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    Summary
    EudraCT Number:2021-002864-36
    Sponsor's Protocol Code Number:PKRPC001
    National Competent Authority:Germany - BfArM
    Clinical Trial Type:EEA CTA
    Trial Status:Trial now transitioned
    Date on which this record was first entered in the EudraCT database:2022-04-19
    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
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedGermany - BfArM
    A.2EudraCT number2021-002864-36
    A.3Full title of the trial
    A prospective randomized, double-blind, placebo-controlled, multi-center phase III study to evaluate the efficacy and safety of mocravimod as an adjunctive and maintenance treatment in adult in acute myeloid leukemia (AML) patients undergoing allogeneic hematopoietic cell transplantation (HCT)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A phase III placebo-controlled efficacy and safety study of mocravimod as an adjunctive and maintenance treatment in AML patients undergoing allo-HCT (MO-TRANS Study)
    A.4.1Sponsor's protocol code numberPKRPC001
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT05429632
    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 SponsorPriothera S.A.S.
    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 supportPriothera S.A.S.
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationPriothera S.A.S.
    B.5.2Functional name of contact pointClinical Sciences & Operations
    B.5.3 Address:
    B.5.3.1Street Address57 avenue du Général de Gaulle
    B.5.3.2Town/ citySaint-Louis
    B.5.3.3Post code68300
    B.5.3.4CountryFrance
    B.5.4Telephone number+33 (0) 6 85 53 55 46
    B.5.6E-mailmalika.souquieres@priothera.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/3/21/2504
    D.3 Description of the IMP
    D.3.1Product namemocravimod
    D.3.2Product code KRP203, 1.0 mg
    D.3.4Pharmaceutical form Capsule, hard
    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 INNMocravimod
    D.3.9.1CAS number 509088-69-1
    D.3.9.2Current sponsor codeKRP203
    D.3.9.4EV Substance CodeSUB195626
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1
    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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboCapsule, hard
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Adjunctive and maintenance treatment to HCT
    E.1.1.1Medical condition in easily understood language
    Adjunctive and maintenance treatment to HCT
    E.1.1.2Therapeutic area Diseases [C] - Blood and lymphatic diseases [C15]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.0
    E.1.2Level LLT
    E.1.2Classification code 10000886
    E.1.2Term Acute myeloid leukemia
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To compare the efficacy of mocravimod to that of placebo
    E.2.2Secondary objectives of the trial
    To compare mocravimod's effect on overall survival (OS) to that of placebo
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1.Subjects with a diagnosis of AML (excluding acute promyelocytic
    leukemia) according to the World Health Organization (WHO) 2022
    classification of AML and related precursor neoplasms, including therapy
    AML with myelodysplasia related gene mutations.
    2.Subjects with European LeukemiaNet (ELN) high risk or intermediate
    risk or AML in CR1, or AML of any risk in CR2. (Complete remission with
    incomplete count recovery [CRi] is also allowable).
    - Complete remission is defined as: < 5% marrow blasts by morphologic
    examination and no circulating peripheral blasts ; absence of
    extramedullary disease; absolute neutrophil count ≥ 1.0x109/L
    (1000/μL); platelet count ≥ 100x109/L (100 000/μL)
    - CRi is defined as meeting all complete remission criteria except for
    residual absolute neutropenia < 1000/μL and/or thrombocytopenia <
    100 000/μL
    3.Planned use of a related or unrelated donor or with no more than 1
    antigen mismatch or planned use of a haploidentical donor
    4.Life expectancy ≥ 6 months at screening.
    5.Eastern Cooperative Oncology Group (ECOG) performance status of 0
    or 1
    6.Male or female, age ≥ 18 years and ≤ 75 years.
    E.4Principal exclusion criteria
    1.Planned use of anti-thymocyte globulin (ATG), alemtuzumab,
    abatacept for GvHD prophylaxis.
    2.Planned use of serotherapy during conditioning, including ATG and
    alemtuzumab.
    3.Planned ex vivo major graft manipulation, including T-cell depletion or
    CD34+ selection.
    4.Subjects having received prior allogeneic HCT or recipients of a solid
    organ transplant.
    5.Immunosuppressive drugs for concomitant disease. Subjects must be
    able to be off prednisone (> 10 mg/day) or other immunosuppressive
    medications for at least 3 days prior to the start of treatment of the
    study. Physiologic replacement dosing of hydrocortisone is permissible.
    6.Require treatments for cardiac dysfunction
    7.Subjects with acute promyelocytic leukemia.
    8.Blast crisis of chronic myeloid leukemia
    9.Cardiac dysfunction
    10.Pulmonary dysfunction.
    11.Significant liver disease or liver injury or known history of alcohol
    abuse, chronic liver or biliary disease. Hepatic dysfunction as defined by
    aspartate aminotransferase (AST) and/or alanine aminotransferase
    (ALT) > 2.5 x upper limit of normal (ULN); or total bilirubin > 1.5 x ULN
    12.Renal dysfunction with creatinine clearance < 45 mL/min by the
    Cockcroft-Gault formula.
    13.History of stroke or intracranial hemorrhage within 1 year prior to
    screening.
    14.Active clinically significant infection (viral, bacterial, or fungal) that
    requires ongoing antimicrobial therapy and in the judgment of the
    investigator represents a risk to proceeding with HCT.
    E.5 End points
    E.5.1Primary end point(s)
    Relapse-free survival (RFS)
    E.5.1.1Timepoint(s) of evaluation of this end point
    1° EP will be assessed once 46 events (relapse or death of any cause)
    have been reached or once all subjects have completed their EOT visit,
    whichever comes last. (EOT – End-of-Treatment)
    E.5.2Secondary end point(s)
    Key 2° Endpoints:
    -Overall Survival (OS) - mocravimod's effect on OS to that to placebo
    - RFS at EOS (End-of-study) - to assess the sustained efficacy of moc in
    comparison to placebo
    -Survival free from Grade III/IV aGvHD at 12 mo & time to acute GvHD
    -Survival free from moderate /severe cGvHD at EOS & time to cGvHD
    -GRFS (GvHD-free, Relapse-free survival at 12 mo and at EOS)
    E.5.2.1Timepoint(s) of evaluation of this end point
    Event-driven trial
    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 Yes
    E.6.13.1Other scope of the trial description
    Quality of Life (QoL)
    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) Yes
    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 No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    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 Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial3
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned5
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA44
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Argentina
    Switzerland
    Taiwan
    Brazil
    Israel
    Japan
    United Kingdom
    United States
    France
    Germany
    Italy
    Poland
    Romania
    Spain
    E.8.7Trial has a data monitoring committee Yes
    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 (last subject last visit – LSLV)
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months2
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months2
    E.8.9.2In all countries concerned by the trial days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    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) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 200
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 49
    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.4.1In the member state10
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 80
    F.4.2.2In the whole clinical trial 249
    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)
    After participation, subjects will be managed in accordance with clinical practice, i.e. as per local guidelines and standard of care.
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2022-07-26
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2022-12-14
    P. End of Trial
    P.End of Trial StatusTrial now transitioned
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