A Study to Test an Oral Medicine, Belumosudil, in Combination With Corticosteroids in Participants at Least 12 Years of Age With Newly Diagnosed Chronic Graft Versus Host Disease.

PHASE3Active, not recruitingINTERVENTIONAL
Enrollment

260

Participants

Timeline

Start Date

January 23, 2024

Primary Completion Date

September 29, 2028

Study Completion Date

September 29, 2028

Conditions
Chronic Graft Versus Host Disease
Interventions
DRUG

Belumosudil

Pharmaceutical form:Tablet-Route of administration:oral

DRUG

Placebo

Pharmaceutical form:Table-Route of administration:oral

DRUG

Prednisone

Pharmaceutical form:Tablet-Route of administration:oral

DRUG

Prednisolone

Pharmaceutical form:Tablet-Route of administration:oral

Trial Locations (151)

1090

Investigational Site Number : 0400004, Vienna

1200

Cliniques Universitaires St. Luc-Investigational Site Number : 0560005, Woluwe

1227

Investigational Site Number : 0320005, Buenos Aires

1280

Investigational Site Number : 0320003, Buenos Aires

1426

Investigational Site Number : 0320001, Buenos Aires

1431

Investigational Site Number : 0320002, Buenos Aires

1629

Investigational Site Number : 0320006, Pilar

2100

Rigshospitalet Copenhagen University Hospital-Investigational Site Number : 2080002, Copenhagen

2145

Investigational Site Number : 0360005, Westmead

3000

Investigational Site Number : 0360001, Melbourne

UZ Leuven-Investigational Site Number : 0560001, Leuven

4000

CHU de Liège-Investigational Site Number : 0560004, Liège

4020

Investigational Site Number : 0400001, Linz

4029

Investigational Site Number : 0360003, Brisbane

5000

Investigational Site Number : 0320004, Córdoba

Odense University Hospital-Investigational Site Number : 2080003, Odense

6150

Investigational Site Number : 0360004, Murdoch

8000

Investigational Site Number : 0560006, Bruges

8036

Investigational Site Number : 0400003, Graz

8200

Department of hematology-Investigational Site Number : 2080001, Aarhus

8800

AZ Delta-Investigational Site Number : 0560002, Roeselare

9000

UZ Gent-Investigational Site Number : 0560003, Ghent

10126

Investigational Site Number : 3800007, Turin

13273

Institut Paoli Calmettes-Investigational Site Number : 2500004, Marseille

13353

Investigational Site Number : 2760007, Berlin

15232

UPMC Hillman Cancer Center- Site Number : 8400008, Pittsburgh

16132

Investigational Site Number : 3800005, Genoa

20089

Investigational Site Number : 3800002, Rozzano

20132

Investigational Site Number : 3800009, Milan

20246

Investigational Site Number : 2760002, Hamburg

21287

Johns Hopkins Hospital- Site Number : 8400033, Baltimore

22903

University of Virginia Comprehensive Cancer Center-Site Number : 8400031, Charlottesville

24105

Investigational Site Number : 2760010, Kiel

24127

Investigational Site Number : 3800003, Bergamo

27100

Investigational Site Number : 3800011, Pavia

27157

Atrium Health Wake Forest Baptist Medical Center - Winston-Salem - Medical Center Boulevard- Site Number : 8400007, Winston-Salem

27514

UNC Children's Hospital- Site Number : 8400025, Chapel Hill

28007

Investigational Site Number : 7240004, Madrid

28009

Hospital Niño Jesús-Site Number : 7240002, Madrid

29010

Hospital Regional Universitarioa de Malaga-Site Number : 7240003, Málaga

30030

The Hope Clinic of Emory University- Site Number : 8400020, Decatur

32803

AdventHealth Orlando- Site Number : 8400023, Orlando

33100

Investigational Site Number : 3800008, Udine

33600

CHU Bordeaux-Hôpital Haut-Lévêque-Investigational Site Number : 2500002, Pessac

34010

Investigational Site Number : 7920005, Istanbul

35033

Hôpital Pontchaillou - CHU de Rennes-Investigational Site Number : 2500008, Rennes

35100

Investigational Site Number : 7920003, Izmir

37007

Hospital Universitario de Salamanca-Site Number : 7240007, Salamanca

37203

Sarah Cannon Research Institute Site Number : 8400003, Nashville

39008

Investigational Site Number : 7240011, Santander

40138

Investigational Site Number : 3800004, Bologna

40536

University of Kentucky Chandler Medical Center- Site Number : 8400024, Lexington

41013

Hospital Universitario Virgen del Rocío.-Site Number : 7240008, Seville

43210

The Ohio State University Comprehensive Cancer Center (OSUCCC) - The James Cancer Hospital and Solove Research Institute- Site Number : 8400026, Columbus

44093

CHU Hotel Dieu-Investigational Site Number : 2500005, Nantes

45236

Oncology Hematology Care - Kenwood- Site Number : 8400030, Cincinnati

46010

Investigational Site Number : 7240012, Valencia

46026

Hospital Universitari i Politècnic La Fe-Site Number : 7240001, Valencia

46202

Indiana University Health University Hospital- Site Number : 8400006, Indianapolis

48149

Investigational Site Number : 2760009, Münster

48201

Karmanos Cancer Institute - Detroit- Site Number : 8400013, Detroit

50005

IV. Interni hematologicka klinika, Fakultni nemocnice Hradec Kralove-Site Number : 2030002, Hradec Králové

50937

Investigational Site Number : 2760003, Cologne

53792

University of Wisconsin Carbone Cancer Center-Site Number : 8400029, Madison

54511

Investigational Site Number : 2500006, Vandœuvre-lès-Nancy

60020

Investigational Site Number : 3800012, Torette

60611

Northwestern University- Site Number : 8400017, Chicago

62500

Interni hematologicka a onkologicka klinika Fakultni nemocnice Brno-Site Number : 2030003, Brno

69310

Hôpital Lyon Sud-Investigational Site Number : 2500007, Pierre-Bénite

70852

Klinika hematoonkologie, Fakultni nemocnice Ostrava-Site Number : 2030001, Ostrava

72076

Investigational Site Number : 2760008, Tübingen

72205

University of Arkansas for Medical Sciences-Site Number : 8400019, Little Rock

75010

Investigational Site Number : 2500003, Paris

75246

Texas Oncology - Dallas - Worth Street- Site Number : 8400010, Dallas

75571

Investigational Site Number : 2500001, Paris

78229

Texas Transplant Institute - Methodist Hospital- Site Number : 8400037, San Antonio

78704

St. David's South Austin Medical Center- Site Number : 8400002, Austin

79106

Investigational Site Number : 2760005, Freiburg im Breisgau

89133

Investigational Site Number : 3800006, Reggio Calabria

91010

City of Hope National Medical Center- Site Number : 8400001, Duarte

93053

Investigational Site Number : 2760006, Regensburg

94143

University of California San Francisco - Parnassus Heights- Site Number : 8400035, San Francisco

97239

Oregon Health and Science University- Site Number : 8400027, Portland

98109

Fred Hutchinson Cancer Research Center- Site Number : 8400004, Seattle

100050

Investigational Site Number : 1560019, Beijing

130021

Investigational Site Number : 1560012, Changchun

215006

Investigational Site Number : 1560001, Suzhou

215025

Investigational Site Number : 1560006, Suzhou

230001

Investigational Site Number : 1560014, Hefei

250001

Investigational Site Number : 1560008, Jinan

250014

Investigational Site Number : 1560007, Jinan

300020

Investigational Site Number : 1560003, Tianjin

Investigational Site Number : 1560004, Tianjin

310003

Investigational Site Number : 1560002, Hangzhou

350001

Investigational Site Number : 1560011, Fuzhou

410008

Investigational Site Number : 1560010, Changsha

430022

Investigational Site Number : 1560013, Wuhan

430030

Investigational Site Number : 1560015, Wuhan

450008

Investigational Site Number : 1560009, Zhengzhou

510000

Investigational Site Number : 1560005, Guangzhou

999077

Investigational Site Number : 3440001, Pok Fu Lam

3109601

Investigational Site Number : 3760002, Haifa

4920235

Investigational Site Number : 3760006, Petah Tikva

5262100

Investigational Site Number : 3760003, Ramat Gan

Investigational Site Number : 3760004, Ramat Gan

6423906

Investigational Site Number : 3760001, Tel Aviv

9112001

Investigational Site Number : 3760005, Jerusalem

02115

Dana Farber Cancer Institute Site Number : 8400005, Boston

H1T 2M4

Hôpital Maisonneuve Rosemont-Investigational Site Number : 1240001, Montreal

H3T1C5

CHU Sainte-Justine-Site Number : 1240003, Montreal

H4A 3J1

Investigational Site Number : 1240002, Montreal

S7N 4H4

Investigational Site Number : 1240008, Saskatoon

128 00

Ustav hematologie a krevni transfuze-Site Number : 2030004, Prague

80060-900

Hospital de Clinicas da Universidade Federal do Parana- Site Number : 0760008, Curitiba

15090-000

Fundação Faculdade Regional de Medicina de São José do Rio Preto- Site Number : 0760006, São José do Rio Preto

20230-130

INCA - Hospital do Câncer - Rio de Janeiro - Praça Da Cruz Vermelha- Site Number : 0760007, Rio de Janeiro

05403-000

Hospital das Clinicas FMUSP- Site Number : 0760004, São Paulo

05651-901

Hospital Israelita Albert Einstein- Site Number : 0760003, São Paulo

T2N 5G2

Investigational Site Number : 1240007, Calgary

M5G 2M9

Investigational Site Number : 1240005, Toronto

01307

Investigational Site Number : 2760001, Dresden

115 27

Nosokomeio Paidon I Agia Sofia-Site Number : 3000002, Athens

570 10

"General Hospital of Thessaloniki George Papanikolaou-Site Number : 3000001", Thessaloniki

00168

Investigational Site Number : 3800001, Rome

06156

Investigational Site Number : 3800010, Perugia

1081 HV

Amsterdam Universitair Medisch Centrum-Site Number : 5280005, Amsterdam

9713 GR

Investigational Site Number : 5280003, Groningen

3015 CE

Investigational Site Number : 5280002, Rotterdam

3584 CS

Investigational Site Number : 5280001, Utrecht

80-952

Investigational Site Number : 6160001, Gdansk

71-252

Investigational Site Number : 6160008, Szczecin

1099-023

Investigational Site Number : 6200003, Lisbon

1649-035

Investigational Site Number : 6200002, Lisbon

03080

Investigational Site Number : 4100002, Seoul

03722

Investigational Site Number : 4100003, Seoul

06351

Investigational Site Number : 4100004, Seoul

06591

Investigational Site Number : 4100001, Seoul

08036

Investigational Site Number : 7240005, Barcelona

08908

ICO Institut Català d'Oncologia-Site Number : 7240006, Barcelona

413 45

Investigational Site Number : 7520003, Gothenburg

141 57

Investigational Site Number : 7520001, Huddinge

221 85

Investigational Site Number : 7520002, Lund

01120

Investigational Site Number : 7920006, Adana

06200

Investigational Site Number : 7920002, Ankara

06560

Investigational Site Number : 7920004, Ankara

06620

Investigational Site Number : 7920001, Ankara

CF14 4XW

Investigational Site Number : 8260006, Cardiff

SE5 9RL

Investigational Site Number : 8260002, London

LS9 7TF

Investigational Site Number : 8260003, Leeds

M20 4BX

Investigational Site Number : 8260001, Manchester

NE7 7DN

Investigational Site Number : 8260004, Newcastle upon Tyne

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Sanofi

INDUSTRY

NCT06143891 - A Study to Test an Oral Medicine, Belumosudil, in Combination With Corticosteroids in Participants at Least 12 Years of Age With Newly Diagnosed Chronic Graft Versus Host Disease. | Biotech Hunter | Biotech Hunter