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NCT03978637 · ClinicalTrials.gov registry record · Phase 1
Safety and Efficacy of Itacitinib in Participants With Bronchiolitis Obliterans Syndrome Following Lung Transplantation
A Phase 1 study, sponsored by Incyte Corporation.
- Terminated
- Registry status
- Phase 1
- Development phase
- 23
- Enrollment target
NCT03978637: Clinical Trial Phase 1 study, sponsored by Incyte Corporation.
NCT03978637 is a Phase 1 study that was terminated before completion, run by Incyte Corporation. The registered enrollment target is 23 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (62% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03978637, a Phase 1 study, was terminated before completion, sponsored by Incyte Corporation.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 23 participants
- Enrollment target
Study Summary
The purpose of this study is to evaluate the safety, efficacy, pharmacokinetics, and pharmacodynamics of itacitinib in participants with post-lung transplant bronchiolitis obliterans syndrome (BOS).
Primary Outcome
An adverse event (AE) was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. An AE could therefore be any unfavorable and 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 either an AE reported for the first time or the worsening of a pre-existing condition after the first dose of itacitinib un
Interventions
- DRUG Itacitinib
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 23 participants |
| Start Date | 2020-02-04 |
| Est. Completion | 2023-10-13 |
| Phase | Phase 1 |
Why NCT03978637 stopped before completion
NCT03978637 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 23 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (62% lower).
The record links to 0 conditions, and to 1 intervention - of which Itacitinib is the first listed.
NCT03978637 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03978637 about?
NCT03978637 is a clinical study titled "Safety and Efficacy of Itacitinib in Participants With Bronchiolitis Obliterans Syndrome Following Lung Transplantation". The purpose of this study is to evaluate the safety, efficacy, pharmacokinetics, and pharmacodynamics of itacitinib in participants with post-lung transplant bronchiolitis obliterans syndrome (BOS).
What is the current status of trial NCT03978637?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 23 participants. The study started on 2020-02-04. Estimated completion is 2023-10-13.
What interventions are being tested in trial NCT03978637?
The interventions under investigation include: Itacitinib (DRUG).
Who is sponsoring clinical trial NCT03978637?
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 NCT03978637's enrollment target sits among peer trials
23 1596th of 2000 higher than 400 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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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