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NCT06351631RecruitingPhase 3

A Study to Evaluate Safety and Efficacy of Bomedemstat (MK-3543-017)

A Multicenter, Open-Label, Extension Study Evaluating the Safety and Efficacy of Bomedemstat for the Treatment of Participants Enrolled in a Prior Bomedemstat Clinical Study

Source: ClinicalTrials.gov · Last updated 2 Apr 2026

Brief summary (registry, in English)

The primary purpose of the study is to transition participants into an extension study to collect long-term safety and efficacy data. The study will include participants who are safely tolerating bomedemstat, receiving clinical benefit from its use in estimation of the investigator, and have shown the following criteria: * Participants from the IMG-7289-202/MK-3543-005 (NCT05223920) study must have received at least 6 months of treatment with bomedemstat; * Essential thrombocythemia (ET) and polycythemia vera (PV) participants from studies other than IMG-7289-202/MK-3543-005 must have achieved confirmed hematologic remission. No hypothesis testing will be conducted in this study.

Status (registry)
Recruiting
Phase (registry)
Phase 3
Study type
Interventional
Enrollment
400 (estimated)
First submitted
2 Apr 2024
Start date
23 May 2024
Primary completion date
4 Dec 2034
Lead sponsor
Merck Sharp & Dohme LLC
NCT number
NCT06351631
EU CT number
2023-506996-89-00

What you commit to

  • Study type: Interventional · Phase 3
  • Planned participants: 400
  • From 23 May 2024 to the primary completion date, 4 Dec 2034
  • 21 sites in 6 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Has received prohibited concomitant medications
  • Has noncompliance in prior bomedemstat study receiving \<90% of assigned doses excluding suspensions or holds as assigned by the investigator

Other

  • Ongoing or planned participation in another investigational study

Who the study is looking for

  • Is from a bomedemstat study sponsored by Imago BioSciences, Inc. (a subsidiary of Merck \& Co., Inc.) or MSD, and established by the Sponsor as MK-3543-017 ready
  • Has received at least 6 months of treatment with bomedemstat in the IMG-7289-202/MK-3543-005 study, while safely tolerating bomedemstat, and receiving clinical benefit from its use in the estimation of the investigator
  • ET and PV participants from established feeder studies other than IMG-7289- 202/MK-3543-005 must have achieved confirmed hematologic remission, must be safely tolerating bomedemstat, and must be receiving clinical benefit from its use in the estimation of the investigator
  • Is not currently on a dose hold
  • Participant must be able to swallow oral medication and follow instructions for at-home dosing of bomedemstat

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (21)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Royal Adelaide Hospital-Haematology Clinical Trials Unit ( Site 1000)
Coordinator of this site? Confirm its status
AdelaideAustraliaRecruiting
Sunshine Coast Hematology and Oncology Clinic ( Site 1006)
Coordinator of this site? Confirm its status
BuderimAustraliaRecruiting
Royal Prince Alfred Hospital ( Site 1003)
Coordinator of this site? Confirm its status
CamperdownAustraliaRecruiting
Monash Health ( Site 1004)
Coordinator of this site? Confirm its status
ClaytonAustraliaRecruiting
Gold Coast University Hospital-Cancer and Blood Disorders Clinical Trial Team ( Site 1002)
Coordinator of this site? Confirm its status
SouthportAustraliaRecruiting
Royal North Shore Hospital ( Site 1001)
Coordinator of this site? Confirm its status
St LeonardsAustraliaRecruiting
Boston Pilgrim Hospital ( Site 3403)
Coordinator of this site? Confirm its status
BostonUnited KingdomRecruiting
University College London Hospital ( Site 3400)
Coordinator of this site? Confirm its status
LondonUnited KingdomRecruiting
Guy's & St Thomas' NHS Foundation Trust ( Site 3401)
Coordinator of this site? Confirm its status
LondonUnited KingdomRecruiting
Imperial College Healthcare NHS Trust - Hammersmith Hospital ( Site 3402)
Coordinator of this site? Confirm its status
LondonUnited KingdomRecruiting
Queen Mary Hospital ( Site 1601)
Coordinator of this site? Confirm its status
HksarHong Kong SAR ChinaActive, not recruiting
Azienda Ospedaliera Nazionale Ss Antonio E Biagio E C Arrigo Alessandria
Coordinator of this site? Confirm its status
AlexandriaItalyRecruiting
Azienda Ospedaliero-Universitaria Di Bologna IRCCS Istituto Di Ricerca E Di Cura A Carattere Scientifico
Coordinator of this site? Confirm its status
BolognaItalyRecruiting
Careggi University Hospital
Coordinator of this site? Confirm its status
FlorenceItalyRecruiting
Azienda Ospedaliera Ospedale Di Circolo E Fondazione Macchi
Coordinator of this site? Confirm its status
VareseItalyRecruiting
North Shore Hospital-Department of Haematology ( Site 1401)
Coordinator of this site? Confirm its status
AucklandNew ZealandActive, not recruiting
Aotearoa Clinical Trials ( Site 1400)
Coordinator of this site? Confirm its status
AucklandNew ZealandActive, not recruiting
University of Michigan ( Site 6000)
Coordinator of this site? Confirm its status
Ann ArborUnited StatesRecruiting
The James Cancer Hospital and Solove Research Institute at The Ohio State University Comprehensive C ( Site 6007)
Coordinator of this site? Confirm its status
ColumbusUnited StatesRecruiting
DUHS Duke Blood Cancer Center ( Site 6005)
Coordinator of this site? Confirm its status
DurhamUnited StatesRecruiting
UPMC Hillman Cancer Center ( Site 6004)
Coordinator of this site? Confirm its status
PittsburghUnited StatesRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.