Phase 3: testing Bomedemstat for Thrombocythemia, Essential
The primary purpose of the study is to transition participants into an extension study to collect long-term safety and how well it works 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.
Official registry: https://clinicaltrials.gov/study/NCT06351631 · Merck Sharp & Dohme LLC · enrollment listed as 400
What this phase means
Phase 3: this treatment already looked useful in smaller studies. Now it is tested in a large group, often against standard care or a dummy treatment, to see if it should be approved.
Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.
What the registry says happens
If you join, the listed intervention(s) are Bomedemstat. The registry lists allocation as na. The primary purpose of the study is to transition participants into an extension study to collect long-term safety and how well it works data.
They plan to enroll about 400 people at 21 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.
Official title (unrewritten)
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
Interventions: Bomedemstat
Primary outcome (registry wording): Percentage of participants with one or more adverse events (AEs)
Who it is for (from inclusion criteria)
- Ages 18 Years to any
- 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
Who the registry excludes
- 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
Public study contact (from the registry)
Toll Free Number
Published on ClinicalTrials.gov. Contact them as a possible participant. They decide eligibility.
Sites listed on ClinicalTrials.gov
21 listed- University of Michigan ( Site 6000) — Ann Arbor, Michigan (recruiting)
- DUHS Duke Blood Cancer Center ( Site 6005) — Durham, North Carolina (recruiting)
- The James Cancer Hospital and Solove Research Institute at The Ohio State University Comprehensive C ( Site 6007) — Columbus, Ohio (recruiting)
- UPMC Hillman Cancer Center ( Site 6004) — Pittsburgh, Pennsylvania (recruiting)
+ 17 sites outside the US on the same record
FAQ about this NCT record
Is NCT06351631 still recruiting?
The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.
What phase is NCT06351631?
Phase 3. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.
Can PlainTrials tell me if I qualify for NCT06351631?
No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.
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