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

Launched by MERCK SHARP & DOHME LLC · Apr 2, 2024

Keywords

ClinConnect Summary

This clinical trial, titled "A Study to Evaluate Safety and Efficacy of Bomedemstat," focuses on gathering long-term information about the safety and effectiveness of a medication called bomedemstat for patients with certain blood disorders, including thrombocythemia and myelofibrosis. The trial aims to include participants who have already been treated with bomedemstat in a previous study for at least six months and have shown positive results without serious side effects.

To be eligible, participants must have been part of a specific bomedemstat study and should be able to take the medication regularly. Key requirements include safely tolerating bomedemstat and achieving a certain level of improvement in their condition. During the trial, participants can expect to continue taking bomedemstat and will be monitored closely for their health and response to the treatment. It's important to note that this study is currently recruiting participants, and no new treatment comparisons will be made within this phase.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 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
• Exclusion Criteria:
• • Has received prohibited concomitant medications
• • Ongoing or planned participation in another investigational study
• • Has noncompliance in prior bomedemstat study receiving \<90% of assigned doses excluding suspensions or holds as assigned by the investigator