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    Summary
    EudraCT Number:2026-000401-14
    Sponsor's Protocol Code Number:ACT18369
    Clinical Trial Type:Outside EU/EEA
    Date on which this record was first entered in the EudraCT database:2026-10-08
    Trial results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    H.4 THIRD COUNTRY IN WHICH THE TRIAL WAS FIRST AUTHORISED
    Expand All   Collapse All
    A. Protocol Information
    A.2EudraCT number2026-000401-14
    A.3Full title of the trial
    A multicenter, open-label, single-arm, Phase 4 clinical study to evaluate the pharmacokinetics, efficacy, and safety of belumosudil mesylate tablets in Chinese adolescents (aged from 12 to less than 18 years) with chronic graft-versus-host disease (cGVHD) who have had an inadequate response to glucocorticoids or other systemic therapies
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A clinical study to evaluate the pharmacokinetics, efficacy, and safety of belumosudil in Chinese adolescents with cGVHD who have had an inadequate response to glucocorticoids or other systemic therapies
    A.4.1Sponsor's protocol code numberACT18369
    A.5.3WHO Universal Trial Reference Number (UTRN)U1111-1305-7436
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorSanofi-Aventis Recherche & Développement
    B.1.3.4CountryFrance
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportSanofi-Aventis Recherche & Développement
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationSanofi-Aventis Recherche & Développement
    B.5.2Functional name of contact pointGlobal Regulatory Affairs
    B.5.3 Address:
    B.5.3.1Street Address13 Quai Jules Guesde
    B.5.3.2Town/ cityVitry Sur Seine
    B.5.3.3Post code94400
    B.5.3.4CountryFrance
    B.5.6E-mailsma-cta-coordination@sanofi.com
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community Yes
    D.2.5.1Orphan drug designation numberEU/3/19/2205
    D.3 Description of the IMP
    D.3.1Product nameBelumosudil
    D.3.2Product code SAR445761
    D.3.4Pharmaceutical form Tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    chronic graft versus host disease
    E.1.1.1Medical condition in easily understood language
    chronic graft versus host disease
    E.1.1.2Therapeutic area Diseases [C] - Immune System Diseases [C20]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 27.0
    E.1.2Level PT
    E.1.2Classification code 10066261
    E.1.2Term Chronic graft versus host disease
    E.1.2System Organ Class 10021428 - Immune system disorders
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To assess the pharmacokinetics of belumosudil mesylate tablets in Chinese adolescent participants with cGVHD aged from 12 to less than 18 who have had an inadequate response to glucocorticoids or other systemic therapies
    E.2.2Secondary objectives of the trial
    • To assess the clinical efficacy of belumosudil mesylate tablets in Chinese adolescent participants with cGVHD aged from 12 to less than 18 who have had an inadequate response to glucocorticoids or other systemic therapies
    • To assess the safety of belumosudil mesylate tablets in Chinese adolescent participants with cGVHD aged from 12 to less than 18 who have had an inadequate response to glucocorticoids or other systemic therapies
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    -Participant must be 12 to less than 18 years of age at the time of signing the informed consent.
    -Participant has undergone allogeneic hematopoietic stem cell transplantation (allo-HSCT)
    -Has active moderate to severe cGVHD
    -Has received at least one line of prior systemic therapy for cGVHD
    -Participant must receive a corticosteroid therapy for cGVHD with a stable dose for at least 2 weeks prior to the first dose of the IMP
    -Has a Lansky-Play performance score of ≥60
    -Participants should have an expected survival of longer than 6 months
    -Body weight of 30 kg and above
    -Contraceptive use by men and women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies
    -The participant or their legally authorized representative (LAR) must be capable of giving signed informed consent
    -Participants should have an expected survival of longer than 6 months
    -Body weight of 30 kg and above
    -Contraceptive use by men and women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies
    -The participant or their legally authorized representative (LAR) must be capable of giving signed informed consent
    E.4Principal exclusion criteria
    Participants are excluded from the study if any of the following criteria apply:
    -Recurrence of hematologic neoplasms (according to the corresponding criteria for recurrence of primary hematologic neoplasms) or post-transplant lymphoproliferative disease at screening
    -Received investigational systemic therapy for cGVHD within 28 days prior to enrollment, unless the prior treatment had been washed out for at least 28 days or 5 half-lives prior to enrollment, whichever is shorter
    -Absolute neutrophil count (ANC) <1.0 × 109/L.
    -Platelet count <50 × 109/L
    -Alanine aminotransferase (ALT) >3× the upper limit of normal (ULN), aspartate aminotransferase (AST) >3 × ULN
    -Total bilirubin (TBIL) >1.5 × ULN (>3 ULN if Gilbert’s syndrome)
    -Estimated Glomerular Filtration Rate (eGFR) <30 mL/min/1.73 m2 using the revised Bedside Schwartz formula . Revised Schwartz equation: CrCl (mL/min/1.73 m2) = 0.413 × (height [in cm])/Creatinine (in mg/dL) at screening visit.
    -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
    E.5 End points
    E.5.1Primary end point(s)
    Plasma concentrations of belumosudil at specified time points
    E.5.1.1Timepoint(s) of evaluation of this end point
    At Day 1 and Day 29(±3)
    E.5.2Secondary end point(s)
    1) Overall response rate (ORR)
    2) Duration of response (DoR)
    3) System organ response rate
    4) Number and proportion of participants with dose reduction in corticosteroid during the treatment period
    5) Failure-free survival (FFS)
    6) Overall survival (OS)
    7) Change in cGVHD severity based on physician-reported overall cGVHD activity
    8) Change in symptom activity assessed based on patient-reported cGVHD activity
    9) Modified Lee cGVHD Symptom Scale change
    10) Number and proportion of participants with calcineurin inhibitor (CNI) dose reduction or discontinuation during the treatment period
    11) Number of participants with treatment-emergent
    adverse events [TEAEs], serious TEAEs, and
    adverse events of special interest (AESIs)


    E.5.2.1Timepoint(s) of evaluation of this end point
    From 1 to 11 - Up to 18 month
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy No
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) Yes
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised No
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial1
    E.8.3 Will this trial be conducted at a single site globally? No
    E.8.4 Will this trial be conducted at multiple sites globally? Yes
    E.8.6 Trial involving sites outside the EEA
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3Specify the countries outside of the EEA in which trial sites are planned
    China
    E.8.7Trial has a data monitoring committee No
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months6
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 Yes
    F.1.1Number of subjects for this age range: 7
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 7
    F.1.2Adults (18-64 years) No
    F.1.3Elderly (>=65 years) No
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.2 For a multinational trial
    F.4.2.2In the whole clinical trial 7
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    None
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    G.4.1Name of Organisation Beijing Children's Hospital, Capital Medical University
    G.4.3.4Network Country China
    G.4 Investigator Network to be involved in the Trial: 2
    G.4.1Name of Organisation Shanghai Children's Medical Center, Shanghai Jiao Tong University School of Medicine
    G.4.3.4Network Country China
    H.4 Third Country in which the Trial was first authorised
    H.4.1Third Country in which the trial was first authorised: China
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