Trial Title:
A Study to Evaluate Safety and Efficacy of Bomedemstat (MK-3543-017)
NCT ID:
NCT06351631
Condition:
Thrombocythemia, Essential
Primary Myelofibrosis
Myelofibrosis
Post-polycythemia Vera Myelofibrosis
Post-essential Thrombocythemia Myelofibrosis
Polycythemia Vera
Conditions: Official terms:
Polycythemia Vera
Primary Myelofibrosis
Polycythemia
Thrombocytosis
Thrombocythemia, Essential
Study type:
Interventional
Study phase:
Phase 3
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Bomedemstat
Description:
10, 15, 20, and 50 mg oral capsules
Arm group label:
Bomedemstat
Other name:
MK-3543
Other name:
IMG-7289
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.
Criteria for 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
- Be able to initiate study intervention on Day 1 of the extension study (ie, 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
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
University of Michigan ( Site 6000)
Address:
City:
Ann Arbor
Zip:
48109
Country:
United States
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
734-763-4695
Facility:
Name:
UPMC Hillman Cancer Center ( Site 6004)
Address:
City:
Pittsburgh
Zip:
15232
Country:
United States
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
412-864-6627
Facility:
Name:
Royal Prince Alfred Hospital ( Site 1003)
Address:
City:
Camperdown
Zip:
2050
Country:
Australia
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
+6195158031
Facility:
Name:
Royal North Shore Hospital ( Site 1001)
Address:
City:
St Leonards
Zip:
2065
Country:
Australia
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
02 99264171
Facility:
Name:
Gold Coast University Hospital-Cancer and Blood Disorders Clinical Trial Team ( Site 1002)
Address:
City:
Southport
Zip:
4215
Country:
Australia
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
56870000
Facility:
Name:
Royal Adelaide Hospital-Haematology Clinical Trials Unit ( Site 1000)
Address:
City:
Adelaide
Zip:
5000
Country:
Australia
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
61870744133
Facility:
Name:
Queen Mary Hospital ( Site 1601)
Address:
City:
Hksar
Country:
Hong Kong
Status:
Active, not recruiting
Facility:
Name:
Azienda Ospedaliera Universitaria Careggi ( Site 2700)
Address:
City:
Firenze
Zip:
50134
Country:
Italy
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
+390557947824
Facility:
Name:
Azienda Ospedaliera Nazionale SS. Antonio e Biagio e Cesare Arrigo ( Site 2703)
Address:
City:
Alessandria
Zip:
15121
Country:
Italy
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
+39 0131 206440
Facility:
Name:
IRCCS Azienda Ospedaliero-Universitaria di Bologna, Policlinico di Sant'Orsola ( Site 2702)
Address:
City:
Bologna
Zip:
40138
Country:
Italy
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
+39 0512143044
Facility:
Name:
Ospedale di Circolo e Fondazione Macchi Varese ( Site 2701)
Address:
City:
Varese
Zip:
21100
Country:
Italy
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
+390332393906
Facility:
Name:
North Shore Hospital-Department of Haematology ( Site 1401)
Address:
City:
Auckland
Zip:
0622
Country:
New Zealand
Status:
Active, not recruiting
Facility:
Name:
Aotearoa Clinical Trials ( Site 1400)
Address:
City:
Auckland
Zip:
2025
Country:
New Zealand
Status:
Active, not recruiting
Facility:
Name:
University College London Hospital ( Site 3400)
Address:
City:
London
Zip:
NW1 2PG
Country:
United Kingdom
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
020 3447 7101
Facility:
Name:
Guy's & St Thomas' NHS Foundation Trust ( Site 3401)
Address:
City:
London
Zip:
SE1 9RT
Country:
United Kingdom
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
4402071882742
Start date:
May 23, 2024
Completion date:
December 4, 2034
Lead sponsor:
Agency:
Merck Sharp & Dohme LLC
Agency class:
Industry
Source:
Merck Sharp & Dohme LLC
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06351631
https://www.merckclinicaltrials.com/
https://trialstransparency.merckclinicaltrials.com/Study.aspx?id=3543-017&&kw=3543-017
