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

PHASE3Active, not recruitingINTERVENTIONAL
Enrollment

9

Participants

Timeline

Start Date

June 4, 2025

Primary Completion Date

May 31, 2028

Study Completion Date

November 30, 2032

Conditions
Chronic Graft-versus-host-disease
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.

Trial Locations (130)

10117

Charite - Universitaetsmedizin Berlin, Berlin

10126

A.O.U. Citta Della Salute E Della Scienza Di Torino, Torino

10676

General Hospital of Athens Evangelismos - Eye Hospital, Athens

12462

Attikon Hospital and Cutaneous Lymphoma Clinic-Athens University Medical School, Athens

12808

Ustav Hematologie A Krevni Transfuze (Uhkt), the Institute of Hematology and Blood Transfusion (Ihbt, Prague

13009

Institut Paoli Calmettes, Marseille

14000

CHU CAEN, Caen

14186

Karolinska Universitetssjukhuset, Centrum For Cellterapi Och Allogen Stamcellstransplantation, Stockholm

15121

Ss Antonio & Biagio and C. Arrigo Hospital, Alessandria

16132

Irccs - Azienda Ospedaliera Universitaria - Ist San Martino, Genova

18014

Hospital Universitario Virgen de Las Nieves, Granada

20014

Hospital Universitario de Donostia, SAN Sebasttian

20089

Irccs Istituto Clinico Humanitas, Rozzano

20122

Fondazione Irccs Ca' Granda - Ospedale Maggiore Policlinico, Milan

20132

Istituto Di Ricovero E Cura A Carattere Scientifico (Irccs) - Ospedale San Raffaele (Hsr) (Istituto, Milan

20162

Asst Grande Ospedale Metropolitano Niguarda, Milan

20520

Turku University Hospital, Turku

20900

Azienda Ospedaliera San Gerardo Di Monza, Monza

24105

Universitaetsklinikum Schleswig-Holstein, Uksh-Campus Kiel, Kiel

24127

Azienda Ospedaliera Papa Giovanni Xxiii, Bergamo

25123

Universita Degli Studi Di Brescia - Azienda Ospedaliera Spedali Civili Di Brescia, Brescia

26504

University Hospital of Patras, RIO Patras

27100

Irccs Fondazione Policlinico San Matteo, Pavia

28007

Hospital General Universitario Gregorio Maranon (Hgugm), Madrid

28009

Hospital Universitario Infantil Nino Jesus, Madrid

28034

Hospital Universitario Ramon Y Cajal, Madrid

28041

Hospital Universitario 12 de Octubre, Madrid

29010

Hospital Regional Universitario de Malaga, Málaga

30120

Hospital Clinico Universitario Virgen de La Arrixaca, El Palmar

31059

Institut Claudius Regaud Cancer Comprehensive Center - Iuct Oncopole, Toulouse

31100

Ospedale Santa Maria Di Ca' Foncello, Treviso

33100

Clinica Ematologica, Dism Azienda Ospedaliero Universitaria, Udine

33600

Centre Hospitalier Universitaire de Bordeaux - Hopital Haut-Leveque, Pessac

35010

Hospital Universitario de Gran Canaria Doctor Negrín, Las Palmas de Gran Canaria

35128

Azienda Ospedale Universita Di Padova, Padua

37007

Hospital Clinico Universitario de Salamanca, Salamanca

37075

Universitaetsmedizin Goettingen, Göttingen

37134

Uoc Ematologia E Centro Trapianti Midollo Osseo Br, Ospedale Borgo Roma, Verona

39008

Hospital Universitario Marques de Valdecilla, Santander

40138

Azienda Ospedaliera Sant'Orsola Malpighi, Bologna

Azienda Ospedaliero Universitaria Di Bologna - Policlinico S. Orsola-Malpighi - Istituto Di Ematolog, Bologna

41013

Hospital Universitario Virgen Del Rocio, Seville

41650

University of Gothenburg and Queen Silvia Children S Hospital At Sahlgrenska University Hospital, Gothenburg

44000

Chu de Nantes, Nantes

46010

Hospital Clinico Universitario de Valencia (Instituto de Investigacion Sanitaria Incliva), Valencia

46026

Universitat de Valencia - Hospital Universitari I Politecnic La Fe de Valencia, Valencia

48149

Universitaetsklinikum Muenster, Münster

50009

Hospital Universitario Miguel Servet, Zaragoza

50134

Azienda Ospedaliero Universitaria Careggi-S.O.D. Patologia Medica, Florence

50937

Universitaetsklinikum Koeln, Cologne

52074

Uniklinik Rwth Aachen Medizinische Klinik Iv, Aachen

54511

Chru Nancy, Vandœuvre-lès-Nancy

55131

Universitatsmedizin Der Johannes Gutenberg-Universitat Mainz Iii, Mainz

57010

General Hospital of Thessalonikis George Papanikolaou - Gene and Cell Therapy Center, Thessaloniki

59037

Centre Hospitalier Regional Universitaire (Chru) de Lille - Hopital Claude Huriez, Lille

60126

Azienda Ospedaliero Universitaria Delle Marche Clinica Ematologica, Ancona

60590

Klinikum Der Johann Wolfgang Goethe-Universitaet, Frankfurt am Main

65124

Presidio Ospedaliero Spirito Santo Azienda U.S.L. Pescara, Pescara

66421

Universitaetsklinikum Des Saarlandes, Homburg

69495

Centre Hospitalier Lyon Sud, Pierre-Bénite

71013

Fondazione Ircss Casa Sollievo Della Sofferenza, San Giovanni Rotondo

73039

Pia Fondazione Cardinale Giovanni Panico Azienda Ospedaliera, Lecce

75010

Hospital Saint-Louis - Aphp, Paris

75019

Hopital Universitaire Robert Debre, Paris

75185

Uppsala University Hospital, Uppsala

76038

Centre Henri Becquerel, Rouen

79106

Universitaetsklinikum Freiburg, Freiburg im Breisgau

80054

Chu D'Amiens-Picardie - Hopital Sud, Amiens

80131

Azienda Ospedaliero Universitaria Federico Ii Di Napoli, Naples

Azienda Ospedaliera Di Rilievo Nazionale (Aorn) 'Antonio Cardarelli', Napoli

89081

University Hospital of Ulm, Universitatsklinikum Ulm, Ulm

89133

Morelli Hospital, Reggio Calabria

90146

Azienda Ospedaliera Ospedali Riuniti Villa Sofia - Cervello, Palermo

91054

Universitatsklinikum Erlangen, Erlangen

93053

University Clinic Regensburg, Regensburg

94805

Gustave Roussy Cancer Campus Grand Paris- (Institut de Cancerologie Gustave-Roussy), Villejuif

95125

Azienda Policlinico Vittorio Emanuele, Presidio G Rodolico, Universita Di Catania, Catania

97080

University of Wuerzburg, Würzburg

08036

Medical University of Graz, Graz

Hospital Clinic de Barcelona (Hospital Clinic I Provincial), Barcelona

06020

Medizinische Universitaet Innsbruck - Universitaetsklinik Fuer Innere Medizin Iii, Innsbruck

04020

Krankenhaus Der Elisabethinen Linz Gmbh, Linz

01090

Medizinische Universitat Wien, Universitatsklinik Fur Innere Medizin I, Vienna

St. Anna Childrens Hospital, Vienna

08000

Az Sint-Jan Brugge Av, Bruges

05530

Chu Ucl Namur Site Godinne, Godinne-mont

03000

Universitair Ziekenhuis Leuven, Leuven

04000

Chu Liege -Centre Hospitalier Universitaire Sart Tilman, Liège

08800

Algemeen Ziekenhuis Delta, Roeselare

01200

Universite Catholique de Louvain (Ucl) - Cliniques Universitaires Saint-Luc, Woluwe-Saint-Lambert

500 05

Fakultni Nemocnice Hradec Kralove, Hradec Králové

708 52

Fakultni Nemocnice Ostrava, Ostrava-poruba

00029

Helsinki University Central Hospital, Helsinki

00290

New Children'S Hospital, University of Helsinki and Helsinki University Hospital, Helsinki

06200

Centre Hospitalier Universitaire de Nice,Hopital L Archet, Nice

01307

University Hospital Carl Gustav Carus, Dresden

06120

Universitaetsklinikum Halle, Halle

04103

University Hospital Leipzig, Leipzig

D08 NHY1

St. James Hospital, Dublin

00161

Aou Policlinico Umberto I, Roma

00168

A. Gemelli University Hospital, Catholic University of the Sacred Heart, Roma

00133

Fondazione Ptv Policlinico Tor Vergata, Rome

00165

Irccs Ospedale Pediatrico Bambino Gesu, Rome

1081 HV

Amsterdam University Medical Center (Amsterdam Umc), Vrije University Medical Center (Vumc), Amsterdam

9713 GZ

University Medical Center Groningen, Groningen

2333 ZA

Leiden University Medical Center (Leids Universitair Medisch Centrum (Lumc)), Leiden

6229 HX

Maastricht University Medical Center (Mumc), Maastricht

3015 GD

Erasmus Medisch Centrum 1, Rotterdam

3584 CX

Universitair Medisch Centrum Utrecht (Umc Utrecht), Utrecht

05021

Haukeland University Hospital, Bergen

00027

Rikshospitalet University Hospital, Oslo

1099-035

Ipo Lisboa Francisco Gentil, Lisbon

1649-028

Centro Hospitalar Universitario Lisboa Norte Epe, Lisbon

4200-072

Instituto Portugues de Oncologia Do Porto Francisco Gentil E.P.E, Porto

08916

Institut Catala D'Oncologia Badalona, Hospital Germans Trias I Pujol, Badalona

08035

Hospital Universitario Vall D'Hebron, Barcelona

08041

Hospital de La Santa Creu I Sant Pau, Barcelona

08908

Institut Catala D Oncologia, Barcelona

08950

Hospital Sant Joan de Deu Barcelona - Children'S Hospital, Esplugues de Llobregat

413 45

Sahlgrenska University Hospital, Gothenburg

221 85

Skanes Universitetssjukhus - Universitetssjukhuset I Lund, Lund

04031

University Hospital Basel, Basel

01205

Hopitaux Universitaires de Geneve (Hug) - Centre de Recherche Clinique (Crc), Geneva

08091

Universitatsspital Zurich, Zurich

CH-8032

Universitats-Kinderspital Zurich Eleonorenstiftung, Zurich

CF14 4XW

Cardiff and Vale Nhs Trust - University Hospital of Wales (Uhw), Cardiff

G51 4TF

Queen Elizabeth University Hospital, Glasgow

LS9 7TF

St James'S University Hospital - Leeds Teaching Hospitals Nhs Trust, Leeds

LE1 5WW

University Hospitals of Leicester Nhs Trust-Leicester Royal Infirmary, Leicester

SE5 9RS

King'S College Hospital Nhs Foundation Trust, London

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Incyte Corporation

INDUSTRY

NCT06821542 - 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 | Biotech Hunter | Biotech Hunter