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
Status: Recruiting
Location: See all (21) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• 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
Locations
United States
Michigan
University of Michigan ( Site 6000)
RECRUITING
Ann Arbor
North Carolina
DUHS Duke Blood Cancer Center ( Site 6005)
RECRUITING
Durham
Ohio
The James Cancer Hospital and Solove Research Institute at The Ohio State University Comprehensive C ( Site 6007)
RECRUITING
Columbus
Pennsylvania
UPMC Hillman Cancer Center ( Site 6004)
RECRUITING
Pittsburgh
Other Locations
Australia
Royal Adelaide Hospital-Haematology Clinical Trials Unit ( Site 1000)
RECRUITING
Adelaide
Sunshine Coast Hematology and Oncology Clinic ( Site 1006)
RECRUITING
Buderim
Royal Prince Alfred Hospital ( Site 1003)
RECRUITING
Camperdown
Monash Health ( Site 1004)
RECRUITING
Clayton
Gold Coast University Hospital-Cancer and Blood Disorders Clinical Trial Team ( Site 1002)
RECRUITING
Southport
Royal North Shore Hospital ( Site 1001)
RECRUITING
St Leonards
Hong Kong Special Administrative Region
Queen Mary Hospital ( Site 1601)
ACTIVE_NOT_RECRUITING
Hksar
Italy
Azienda Ospedaliero-Universitaria SS. Antonio e Biagio e Cesare Arrigo ( Site 2703)
RECRUITING
Alessandria
IRCCS Azienda Ospedaliero-Universitaria di Bologna, Policlinico di Sant'Orsola ( Site 2702)
RECRUITING
Bologna
Azienda Ospedaliera Universitaria Careggi ( Site 2700)
RECRUITING
Florence
Ospedale di Circolo e Fondazione Macchi Varese ( Site 2701)
RECRUITING
Varese
New Zealand
Aotearoa Clinical Trials ( Site 1400)
ACTIVE_NOT_RECRUITING
Auckland
North Shore Hospital-Department of Haematology ( Site 1401)
ACTIVE_NOT_RECRUITING
Auckland
United Kingdom
Boston Pilgrim Hospital ( Site 3403)
RECRUITING
Boston
Guy's & St Thomas' NHS Foundation Trust ( Site 3401)
RECRUITING
London
Imperial College Healthcare NHS Trust - Hammersmith Hospital ( Site 3402)
RECRUITING
London
University College London Hospital ( Site 3400)
RECRUITING
London
Contact Information
Primary
Toll Free Number
Trialsites@msd.com
1-888-577-8839
Time Frame
Start Date:2024-05-23
Estimated Completion Date:2034-12-04
Participants
Target number of participants:400
Treatments
Experimental: Bomedemstat
Participants will receive oral capsules of bomedemstat once daily for up to 10 years, with the starting dose as the same dose that the participant was on at the time of transition from the feeder study.