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NCT04173494 · ClinicalTrials.gov registry record · Phase 3
A Study of Momelotinib Versus Danazol in Symptomatic and Anemic Myelofibrosis Participants (MOMENTUM)
A Phase 3 study, sponsored by Sierra Oncology LLC - a GSK company.
- Completed
- Registry status
- Phase 3
- Development phase
- 195
- Enrollment target
NCT04173494 is a Phase 3 study that has completed, run by Sierra Oncology LLC - a GSK company. The registered enrollment target is 195 participants.
The verdict
NCT04173494, a Phase 3 study, has completed, sponsored by Sierra Oncology LLC - a GSK company.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 195 participants
- Enrollment target
Study Summary
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 participants who have previously received an approved Janus kinase inhibitor (JAKi) therapy for myelofibrosis (MF). The purpose of this clinical study is to compare the effectiveness and safety of MMB to DAN in treating and reducing: 1) disease related symptoms, 2) the need for blood transfusions and 3) splenomegaly, in adults with primary MF, post-polycythemia vera MF or post-essential thrombocythemia MF. 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, United Kingdom (UK) and United States (US). Participants must be symptomatic with a Myelofibrosis Symptom Assessment Form (MFSAF) version (v) 4.0 Total Symptom Score of \>= 10 at screening, and be anemic with hemoglobin (Hgb) \< 10 gram/deciliter (g/dL). For participants with ongoing JAKi therapy at screening, JAKi therapy must be tapered over a period of at least 1 week, followed by a 2-week non-treatment washout interval prior to randomization. Participants will be randomized 2:1 to orally self-administer blinded treatment: MMB plus placebo or DAN plus placebo. Participants randomized to receive MMB who complete the randomized treatment period to the end of Week 24 may continue to receive MMB in the open-label extended treatment period to the end of Week 204 (a total period of treatment of approximately 4 years) if the participants tolerates and continues to benefit from MMB. Participants randomized to receive DAN may cross-over to MMB open-label treatment in the following circumstances: at the end of Week 24 if they complete the randomized treatment period; or at the end of Week 24 if they dis
Interventions
- DRUG Momelotinib
- DRUG Danazol
- DRUG Placebo to match momelotinib
- DRUG Placebo to match danazol
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 195 participants |
| Start Date | 2020-02-07 |
| Est. Completion | 2022-12-29 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04173494
The ClinicalTrials.gov registry entry for NCT04173494 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 195 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Sierra Oncology LLC - a GSK company, which has 17 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 4 interventions - of which Momelotinib is the first listed.
NCT04173494 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT04173494 about?
NCT04173494 is a clinical study titled "A Study of Momelotinib Versus Danazol in Symptomatic and Anemic Myelofibrosis Participants (MOMENTUM)". 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 participants who have previously received an approved Janus kinase inhibitor (JAK...
What is the current status of trial NCT04173494?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 195 participants. The study started on 2020-02-07. Estimated completion is 2022-12-29.
What interventions are being tested in trial NCT04173494?
The interventions under investigation include: Momelotinib (DRUG), Danazol (DRUG), Placebo to match momelotinib (DRUG), Placebo to match danazol (DRUG).
Who is sponsoring clinical trial NCT04173494?
This trial is sponsored by Sierra Oncology LLC - a GSK company, which has 17 total clinical trials registered on ClinicalTrials.gov.
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