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A Study to Evaluate Axatilimab Versus Best Available Therapy in Participants With Chronic Graft Versus Host Disease After at Least 2 Prior Lines of Systemic Therapy
Sponsor: Incyte Corporation
Summary
This study will be conducted to compare Axatilimab Versus Best Available Therapy in Participants With Chronic Graft Versus Host Disease After at Least 2 Prior Lines of Systemic Therapy.
Official title: A Phase 3, Randomized, Open-Label Study of Axatilimab Versus Best Available Therapy in Participants With Chronic Graft Versus Host Disease After at Least 2 Prior Lines of Systemic Therapy
Key Details
Gender
All
Age Range
12 Years - Any
Study Type
INTERVENTIONAL
Enrollment
9
Start Date
2025-06-04
Completion Date
2032-11-30
Last Updated
2026-03-23
Healthy Volunteers
No
Conditions
Interventions
INCA034176
IV infusion
Best Available Therapy (BAT)
Best Available Therapy (BAT) will be selected by the Investigator for each participant. BAT may not include experimental agents (i.e. those not approved for the treatment of any indication) as well as a limited number of other selected drugs in accordance with the protocol-defined requirements.
Locations (130)
Medical University of Graz
Graz, Austria
Medizinische Universitaet Innsbruck - Universitaetsklinik Fuer Innere Medizin Iii
Innsbruck, Austria
Krankenhaus Der Elisabethinen Linz Gmbh
Linz, Austria
Medizinische Universitat Wien, Universitatsklinik Fur Innere Medizin I
Vienna, Austria
St. Anna Childrens Hospital
Vienna, Austria
Az Sint-Jan Brugge Av
Bruges, Belgium
Chu Ucl Namur Site Godinne
Godinne-mont, Belgium
Universitair Ziekenhuis Leuven
Leuven, Belgium
Chu Liege -Centre Hospitalier Universitaire Sart Tilman
Liège, Belgium
Algemeen Ziekenhuis Delta
Roeselare, Belgium
Universite Catholique de Louvain (Ucl) - Cliniques Universitaires Saint-Luc
Woluwe-Saint-Lambert, Belgium
Fakultni Nemocnice Hradec Kralove
Hradec Králové, Czechia
Fakultni Nemocnice Ostrava
Ostrava-poruba, Czechia
Ustav Hematologie A Krevni Transfuze (Uhkt), the Institute of Hematology and Blood Transfusion (Ihbt
Prague, Czechia
Helsinki University Central Hospital
Helsinki, Finland
New Children'S Hospital, University of Helsinki and Helsinki University Hospital
Helsinki, Finland
Turku University Hospital
Turku, Finland
Chu D'Amiens-Picardie - Hopital Sud
Amiens, France
CHU CAEN
Caen, France
Centre Hospitalier Regional Universitaire (Chru) de Lille - Hopital Claude Huriez
Lille, France
Institut Paoli Calmettes
Marseille, France
Chu de Nantes
Nantes, France
Centre Hospitalier Universitaire de Nice,Hopital L Archet
Nice, France
Hospital Saint-Louis - Aphp
Paris, France
Hopital Universitaire Robert Debre
Paris, France
Centre Hospitalier Universitaire de Bordeaux - Hopital Haut-Leveque
Pessac, France
Centre Hospitalier Lyon Sud
Pierre-Bénite, France
Centre Henri Becquerel
Rouen, France
Institut Claudius Regaud Cancer Comprehensive Center - Iuct Oncopole
Toulouse, France
Chru Nancy
Vandœuvre-lès-Nancy, France
Gustave Roussy Cancer Campus Grand Paris- (Institut de Cancerologie Gustave-Roussy)
Villejuif, France
Uniklinik Rwth Aachen Medizinische Klinik Iv
Aachen, Germany
Charite - Universitaetsmedizin Berlin
Berlin, Germany
Universitaetsklinikum Koeln
Cologne, Germany
University Hospital Carl Gustav Carus
Dresden, Germany
Universitatsklinikum Erlangen
Erlangen, Germany
Klinikum Der Johann Wolfgang Goethe-Universitaet
Frankfurt am Main, Germany
Universitaetsklinikum Freiburg
Freiburg im Breisgau, Germany
Universitaetsmedizin Goettingen
Göttingen, Germany
Universitaetsklinikum Halle
Halle, Germany
Universitaetsklinikum Des Saarlandes
Homburg, Germany
Universitaetsklinikum Schleswig-Holstein, Uksh-Campus Kiel
Kiel, Germany
University Hospital Leipzig
Leipzig, Germany
Universitatsmedizin Der Johannes Gutenberg-Universitat Mainz Iii
Mainz, Germany
Universitaetsklinikum Muenster
Münster, Germany
University Clinic Regensburg
Regensburg, Germany
University Hospital of Ulm, Universitatsklinikum Ulm
Ulm, Germany
University of Wuerzburg
Würzburg, Germany
General Hospital of Athens Evangelismos - Eye Hospital
Athens, Greece
Attikon Hospital and Cutaneous Lymphoma Clinic-Athens University Medical School
Athens, Greece
University Hospital of Patras
RIO Patras, Greece
General Hospital of Thessalonikis George Papanikolaou - Gene and Cell Therapy Center
Thessaloniki, Greece
St. James Hospital
Dublin, Ireland
Ss Antonio & Biagio and C. Arrigo Hospital
Alessandria, Italy
Azienda Ospedaliero Universitaria Delle Marche Clinica Ematologica
Ancona, Italy
Azienda Ospedaliera Papa Giovanni Xxiii
Bergamo, Italy
Azienda Ospedaliera Sant'Orsola Malpighi
Bologna, Italy
Azienda Ospedaliero Universitaria Di Bologna - Policlinico S. Orsola-Malpighi - Istituto Di Ematolog
Bologna, Italy
Universita Degli Studi Di Brescia - Azienda Ospedaliera Spedali Civili Di Brescia
Brescia, Italy
Azienda Policlinico Vittorio Emanuele, Presidio G Rodolico, Universita Di Catania
Catania, Italy
Azienda Ospedaliero Universitaria Careggi-S.O.D. Patologia Medica
Florence, Italy
Irccs - Azienda Ospedaliera Universitaria - Ist San Martino
Genova, Italy
Pia Fondazione Cardinale Giovanni Panico Azienda Ospedaliera
Lecce, Italy
Fondazione Irccs Ca' Granda - Ospedale Maggiore Policlinico
Milan, Italy
Istituto Di Ricovero E Cura A Carattere Scientifico (Irccs) - Ospedale San Raffaele (Hsr) (Istituto
Milan, Italy
Asst Grande Ospedale Metropolitano Niguarda
Milan, Italy
Azienda Ospedaliera San Gerardo Di Monza
Monza, Italy
Azienda Ospedaliera Di Rilievo Nazionale (Aorn) 'Antonio Cardarelli'
Naples, Italy
Azienda Ospedaliero Universitaria Federico Ii Di Napoli
Naples, Italy
Azienda Ospedale Universita Di Padova
Padova, Italy
Azienda Ospedaliera Ospedali Riuniti Villa Sofia - Cervello
Palermo, Italy
Irccs Fondazione Policlinico San Matteo
Pavia, Italy
Presidio Ospedaliero Spirito Santo Azienda U.S.L. Pescara
Pescara, Italy
Morelli Hospital
Reggio Calabria, Italy
Aou Policlinico Umberto I
Roma, Italy
A. Gemelli University Hospital, Catholic University of the Sacred Heart
Roma, Italy
Fondazione Ptv Policlinico Tor Vergata
Rome, Italy
Irccs Ospedale Pediatrico Bambino Gesu
Rome, Italy
Irccs Istituto Clinico Humanitas
Rozzano, Italy
Fondazione Ircss Casa Sollievo Della Sofferenza
San Giovanni Rotondo, Italy
A.O.U. Citta Della Salute E Della Scienza Di Torino
Torino, Italy
Ospedale Santa Maria Di Ca' Foncello
Treviso, Italy
Clinica Ematologica, Dism Azienda Ospedaliero Universitaria
Udine, Italy
Uoc Ematologia E Centro Trapianti Midollo Osseo Br, Ospedale Borgo Roma
Verona, Italy
Amsterdam University Medical Center (Amsterdam Umc), Vrije University Medical Center (Vumc)
Amsterdam, Netherlands
University Medical Center Groningen
Groningen, Netherlands
Leiden University Medical Center (Leids Universitair Medisch Centrum (Lumc))
Leiden, Netherlands
Maastricht University Medical Center (Mumc)
Maastricht, Netherlands
Erasmus Medisch Centrum 1
Rotterdam, Netherlands
Universitair Medisch Centrum Utrecht (Umc Utrecht)
Utrecht, Netherlands
Haukeland University Hospital
Bergen, Norway
Rikshospitalet University Hospital
Oslo, Norway
Ipo Lisboa Francisco Gentil
Lisbon, Portugal
Centro Hospitalar Universitario Lisboa Norte Epe
Lisbon, Portugal
Instituto Portugues de Oncologia Do Porto Francisco Gentil E.P.E
Porto, Portugal
Institut Catala D'Oncologia Badalona, Hospital Germans Trias I Pujol
Badalona, Spain
Hospital Universitario Vall D'Hebron
Barcelona, Spain
Hospital Clinic de Barcelona (Hospital Clinic I Provincial)
Barcelona, Spain
Hospital de La Santa Creu I Sant Pau
Barcelona, Spain
Institut Catala D Oncologia
Barcelona, Spain
Hospital Clinico Universitario Virgen de La Arrixaca
El Palmar, Spain
Hospital Sant Joan de Deu Barcelona - Children'S Hospital
Esplugues de Llobregat, Spain
Hospital Universitario Virgen de Las Nieves
Granada, Spain
Hospital Universitario de Gran Canaria Doctor Negrín
Las Palmas de Gran Canaria, Spain
Hospital General Universitario Gregorio Maranon (Hgugm)
Madrid, Spain
Hospital Universitario Infantil Nino Jesus
Madrid, Spain
Hospital Universitario Ramon Y Cajal
Madrid, Spain
Hospital Universitario 12 de Octubre
Madrid, Spain
Hospital Regional Universitario de Malaga
Málaga, Spain
Hospital Clinico Universitario de Salamanca
Salamanca, Spain
Hospital Universitario de Donostia
SAN Sebasttian, Spain
Hospital Universitario Marques de Valdecilla
Santander, Spain
Hospital Universitario Virgen Del Rocio
Seville, Spain
Hospital Clinico Universitario de Valencia (Instituto de Investigacion Sanitaria Incliva)
Valencia, Spain
Universitat de Valencia - Hospital Universitari I Politecnic La Fe de Valencia
Valencia, Spain
Hospital Universitario Miguel Servet
Zaragoza, Spain
Sahlgrenska University Hospital
Gothenburg, Sweden
University of Gothenburg and Queen Silvia Children S Hospital At Sahlgrenska University Hospital
Gothenburg, Sweden
Skanes Universitetssjukhus - Universitetssjukhuset I Lund
Lund, Sweden
Karolinska Universitetssjukhuset, Centrum For Cellterapi Och Allogen Stamcellstransplantation
Stockholm, Sweden
Uppsala University Hospital
Uppsala, Sweden
University Hospital Basel
Basel, Switzerland
Hopitaux Universitaires de Geneve (Hug) - Centre de Recherche Clinique (Crc)
Geneva, Switzerland
Universitatsspital Zurich
Zurich, Switzerland
Universitats-Kinderspital Zurich Eleonorenstiftung
Zurich, Switzerland
Cardiff and Vale Nhs Trust - University Hospital of Wales (Uhw)
Cardiff, United Kingdom
Queen Elizabeth University Hospital
Glasgow, United Kingdom
St James'S University Hospital - Leeds Teaching Hospitals Nhs Trust
Leeds, United Kingdom
University Hospitals of Leicester Nhs Trust-Leicester Royal Infirmary
Leicester, United Kingdom
King'S College Hospital Nhs Foundation Trust
London, United Kingdom