Trials / Completed
CompletedNCT03497273
Safety of Itacitinib in Combination With Corticosteroids for Treatment of Steroid-Naive Acute Graft-Versus-Host Disease in Japanese Subjects
An Open-Label Single-Arm Phase 1 Study Evaluating Safety of Itacitinib in Combination With Corticosteroids for the Treatment of Steroid-Naive Acute Graft-Versus-Host Disease in Japanese Subjects
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 14 (actual)
- Sponsor
- Incyte Corporation · Industry
- Sex
- All
- Age
- 20 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this study is to assess the safety and tolerability of itacitinib in combination with corticosteroids in Japanese subjects with Grades II to IV acute graft-versus-host disease (aGVHD).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Itacitinib | Itacitinib administered orally once daily at the protocol-defined dose. |
| DRUG | Corticosteroid | Either oral prednisolone or intravenous methylprednisolone at the investigator's discretion. |
Timeline
- Start date
- 2018-03-20
- Primary completion
- 2019-11-30
- Completion
- 2020-02-17
- First posted
- 2018-04-13
- Last updated
- 2020-03-03
Locations
17 sites across 1 country: Japan
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03497273. Inclusion in this directory is not an endorsement.