NCT03139604

GRAVITAS-301: A Study of Itacitinib or Placebo in Combination With Corticosteroids for Treatment of Acute Graft-Versus-Host Disease

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 439 (actual)
• Sponsor: Incyte Corporation · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Graft-versus-host Disease (GVHD)

Interventions

Type	Name	Description
DRUG	Itacitinib	Itacitinib at the protocol-defined dose administered orally once daily (QD) plus corticosteroids.
DRUG	Placebo	Matching placebo tablets administered orally once daily (QD) plus corticosteroids.
DRUG	Prednisone	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.
DRUG	Methylprednisolone	Methylprednisolone 2 mg/kg IV daily (or prednisone equivalent) or at a dose appropriate for the severity of disease as background treatment.

Timeline

• Start date: 2017-07-19
• Primary completion: 2019-05-02
• Completion: 2020-07-13
• First posted: 2017-05-04
• Last updated: 2025-09-02
• Results posted: 2020-05-15

Locations

129 sites across 19 countries: United States, Australia, Austria, Belgium, Czechia, Finland, France, Germany, Greece, Israel, Italy, New Zealand, Poland, Portugal, South Korea, Spain, Switzerland, Taiwan, United Kingdom

Regulatory

• FDA-regulated drug study