AzTrials
AzTrials

Essential ThrombocythemiaPhase 3NCT06456346

Bomedemstat vs Hydroxyurea for Essential Thrombocythemia (MK-3543-007)

A Phase 3 study testing Bomedemstat and Hydroxyurea in people with Essential Thrombocythemia, run by Merck Sharp & Dohme LLC at 171 sites in 23 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

The purpose of this study is to evaluate the efficacy and safety of bomedemstat compared with hydroxyurea in cytoreductive therapy naïve essential thrombocythemia (ET) participants for whom cytoreductive therapy is indicated. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Essential Thrombocythemia
What is being tested?
Bomedemstat and Hydroxyurea
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
300 participants
Where
171 sitesin 23 countries
Study dates
16 Jul 2024to 24 Mar 2028
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Diagnosis of Essential Thrombocythemia (ET) based on World Health Organization Criteria for myeloproliferative neoplasms, and an indication for cytoreductive therapy regardless of age or risk status
  • 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 received no prior cytoreductive treatment for their ET
  • Human Immunodeficiency Virus (HIV)-infected participants have well controlled HIV on antiretroviral therapy
  • Participants who are Hepatitis B surface antigen (HBsAg) positive are eligible if they have received Hepatitis B Virus (HBV) antiviral therapy for at least 4 weeks and have undetectable HBV viral load
  • Participants with history of Hepatitis C Virus (HCV) infection are eligible if HCV viral load is undetectable

Who cannot join

  • History of any illness/impairment of gastrointestinal function that might interfere with drug absorption
  • History of a malignancy, unless potentially curative treatment has been completed with no evidence of malignancy for 2 years
  • HIV-infected participants with a history of Kaposi's sarcoma and/or Multicentric Castleman's Disease
  • Has an active infection requiring systemic therapy
  • Has had a major surgery <4 weeks prior to first dose of study intervention or has not recovered from side effects of major surgery >4 weeks prior to first dose

Trial locations and contacts

171 sites in 23 countries.

171 sites in 23 countries

China24 sites

  • Peking University Third Hospital-Hematology ( Site 0659)

    Beijing, Beijing Municipality, 100191

  • Chinese Academy of medical science, Peking Union Medical College Hospital(Dongdan) ( Site 0675)

    Beijing, Beijing Municipality, 100730

  • The First Afflilated Hospital of Bengbu Medical College ( Site 0651)

    Bengbu, Anhui, 233004

  • The First Hospital of Jilin University-Hematology ( Site 0672)

    Changchun, Jilin, 130021

  • West China Hospital, Sichuan University ( Site 0661)

    Chengdu, Sichuan, 610041

  • Chongqing University Cancer Hospital ( Site 0666)

    Chongqing, Chongqing Municipality, 400030

  • Sun Yat-sen Memorial Hospital, Sun Yat-sen University-hematology department ( Site 0668)

    Guangzhou, Guangdong, 510120

  • Southern Medical University Nanfang Hospital-Department of Hematopathology ( Site 0655)

    Guangzhou, Guangdong, 510515

  • The first Affiliated Hospital, Zhejiang University School of Medicine ( Site 0646)

    Hangzhou, Zhejiang, 310000

  • Anhui Provincial Hospital ( Site 0657)

    Hefei, Anhui, 230001

  • Jinan Central Hospital ( Site 0667)

    Jinan, Shandong, 250013

  • The First affiliated hospital of Nanchang University (Xianghu campus) ( Site 0645)

    Nanchang, Jiangxi, 330209

  • The Second Affiliated Hospital of Fujian Medical University ( Site 0671)

    Quanzhou, Fujian, 362000

  • Zhongshan Hospital,Fudan University-Hematology ( Site 0674)

    Shanghai, Shanghai Municipality, 200032

  • Huashan Hospital, Fudan University ( Site 0669)

    Shanghai, Shanghai Municipality, 200040

  • The Second Afilliated Hospital of Hebei Medical University ( Site 0650)

    Shijiazhuang, Hebei, 050000

  • The First Hospital of Hebei Medical University ( Site 0649)

    Shijiazhuang, Hebei, 050031

  • The First Affiliated Hospital of Soochow University ( Site 0676)

    Suzhou, Jiangsu, 215006

  • Institute of hematology&blood disease hospital-Hematology ( Site 0641)

    Tianjin, Tianjin Municipality, 301636

  • Union Hospital Tongji Medical College Huazhong University of Science and Technology ( Site 0642)

    Wuhan, Hubei, 430022

  • Shaanxi provincial people's hospital ( Site 0652)

    Xi'an, Shaanxi, 710068

  • The First Affiliated hospital of Xiamen University ( Site 0658)

    Xiamen, Fujian, 361003

  • Zhejiang University School of Medicine-The Fourth Affiliated Hospital ( Site 0662)

    Yiwu, Zhejiang, 322000

  • Henan Cancer Hospital-hematology department ( Site 0644)

    Zhengzhou, Henan, 450008

Other trials in China

United States22 sites

  • Texas Oncology - West Texas ( Site 8003)

    Amarillo, Texas, 79124

  • University of Michigan ( Site 0003)

    Ann Arbor, Michigan, 48109

  • Levine Cancer Institute ( Site 0009)

    Charlotte, North Carolina, 28204

  • University of Virginia ( Site 0020)

    Charlottesville, Virginia, 22908

  • The Ohio State University Wexner Medical Center ( Site 0028)

    Columbus, Ohio, 43210

  • Texas Oncology - DFW ( Site 8006)

    Dallas, Texas, 75246

  • Duke University Health System (DUHS) ( Site 0012)

    Durham, North Carolina, 27710

  • Oncology Associates of Oregon, P.C.(Willamette Valley Cancer Institute) (WVCI) ( Site 8005)

    Eugene, Oregon, 97401

  • Parkview Research Center at Parkview Regional Medical Center ( Site 0006)

    Fort Wayne, Indiana, 46845

  • Palo Verde Cancer Specialists ( Site 0052)

    Glendale, Arizona, 85304

  • Los Angeles Cancer Network ( Site 0025)

    Glendale, California, 91206

  • Exempla Lutheran Medical Center ( Site 0014)

    Golden, Colorado, 80401

  • University of Texas MD Anderson Cancer Center ( Site 0026)

    Houston, Texas, 77030

  • Optum Care Cancer Center ( Site 0053)

    Las Vegas, Nevada, 89102

  • TriStar Bone Marrow ( Site 7000)

    Nashville, Tennessee, 37203

  • Yale University School of Medicine ( Site 0051)

    New Haven, Connecticut, 06510

  • Stanford Cancer Center ( Site 0024)

    Palo Alto, California, 94304

  • Oregon Health & Science University ( Site 0018)

    Portland, Oregon, 97239

  • VCU Health Adult Outpatient Pavillion ( Site 0008)

    Richmond, Virginia, 23219

  • University of Texas Health Science Center at San Antonio ( Site 0021)

    San Antonio, Texas, 78229

  • Texas Oncology - Gulf Coast ( Site 8008)

    Webster, Texas, 77598

  • Wake Forest Baptist Health-Internal Medicine, Section on Hematology & Oncology ( Site 0013)

    Winston-Salem, North Carolina, 27157

Other trials in United States

Japan16 sites

  • Juntendo University Hospital ( Site 0611)

    Bunkyo-ku, Tokyo, 113-8431

  • University of Yamanashi Hospital ( Site 0606)

    Chūō, Yamanashi, 409-3898

  • Kyushu University Hospital ( Site 0605)

    Fukuoka, 812-8582

  • Fukushima Medical University Hospital ( Site 0616)

    Fukushima, 960-1295

  • Kansai Medical University Hospital ( Site 0607)

    Hirakata, Osaka, 573-1191

  • Kanazawa University Hospital ( Site 0614)

    Kanazawa, Ishikawa-ken, 920-8641

  • Kobe City Medical Center General Hospital ( Site 0603)

    Kobe, Hyōgo, 650-0047

  • University of Miyazaki Hospital ( Site 0609)

    Miyazaki, 889-1692

  • Okayama University Hospital ( Site 0604)

    Okayama, 700-8558

  • Kindai University Hospital ( Site 0600)

    Sakai, Osaka, 590-0197

  • Hokkaido University Hospital ( Site 0601)

    Sapporo, Hokkaido, 060-8648

  • National Hospital Organization Sendai Medical Center ( Site 0617)

    Sendai, Miyagi, 983-8520

  • Nippon Medical School Hospital ( Site 0608)

    Tokyo, 113-8603

  • Ehime University Hospital ( Site 0612)

    Tōon, Ehime, 791-0295

  • Fujita Health University Hospital ( Site 0613)

    Toyoake, Aichi-ken, 470-1192

  • Mie University Hospital ( Site 0615)

    Tsu, Mie-ken, 514-8507

Other trials in Japan

France10 sites

  • HENRI MONDOR HOSPITAL ( Site 0348)

    Créteil, Val-de-Marne, 94010

  • Centre Hospitalier Universitaire de Limoges - Hôpital Dupuytren ( Site 0344)

    Limoges, Haute-Vienne, 87042

  • Hôpital de la Conception ( Site 0351)

    Marseille, Bouches-du-Rhone, 13005

  • Centre Hospitalier Universitaire de Nantes - L' Hopital l'hôtel-Dieu ( Site 0347)

    Nantes, Pays de la Loire Region, 44093

  • Centre Hospitalier Universitaire de Nice - Hôpital l'Archet-Hematology ( Site 0349)

    Nice, Alpes-Maritimes, 06202

  • Hopital Saint-Louis ( Site 0341)

    Paris, 75010

  • CHU Bordeaux Haut-Leveque-service de mèdecine interne et maladies infectieuses ( Site 0346)

    Pessac, Aquitaine, 33600

  • centre hospitalier lyon sud ( Site 0343)

    Pierre-Bénite, Rhone, 69310

  • Institut Universitaire du Cancer Toulouse - Oncopole - CHU de TOULOUSE ( Site 0352)

    Toulouse, Haute-Garonne, 31059

  • Centre Hospitalier Régional Universitaire de Tours - Hôpital-Hématologie et Thérapie Cellulaire ( Site 0342)

    Tours, Indre-et-Loire, 37000

Other trials in France

Spain10 sites

  • Hospital Germans Trias i Pujol-Instituto Catalán de Oncología de Badalona ( Site 0490)

    Badalona, Barcelona, 08916

  • HOSPITAL CLÍNIC DE BARCELONA ( Site 0481)

    Barcelona, Catalonia, 08036

  • Hospital Universitari Vall d'Hebron-Departamento de Oncologia- VHIO ( Site 0489)

    Barcelona, 08035

  • Institut Català d'Oncologia - L'Hospitalet ( Site 0482)

    L'Hospitalet de Llobregat, Barcelona, 08908

  • Clinica Universidad de Navarra-Hematology Department ( Site 0485)

    Madrid, Madrid, Comunidad de, 28027

  • Hospital Universitario Ramón y Cajal-Hematology ( Site 0484)

    Madrid, Madrid, Comunidad de, 28034

  • Hospital Universitario 12 de Octubre ( Site 0494)

    Madrid, 28041

  • Hospital Costa del Sol-Hematology Service ( Site 0493)

    Marbella, Malaga, 29603

  • Hospital Universitario de Salamanca - Complejo Asistencial Universitario de Salamanca-Hematology ( Site 0488)

    Salamanca, 37007

  • Hospital Universitario Marqués de Valdecilla-Haematology ( Site 0486)

    Santander, Cantabria, 39008

Other trials in Spain

Turkey (Türkiye)10 sites

  • Dr. Abdurrahman Yurtaslan Ankara Onkoloji Egitim ve Arastırma Hastanesi-Hemotology ( Site 0510)

    Ankara, 06200

  • Hacettepe Universite Hastaneleri-Department of Hematology ( Site 0505)

    Ankara, 06230

  • Ankara Bilkent Şehir Hastanesi-Medical Oncology ( Site 0502)

    Ankara, 06800

  • Ankara UTF Cebeci Arastırma ve Uygulama Hastanesi ( Site 0511)

    Ankara, 6620

  • Antalya Egitim ve Arastırma Hastanesi ( Site 0508)

    Antalya, 07100

  • Ege Universitesi Hastanesi ( Site 0503)

    Bornova, İzmir, 35100

  • Trakya University Medical Faculty Hospital-Hematology ( Site 0501)

    Edirne, 22030

  • Medipol Mega Universite Hastanesi ( Site 0504)

    Istanbul, 34214

  • Kocaeli Üniversitesi-Hematology ( Site 0506)

    Kocaeli, 41380

  • Ondokuz Mayıs Universitesi-hematology ( Site 0507)

    Samsun, 55139

Other trials in Turkey (Türkiye)

Israel9 sites

  • Soroka Medical Center ( Site 0427)

    Beersheba, 8410101

  • Rambam Health Care Campus ( Site 0429)

    Haifa, 3109601

  • Carmel Hospital ( Site 0426)

    Haifa, 3436212

  • Hadassah Medical Center ( Site 0424)

    Jerusalem, 9112001

  • Galilee Medical Center ( Site 0431)

    Nahariya, 2201202

  • Rabin Medical Center ( Site 0425)

    Petah Tikva, 4941492

  • Sheba Medical Center ( Site 0428)

    Ramat Gan, 5265601

  • Sourasky Medical Center ( Site 0422)

    Tel Aviv, 6423906

  • Yitzhak Shamir Medical Center. ( Site 0421)

    Ẕerifin, 7033001

Other trials in Israel

United Kingdom9 sites

  • Glan Clwyd Hospital ( Site 0528)

    Bodelwyddan, Denbighshire, LL18 5UJ

  • Boston Pilgrim Hospital ( Site 0525)

    Boston, Lincolnshire, PE21 9QS

  • Gloucestershire Royal Hospital ( Site 0521)

    Gloucester, Gloucestershire, Gl1 3NN

  • Lincoln County Hospital ( Site 0535)

    Lincoln, Great Britain, LN2 5QY

  • University College London Hospital ( Site 0527)

    London, London, City of, NW1 2PG

  • Guy's & St Thomas' NHS Foundation Trust ( Site 0523)

    London, London, City of, SE1 9RT

  • Hammersmith Hospital ( Site 0533)

    London, London, City of, W12 OHS

  • Freeman Hospital ( Site 0532)

    Newcastle upon Tyne, NE7 7DN

  • Royal Gwent Hospital ( Site 0524)

    Newport, NP20 2EF

Other trials in United Kingdom

Germany8 sites

  • Universitätsklinikum Aachen ( Site 0367)

    Aachen, North Rhine-Westphalia, 52074

  • Charité Universitaetsmedizin Berlin - Campus Mitte ( Site 0369)

    Berlin, 13353

  • Universitaetsklinikum Essen ( Site 0366)

    Essen, North Rhine-Westphalia, 45147

  • Universitätsklinikum Halle ( Site 0361)

    Halle, Saxony-Anhalt, 06120

  • Medizinische Hochschule Hannover ( Site 0371)

    Hanover, Lower Saxony, 30625

  • Universitätsklinikum Jena-Klinik für Innere Medizin II, Abt. Hämatologie und Internistische Onkolog ( Site 0364)

    Jena, Thuringia, 07747

  • VK&K Studien GbR ( Site 0370)

    Landshut, Bavaria, 84036

  • Universitätsmedizin Johannes Gutenberg Universität Mainz-3. Medizinische Klinik und Poliklinik ( Site 0365)

    Mainz, Rhineland-Palatinate, 55131

Other trials in Germany

Italy7 sites

  • Azienda Ospedaliero-Universitaria SS. Antonio e Biagio e Cesare Arrigo ( Site 0443)

    Alessandria, 15121

  • IRCCS Azienda Ospedaliero-Universitaria di Bologna, Policlinico di Sant'Orsola ( Site 0446)

    Bologna, 40138

  • Azienda Ospedaliera Universitaria Careggi ( Site 0441)

    Florence, Tuscany, 50134

  • Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico ( Site 0447)

    Milan, 20122

  • Fondazione IRCCS Policlinico San Matteo-Oncology ( Site 0444)

    Pavia, 27100

  • Fondazione Policlinico Universitario Agostino Gemelli IRCCS - Università Cattolica del Sacro Cuore ( Site 0445)

    Roma, 00168

  • Ospedale di Circolo e Fondazione Macchi Varese ( Site 0442)

    Varese, 21100

Other trials in Italy

Chile6 sites

  • Biocenter ( Site 0149)

    Concepción, Biobio, 4070196

  • IC La Serena Research ( Site 0150)

    La Serena, Coquimbo Region, 1720430

  • FALP-UIDO ( Site 0148)

    Santiago, Region M. de Santiago, 7500921

  • Clínica Inmunocel ( Site 0147)

    Santiago, Region M. de Santiago, 7580206

  • Clínica Alemana de Santiago ( Site 0143)

    Santiago, Region M. de Santiago, 7650568

  • Bradfordhill-Clinical Area ( Site 0142)

    Santiago, Region M. de Santiago, 8420383

Other trials in Chile

Australia5 sites

  • Royal Adelaide Hospital-Haematology Clinical Trials Unit ( Site 0203)

    Adelaide, South Australia, 5000

  • Monash Health-Haematology Research ( Site 0202)

    Clayton, Victoria, 3168

  • Austin Health-Cancer Clinical Trials Centre ( Site 0206)

    Heidelberg, Victoria, 3084

  • Royal Perth Hospital-Haematology ( Site 0204)

    Perth, Western Australia, 6000

  • Westmead Hospital ( Site 0201)

    Westmead, New South Wales, 2115

Other trials in Australia

Hungary5 sites

  • Debreceni Egyetem Klinikai Kozpont-Belgyógyászati Klinika (Haematologia) ( Site 0402)

    Debrecen, 4032

  • Petz Aladar Egyetemi Oktato Korhaz-Hematológia ( Site 0405)

    Győr, Győr-Moson-Sopron, 9024

  • Somogy Vármegyei Kaposi Mór Oktató Kórház-Haematológiai osztály ( Site 0406)

    Kaposvár, Somogy County, 7400

  • Szabolcs-Szatmár-Bereg Megyei Kórházak és Egyetemi Oktatókór-Haematológia osztály ( Site 0404)

    Nyíregyháza, Szabolcs-Szatmár-Bereg, 4400

  • Szegedi Tudományegyetem Szent-Györgyi Albert Klinikai Központ-Belgyógyászati Klinika ( Site 0407)

    Szeged, Csongrád megye, 6725

Other trials in Hungary

Sweden5 sites

  • Sahlgrenska Universitetssjukhuset-Department of hematology and coagulation ( Site 0543)

    Gothenburg, Västra Götaland County, 413 45

  • Karolinska Universitetssjukhuset Huddinge ( Site 0541)

    Huddinge, Stockholm County, 141 86

  • Skånes Universitetssjukhus Lund-Department of Hematology ( Site 0544)

    Lund, Skåne County, 22185

  • Universitetssjukhuset Örebro ( Site 0542)

    Örebro, Örebro County, 701 85

  • Akademiska sjukhuset ( Site 0545)

    Uppsala, Uppsala County, 751 85

Other trials in Sweden

Argentina4 sites

  • Hospital Italiano de Buenos Aires ( Site 0102)

    ABB, Buenos Aires F.D., C1199ABB

  • Hospital Universitario Austral ( Site 0101)

    Pilar, Buenos Aires, B1629AHJ

  • C.I.C.E. 9 de Julio ( Site 0104)

    San Miguel de Tucumán, Tucumán Province, T4000IKO

  • Clínica de Nefrología, Urología y Enfermedades Cardiovasculares ( Site 0105)

    Santa Fe, 3000

Other trials in Argentina

Denmark4 sites

  • Aarhus Universitetshospital, Skejby-Blodsygdomme ( Site 0324)

    Aarhus, Central Jutland, 8200

  • Rigshospitalet-Hematology - CTU ( Site 0321)

    Copenhagen, Capital Region, 2100

  • Odense Universitetshospital-Department of Hematology ( Site 0325)

    Odense C, Region Syddanmark, 5000

  • Roskilde Sygehus-Department of Hematology ( Site 0323)

    Roskilde, Region Sjælland, 4000

Other trials in Denmark

Taiwan4 sites

  • Chang Gung Memorial Hospital- Chiayi ( Site 0242)

    Chiayi City, Chiayi, 613

  • National Cheng Kung University Hospital-Clinical Trial Center ( Site 0245)

    Tainan, 704

  • National Taiwan University Hospital ( Site 0241)

    Taipei, 10002

  • Chang Gung Medical Foundation-Linkou Branch ( Site 0243)

    Taoyuan, 33305

Other trials in Taiwan

Colombia3 sites

  • Los Cobos Medical Center ( Site 0165)

    Bogotá, Bogota D.C., 110121

  • Fundacion Colombiana de Cancerología Clinica Vida ( Site 0164)

    Medellín, Antioquia, 050030

  • IMAT S.A.S ( Site 0162)

    Montería, Departamento de Córdoba, 230002

Other trials in Colombia

Mexico3 sites

  • Medivest Centro de Investigación Integral ( Site 0183)

    Chihuahua City, Chihuahua, 31203

  • Higiea Oncologia ( Site 0184)

    Mexico City, Mexico City, 11819

  • Centro de Investigacion Clinica de Oaxaca ( Site 0181)

    Oaxaca City, Oaxaca, 68020

Other trials in Mexico

Poland3 sites

  • Pratia Onkologia Katowice ( Site 0461)

    Katowice, Silesian Voivodeship, 40-519

  • Swietokrzyskie Centrum Onkologii, Samodzielny Publiczny Zakl-Klinika Hematologii i Transplantacji S ( Site 0466)

    Kielce, Świętokrzyskie Voivodeship, 25-734

  • Samodzielny Publiczny Szpital Kliniczny nr 1 w Lublinie-Oddział Hematoonkologii, Transplantacji Szp ( Site 0463)

    Lublin, Lublin Voivodeship, 20-081

Other trials in Poland

Canada2 sites

  • Arthur J.E. Child Comprehensive Cancer Centre ( Site 0038)

    Calgary, Alberta, T2N 5G2

  • Centre Intégré de Santé et de Services Sociaux de la Montérégie-Centre ( Site 0037)

    Greenfield Park, Quebec, J4V 2H1

Other trials in Canada

Austria1 site

  • Ordensklinikum Linz GmbH Elisabethinen ( Site 0562)

    Linz, Upper Austria, 4020

Other trials in Austria

Hong Kong1 site

  • Queen Mary Hospital ( Site 0221)

    Hksar

Other trials in Hong Kong

About this study

Official title: A Phase 3, Randomized, Double-blind, Active-Comparator-Controlled Clinical Study to Evaluate the Efficacy and Safety of Bomedemstat (MK-3543) Versus Hydroxyurea in Cytoreductive Therapy Naïve Essential Thrombocythemia Participants

The purpose of this study is to evaluate the efficacy and safety of bomedemstat compared with hydroxyurea in cytoreductive therapy naïve essential thrombocythemia (ET) participants for whom cytoreductive therapy is indicated. Its primary objective is to compare bomedemstat to hydroxyurea with respect to durable clinicohematologic response (DCHR). The primary hypothesis is that bomedemstat is superior to hydroxyurea with respect to DCHR.

Being tested
Bomedemstat, Hydroxyurea, Bomedemstat placebo, Hydroxyurea placebo
Keywords
essential thrombocythemia, ET, bomedemstat, IMG-7289
Medical subject headings
Thrombocythemia, Essential

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • BomedemstatDrug

    Also called MK-3543, IMG-7289, bomedemstat tosylate

    Oral capsule

  • HydroxyureaDrug

    Oral capsule

  • Bomedemstat placeboDrug

    Oral capsule placebo

  • Hydroxyurea placeboDrug

    Oral capsule placebo

Study groups in NCT06456346
Study groupRoleWhat they receive
BomedemstatExperimentalParticipants will receive active bomedemstat and hydroxyurea placebo daily for up to approximately 52 weeks. 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. Participants who complete treatment at Week 52 will be eligible to continue treatment in the extended treatment phase. Unblinding will occur and placebo discontinued once all participants have completed at least 52 weeks of therapy or otherwise discontinued.
Receives: Drug: Bomedemstat; Drug: Hydroxyurea placebo
HydroxyureaActive comparatorParticipants will receive active hydroxyurea and bomedemstat placebo daily for up to 52 weeks. 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. Participants who complete treatment at Week 52 will be eligible to continue treatment in the extended treatment phase. Unblinding will occur and placebo discontinued once all participants have completed at least 52 weeks of therapy or otherwise discontinued.
Receives: Drug: Hydroxyurea; Drug: Bomedemstat placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  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, starting by Week 24 and maintained for at least 24 weeks, 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.

    Measured: Up to approximately 52 weeks

Secondary outcomes (12)

  1. Clinicohematologic Response (CHR) Rate

    CHR rate is the percentage of participants with CHR, 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, starting by Week 12 and maintained for at least 12 weeks, 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.

    Measured: Up to approximately 52 weeks

  2. Hematologic Response (HR) Rate

    HR rate is the percentage of participants with HR, HR is defined as the time from the first confirmed hematologic response to first documented evidence of confirmed platelet increase or confirmed WBC increase after latest confirmed hematologic response date.

    Measured: Up to approximately 52 weeks

  3. Change From Baseline in Patient-reported Outcomes Measurement Information System (PROMIS) Fatigue SF-7a Total Fatigue Score

    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. The total score is used in the analysis and is obtained by summing keyed scores of all items. Scores can range from 7 to 35, with higher scores indicating greater fatigue.

    Measured: Baseline and pre-specified timepoints up to Week 52

  4. Change From Baseline in MFSAF v4.0 Total Symptom Score

    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. The change from baseline in MFSAF total score for all symptoms will be presented.

    Measured: Baseline and pre-specified timepoints up to Week 52

  5. Duration of Durable Clinicohematologic Response (DODCHR)

    For participants who demonstrate DCHR, DODCHR 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, locally assessed to be due to ET after latest confirmed hematologic response date or thrombotic or major hemorrhagic events or disease progression to MF, MDS or AML.

    Measured: Up to approximately 52 weeks

  6. Duration of Clinicohematologic Response (DOCHR)

    For participants who demonstrate CHR, 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, locally assessed to be due to ET after latest confirmed hematologic response date or thrombotic or major hemorrhagic events or disease progression to MF, MDS or AML.

    Measured: Up to approximately 52 weeks

  7. Duration of Hematologic Response (DOHR)

    For participants who show confirmed hematologic response, DOHR is defined as the time from the first confirmed hematologic response to first documented evidence of confirmed platelet increase or confirmed WBC increase after latest confirmed hematologic response date.

    Measured: Up to approximately 52 weeks

  8. Percentage of Participants Who Experience Thrombotic Events

    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.

    Measured: Up to approximately 52 weeks

  9. Percentage of Participants Who Experience Major Hemorrhagic Events

    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.

    Measured: Up to approximately 52 weeks

  10. Percentage of Participants with Disease Progression to post-essential thrombocythemia myelofibrosis or myelodysplastic syndrome (MDS) /acute myeloid leukemia (AML)

    Disease progression rate is the percentage of participants with disease progression, defined as the transformation to post-essential thrombocythemia myelofibrosis, myelodysplastic syndrome, or AML as assessed by the adjudication committee.

    Measured: Up to approximately 52 weeks

  11. Number of Participants Who Experience One or More Adverse Events (AEs)

    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.

    Measured: Up to approximately 52 weeks

  12. Number of Participants Who Discontinue Study Intervention Due to an AE

    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.

    Measured: Up to approximately 52 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Jun 2024
  2. Study start16 Jul 2024
  3. Primary completion28 Sep 2027 (estimated)
  4. Study completion24 Mar 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
300 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06456346
Sponsor's protocol ID
3543-007
Other IDs
2023-505232-36-00, MK-3543-007, jRCT2031240181, U1111-1290-8287, 2023
Status last verified
Aug 2026
First submitted
7 Jun 2024
Last updated
27 Aug 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Bomedemstat and Hydroxyurea in people with Essential Thrombocythemia, run by Merck Sharp & Dohme LLC at 171 sites in 23 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 27 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 171 sites in China, United States, Japan, France, Spain and 18 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Durable Clinicohematologic Response (DCHR) Rate (time frame: Up to approximately 52 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06456346.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Aug 2026.

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