439
Participants
Start Date
July 19, 2017
Primary Completion Date
May 2, 2019
Study Completion Date
July 13, 2020
Itacitinib
Itacitinib at the protocol-defined dose administered orally once daily (QD) plus corticosteroids.
Placebo
Matching placebo tablets administered orally once daily (QD) plus corticosteroids.
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.
Methylprednisolone
Methylprednisolone 2 mg/kg IV daily (or prednisone equivalent) or at a dose appropriate for the severity of disease as background treatment.
Institut Jules Bordet, Brussels
Auckland District Health Board, Auckland
Cliniques Universitaires Saint-Luc, Brussels
Hopitaux Universitaires de Geneve, Geneva
University Clinic Carl Gustav Carus, Technical University Dresden, Dresden
ZNA Stuivenberg, Antwerp
Seoul National University Hospital, Seoul
Jessa Ziekenhuis, Hasselt
Hopital universitaire du Sart Tilman de Liege, Liège
Ordensklinikum Linz GmbH Elisabethinen, Linz
Universtity Hospital Basel - Haematology, Basel
Universitaetsklinikum Leipzig, Leipzig
General Hospital Sint-Jan Brugge-Oostend, Bruges
AZ Delta, Roeselare
Universitair Ziekenhuis Gent (UZG), Ghent
Columbia University, New York
Memorial Sloan Kettering Cancer Center, New York
A.O.U. Città della Salute e della Scienza di Torino, Torino
Northwell Health, Lake Success
Stony Brook University Medical Center, Stony Brook
University of Pittsburgh Medical Center (UPMC) - Hillman Cancer Center, Pittsburgh
Hospital Clinico de Santiago de Compostela, Santiago de Compostela
Complejo Hospitalario Universitario de Granada - Hospital Universitario Virgen de las Nieves, Granada
Thomas Jefferson University, Philadelphia
Hospital Universitario de Donostia, San Sebastián
Istituto Clinico Humanitas, Rozzano
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico di Milano, Milan
IRCCS Ospedale San Raffaele, Milan
ASST Grande Ospedale Metropolitano Niguarda, Milan
Universitatsklinikum Hamburg - Eppendorf, Hamburg
"Clinica Ematologica CTA, Ospedale San Gerardo di Monza", Monza
University of Maryland Medical Center, Baltimore
University of Virginia Medical Center, Charlottesville
Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII, Bergamo
Fondazione IRCCS Policlinco San Matteo, Pavia
Wake Forest Baptist Medical Center - Wake Forest University School of Medicine, Winston-Salem
Hospital General Universitario Gregorio Maranon, Madrid
Hospital Universitario Ramon y Cajal, Madrid
Hospital Universitario La Paz, Madrid
Levine Cancer Institute, Charlotte
Hospital Universitario Puerta de Hierro Majadahonda, Madrid
Greenville Health System, Greenville
Institut Claudius Regaud-Universitaire du Cancer Toulouse Oncopol, Toulouse
University of Florida (UF) - Division of Hematology & Oncology, Gainesville
Florida Hospital Cancer Institute, Orlando
SOC Clinica Ematologica, Azienda Ospediero-Universitaria di Udine, Udine
University of Miami - Sylvester Cancer Center, Miami
Hopital Haut Leveque - CHU Bordeaux - Maladies du sang, Pessac
UKGM Marburg Innere Medizin: Haematologie Onkolog, Marburg
Hospital Universitario de Salamanca, Salamanca
Sarah Cannon Research Institute, LLC (SCRI), Nashville
Vanderbilt University Medical Center, Nashville
Methodist Healthcare Foundation, Memphis
Hospital Universitario Marques de Valdecilla, Santander
University of Mississippi Medical Center, Jackson
Hospital Universitario Virgen del Rocio, Seville
Azienda Unità Sanitaria Locale di Reggio Emilia, Reggio Emilia
The Ohio State University (OSU), Columbus
Hotel Dieu Hospital - Hematologie, Nantes
University Hospitals Cleveland Medical Center, Cleveland
Oncology Hematology in Cincinnati, Cincinnati
Hospital Clinico Universitario de Valencia, Valencia
Hospital Universitari i Politecnic La Fe, Valencia
Indiana University (IU) Melvin and Bren Simon Cancer Center, Indianapolis
Indiana Blood and Marrow Transplant, Indianapolis
University of Michigan, Ann Arbor
Henry Ford Hospital, Detroit
Spectrum Health, Grand Rapids
Azienda Ospedaliero Universitaria Careggi, Florence
Universitaet zu Koln - Universitaetsklinikum Koeln (Uniklinik Koeln), Cologne
University of Iowa, Iowa City
CHU de Nancy, Vandœuvre-lès-Nancy
Universitaetsmedizin der Johannes Gutenberg, Mainz
General Hospital of Thessaloniki G. Papanikolaou - Hematology Department, Chortiatis
CHRU de Lille-Hopital Claude Huriez, Lille
Advocate Lutheran General Hospital - Oncology Specialists SC, Park Ridge
University of Illinois at Chicago, Chicago
University of Chicago, Chicago
Washington University School of Medicine, St Louis
Presidio Ospedaliero Pescara, Pescara
University of Kansas Cancer Center, Westwood
Hopital de Hautepierre, Strasbourg
Tulane University Medical Center, New Orleans
University of Oklahoma - Health Sciences Center, Oklahoma City
Hopital Saint Louis, Paris
Texas Transplant Institute, San Antonio
Universitatsklinikum Freiburg - Klinik fur Innere Medizin I, Freiburg im Breisgau
University of Colorado - Aurora Cancer Center, Aurora
CHU Amiens Picardie - Hopital Sud, Amiens
Azienda Ospedaliera Bianchi-Melacrino-Morelli Ospedali Riuniti, Reggio Calabria
University of Southern California, Los Angeles
Casa di Cura La Maddalena, Palermo
Stanford Cancer Center, Stanford
Azienda Ospedaliero Universitaria (AOU) Policlinico - Vittorio Emanuele - Presidio Ospedaliero Ferrarotto Alessi, Catania
Rambam Health Care Campus, Haifa
Chaim Sheba Medical Center, Ramat Gan
Tel Aviv Sourasky Medical Center, Tel Aviv
Hadassah Hebrew University Medical Center Ein Karem, Jerusalem
University of California, San Diego (UCSD) - Moores Cancer Center, La Jolla
University of California, Los Angeles (UCLA) - Medical Center, Los Angeles
Tufts Medical Center, Boston
Massachusetts General Hospital, Boston
Beth Israel Deaconess Medical Center, Boston
Dana Farber Cancer Institute, Boston
University of Nebraska Medical Center, Omaha
Dartmouth Hitchcock Medical Center, Lebanon
John Theurer Cancer Center At Hackensack UMC, Hackensack
Rutgers Cancer Institute of New Jersey, New Brunswick
Oregon Health & Science University (OHSU), Portland
St Vincents Hospital Sydney Limited, Darlinghurst
UHKT Prague - Institute of Hematology and Blood Transfusion, Prague
Helsinki University Central Hospital, Helsinki
C.T.M.O. Ospedale Roberto Binaghi ATS Cagliari, Cagliari
University of Rome La Sapienza, Roma
Centrum Onkologii- Instytut w Gliwicach, Gliwice
Klinika Transplantacji Komorek Krwiotworczych - Instytut Hematologii i Transfuzjologii, Warsaw
Instituto Portugues de Oncologia de Lisboa Francisco Gentil EPE (IPO-Lisboa), Lisbon
Centro Hospitalar Lisboa Norte - Hospital de Santa Maria, Lisbon
Instituto Portugues de Oncologia do Porto Francisco Gentil, EPE, Porto
Hospital de la Santa Creu i Sant Pau - Servei de Hematologia Clinica, Barcelona
Hospital Universitario Vall d'Hebron, Barcelona
Hospital Clinic i Provincial de Barcelona, Barcelona
Instituto Catalan de Oncologia - Hospital Duran i Reynals, Barcelona
Universitaetsspital Zuerich - Klinik fuer Haematology, Zurich
China Medical University Hospital, Taichung
Addenbrooke's Hospital, Cambridge
University Hospital of Wales, Cardiff
Hammersmith Hospital, London
Nottingham University Hospitals, Nottingham
Lead Sponsor
Incyte Corporation
INDUSTRY