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NCT03584516 · ClinicalTrials.gov registry record · Phase 2
GRAVITAS-309: Itacitinib and Corticosteroids as Initial Treatment for Chronic Graft-Versus-Host Disease
A Phase 2 study, sponsored by Incyte Corporation.
- Terminated
- Registry status
- Phase 2
- Development phase
- 155
- Enrollment target
NCT03584516: Clinical Trial Phase 2 study, sponsored by Incyte Corporation.
NCT03584516 is a Phase 2 study that was terminated before completion, run by Incyte Corporation. The registered enrollment target is 155 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (17% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03584516, a Phase 2 study, was terminated before completion, sponsored by Incyte Corporation.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 155 participants
- Enrollment target
Study Summary
The purpose of this study is to assess the efficacy and safety of itacitinib in combination with corticosteroids as first-line treatment for moderate or severe chronic graft-versus-host disease (cGVHD).
Primary Outcome
A DLT was defined as the occurrence of any protocol-defined toxicity with onset up to and including Day 28, except those with a clear alternative explanation. Participants who received at least 21 of 28 doses of study drug at the level assigned or had a DLT were considered evaluable for determining tolerability of the dose. Participants who did not achieve this duration of exposure and did not have a DLT were to be replaced for purposes of toxicity identification.
Interventions
- DRUG Placebo
- DRUG Prednisone
- DRUG Methylprednisolone
- DRUG Itacitinib
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 155 participants |
| Start Date | 2019-01-17 |
| Est. Completion | 2023-11-03 |
| Phase | Phase 2 |
Why NCT03584516 stopped before completion
NCT03584516 is an interventional study that assigns participants to a tested intervention. The registered 155 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (17% higher).
The record links to 0 conditions, and to 4 interventions - of which Placebo is the first listed.
NCT03584516 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03584516 about?
NCT03584516 is a clinical study titled "GRAVITAS-309: Itacitinib and Corticosteroids as Initial Treatment for Chronic Graft-Versus-Host Disease". The purpose of this study is to assess the efficacy and safety of itacitinib in combination with corticosteroids as first-line treatment for moderate or severe chronic graft-versus-host disease (cGVHD).
What is the current status of trial NCT03584516?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 155 participants. The study started on 2019-01-17. Estimated completion is 2023-11-03.
What interventions are being tested in trial NCT03584516?
The interventions under investigation include: Placebo (DRUG), Prednisone (DRUG), Methylprednisolone (DRUG), Itacitinib (DRUG).
Who is sponsoring clinical trial NCT03584516?
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 NCT03584516's enrollment target sits among peer trials
155 448th of 2000 higher than 1,553 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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