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    Summary
    EudraCT Number:2013-003134-33
    Sponsor's Protocol Code Number:R1033-SRC-1239
    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:2013-11-27
    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 number2013-003134-33
    A.3Full title of the trial
    A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTICENTER STUDY OF THE SAFETY AND EFFICACY OF 3-MONTH SUBCUTANEOUS REGN1033 TREATMENT IN PATIENTS WITH SARCOPENIA
    ESTUDIO ALEATORIZADO, DOBLE CIEGO, CONTROLADO CON PLACEBO Y MULTICÉNTRICO, PARA EVALUAR LA SEGURIDAD Y LA EFICACIA DEL TRATAMIENTO CON REGN1033 POR VÍA SUBCUTÁNEA, DURANTE 3 MESES, EN PACIENTES CON SARCOPENIA
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A STUDY OF THE SAFETY AND EFFICACY OF REGN1033
    UN ESTUDIO DE SEGURIDAD Y EFICACIA DE REGN1033
    A.4.1Sponsor's protocol code numberR1033-SRC-1239
    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 SponsorRegeneron Pharmaceuticals, 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 supportRegeneron Pharmaceuticals, Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationRegeneron Pharmaceuticals, Inc.
    B.5.2Functional name of contact pointClin Dev & Regulatory Affairs
    B.5.3 Address:
    B.5.3.1Street Address777 Old Saw Mill River Road
    B.5.3.2Town/ cityTarrytown, NY
    B.5.3.3Post code10591
    B.5.3.4CountryUnited States
    B.5.4Telephone number+19148475700
    B.5.5Fax number+19148477688
    B.5.6E-mailrichard.swanson@regeneron.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 nameREGN1033
    D.3.2Product code REGN1033
    D.3.4Pharmaceutical form Lyophilisate for 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 INNNot available
    D.3.9.2Current sponsor codeREGN1033
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    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 placeboLyophilisate for solution for injection
    D.8.4Route of administration of the placeboSubcutaneous 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
    muscle wasting
    pérdida de masa muscular
    E.1.1.2Therapeutic area Diseases [C] - Musculoskeletal Diseases [C05]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    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
    The primary objective of the study is to evaluate the effect of multiple doses of REGN1033 administered SC for 12 weeks on total lean body mass measured by DEXA in patients with sarcopenia.
    El objetivo principal del estudio es evaluar el efecto de dosis repetidas de REGN1033 administradas S.C. durante 12 semanas sobre la masa corporal magra total, medida por DEXA, en pacientes con sarcopenia.
    E.2.2Secondary objectives of the trial
    - To assess the safety and tolerability of REGN1033 administered SC for 12 weeks in patients with sarcopenia
    - To assess the effects of REGN1033 administered SC for 12 weeks on measures of strength and function
    - Evaluar la seguridad y tolerabilidad de REGN1033 administrado S.C. durante 12 semanas en pacientes con sarcopenia
    - Evaluar los efectos de REGN1033 administrado S.C. durante 12 semanas sobre las medidas de fuerza y funcionalidad
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    Optional Genomics Sub-Study
    Subestudio Genómico Opcional
    E.3Principal inclusion criteria
    1. Men and women aged 70 years and older
    2. Are capable, in the investigator's opinion, to complete the study per protocol and have no significant health issues or conditions (including but not limited to severe arthritis of the major lower extremity joints and symptom-limited ambulation) that would impact the capability to get an accurate measurement of study endpoints
    3. Appendicular lean mass relative to height squared: ?7.23 kg/m² (men); ?5.67 kg/m² (women)
    4. 4M gait speed <1.0 m/s
    5. BMI between 18.5 kg/m² and 37 kg/m², inclusive
    6. Ability to follow the First Step to Active Health program
    7. Willing and able to comply with clinic visits and study-related procedures
    8. Provide signed informed consent
    9. Able to understand and complete study-related questionnaires
    1. Varón o mujer de 70 o más años de edad
    2. Capaz, en opinión del investigador, de completar el estudio conforme al protocolo. No podrá presentar patologías o problemas de salud significativos (entre otros: artrosis severa de las principales articulaciones de las extremidades inferiores o deambulación limitada por la presencia de síntomas) que afecten a la obtención de mediciones exactas de los criterios de valoración del estudio
    3. Masa magra apendicular dividida por altura al cuadrado: ?7,23 kg/m² (varones); ?5,67 kg/m² (mujeres)
    4. Velocidad de la marcha en 4m <1,0 m/s
    5. IMC entre 18,5 kg/m² y 37 kg/m², ambos incluidos
    6. Capaz de seguir la Primera Fase del programa de Salud Activa
    7. Capaz y dispuesto/a a acudir a las visitas en el centro y a cumplir con los procedimientos relacionados con el estudio
    8. Dispuesto a proporcionar su consentimiento informado firmado
    9. Capaz de comprender y completar los cuestionarios relacionados con el estudio
    E.4Principal exclusion criteria
    1. Hospitalization or immobilization with a duration of >48 hours within the month prior to screening
    2. Surgical procedure requiring general anesthesia within 2 months prior to screening, or a planned surgical procedure requiring general anesthesia within the next 6 months
    3. Participate in resistance training more than 2 times per week or regular exercise consisting of an average of 30 minutes per day or more of at least moderate physical activity
    4. Chronic medications introduced within 2 weeks prior to screening
    5. Weight loss of >10% body weight within 6 months prior to screening
    6. Respiratory disease (eg, severe chronic obstructive pulmonary disease) that requires oxygen treatment
    7. Cancer requiring treatment currently or in the past 3 years (except primary nonmelanoma skin cancer or in situ cervical cancer)
    8. Neurological conditions that are causing impaired muscle function or mobility (may include stroke with residual paresis, paralysis, neuropathy, Parkinson disease, or multiple sclerosis)
    9. Mini Mental State Exam score of <24
    10. Active Major Depressive Disorder per Diagnostic and Statistical Manual-V criteria within 3 months prior to screening
    11. Cardiovascular conditions such as New York Heart Association class III or IV heart failure, cardiomyopathy, intermittent claudication, myocardial infarction, or acute coronary syndrome within 6 months prior to screening; symptomatic ventricular cardiac arrhythmia (note: sinus dysrhythmia, asymptomatic block or well controlled atrial fibrillation with normal resting ventricular rate are not exclusion criteria)
    12. Abnormal echocardiogram findings at screening that are clinically significant, which may include but are not limited to:
    - Cardiomyopathy
    - Left ventricular ejection fraction <50%
    - Moderate or severe diastolic dysfunction, grade II/III
    - Aortic stenosis
    - Valvular disease with hemodynamic significance
    - Left ventricular wall thickness ?1.4 cm (men) and ?1.3 cm (women)
    13. Uncontrolled diabetes defined as hemoglobin A1C (HbA1C) >10% at screening
    14. Diastolic blood pressure >100 mm Hg or systolic blood pressure >180 mm Hg (average of 2 readings)
    15. Alanine aminotransferase (ALT) >3x the upper limit of normal (1 retest allowed)
    16. Reduced renal function defined as estimated glomerular filtration rate <30 mL/min/1.73 m² (1 retest allowed)
    17. Creatine phosphokinase >5 x the upper limit of normal (1 repeat lab is allowed)
    18. Use of any prescription or over-the-counter agents known to influence muscle mass or performance within 1 year prior to screening. These may include but are not limited to
    anabolic steroids, insulin-like growth factor-1 (IGF-1), growth hormone (GH), replacement androgen therapy, and anti-androgen therapy.
    19. Participation in any clinical trial of small molecule drugs within 30 days prior to screening or biologics within 3 months prior to screening
    20. Participation within 6 months prior to screening in clinical trials of interventions that are intended to influence muscle mass or performance
    21. History of human immunodeficiency virus infection
    22. Positive test for hepatitis B surface antigen and/or hepatitis C antibody at the screening visit
    23. Pregnant or breastfeeding women
    24. Sexually active men* or women of childbearing potential** who are unwilling to practice adequate contraception during the study (adequate contraceptive measures include stable use of oral contraceptives or other prescription pharmaceutical contraceptives for 2 or more menstrual cycles prior to screening; intrauterine device; bilateral tubal ligation; vasectomy; condom plus contraceptive sponge, foam, or jelly, or diaphragm plus contraceptive sponge, foam, or jelly)
    *Contraception is not required for men with documented vasectomy.
    **Postmenopausal women must be amenorrheic for at least 12 months in order not to be considered of childbearing potential. Pregnancy testing and contraception are not required for women with documented hysterectomy or tubal ligation.
    1. Hospitalización o inmovilización de duración >48 horas durante el mes anterior a la selección
    2. Cirugía con anestesia general en los 2 meses anteriores a la selección, o cirugía electiva con anestesia general prevista en los 6 meses siguientes
    3. Participación en entrenamiento de resistencia más de 2 veces por semana, o ejercicio regular consistente en una media de 30 minutos al día o más de actividad física al menos moderada
    4. Medicaciones crónicas introducidas en las 2 semanas anteriores a la selección
    5. Pérdida de peso >10% del peso corporal en los 6 meses anteriores a la selección
    6. Enfermedad respiratoria (por ej., enfermedad pulmonar obstructiva crónica severa) que requiera oxigenoterapia
    7. Cáncer que requiera tratamiento actualmente o durante los 3 años anteriores (a excepción del cáncer de piel no melanoma primario o el carcinoma in situ de cuello uterino)
    8. Trastornos neurológicos que afecten a la función muscular o la movilidad (pueden incluir el ictus con paresia residual, parálisis, neuropatías, enfermedad de Parkinson o esclerosis múltiple)
    9. Puntuación del Mini-Examen del Estado Mental <24
    10. Trastorno depresivo mayor activo, definido según los criterios del Manual Diagnóstico y Estadístico-V, en los 3 meses anteriores a la selección
    11. Patologías cardiovasculares, como la insuficiencia cardiaca de clase III o IV de la New York Heart Association, miocardiopatía, claudicación intermitente, infarto de miocardio o síndrome coronario agudo en los 6 meses anteriores a la selección; arritmias ventriculares sintomáticas (nota: la arritmia sinusal, el bloqueo asintomático y la fibrilación auricular bien controlada con frecuencia ventricular en reposo normal no constituyen criterios de exclusión)
    12. Anomalías clínicamente significativas en el ecocardiograma de la selección, entre otras:
    - Miocardiopatía
    - Fracción de eyección ventricular izquierda <50%
    - Disfunción diastólica moderada o severa, grado II/III
    - Estenosis aórtica
    - Valvulopatía con repercusión hemodinámica
    - Grosor de la pared ventricular izquierda ?1,4 cm (varones) o ?1,3 cm (mujeres)
    13. Diabetes no controlada, definida como hemoglobina A1C (HbA1C) >10% en la selección
    14. Presión arterial diastólica >100 mm Hg o presión arterial sistólica >180 mm Hg (promedio de dos lecturas)
    15. Alanina aminotransferasa (ALT) >3x el límite superior de la normalidad (se permite una repetición de la prueba)
    16. Función renal reducida, definida como una tasa de filtración glomerular <30 ml/min/1,73 m2 (se permite una repetición de la prueba)
    17. Creatín fosfocinasa >5x el límite superior de la normalidad (se permite una repetición de la prueba)
    18. Uso de cualquier fármaco, a obtener con receta o de venta libre en farmacia, conocido por influir sobre la masa o el rendimiento muscular, administrado en el año anterior a la selección. Ello incluye, entre otros, los esteroides anabolizantes, el factor de crecimiento insulin-like-1 (IGF-1), la hormona de crecimiento (HC), la terapia sustitutiva con andrógenos y la terapia antiandrogénica.
    19. Participación en cualquier ensayo clínico con moléculas pequeñas en los 30 días anteriores a la selección, o con fármacos biológicos en los 3 meses anteriores a la selección
    20. Participación, en los 6 meses anteriores a la selección, en ensayos clínicos de intervenciones destinadas a influir sobre la masa o el rendimiento muscular
    21. Antecedentes de infección por el virus de la inmunodeficiencia humana
    22. Prueba positiva del antígeno de superficie de la hepatitis B y/o de anticuerpos de la hepatitis C en la visita de selección
    23. Mujeres embarazadas o lactantes
    24. Varones sexualmente activos* o mujeres potencialmente fértiles** que no estén dispuestos/as a usar métodos anticonceptivos adecuados durante el estudio (los métodos anticonceptivos adecuados comprenden el uso continuado de anticonceptivos orales o de otros anticonceptivos farmacológicos a obtener con receta durante dos o más ciclos menstruales anteriormente a la selección; dispositivo intrauterino; ligadura de trompas bilateral; vasectomía; preservativo más esponja, gel o espuma anticonceptiva, o diafragma más esponja, gel o espuma anticonceptiva)
    *no se requiere anticoncepción en los varones con vasectomía documentada.
    **las mujeres postmenopáusicas deben haber permanecido amenorreicas durante al menos 12 meses para no ser consideradas potencialmente fértiles. No se requiere prueba de embarazo ni anticoncepción en las mujeres con histerectomía o ligadura de trompas documentada.
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint in the study is the percent change in total lean body mass.
    El criterio de valoración principal del estudio es el cambio porcentual en la masa corporal magra total
    E.5.1.1Timepoint(s) of evaluation of this end point
    Week 12.
    Semana 12
    E.5.2Secondary end point(s)
    The secondary endpoints are:
    TEAEs from baseline to the end of the study
    Changes from baseline in:
    - Appendicular lean mass by DEXA
    - Maximal leg press strength (1-RM)
    - Maximal chest press strength (1-RM)
    - 4M gait speed
    - SPPB and SPPB subscores
    - Distance walked in the 6MWT
    - Regional and total fat mass by DEXA
    - Hand grip strength by handheld dynamometer
    Los criterios de valoración secundarios son:
    Acontecimientos adversos surgidos durante el tratamiento (AAST) desde la visita basal hasta el final del estudio
    Cambios desde la visita basal en cuanto a:
    - Masa magra apendicular por DEXA
    - Fuerza máxima de prensa de piernas, 1 repetición máx (1-RM)
    - Fuerza máxima de prensa de pecho (1-RM)
    - Velocidad de marcha en 4m
    - SPPB y subpuntuaciones de la SPPB
    - Distancia caminada en la prueba 6MWT
    - Masa grasa regional y total por DEXA
    - Fuerza de prensión de la mano mediante dinamómetro manual
    E.5.2.1Timepoint(s) of evaluation of this end point
    The secondary endpoints will be evaluated from the timepoint of baseline estimation to the end of the study.
    Los criterios de valoración secundarios serán evaluados desde la visita basal hasta el final del estudio.
    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 No
    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 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 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 concerned3
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA14
    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
    France
    Germany
    Netherlands
    Spain
    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 llamada al último paciente.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years0
    E.8.9.1In the Member State concerned months10
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months1
    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) No
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 240
    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 state18
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 84
    F.4.2.2In the whole clinical trial 240
    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 Decision2014-01-31
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-01-08
    P. End of Trial
    P.End of Trial StatusCompleted
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
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