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    The EU Clinical Trials Register currently displays   44335   clinical trials with a EudraCT protocol, of which   7366   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

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    Summary
    EudraCT Number:2021-002864-36
    Sponsor's Protocol Code Number:PKRPC001
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2022-04-13
    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 ConcernedSpain - AEMPS
    A.2EudraCT number2021-002864-36
    A.3Full title of the trial
    A prospective randomized, double-blind, placebo-controlled, multi-center phase IIb 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 stem cell transplantation (HSCT)
    Ensayo prospectivo, aleatorizado, doble ciego, controlado con placebo y multicéntrico de fase IIb para evaluar la eficacia y seguridad del mocravimod como tratamiento adyuvante y de mantenimiento en la leucemia mieloide aguda (LMA) en pacientes adultos sometidos a un trasplante alogénico de células madre hematopoyéticas (TCMH)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A phase IIb placebo-controlled efficacy and safety study of mocravimod as an adjunctive and maintenance treatment in AML patients undergoing allo-HSCT (MO-TRANS Study)
    Ensayo de fase IIb controlado con placebo para evaluar la eficacia y seguridad del mocravimod como tratamiento adyuvante y de mantenimiento en la leucemia mieloide aguda (LMA) en pacientes sometidos a un trasplante alogénico de células madre hematopoyéticas (TCMH) (Estudio Mo-TRANS)
    A.4.1Sponsor's protocol code numberPKRPC001
    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 organisationAccovion, S.L. (Clinipace)
    B.5.2Functional name of contact pointMónica Reale
    B.5.3 Address:
    B.5.3.1Street AddressC/ O’Donnell, 12 4th floor
    B.5.3.2Town/ cityMadrid
    B.5.3.3Post code28009
    B.5.3.4CountrySpain
    B.5.4Telephone number+34657316821
    B.5.6E-mailEUClinicalTrials@clinipace.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 HSCT
    Tratamiento adyuvante y de mantenimiento en la TCMH
    E.1.1.1Medical condition in easily understood language
    Adjunctive and maintenance treatment to HSCT
    Tratamiento adyuvante y de mantenimiento en la TCMH
    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 100000004864
    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
    Comparar la eficacia de mocravimod con la de placebo
    E.2.2Secondary objectives of the trial
    To compare mocravimod's effect on overall survival (OS) to that of placebo
    Comparar el efecto de mocravimod sobre la supervivencia general (SG) con el del 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) 2016 classification of AML and related precursor neoplasms, including secondary AML after an antecedent hematological disease (e.g. myelodysplastic syndrome) and therapy-related AML.
    2.Subjects with European LeukemiaNet (ELN) high risk AML in CR1, intermediate risk AML in CR1 if MRDpos, or AML of any risk in CR2.
    - Complete remission is defined as: < 5% marrow blasts by morphologic examination and no circulating peripheral blasts and blasts with Auer rods; absence of extramedullary disease; absolute neutrophil count ≥ 1.0x109/L (1000/µL); platelet count ≥ 100x109/L (100 000/µL)
    3.Subjects planned to undergo allogeneic HSCT
    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.
    1.Sujetos con diagnóstico de LMA (excluida la leucemia promielocítica aguda) según la clasificación de 2016 de la Organización Mundial de la Salud (OMS) de la LMA y las neoplasias precursoras relacionadas, incluida la LMA secundaria después de una enfermedad hematológica antecedente (por ejemplo, el síndrome mielodisplásico) y la LMA relacionada con la terapia.
    2.Sujetos con LMA de alto riesgo según la European LeukemiaNet (ELN) en RC1, LMA de riesgo intermedio en RC1 si MRDpos, o LMA de cualquier riesgo en RC2.
    - La remisión completa se define como: < 5% de blastos en la médula por examen morfológico y ausencia de blastos periféricos circulantes y blastos con bastones de Auer; ausencia de enfermedad extramedular; recuento absoluto de neutrófilos ≥ 1,0x109/L (1000/µL); recuento de plaquetas ≥ 100x109/L (100 000/µL).
    3.Sujetos que tienen previsto someterse a un TCMH alogénico
    4.Esperanza de vida ≥ 6 meses en el momento de la selección.
    5.Estado de rendimiento del Eastern Cooperative Oncology Group (ECOG) de 0 o 1.
    6.Hombre o mujer, edad ≥ 18 años y ≤ 75 años.

    Traducción realizada con la versión gratuita del traductor www.DeepL.com/Translator
    E.4Principal exclusion criteria
    1.Planned use of anti-thymocyte globulin (ATG), post-transplantation cyclophosphamide, sirolimus, mycophenolate mofetil, abatacept, or any approved or non-approved medication other than MTX plus CsA or MTX plus TAC 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 HSCT 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 < 60 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 HSCT.
    1.Uso previsto de globulina antitimocítica (ATG), ciclofosfamida postrasplante, sirolimus, micofenolato mofetilo, abatacept o cualquier medicamento aprobado o no aprobado que no sea MTX más CsA o MTX más TAC para la profilaxis de la EICH.
    2. Uso previsto de sueroterapia durante el acondicionamiento, incluyendo ATG y alemtuzumab.
    3. Manipulación ex vivo del injerto principal, incluida la depleción de células T o la selección de CD34+.
    4.Sujetos que hayan recibido un TCMH alogénico previo o receptores de un trasplante de órgano sólido.
    5.Fármacos inmunosupresores para enfermedades concomitantes. Los sujetos deben poder estar sin prednisona (> 10 mg/día) u otros medicamentos inmunosupresores durante al menos 3 días antes del inicio del tratamiento del estudio. Se permite la dosificación fisiológica de sustitución de hidrocortisona.
    6.Requerir tratamientos para la disfunción cardíaca
    7.Sujetos con leucemia promielocítica aguda.
    8.Crisis blástica de leucemia mieloide crónica
    9.Disfunción cardíaca
    10.Disfunción pulmonar.
    11.Enfermedad hepática significativa o lesión hepática o historia conocida de abuso de alcohol, enfermedad hepática o biliar crónica. Disfunción hepática definida por aspartato aminotransferasa (AST) y/o alanina aminotransferasa (ALT) > 2,5 x límite superior de la normalidad (ULN); o bilirrubina total > 1,5 x ULN
    12.Disfunción renal con aclaramiento de creatinina < 60 mL/min según la fórmula de Cockcroft-Gault.
    13.Antecedentes de ictus o hemorragia intracraneal en el plazo de 1 año antes la selección.
    14.Infección activa clínicamente significativa (vírica, bacteriana o fúngica) que requiera un tratamiento antimicrobiano continuado y que, a juicio del investigador, represente un riesgo para proceder al TCMH.


    Traducción realizada con la versión gratuita del traductor www.DeepL.com/Translator
    E.5 End points
    E.5.1Primary end point(s)
    Relapse-free survival (RFS)
    Supervivencia sin recidiva (SSR)
    E.5.1.1Timepoint(s) of evaluation of this end point
    following 46 events occurred (relapse or death of any cause)
    Después de 46 eventos (recaída o muerte por cualquier causa)
    E.5.2Secondary end point(s)
    - Overall survival (OS)
    -Time to relapse
    -Non-relapse mortality
    - Supervivencia global (SG)
    - Tiempo hasta la recidiva
    - Mortalidad o relacionada con la recidiva
    E.5.2.1Timepoint(s) of evaluation of this end point
    Event-driven trial
    Ensayo basado en eventos
    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)
    Calidad de Vida (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) 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 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 concerned11
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA54
    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
    Israel
    Japan
    United States
    France
    Germany
    Italy
    United Kingdom
    Spain
    Switzerland
    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)
    UVUP (última visita último paciente - UVUP)
    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 state30
    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.
    Después de la participación, los sujetos serán tratados de acuerdo con la práctica clínica, es decir, según las pautas locales y el estándar de atención.
    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 Decision2022-07-12
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2022-07-06
    P. End of Trial
    P.End of Trial StatusOngoing
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