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NCT06351631 · ClinicalTrials.gov registry record · Phase 3
A Study to Evaluate Safety and Efficacy of Bomedemstat (MK-3543-017)
A Phase 3 study of Myelofibrosis and Primary Myelofibrosis, sponsored by Merck Sharp & Dohme.
- Recruiting
- Registry status
- Phase 3
- Development phase
- 400
- Enrollment target
- 20
- Study locations
NCT06351631: Recruiting Phase 3 study of Myelofibrosis and Primary Myelofibrosis, sponsored by Merck Sharp & Dohme.
NCT06351631 is a Phase 3 study of Myelofibrosis and Primary Myelofibrosis that is actively recruiting participants, run by Merck Sharp & Dohme. The registered enrollment target is 400 participants, above the 189-participant average among 61 other Myelofibrosis trials with a reported enrollment target (112% higher). The trial reports 20 study locations across 13 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06351631, a Phase 3 study of Myelofibrosis and Primary Myelofibrosis, is actively recruiting participants, sponsored by Merck Sharp & Dohme.
- RECRUITING
- Registry status
- Phase 3
- Development phase
- 400 participants
- Enrollment target
- 20
- Study locations
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.
Primary Outcome
An AE is any undesirable physical, psychological or behavioral effect experienced by a patient during participation in an investigational study, in conjunction with the use of the drug or biologic, whether or not product-related. This includes any untoward signs or symptoms experienced by the patient from the time of first dose with bomedemstat under this protocol until completion of the study. The percentage of participants with AEs will be presented.
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 |
What NCT06351631 shows while recruiting
NCT06351631 is an interventional study that assigns participants to a tested intervention. The registered 400 participants enrollment target is mid-sized for trials with a published cap, above the 189-participant average among 61 other Myelofibrosis trials with a reported enrollment target (112% higher).
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.
NCT06351631 names 20 study sites across 13 states, led by Other, New South Wales, Queensland.
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.
What interventions are being tested in trial NCT06351631?
The interventions under investigation include: Bomedemstat (DRUG).
Who is sponsoring clinical trial NCT06351631?
This trial is sponsored by Merck Sharp & Dohme, which has 558 total clinical trials registered on ClinicalTrials.gov.
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.
Learn More About Clinical Trials
Similar trials for Myelofibrosis
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT06351631's enrollment target sits among peer trials
400 5th of 61 higher than 57 of 61 other Myelofibrosis trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Myelofibrosis trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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