Momelotinib Versus Ruxolitinib in Subjects With Myelofibrosis
Status:
Completed
Trial end date:
2019-05-02
Target enrollment:
Participant gender:
Summary
This study is to determine the efficacy of momelotinib (MMB) versus ruxolitinib 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.