GRAVITAS-301: A Study of Itacitinib or Placebo in Combination With Corticosteroids for Treatment of Acute Graft-Versus-Host Disease

PHASE3CompletedINTERVENTIONAL
Enrollment

439

Participants

Timeline

Start Date

July 19, 2017

Primary Completion Date

May 2, 2019

Study Completion Date

July 13, 2020

Conditions
Graft-versus-host Disease (GVHD)
Interventions
DRUG

Itacitinib

Itacitinib at the protocol-defined dose administered orally once daily (QD) plus corticosteroids.

DRUG

Placebo

Matching placebo tablets administered orally once daily (QD) plus corticosteroids.

DRUG

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.

DRUG

Methylprednisolone

Methylprednisolone 2 mg/kg IV daily (or prednisone equivalent) or at a dose appropriate for the severity of disease as background treatment.

Trial Locations (129)

1000

Institut Jules Bordet, Brussels

1023

Auckland District Health Board, Auckland

1200

Cliniques Universitaires Saint-Luc, Brussels

1211

Hopitaux Universitaires de Geneve, Geneva

1307

University Clinic Carl Gustav Carus, Technical University Dresden, Dresden

2060

ZNA Stuivenberg, Antwerp

3080

Seoul National University Hospital, Seoul

3500

Jessa Ziekenhuis, Hasselt

4000

Hopital universitaire du Sart Tilman de Liege, Liège

4020

Ordensklinikum Linz GmbH Elisabethinen, Linz

4031

Universtity Hospital Basel - Haematology, Basel

4103

Universitaetsklinikum Leipzig, Leipzig

8000

General Hospital Sint-Jan Brugge-Oostend, Bruges

8800

AZ Delta, Roeselare

9000

Universitair Ziekenhuis Gent (UZG), Ghent

10032

Columbia University, New York

10065

Memorial Sloan Kettering Cancer Center, New York

10126

A.O.U. Città della Salute e della Scienza di Torino, Torino

11042

Northwell Health, Lake Success

11794

Stony Brook University Medical Center, Stony Brook

15232

University of Pittsburgh Medical Center (UPMC) - Hillman Cancer Center, Pittsburgh

15706

Hospital Clinico de Santiago de Compostela, Santiago de Compostela

18014

Complejo Hospitalario Universitario de Granada - Hospital Universitario Virgen de las Nieves, Granada

19107

Thomas Jefferson University, Philadelphia

20014

Hospital Universitario de Donostia, San Sebastián

20089

Istituto Clinico Humanitas, Rozzano

20122

Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico di Milano, Milan

20132

IRCCS Ospedale San Raffaele, Milan

20162

ASST Grande Ospedale Metropolitano Niguarda, Milan

20246

Universitatsklinikum Hamburg - Eppendorf, Hamburg

20900

"Clinica Ematologica CTA, Ospedale San Gerardo di Monza", Monza

21201

University of Maryland Medical Center, Baltimore

22908

University of Virginia Medical Center, Charlottesville

24127

Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII, Bergamo

27100

Fondazione IRCCS Policlinco San Matteo, Pavia

27157

Wake Forest Baptist Medical Center - Wake Forest University School of Medicine, Winston-Salem

28007

Hospital General Universitario Gregorio Maranon, Madrid

28034

Hospital Universitario Ramon y Cajal, Madrid

28046

Hospital Universitario La Paz, Madrid

28204

Levine Cancer Institute, Charlotte

28222

Hospital Universitario Puerta de Hierro Majadahonda, Madrid

29615

Greenville Health System, Greenville

31059

Institut Claudius Regaud-Universitaire du Cancer Toulouse Oncopol, Toulouse

32610

University of Florida (UF) - Division of Hematology & Oncology, Gainesville

32804

Florida Hospital Cancer Institute, Orlando

33100

SOC Clinica Ematologica, Azienda Ospediero-Universitaria di Udine, Udine

33136

University of Miami - Sylvester Cancer Center, Miami

33604

Hopital Haut Leveque - CHU Bordeaux - Maladies du sang, Pessac

35043

UKGM Marburg Innere Medizin: Haematologie Onkolog, Marburg

37007

Hospital Universitario de Salamanca, Salamanca

37203

Sarah Cannon Research Institute, LLC (SCRI), Nashville

37232

Vanderbilt University Medical Center, Nashville

38104

Methodist Healthcare Foundation, Memphis

39008

Hospital Universitario Marques de Valdecilla, Santander

39216

University of Mississippi Medical Center, Jackson

41013

Hospital Universitario Virgen del Rocio, Seville

42123

Azienda Unità Sanitaria Locale di Reggio Emilia, Reggio Emilia

43210

The Ohio State University (OSU), Columbus

44000

Hotel Dieu Hospital - Hematologie, Nantes

44106

University Hospitals Cleveland Medical Center, Cleveland

45236

Oncology Hematology in Cincinnati, Cincinnati

46010

Hospital Clinico Universitario de Valencia, Valencia

46026

Hospital Universitari i Politecnic La Fe, Valencia

46202

Indiana University (IU) Melvin and Bren Simon Cancer Center, Indianapolis

46237

Indiana Blood and Marrow Transplant, Indianapolis

48109

University of Michigan, Ann Arbor

48202

Henry Ford Hospital, Detroit

49503

Spectrum Health, Grand Rapids

50134

Azienda Ospedaliero Universitaria Careggi, Florence

50924

Universitaet zu Koln - Universitaetsklinikum Koeln (Uniklinik Koeln), Cologne

52242

University of Iowa, Iowa City

54500

CHU de Nancy, Vandœuvre-lès-Nancy

55131

Universitaetsmedizin der Johannes Gutenberg, Mainz

57010

General Hospital of Thessaloniki G. Papanikolaou - Hematology Department, Chortiatis

59037

CHRU de Lille-Hopital Claude Huriez, Lille

60028

Advocate Lutheran General Hospital - Oncology Specialists SC, Park Ridge

60612

University of Illinois at Chicago, Chicago

60637

University of Chicago, Chicago

63110

Washington University School of Medicine, St Louis

65124

Presidio Ospedaliero Pescara, Pescara

66205

University of Kansas Cancer Center, Westwood

67098

Hopital de Hautepierre, Strasbourg

70112

Tulane University Medical Center, New Orleans

73104

University of Oklahoma - Health Sciences Center, Oklahoma City

75010

Hopital Saint Louis, Paris

78229

Texas Transplant Institute, San Antonio

79106

Universitatsklinikum Freiburg - Klinik fur Innere Medizin I, Freiburg im Breisgau

80045

University of Colorado - Aurora Cancer Center, Aurora

80054

CHU Amiens Picardie - Hopital Sud, Amiens

89124

Azienda Ospedaliera Bianchi-Melacrino-Morelli Ospedali Riuniti, Reggio Calabria

90033

University of Southern California, Los Angeles

90146

Casa di Cura La Maddalena, Palermo

94305

Stanford Cancer Center, Stanford

95124

Azienda Ospedaliero Universitaria (AOU) Policlinico - Vittorio Emanuele - Presidio Ospedaliero Ferrarotto Alessi, Catania

3109601

Rambam Health Care Campus, Haifa

5262160

Chaim Sheba Medical Center, Ramat Gan

6423906

Tel Aviv Sourasky Medical Center, Tel Aviv

9112001

Hadassah Hebrew University Medical Center Ein Karem, Jerusalem

92093-0698

University of California, San Diego (UCSD) - Moores Cancer Center, La Jolla

90095-1678

University of California, Los Angeles (UCLA) - Medical Center, Los Angeles

02111

Tufts Medical Center, Boston

02114

Massachusetts General Hospital, Boston

02215

Beth Israel Deaconess Medical Center, Boston

Dana Farber Cancer Institute, Boston

68198-7680

University of Nebraska Medical Center, Omaha

03756

Dartmouth Hitchcock Medical Center, Lebanon

07601

John Theurer Cancer Center At Hackensack UMC, Hackensack

08903-2681

Rutgers Cancer Institute of New Jersey, New Brunswick

97239-3098

Oregon Health & Science University (OHSU), Portland

NSW 2010

St Vincents Hospital Sydney Limited, Darlinghurst

128 20

UHKT Prague - Institute of Hematology and Blood Transfusion, Prague

00290

Helsinki University Central Hospital, Helsinki

09126

C.T.M.O. Ospedale Roberto Binaghi ATS Cagliari, Cagliari

00161

University of Rome La Sapienza, Roma

44-101

Centrum Onkologii- Instytut w Gliwicach, Gliwice

02-776

Klinika Transplantacji Komorek Krwiotworczych - Instytut Hematologii i Transfuzjologii, Warsaw

1099-023

Instituto Portugues de Oncologia de Lisboa Francisco Gentil EPE (IPO-Lisboa), Lisbon

1649-035

Centro Hospitalar Lisboa Norte - Hospital de Santa Maria, Lisbon

4200-072

Instituto Portugues de Oncologia do Porto Francisco Gentil, EPE, Porto

08025

Hospital de la Santa Creu i Sant Pau - Servei de Hematologia Clinica, Barcelona

08035

Hospital Universitario Vall d'Hebron, Barcelona

08036

Hospital Clinic i Provincial de Barcelona, Barcelona

08907

Instituto Catalan de Oncologia - Hospital Duran i Reynals, Barcelona

CH-8091

Universitaetsspital Zuerich - Klinik fuer Haematology, Zurich

40447 ROC

China Medical University Hospital, Taichung

CB2 0QQ

Addenbrooke's Hospital, Cambridge

CF14 4XW

University Hospital of Wales, Cardiff

W12 0HS

Hammersmith Hospital, London

NG5 1PB

Nottingham University Hospitals, Nottingham

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Incyte Corporation

INDUSTRY

NCT03139604 - GRAVITAS-301: A Study of Itacitinib or Placebo in Combination With Corticosteroids for Treatment of Acute Graft-Versus-Host Disease | Biotech Hunter | Biotech Hunter