NCT06351631 A Study to Evaluate Safety and Efficacy of Bomedemstat (MK-3543-017)
| NCT ID | NCT06351631 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Merck Sharp & Dohme LLC |
| Condition | Thrombocythemia, Essential |
| Study Type | INTERVENTIONAL |
| Enrollment | 400 participants |
| Start Date | 2024-05-23 |
| Primary Completion | 2034-12-04 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 400 participants in total. It began in 2024-05-23 with a primary completion date of 2034-12-04.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
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
Contact & Investigator
Medical Director
STUDY DIRECTOR
Merck Sharp and Dohme LLC
Frequently Asked Questions
Who can join the NCT06351631 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Thrombocythemia, Essential. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06351631 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 400 participants.
Is NCT06351631 currently recruiting?
Yes, NCT06351631 is actively recruiting participants. Contact the research team at Trialsites@msd.com for enrollment information.
Where is the NCT06351631 trial being conducted?
This trial is being conducted at Ann Arbor, United States, Durham, United States, Columbus, United States, Pittsburgh, United States and 11 additional locations.
Who is sponsoring the NCT06351631 clinical trial?
NCT06351631 is sponsored by Merck Sharp & Dohme LLC. The principal investigator is Medical Director at Merck Sharp and Dohme LLC. The trial plans to enroll 400 participants.