155
Participants
Start Date
January 17, 2019
Primary Completion Date
November 3, 2023
Study Completion Date
November 3, 2023
Itacitinib
In Part 1dose determination participants will receive itacitinib administered orally once daily at the protocol-defined dose according to cohort enrollment. In Part 1 expansion, participants will receive either itacitinib administered orally either once daily or twice a day or corticosteroid alone based on the assigned treatment regimen according to cohort enrollment. In Part 2, participants will receive the recommended dose from Part 1 expansion.
Placebo
In Part 2, participants will receive matching placebo.
Methylprednisolone
Administered in Parts 1 and 2 as background reference therapy at a dose level that is commensurate with institutional guidelines based on organ involvement and severity of disease.
Prednisone
Administered in Parts 1 and 2 as background reference therapy at a dose level that is commensurate with institutional guidelines based on organ involvement and severity of disease.
Azienda Ospedaliero Universitaria Citta Della Salute E Della Scienza, Torino
Stony Brook University Medical Center, Stony Brook
Charite Berlin, Berlin
Institut Paoli-Calmettes, Marseille
Western Pennsylvania Hospital, Pittsburgh
Hospital Clinico de Santiago de Compostela, Santiago de Compostela
Hospital Universitario Virgen de Las Nieves, Granada
Universitaetsmedizin Rostock, Rostock
University of Pennsylvania Abramson Cancer Center, Philadelphia
Jefferson University Hospitals, Philadelphia
Irrcs Instituto Clinico Humanitas, Rozzano
Fondazione Irccs Ca Granda Ospedale Maggiore, Milan
Istituto Di Ricovero E Cura A Carattere Scientifico (Irccs) Ospedale San Raffaele, Milan
University Medical Centre Hamburg-Eppendorf Centre of Oncology, Hamburg
Turku University Hospital, Turku
University of Maryland - Greenebaum Cancer Center, Baltimore
Skane University Hospital Lund, Lund
Azienda Ospedaliera Papa Giovanni Xxiii, Bergamo
Azienda Socio Sanitaria Territoriale Degli Spedali Civili Di Brescia, Brescia
Comitato Di Bioetica Della Fondazione Irccs Policlinico San Matteo, Pavia
Duke University Medical Center, Durham
Hospital General Universitario Gregorio Maranon, Madrid
Hospital Universitario Ramon Y Cajal, Madrid
Hospital Regional Universitario de Malaga, Málaga
Winship Cancer Institute of Emory University, Atlanta
Augusta University - Medical College of Georgia, Augusta
Clinica Universidad de Navarra (Cun), Pamplona
Azienda Ospedaliero-Universitaria Santa Maria Della Misericordia, Udine
Chu de Rennes - Hospital Pontchaillou, Rennes
Chru Hopitaux de Tours Hospital Bretonneau, Tours
Hospital Clinico Universitario de Salamanca, Salamanca
Centro Ricerche Cliniche Di Verona (Crc), Verona
Tri Star Bone Marrow Transplant, Nashville
Vanderbilt-Ingram Cancer Center, Nashville
Chu de Grenoble - Hopital Albert Michallon, Grenoble
Hospital Universitario Marques de Valdecilla, Santander
L AZIENDA OSPEDALIERO-UNIVERSITARIA DI BOLOGNA POLICLINICO S. ORSOLA � MALPIGHI, Bologna
A.O.U. Di Modena - Policlinico, Modena
Centre Hospitalier Universitaire de Nantes (Chu de Nantes) - Hotel-Dieu, Nantes
Universitatsklinikum Essen, Essen
Oncology Hematology Care, Inc, Cincinnati
Hospital Universitario Y Politcnico de La Fe, Valencia
Hospital Clinico Universitario de Valencia, Valencia
University of Michigan, Ann Arbor
Universitatsklinikum Munster, Münster
Henry Ford Health System, Detroit
Centre Hospitalier D'Angers, Angers
Rabin Medical Center - Beilinson Hospital, Petach Tiqwa
Spectrum Health, Grand Rapids
Universitatsklinikum Koln, Cologne
Hopitaux de Brabois, Vandœuvre-lès-Nancy
Universitatsmedizin Der Johannes Gutenberg-Universitat Mainz Iii, Mainz
University of Minnesota, Masonic Cancer Center, Minneapolis
General Hospital of Thessaloniki G. Papanikolaou, Thessaloniki
Advocate Lutheran General Hospital - Oncology Specislists Sc, Park Ridge
CLINICA DI EMATOLOGIA, UNIVERSIT� POLITECNICA DELLE MARCHE, Ancona
Rush University Medical Center, Chicago
Illinois Cancer Specialists, Chicago
Saint Louis University Cancer Center, St Louis
Tel Aviv Sourasky Medical Center, Tel Aviv
University of Kansas Hospital Authority, Westwood
University Hospital Mannheim, Mannheim
I.R.C.C.S. Casa Sollievo Della Sofferenza, San Giovanni Rotondo
Universitaetsklinikum in Tubingen, Tübingen
University of Arkansas For Medical Sciences - Winthrop P Rockefeller Cancer Institute, Little Rock
Texas Oncology - Medical City Dallas, Dallas
Texas Oncology - Baylor Sammons Cancer Center, Dallas
Centre Henri Becquerel, Rouen
St David'S South Austin Medical Center, Austin
Chu Amiens Picardie - Hopital Sud, Amiens
A.O.U. Federico Ii, Napoli
Iii Medizinische Klinik Und Poliklinik Klinikum Rechts Der Isar Technische Universitat Munchen, Munich
University of Arizona Cancer Center - Out Pt., Tucson
Azienda Ospedaliera Bianchi-Melacrino-Morelli Ospedali Riuniti, Reggio Calabria
"Azienda Ospedaliera Ospedali Riuniti Villa Sofia - Cervello", Palermo
City of Hope National Medical Center, Duarte
Universitaetsklinikum Erlangen - Medizinische Klinik 5, Erlangen
Hadassah Hebrew University Medical Center Ein Karem Hadassah, Jerusalem
University of California San Diego Medical Center, Moores Cancer Center, La Jolla
Azienda Policlinico Vittorio Emanuele, Catania
Fred Hutchinson Cancer Research Center, Seattle
Rambam Medical Center, Haifa
University of Miami Sylvester Comprehensive Cancer Center, Miami
Loyola University Medical Center, Maywood
Indiana University Melvin and Bren Simon Cancer Center, Indianapolis
Tulane University, New Orleans
Tufts Medical Center, Boston
Massachusetts General Hospital, Boston
Hackensack University Medical Center, Hackensack
University of Rochester, James P. Wilmot Cancer Center, Rochester
University Hospitals Cleveland Medical Center, Cleveland
University of Pittsburgh, Pittsburgh
Avera Cancer Institute, Sioux Falls
Ordensklinikum Linz Gmbh Elisabethinen, Linz
Zna Stuivenberg, Antwerp
Institut Jules Bordet, Brussels
Universitair Ziekenhuis Antwerpen (Uza), Edegem
Universitair Ziekenhuis Gent, Ghent
Universitaire Ziekenhuis Leuven - Gasthuisberg, Leuven
CENTRE HOSPITALIER UNIVERSITAIRE DE LI�GE - SART TILMAN, Liège
AZ DELTA, Roeselare
University of Alberta, Edmonton
University Health Network, Toronto
Hospital Maisonneuve Rosemont, Montreal
Saskatchewan Cancer, Saskatoon
The Finsen Centre National Hospital, Copenhagen
Chu de Nice - Hospital L Archet, Nice
Universitatsklinikum Bonn Aoer, Bonn
University Clinic Carl Gustav Carus Technical University Dresden, Dresden
UNIVERSIT�TSKLINIKUM HALLE (SAALE), Halle
Universitaetsklinikum Jena, Jena
Selbststandige Abteilung Fur Hamatologie Und Internistische Onkologie, Leipzig
University Hospital of West Attica - Attikon, Chaïdári
Universita Degli Studi Di Roma La Sapienza - Umberto I Policlinico Di Roma - Centro Di Ematologia, Roma
Policlinico Universitario Agostino Gemelli Universita Cattolica Del Sacro Cuore, Roma
Uniwersyteckie Centrum Kliniczne, Gdansk
Narodowy Instytut Onkologii Im. Marii Sklodowskiej-Curie Panstwowy Instytut Badawczy Oddzial W Gliwi, Gliwice
Szpital Kliniczny Przemienienia Panskiego, Poznan
Mtz Clinical Research Sp. Zo.O., Warsaw
Institut Catala D Oncologia, Badalona
Hospital de La Santa Creu I Sant Pau, Barcelona
Ico Institut Catala D Oncologia, L'Hospitalet de Llobregat
Son Espases University Hospital, Palma
Karolinska University Hospital Huddinge, Huddinge
Universitatsspital Zurich, Zurich
Bristol Haematology & Oncology Centre, Bristol
University Hospital of Wales, Cardiff
Barts Health Nhs Trust - St Bartholomews Hospital, London
King'S College Hospital (Nhs Foundation), London
Imperial College Healthcare Nhs Trust - Hammersmith Hospital, London
Nottingham University Hospitals Nhs Trust, Nottingham
The Royal Marsden Nhs Foundation Trust - Sutton, Sutton
St. George'S University Hospitals Nhs Foundation Trust, Tooting
Lead Sponsor
Incyte Corporation
INDUSTRY