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

NCT03139604 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 439

Last updated 2025-09-02

Study results available
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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

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.

Sponsors & Collaborators

Principal Investigators

  • Rodica Morariu-Zamfir, MD · Incyte Corporation

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-07-19
Primary Completion
2019-05-02
Completion
2020-07-13
FDA Drug
Yes

Countries

  • United States
  • Australia
  • Austria
  • Belgium
  • Czechia
  • Finland
  • France
  • Germany
  • Greece
  • Israel
  • Italy
  • New Zealand
  • Poland
  • Portugal
  • South Korea
  • Spain
  • Switzerland
  • Taiwan
  • United Kingdom

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 NCT03139604 on ClinicalTrials.gov