Momelotinib Versus Ruxolitinib in Subjects With Myelofibrosis (Simplify 1)
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 168 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.
|Primary Myelofibrosis Post-Polycythemia Vera Myelofibrosis Post-Essential Thrombocythemia Myelofibrosis||Drug: Momelotinib Drug: Ruxolitinib Drug: Placebo to match momelotinib Drug: Placebo to match ruxolitinib||Phase 3|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Participant, Care Provider, Investigator, Outcomes Assessor
Primary Purpose: Treatment
|Official 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)|
- Splenic response rate at Week 24 [ Time Frame: Week 24 ]Splenic response rate at Week 24 is defined as the proportion of participants achieving a ≥ 35% reduction in spleen volume at Week 24 from baseline as measured by MRI or CT.
- Response rate in total symptom score at Week 24 [ Time Frame: Week 24 ]Total symptom score (TSS) is defined as the proportion of participants who achieve a ≥ 50% reduction in TSS from baseline to Week 24 as measured by the modified Myeloproliferative Neoplasm Symptom Assessment Form Total Symptom Score (MPNSAF TSS) v2.0 diary.
- Rate of red blood cell (RBC) transfusion through Week 24 [ Time Frame: Baseline to Week 24 ]Rate of RBC transfusion is defined as the average number of RBC units per participant per month.
- RBC transfusion independence rate at Week 24 [ Time Frame: Week 24 ]RBC transfusion independence is the proportion of participants who are transfusion independent at Week 24, defined as absence of RBC transfusions and no hemoglobin level below 8 g/dL in the prior 12 weeks.
- RBC transfusion dependence rate at Week 24 [ Time Frame: Week 24 ]RBC transfusion dependence is the proportion of participants who are transfusion dependent at Week 24, defined as at least 4 units of RBC transfusions, or a hemoglobin level below 8 g/dL in the prior 8 weeks.
|Actual Study Start Date:||December 6, 2013|
|Estimated Study Completion Date:||June 2018|
|Primary Completion Date:||September 12, 2016 (Final data collection date for primary outcome measure)|
Participants will receive momelotinib plus placebo to match ruxolitinib.
Momelotinib tablet administered orally once daily
Other Names:Drug: Placebo to match ruxolitinib
Placebo to match ruxolitinib tablets administered orally twice daily
Active Comparator: Ruxolitinib
Participants will receive ruxolitinib plus placebo to match momelotinib.
Ruxolitinib tablets administered orally twice dailyDrug: Placebo to match momelotinib
Placebo to match momelotinib tablets administered orally once daily
Please refer to this study by its ClinicalTrials.gov identifier: NCT01969838
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|Study Director:||Gilead Study Director||Gilead Sciences|