drugset / Trial / NCT03721965
Safety and Efficacy of Itacitinib in Combination With Corticosteroids for Treatment of Graft-Versus-Host Disease in Pediatric Subjects
NaSingle-groupOpen-labelTreatment
Summary
The purpose of this study is to evaluate itacitinib in combination with corticosteroids for the treatment of Grades II to IV acute graft-versus-host disease (aGVHD) in steroid-naive pediatric participants.
Timeline
- Start
- 2019-12-31
- Primary completion
- 2020-02-17
- Completion
- 2020-02-17
Outcome
Outcome not reported
Stopped: “The study was terminated due to insufficient efficacy in a separate phase III study”
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Itacitinib | Small molecule | — | Oral |
| Background | Methylprednisolone | Other / unclassified | 2 mg/kg | Intravenous |
| Background | Prednisone | Other / unclassified | — | — |