This is a multi-center, open-label extension study to assess the long-term safety and efficacy of bomedemstat administered orally once daily in patients with an MPN who participated in a prior bomedemstat study such as, but not limited to, IMG-7289-CTP-102 and IMG-7289-CTP-201 (referred to hereafter as 'feeder studies').
Accepts Healthy Volunteers
Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms |
No |
Study Type
An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies. |
Interventional |
Eligible Ages | 18 Years and Over |
Gender | All |
Trial ID:
This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries. |
NCT05223920 |
Phase
Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use. |
Phase 2 |
Lead Sponsor
The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data. |
Imago BioSciences,Inc. |
Principal Investigator
The person who is responsible for the scientific and technical direction of the entire clinical study. |
Hugh Rienhoff, MD |
Principal Investigator Affiliation | Imago BioSciences |
Agency Class
Category of organization(s) involved as sponsor (and collaborator) supporting the trial. |
Industry |
Overall Status | Recruiting |
Countries | Germany, Hong Kong, Italy, United Kingdom, United States |
Conditions
The disease, disorder, syndrome, illness, or injury that is being studied. |
Thrombocythemia, Essential, Primary Myelofibrosis |
Experimental: Bomedemstat
All patients will be dosed with bomedemstat daily for 169 days with additional treatment continuing in patients deriving clinical benefit.
Drug: - Bomedemstat
Capsule (oral)
If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.
Status
Recruiting
Address
University of Miami Leonard M. Miller
Miami, Florida, 33136
Status
Recruiting
Address
University of Michigan
Ann Arbor, Michigan, 48109
Status
Recruiting
Address
UMPC Hillman Cancer Center
Pittsburgh, Pennsylvania, 15232
Status
Recruiting
Address
Universittsklinikum Essen
Essen, , 45147
Status
Recruiting
Address
Queen Mary Hospital
Hong Kong, ,
Status
Recruiting
Address
Ospedale di Circolo-a Fondazione Macchi
Varese, VA, 2100
Status
Recruiting
Address
Azienda Ospedaliera SS. Antonio
Alessandria, , 15121
Status
Recruiting
Address
Azienda Ospedaliero Universitaria di Bologna
Pavia, , 27100
Status
Recruiting
Address
Guy's and Saint Thomas' NHS Foundation Trus
London, , SE1 9RT