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ACTIVE NOT RECRUITING

NCT06143891

PHASE3

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.

Sponsor: Sanofi

View on ClinicalTrials.gov

Summary

This is a parallel, Phase 3, two-arm study for the treatment of newly diagnosed moderate or severe chronic GVHD. 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.

Official title: A Randomized, Double-blind, Multicenter, Phase 3 Study to Evaluate Efficacy and Safety of Belumosudil in Combination With Corticosteroids Versus Placebo in Combination With Corticosteroids in Participants at Least 12 Years of Age With Newly Diagnosed Chronic Graft Versus Host Disease (cGVHD)

Key Details

Gender

All

Age Range

12 Years - Any

Study Type

INTERVENTIONAL

Enrollment

260

Start Date

2024-01-23

Completion Date

2028-09-29

Last Updated

2025-10-14

Healthy Volunteers

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

Inclusion Criteria: * Patients must be at least 12 years of age inclusive, at the time of signing the informed consent * 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: Participants are excluded from the study if any of the following criteria apply: 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

Locations (151)

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

Clinical Research Directory

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.

Summary

Key Details

Conditions

Interventions

Eligibility Criteria

Locations (151)