At a glance
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GRAVITAS-301: A Randomized, Double-Blind, Placebo-Controlled Phase 3 Study of Itacitinib or Placebo in Combination With Corticosteroids for the Treatment of First-Line Acute Graft-Versus-Host Disease
In Brief
A Phase 3 clinical trial evaluating Itacitinib, Placebo, and 2 other interventions for Graft-versus-host Disease (GVHD). Completed, enrolled 439 participants across 129 sites in 19 countries.
Detailed Summary
The purpose of this study is to evaluate itacitinib or placebo in combination with corticosteroids as first-line treatment of participants with Grade II to IV acute graft-versus-host disease (aGVHD).
Study Details
Timeline
Interventions
Itacitinib at the protocol-defined dose administered orally once daily (QD) plus corticosteroids.
Matching placebo tablets administered orally once daily (QD) plus corticosteroids.
Oral prednisone may be used to begin standard corticosteroid background treatment at the investigator's discretion, at a dose equivalent to methylprednisolone 2 mg/kg per day.
Methylprednisolone 2 mg/kg IV daily (or prednisone equivalent) or at a dose appropriate for the severity of disease as background treatment.