Safety of Itacitinib in Combination With Corticosteroids for Treatment of Steroid-Naive Acute Graft-Versus-Host Disease in Japanese Subjects

Sponsor
Incyte Corporation
Study ID
NCT03497273
Phase
PHASE1
Status
Completed

Conditions

  • Acute Graft-versus-host Disease

Eligibility Criteria

Sex
ALL
Age
20 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Itacitinib — DRUG
    Itacitinib administered orally once daily at the protocol-defined dose.
  • Corticosteroid — DRUG
    Either oral prednisolone or intravenous methylprednisolone at the investigator's discretion.

Study Details

The purpose of this study is to assess the safety and tolerability of itacitinib in combination with corticosteroids in Japanese subjects with Grades II to IV acute graft-versus-host disease (aGVHD).

Key Dates

Start date
Mar 20, 2018
Status verified
Mar 2020
Primary completion
Nov 30, 2019
Completion
Feb 17, 2020

Study Design

Enrollment
14 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Itacitinib + corticosteroids
    Itacitinib administered in combination with corticosteroids.

Primary Outcome Measure

Number of treatment-emergent adverse events [ Time Frame: Up to approximately 12 months ]

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