Conditions: Primary Myelofibrosis Post-Polycythemia Vera Myelofibrosis Post-Essential Thrombocythemia Myelofibrosis
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 432
Healthy volunteers: no

Brief summary:
This study is to determine the efficacy of momelotinib (MMB) versus ruxolitinib (RUX) in participants with primary myelofibrosis (PMF) or post-polycythemia vera or post-essential thrombocythemia myelofibrosis (post-PV/ET MF) who have not yet received treatment with a Janus kinase inhibitor (JAK inhibitor).

Participants will be randomized to receive either MMB or ruxolitinib for 24 weeks during a double-blind treatment phase, after which they will be eligible to receive open-label MMB for up to an additional 216 weeks. After discontinuation of study medication, assessments will continue for 12 additional weeks, after which participants will be contacted for survival follow-up approximately every 6 months for up to 5 years from the date of enrollment or until study termination. For those participants planning to continue treatment with MMB following the end of the study, the Early Study Drug Discontinuation (ESDD), 30-day, 12-Week, and survival follow-up visits are not required.

Detailed description:

Arms:
arm 1: Participants will receive momelotinib plus placebo to match ruxolitinib. arm 2: Participants will receive ruxolitinib plus placebo to match momelotinib.

Interventions: intervention 1: Momelotinib intervention 2: Ruxolitinib intervention 3: Placebo to match momelotinib intervention 4: Placebo to match ruxolitinib
Intervention descriptions: intervention 1: Momelotinib tablet administered orally once daily intervention 2: Ruxolitinib tablets administered orally twice daily intervention 3: Placebo to match momelotinib tablets administered orally once daily intervention 4: Placebo to match ruxolitinib tablets administered orally twice daily

Protocol document: