Long-term bomedemstat use in people with blood disorders who took it before
Follows people with essential thrombocythemia or polycythemia vera who continue bomedemstat.
Plain-language title generated from the registry record
Registry title: A Study to Evaluate Safety and Efficacy of Bomedemstat (MK-3543-017)
Key facts
- Where
- Alexandria, Bologna, Florence, and Varese, ItalySee the 4 sites
- Phase
- Phase 3
Where in Italy
- Azienda Ospedaliera Nazionale Ss Antonio E Biagio E C Arrigo AlessandriaAlexandria, ItalyTaking people
- Azienda Ospedaliero-Universitaria Di Bologna IRCCS Istituto Di Ricerca E Di Cura A Carattere ScientificoBologna, ItalyTaking people
- Careggi University HospitalFlorence, ItalyTaking people
- Azienda Ospedaliera Ospedale Di Circolo E Fondazione MacchiVarese, ItalyTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Merck Sharp & Dohme LLC
- Trial code
- NCT06351631EU 2023-506996-89-00
- Record updated
- 10 November 2026
- Original description
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:Read full original descriptionShow less
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
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 response.
No hypothesis testing will be conducted in this study.
Inclusion: 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 response, 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.
Exclusion: 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; Ongoing or planned participation in another investigational study.