What is bomedemstat studying for essential thrombocythemia?

Bomedemstat is being studied to see if it is better than current best treatments for adults with essential thrombocythemia who do not respond well to or cannot tolerate hydroxyurea. The trial compares bomedemstat to other approved therapies to understand its safety and lasting effects on blood counts and symptoms.

Who may be eligible for this essential thrombocythemia clinical trial?

Adults aged 18 years and older with a confirmed diagnosis of essential thrombocythemia and a history of poor response or intolerance to hydroxyurea may be eligible. Both men and women can participate. Participants should have specific blood counts and no certain allergies or bleeding risks. Please review eligibility criteria for more details.

Is there any cost to participate in this essential thrombocythemia clinical trial?

Study-related care, including the study drug or procedure and all trial visits, is provided at no cost. Personal travel expenses may vary and are not guaranteed to be covered. Participants should plan accordingly for any travel or lodging costs.

Actively Recruiting

Phase 3

Age: 18Years +

All Genders

ID06079879

A Phase 3 Study Comparing Bomedemstat MK-3543IMG-7289 to Best Available Therapy in Adults With Essential Thrombocythemia Not Responding to Hydroxyurea

Led by Merck Sharp & Dohme LLC · Updated on 2026-06-01

340

Participants Needed

163

Research Sites

55 weeks

Total Duration

AI-Summary

What this Trial Is About

Researchers are evaluating the safety and effectiveness of bomedemstat MK-3543 compared to the best available therapy BAT in adults with essential thrombocythemia ET who have not responded well to or cannot tolerate hydroxyurea. The study aims to determine if bomedemstat provides a better lasting clinical and blood response than current treatments. This is a phase 3, randomized, open-label trial sponsored by Merck Sharp Dohme LLC. Participants will be randomly assigned to receive either bomedemstat or one of several approved therapies including anagrelide, busulfan, interferon alfa or pegylated forms, or ruxolitinib. Bomedemstat will start at 50 mg daily, with dose adjustments to safely lower platelet counts. Each participant will be treated daily for up to 52 weeks, with an option to continue an extended treatment phase up to 156 weeks. Those initially on BAT who stop responding may switch to bomedemstat during the extension. During the study, participants will have regular assessments of blood counts, symptoms, and side effects. Researchers will measure the durable clinicohematologic response over about 52 weeks as the main outcome. Other outcomes include symptom changes, event rates like thrombosis or bleeding, disease progression, and safety up to 180 weeks. The study includes monitoring of fatigue and quality of life using patient questionnaires to understand treatment impact over time.

CONDITIONS

Brief Title

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)

Who Can Participate

Age: 18Years +

All Genders

Eligibility Criteria

You may qualify if you...

Adults aged 18 years or older
Diagnosis of essential thrombocythemia confirmed by WHO 2016 criteria
Bone marrow fibrosis Grade 0 or 1 according to European Consensus Criteria
History of inadequate response or intolerance to hydroxyurea
Platelet count greater than 450 x 10^9/L before first dose
Absolute neutrophil count at least 0.75 x 10^9/L before first dose
May have received up to 3 prior cytoreductive treatments including hydroxyurea

You will not qualify if you...

Allergy or intolerance to bomedemstat, related drugs, or best available therapy options
History of gastrointestinal conditions affecting drug absorption or increased risk from participation
Evidence of increased bleeding risk at screening
History of malignancy unless treated and no evidence for 2 years, except certain skin cancers or carcinoma in situ
HIV infection with history of Kaposi's sarcoma or Multicentric Castleman's Disease

Research Team

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