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A Study to Evaluate Safety and Efficacy of Bomedemstat (MK-3543-017)
NCT06351631 · View on ClinicalTrials.gov ↗
Study 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.
Conditions Studied
Interventions
- DRUG Bomedemstat
Study Locations (20)
Other
- Queen Mary Hospital ( Site 1601) — Hksar
- Azienda Ospedaliero-Universitaria SS. Antonio e Biagio e Cesare Arrigo ( Site 2703) — Alessandria
- IRCCS Azienda Ospedaliero-Universitaria di Bologna, Policlinico di Sant'Orsola ( Site 2702) — Bologna
- Ospedale di Circolo e Fondazione Macchi Varese ( Site 2701) — Varese
- North Shore Hospital-Department of Haematology ( Site 1401) — Auckland
- Aotearoa Clinical Trials ( Site 1400) — Auckland
New South Wales
- Royal Prince Alfred Hospital ( Site 1003) — Camperdown
- Royal North Shore Hospital ( Site 1001) — St Leonards
Queensland
- Sunshine Coast Hematology and Oncology Clinic ( Site 1006) — Buderim
- Gold Coast University Hospital-Cancer and Blood Disorders Clinical Trial Team ( Site 1002) — Southport
Michigan
- University of Michigan ( Site 6000) — Ann Arbor
North Carolina
- DUHS Duke Blood Cancer Center ( Site 6005) — Durham
Ohio
- The James Cancer Hospital and Solove Research Institute at The Ohio State University Comprehensive C ( Site 6007) — Columbus
Pennsylvania
- UPMC Hillman Cancer Center ( Site 6004) — Pittsburgh
South Australia
- Royal Adelaide Hospital-Haematology Clinical Trials Unit ( Site 1000) — Adelaide
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 400 participants |
| Start Date | 2024-05-23 |
| Est. Completion | 2034-12-04 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06351631
The ClinicalTrials.gov registry entry for NCT06351631 describes a study currently listed as recruiting. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 400 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Merck Sharp & Dohme, which has 741 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 6 conditions, with Myelofibrosis appearing as the primary indexed condition, and to 1 intervention — of which Bomedemstat is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT06351631 reports 20 study locations spanning 13 distinct geographic areas — top geographies include Other, New South Wales, Queensland. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT06351631 about?
NCT06351631 is a clinical study titled "A Study to Evaluate Safety and Efficacy of Bomedemstat (MK-3543-017)". 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 t...
What is the current status of trial NCT06351631?
This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 400 participants. The study started on 2024-05-23. Estimated completion is 2034-12-04.
What conditions does trial NCT06351631 study?
This clinical trial studies the following conditions: Myelofibrosis, Primary Myelofibrosis, Polycythemia Vera, Post-essential Thrombocythemia Myelofibrosis, Post-polycythemia Vera Myelofibrosis. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT06351631?
The interventions under investigation include: Bomedemstat (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT06351631?
This trial is sponsored by Merck Sharp & Dohme, which has 741 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT06351631 being conducted?
This trial has 20 study locations across Michigan, North Carolina, Ohio, Pennsylvania, New South Wales. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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