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Clinical Trials in the UK / NCT06143891
Active, not recruiting Phase 3

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.

NCT06143891 · tracked via the Priya Life Science UK tracker
Sponsor
Sanofi
Phase
Phase 3
Started
2024-01-23
Last updated
2025-10-14

Condition(s) studied

Chronic Graft Versus Host Disease

Investigational drug(s) / intervention(s)

BelumosudilPlaceboPrednisonePrednisolone

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

Study 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.

Eligibility

Sex
ALL
Min age
12 Years
Max age
Healthy volunteers
No
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

Primary outcome measure(s)

Trial sites (151)

FacilityCityRegionStatus
University of Arkansas for Medical Sciences-Site Number : 8400019 Little Rock Arkansas
City of Hope National Medical Center- Site Number : 8400001 Duarte California
University of California San Francisco - Parnassus Heights- Site Number : 8400035 San Francisco California
AdventHealth Orlando- Site Number : 8400023 Orlando Florida
The Hope Clinic of Emory University- Site Number : 8400020 Decatur Georgia
Northwestern University- Site Number : 8400017 Chicago Illinois
Indiana University Health University Hospital- Site Number : 8400006 Indianapolis Indiana
University of Kentucky Chandler Medical Center- Site Number : 8400024 Lexington Kentucky
Johns Hopkins Hospital- Site Number : 8400033 Baltimore Maryland
Dana Farber Cancer Institute Site Number : 8400005 Boston Massachusetts
Karmanos Cancer Institute - Detroit- Site Number : 8400013 Detroit Michigan
UNC Children's Hospital- Site Number : 8400025 Chapel Hill North Carolina
Atrium Health Wake Forest Baptist Medical Center - Winston-Salem - Medical Center Boulevard- Site Number : 8400007 Winston-Salem North Carolina
Oncology Hematology Care - Kenwood- Site Number : 8400030 Cincinnati Ohio
The Ohio State University Comprehensive Cancer Center (OSUCCC) - The James Cancer Hospital and Solove Research Institute- Site Number : 8400026 Columbus Ohio
Oregon Health and Science University- Site Number : 8400027 Portland Oregon
UPMC Hillman Cancer Center- Site Number : 8400008 Pittsburgh Pennsylvania
Sarah Cannon Research Institute Site Number : 8400003 Nashville Tennessee
St. David's South Austin Medical Center- Site Number : 8400002 Austin Texas
Texas Oncology - Dallas - Worth Street- Site Number : 8400010 Dallas Texas
Texas Transplant Institute - Methodist Hospital- Site Number : 8400037 San Antonio Texas
University of Virginia Comprehensive Cancer Center-Site Number : 8400031 Charlottesville Virginia
Fred Hutchinson Cancer Research Center- Site Number : 8400004 Seattle Washington
University of Wisconsin Carbone Cancer Center-Site Number : 8400029 Madison Wisconsin
Investigational Site Number : 0320006 Pilar Buenos Aires
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
Investigational Site Number : 0360003 Brisbane Queensland
Investigational Site Number : 0360001 Melbourne Victoria
Investigational Site Number : 0360004 Murdoch Western 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
UZ Leuven-Investigational Site Number : 0560001 Leuven Vlaams-Brabant
Investigational Site Number : 0560006 Bruges Belgium

+ 111 more sites — see the full list on the official registry below.

On this site

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06143891 on ClinicalTrials.gov ↗ ← All trials in the UK