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Study of Itacitinib in Combination With Corticosteroids for the Treatment of Acute GVHD

NCT02614612 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 31

Last updated 2019-03-08

No results posted yet for this study

Summary

To determine if Itacitinib in combination with corticosteroids is safe and tolerable in patients with Grade IIB-IVD acute graft-versus-host disease (GVHD).

Conditions

  • Graft-versus-host Disease (GVHD)

Interventions

DRUG

Itacitinib (200 mg)

DRUG

Itacitinib (300 mg)

DRUG

prednisone or methylprednisolone (corticosteroids)

All subjects will receive prednisone 2.5 mg/kg per day PO (or methylprednisolone 2 mg/kg IV daily) on Days 1 through 5. Subjects will be tapered as tolerated beginning on Day 6 to no less than 0.25 mg/kg per day PO (or methylprednisolone 0.2 mg/kg per day) by Day 28. After Day 28, corticosteroids should be tapered according to institutional guidelines to attain ≤ prednisone 0.2 mg/kg per day (or ≤ methylprednisolone 0.16 mg/kg per day) by Day 56.

Sponsors & Collaborators

Principal Investigators

  • Rodica Morariu-Zamfir, MD · Incyte Corporation

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-12-31
Primary Completion
2016-06-30
Completion
2018-08-31

Countries

  • United States

Study Locations

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Entities

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 NCT02614612 on ClinicalTrials.gov