A Phase 3, Randomized, Double-blind, Active-control Study of Pelabresib (DAK539) and Ruxolitinib vs. Placebo and Ruxolitinib in Adult Patients With Myelofibrosis Who Are JAK Inhibitor Naive
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.
• Participants have diagnosis of primary myelofibrosis (PMF) or post-polycythemia vera myelofibrosis (post-PV MF) or post-essential thrombocythemia myelofibrosis (post-ET MF) according to the International Consensus Classification (ICC) of Myeloid Neoplasms and Acute Leukemias 2022
• DIPSS risk category of intermediate-1, intermediate-2 or high-risk
• Spleen volume ≥ 450 cm3 by CT or MRI scan (local read sufficient if no central read available)
• Have an average TSS of ≥15 within 7 days prior to randomization, using MFSAF v. 4.0 (at least 4 out of 7 TSS assessments required for average calculation)
• Participants with an Eastern Cooperative Oncology Group (ECOG) performance status score of 0, 1, or 2
• Blasts \<5% in peripheral blood. Assessment of blasts in peripheral blood is mandatory at screening
• Platelet count ≥ 100 x 10\^9/L in the absence of growth factors or transfusions for the previous 4 weeks