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A Study to Evaluate Axatilimab and Corticosteroids as Initial Treatment for Chronic Graft-Versus-Host Disease
Sponsor: Incyte Corporation
Summary
This study will be conducted to compare the efficacy of axatilimab versus placebo in combination with corticosteroids as initial treatment for moderate or severe chronic graft-versus-host disease (cGVHD).
Official title: A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study of Axatilimab and Corticosteroids as Initial Treatment for Chronic Graft-Versus-Host Disease (AXemplify-357)
Key Details
Gender
All
Age Range
12 Years - Any
Study Type
INTERVENTIONAL
Enrollment
240
Start Date
2025-01-21
Completion Date
2030-03-31
Last Updated
2026-04-06
Healthy Volunteers
No
Conditions
Interventions
INCA034176
IV infusion
Placebo
IV infusion
Corticosteroids
Oral/IV Infusion
Locations (118)
University of Alabama Birmingham
Birmingham, Alabama, United States
University of California San Diego Medical Center, Moores Cancer Center
La Jolla, California, United States
University of Southern California
Los Angeles, California, United States
Colorado Blood Cancer Institute
Denver, Colorado, United States
Childrens National Hospital
Washington D.C., District of Columbia, United States
Miami Cancer Institute
Miami, Florida, United States
Orlando Health Cancer Institute Downtown Orlando
Orlando, Florida, United States
Memorial Cancer Institute
Pembroke Pines, Florida, United States
Emory University-Winship Cancer Institute
Atlanta, Georgia, United States
University of Illinois
Chicago, Illinois, United States
The University of Kansas Cancer Center
Kansas City, Kansas, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
Dana Farber Cancer Institute
Boston, Massachusetts, United States
University of Michigan
Ann Arbor, Michigan, United States
Henry Ford Hospital
Detroit, Michigan, United States
Corewell Health Hematology Oncology
Grand Rapids, Michigan, United States
Hackensack University Medical Center
Hackensack, New Jersey, United States
Rutgers Cancer Institute of Nj
New Brunswick, New Jersey, United States
University of Rochester Medical Center
Rochester, New York, United States
Stony Brook University Medical Center
Stony Brook, New York, United States
Wake Forest Baptist Medical Center
Winston-Salem, North Carolina, United States
Oregon Health and Science University
Portland, Oregon, United States
Jefferson University Hospitals
Philadelphia, Pennsylvania, United States
Medical University of South Carolina
Charleston, South Carolina, United States
Prisma Health Upstate
Greenville, South Carolina, United States
Baptist Cancer Center
Memphis, Tennessee, United States
St David'S South Austin Medical Center
Austin, Texas, United States
Texas Transplant Institute
San Antonio, Texas, United States
Intermountain Blood and Marrow Transplant
Salt Lake City, Utah, United States
Virginia Commonwealth University Massey Cancer Center
Richmond, Virginia, United States
West Virginia University Cancer Institute
Morgantown, West Virginia, United States
Royal Prince Alfred Hospital
Sydney, New South Wales, Australia
Royal Adelaide Hospital
Adelaide, South Australia, Australia
Austin Health Medical Oncology and Clinical Haematology
Heidelberg, Victoria, Australia
Landeskrankenhaus Universitatsklinikum Graz
Graz, Austria
Innsbruck University Hospital
Innsbruck, Austria
Ordensklinikum Linz Gmbh Elisabethinen
LINZ CET, Austria
Akh Und Medizinische Universitat Wien Universitatsklinik Fur Innere Medizin I
Vienna, Austria
St. Anna Childrens Hospital
Vienna, Austria
Alberta'S Children Hospital
Calgary, Alberta, Canada
Stollery Children'S Hospital
Edmonton, Alberta, Canada
Bc Children'S Hospital
Vancouver, British Columbia, Canada
Queen Elizabeth Ii Health Sciences Centre
Halifax, Nova Scotia, Canada
Juravinski Cancer Centre
Hamilton, Ontario, Canada
Princess Margaret Cancer Center
Toronto, Ontario, Canada
Hospital Maisonneuve Rosemont
Montreal, Quebec, Canada
Vancouver General Hospital
Vancouver, Canada
Rigshospitalet
Copenhagen, Denmark
Chu Amiens Picardie - Hopital Sud
Amiens, France
Institut Paoli Calmettes
Marseille, France
Hopitaux de Brabois
Nancy, France
Centre Hospitalier Universitaire de Nantes (Chu de Nantes) - Hotel-Dieu
Nantes, France
Chu de Nice - Hospital L Archet
Nice, France
Hospital Saint Louis
Paris, France
Hospital Saint Antoine
Paris, France
Hospices Civils de Lyon Centre Hospitalier Lyon Sud
Pierre-Bénite, France
Universitaire Du Cancer de Toulouse Institut Claudius Regaud Iuct-Oncopole
Toulouse, France
University Medical Center Rwth Aachen
Aachen, Germany
Charite Universitatsmedizin Berlin
Berlin, Germany
Universitaetsklinikum Bonn, University Hospital Bonn
Bonn, Germany
University Clinic Carl Gustav Carus Technical University Dresden
Dresden, Germany
University Hospital Duesseldorf
Düsseldorf, Germany
Universitaetsklinikum Erlangen
Erlangen, Germany
Universitatsklinikum Essen
Essen, Germany
Universitatsklinikum Halle (Saale)
Halle, Germany
University Hospital Schleswig-Holstein Campus Kiel
Kiel, Germany
Universitatsklinikum Leipzig
Leipzig, Germany
Universitatsmedizin Der Johannes Gutenberg-Universitat Mainz Iii
Mainz, Germany
Klinikum Der Philipps-Universitaet Marburg
Marburg, Germany
Universitatsklinikum Munster
Münster, Germany
St. James Hospital
Dublin, Ireland
Azienda Ospedaliero-Universitaria Di Alessandria Ss.Antonio E Biagio E Cesare Arrigo
Alessandria, Italy
Azienda Ospedaliero Universitaria Delle Marche
Ancona, Italy
Asst Degli Spedali Civili Di Brescia
Brescia, Italy
Irccs Azienda Ospedaliera Universitaria San Martino
Genova, Italy
Azienda Socio Sanitaria Territoriale Grande Ospedale Metropolitano Niguarda
Milan, Italy
Ospedale San Raffaele - Milano
Milan, Italy
Azienda Ospedaliera Di Rilievo Nazionale Antonio Cardarelli
Naples, Italy
Azienda Ospedaliera Ospedali Riuniti Villa Sofia - Cervello
Palermo, Italy
Irccs Fondazione Policlinico San Matteo
Pavia, Italy
Grande Ospedale Metropolitano Bianchi-Melacrino-Morelli
Reggio Calabria, Italy
Azienda Policlinico Umberto 1 Universita Sapienza Di Roma
Rome, Italy
Ospedale Pediatrico Bambino Gesu Irccs
Rome, Italy
I.R.C.C.S. Casa Sollievo Della Sofferenza
San Giovanni Rotondo, Italy
Azienda Ospedaliera Card. G. Panico
Tricase, Italy
Centro Ricerche Cliniche Di Verona
Verona, Italy
Anjo Kosei Hospital
Aichi, Japan
Fujita Health University Hospital
Aichi, Japan
Kyushu University Hospital
Fukuoka, Japan
Hiroshima University Hospital
Hiroshima, Japan
Kobe City Medical Center General Hospital
Hyōgo, Japan
Tokai University Hospital
Kanagawa, Japan
National Hospital Organization Kumamoto Medical Center
Kumamoto, Japan
Gunma Saiseikai Maebashi Hospital
Maebashi, Japan
Tohoku University Hospital
Miyagi, Japan
Okayama University Hospital
Okayama Okayama, Japan
Osaka Metropolitan University Hospital
Osaka, Japan
Hokkaido University Hospital
Sapporo Hokkaido, Japan
Tokyo Metropolitan Cancer and Infectious Diseases Center Komagome Hospital
Tokyo, Japan
Amsterdam University Medical Centre
Amsterdam, Netherlands
Maastricht University Medical Center
Maastricht, Netherlands
Hospital General Universitario Vall D Hebron
Barcelona, Spain
Hospital de La Santa Creu I Sant Pau
Barcelona, Spain
Hospital Universitario Donostia
Donostia / San Sebastian, Spain
Institut Catala Doncologia Ico - Hospital Duran I Reynals Location
L'Hospitalet de Llobregat, Spain
Hospital Universitario de Gran Canaria Doctor Negrin
Las Palmas de Gran Canaria, Spain
Hospital General Universitario Gregorio Maranon
Madrid, Spain
Hospital Puerta de Hierro
Majadahonda, Spain
Hospital Universitario Virgen Del Rocio
Seville, Spain
Hospital Universitari I Politecnic La Fe
Valencia, Spain
Hospital Universitario Miguel Servet
Zaragoza, Spain
Bristol Haematology and Oncology Centre
Bristol, United Kingdom
Queen Elizabeth University Hospital
Glasgow, United Kingdom
Royal Marsden Hospital
London, United Kingdom
University College London Hospitals (Uclh)
London, United Kingdom
Manchester University Nhs Foundation Trust
Manchester, United Kingdom
Nottingham University Hospitals
Nottingham, United Kingdom
Plymouth Hospitals Nhs Trust
Plymouth, United Kingdom