NCT01969838

Momelotinib Versus Ruxolitinib in Subjects With Myelofibrosis

A Phase 3, Randomized, Double-blind Active-controlled Study Evaluating Momelotinib vs. Ruxolitinib in Subjects With Primary Myelofibrosis (PMF) or Post-Polycythemia Vera or Post-Essential Thrombocythemia Myelofibrosis (Post-PV/ET MF)

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 432 (actual)
• Sponsor: Sierra Oncology LLC - a GSK company · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Primary Myelofibrosis
• Post-Polycythemia Vera Myelofibrosis
• Post-Essential Thrombocythemia Myelofibrosis

Interventions

Type	Name	Description
DRUG	Momelotinib	Momelotinib tablet administered orally once daily
DRUG	Ruxolitinib	Ruxolitinib tablets administered orally twice daily
DRUG	Placebo to match momelotinib	Placebo to match momelotinib tablets administered orally once daily
DRUG	Placebo to match ruxolitinib	Placebo to match ruxolitinib tablets administered orally twice daily

Timeline

• Start date: 2013-12-06
• Primary completion: 2016-09-12
• Completion: 2019-05-02
• First posted: 2013-10-25
• Last updated: 2023-05-12
• Results posted: 2023-05-12

Locations

114 sites across 22 countries: United States, Australia, Austria, Belgium, Bulgaria, Canada, Czechia, Denmark, France, Germany, Hungary, Israel, Japan, Netherlands, Poland, Romania, Singapore, South Korea, Spain, Sweden, Taiwan, United Kingdom

Regulatory

• FDA-regulated drug study