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    Summary
    EudraCT Number:2014-003482-25
    Sponsor's Protocol Code Number:CBYM338E2202
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2014-12-16
    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 number2014-003482-25
    A.3Full title of the trial
    A 28 week, randomized, double-blind, placebo-controlled, multi-center, parallel group dose range finding study to assess the effect of monthly doses of bimagrumab 70, 210, and 700 mg on skeletal muscle strength and function in older adults with sarcopenia
    Estudio multicéntrico, aleatorizado, doble ciego, controlado con placebo, de grupos paralelos, de búsqueda de intervalo de dosis, de 28 semanas de duración para evaluar el efecto de dosis mensuales de bimagrumab 70, 210 y 700 mg en la fuerza y la función muscular esquelética en adultos de edad avanzada con sarcopenia.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Dose range finding study in sarcopenia
    Estudio en sarcopenia de búsqueda de dosis
    A.4.1Sponsor's protocol code numberCBYM338E2202
    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 SponsorNovartis Farmacéutica, S.A.
    B.1.3.4CountrySpain
    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 supportNovartis Pharma Services AG
    B.4.2CountrySwitzerland
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationNovartis Farmacéutica, S.A.
    B.5.2Functional name of contact pointDepartamento Médico (ICRO)
    B.5.3 Address:
    B.5.3.1Street AddressGran Via de les Corts Catalanes 764
    B.5.3.2Town/ cityBarcelona
    B.5.3.3Post code08013
    B.5.3.4CountrySpain
    B.5.4Telephone number+34900353036
    B.5.5Fax number+34932479903
    B.5.6E-maileecc.novartis@novartis.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 nameBimagrumab
    D.3.2Product code BYM338
    D.3.4Pharmaceutical form Concentrate for solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNBimagrumab
    D.3.9.1CAS number 1356922-05-8
    D.3.9.2Current sponsor codeBYM338
    D.3.9.3Other descriptive nameHuman Monoclonal Antibody against ActRII
    D.3.9.4EV Substance CodeSUB32641
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number150
    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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboSolution for infusion
    D.8.4Route of administration of the placeboIntravenous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    sarcopenia
    Sarcopenia
    E.1.1.1Medical condition in easily understood language
    low muscle mass and gait speed in elderly subjects
    Baja masa muscular y baja velocidad de la marcha en pacientes ancianos.
    E.1.1.2Therapeutic area Diseases [C] - Musculoskeletal Diseases [C05]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 17.1
    E.1.2Level PT
    E.1.2Classification code 10063024
    E.1.2Term Sarcopenia
    E.1.2System Organ Class 10028395 - Musculoskeletal and connective tissue disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Assess the effect of bimagrumab on the 6 minute walk test (6MWT) as assessed by change from baseline to week 25 relative to placebo.
    Evaluar el efecto de bimagrumab mediante la prueba de marcha de 6 minutos (6MWT) determinando el cambio desde la basal hasta la semana 25 en comparación con placebo.
    E.2.2Secondary objectives of the trial
    - assess safety and tolerability of bimagrumab variables,
    - assess the effect of bimagrumab compared to placebo on the change from baseline to week 25 in the Short Physical Performance Battery (SPPB)
    - assess the effect of bimagrumab compared to placebo on the
    change from baseline at week 25 in gait speed
    - assess the effect of bimagrumab on total lean body mass and
    appendicular skeletal muscle index (ASMI) as assessed by change from baseline to week 25 compared to placebo
    - Evaluar variables de seguridad y tolerabilidad del bimagrumab,
    - Evaluar el efecto de bimagrumab comparado con placebo en el cambio desde la visita basal a la semana 25 en la bateria breve de actividad física (SPPB),
    - Evaluar el efecto de bimagrumab comparado con placebo en el cambio desde la visita basal a la semana 25 en la velocidad de la marcha,
    - Evaluar el efecto de bimagrumab en la masa corporal magra total y el índice muscular esquelético apendicular (ASMI) mediante el cambio desde la basal hasta la semana 25 en comparación con placebo
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Low muscle mass as confirmed by DXA; Low gait speed; Weigh at least 40kg; Adequate dietary intake
    1. El consentimiento informado por escrito se debe obtener antes de realizar cualquier evaluación.
    2.Hombres y mujeres postmenopáusicas ? 70 años de edad con limitaciones de la movilidad indicadas por el paciente como la dificultad para levantarse de una silla, para caminar más de 10 minutos en una superficie llana o para subir un tramo de escaleras
    3.Velocidad de la marcha a lo largo de 4 metros < 0,8 m/s pero ? 0,3 m/s en la selección y la basal.
    4.Índice muscular esquelético apendicular (músculo esquelético de brazos y piernas en kg/estatura en m2) mediante DEXA:
    ? ? 7,26 kg/m2 para los hombres y ? 5,5 kg/m2 para las mujeres que se evaluará durante la selección.
    5.Los pacientes deben pesar al menos 40,0 kg para participar en el estudio y deben tener un índice de masa corporal (IMC) entre 18,0 y 30,0 kg/m2.
    6.Dieta habitual ? 20 kcal/kg de peso corporal y ? 0,8 g proteína/kg al día durante las 4 semanas anteriores a la selección, calculada mediante un método establecido de evaluación de la dieta.
    7.Ser capaz de comunicarse bien con el investigador y comprender y cumplir el programa de ejercicios, los suplementos nutricionales, el programa de visitas y otros requisitos del estudio.
    E.4Principal exclusion criteria
    A lower limb fracture in the past 6 months or any impairment or disease severely affecting gait (e.g. stroke with hemiparesis, myasthenia gravis, Parkinson's disease, peripheral polyneuropathy, intermittent claudication in advanced peripheral vascular disease, spinal stenosis, or severe osteoarthritis of the knee or hip); Any underlying muscle disease including active myopathy or muscular dytrophy; Confirmed diagnosis of heart failure classified as New York Heart Association Class III and IV (e.g. cardiomyopathy) or hypertrophic cardiomyopathy; Type I diabetes or uncontrolled Type 2 diabetes; Requires regular assistance from another person for general activities of daily living (e.g. bathing, dressing).
    1. Antecedentes de fractura de un miembro inferior (p. ej., fémur, tibia) durante los últimos 6 meses con un efecto negativo permanente en la función de la extremidad inferior o cualquier afectación o enfermedad significativa que afecte negativamente a la marcha (p. ej., claudicación intermitente de una enfermedad vascular periférica avanzada, estenosis espinal u osteoartritis grave de la rodilla o la cadera).
    2. Diagnóstico confirmado de una enfermedad psiquiátrica significativa (p. ej., demencia/enfermedad de Alzheimer, esquizofrenia, depresión o trastorno bipolar).
    3. Pacientes con una puntuación ? 10 en el cuestionario de la salud del paciente ? 9 (PHQ-9) en la selección.
    4. Lesión / trastorno neurológico con un déficit neurológico o funcional permanente significativo (p. ej., accidente cerebrovascular con hemiparesia, lesión de médula espinal, distrofia muscular, miopatía, miastenia gravis, enfermedad de Parkinson o polineuropatía periférica).
    5. Trauma ocular, cirugía oftalmológica o tratamiento láser ocular durante los 6 meses anteriores a la selección.
    6. Deficiencia de vitamina D definida como niveles de 25-OH vitamina D < 12,0 ng/ml en la selección y la basal.
    7. Concentración de hemoglobinapor debajo de 11,0 g/dl en la selección.
    8. Enfermedad renal crónica [tasa de filtración glomerular estimada (TFG) < 30 ml/min].
    9. Antecedentes de enfermedad pulmonar obstructiva crónica confirmada con un nivel de gravedad > 2 en la escala de disnea del Medical Research Council.
    10. Hipotiroidismo o hipertiroidismo no controlado. Los pacientes con hipotiroidismo que hayan modificado su dosis de terapia hormonal sustitutiva durante las 6 semanas anteriores a la selección no son elegibles para el estudio.
    11. Enfermedades musculares subyacentes, incluyendo antecedentes o miopatía actualmente activa (p. ej., dermatomiositis, polimiositis, etc.) o distrofias musculares.
    12. Artritis reumatoide confirmada, síndrome de inmunodeficiencia adquirido (SIDA) o diabetes mellitus tipo 1.
    13. Antecedentes o enfermedades gastrointestinales activas que causen una mala absorción de las proteínas o la energía, como enfermedad intestinal inflamatoria, enfermedad celíaca, síndrome del intestino corto o insuficiencia pancreática.
    14. Resultados anómalos de las pruebas de función hepática como SGOT (AST), SGPT (ALT), fosfatasa alcalina o bilirrubina sérica (salvo enfermedad de Gilbert).
    15. Antecedentes conocidos o presencia de una enfermedad hepática aguda o crónica activa grave (p. ej., cirrosis) o enfermedades con potencial hepatotóxico (p. ej., enfermedad conocida de la vesícula biliar o del conducto biliar, pancreatitis aguda o crónica).
    16. Presión arterial sistólica >180 o <90 mmHg o presión arterial diastólica >100 o <50 mmHg en la selección o la basal o hipertensión maligna.
    17. Diagnóstico confirmado de insuficiencia cardíaca clase III y IV de la New York Heart Association (p. ej., miocardiopatía) o miocardiopatía hipertrófica.
    18. Antecedentes de angina de pecho inestable, infarto de miocardio, bypas arterial coronario con injerto o intervención coronaria percutánea (p. ej., angioplastia o colocación de estent), trombosis venosa profunda/embolia pulmonar durante los 6 meses anteriores a la selección o 1 año para los estents farmacoactivos.
    19. Trastornos o defectos graves de las válvulas cardíacas (p. ej., estenosis aórtica o mitral, defectos septales o presencia de válvula cardíaca artificial).
    20. Hipertensión pulmonar grave.
    21. Antecedentes de conducción cardíaca /trastorno electrofisiológico significativos, p. ej., antecedentes familiares del síndrome de QT largo o antecedentes familiares conocidos de Torsades de Pointes o del síndrome de QT prolongado o QTcF ? 450 ms (corregido por la fórmula de Fridericia) para los hombres y ? 460 ms para las mujeres en la selección o la basal (según la lectura de ECG local).
    22. Arritmia cardíaca significativa confirmada (p. ej., bloqueo cardíaco de segundo/tercer grado, TSV, taquicardia ventricular, cardioversor/desfibrilador automático). Cualquier arritmia supraventricular actual con una respuesta ventricular no controlada (frecuencia cardíaca media > 100 latidos por minuto [lpm] en reposo a pesar de un tratamiento médico o con dispositivos.
    23. Antecedentes de hipersensibilidad a anticuerpos administrados terapéuticamente.
    24. Dolor de pecho, respiración difícil grave o presencia de otros problemas de seguridad durante las evaluaciones de la selección o la basal.
    25. Ausencia de acceso venoso periférico
    26. Cáncer activo (es decir, actualmente en tratamiento) o cáncer que haya requerido tratamiento durante los últimos 5 años excepto cánceres de piel no melanomatosos o cánceres con un pronóstico excelente (p. ej., cáncer de próstata o pecho en fase temprana, carcinoma de cuello de útero in situ).
    27. Diabetes mellitus tipo 2 no controlada (es decir, HbA1C ? 8,0% o hipoglucemia frecuente).
    Para el resto de criterios de exclusión, revisar protocolo.
    E.5 End points
    E.5.1Primary end point(s)
    6 minute walk test
    Tes de marcha de los 6 minutos
    E.5.1.1Timepoint(s) of evaluation of this end point
    week 25
    Semana 25
    E.5.2Secondary end point(s)
    - Safety and tolerability
    - Short Physical Performance Battery
    - Gait speed
    - Total lean body mass and appendicular skeletal muscle index measured by DXA
    - Seguridad y tolerabilidad
    - Batería breve de la actividad física (SPPB)
    - Velocidad de la marcha
    - Masa corporal magra total e índice muscular esquelético apendicular
    E.5.2.1Timepoint(s) of evaluation of this end point
    - Safety and tolerability: baseline, weeks 1, 5, 9, 13, 17, 21 and 25
    - Short Physical Performance Battery; Gait speed; and Total lean body mass and appendicular skeletal muscle index measured by DXA: week 25
    - Seguridad y tolerabilidad: visita basal y semanas 1,5, 9, 13, 17, 21 y 25.
    - Batería breve de la actividad física, velocidad de la marcha y masa corporal magra total e índice muscular esquelético apendicular medido por DEXA : semana 25.
    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 Yes
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    E.6.10Pharmacogenetic Yes
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    tolerability and biomarker assessments
    Evaluaciones de tolerabilidad y biomarcadores.
    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 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 Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial4
    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 concerned4
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA11
    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
    European Union
    Japan
    Switzerland
    Taiwan
    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
    LVLS
    Última visita del último paciente
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    E.8.9.1In the Member State concerned months22
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial months22
    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) No
    F.1.2.1Number of subjects for this age range: 0
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 280
    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 No
    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 No
    F.4 Planned number of subjects to be included
    F.4.1In the member state20
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 105
    F.4.2.2In the whole clinical trial 280
    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 Decision2015-01-30
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-01-12
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2018-09-27
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