Purpose

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).

Condition

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Has undergone 1 allo-HSCT from any donor (related or unrelated with any degree of HLA matching) and any donor source (bone marrow, peripheral blood stem cells, or cord blood) for a hematologic malignancy or disorder. Recipients of myeloablative and reduced-intensity conditioning regimens are eligible. - Clinically suspected Grade II to IV aGVHD as per MAGIC criteria, occurring after allo-HSCT and any GVHD prophylaxis regimen. - Evidence of myeloid engraftment. Use of growth factor supplementation is allowed. - Serum creatinine ≤ 2.0 mg/dL or creatinine clearance ≥ 40 mL/min measured or calculated by Cockroft Gault equation. - Willing to avoid pregnancy or fathering children. - Able to give written informed consent and comply with all study visits and procedures. - Able to swallow and retain oral medication.

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: - Cholestatic disorders or unresolved veno-occlusive disease of the liver. - Clinically significant or uncontrolled cardiac disease. - Clinically significant respiratory disease that requires mechanical ventilation support or 50% oxygen. - 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.

Study Design

Phase
Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Double (Participant, Investigator)
Masking Description
Double Blind

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Itacitinib
Itacitinib plus corticosteroids
  • Drug: Itacitinib
    Itacitinib at the protocol-defined dose administered orally once daily (QD) plus corticosteroids.
    Other names:
    • INCB039110
  • 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.
    Other names:
    • Deltasone
    • Prednicot
    • predniSONE Intensol
    • Rayos
    • Sterapred
    • Sterapred DS
  • Drug: Methylprednisolone
    Methylprednisolone 2 mg/kg IV daily (or prednisone equivalent) or at a dose appropriate for the severity of disease as background treatment.
    Other names:
    • Medrol
    • Medrol Dosepak
    • Solu-Medrol
Placebo Comparator
Placebo
Matching placebo 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.
    Other names:
    • Deltasone
    • Prednicot
    • predniSONE Intensol
    • Rayos
    • Sterapred
    • Sterapred DS
  • Drug: Methylprednisolone
    Methylprednisolone 2 mg/kg IV daily (or prednisone equivalent) or at a dose appropriate for the severity of disease as background treatment.
    Other names:
    • Medrol
    • Medrol Dosepak
    • Solu-Medrol

More Details

Status
Completed
Sponsor
Incyte Corporation

Study Contact

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.