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.
NCT ID: NCT06143891
Last Updated: 2025-10-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE3
260 participants
INTERVENTIONAL
2024-01-23
2028-09-29
Brief Summary
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The study duration for a participant includes up to 4 weeks for screening; a treatment period until clinically meaningful cGVHD progression (defined as progression requiring addition of new systemic treatment for cGVHD), relapse/recurrence of the underlying disease, participant starts new systemic treatment for cGVHD or experiences an unacceptable toxicity, at the request of the participants or the investigators, or until the end of study is reached, whichever comes first; at least 30 days follow-up of adverse events (AEs) after the last dose until resolution or stabilization, if applicable; and long-term follow-up until death or study close-out, whichever comes first.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Belumosudil
Participants will receive belumosudil 200 mg tablets per os(PO) once daily (QD) per 28-day cycles starting on Day 1 until discontinuation criteria are met or until end of study
Note: 200mg two times a day (BID) is used in some cases, when the subject is taking a proton pump inhibitor or a strong CYP3A4 inducer)
Belumosudil
Pharmaceutical form:Tablet-Route of administration:oral
Prednisone
Pharmaceutical form:Tablet-Route of administration:oral
Prednisolone
Pharmaceutical form:Tablet-Route of administration:oral
Placebo
Participants will receive matching placebo tablets PO QD per 28-day cycles starting on Day 1 until discontinuation criteria are met or until end of study
Placebo
Pharmaceutical form:Table-Route of administration:oral
Prednisone
Pharmaceutical form:Tablet-Route of administration:oral
Prednisolone
Pharmaceutical form:Tablet-Route of administration:oral
Interventions
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Belumosudil
Pharmaceutical form:Tablet-Route of administration:oral
Placebo
Pharmaceutical form:Table-Route of administration:oral
Prednisone
Pharmaceutical form:Tablet-Route of administration:oral
Prednisolone
Pharmaceutical form:Tablet-Route of administration:oral
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Participants who have undergone allogenic HCT with newly diagnosed moderate to severe cGVHD according to NIH consensus diagnosis and staging criteria (2014)
* Participants who require systemic treatment with corticosteroids for cGVHD
* Participants who have not received any prior systemic treatment for cGVHD (including ECP)
* If participants are receiving other immunosuppressive agents for the prophylaxis or treatment of acute GVHD, the dose should be under the threshold pre-defined in protocol
* For adult participants, the body weight should be ≥40 kg. For adolescent participants, the body weight should be ≥30 kg
* Contraceptive use by men and women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
* Participants or their legally authorized representative must be capable of giving signed informed consent
Exclusion Criteria
Medical conditions
* Any evidence (histologic, cytogenetic, molecular, hematologic, or mixed) of progressive or relapsed underlying disease after the most recent allogeneic HCT
* Post-transplant lymphoproliferative disease within 4 weeks prior to randomization
* Female participants who are pregnant or breastfeeding
* Unable to tolerate a prednisone equivalent dose of corticosteroids ≥ 1 mg/kg/day Prior/concomitant therapy
* Participant has had previous exposure to belumosudil.
* Received any previous systemic treatment for cGVHD with the following exception: Corticosteroids for cGVHD received within 7 days prior to the planned administration of IMP only if in the interest of participant.
Prior/concurrent clinical study experience
* Received any investigational agents, or any investigational device or procedure, or prohibited therapy for this study within 28 days or 5 elimination half-lives prior to randomization, whichever is longer Diagnostic assessments
* Karnofsky (if aged ≥16 years)/Lansky (if aged \<16 years) Performance Score of \< 60
* Platelets \<25 x 109/L. Platelet transfusion is not allowed within 3 days before the screening hematological test
* Absolute neutrophil count (ANC) \<0.5 x 109/L. The use of granulocyte-colony stimulating factor (G-CSF) is not allowed to reach this level during screening
* Estimated Glomerular Filtration Rate (eGFR) \<30 mL/min/1.73 m2 using the MDRD-4 variable formula (if aged ≥18 years) or using the Bedside Schwartz formula (if aged \<18 years)
* Aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) \>3 x ULN without liver cGVHD or\>5 × ULN with liver) cGVHD
* Total bilirubin \>1.5 × (ULN) (\>3 × ULN if Gilbert syndrome)
* Participant has forced expiratory volume in 1 second (FEV1) of predicted ≤39% or has lung score of 3 according to NIH consensus diagnostic and staging criteria (2014)
* History or other evidence of severe illness or any other conditions that would make the participant, in the opinion of the Investigator, unsuitable for the study (such as malabsorption syndromes, poorly controlled psychiatric disease or coronary artery disease)
* Known history of human immunodeficiency virus (HIV)
* Active viral disease including hepatitis B virus (HBV) or hepatitis C virus (HCV)
* Active uncontrolled cytomegalovirus (CMV) and Epstein-Barr virus (EBV) infection. Infections are considered controlled if appropriate therapy has been instituted and, at the time of screening, no signs of infection worsening are present according to Investigator's judgement
* Diagnosed or treated for another malignancy other than the underlying disease allogeneic HCT was indicated for, within 3 years prior to randomization with the exception of complete resection of basal cell carcinoma or squamous cell carcinoma of the skin, an in-situ malignancy, or low risk prostate cancer after curative therapy
* Unable to swallow tablets
* Participant not suitable for participation, whatever the reason, as judged by the Investigator, including medical or clinical conditions, or participants potentially at risk of noncompliance to study procedures
* Any active, uncontrolled infections assessed to be clinically significant by the Investigator
12 Years
ALL
No
Sponsors
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Sanofi
INDUSTRY
Responsible Party
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Locations
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University of Arkansas for Medical Sciences-Site Number : 8400019
Little Rock, Arkansas, United States
City of Hope National Medical Center- Site Number : 8400001
Duarte, California, United States
University of California San Francisco - Parnassus Heights- Site Number : 8400035
San Francisco, California, United States
AdventHealth Orlando- Site Number : 8400023
Orlando, Florida, United States
The Hope Clinic of Emory University- Site Number : 8400020
Decatur, Georgia, United States
Northwestern University- Site Number : 8400017
Chicago, Illinois, United States
Indiana University Health University Hospital- Site Number : 8400006
Indianapolis, Indiana, United States
University of Kentucky Chandler Medical Center- Site Number : 8400024
Lexington, Kentucky, United States
Johns Hopkins Hospital- Site Number : 8400033
Baltimore, Maryland, United States
Dana Farber Cancer Institute Site Number : 8400005
Boston, Massachusetts, United States
Karmanos Cancer Institute - Detroit- Site Number : 8400013
Detroit, Michigan, United States
UNC Children's Hospital- Site Number : 8400025
Chapel Hill, North Carolina, United States
Atrium Health Wake Forest Baptist Medical Center - Winston-Salem - Medical Center Boulevard- Site Number : 8400007
Winston-Salem, North Carolina, United States
Oncology Hematology Care - Kenwood- Site Number : 8400030
Cincinnati, Ohio, United States
The Ohio State University Comprehensive Cancer Center (OSUCCC) - The James Cancer Hospital and Solove Research Institute- Site Number : 8400026
Columbus, Ohio, United States
Oregon Health and Science University- Site Number : 8400027
Portland, Oregon, United States
UPMC Hillman Cancer Center- Site Number : 8400008
Pittsburgh, Pennsylvania, United States
Sarah Cannon Research Institute Site Number : 8400003
Nashville, Tennessee, United States
St. David's South Austin Medical Center- Site Number : 8400002
Austin, Texas, United States
Texas Oncology - Dallas - Worth Street- Site Number : 8400010
Dallas, Texas, United States
Texas Transplant Institute - Methodist Hospital- Site Number : 8400037
San Antonio, Texas, United States
University of Virginia Comprehensive Cancer Center-Site Number : 8400031
Charlottesville, Virginia, United States
Fred Hutchinson Cancer Research Center- Site Number : 8400004
Seattle, Washington, United States
University of Wisconsin Carbone Cancer Center-Site Number : 8400029
Madison, Wisconsin, United States
Investigational Site Number : 0320006
Pilar, Buenos Aires, Argentina
Investigational Site Number : 0320005
Buenos Aires, , Argentina
Investigational Site Number : 0320003
Buenos Aires, , Argentina
Investigational Site Number : 0320001
Buenos Aires, , Argentina
Investigational Site Number : 0320002
Buenos Aires, , Argentina
Investigational Site Number : 0320004
Córdoba, , Argentina
Investigational Site Number : 0360005
Westmead, New South Wales, Australia
Investigational Site Number : 0360003
Brisbane, Queensland, Australia
Investigational Site Number : 0360001
Melbourne, Victoria, Australia
Investigational Site Number : 0360004
Murdoch, Western Australia, Australia
Investigational Site Number : 0400003
Graz, , Austria
Investigational Site Number : 0400001
Linz, , Austria
Investigational Site Number : 0400004
Vienna, , Austria
Cliniques Universitaires St. Luc-Investigational Site Number : 0560005
Woluwe, Brussels Capital, Belgium
UZ Leuven-Investigational Site Number : 0560001
Leuven, Vlaams-Brabant, Belgium
Investigational Site Number : 0560006
Bruges, , Belgium
UZ Gent-Investigational Site Number : 0560003
Ghent, , Belgium
CHU de Liège-Investigational Site Number : 0560004
Liège, , Belgium
AZ Delta-Investigational Site Number : 0560002
Roeselare, , Belgium
Hospital de Clinicas da Universidade Federal do Parana- Site Number : 0760008
Curitiba, Paraná, Brazil
Fundação Faculdade Regional de Medicina de São José do Rio Preto- Site Number : 0760006
São José do Rio Preto, São Paulo, Brazil
INCA - Hospital do Câncer - Rio de Janeiro - Praça Da Cruz Vermelha- Site Number : 0760007
Rio de Janeiro, , Brazil
Hospital das Clinicas FMUSP- Site Number : 0760004
São Paulo, , Brazil
Hospital Israelita Albert Einstein- Site Number : 0760003
São Paulo, , Brazil
Investigational Site Number : 1240007
Calgary, Alberta, Canada
Investigational Site Number : 1240005
Toronto, Ontario, Canada
Hôpital Maisonneuve Rosemont-Investigational Site Number : 1240001
Montreal, Quebec, Canada
CHU Sainte-Justine-Site Number : 1240003
Montreal, Quebec, Canada
Investigational Site Number : 1240002
Montreal, Quebec, Canada
Investigational Site Number : 1240008
Saskatoon, Saskatchewan, Canada
Investigational Site Number : 1560019
Beijing, , China
Investigational Site Number : 1560012
Changchun, , China
Investigational Site Number : 1560010
Changsha, , China
Investigational Site Number : 1560011
Fuzhou, , China
Investigational Site Number : 1560005
Guangzhou, , China
Investigational Site Number : 1560002
Hangzhou, , China
Investigational Site Number : 1560014
Hefei, , China
Investigational Site Number : 1560008
Jinan, , China
Investigational Site Number : 1560007
Jinan, , China
Investigational Site Number : 1560001
Suzhou, , China
Investigational Site Number : 1560006
Suzhou, , China
Investigational Site Number : 1560003
Tianjin, , China
Investigational Site Number : 1560004
Tianjin, , China
Investigational Site Number : 1560013
Wuhan, , China
Investigational Site Number : 1560015
Wuhan, , China
Investigational Site Number : 1560009
Zhengzhou, , China
Interni hematologicka a onkologicka klinika Fakultni nemocnice Brno-Site Number : 2030003
Brno, , Czechia
IV. Interni hematologicka klinika, Fakultni nemocnice Hradec Kralove-Site Number : 2030002
Hradec Králové, , Czechia
Klinika hematoonkologie, Fakultni nemocnice Ostrava-Site Number : 2030001
Ostrava, , Czechia
Ustav hematologie a krevni transfuze-Site Number : 2030004
Prague, , Czechia
Rigshospitalet Copenhagen University Hospital-Investigational Site Number : 2080002
Copenhagen, Capital, Denmark
Odense University Hospital-Investigational Site Number : 2080003
Odense, Funen, Denmark
Department of hematology-Investigational Site Number : 2080001
Aarhus, Jutland, Denmark
Institut Paoli Calmettes-Investigational Site Number : 2500004
Marseille, , France
CHU Hotel Dieu-Investigational Site Number : 2500005
Nantes, , France
Investigational Site Number : 2500003
Paris, , France
Investigational Site Number : 2500001
Paris, , France
CHU Bordeaux-Hôpital Haut-Lévêque-Investigational Site Number : 2500002
Pessac, , France
Hôpital Lyon Sud-Investigational Site Number : 2500007
Pierre-Bénite, , France
Hôpital Pontchaillou - CHU de Rennes-Investigational Site Number : 2500008
Rennes, , France
Investigational Site Number : 2500006
Vandœuvre-lès-Nancy, , France
Investigational Site Number : 2760007
Berlin, , Germany
Investigational Site Number : 2760003
Cologne, , Germany
Investigational Site Number : 2760001
Dresden, , Germany
Investigational Site Number : 2760005
Freiburg im Breisgau, , Germany
Investigational Site Number : 2760002
Hamburg, , Germany
Investigational Site Number : 2760010
Kiel, , Germany
Investigational Site Number : 2760009
Münster, , Germany
Investigational Site Number : 2760006
Regensburg, , Germany
Investigational Site Number : 2760008
Tübingen, , Germany
Nosokomeio Paidon I Agia Sofia-Site Number : 3000002
Athens, , Greece
General Hospital of Thessaloniki "George Papanikolaou"-Site Number : 3000001
Thessaloniki, , Greece
Investigational Site Number : 3440001
Pok Fu Lam, , Hong Kong
Investigational Site Number : 3760002
Haifa, , Israel
Investigational Site Number : 3760005
Jerusalem, , Israel
Investigational Site Number : 3760006
Petah Tikva, , Israel
Investigational Site Number : 3760003
Ramat Gan, , Israel
Investigational Site Number : 3760004
Ramat Gan, , Israel
Investigational Site Number : 3760001
Tel Aviv, , Israel
Investigational Site Number : 3800012
Torette, Ancona, Italy
Investigational Site Number : 3800005
Genoa, Genova, Italy
Investigational Site Number : 3800009
Milan, Milano, Italy
Investigational Site Number : 3800002
Rozzano, Milano, Italy
Investigational Site Number : 3800001
Rome, Roma, Italy
Investigational Site Number : 3800007
Turin, Torino, Italy
Investigational Site Number : 3800003
Bergamo, , Italy
Investigational Site Number : 3800004
Bologna, , Italy
Investigational Site Number : 3800011
Pavia, , Italy
Investigational Site Number : 3800010
Perugia, , Italy
Investigational Site Number : 3800006
Reggio Calabria, , Italy
Investigational Site Number : 3800008
Udine, , Italy
Amsterdam Universitair Medisch Centrum-Site Number : 5280005
Amsterdam, , Netherlands
Investigational Site Number : 5280003
Groningen, , Netherlands
Investigational Site Number : 5280002
Rotterdam, , Netherlands
Investigational Site Number : 5280001
Utrecht, , Netherlands
Investigational Site Number : 6160001
Gdansk, Pomeranian Voivodeship, Poland
Investigational Site Number : 6160008
Szczecin, , Poland
Investigational Site Number : 6200003
Lisbon, , Portugal
Investigational Site Number : 6200002
Lisbon, , Portugal
Investigational Site Number : 4100002
Seoul, Seoul-teukbyeolsi, South Korea
Investigational Site Number : 4100003
Seoul, Seoul-teukbyeolsi, South Korea
Investigational Site Number : 4100004
Seoul, Seoul-teukbyeolsi, South Korea
Investigational Site Number : 4100001
Seoul, Seoul-teukbyeolsi, South Korea
Investigational Site Number : 7240011
Santander, Cantabria, Spain
Investigational Site Number : 7240005
Barcelona, Catalunya [Cataluña], Spain
ICO Institut Català d'Oncologia-Site Number : 7240006
Barcelona, Catalunya [Cataluña], Spain
Investigational Site Number : 7240004
Madrid, , Spain
Hospital Niño Jesús-Site Number : 7240002
Madrid, , Spain
Hospital Regional Universitarioa de Malaga-Site Number : 7240003
Málaga, , Spain
Hospital Universitario de Salamanca-Site Number : 7240007
Salamanca, , Spain
Hospital Universitario Virgen del Rocío.-Site Number : 7240008
Seville, , Spain
Investigational Site Number : 7240012
Valencia, , Spain
Hospital Universitari i Politècnic La Fe-Site Number : 7240001
Valencia, , Spain
Investigational Site Number : 7520003
Gothenburg, , Sweden
Investigational Site Number : 7520001
Huddinge, , Sweden
Investigational Site Number : 7520002
Lund, , Sweden
Investigational Site Number : 7920006
Adana, , Turkey (Türkiye)
Investigational Site Number : 7920002
Ankara, , Turkey (Türkiye)
Investigational Site Number : 7920004
Ankara, , Turkey (Türkiye)
Investigational Site Number : 7920001
Ankara, , Turkey (Türkiye)
Investigational Site Number : 7920005
Istanbul, , Turkey (Türkiye)
Investigational Site Number : 7920003
Izmir, , Turkey (Türkiye)
Investigational Site Number : 8260006
Cardiff, Cardiff [Caerdydd Gb-crd], United Kingdom
Investigational Site Number : 8260002
London, London, City of, United Kingdom
Investigational Site Number : 8260003
Leeds, , United Kingdom
Investigational Site Number : 8260001
Manchester, , United Kingdom
Investigational Site Number : 8260004
Newcastle upon Tyne, , United Kingdom
Countries
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Related Links
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EFC17757 Plain Language Results Summary
Other Identifiers
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2023-505394-32
Identifier Type: REGISTRY
Identifier Source: secondary_id
U1111-1280-4918
Identifier Type: REGISTRY
Identifier Source: secondary_id
EFC17757
Identifier Type: -
Identifier Source: org_study_id
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