Bomedemstat vs Hydroxyurea for Essential Thrombocythemia

• Research type

  Research Study

• Full 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

• IRAS ID

  1009600

• Contact name

  - -

• Contact email

  N/A

• Sponsor organisation

  Merck Sharp & Dohme LLC

• Clinicaltrials.gov Identifier

  NCT06456346

• Research summary

  Researchers are looking for new ways to treat essential thrombocythemia (ET). ET is a rare type of blood disease in which the body makes too many platelets. Platelets are cells that help blood clot. ET can raise the chance of having blood clots or bleeding problems.

  People with ET are usually treated with hydroxyurea (standard treatment). However, hydroxyurea may not work for some people. Bomedemstat is a trial treatment designed to treat ET.

  The goal of this trial is to compare bomedemstat to hydoxyurea to learn if more people who take bomedemstat have the following response:
  • Lower the number of platelets
  • Lower the number of white blood cells (if a person’s white blood cells were high)
  • Prevent blood clots, major bleeding problems, or ET leading to other blood diseases

  About 300 people with ET, aged at least 18 years old, will be in this trial and:
  • Have not previously received treatment for ET that lowers the number of platelets (called cytoreductive treatment)
  • Have not had certain other cancers in the last 2 years

  People will take one of these treatments by mouth as a capsule:
  • Bomedemstat
  • Hydroxyurea

  This trial has 2 parts:
  • Part 1 (about 1 year): People will be assigned by equal chance to take either bomedemstat or hydroxyurea. After 1 year, researchers will review the data for safety and how well the treatments worked.
  • Part 2 (up to 2 more years): People will continue to take the same treatment they took in Part 1.

  In both Part 1 and Part 2, researchers may raise or lower the amount of bomedemstat that a person in the trial may take based on the numbers of their platelets and other blood cells.

  The trial is sponsored by Merck Sharp & Dohme LLC., a subsidiary of Merck & Co., Inc. (MSD).

• REC name

  North East - York Research Ethics Committee

• REC reference

  24/NE/0195

• Date of REC Opinion

  28 Oct 2024

• REC opinion

  Favourable Opinion