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NCT04551053 · ClinicalTrials.gov registry record · Phase 3
To Evaluate Efficacy and Safety of Parsaclisib and Ruxolitinib in Participants With Myelofibrosis Who Have Suboptimal Response to Ruxolitinib (LIMBER-304)
A Phase 3 study, sponsored by Incyte Corporation.
- Terminated
- Registry status
- Phase 3
- Development phase
- 177
- Enrollment target
NCT04551053: Clinical Trial Phase 3 study, sponsored by Incyte Corporation.
NCT04551053 is a Phase 3 study that was terminated before completion, run by Incyte Corporation. The registered enrollment target is 177 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (77% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04551053, a Phase 3 study, was terminated before completion, sponsored by Incyte Corporation.
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 177 participants
- Enrollment target
Study Summary
The purpose of the study is to compare the efficacy and safety of parsaclisib when combined with ruxolitinb versus placebo combined with ruxolitinib in participants with myelofibrosis who have suboptimal response while receiving ruxolitinib monotherapy.
Primary Outcome
Participants had an MRI of the upper and lower abdomen and pelvis to determine the spleen volume. A CT scan was substituted for participants who were not candidates for MRI or when MRI was not readily available.
Interventions
- DRUG placebo
- DRUG ruxolitinib
- DRUG parsaclisib
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 177 participants |
| Start Date | 2021-05-26 |
| Est. Completion | 2024-08-21 |
| Phase | Phase 3 |
Why NCT04551053 stopped before completion
NCT04551053 is an interventional study that assigns participants to a tested intervention. The registered 177 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 (77% lower).
The record links to 0 conditions, and to 3 interventions - of which placebo is the first listed.
NCT04551053 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04551053 about?
NCT04551053 is a clinical study titled "To Evaluate Efficacy and Safety of Parsaclisib and Ruxolitinib in Participants With Myelofibrosis Who Have Suboptimal Response to Ruxolitinib (LIMBER-304)". The purpose of the study is to compare the efficacy and safety of parsaclisib when combined with ruxolitinb versus placebo combined with ruxolitinib in participants with myelofibrosis who have suboptimal response while receiving ruxolitinib monotherapy.
What is the current status of trial NCT04551053?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 177 participants. The study started on 2021-05-26. Estimated completion is 2024-08-21.
What interventions are being tested in trial NCT04551053?
The interventions under investigation include: placebo (DRUG), ruxolitinib (DRUG), parsaclisib (DRUG).
Who is sponsoring clinical trial NCT04551053?
This trial is sponsored by Incyte Corporation, which has 239 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04551053's enrollment target sits among peer trials
177 1438th of 2000 higher than 563 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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