IMG-7289-CTP-203 Phase 2 Polycythemia Vera Study

• Research type

  Research Study

• Full title

  A Phase 2 Multi-Center, Open Label Study to Assess the Safety, Efficacy, Pharmacokinetics and Pharmacodynamics of Bomedemstat in Patients with Polycythemia Vera (PV)

• IRAS ID

  1006523

• Contact name

  Hugh Rienhoff

• Contact email

  hugh@imagobio.com

• Sponsor organisation

  Imago BioSciences, Inc.

• Eudract number

  2022-002262-32

• Clinicaltrials.gov Identifier

  NCT05558696

• Research summary

  This study is for people who have been diagnosed with Polycythemia Vera (PV), which is part of a group of diseases called Myeloproliferative Neoplasms (MPNs). MPNs are a family of related neoplastic disorders of bone marrow.
  The aims of this clinical study are to learn about bomedemstat in patients with PV who have failed at least one standard drug to treat their condition. Specifically, we are trying to learn about how safe, tolerable and effective bomedemstat is.
  There will be approximately 20 patients taking part in this study, in Australia, USA and the United Kingdom. About 6 patients from NHS Trusts in the United Kingdom are expected to enroll.
  Participants who meet the screening requirements of the trial, and consent to take part will take bomedemstat for about 36 weeks and attend the clinic for at least 13 study visits. They will return to the clinic every 2 weeks for the first 12 weeks and monthly thereafter. They may need more frequent visits if it takes longer than expected for the dose to become stable. After 36 weeks of treatment, and if the study doctor decides there is a benefit from bomedemstat, participants may be able to continue treatment with bomedemstat. They will return to the clinic at least monthly until the study ends. When this study ends, participants may be offered the opportunity to enroll in an extension study. Many of the procedures done in this study would be done occasionally as part of routine care for PV. For example, checking health by blood tests and bone marrow by bone marrow aspiration (collection of bone marrow cells with a needle) and bone marrow biopsy (collection of solid bone marrow tissue with a needle). Some of these procedures will need to be performed more often during this study.

• REC name

  East Midlands - Leicester Central Research Ethics Committee

• REC reference

  22/EM/0245

• Date of REC Opinion

  22 Jun 2023

• REC opinion

  Further Information Favourable Opinion