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    Summary
    EudraCT Number:2024-000203-67
    Sponsor's Protocol Code Number:DRI17633
    Clinical Trial Type:Outside EU/EEA
    Date on which this record was first entered in the EudraCT database:2024-04-30
    Trial results View 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 number2024-000203-67
    A.3Full title of the trial
    A Phase 2, Randomized, Multicenter Study to Evaluate the Efficacy and Safety of KD025 in Subjects With Chronic Graft Versus Host Disease (cGVHD) After At Least 2 Prior Lines of Systemic Therapy (The ROCKstar Study)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Efficacy and Safety of KD025 in Subjects With cGVHD After At Least 2 Prior Lines of Systemic Therapy
    A.3.2Name or abbreviated title of the trial where available
    ROCKstar
    A.4.1Sponsor's protocol code numberDRI17633
    A.5.3WHO Universal Trial Reference Number (UTRN)U1111-1279-2518
    A.7Trial is part of a Paediatric Investigation Plan Yes
    A.8EMA Decision number of Paediatric Investigation PlanP/065/2024
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorKadmon Corporation, LLC
    B.1.3.4CountryUnited States
    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 supportKadmon Corporation, LLC
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationSanofi-Aventis Recherche & Developpement
    B.5.2Functional name of contact point-
    B.5.3 Address:
    B.5.3.1Street Address-
    B.5.3.2Town/ city-
    B.5.3.3Post code-
    B.5.3.4CountryUnited States
    B.5.4Telephone number----
    B.5.5Fax number----
    B.5.6E-mailcontactus@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 No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameSar445761
    D.3.2Product code Sar445761
    D.3.4Pharmaceutical form Film-coated tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNBelumosudil mesIlate
    D.3.9.2Current sponsor codeSar445761
    D.3.9.4EV Substance CodeSUB219310
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number200
    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 No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    • The objective of this study is to evaluate the efficacy of belumosudil, at dose levels of 200 mg QD and 200 mg BID, in participants with cGVHD who have previously been treated with at least 2 prior lines of systemic therapy
    E.2.2Secondary objectives of the trial
    • The secondary objectives of the study are to evaluate:
    • Duration of response (DOR)
    • Changes in the Lee Symptom Scale Score
    • Response by organ system
    • Time to response (TTR)
    • Time to next treatment (TTNT)
    • Percentage of participants who have a best response of PR and percentage of participants who have a best response of CR
    • Change in corticosteroid dose
    • Change in calcineurin inhibitor dose
    • Failure-free-survival (FFS)
    • Overall survival (OS)
    • Change in cGVHD global severity rating using the Clinician-Reported Global cGVHD Activity Assessment
    • Change in symptom activity using the cGVHD Activity Assessment Patient Self-Report
    • PK of belumosudil in participants with cGVHD
    • Safety
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Male and female participants at least 12 years of age who have had allogenic hematopoietic cell transplant (HCT).
    2. Previously received at least 2 and not more than 5 lines of systemic therapy for cGVHD
    3. Receiving glucocorticoid therapy with a stable dose over the 2 weeks prior to screening
    4. Have persistent cGVHD manifestations and systemic therapy is indicated
    Karnofsky Performance Score of ≥ 60 (if aged 16 years or older); Lansky
    5. Performance Score of ≥ 60 (if aged < 16 years)
    6. Weight ≥ 40kg
    E.4Principal exclusion criteria
    1. Participant has not been on a stable dose / regimen of systemic cGVHD treatments for at least 2 weeks prior to screening. (Note: Concomitant corticosteroids, calcineurin inhibitors, sirolimus, MMF, methotrexate, rituximab, and extracorporeal photophoresis (ECP) are acceptable. Systemic investigational GVHD treatments are not permitted).
    2. Histological relapse of the underlying cancer or post-transplant lymphoproliferative disease at the time of screening.
    3. Current treatment with ibrutinib. Prior treatment with ibrutinib is allowed with a washout of at least 28 days prior to randomization
    E.5 End points
    E.5.1Primary end point(s)
    Overall Response Rate (ORR)
    E.5.1.1Timepoint(s) of evaluation of this end point
    up to approximately 40 months
    E.5.2Secondary end point(s)
    1/ Duration of Response (DOR)
    2/ Change in Lee Symptom Scale Score
    3/ Response rate by organ system
    4/ Percentage of participants who have a best response of PR or CR
    5/ Change in corticosteroid dose
    6/ Change in calcineurin inhibitor dose
    7/ Failure-free survival (FFS)
    8/ Overall Survival (OS)
    9/ Change in cGVHD severity as based on the Physician-reported global cGVHD Activity Assessment
    10/ Change in symptom activity as based on cGVHD Activity Assessment Patient Self-Report
    11/ Determine the Peak Plasma Concentration (Cmax) of belumosudil
    12/ Determine the observed time to reach peak plasma concentration (Tmax) of belumosudil
    13/ Determine the half-life (T1/2) of belumosudil
    14/ Determine the area under the plasma concentration versus time curve (AUC) of belumosudil
    15/ Time to Response
    16/ Time to next treatment
    17/ Number pf participants with adverse event and serious adverse events
    E.5.2.1Timepoint(s) of evaluation of this end point
    1/ to 6/ and 9/ and 10/ and 15/ and 16/: up to approximately 40 months
    7/ and 8/: up to approximately 7 years
    11/ to 14/: Pre-dose and post-dose sampling within 12 hours
    17/: Up to 28 days after the last dose of study treatment i.e., up to approximately 7 years
    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) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group Yes
    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 Yes
    E.8.2.3.1Comparator description
    same drug with a different dosing regimen
    E.8.2.4Number of treatment arms in the trial2
    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 Yes
    E.8.6.3Specify the countries outside of the EEA in which trial sites are planned
    United States
    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 years5
    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: 23
    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: 23
    F.1.2Adults (18-64 years) No
    F.1.2.1Number of subjects for this age range: 221
    F.1.3Elderly (>=65 years) No
    F.1.3.1Number of subjects for this age range: 26
    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 For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2024-04-30. Yes
    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 270
    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
    H.4 Third Country in which the Trial was first authorised
    H.4.1Third Country in which the trial was first authorised: United States
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