokuz Mayıs Universitesi-hematology ( Site 3206)
Samsun, 55270, Turkey (Türkiye)
Addenbrooke's Hospital ( Site 3303)
Cambridge, Cambridgeshire, CB2 2QQ, United Kingdom
Gloucestershire Royal Hospital ( Site 3302)
Gloucester, Gloucestershire, Gl1 3NN, United Kingdom
Lincoln County Hospital ( Site 3310)
Lincoln, Great Britain, LN2 5QY, United Kingdom
Boston Pilgrim Hospital ( Site 3301)
Boston, Lincolnshire, PE21 9QS, United Kingdom
University College London Hospital ( Site 3300)
London, London, City of, NW1 2PG, United Kingdom
Guy's & St Thomas' NHS Foundation Trust ( Site 3305)
London, London, City of, SE1 9RT, United Kingdom
King's College Hospital ( Site 3308)
London, London, City of, SE5 9RS, United Kingdom
Royal Gwent Hospital ( Site 3304)
Gwent, Newport, NP20 2UB, United Kingdom
GenesisCare - Windsor ( Site 3309)
Windsor, Windsor And Maidenhead, SL4 3HD, United Kingdom
The Christie NHS Foundation Trust ( Site 3307)
Manchester, m20 4bx, United Kingdom
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Medical Director
Merck Sharp & Dohme LLC
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 6, 2023
First Posted
October 12, 2023
Study Start
December 31, 2023
Primary Completion (Estimated)
July 30, 2027
Study Completion (Estimated)
August 18, 2028
Last Updated
June 12, 2026
Record last verified: 2026-06
Data Sharing
- IPD Sharing
- Will share
https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf