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ACTIVE NOT RECRUITING
NCT06821542
PHASE3

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

View on ClinicalTrials.gov

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

Interventions

DRUG

INCA034176

IV infusion

DRUG

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