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)

May 29, 2026 updated by: Merck Sharp & Dohme LLC

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

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).

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

340

Phase

  • Phase 3

Contacts and Locations

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

Study Contact

Study Locations

  • Argentina
    • Buenos Aires
      • Pilar, Buenos Aires, Argentina, B1629AHJ
        • Recruiting
        • Hospital Universitario Austral ( Site 0104)
        • Contact:
          • Study Coordinator
          • Phone Number: +542304388888
    • Buenos Aires F.D.
      • ABB, Buenos Aires F.D., Argentina, C1199ABB
        • Recruiting
        • Hospital Italiano de Buenos Aires ( Site 0105)
        • Contact:
          • Study Coordinator
          • Phone Number: +541149590200
    • Tucumán Province
      • San Miguel de Tucumán, Tucumán Province, Argentina, T4000IKO
        • Recruiting
        • C.I.C.E. 9 de Julio ( Site 1001)
        • Contact:
          • Study Coordinator
          • Phone Number: +543814524400
  • Australia
    • New South Wales
      • Camperdown, New South Wales, Australia, 2050
        • Active, not recruiting
        • Royal Prince Alfred Hospital ( Site 1100)
      • Liverpool, New South Wales, Australia, 2170
        • Active, not recruiting
        • Liverpool Hospital-Haematology ( Site 0501)
      • St Leonards, New South Wales, Australia, 2065
        • Active, not recruiting
        • Royal North Shore Hospital ( Site 0003)
      • Waratah, New South Wales, Australia, 2298
        • Active, not recruiting
        • Calvary Mater Newcastle ( Site 0505)
    • South Australia
      • Adelaide, South Australia, Australia, 5000
        • Active, not recruiting
        • Royal Adelaide Hospital-Haematology Clinical Trials Unit ( Site 0001)
    • Victoria
      • Clayton, Victoria, Australia, 3168
        • Active, not recruiting
        • Monash Health-Haematology Research ( Site 0006)
      • Melbourne, Victoria, Australia, 3021
        • Active, not recruiting
        • Western Health-Sunshine & Footscray Hospitals-Cancer Services-Cancer Research ( Site 0502)
    • Western Australia
      • Perth, Western Australia, Australia, 6000
        • Active, not recruiting
        • Royal Perth Hospital-Haematology ( Site 0504)
  • Belgium
      • Antwerp, Belgium, 2030
        • Active, not recruiting
        • ZAS Cadix ( Site 1200)
  • Canada
    • Alberta
      • Edmonton, Alberta, Canada, T6G 2B7
        • Recruiting
        • University Of Alberta Hospital ( Site 1504)
        • Contact:
          • Study Coordinator
          • Phone Number: 780-407-1584x2
    • New Brunswick
      • Moncton, New Brunswick, Canada, E1C 6Z8
        • Recruiting
        • The Moncton Hospital-Oncology ( Site 1500)
        • Contact:
          • Study Coordinator
          • Phone Number: 5068575756
  • China
    • Anhui
      • Bengbu, Anhui, China, 233004
        • Active, not recruiting
        • The First Afflilated Hospital of Bengbu Medical College ( Site 3509)
      • Hefei, Anhui, China, 230071
        • Active, not recruiting
        • Anhui Provincial Hospital ( Site 3513)
    • Beijing Municipality
      • Beijing, Beijing Municipality, China, 100191
        • Active, not recruiting
        • Peking University Third Hospital-Hematology ( Site 3502)
      • Beijing, Beijing Municipality, China, 100730
        • Active, not recruiting
        • Peking Union Medical College Hospital ( Site 3531)
    • Fujian
      • Quanzhou, Fujian, China, 362000
        • Active, not recruiting
        • The Second Affiliated Hospital Of Fujian Medical University ( Site 3525)
      • Xiamen, Fujian, China, 361003
        • Completed
        • The First Affiliated hospital of Xiamen University ( Site 3515)
    • Guangdong
      • Guangzhou, Guangdong, China, 510120
        • Active, not recruiting
        • Sun Yat-sen Memorial Hospital of Sun Yat-sen University ( Site 3524)
      • Guangzhou, Guangdong, China, 510515
        • Active, not recruiting
        • Southern Medical University Nanfang Hospital-Department of Hematopathology ( Site 3511)
    • Hebei
      • Shijiazhuang, Hebei, China, 050031
        • Active, not recruiting
        • The First Hospital of Hebei Medical University ( Site 3510)
    • Henan
      • Zhengzhou, Henan, China, 450008
        • Active, not recruiting
        • Henan Cancer Hospital-hematology department ( Site 3504)
    • Hubei
      • Wuhan, Hubei, China, 430022
        • Active, not recruiting
        • Wuhan Union Hospital ( Site 3500)
    • Jiangsu
      • Nanjing, Jiangsu, China, 210029
        • Active, not recruiting
        • Jiangsu Province Hospital ( Site 3507)
      • Nantong, Jiangsu, China, 226001
        • Completed
        • Affiliated Hospital of Nantong University ( Site 3527)
    • Jiangxi
      • Nanchang, Jiangxi, China, 330209
        • Recruiting
        • The First affiliated hospital of Nanchang University (Xianghu campus) ( Site 3505)
        • Contact:
          • Study Coordinator
          • Phone Number: 079188695051
    • Jilin
      • Changchun, Jilin, China, 130021
        • Completed
        • The First Hospital of Jilin University-Hematology ( Site 3526)
    • Shaanxi
      • Xi'an, Shaanxi, China, 710068
        • Active, not recruiting
        • Shaanxi provincial people's hospital ( Site 3516)
    • Shandong
      • Jinan, Shandong, China, 250013
        • Active, not recruiting
        • Jinan Central Hospital ( Site 3523)
    • Shanghai Municipality
      • Shanghai, Shanghai Municipality, China, 200032
        • Active, not recruiting
        • Zhongshan Hospital,Fudan University-Hematology ( Site 3530)
      • Shanghai, Shanghai Municipality, China, 200040
        • Active, not recruiting
        • Huashan Hospital, Fudan University ( Site 3529)
    • Sichuan
      • Chengdu, Sichuan, China, 610041
        • Recruiting
        • West China Hospital, Sichuan University ( Site 3518)
        • Contact:
          • Study Coordinator
          • Phone Number: 028-85422114
    • Tianjin Municipality
      • Tianjin, Tianjin Municipality, China, 300020
        • Active, not recruiting
        • Institute of hematology&blood disease hospital ( Site 3501)
    • Zhejiang
      • Hangzhou, Zhejiang, China, 310006
        • Recruiting
        • The first Affiliated Hospital, Zhejiang University School of Medicine ( Site 3508)
        • Contact:
          • Study Coordinator
          • Phone Number: 86 0571-87236896
      • Yiwu, Zhejiang, China, 322000
        • Active, not recruiting
        • Zhejiang University School of Medicine-The Fourth Affiliated Hospital ( Site 3517)
  • Colombia
    • Antioquia
      • Medellín, Antioquia, Colombia, 050030
        • Active, not recruiting
        • Fundacion Colombiana de Cancerología Clinica Vida ( Site 1403)
    • Bogota D.C.
      • Bogotá, Bogota D.C., Colombia, 110121
        • Active, not recruiting
        • Los Cobos Medical Center ( Site 1404)
    • Departamento de Córdoba
      • Montería, Departamento de Córdoba, Colombia, 230002
        • Active, not recruiting
        • IMAT S.A.S ( Site 1401)
  • France
      • Paris, France, 75010
        • Recruiting
        • Hôpital Saint-Louis-Centre d'Investigations Cliniques ( Site 0405)
        • Contact:
          • Study Coordinator
          • Phone Number: +33142499418
    • Brittany Region
      • Rennes, Brittany Region, France, 35000
        • Completed
        • Centre Hospitalier Universitaire de Rennes - Hôpital Pontchaillou ( Site 0417)
    • Indre-et-Loire
      • Tours, Indre-et-Loire, France, 37000
        • Recruiting
        • Centre Hospitalier Régional Universitaire de Tours - Hôpital-Hématologie et Thérapie Cellulaire ( Site 0413)
        • Contact:
          • Study Coordinator
          • Phone Number: +33247475908
    • Limousin
      • Limoges, Limousin, France, 87042
        • Completed
        • Centre Hospitalier Universitaire de Limoges - Hôpital Dupuyt-Hématologie Clinique et Thérapie Cellu ( Site 1701)
    • Lorraine
      • Vandœuvre-lès-Nancy, Lorraine, France, 54511
        • Recruiting
        • Centre Hospitalier Régional Universitaire de Nancy - Hôpitaux de Brabois-HEMATOLOGY ( Site 0407)
        • Contact:
          • Study Coordinator
          • Phone Number: +33383155234
    • Nord
      • Roubaix, Nord, France, 59100
        • Completed
        • Centre Hospitalier de Roubaix ( Site 1703)
    • Rhone
      • Pierre-Bénite, Rhone, France, 69310
        • Recruiting
        • centre hospitalier lyon sud ( Site 0406)
        • Contact:
          • Study Coordinator
          • Phone Number: +33478861679
    • Île-de-France Region
      • Paris, Île-de-France Region, France, 75571
        • Completed
        • Hôpital Saint Antoine-Service d'Hématologie et de Thérapie Cellulaire ( Site 1702)
  • Germany
    • North Rhine-Westphalia
      • Aachen, North Rhine-Westphalia, Germany, 52074
        • Completed
        • Universitätsklinikum Aachen ( Site 1801)
    • Saxony
      • Dresden, Saxony, Germany, 01307
        • Active, not recruiting
        • Universitaetsklinikum Carl Gustav Carus Dresden-Medical Dept I - Medical Oncology ( Site 0402)
    • Saxony-Anhalt
      • Halle, Saxony-Anhalt, Germany, 06120
        • Active, not recruiting
        • Universitätsklinikum Halle ( Site 0401)
  • Hong Kong
      • Hksar, Hong Kong
        • Recruiting
        • Queen Mary Hospital ( Site 1901)
        • Contact:
          • Study Coordinator
          • Phone Number: +85222555859
  • Hungary
      • Budapest, Hungary, 1088
        • Active, not recruiting
        • Semmelweis Egyetem-Belgyógyászati és Hematológiai Klinika ( Site 0708)
      • Debrecen, Hungary, 4032
        • Active, not recruiting
        • Debreceni Egyetem Klinikai Kozpont-Belgyógyászati Klinika (Haematologia) ( Site 0707)
    • Győr-Moson-Sopron
      • Győr, Győr-Moson-Sopron, Hungary
        • Active, not recruiting
        • Petz Aladar Egyetemi Oktato Korhaz ( Site 2000)
    • Szabolcs-Szatmár-Bereg
      • Nyíregyháza, Szabolcs-Szatmár-Bereg, Hungary, 4400
        • Active, not recruiting
        • Szabolcs-Szatmár-Bereg Megyei Kórházak és Egyetemi Oktatókór-Haematológia osztály ( Site 0706)
  • Israel
      • Beersheba, Israel, 8410101
        • Active, not recruiting
        • Soroka Medical Center ( Site 2100)
      • Haifa, Israel, 3109601
        • Active, not recruiting
        • Rambam Health Care Campus ( Site 2102)
      • Haifa, Israel, 3436212
        • Active, not recruiting
        • Carmel Hospital ( Site 0906)
      • Jerusalem, Israel, 9112001
        • Active, not recruiting
        • Hadassah Medical Center ( Site 0904)
      • Petah Tikva, Israel, 4941492
        • Recruiting
        • Rabin Medical Center ( Site 0905)
        • Contact:
          • Study Coordinator
          • Phone Number: 97239378002
      • Ramat Gan, Israel, 5265601
        • Active, not recruiting
        • Sheba Medical Center ( Site 2101)
      • Tel Aviv, Israel, 6423906
        • Active, not recruiting
        • Sourasky Medical Center ( Site 0902)
      • Ẕerifin, Israel, 7033001
        • Active, not recruiting
        • Yitzhak Shamir Medical Center. ( Site 0901)
  • Italy
      • Alessandria, Italy, 15121
        • Active, not recruiting
        • Azienda Ospedaliero-Universitaria SS. Antonio e Biagio e Cesare Arrigo ( Site 0034)
      • Ancona, Italy, 60126
        • Recruiting
        • Azienda Ospedaliero Universitaria delle Marche ( Site 0302)
        • Contact:
          • Study Coordinator
          • Phone Number: 0715964771
      • Reggio Emilia, Italy, 42123
        • Recruiting
        • Arcispedale Santa Maria Nuova ( Site 0301)
        • Contact:
          • Study Coordinator
          • Phone Number: +39 0522 296567
      • Torino, Italy, 10128
        • Recruiting
        • Ospedale Mauriziano ( Site 0305)
        • Contact:
          • Study Coordinator
          • Phone Number: +390115082224
      • Varese, Italy, 21100
        • Active, not recruiting
        • Ospedale di Circolo e Fondazione Macchi Varese ( Site 2200)
    • Ferrara
      • Cona, Ferrara, Italy, 44124
        • Active, not recruiting
        • Azienda Ospedaliero Universitaria di Ferrara ( Site 0304)
    • Forli-Cesena
      • Meldola, Forli-Cesena, Italy, 47014
        • Active, not recruiting
        • IRCCS - Istituto Romagnolo per lo Studio dei Tumori (IRST) "Dino Amadori" ( Site 0308)
    • Lombardy
      • Milan, Lombardy, Italy, 20122
        • Active, not recruiting
        • Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico ( Site 2201)
    • Tuscany
      • Florence, Tuscany, Italy, 50134
        • Active, not recruiting
        • Azienda Ospedaliera Universitaria Careggi ( Site 0030)
      • Pisa, Tuscany, Italy, 56126
        • Completed
        • Azienda Ospedaliero Universitaria Pisana-UO Ematologia UNIV ( Site 0309)
    • Veneto
      • Castelfranco Veneto, Veneto, Italy, 31033
        • Active, not recruiting
        • Istituto Oncologico Veneto IRCCS-Oncoematologia ( Site 0306)
  • Japan
      • Fukuoka, Japan, 812-8582
        • Recruiting
        • Kyushu University Hospital ( Site 3605)
        • Contact:
          • Study Coordinator
          • Phone Number: +8192-641-1151
      • Fukushima, Japan, 960-1295
        • Recruiting
        • Fukushima Medical University Hospital ( Site 3616)
        • Contact:
          • Study Coordinator
          • Phone Number: +81-24-547-1111
      • Miyazaki, Japan, 889-1692
        • Recruiting
        • University of Miyazaki Hospital ( Site 3609)
        • Contact:
          • Study Coordinator
          • Phone Number: +81-985-85-1510
      • Okayama, Japan, 700-8558
        • Recruiting
        • Okayama University Hospital ( Site 3604)
        • Contact:
          • Study Coordinator
          • Phone Number: +81-86-223-7151
    • Aichi-ken
      • Toyoake, Aichi-ken, Japan, 470-1192
        • Recruiting
        • Fujita Health University Hospital ( Site 3613)
        • Contact:
          • Study Coordinator
          • Phone Number: +81-562-93-2111
    • Chiba
      • Kashiwa, Chiba, Japan, 277-8577
        • Recruiting
        • National Cancer Center Hospital East ( Site 3610)
        • Contact:
          • Study Coordinator
          • Phone Number: +81-4-7133-1111
    • Ehime
      • Tōon, Ehime, Japan, 791-0295
        • Recruiting
        • Ehime University Hospital ( Site 3612)
        • Contact:
          • Study Coordinator
          • Phone Number: +81-89-964-5111
    • Hokkaido
      • Sapporo, Hokkaido, Japan, 060-8648
        • Recruiting
        • Hokkaido University Hospital ( Site 3601)
        • Contact:
          • Study Coordinator
          • Phone Number: +81-11-716-1161
    • Hyōgo
      • Kobe, Hyōgo, Japan, 650-0047
        • Recruiting
        • Kobe City Medical Center General Hospital ( Site 3603)
        • Contact:
          • Study Coordinator
          • Phone Number: +81783024321
    • Ishikawa-ken
      • Kanazawa, Ishikawa-ken, Japan, 920-8641
        • Recruiting
        • Kanazawa University Hospital ( Site 3614)
        • Contact:
          • Study Coordinator
          • Phone Number: +81-76-265-2000
    • Mie-ken
      • Tsu, Mie-ken, Japan, 514-8507
        • Recruiting
        • Mie University Hospital ( Site 3615)
        • Contact:
          • Study Coordinator
          • Phone Number: +81-59-232-1111
    • Miyagi
      • Sendai, Miyagi, Japan, 983-8520
        • Recruiting
        • National Hospital Organization Sendai Medical Center ( Site 3617)
        • Contact:
          • Study Coordinator
          • Phone Number: +81-22-293-1111
    • Osaka
      • Hirakata, Osaka, Japan, 573-1191
        • Recruiting
        • Kansai Medical University Hospital ( Site 3607)
        • Contact:
          • Study Coordinator
          • Phone Number: +81-72-804-0101
      • Sakai, Osaka, Japan, 590-0197
        • Recruiting
        • Kindai University Hospital ( Site 3600)
        • Contact:
          • Study Coordinator
          • Phone Number: +81-72-366-0221
    • Tokyo
      • Bunkyo-ku, Tokyo, Japan, 113-8603
        • Recruiting
        • Nippon Medical School Hospital ( Site 3608)
        • Contact:
          • Study Coordinator
          • Phone Number: +81-3-3822-2131
      • Bunkyo-ku, Tokyo, Japan, 113-8431
        • Recruiting
        • Juntendo University Hospital ( Site 3611)
        • Contact:
          • Study Coordinator
          • Phone Number: +81-3-3813-3111
    • Yamanashi
      • Chūō, Yamanashi, Japan, 409-3898
        • Recruiting
        • University of Yamanashi Hospital ( Site 3606)
        • Contact:
          • Study Coordinator
          • Phone Number: +81-55-273-1111
  • Netherlands
      • Groningen, Netherlands, 9728 NT
        • Active, not recruiting
        • Martini Ziekenhuis ( Site 2300)
      • Groningen, Netherlands, 9713 GZ
        • Active, not recruiting
        • University Medical Center Groningen ( Site 2304)
    • North Holland
      • Hoofddorp, North Holland, Netherlands, 2134 TM
        • Completed
        • Spaarne Gasthuis - Hoofddorp-Oncology ( Site 2301)
    • South Holland
      • Dordrecht, South Holland, Netherlands, 3318 AT
        • Active, not recruiting
        • Albert Schweitzer Ziekenhuis, locatie Dordwijk-Internal Medicine ( Site 2302)
  • New Zealand
      • Auckland, New Zealand, 0622
        • Active, not recruiting
        • North Shore Hospital-Department of Haematology ( Site 0051)
      • Auckland, New Zealand, 2025
        • Active, not recruiting
        • Aotearoa Clinical Trials ( Site 0050)
  • Poland
    • Silesian Voivodeship
      • Katowice, Silesian Voivodeship, Poland, 40-519
        • Active, not recruiting
        • Pratia Onkologia Katowice ( Site 0702)
    • Świętokrzyskie Voivodeship
      • Kielce, Świętokrzyskie Voivodeship, Poland, 25-734
        • Completed
        • Swietokrzyskie Centrum Onkologii, Samodzielny Publiczny Zakl-Klinika Hematologii i Transplantacji S ( Site 2504)
  • Portugal
      • Braga, Portugal, 4710-243
        • Recruiting
        • Unidade Local de Saude de Braga - Hospital de Braga ( Site 0415)
        • Contact:
          • Study Coordinator
          • Phone Number: +351225084023
      • Lisbon, Portugal, 1449-005
        • Recruiting
        • Unidade Local de Saude Lisboa Ocidental - Hospital de São Francisco Xavier ( Site 2600)
        • Contact:
          • Study Coordinator
          • Phone Number: +351225084023
      • Porto, Portugal, 4200-072
        • Recruiting
        • Instituto Português de Oncologia do Porto Francisco Gentil, EPE ( Site 0414)
        • Contact:
          • Study Coordinator
          • Phone Number: +351225084023
  • South Korea
      • Seoul, South Korea, 02841
        • Completed
        • Korea University Anam Hospital ( Site 0604)
      • Seoul, South Korea, 05505
        • Active, not recruiting
        • Asan Medical Center ( Site 0603)
      • Seoul, South Korea, 06591
        • Active, not recruiting
        • The Catholic Univ. of Korea Seoul St. Mary's Hospital ( Site 0606)
    • Kyonggi-do
      • Seongnam, Kyonggi-do, South Korea, 13620
        • Completed
        • Seoul National University Bundang Hospital-Hematology ( Site 0605)
  • Spain
      • Albacete, Spain, 02006
        • Active, not recruiting
        • Hospital General Universitario de Albacete ( Site 0408)
      • Barcelona, Spain, 08035
        • Recruiting
        • Hospital Universitari Vall d'Hebron-Departamento de Oncologia- VHIO ( Site 0404)
        • Contact:
          • Study Coordinator
          • Phone Number: 932746000
      • Madrid, Spain, 28041
        • Recruiting
        • Hospital Universitario 12 de Octubre ( Site 2806)
        • Contact:
          • Study Coordinator
          • Phone Number: 917792878
      • Málaga, Spain, 29010
        • Active, not recruiting
        • Hospital Universitario Virgen de la Victoria ( Site 0418)
      • Salamanca, Spain, 37007
        • Completed
        • Hospital Universitario de Salamanca - Complejo Asistencial U-Servicio de Hematologia ( Site 0419)
      • Valencia, Spain, 46017
        • Active, not recruiting
        • Hospital Universitario Doctor Peset ( Site 0411)
    • Barcelona
      • Badalona, Barcelona, Spain, 08916
        • Active, not recruiting
        • Hospital Germans Trias i Pujol-Instituto Catalán de Oncología de Badalona ( Site 0409)
      • L'Hospitalet Del Llobregat, Barcelona, Spain, 08908
        • Active, not recruiting
        • Institut Català d'Oncologia - L'Hospitalet-Haematology Department ( Site 2801)
    • Catalonia
      • Barcelona, Catalonia, Spain, 08003
        • Active, not recruiting
        • Hospital del Mar ( Site 2807)
      • Barcelona, Catalonia, Spain, 08036
        • Active, not recruiting
        • HOSPITAL CLÍNIC DE BARCELONA ( Site 2800)
    • La Coruna
      • Santiago de Compostela, La Coruna, Spain, 19706
        • Active, not recruiting
        • CHUS - Hospital Clinico Universitario ( Site 0421)
    • Madrid, Comunidad de
      • Madrid, Madrid, Comunidad de, Spain, 28034
        • Active, not recruiting
        • Hospital Universitario Ramón y Cajal-Hematology ( Site 2803)
    • Malaga
      • Marbella, Malaga, Spain, 29603
        • Active, not recruiting
        • Hospital Costa del Sol-Hematology Service ( Site 0412)
  • Sweden
    • Stockholm County
      • Huddinge, Stockholm County, Sweden, 141 86
        • Active, not recruiting
        • Karolinska Universitetssjukhuset Huddinge ( Site 2900)
    • Örebro County
      • Örebro, Örebro County, Sweden, 701 85
        • Active, not recruiting
        • Universitetssjukhuset Örebro ( Site 0403)
  • Taiwan
      • Kaohsiung City, Taiwan, 83301
        • Active, not recruiting
        • Chang Gung Memorial Hospital at Kaohsiung-Division of Hematology and Oncology ( Site 3104)
      • Tainan, Taiwan, 704
        • Active, not recruiting
        • National Cheng Kung University Hospital-Clinical Trial Center ( Site 3105)
      • Taipei, Taiwan, 10048
        • Active, not recruiting
        • National Taiwan University Hospital ( Site 3101)
      • Taoyuan, Taiwan, 33305
        • Active, not recruiting
        • Chang Gung Medical Foundation-Linkou Branch ( Site 3103)
    • Chiayi
      • Chiayi City, Chiayi, Taiwan, 613
        • Active, not recruiting
        • Chang Gung Memorial Hospital- Chiayi ( Site 3102)
  • Turkey (Türkiye)
      • Ankara, Turkey (Türkiye), 06230
        • Recruiting
        • Hacettepe Universite Hastaneleri-Department of Hematology ( Site 3204)
        • Contact:
          • Study Coordinator
          • Phone Number: +905058229916
      • Ankara, Turkey (Türkiye), 06620
        • Recruiting
        • Ankara UTF Cebeci Arastırma ve Uygulama Hastanesi ( Site 3210)
        • Contact:
          • Study Coordinator
          • Phone Number: +905326560206
      • Ankara, Turkey (Türkiye), 06800
        • Recruiting
        • Ankara Bilkent Şehir Hastanesi ( Site 3201)
        • Contact:
          • Study Coordinator
          • Phone Number: +905336512142
      • Antalya, Turkey (Türkiye), 07100
        • Recruiting
        • Antalya Egitim ve Arastırma Hastanesi ( Site 3207)
        • Contact:
          • Study Coordinator
          • Phone Number: +905057656778
      • Edirne, Turkey (Türkiye), 22030
        • Recruiting
        • Trakya University Medical Faculty Hospital-Hematology ( Site 3200)
        • Contact:
          • Study Coordinator
          • Phone Number: 905335544797
      • Istanbul, Turkey (Türkiye), 34214
        • Recruiting
        • Medipol Mega Universite Hastanesi-oncology ( Site 3203)
        • Contact:
          • Study Coordinator
          • Phone Number: 05077078197
      • Kocaeli, Turkey (Türkiye), 41380
        • Recruiting
        • Kocaeli Üniversitesi-Hematology ( Site 3205)
        • Contact:
          • Study Coordinator
          • Phone Number: +902623037575
      • Mersin, Turkey (Türkiye), 33440
        • Recruiting
        • VM Medical Park Mersin Hastanesi ( Site 3208)
        • Contact:
          • Study Coordinator
          • Phone Number: +905323460767
      • Samsun, Turkey (Türkiye), 55270
        • Recruiting
        • Ondokuz Mayıs Universitesi-hematology ( Site 3206)
        • Contact:
          • Study Coordinator
          • Phone Number: +905324412859
    • İzmir
      • Bornova, İzmir, Turkey (Türkiye), 35100
        • Recruiting
        • Ege Universitesi Hastanesi ( Site 3202)
        • Contact:
          • Study Coordinator
          • Phone Number: 905325566128
  • United Kingdom
      • Manchester, United Kingdom, m20 4bx
        • Active, not recruiting
        • The Christie NHS Foundation Trust ( Site 3307)
    • Cambridgeshire
      • Cambridge, Cambridgeshire, United Kingdom, CB2 2QQ
        • Active, not recruiting
        • Addenbrooke's Hospital ( Site 3303)
    • Gloucestershire
      • Gloucester, Gloucestershire, United Kingdom, Gl1 3NN
        • Active, not recruiting
        • Gloucestershire Royal Hospital ( Site 3302)
    • Great Britain
      • Lincoln, Great Britain, United Kingdom, LN2 5QY
        • Active, not recruiting
        • Lincoln County Hospital ( Site 3310)
    • Lincolnshire
      • Boston, Lincolnshire, United Kingdom, PE21 9QS
        • Completed
        • Boston Pilgrim Hospital ( Site 3301)
    • London, City of
      • London, London, City of, United Kingdom, SE1 9RT
        • Active, not recruiting
        • Guy's & St Thomas' NHS Foundation Trust ( Site 3305)
      • London, London, City of, United Kingdom, NW1 2PG
        • Active, not recruiting
        • University College London Hospital ( Site 3300)
      • London, London, City of, United Kingdom, SE5 9RS
        • Active, not recruiting
        • King's College Hospital ( Site 3308)
    • Newport
      • Gwent, Newport, United Kingdom, NP20 2UB
        • Active, not recruiting
        • Royal Gwent Hospital ( Site 3304)
    • Windsor And Maidenhead
      • Windsor, Windsor And Maidenhead, United Kingdom, SL4 3HD
        • Active, not recruiting
        • GenesisCare - Windsor ( Site 3309)
  • United States
    • Arizona
      • Glendale, Arizona, United States, 85304
        • Recruiting
        • Palo Verde Hematology/ Oncology Center, Ltd. ( Site 3496)
        • Contact:
          • Study Coordinator
          • Phone Number: 602-978-6255
    • California
      • Glendale, California, United States, 91206
        • Recruiting
        • Los Angeles Cancer Network ( Site 3491)
        • Contact:
          • Study Coordinator
          • Phone Number: 213-977-1214
      • Stanford, California, United States, 94305-5826
        • Recruiting
        • Stanford Cancer Institute ( Site 0107)
        • Contact:
          • Study Coordinator
          • Phone Number: 650-497-6575
      • Torrance, California, United States, 90502
        • Recruiting
        • The Lundquist Institute ( Site 3423)
        • Contact:
          • Study Coordinator
          • Phone Number: 323-457-1378
    • Colorado
      • Aurora, Colorado, United States, 80045
        • Recruiting
        • University of Colorado Anschutz Medical Campus ( Site 3425)
        • Contact:
          • Study Coordinator
          • Phone Number: 720-848-9260
    • Massachusetts
      • Boston, Massachusetts, United States, 02111
        • Recruiting
        • Tufts Medical Center ( Site 3408)
        • Contact:
          • Study Coordinator
          • Phone Number: 617-636-2675
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • Recruiting
        • University of Michigan ( Site 0008)
        • Contact:
          • Study Coordinator
          • Phone Number: 734-615-3137
      • Detroit, Michigan, United States, 48202
        • Recruiting
        • Henry Ford Hospital ( Site 3413)
        • Contact:
          • Study Coordinator
          • Phone Number: 313-556-8833
    • Nevada
      • Las Vegas, Nevada, United States, 89102
        • Recruiting
        • Optum Care Cancer Center ( Site 3497)
        • Contact:
          • Study Coordinator
          • Phone Number: 702-724-8787
    • New York
      • Buffalo, New York, United States, 14263
        • Recruiting
        • Roswell Park Cancer Institute ( Site 3421)
        • Contact:
          • Study Coordinator
          • Phone Number: 317-966-5359
    • North Carolina
      • Durham, North Carolina, United States, 27710
        • Recruiting
        • Duke University Health System (DUHS) ( Site 0016)
        • Contact:
          • Study Coordinator
          • Phone Number: 919-668-1608
      • Winston-Salem, North Carolina, United States, 27157
        • Recruiting
        • Wake Forest Baptist Health-Internal Medicine, Section on Hematology & Oncology ( Site 3400)
        • Contact:
          • Study Coordinator
          • Phone Number: 336-713-5440
    • Oregon
      • Eugene, Oregon, United States, 97401
        • Recruiting
        • Oncology Associates of Oregon, P.C.(Willamette Valley Cancer Institute) (WVCI) ( Site 8000)
        • Contact:
          • Study Coordinator
          • Phone Number: 541-683-5001
    • South Carolina
      • Charleston, South Carolina, United States, 29425
        • Recruiting
        • Medical University of South Carolina-Hollings Cancer Center ( Site 3426)
        • Contact:
          • Study Coordinator
          • Phone Number: 843-792-9300
    • Virginia
      • Charlottesville, Virginia, United States, 22908
        • Recruiting
        • University of Virginia ( Site 3422)
        • Contact:
          • Study Coordinator
          • Phone Number: 434-310-0987
      • Richmond, Virginia, United States, 23219
        • Recruiting
        • VCU Health Adult Outpatient Pavillion ( Site 3416)
        • Contact:
          • Study Coordinator
          • Phone Number: 804-828-2177

Participation Criteria

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

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Plan

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

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Bomedemstat
Participants 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.
Drug: Bomedemstat
Oral Capsule
Other Names:
  • IMG-7289
  • MK-3543
  • Bomedemstat tosylate
Active Comparator: Best Available Therapy
Each 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.
Drug: Anagrelide
Oral Capsule
Drug: Ruxolitinib
Oral Tablet
Drug: Busulfan
Oral Tablet
Drug: Interferon alfa/pegylated interferon alfa 2a/pegylated interferon alfa 2b
Subcutaneous Solution

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Durable Clinicohematologic Response (DCHR) Rate
Time Frame: Up to approximately 52 weeks
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change From Baseline in Myelofibrosis Symptom Assessment Form (MFSAF) v4.0 Individual Fatigue Symptom Item Score
Time Frame: Baseline and pre-specified timepoints through Week 156
The MFSAF v4.0 is a 7-item participant-reported myelofibrosis symptom assessment which asks respondents to report symptom severity at its worst for each of the 7 items on a 0 (Absent) to 10 (Worst Imaginable) numeric rating scale. For this outcome measure, the change from baseline through Week 156 in scores for the individual item of fatigue severity will be presented.
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
Time Frame: Baseline and pre-specified timepoints through Week 156
The PROMIS F SF-7a is a 7-item participant-reported assessment that measures both the experience of fatigue and the interference of fatigue on daily activities over the past week. Response options are on a 5-point Likert scale, ranging from 1 = never to 5 = always. Change from baseline in PROMIS Fatigue SF-7a through Week 156 will be presented.
Baseline and pre-specified timepoints through Week 156
Change From Baseline in Total Symptom Score as Measured on the MFSAF v4.0
Time Frame: Baseline and pre-specified timepoints through Week 156
The MFSAF v4.0 is a 7-item participant-reported myelofibrosis symptom assessment which asks respondents to report symptom severity at its worst for each of the 7 items on a 0 (Absent) to 10 (Worst Imaginable) numeric rating scale. MFSAF total score for all symptoms at baseline through Week 156 will be presented.
Baseline and pre-specified timepoints through Week 156
Duration of Clinicohematologic Response (DOCHR)
Time Frame: Up to approximately 52 weeks
For participants who demonstrate DCHR, duration of clinicohematologic response is defined as the time from the first documented evidence of confirmed reduction of platelet and WBC count until confirmed increase of platelet and WBC counts to above acceptable threshold, thrombotic or major hemorrhagic events or disease progression to MF, MDS or AML.
Up to approximately 52 weeks
Percentage of Participants with Thrombotic Events
Time Frame: Up to 156 weeks
Thrombotic events include but are not limited to new or recurrent acute myocardial infarction, unstable angina, stroke, transient ischemic attack, deep venous thrombosis, pulmonary embolism, thrombotic digital ischemia, or other thrombotic events.
Up to 156 weeks
Percentage of Participants with Major Hemorrhagic Events
Time Frame: Up to 156 weeks
Major hemorrhagic events include but are not limited to fatal bleeding, and/or symptomatic bleeding in a critical area or organ such as intracranial, intraspinal, intraocular, retroperitoneal, intra-articular or pericardial, or intramuscular with compartment syndrome, and/or bleeding causing a decrease in hemoglobin level of 2 g/dL or more, or leading to transfusion of 2 or more units of whole blood or red cells.
Up to 156 weeks
Disease Progression Rate
Time Frame: Up to approximately 52 weeks
Disease progression rate is the percentage of participants with disease progression, defined as the transformation to post-essential thrombocythemia myelofibrosis, myelodysplastic syndrome, or acute myeloid leukemia as assessed by the adjudication committee. The disease progression rate of participants in each arm will be presented.
Up to approximately 52 weeks
Number of Participants with An Adverse Event (AE)
Time Frame: Up to 180 weeks
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.
Up to 180 weeks
Number of Participants Discontinuing From Study Therapy Due to an AE
Time Frame: Up to 152 weeks
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The number of participants who discontinue study treatment due to an adverse event will be presented.
Up to 152 weeks
Duration of Hematologic Remission (DOHR)
Time Frame: Up to approximately 52 weeks
For participants who demonstrate hematologic remission, DOHR is defined as the time from the first documented evidence of platelet and WBC counts reduction until platelet or WBC counts increase to above acceptable threshold.
Up to approximately 52 weeks

Collaborators and Investigators

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

Sponsor

Merck Sharp & Dohme LLC

Investigators

  • Study Director: Medical Director, Merck Sharp & Dohme LLC

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

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

Study Major Dates

Study Start (Actual)

December 31, 2023

Primary Completion (Estimated)

July 30, 2027

Study Completion (Estimated)

August 18, 2028

Study Registration Dates

First Submitted

October 6, 2023

First Submitted That Met QC Criteria

October 6, 2023

First Posted (Actual)

October 12, 2023

Study Record Updates

Last Update Posted (Actual)

June 1, 2026

Last Update Submitted That Met QC Criteria

May 29, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 3543-006
  • IMG-7289-CTP-301 (Other Identifier: Imagobio)
  • MK-3543-006 (Other Identifier: MSD)
  • jRCT2031230658 (Registry Identifier: Japan Registry of Clinical Trials (jRCT))
  • U1111-1290-2942 (Registry Identifier: UTN)
  • 2023-504865-21-00 (Registry Identifier: EU CT)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

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

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