Clinical Trial

A Phase 3 Study of Pelabresib (DAK539) and Ruxolitinib in Myelofibrosis (MF)

Study acronym: MANIFEST-3
Recruiting Phase 3
View on ClinicalTrials.gov →
Summary
The purpose of this trial is to evaluate whether treatment with pelabresib in combination with ruxolitinib leads to improved clinical outcomes compared to ruxolitinib alone in patients with primary myelofibrosis (PMF), post-polycythemia vera myelofibrosis (PPV-MF), or post-essential thrombocythemia myelofibrosis (PET-MF) who have not previously received Janus kinase (JAK) inhibitor therapy.
Protocol Amendment History 5 changes
notable Trial sites expanded: 25 -> 29 locations 2026-07-15
notable Trial sites expanded: 20 -> 25 locations 2026-07-10
notable Trial sites expanded: 15 -> 18 locations 2026-06-27
notable Trial sites expanded: 6 -> 9 locations 2026-06-03
critical Recruitment opened 2026-04-17
Trial Details
NCT Number NCT07357727
Lead Sponsor Novartis Pharmaceuticals
Conditions Primary Myelofibrosis (PMF), Post-polycythemia Vera Myelofibrosis (PPV-MF), Post-essential Thrombocythemia Myelofibrosis (PET-MF)
Enrollment 460 participants
Start Date 2026-06-16
Primary Completion 2028-05-17 (estimated)
Study Completion 2030-12-27 (estimated)
Updated on ClinicalTrials.gov 2026-07-17