31
Participants
Start Date
December 31, 2015
Primary Completion Date
June 30, 2016
Study Completion Date
August 31, 2018
Itacitinib (200 mg)
Itacitinib (300 mg)
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.
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
Lead Sponsor
Incyte Corporation
INDUSTRY