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New hope for transplant patients: drug combo targets debilitating GVHD

NCT ID NCT06143891

Disease control Sponsor: Sanofi Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests whether adding the drug belumosudil to standard steroids helps control chronic graft-versus-host disease (cGVHD) better than steroids alone. cGVHD is a serious condition where donor immune cells attack the recipient's body after a stem cell transplant. About 260 people aged 12 and older with newly diagnosed moderate or severe cGVHD will take part. The goal is to see if the combination delays disease worsening and improves symptoms.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 260 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jan 2024

Expected to finish

Sep 2028

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

12 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

Bronchiolitis Obliterans Syndrome chronic graft versus host disease

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Chronic graft versus host disease

Contacts and locations

Locations

  • AZ Delta-Investigational Site Number : 0560002

    Roeselare, 8800, Belgium

  • AdventHealth Orlando- Site Number : 8400023

    Orlando, Florida, 32803, United States

  • Amsterdam Universitair Medisch Centrum-Site Number : 5280005

    Amsterdam, 1081 HV, Netherlands

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

    Winston-Salem, North Carolina, 27157, United States

  • CHU Bordeaux-Hôpital Haut-Lévêque-Investigational Site Number : 2500002

    Pessac, 33600, France

  • CHU Hotel Dieu-Investigational Site Number : 2500005

    Nantes, 44093, France

  • CHU Sainte-Justine-Site Number : 1240003

    Montreal, Quebec, H3T1C5, Canada

  • CHU de Liège-Investigational Site Number : 0560004

    Liège, 4000, Belgium

  • City of Hope National Medical Center- Site Number : 8400001

    Duarte, California, 91010, United States

  • Cliniques Universitaires St. Luc-Investigational Site Number : 0560005

    Woluwe, Brussels Capital, 1200, Belgium

  • Dana Farber Cancer Institute Site Number : 8400005

    Boston, Massachusetts, 02115, United States

  • Department of hematology-Investigational Site Number : 2080001

    Aarhus, Jutland, 8200, Denmark

  • Fred Hutchinson Cancer Research Center- Site Number : 8400004

    Seattle, Washington, 98109, United States

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

    São José do Rio Preto, São Paulo, 15090-000, Brazil

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

    Thessaloniki, 570 10, Greece

  • Hospital Israelita Albert Einstein- Site Number : 0760003

    São Paulo, 05651-901, Brazil

  • Hospital Niño Jesús-Site Number : 7240002

    Madrid, 28009, Spain

  • Hospital Regional Universitarioa de Malaga-Site Number : 7240003

    Málaga, 29010, Spain

  • Hospital Universitari i Politècnic La Fe-Site Number : 7240001

    Valencia, 46026, Spain

  • Hospital Universitario Virgen del Rocío.-Site Number : 7240008

    Seville, 41013, Spain

  • Hospital Universitario de Salamanca-Site Number : 7240007

    Salamanca, 37007, Spain

  • Hospital das Clinicas FMUSP- Site Number : 0760004

    São Paulo, 05403-000, Brazil

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

    Curitiba, Paraná, 80060-900, Brazil

  • Hôpital Lyon Sud-Investigational Site Number : 2500007

    Pierre-Bénite, 69310, France

  • Hôpital Maisonneuve Rosemont-Investigational Site Number : 1240001

    Montreal, Quebec, H1T 2M4, Canada

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

    Rennes, 35033, France

  • ICO Institut Català d'Oncologia-Site Number : 7240006

    Barcelona, Catalunya [Cataluña], 08908, Spain

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

    Rio de Janeiro, 20230-130, Brazil

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

    Hradec Králové, 50005, Czechia

  • Indiana University Health University Hospital- Site Number : 8400006

    Indianapolis, Indiana, 46202, United States

  • Institut Paoli Calmettes-Investigational Site Number : 2500004

    Marseille, 13273, France

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

    Brno, 62500, Czechia

  • Investigational Site Number : 0320001

    Buenos Aires, 1426, Argentina

  • Investigational Site Number : 0320002

    Buenos Aires, 1431, Argentina

  • Investigational Site Number : 0320003

    Buenos Aires, 1280, Argentina

  • Investigational Site Number : 0320004

    Córdoba, 5000, Argentina

  • Investigational Site Number : 0320005

    Buenos Aires, 1227, Argentina

  • Investigational Site Number : 0320006

    Pilar, Buenos Aires, 1629, Argentina

  • Investigational Site Number : 0360001

    Melbourne, Victoria, 3000, Australia

  • Investigational Site Number : 0360003

    Brisbane, Queensland, 4029, Australia

  • Investigational Site Number : 0360004

    Murdoch, Western Australia, 6150, Australia

  • Investigational Site Number : 0360005

    Westmead, New South Wales, 2145, Australia

  • Investigational Site Number : 0400001

    Linz, 4020, Austria

  • Investigational Site Number : 0400003

    Graz, 8036, Austria

  • Investigational Site Number : 0400004

    Vienna, 1090, Austria

  • Investigational Site Number : 0560006

    Bruges, 8000, Belgium

  • Investigational Site Number : 1240002

    Montreal, Quebec, H4A 3J1, Canada

  • Investigational Site Number : 1240005

    Toronto, Ontario, M5G 2M9, Canada

  • Investigational Site Number : 1240007

    Calgary, Alberta, T2N 5G2, Canada

  • Investigational Site Number : 1240008

    Saskatoon, Saskatchewan, S7N 4H4, Canada

  • Investigational Site Number : 1560001

    Suzhou, 215006, China

  • Investigational Site Number : 1560002

    Hangzhou, 310003, China

  • Investigational Site Number : 1560003

    Tianjin, 300020, China

  • Investigational Site Number : 1560004

    Tianjin, 300020, China

  • Investigational Site Number : 1560005

    Guangzhou, 510000, China

  • Investigational Site Number : 1560006

    Suzhou, 215025, China

  • Investigational Site Number : 1560007

    Jinan, 250014, China

  • Investigational Site Number : 1560008

    Jinan, 250001, China

  • Investigational Site Number : 1560009

    Zhengzhou, 450008, China

  • Investigational Site Number : 1560010

    Changsha, 410008, China

  • Investigational Site Number : 1560011

    Fuzhou, 350001, China

  • Investigational Site Number : 1560012

    Changchun, 130021, China

  • Investigational Site Number : 1560013

    Wuhan, 430022, China

  • Investigational Site Number : 1560014

    Hefei, 230001, China

  • Investigational Site Number : 1560015

    Wuhan, 430030, China

  • Investigational Site Number : 1560019

    Beijing, 100050, China

  • Investigational Site Number : 2500001

    Paris, 75571, France

  • Investigational Site Number : 2500003

    Paris, 75010, France

  • Investigational Site Number : 2500006

    Vandœuvre-lès-Nancy, 54511, France

  • Investigational Site Number : 2760001

    Dresden, 01307, Germany

  • Investigational Site Number : 2760002

    Hamburg, 20246, Germany

  • Investigational Site Number : 2760003

    Cologne, 50937, Germany

  • Investigational Site Number : 2760005

    Freiburg im Breisgau, 79106, Germany

  • Investigational Site Number : 2760006

    Regensburg, 93053, Germany

  • Investigational Site Number : 2760007

    Berlin, 13353, Germany

  • Investigational Site Number : 2760008

    Tübingen, 72076, Germany

  • Investigational Site Number : 2760009

    Münster, 48149, Germany

  • Investigational Site Number : 2760010

    Kiel, 24105, Germany

  • Investigational Site Number : 3440001

    Pok Fu Lam, 999077, Hong Kong

  • Investigational Site Number : 3760001

    Tel Aviv, 6423906, Israel

  • Investigational Site Number : 3760002

    Haifa, 3109601, Israel

  • Investigational Site Number : 3760003

    Ramat Gan, 5262100, Israel

  • Investigational Site Number : 3760004

    Ramat Gan, 5262100, Israel

  • Investigational Site Number : 3760005

    Jerusalem, 9112001, Israel

  • Investigational Site Number : 3760006

    Petah Tikva, 4920235, Israel

  • Investigational Site Number : 3800001

    Rome, Roma, 00168, Italy

  • Investigational Site Number : 3800002

    Rozzano, Milano, 20089, Italy

  • Investigational Site Number : 3800003

    Bergamo, 24127, Italy

  • Investigational Site Number : 3800004

    Bologna, 40138, Italy

  • Investigational Site Number : 3800005

    Genoa, Genova, 16132, Italy

  • Investigational Site Number : 3800006

    Reggio Calabria, 89133, Italy

  • Investigational Site Number : 3800007

    Turin, Torino, 10126, Italy

  • Investigational Site Number : 3800008

    Udine, 33100, Italy

  • Investigational Site Number : 3800009

    Milan, Milano, 20132, Italy

  • Investigational Site Number : 3800010

    Perugia, 06156, Italy

  • Investigational Site Number : 3800011

    Pavia, 27100, Italy

  • Investigational Site Number : 3800012

    Torette, Ancona, 60020, Italy

  • Investigational Site Number : 4100001

    Seoul, Seoul-teukbyeolsi, 06591, South Korea

  • Investigational Site Number : 4100002

    Seoul, Seoul-teukbyeolsi, 03080, South Korea

  • Investigational Site Number : 4100003

    Seoul, Seoul-teukbyeolsi, 03722, South Korea

  • Investigational Site Number : 4100004

    Seoul, Seoul-teukbyeolsi, 06351, South Korea

  • Investigational Site Number : 5280001

    Utrecht, 3584 CS, Netherlands

  • Investigational Site Number : 5280002

    Rotterdam, 3015 CE, Netherlands

  • Investigational Site Number : 5280003

    Groningen, 9713 GR, Netherlands

  • Investigational Site Number : 6160001

    Gdansk, Pomeranian Voivodeship, 80-952, Poland

  • Investigational Site Number : 6160008

    Szczecin, 71-252, Poland

  • Investigational Site Number : 6200002

    Lisbon, 1649-035, Portugal

  • Investigational Site Number : 6200003

    Lisbon, 1099-023, Portugal

  • Investigational Site Number : 7240004

    Madrid, 28007, Spain

  • Investigational Site Number : 7240005

    Barcelona, Catalunya [Cataluña], 08036, Spain

  • Investigational Site Number : 7240011

    Santander, Cantabria, 39008, Spain

  • Investigational Site Number : 7240012

    Valencia, 46010, Spain

  • Investigational Site Number : 7520001

    Huddinge, 141 57, Sweden

  • Investigational Site Number : 7520002

    Lund, 221 85, Sweden

  • Investigational Site Number : 7520003

    Gothenburg, 413 45, Sweden

  • Investigational Site Number : 7920001

    Ankara, 06620, Turkey (Türkiye)

  • Investigational Site Number : 7920002

    Ankara, 06200, Turkey (Türkiye)

  • Investigational Site Number : 7920003

    Izmir, 35100, Turkey (Türkiye)

  • Investigational Site Number : 7920004

    Ankara, 06560, Turkey (Türkiye)

  • Investigational Site Number : 7920005

    Istanbul, 34010, Turkey (Türkiye)

  • Investigational Site Number : 7920006

    Adana, 01120, Turkey (Türkiye)

  • Investigational Site Number : 8260001

    Manchester, M20 4BX, United Kingdom

  • Investigational Site Number : 8260002

    London, London, City of, SE5 9RL, United Kingdom

  • Investigational Site Number : 8260003

    Leeds, LS9 7TF, United Kingdom

  • Investigational Site Number : 8260004

    Newcastle upon Tyne, NE7 7DN, United Kingdom

  • Investigational Site Number : 8260006

    Cardiff, Cardiff [Caerdydd Gb-crd], CF14 4XW, United Kingdom

  • Johns Hopkins Hospital- Site Number : 8400033

    Baltimore, Maryland, 21287, United States

  • Karmanos Cancer Institute - Detroit- Site Number : 8400013

    Detroit, Michigan, 48201, United States

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

    Ostrava, 70852, Czechia

  • Northwestern University- Site Number : 8400017

    Chicago, Illinois, 60611, United States

  • Nosokomeio Paidon I Agia Sofia-Site Number : 3000002

    Athens, 115 27, Greece

  • Odense University Hospital-Investigational Site Number : 2080003

    Odense, Funen, 5000, Denmark

  • Oncology Hematology Care - Kenwood- Site Number : 8400030

    Cincinnati, Ohio, 45236, United States

  • Oregon Health and Science University- Site Number : 8400027

    Portland, Oregon, 97239, United States

  • Rigshospitalet Copenhagen University Hospital-Investigational Site Number : 2080002

    Copenhagen, Capital, 2100, Denmark

  • Sarah Cannon Research Institute Site Number : 8400003

    Nashville, Tennessee, 37203, United States

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

    Austin, Texas, 78704, United States

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

    Dallas, Texas, 75246, United States

  • Texas Transplant Institute - Methodist Hospital- Site Number : 8400037

    San Antonio, Texas, 78229, United States

  • The Hope Clinic of Emory University- Site Number : 8400020

    Decatur, Georgia, 30030, United States

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

    Columbus, Ohio, 43210, United States

  • UNC Children's Hospital- Site Number : 8400025

    Chapel Hill, North Carolina, 27514, United States

  • UPMC Hillman Cancer Center- Site Number : 8400008

    Pittsburgh, Pennsylvania, 15232, United States

  • UZ Gent-Investigational Site Number : 0560003

    Ghent, 9000, Belgium

  • UZ Leuven-Investigational Site Number : 0560001

    Leuven, Vlaams-Brabant, 3000, Belgium

  • University of Arkansas for Medical Sciences-Site Number : 8400019

    Little Rock, Arkansas, 72205, United States

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

    San Francisco, California, 94143, United States

  • University of Kentucky Chandler Medical Center- Site Number : 8400024

    Lexington, Kentucky, 40536, United States

  • University of Virginia Comprehensive Cancer Center-Site Number : 8400031

    Charlottesville, Virginia, 22903, United States

  • University of Wisconsin Carbone Cancer Center-Site Number : 8400029

    Madison, Wisconsin, 53792, United States

  • Ustav hematologie a krevni transfuze-Site Number : 2030004

    Prague, 128 00, Czechia

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