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A Phase 3, Multicenter, Open-label, Randomized Study to Evaluate the Efficacy and Safety of Fedratinib Compared to Best Available Therapy (BAT) in Subjects With DIPSS (Dynamic International Prognostic Scoring System)-Intermediate or High-risk Primary Myelofibrosis (PMF), Post-polycythemia Vera Myelofibrosis (Post-PV MF), or Post-essential Thrombocythemia Myelofibrosis (Post-ET MF) and Previously Treated With Ruxolitinib

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Trial Profile

A Phase 3, Multicenter, Open-label, Randomized Study to Evaluate the Efficacy and Safety of Fedratinib Compared to Best Available Therapy (BAT) in Subjects With DIPSS (Dynamic International Prognostic Scoring System)-Intermediate or High-risk Primary Myelofibrosis (PMF), Post-polycythemia Vera Myelofibrosis (Post-PV MF), or Post-essential Thrombocythemia Myelofibrosis (Post-ET MF) and Previously Treated With Ruxolitinib

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 01 Oct 2025

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At a glance

  • Drugs Fedratinib (Primary)
  • Indications Essential thrombocythaemia; Myelofibrosis; Polycythaemia vera
  • Focus Registrational; Therapeutic Use
  • Acronyms FREEDOM2
  • Sponsors Celgene Corporation; Impact Biomedicines

Most Recent Events

  • 28 Aug 2025 Status changed from active, no longer recruiting to completed.
  • 15 Jul 2025 Planned End Date changed from 23 Jun 2025 to 30 Jul 2025.
  • 19 Nov 2024 According to a Bristol Myers Squibb media release, results from this trial will be presented at the 66th American Society of Hematology (ASH) Annual Meeting and Exposition, to be held from December 7 to 10 in San Diego, California.

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