IMG-7289-CTP-201
A PHASE 2 CLINICAL STUDY IN PATIENTS WITH ESSENTIAL THROMBOCYTHEMIA
IF YOU ARE INTERESTED IN LEARNING MORE ABOUT THE STUDY, PLEASE VISIT WWW.CLINICALTRIALS.GOV: NCT04254978
Essential thrombocythemia (ET) is one of a family of rare bone marrow diseases called myeloproliferative neoplasms (MPNs).
Bone marrow, the spongy tissue within the hollow portion of the bones, contains specialized cells that make platelets (cells that help your blood clot). ET is a condition in which the bone marrow makes too many platelets that can lead to abnormal blood clots or bleeding. Patients with ET may experience symptoms including fatigue, weight loss and a decrease in appetite that can make their quality of life worse. Rarely, patients with ET develop bone marrow failure or leukemia.
Bomedemstat (IMG-7289) is a new investigational medication, meaning it has not been approved by the U.S. Food and Drug Administration (FDA), taken daily by mouth. The FDA has granted Fast Track designation to bomedemstat for the treatment of essential thrombocythemia. The goal of this treatment is to reduce the activity of the bone marrow cells that make platelets. Bomedemstat has been studied in patients with other diseases of the bone marrow. This is the first Imago study using bomedemstat for the treatment of ET.
The IMG-7289-CTP-201 study is a Phase 2 study in patients with a diagnosis of ET. To enter this study, patients must have a platelet count above the normal range in need of treatment. Patients must also have been treated with another platelet-lowering drug that no longer benefits them.
Participants will need to visit a study site to see if they meet the criteria for the study.
The initial treatment period with bomedemstat is 24 weeks (about 6 months), during which, participants will visit the clinic about 10 times. There will be regular physical examinations and laboratory tests such as blood counts. In addition, there will be bone marrow samples taken before the start of treatment and at Week 24.
Participants receiving clinical benefit from bomedemstat can continue treatment beyond 24 weeks.
You may be eligible for the study if you:
This study is being conducted at sites in the United States, United Kingdom, Australia, New Zealand, Germany and Italy. For additional information about the study, visit ClinicalTrials.gov and enter the study identifier (NCT number: NCT04254978)