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
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
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).
Inclusion Criteria:
Exclusion Criteria:
Has received more than 1 allo-HSCT.
Has received more than 2 days of systemic corticosteroids for aGVHD.
Presence of GVHD overlap syndrome.
Presence of an active uncontrolled infection.
Known human immunodeficiency virus infection.
Active hepatitis B virus (HBV) or hepatitis C virus infection that requires treatment or at risk for HBV reactivation.
Participants with evidence of relapsed primary disease, or participants who have been treated for relapse after the allo-HSCT was performed.
Any corticosteroid therapy for indications other than GVHD at doses > 1 mg/kg per day methylprednisolone (or prednisone equivalent) within 7 days of randomization.
Severe organ dysfunction unrelated to underlying GVHD, including:
Currently breast feeding.
Received JAK inhibitor therapy after allo-HSCT for any indication. Treatment with a JAK inhibitor before allo-HSCT is permitted.
Treatment with any other investigational agent, device, or procedure within 21 days (or 5 half-lives, whichever is greater) of enrollment.
Any medical complications or conditions that would, in the investigator's judgment, interfere with full participation in the study, including administration of study drug and attending required study visits; pose a significant risk to the participant; or interfere with interpretation of study data.
Known allergies, hypersensitivity, or intolerance to any of the study medications, excipients, or similar compounds.
La Jolla, California 92093-0698, United States
Los Angeles, California 90095-1678, United States
Gainesville, Florida 32610, United States
Park Ridge, Illinois 60028, United States
Indianapolis, Indiana 46202, United States
Winston-Salem, North Carolina 27157, United States
Pittsburgh, Pennsylvania 15232, United States
Catania, 95124, Italy
Warsaw, 02-776, Poland
Lisbon, 1099-023, Portugal
Granada, 18014, Spain