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    Summary
    EudraCT Number:2018-000550-21
    Sponsor's Protocol Code Number:20170534
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2019-07-05
    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
    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 number2018-000550-21
    A.3Full title of the trial
    Multicenter, Single-arm Open-label Extension Study to Assess Long term Safety and Efficacy of Current or Prior Treatment with Denosumab in Children/Young Adults with Osteogenesis Imperfecta
    Estudio de extensión abierto, multicéntrico y de un solo grupo
    para evaluar la seguridad y eficacia a largo plazo del tratamiento actual o previo con denosumab en niños y adultos jóvenes con osteogénesis imperfecta
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Study to Assess Long term Safety and Efficacy of Current or Prior Treatment with Denosumab in Children/Young Adults with Osteogenesis Imperfecta
    Estudio para evaluar la seguridad y eficacia a largo plazo del tratamiento actual o previo con denosumab en niños y adultos jóvenes con osteogénesis imperfecta
    A.4.1Sponsor's protocol code number20170534
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation PlanP/058/2016
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorAmgen 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 supportAmgen Inc
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAmgen S.A.
    B.5.2Functional name of contact pointIHQ-Medical Info - Clinical Trials
    B.5.3 Address:
    B.5.3.1Street AddressWTC Barcelona, Moll de Barcelona, s/n, Edifici Sud, 7a planta
    B.5.3.2Town/ cityBarcelona
    B.5.3.3Post code08039
    B.5.3.4CountrySpain
    B.5.4Telephone number+34936001860
    B.5.6E-mailiCOM_Spain@amgen.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 Yes
    D.2.1.1.1Trade name XGEVA
    D.2.1.1.2Name of the Marketing Authorisation holderAmgen Europe B.V.
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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 nameDenosumab
    D.3.2Product code AMG 162
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSubcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNDenosumab
    D.3.9.1CAS number 615258-40-7
    D.3.9.2Current sponsor codeAMG 162
    D.3.9.3Other descriptive nameDenosumab - Immunoglobulin G2 Human Monoclonal Antibody to RANK Ligand
    D.3.9.4EV Substance CodeSUB29173
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number70
    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 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 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
    Osteogenesis Imperfecta (OI)
    Osteogénesis imperfecta (OI)
    E.1.1.1Medical condition in easily understood language
    Osteogenesis Imperfecta
    Osteogénesis imperfecta (OI)
    E.1.1.2Therapeutic area Diseases [C] - Musculoskeletal Diseases [C05]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10031243
    E.1.2Term Osteogenesis imperfecta
    E.1.2System Organ Class 10010331 - Congenital, familial and genetic 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 evaluate long-term safety of denosumab in subjects with pediatric OI completing Study 20130173
    -Evaluar la seguridad a largo plazo de denosumab en sujetos con osteogénesis imperfecta (OI) pediátrica que completen el estudio 20130173.
    E.2.2Secondary objectives of the trial
    -To describe changes in bone mineral density (BMD) of lumbar spine and proximal femur (total hip and femoral neck) from baseline to 12 and 24 months
    -To describe the incidence of X-ray confirmed long bone and new and worsening vertebral fractures from baseline to 12 and 24 months
    -To describe the incidence of vertebral and non-vertebral fractures from baseline to 12 months and 24 months
    -To describe the change in growth velocity (determined by calculating age-adjusted Z-scores for height, weight, and body mass index [BMI]) at 12 and 24 months
    -Describir los cambios en la densidad mineral ósea (DMO) de la columna lumbar y el fémur proximal (cadera total y cuello femoral) desde el nivel basal hasta los 12 y 24 meses.
    -Describir la incidencia de fracturas de huesos largos y fracturas vertebrales nuevas y empeoradas confirmadas mediante radiografías desde el nivel basal hasta los 12 y 24 meses.
    -Describir la incidencia de fracturas vertebrales y no
    vertebrales desde el nivel basal hasta los 12 y 24 meses.
    -Describir el cambio en la velocidad de crecimiento
    (determinada mediante el cálculo de las puntuaciones Z ajustadas por edad para la altura, el peso y
    el índice de masa corporal [IMC]) a los 12 y 24 meses.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Subjects are eligible to be included in the study only if all of the following criteria apply:
    -Subject has provided informed consent/assent prior to initiation of any Study 20170534 specific activities/procedures.
    Subject’s legally acceptable representative has provided informed consent when the subject is legally too young to provide informed consent and the subject has provided written assent based on local regulations and/or guidelines prior to any study-specific activities/procedures being initiated.
    -Subject is currently/was enrolled in Study 20130173 and completed the month 36 visit.
    Los sujetos son elegibles para ser incluidos en el estudio solo si cumplen todos los criterios siguientes:
    -El sujeto ha proporcionado su consentimiento informado/asentimiento antes de iniciar cualquier actividad/procedimiento específico del estudio 20170534.
    El representante legal autorizado del sujeto ha dado su consentimiento informado cuando el sujeto es legalmente demasiado joven para dar su consentimiento informado y el sujeto ha dado su asentimiento por escrito de acuerdo con las normativas y/o directrices locales antes de iniciar cualquier actividad/procedimiento específico del estudio.
    -El sujeto se ha incluido en el estudio 20130173 y ha completado la visita del mes 36.
    E.4Principal exclusion criteria
    Subjects are excluded from the study if any of the following criteria apply:
    Prior/Concomitant Therapy
    -Treatment with any prohibited proscribed medications during Study 20130173 (see Section 7.1.7)
    Prior/Concurrent Clinical Study Experience
    -Subjects currently receiving treatment in another investigational device or drug study other than Study 20130173. Other investigational procedures while participating in this study are excluded.
    Other Exclusions
    -Female subject is pregnant or breastfeeding or planning to become pregnant or breastfeed during treatment and for an additional 5 months after the last dose of denosumab. Females of childbearing potential (Tanner Stage ≥ 2) should only be included in the study after a negative highly sensitive urine or serum pregnancy test.
    -Female subjects of childbearing potential unwilling to practice true sexual abstinence (refrain from heterosexual intercourse) or use 1 highly effective method of contraception during treatment and for an additional 5 months after the last dose of investigational product (IP) (denosumab). For study treatment with alternative osteoporosis medication/s of investigator’s choice, follow contraception guidelines per the specific alternative osteoporosis medication/s selected. For subjects not receiving any IP (observation only), no contraception required. Refer to Appendix 1 for additional contraceptive information.
    -History or evidence of any other clinically significant disorder, condition or disease (with the exception of those outlined above) that, in the opinion of the investigator or Amgen physician, if consulted, would pose a risk to subject safety or interfere with the study evaluation, procedures or completion.
    Los sujetos son excluidos del estudio si cumplen alguno de los criterios siguientes:
    Tratamiento previo/concomitante
    -Tratamiento con algún medicamento prescrito prohibido durante el estudio 20130173 (consulte el apartado 7.1.7).
    Experiencia previa/concomitante en ensayos clínicos
    -Sujetos que estén recibiendo tratamiento en algún otro estudio de un fármaco o dispositivo en investigación que no sea el estudio 20130173. Queda excluido cualquier otro procedimiento de investigación durante la participación en este estudio.
    Otras exclusiones
    -Mujeres embarazadas o que den el pecho o que planeen quedarse embarazadas o dar el pecho durante el tratamiento y durante los 5 meses posteriores a la última dosis de denosumab. Las mujeres en edad fértil
    (estadio de Tanner ≥ 2) solo deben incluirse en el estudio después de dar negativo en una prueba de embarazo en suero u orina altamente sensible.
    -Mujeres en edad fértil que no quieran practicar una estricta abstinencia sexual (abstenerse de mantener relaciones heterosexuales) o utilizar un método anticonceptivo muy eficaz durante el tratamiento y durante los 5 meses posteriores a la última dosis del producto en investigación (denosumab). Cuando el tratamiento del estudio se combina con otros medicamentos alternativos para la osteoporosis elegidos por el investigador, se deben seguir las pautas de anticoncepción específicas de los medicamentos alternativos seleccionados para tratar la osteoporosis. No es
    necesario que los sujetos que no reciben ningún producto en investigación (solo observación) utilicen métodos anticonceptivos. Consulte el apartado 12.5 para obtener más información sobre métodos anticonceptivos.
    -Antecedentes o evidencia de cualquier otro trastorno, condición o enfermedad clínicamente significativos (excepto los indicados anteriormente) que, en opinión del investigador o del médico de Amgen, si se le consulta, pudieran suponer un riesgo para la seguridad del sujeto o interferir en la evaluación, los procedimientos o la realización del estudio.
    E.5 End points
    E.5.1Primary end point(s)
    -The primary endpoint is safety monitoring, including subject incidence of adverse events and serious adverse events, subject prevalence of immunogenicity, changes from baseline in laboratory values and vital signs, and subject incidence of metaphyseal index Z score above age-appropriate normal range, abnormal molar eruption, and mandibular shaping
    - La variable principal es la supervisión de la
    seguridad, que incluye la incidencia en los
    sujetos de acontecimientos adversos y
    acontecimientos adversos graves, la incidencia en los sujetos de inmunogenicidad, cambios respecto al valor basal de los valores analíticos y constantes vitales, y la incidencia en los sujetos de la puntuación Z del índice metafisario por encima del intervalo normal adecuado para la edad, erupción molar anormal y conformación mandibular anormal.
    E.5.1.1Timepoint(s) of evaluation of this end point
    -at 12 and 24 months
    - a los 12 y 24 meses
    E.5.2Secondary end point(s)
    -Actual values and changes in BMD-Z score of lumbar spine and proximal femur (total hip and femoral neck) from baseline and from Study 20130173 baseline, as assessed by dual X-ray absorptometry (DXA), at 12 and 24 months
    -Subject incidence of X-ray confirmed long bone and new and worsening vertebral fractures from baseline and from Study 20130173 baseline to 12 and 24 months
    -Subject incidence of vertebral and non-vertebral fractures from baseline and from Study 20130173 baseline to 12 and 24 months
    -Change from baseline in growth velocity (determined by calculating age-adjusted Z-scores for height, weight, and BMI) at 12 and 24 months
    - Valores reales y cambios en la puntuación Z de la DMO de la columna lumbar y el fémur proximal (cadera total y cuello femoral) desde el nivel basal y desde el nivel basal del estudio 20130173, evaluada mediante absorciometría por rayos X de energía dual (DXA), a los 12 y 24 meses.
    - Incidencia en los sujetos de fracturas de
    huesos largos y fracturas vertebrales nuevas y empeoradas confirmadas mediante radiografías desde el nivel basal y desde el nivel basal del estudio 20130173 hasta los 12 y 24 meses.
    - Incidencia en los sujetos de fracturas
    vertebrales y no vertebrales desde el nivel
    basal y desde el nivel basal del estudio
    20130173 hasta los 12 y 24 meses.
    - Cambio respecto al valor basal en la velocidad de crecimiento (determinada mediante el cálculo de las puntuaciones Z ajustadas por edad para la altura, el peso y el IMC) a los 12 y 24 meses.
    E.5.2.1Timepoint(s) of evaluation of this end point
    -at 12 and 24 months
    - a los 12 y 24 meses
    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 Yes
    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) Yes
    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.8.2.4Number of treatment arms in the trial1
    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 concerned3
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA23
    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
    Australia
    Belgium
    Bulgaria
    Canada
    Czech Republic
    France
    Germany
    Hungary
    Italy
    Poland
    Spain
    United Kingdom
    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
    The end of study date is defined as the date when the last subject across all sites is assessed or receives an intervention for evaluation in the study (ie, last subject last visit), following any additional parts in the study (eg, long-term follow-up), as applicable.
    La fecha de fin de estudio se define como la fecha en la que el último sujeto, de todos los centros, es evaluado o es intervenido para su evaluación en el estudio (por ejemplo, última visita del último paciente), además de otras partes adicionales del estudio (por ejemplo, seguimiento a largo plazo), si aplica.
    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 months5
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years5
    E.8.9.2In all countries concerned by the trial months1
    E.8.9.2In all countries concerned by the trial days5
    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: 114
    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) Yes
    F.1.1.5.1Number of subjects for this age range: 49
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 65
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 36
    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 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 Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    Subjects under age incapable of giving consent personally.
    Sujetos sin edad suficiente para poder dar su consentimiento personalmente.
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state5
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 105
    F.4.2.2In the whole clinical trial 150
    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
    Ninguno
    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 Decision2019-10-01
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-09-27
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2022-03-28
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