Momelotinib Versus Ruxolitinib in Subjects With Myelofibrosis (Simplify 1)
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|ClinicalTrials.gov Identifier: NCT01969838|
Recruitment Status : Active, not recruiting
First Posted : October 25, 2013
Last Update Posted : August 7, 2018
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.
|Condition or disease||Intervention/treatment||Phase|
|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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||432 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|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)|
|Actual Study Start Date :||December 6, 2013|
|Actual Primary Completion Date :||September 12, 2016|
|Estimated Study Completion Date :||March 2019|
Participants will receive momelotinib plus placebo to match ruxolitinib.
Momelotinib tablet administered orally once daily
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 daily
Drug: Placebo to match momelotinib
Placebo to match momelotinib tablets administered orally once daily
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01969838
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|Study Director:||Gilead Study Director||Gilead Sciences|