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    Summary
    EudraCT Number:2018-003291-12
    Sponsor's Protocol Code Number:SHP611-201
    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:2019-04-12
    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 number2018-003291-12
    A.3Full title of the trial
    A Global, Multicenter, Open-label, Matched Historical Control Study of Intrathecal SHP611 in Subjects with Late Infantile Metachromatic Leukodystrophy
    Estudio global, multicéntrico, abierto, comparativo con controles históricos equiparables,
    de SHP611 intratecal en sujetos con leucodistrofia metacromática infantil tardía
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Research study to determine the effects of an investigational drug, SHP611 on patients with with Late Infantile Metachromatic Leukodystrophy (MLD) specially the gross motor function, using the Gross Motor Function Classification in Metachromatic Leukodystrophy (GMFC-MLD) compared with matched historical control data in children with MLD.
    Estudio de investigación para determinar los efectos de un fármaco en investigación, SHP611
    en pacientes con leucodistrofia metacromática infantil tardía (LMD) especialmente la función motora gruesa, utilizando la Clasificación de la función motora gruesa en leucodistrofia metacromática (GMFC-MLD) comparada con datos de controles históricos equiparables en niños con MLD.
    A.3.2Name or abbreviated title of the trial where available
    NA
    NA
    A.4.1Sponsor's protocol code numberSHP611-201
    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 SponsorShire Human Genetic Therapies, Inc.
    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 supportShire Human Genetic Therapies, Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationShire Human Genetic Therapies, Inc.
    B.5.2Functional name of contact pointLeslie Jacobsen, MD
    B.5.3 Address:
    B.5.3.1Street Address300 Shire Way
    B.5.3.2Town/ cityLexington
    B.5.3.3Post codeMA 02421
    B.5.3.4CountryUnited States
    B.5.4Telephone number0034900 947 618
    B.5.5Fax number001781266 1365
    B.5.6E-mailmedinfoEMEA@shire.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.3.2Product code SHP611
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntrathecal use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNNot Available
    D.3.9.1CAS number N/A
    D.3.9.2Current sponsor codeSHP611
    D.3.9.3Other descriptive nameRECOMBINANT HUMAN ARYLSULFATASE A
    D.3.9.4EV Substance CodeSUB189761
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number30
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    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 Yes
    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 Yes
    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
    Late Metachromatic Leukodystrophy (MLD)
    Leucodistrofia metacromática tardía (LMT)
    E.1.1.1Medical condition in easily understood language
    Metachromatic leukodystrophy, the most common form of leukodystrophy, is a rare inherited neurometabolic disorder affecting the white matter of the brain (leukoencephalopathy).
    La leucodistrofia metacromática, la forma más común de
    La leucodistrofia, es un trastorno neurometabólico hereditario raro que afecta a la materia blanca del cerebro (leucoencefalopatía).
    E.1.1.2Therapeutic area Diseases [C] - Nervous System Diseases [C10]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10067609
    E.1.2Term Metachromatic leukodystrophy
    E.1.2System Organ Class 10010331 - Congenital, familial and genetic 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 primary objective of this study is to evaluate the effects of intrathecal (IT) administration of SHP611 on gross motor function, using the Gross Motor Function Classification in Metachromatic Leukodystrophy (GMFC-MLD) compared with matched historical control data in children with MLD.
    El objetivo principal de este estudio es evaluar los efectos de la administración intratecal (IT) de
    SHP611 sobre la función motora gruesa mediante la escala GMFC-MLD (Clasificación de la función motora
    gruesa en la leucodistrofia metacromática), en comparación con datos de controles históricos equiparables, en niños con leucodistrofia metacromática (LDM).
    E.2.2Secondary objectives of the trial
    The key secondary objective of this study is to evaluate the effects of IT administration of SHP611 on gross motor function, using the Gross Motor Function Measure 88 (GMFM-88) total score compared with matched historical control data in children with MLD.
    El objetivo secundario fundamental de este estudio consiste en evaluar los
    efectos de la administración IT de SHP611 sobre la función motora gruesa mediante la puntuación GMFM88 (Escala de medición de la función motora gruesa 88) total, en comparación con datos de controles históricos equiparables, en niños con LDM.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Patients must meet all of the following criteria to be considered eligible for
    inclusion as a subject in the study:

    1. The subject must have a documented diagnosis of MLD (Groups A-D)
    a. Low ASA activity in leukocytes
    AND
    b. Elevated sulfatides in urine

    2. The subject must have a gait disorder due to spastic ataxia or weakness attributed to MLD by the investigator and documented by a pediatric neurologist or medical geneticist by 30 months of age (Groups A-C) or presymptomatic (Group D)

    3. The subject’s age at the time of informed consent, must be:
     Group A: 18 to 48 months of age
     Group B: 18 to 72 months of age
     Group C: 18 to 72 months of age
     Group D: <18 months of age

    4. The subject’s GMFC-MLD level at screening must be:
     Group A: GMFC-MLD level of 1 or 2
     Group B: GMFC-MLD level of 3
     Group C: GMFC-MLD level of 4
     Group D: presymptomatic, are younger siblings of enrolled subjects, and have the same ASA allelic constitution

    5. The subject and his/her parent/representative(s) must have the ability to comply with the clinical protocol

    6. Subject's parent or legally authorized representative(s) must provide written informed consent prior to performing any study-related activities. Study-related activities are any procedures that would not have been performed during normal management of the subject

    Inclusion criteria for matched historical controls
    Subjects must meet all of the following criteria to be considered eligible for inclusion as a matched historical control:

    1. The subject must have a documented diagnosis of MLD
    a. Low ASA activity in leukocytes
    AND
    b. Elevated sulfatides in urine

    2. Subjects must have a gait disorder due to spastic ataxia or weakness attributed to MLD by the investigator and documented at baseline

    3. Subjects must have at least 2 motor assessments by GMFC-MLD with the second assessment occurring at approximately 106 (±6) weeks after the first assessment or else a second assessment measured before Week 100 with a GMFC-MLD level 5 or 6. Subjects with GMFC-MLD data (pro or retrospectively determined) must have the earliest observation of level 1 or 2 (walking with support) in the data source-verified medical record

    4. Subjects must be 18 to 48 months of age at the earliest assessment
    Los sujetos deberán cumplir todos los criterios siguientes para poder ser incluidos en
    este estudio:
    1. El sujeto debe tener un diagnóstico documentado de LDM (grupos A-D).
    a. Actividad baja de ASA en los leucocitos
    Y

    b. Sulfátidos elevados en la orina.
    2. El sujeto debe tener un trastorno de la marcha debido a ataxia espástica o debilidad atribuida a la LDMpor el investigador y documentado por un neurólogo pediátrico o genetista médico a los 30 meses deedad (grupos A-C) o encontrarse presintomático (grupo D).
    3. La edad del sujeto en el momento de obtener el consentimiento informado deberá ser:
    • Grupo A: de 18 a 48 meses.
    • Grupo B: de 18 a 72 meses.
    • Grupo C: de 18 a 72 meses.
    • Grupo D: < 18 meses.
    4. El nivel GMFC-MLD del sujeto en el período de selección deberá ser:
    • Grupo A: nivel GMFC-MLD de 1 o 2.
    • Grupo B: nivel GMFC-MLD de 3.
    • Grupo C: nivel GMFC-MLD de 4.
    • Grupo D: sujetos presintomáticos que son hermanos pequeños de sujetos ya incluidos y tienen lamisma constitución alélica de la ASA.
    5. El sujeto y sus padres o representante legal deberán ser capaces de cumplir el protocolo clínico.
    6. Los padres o el representante legal del sujeto deberán otorgar su consentimiento informado por escrito
    antes de realizar ninguna actividad relacionada con el estudio. Se entiende por actividades relacionadascon el estudio cualquier procedimiento que no se habría realizado durante la asistencia normal del sujeto.

    Criterios de inclusión para los controles históricos equiparables: Los sujetos deberán cumplir todos loscriterios siguientes para poder ser incluidos como controles históricos equiparables:
    1. El sujeto debe tener un diagnóstico documentado de LDM.
    a. Actividad baja de ASA en los leucocitos
    Y
    b. Sulfátidos elevados en la orina.
    2. El sujeto debe presentar un trastorno de la marcha debido a ataxia espástica o debilidad atribuida aLDM por el investigador y documentado en el momento basal.
    3. El sujeto debe contar con al menos dos evaluaciones motoras mediante la escala GMFC-MLD; lasegunda evaluación tendrá que haberse realizado unas 106 (± 6) semanas después de la primera o tendráque disponerse de una segunda evaluación realizada de la semana 100 con un nivel GMFC-MLD de 5 o6. Los sujetos con datos de GMFC-MLD (determinados de forma prospectiva o retrospectiva) deberántener una primera observación de 1 o 2 (caminar con apoyo) en la historia clínica verificada con lafuente de datos.
    4. El sujeto debe tener entre 18 y 48 meses de edad en la primera evaluación.
    E.4Principal exclusion criteria
    1. Multiple sulfatase disorder as determined by abnormal activity of another lysosomal sulfatase (based upon the reference laboratory’s normal range)

    2. History of hematopoietic stem cell transplantation (HSCT) or gene therapy or undergoes HSCT or gene therapy at any point during the study

    3. Initial presentation of behavioral or cognitive symptoms of MLD (per investigator’s clinical judgment)

    4. The subject has any known or suspected hypersensitivity to agents used for anesthesia or has history of difficult airway or potential for airway compromise

    5. Any other medical condition or serious comorbid illness that in the opinion of the investigator would preclude participation in the study

    6. The subject is enrolled in another clinical study that involves use of any investigational product (drug or device) within 30 days prior to study enrollment or at any time during the study

    7. The subject has a condition that is contraindicated as described in the SOPH-A-PORT Mini S IDDD Instructions for Use (IFU)


    Exclusion criteria for matched historical controls
    1. History of hematopoietic stem cell transplantation (HSCT) or gene therapy or undergoes HSCT or gene therapy at any point during the study

    2. Initial presentation of behavioral or cognitive symptoms of MLD (per investigator’s
    clinical judgment)
    3. The subject is enrolled in another clinical study that involves use of any investigational product (drug or device)
    1. Trastorno de varias sulfatasas determinado por la actividad anormal de otra sulfatasa lisosómica (segúnel intervalo normal del laboratorio de referencia).
    2. Antecedentes de trasplante de células madre hematopoyéticas (TCMH) o terapia génica o recepción deun TCMH o terapia génica en cualquier momento del estudio.
    3. Cuadro inicial de síntomas conductuales o cognitivos de la LDM (según el criterio clínico delinvestigador).
    4. Hipersensibilidad conocida o sospechada a los fármacos utilizados en la anestesia o antecedentes dedificultad para obtener una vía aérea o posible compromiso de las vías respiratorias.
    5. Cualquier otro proceso médico o enfermedad concomitante grave que, en opinión del investigador,impida la participación en el estudio.
    6. Participación del sujeto en otro estudio clínico que supone el uso de un producto en investigación(fármaco o dispositivo) en los 30 días previos a la inclusión en el estudio o en cualquier momentodurante el mismo.
    7. Presencia de alguna de las contraindicaciones recogidas en el manual de instrucciones de uso del DIAM
    SOPH-A-PORT Mini S.
    Criterios de exclusión para los controles históricos equiparables:
    1. Antecedentes de trasplante de células madre hematopoyéticas (TCMH) o terapia génica o recepción de
    un TCMH o terapia génica en cualquier momento del estudio.
    2. Cuadro inicial de síntomas conductuales o cognitivos de la LDM (según el criterio clínico del
    investigador).
    3. Participación del sujeto en otro estudio clínico que supone el uso de un producto en investigación
    (fármaco o dispositivo).
    E.5 End points
    E.5.1Primary end point(s)
    The primary efficacy endpoint is response in Group A, defined as maintenance of gross motor function at 2 years (Week 106), evaluated as no greater than 2 levels decline from baseline in GMFC-MLD
    El criterio de valoración principal de la eficacia en el grupo A será la respuesta, definida como el
    mantenimiento de la función motora gruesa a los dos años (semana 106), evaluada como un deterioro no superior a dos niveles GMFC-MLD con respecto al valor basal.
    E.5.1.1Timepoint(s) of evaluation of this end point
    2 years
    2 años
    E.5.2Secondary end point(s)
    The key secondary efficacy endpoint is response in Group A, defined as maintenance of gross motor function at 2 years (Week 106), defined as a GMFM-88 total score >40.

    - To evaluate the effects of IT administration of SHP611 on the time course of declining gross motor function using GMFC-MLD
    - To evaluate the effects of IT administration of SHP611 on the time course of declining gross motor function using GMFM-88
    - To evaluate the effects of IT administration of SHP611 on expressive language using the Expressive Language Function Classification in Metachromatic Leukodystrophy (ELFC-MLD)
    - To evaluate the effects of IT administration of SHP611 on cerebrospinal fluid (CSF) biomarker (ie, sulfatides)
    - To evaluate the effects of IT administration of SHP611 on proton magnetic resonance spectroscopy
    El criterio de valoración secundario fundamental de la eficacia en el grupo A será la respuesta, definida como el mantenimiento de la función motora gruesa a los dos años (semana 106), evaluada como una puntuaciónGMFM-88 total > 40.
    Evaluar los efectos de la administración IT de SHP611 sobre la evolución temporal del deterioro de la
    función motora gruesa mediante la escala GMFC-MLD.
    Evaluar los efectos de la administración IT de SHP611 sobre la evolución temporal del deterioro de la
    función motora gruesa mediante la puntuación GMFM-88.
    Evaluar los efectos de la administración IT de SHP611 sobre el lenguaje expresivo mediante la escala
    ELFC-MLD (Clasificación de la función del lenguaje expresivo).
    Evaluar los efectos de la administración IT de SHP611 sobre un biomarcador del líquido cefalorraquídeo
    (LCR) (es decir, sulfátidos).
    Evaluar los efectos de la administración IT de SHP611 sobre la espectroscopia por resonancia magnética
    (ERM) protónica cerebral, en concreto, N-acetilaspartato/creatina (NAA/Cr) en la sustancia blanca.
    E.5.2.1Timepoint(s) of evaluation of this end point
    2 years
    2 años
    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 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.8.3 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 concerned1
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA8
    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
    Belgium
    Brazil
    Canada
    Denmark
    France
    Germany
    Israel
    Japan
    Mexico
    Netherlands
    Spain
    United Kingdom
    United States
    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
    The Study Completion Date is defined as the date on which the last subject in the study completes the final protocol-defined assessment(s). This includes the follow-up visit or contact, whichever is later.
    La Fecha de finalización del estudio se define como la fecha en la que el último sujeto en el estudio completa las evaluaciones finales definidas por el protocolo. Esto incluye la visita de seguimiento o contacto, cualquiera que sea posterior.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    E.8.9.1In the Member State concerned months1
    E.8.9.1In the Member State concerned days15
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months10
    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 Yes
    F.1.1Number of subjects for this age range: 35
    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) Yes
    F.1.1.4.1Number of subjects for this age range: 8
    F.1.1.5Children (2-11years) Yes
    F.1.1.5.1Number of subjects for this age range: 27
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) No
    F.1.2.1Number of subjects for this age range: 0
    F.1.3Elderly (>=65 years) No
    F.1.3.1Number of subjects for this age range: 0
    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 No
    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 No
    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 Yes
    F.3.3.7.1Details of other specific vulnerable populations
    Children up to 72 months
    F.4 Planned number of subjects to be included
    F.4.1In the member state2
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 10
    F.4.2.2In the whole clinical trial 35
    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)
    Subjects who complete the study will be offered the opportunity to continue in a separate extension study (SHP611-202), provided that they meet the study eligibility criteria, where they may continue to receive treatment with SHP611 for an extended duration of time.

    For subjects who elect to discontinue the study, a safety follow-up visit will be conducted at Week 108 and the IDDD will be removed upon discontinuation from the study.
    A los sujetos que completen el estudio se les ofrecerá la oportunidad de continuar en un estudio de extensión independiente (SHP611-202), siempre que cumplan los criterios de elegibilidad del estudio, en el que podrán seguir recibiendo tratamiento con SHP611 durante un período prolongado.
    En los sujetos que decidan abandonar el estudio se realizará una visita de seguimiento de la seguridad en la
    semana 108 y se retirará el DIAM tras la retirada del estudio.
    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 Decision2019-05-16
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-04-30
    P. End of Trial
    P.End of Trial StatusOngoing
    As of 1.2.2020, the UK is no longer an EU Member State. However, EU law still applies to the UK during the transition period
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