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)
Launched by MERCK SHARP & DOHME LLC · Oct 6, 2023
Trial Information
Current as of June 27, 2025
Recruiting
Keywords
ClinConnect Summary
This clinical trial is studying a new medication called bomedemstat (also known as MK-3543) to see if it works better than the best available treatments for people with essential thrombocythemia (ET), a condition where the body makes too many platelets. This study is for individuals who have not responded well to or could not tolerate another common medication called hydroxyurea. The main goal is to determine if bomedemstat can provide a longer-lasting beneficial effect on blood counts compared to other treatments.
To participate, individuals need to be diagnosed with ET and show that they had issues with hydroxyurea. They should also have specific blood test results indicating high platelet counts. People who are not eligible include those with certain allergic reactions to related medications, significant gastrointestinal issues, or a history of certain cancers. Participants can expect to receive either bomedemstat or the best available treatment and will be monitored closely for safety and effectiveness throughout the trial. This study is currently recruiting participants aged 65 and older, and it welcomes individuals of any gender.
Gender
ALL
Eligibility criteria
- 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
About Merck Sharp & Dohme Llc
Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., is a leading global biopharmaceutical company dedicated to discovering, developing, and delivering innovative medicines and vaccines that address unmet medical needs. With a strong focus on research and development, Merck Sharp & Dohme leverages advanced science and technology to enhance patient outcomes across various therapeutic areas, including oncology, infectious diseases, and cardiovascular health. Committed to ethical practices and regulatory compliance, the company actively engages in clinical trials to advance medical knowledge and improve health care for patients worldwide.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Huddinge, Stockholms Lan, Sweden
Kielce, Swietokrzyskie, Poland
Jerusalem, , Israel
Ramat Gan, , Israel
Tel Aviv, , Israel
St Albans, Victoria, Australia
Adelaide, South Australia, Australia
Hksar, , Hong Kong
Zerifin, , Israel
Bunkyo Ku, Tokyo, Japan
Auckland, , New Zealand
Camperdown, New South Wales, Australia
Melbourne, Victoria, Australia
Auckland, , New Zealand
Chuo, Yamanashi, Japan
Miyazaki, , Japan
Tainan, , Taiwan
Taipei, , Taiwan
Clayton, Victoria, Australia
Perth, Western Australia, Australia
Seoul, , Korea, Republic Of
Detroit, Michigan, United States
St Leonards, New South Wales, Australia
Seongnam, Kyonggi Do, Korea, Republic Of
Madrid, , Spain
Valencia, , Spain
Haifa, , Israel
Zerifin, , Israel
Ancona, , Italy
Fukuoka, , Japan
Santiago De Compostela, La Coruna, Spain
Madrid, Madrid, Comunidad De, Spain
Malaga, , Spain
Salamanca, , Spain
Taoyuan, , Taiwan
Meldola, Emilia Romagna, Italy
Seoul, , Korea, Republic Of
Hoofddorp, Noord Holland, Netherlands
Katowice, Slaskie, Poland
Barcelona, Cataluna, Spain
Halle, Sachsen Anhalt, Germany
Firenze, Toscana, Italy
Varese, , Italy
Dordrecht, Zuid Holland, Netherlands
Marbella, Malaga, Spain
Chiayi City, Chiayi, Taiwan
Winston Salem, North Carolina, United States
Tours, Indre Et Loire, France
Aachen, Nordrhein Westfalen, Germany
Alessandria, , Italy
Hirakata, Osaka, Japan
Osakasayama, Osaka, Japan
Groningen, , Netherlands
Badalona, Barcelona, Spain
Barcelona, , Spain
örebro, Orebro Lan, Sweden
Ankara, , Turkey
Kocaeli, , Turkey
Samsun, , Turkey
Durham, North Carolina, United States
Pilar, Buenos Aires, Argentina
San Miguel De Tucumán, Tucuman, Argentina
Waratah, New South Wales, Australia
Montería, Cordoba, Colombia
Vandoeuvre Lès Nancy, Lorraine, France
Dresden, Sachsen, Germany
Budapest, , Hungary
Cona, Ferrara, Italy
Meldola, Forli Cesena, Italy
Milano, Lombardia, Italy
Torino, , Italy
Kobe, Hyogo, Japan
Tsu, Mie, Japan
Bunkyo Ku, Tokyo, Japan
Fukushima, , Japan
Seoul, , Korea, Republic Of
Lisbon, Lisboa, Portugal
Braga, , Portugal
Albacete, , Spain
Kaohsiung, , Taiwan
Taoyuan, , Taiwan
Ankara, , Turkey
Edirne, , Turkey
Moncton, New Brunswick, Canada
Rennes, Ille Et Vilaine, France
Reggio Emilia, , Italy
Sapporo, Hokkaido, Japan
Kanazawa, Ishikawa, Japan
Porto, , Portugal
L'hospitalet Del Llobregat, Barcelona, Spain
Antalya, , Turkey
Ann Arbor, Michigan, United States
Pierre Bénite, Rhone, France
Okayama, , Japan
Braga, , Portugal
Lisboa, , Portugal
Istanbul, , Turkey
Sendai, Miyagi, Japan
Beijing, Beijing, China
Quanzhou, Fujian, China
Guangzhou, Guangdong, China
Shijiazhuang, Hebei, China
Wuhan, Hubei, China
Nanchang, Jiangxi, China
Xian, Shaanxi, China
Jinan, Shandong, China
Shanghai, Shanghai, China
Tianjin, Tianjin, China
Yiwu, Zhejiang, China
Medellin, Antioquia, Colombia
Bogota, Distrito Capital De Bogota, Colombia
Paris, , France
Zerifin, , Israel
Toon, Ehime, Japan
Cambridge, Cambridgeshire, United Kingdom
Gwent, Newport, United Kingdom
Boston, Massachusetts, United States
Richmond, Virginia, United States
Abb, Caba, Argentina
Bengbu, Anhui, China
Guangzhou, Guangdong, China
Zhengzhou, Henan, China
Nantong, Jiangsu, China
Hangzhou, Zhejiang, China
Paris, Ile De France, France
Tours, Indre Et Loire, France
Győr, Gyor Moson Sopron, Hungary
Nyiregyhaza, Szabolcs Szatmar Bereg, Hungary
Debrecen, , Hungary
Pisa, Toscana, Italy
Castelfranco Veneto, Veneto, Italy
Toyoake, Aichi, Japan
Kashiwa, Chiba, Japan
Lincoln, Great Britain, United Kingdom
Boston, , United Kingdom
Changchun, Jilin, China
Yiwu, Zhejiang, China
Manchester, , United Kingdom
Hefei, Anhui, China
Liverpool, New South Wales, Australia
Cheng Du, Sichuan, China
Roubaix, Nord, France
Stanford, California, United States
Buffalo, New York, United States
Charlottesville, Virginia, United States
Nanjing, Jiangsu, China
Limoges, Limousin, France
Haifa, , Israel
Petah Tikva, , Israel
İzmir, , Turkey
Xiamen, Fujian, China
Be'er Sheva, , Israel
Fukushima, , Japan
London, London, City Of, United Kingdom
Glendale, California, United States
Torrance, California, United States
Shanghai, Shanghai, China
Toyoake, Aichi, Japan
Osakasayama, Osaka, Japan
Groningen, , Netherlands
Mersin, , Turkey
Aurora, Colorado, United States
Antwerpen, , Belgium
Beijing, Beijing, China
London, London, City Of, United Kingdom
London, London, City Of, United Kingdom
Charleston, South Carolina, United States
Ankara, , Turkey
Gloucester, Gloucestershire, United Kingdom
Monteria, Cordoba, Colombia
Alessandria, Ancona, Italy
Barcelona, Cataluna, Spain
Tours, Indre Et Loire, France
Limoges, Limousin, France
Kielce, Swietokrzyskie, Poland
Madrid, , Spain
Boston, Lincolnshire, United Kingdom
London, , United Kingdom
London, , United Kingdom
London, , United Kingdom
Patients applied
Trial Officials
Medical Director
Study Director
Merck Sharpe & Dohme LLC
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported