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NCT04629508 · ClinicalTrials.gov registry record · Phase 2
To Assess the Safety, Tolerability and Efficacy of Itacitinib Immediate Release Tablets in Participants With Primary or Secondary Myelofibrosis Who Have Received Prior Ruxolitinib and/or Fedratinib Monotherapy (LIMBER-213)
A Phase 2 study, sponsored by Incyte Corporation.
- Completed
- Registry status
- Phase 2
- Development phase
- 4
- Enrollment target
NCT04629508: Completed Phase 2 study, sponsored by Incyte Corporation.
NCT04629508 is a Phase 2 study that has completed, run by Incyte Corporation. The registered enrollment target is 4 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (97% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04629508, a Phase 2 study, has completed, sponsored by Incyte Corporation.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 4 participants
- Enrollment target
Study Summary
This is a 2-part study. In Part 1, participants will be dosed at 2 different dose levels in order to select the RP2D for Part 2 of the study.
Primary Outcome
An adverse event was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not it was considered drug-related. An AE could therefore have been any unfavorable or unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study treatment. A TEAE was defined as an AE that was reported for the first time or the worsening of a pre-existing event after the first dose of study t
Interventions
- DRUG itacitinib
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 4 participants |
| Start Date | 2021-07-12 |
| Est. Completion | 2023-08-24 |
| Phase | Phase 2 |
What the finished NCT04629508 record still lists
NCT04629508 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 4 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (97% lower).
The record links to 0 conditions, and to 1 intervention - of which itacitinib is the first listed.
NCT04629508 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04629508 about?
NCT04629508 is a clinical study titled "To Assess the Safety, Tolerability and Efficacy of Itacitinib Immediate Release Tablets in Participants With Primary or Secondary Myelofibrosis Who Have Received Prior Ruxolitinib and/or Fedratinib Monotherapy (LIMBER-213)". This is a 2-part study. In Part 1, participants will be dosed at 2 different dose levels in order to select the RP2D for Part 2 of the study.
What is the current status of trial NCT04629508?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 4 participants. The study started on 2021-07-12. Estimated completion is 2023-08-24.
What interventions are being tested in trial NCT04629508?
The interventions under investigation include: itacitinib (DRUG).
Who is sponsoring clinical trial NCT04629508?
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 NCT04629508's enrollment target sits among peer trials
4 2001st of 2000 the lowest of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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