The purpose of this study is to compare the effectiveness and safety of Momelotinib (MMB) to Danazol (DAN) in treating and reducing disease related symptoms, the need for blood transfusions, and splenomegaly, in adults with primary Myelofibrosis (MF), post-polycythemia vera MF or post-essential thrombocythemia MF.
MOMENTUM is a randomized, double-blind, active control Phase 3 trial intended to confirm the differentiated clinical benefits of the investigational drug momelotinib (MMB) versus danazol (DAN) in symptomatic and anemic subjects who have previously received an approved Janus kinase inhibitor (JAKi) therapy for myelofibrosis (MF). The purpose of this clinical study is to c The study is planned in countries including, but not limited to: Australia, Austria, Belgium, Bulgaria, Canada, Czech Republic, Denmark, France, Germany, Hungary, Israel, Italy, New Zealand, Poland, Romania, Singapore, South Korea, Spain, Sweden, Taiwan, UK, and US. Subjects must be symptomatic with a MFSAF v4.0 Total Symptom Score of ≥ 10 at screening, and be anemic with Hgb < 10="" _g2f_dl.="" for="" subjects="" with="" jaki="" therapy="" at="" _screening2c_="" must="" be="" tapered="" over="" a="" period="" of="" least="" 1="" _week2c_="" followed="" by="" 2-week="" non-treatment="" washout="" interval="" prior="" to="" randomization.="" will="" randomized="" _23a_1="" orally="" self-administer="" blinded="" _treatment3a_="" mmb="" plus="" placebo="" or="" dan="" placebo.="" receive="" who="" complete="" the="" treatment="" end="" week="" 24="" may="" continue="" in="" open-label="" extended="" 204="" _28_a="" total="" approximately="" 4="" _years29_="" if="" subject="" tolerates="" and="" continues="" benefit="" from="" mmb.="" cross-over="" following="" _circumstances3a_="" -at="" they="" _period3b_="" discontinue="" but="" study="" assessments="" do="" not="" prohibited="" medications="" including="" alternative="" active="" anti-mf="" _therapy3b_="" any="" time="" during="" meet="" protocol-defined="" criteria="" radiographically-confirmed="" symptomatic="" splenic="" progression.="" are="" receiving="" clinical="" choose="" up="" 48.="" comparator="" _treatment2c_="" _dan2c_="" is="" an="" approved="" medication="" us="" some="" other="" countries="" recommended="" national="" guidelines="" as="" anemia="" />
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