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

NCT03497273 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 14

Last updated 2020-03-03

No results posted yet for this study

Summary

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).

Conditions

  • Acute Graft-versus-host Disease

Interventions

DRUG

Itacitinib

Itacitinib administered orally once daily at the protocol-defined dose.

DRUG

Corticosteroid

Either oral prednisolone or intravenous methylprednisolone at the investigator's discretion.

Sponsors & Collaborators

Principal Investigators

  • Rodica Morariu-Zamfir, MD · Incyte Corporation

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
20 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-03-20
Primary Completion
2019-11-30
Completion
2020-02-17
FDA Drug
Yes

Countries

  • Japan

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03497273 on ClinicalTrials.gov