(duplicate) Momelotinib vs. Ruxolitinib in subjects with Myelofibrosis
Research type
Research Study
Full title
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)
IRAS ID
158216
Contact name
Donal McLornan
Contact email
Sponsor organisation
Gilead Sciences International Ltd.
Eudract number
2013-002707-33
Clinicaltrials.gov Identifier
Research summary
Myelofibrosis is as serious bone marrow disorder that disrupts normal production of blood cells and is often associated with an enlarged spleen. Signs and symptoms include feeling tired, anaemia and bleeding complications (requiring blood transfusions), bone pain (due to spleen increase), frequent infections and night sweats.
This research study is being conducted to see if a novel drug called momelotinib is as effective as ruxolitinib in reducing disease-related spleen enlargement, symptoms, and the need for transfusions in adults with myelofibrosis. The study involves the experimental drug momelotinib and a medication called ruxolitinib. Ruxolitinib has been approved in the United States and 42 other countries (including the UK) for the treatment of myelofibrosis.
Approximately 420 participants at about 200 sites in North, South, and Central America, Europe, Asia and Australia will take part in this study.
Eligible participants will be randomly divided into two groups – either the experimental treatment with momelotinib once daily and ruxolitinib placebo twice daily or the ruxolitinib twice daily and momelotinib placebo once daily. Participants will have a 50/50 of receiving either momelotinib or ruxolitinib. Neither participant nor doctor will know which group they are in. Participants will be taking active study medication (either momelotinib or ruxolitinib) and a placebo regardless of their treatment group.
Participation in this study will last about 24 weeks. During this time, participants will be required to visit the hospital every 2 weeks. After 24 weeks, participants will have the option to receive momelotinib treatment for up to three and a half years in the open-label portion of the study.
End of Treatment visit and long term follow up visits will take place. Tests will be conducted by the doctor during this time to monitor health, including physical examinations, CT or MRI scans. A bone marrow biopsy will be performed.
A pharmaceutical company is funding this research.REC name
London - Chelsea Research Ethics Committee
REC reference
14/LO/1053
Date of REC Opinion
25 Jul 2014
REC opinion
Further Information Favourable Opinion