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
- Diseases
- Myeloproliferative neoplasms
- 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
Sites (21)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Royal Adelaide Hospital-Haematology Clinical Trials Unit ( Site 1000) Coordinator of this site? Confirm its status | Adelaide | Australia | Recruiting |
| Sunshine Coast Hematology and Oncology Clinic ( Site 1006) Coordinator of this site? Confirm its status | Buderim | Australia | Recruiting |
| Royal Prince Alfred Hospital ( Site 1003) Coordinator of this site? Confirm its status | Camperdown | Australia | Recruiting |
| Monash Health ( Site 1004) Coordinator of this site? Confirm its status | Clayton | Australia | Recruiting |
| Gold Coast University Hospital-Cancer and Blood Disorders Clinical Trial Team ( Site 1002) Coordinator of this site? Confirm its status | Southport | Australia | Recruiting |
| Royal North Shore Hospital ( Site 1001) Coordinator of this site? Confirm its status | St Leonards | Australia | Recruiting |
| Boston Pilgrim Hospital ( Site 3403) Coordinator of this site? Confirm its status | Boston | United Kingdom | Recruiting |
| University College London Hospital ( Site 3400) Coordinator of this site? Confirm its status | London | United Kingdom | Recruiting |
| Guy's & St Thomas' NHS Foundation Trust ( Site 3401) Coordinator of this site? Confirm its status | London | United Kingdom | Recruiting |
| Imperial College Healthcare NHS Trust - Hammersmith Hospital ( Site 3402) Coordinator of this site? Confirm its status | London | United Kingdom | Recruiting |
| Queen Mary Hospital ( Site 1601) Coordinator of this site? Confirm its status | Hksar | Hong Kong SAR China | Active, not recruiting |
| Azienda Ospedaliera Nazionale Ss Antonio E Biagio E C Arrigo Alessandria Coordinator of this site? Confirm its status | Alexandria | Italy | Recruiting |
| Azienda Ospedaliero-Universitaria Di Bologna IRCCS Istituto Di Ricerca E Di Cura A Carattere Scientifico Coordinator of this site? Confirm its status | Bologna | Italy | Recruiting |
| Careggi University Hospital Coordinator of this site? Confirm its status | Florence | Italy | Recruiting |
| Azienda Ospedaliera Ospedale Di Circolo E Fondazione Macchi Coordinator of this site? Confirm its status | Varese | Italy | Recruiting |
| North Shore Hospital-Department of Haematology ( Site 1401) Coordinator of this site? Confirm its status | Auckland | New Zealand | Active, not recruiting |
| Aotearoa Clinical Trials ( Site 1400) Coordinator of this site? Confirm its status | Auckland | New Zealand | Active, not recruiting |
| University of Michigan ( Site 6000) Coordinator of this site? Confirm its status | Ann Arbor | United States | Recruiting |
| The James Cancer Hospital and Solove Research Institute at The Ohio State University Comprehensive C ( Site 6007) Coordinator of this site? Confirm its status | Columbus | United States | Recruiting |
| DUHS Duke Blood Cancer Center ( Site 6005) Coordinator of this site? Confirm its status | Durham | United States | Recruiting |
| UPMC Hillman Cancer Center ( Site 6004) Coordinator of this site? Confirm its status | Pittsburgh | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.