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

PHASE1CompletedINTERVENTIONAL
Enrollment

31

Participants

Timeline

Start Date

December 31, 2015

Primary Completion Date

June 30, 2016

Study Completion Date

August 31, 2018

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.

Trial Locations (23)

Unknown

Duarte

La Jolla

Los Angeles

Denver

Coral Gables

Atlanta

Chicago

Kansas City

Westwood

New Orleans

Boston

Detroit

St Louis

Omaha

New York

Rochester

Cincinnati

Cleveland

Portland

Hershey

Pittsburgh

Nashville

San Antonio

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Incyte Corporation

INDUSTRY