drugset / Trial / NCT03584516
GRAVITAS-309: Itacitinib and Corticosteroids as Initial Treatment for Chronic Graft-Versus-Host Disease
RandomizedCrossoverDouble-blindTreatment
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).
Timeline
- Start
- 2019-01-17
- Primary completion
- 2023-11-03
- Completion
- 2023-11-03
Outcome
Outcome not reported
Stopped: “The study was terminated due to insufficient efficacy to support moving into Part 2 of the study; there were no safety concerns that contributed to this decision.”
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Itacitinib | Small molecule | — | Oral |
| Background | Methylprednisolone | Other / unclassified | — | — |
| Background | Prednisone | Other / unclassified | — | — |