Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT04173494 | A Study of Momelotinib Versus Danazol in Symptomatic and Anemic Myelofibrosis Participants (MOMENTUM) | PHASE3 | COMPLETED | 195 | — | — | Feb 7, 2020 | Dec 29, 2022 | Nov 1, 2023 | 167 | United States, Australia +20 |
| NCT01969838 | Momelotinib Versus Ruxolitinib in Subjects With Myelofibrosis | PHASE3 | COMPLETED | 432 | — | — | Dec 6, 2013 | May 2, 2019 | May 12, 2023 | 114 | United States, Australia +20 |
| NCT06517875 | Study of Momelotinib in Combination With Luspatercept in Participants With Transfusion Dependent Myelofibrosis | PHASE2 | RECRUITING | 68 | — | — | Feb 28, 2025 | Mar 17, 2028 | Apr 20, 2026 | 33 | United States, Canada +4 |
| NCT02124746 | Long-term Safety and Efficacy of Momelotinib in Subjects With Primary Myelofibrosis, Post-polycythemia Vera Myelofibrosis, Post-essential Thrombocythemia Myelofibrosis, Polycythemia Vera or Essential Thrombocythemia | PHASE2 | COMPLETED | 87 | — | — | Apr 30, 2014 | Dec 6, 2018 | Jun 18, 2023 | 22 | United States, Australia +3 |
| NCT01236638 | Extension Study Evaluating the Long Term Safety and Efficacy Study of CYT387 in Primary Myelofibrosis (PMF) or Post-polycythemia Vera (PV) or Post-essential Thrombocythemia (ET) | PHASE2 | COMPLETED | 120 | — | — | Nov 1, 2010 | Jun 1, 2014 | Feb 4, 2019 | 6 | United States, Australia +1 |
| NCT01423058 | Safety Study Evaluating Twice-Daily Administration of Momelotinib in Primary Myelofibrosis or Post-Polycythemia Vera or Post-Essential Thrombocythemia Myelofibrosis | PHASE1 | COMPLETED | 61 | — | — | Aug 1, 2011 | Jun 1, 2014 | Feb 4, 2019 | 6 | United States, Canada |
Myelofibrosis Symptom Assessment Form (MFSAF) TSS version (v) 4.0 response rate was defined as percentage of participants with a \>= 50 percent (%) reduction from Baseline in mean MFSAF TSS over consecutive 28-day period immediately before end of Week 24. TSS response rate was measured using MFSAF v4.0. MFSAF v4.0 comprises 7 domains representing 7 most relevant symptoms of myelofibrosis (MF) identified through existing participant and clinician-based evidence: fatigue,night sweats,pruritus,abdominal discomfort,pain under left ribs,early satietyand bone pain. Participants scored each symptom domain using an 11-point numeric rating scale ranging from 0(absent) to 10(worst imaginable). The MFSAF TSS was calculated as sum of scores of 7 domains for a possible range of scores of 0 to 70, with a higher TSS corresponding to more severe symptoms. A reduction from Baseline corresponded to a lessening of MF symptoms. Baseline was the last assessment done before or on the day of first dose date.
Splenic response rate at Week 24 is defined as the percentage of participants who achieved a spleen volume reduction of ≥ 35% from baseline at the Week 24 assessment as measured by MRI or CT.
TI response is defined as not requiring red blood cell (RBC) transfusion (except in the case of clinically overt bleeding) for any ≥12-week interval.
Long-term safety and tolerability profile of momelotinib based on safety data (adverse events and selected hematology and chemistry laboratory parameters) collected after the first dose of momelotinib in the parent study.
Measured by complete response (CR) rate, partial response (PR) rate and clinical improvement (CI) rate according to IWG-MRT consensus criteria
| Arm | Type | Description |
|---|---|---|
| Momelotinib | EXPERIMENTAL | Participants will receive momelotinib plus placebo to match danazol |
| Danazol | ACTIVE_COMPARATOR | Participants will receive danazol plus placebo to match momelotinib |
| Ruxolitinib | ACTIVE_COMPARATOR | Participants will receive ruxolitinib plus placebo to match momelotinib. |
| Momelotinib + Luspatercept | EXPERIMENTAL | Participants with transfusion dependent primary myelofibrosis or post- PV/ ET myelofibrosis that is JAKi naïve or JAKi experienced will receive momelotinib and luspatercept. |
| Cohort 1 | EXPERIMENTAL | Participants previously enrolled in Study CCL09191E will receive momelotinib for approximately 4 years. |
| Cohort 2 | EXPERIMENTAL | Participants previously enrolled in Study YM387-II-02 will receive momelotinib for approximately 4 years. |
| Cohort 3 | EXPERIMENTAL | Participants previously enrolled in Study GS-US-354-0101 will receive momelotinib for up to 4 years. Cohort 3 was closed and all enrolled participants were discontinued from this study because parent Study GS-US-354-0101 was terminated. |
| Cohort 4 | EXPERIMENTAL | Participants previously enrolled in Study GS-US-352-1672 will receive momelotinib for approximately 4 years. |
| Name | Type | Description |
|---|---|---|
| Momelotinib | DRUG | Momelotinib tablets will be self-administered orally once daily |
| Placebo to match danazol | DRUG | Danazol placebo capsules will be self-administered orally twice daily |
| Danazol | DRUG | Danazol capsules will be self-administered orally twice daily |
| Placebo to match momelotinib | DRUG | Momelotinib placebo tablets will be self-administered orally once daily |
| Ruxolitinib | DRUG | Ruxolitinib tablets administered orally twice daily |
| Placebo to match ruxolitinib | DRUG | Placebo to match ruxolitinib tablets administered orally twice daily |
| Luspatercept | DRUG | Luspatercept will be administered subcutaneously. |
Inclusion Criteria: * Age \>= 18 years. * Confirmed diagnosis of PMF in accordance with the World Health Organization (WHO) 2016 criteria, or Post- polycythemia vera/essential thrombocythemia (PV/ET) MF in accordance with the International Working Group-Myeloproliferative Neoplasms Research and Tre...