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NCT01969838 · ClinicalTrials.gov registry record · Phase 3
Momelotinib Versus Ruxolitinib in Subjects With Myelofibrosis
A Phase 3 study, sponsored by Sierra Oncology LLC - a GSK company.
- Completed
- Registry status
- Phase 3
- Development phase
- 432
- Enrollment target
NCT01969838: Completed Phase 3 study, sponsored by Sierra Oncology LLC - a GSK company.
NCT01969838 is a Phase 3 study that has completed, run by Sierra Oncology LLC - a GSK company. The registered enrollment target is 432 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (44% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01969838, a Phase 3 study, has completed, sponsored by Sierra Oncology LLC - a GSK company.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 432 participants
- Enrollment target
Study Summary
This study is to determine the efficacy of momelotinib (MMB) versus ruxolitinib (RUX) 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.
Primary Outcome
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.
Interventions
- DRUG Ruxolitinib
- DRUG Momelotinib
- DRUG Placebo to match momelotinib
- DRUG Placebo to match ruxolitinib
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 432 participants |
| Start Date | 2013-12-06 |
| Est. Completion | 2019-05-02 |
| Phase | Phase 3 |
What the finished NCT01969838 record still lists
NCT01969838 is an interventional study that assigns participants to a tested intervention. The registered 432 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (44% lower).
The record links to 0 conditions, and to 4 interventions - of which Ruxolitinib is the first listed.
NCT01969838 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01969838 about?
NCT01969838 is a clinical study titled "Momelotinib Versus Ruxolitinib in Subjects With Myelofibrosis". This study is to determine the efficacy of momelotinib (MMB) versus ruxolitinib (RUX) 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 inhi...
What is the current status of trial NCT01969838?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 432 participants. The study started on 2013-12-06. Estimated completion is 2019-05-02.
What interventions are being tested in trial NCT01969838?
The interventions under investigation include: Ruxolitinib (DRUG), Momelotinib (DRUG), Placebo to match momelotinib (DRUG), Placebo to match ruxolitinib (DRUG).
Who is sponsoring clinical trial NCT01969838?
This trial is sponsored by Sierra Oncology LLC - a GSK company, which has 17 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01969838's enrollment target sits among peer trials
432 876th of 2000 higher than 1,124 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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