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    Summary
    EudraCT Number:2012-001644-21
    Sponsor's Protocol Code Number:MEA115661
    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:2013-03-06
    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 number2012-001644-21
    A.3Full title of the trial
    MEA115661: A multi-centre, open-label, long-term safety study of mepolizumab in asthmatic subjects who participated in the MEA115588 or MEA115575 trials.
    Estudio multicéntrico, abierto, a largo plazo, de seguridad de mepolizumab en los sujetos con asma que participaron en los estudios MEA115588 o MEA115575.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A safety study for subjects with severe asthma who participated in MEA115575 or MEA115588
    Estudio de seguridad para sujetos con asma grave que participaron en los estudios MEA115588 o MEA115575.
    A.4.1Sponsor's protocol code numberMEA115661
    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 SponsorGlaxoSmithKline, 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 supportGlaxoSmithKline Research & Development Ltd
    B.4.2CountryUnited Kingdom
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationGlaxoSmithKline Research & Development Ltd
    B.5.2Functional name of contact pointClinical Trials Helpdesk
    B.5.3 Address:
    B.5.3.1Street AddressIron Bridge Road, Stockley Park West
    B.5.3.2Town/ cityUxbridge, Middlesex
    B.5.3.3Post codeUB11 - 1BU
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number+442089904466
    B.5.5Fax number+442089904433
    B.5.6E-mailGSKClinicalSupportHD@gsk.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 nameMepolizumab
    D.3.2Product code SB-240563
    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 INNMepolizumab
    D.3.9.1CAS number 196078-29-2
    D.3.9.2Current sponsor codeSB240563
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    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 Yes
    D.3.11.13.1Other medicinal product typeMepolizumab (SB-240563) es un anticuerpo IgG totalmente humanizado (IgG1, kappa) con regiones constantes de cadena ligera y pesada de origen humano.
    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
    Subjects with Severe Asthma.
    Pacientes con asma grave.
    E.1.1.1Medical condition in easily understood language
    Severe asthma.
    Asma grave.
    E.1.1.2Therapeutic area Diseases [C] - Respiratory Tract Diseases [C08]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 15.1
    E.1.2Level LLT
    E.1.2Classification code 10068462
    E.1.2Term Eosinophilic asthma
    E.1.2System Organ Class 100000004855
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To describe the safety profile of mepolizumab in subjects receiving long-term treatment
    Describir el perfil de seguridad de mepolizumab en sujetos que reciben tratamiento a largo plazo.
    E.2.2Secondary objectives of the trial
    To evaluate the effects of mepolizumab on a range of clinical markers of asthma control
    Evaluar los efectos de mepolizumab en un conjunto de marcadores clínicos de control del asma.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Informed Consent: Prior to commencing any study related activities, subjects must be able and willing to provide written informed consent.
    2. MEA115588 or MEA115575 study completion: Completion of the double-blind investigational product treatment during MEA115588 or MEA115575.
    3. Current Anti-Asthma Therapy: Asthma is currently being treated with a controller medication (i.e., ICS or other asthma controlled medication) and the subject has been on a controller medication for the past 12 weeks. Subjects will be expected to continue controller therapy for the duration of the study.
    4. Male or eligible female subjects:
    5. To be eligible for entry into the study, females of childbearing potential must commit to consistent and correct use of an acceptable method of birth control (Appendix 2) for the duration of the trial and for 4 months after the last study drug administration.
    6. A serum pregnancy test is required of all females at the initial Baseline Visit (Visit 1). In addition, a urine pregnancy test will be performed for all females prior to enrollment, during each scheduled study visit prior to the injection of investigational product, and during the Follow-up Visit.
    1. Consentimiento informado: antes de comenzar cualquier actividad relacionada con el estudio, el sujeto debe estar capacitado y dispuesto a proporcionar su consentimiento informado por escrito.
    2. Finalización del estudio MEA115588 o MEA115575: finalización del tratamiento doble ciego con el producto en investigación durante el estudio MEA115588 o MEA115575.
    3. Terapia actual contra el asma: en la actualidad, el asma se trata con un fármaco de control (es decir, CSI u otro fármaco de control) y el sujeto lo lleva tomando las últimas 12 semanas. Se espera que los sujetos continúen con el tratamiento de control durante todo el estudio.
    4. Sujetos masculinos o femeninos que sean elegibles:
    5. Para poder participar en el estudio, las mujeres en edad fértil deben comprometerse a utilizar de forma correcta y constante un método anticonceptivo apropiado (Apéndice 2) durante todo el ensayo y hasta los 4 meses después de la última administración del fármaco del estudio.
    6. Se requiere una prueba sérica de embarazo de todas las pacientes en la visita inicial (visita 1). Asimismo, todas las pacientes se someterán a una prueba de embarazo de orina antes de su inclusión, en cada visita programada antes de la inyección del producto en investigación y en la visita de seguimiento.
    E.4Principal exclusion criteria
    1. Hypersensitivity: Hypersensitivity reaction related to study medication during the MEA115588 or MEA115575 that led to patient withdrawal. Subjects who experienced a localized injection site reaction do not need to be excluded.
    2. Health Status: Clinically significant change in health status during MEA115588 or MEA115575 which in the opinion of the investigator would make the subject unsuitable for participation in this long-term study.
    3. Malignancy: A current malignancy or malignancy that developed during MEA115588 or MEA115575 (subjects that had localized carcinoma of the skin which was resected for cure will not be excluded). [Note for South Korea: Korean subjects with a diagnosis of malignancy within 5 years are excluded]
    4. Prior SAE: A study related SAE in MEA115588 or MEA115575 that was assessed as possibly related to study medication by the investigator.
    5. Pregnancy: Subjects who are pregnant or breastfeeding. Subjects should not be enrolled if they plan to become pregnant during the time of study participation.
    6. ECG: Baseline ECG which has a clinically significant abnormality or which shows QTcF <=450msec or QTcF <=480msec for subjects with Bundle Branch Block.
    7. Smoking status: Current smokers Subjects should also be excluded if any of the following are met:
    1. Liver Function: Liver Function Tests that meet any of the following during one of the last treatment visits in MEA115588 or MEA115575 :
    - ALT >=2 x ULN (upper limit of normal)
    - AST >=2 x ULN
    - Alk Phos >=2 x ULN
    1. Hipersensibilidad: reacción de hipersensibilidad relacionada con el fármaco del estudio durante el MEA115588 o MEA115575, que dio lugar a la retirada del paciente del estudio. Los pacientes que desarrollaron una reacción localizada en el lugar de la inyección, no es necesario que sean excluidos.
    2. Estado de salud: cambio del estado de salud clínicamente significativo durante el estudio MEA115588 o MEA115575 que, en opinión del investigador, haría que el sujeto no fuera adecuado para un estudio a largo plazo.
    3. Neoplasia maligna: una neoplasia maligna actual o que apareció durante los estudios MEA115588 o MEA115575 (no se excluirá a los sujetos que presentaron carcinoma cutáneo localizado y que se extirpó para su cura). [Nota para Corea del Sur: se excluye a los sujetos coreanos que hayan sido diagnosticados con neoplasia maligna en los últimos 5 años].
    4. AAG previos: un AAG en los estudios MEA115588 o MEA115575, que se consideró como posiblemente relacionado con la medicación del estudio por parte del investigador.
    5. Embarazo: pacientes que estén embarazadas o en periodo de lactancia. No se debe incluir a pacientes que estén planeando quedarse embarazadas durante el tiempo de participación en el estudio.
    6. ECG: ECG basal con una anomalía clínicamente significativa o que muestra un
    QTcF <=450 mseg o QTcF <= 480 mseg para sujetos con bloqueo de rama.
    7. Estado de tabaquismo: fumadores actuales. También se debe excluir a los sujetos si se cumple alguna de las situaciones siguientes:
    1. Función hepática: pruebas de función hepática que cumplan cualquiera de las condiciones siguientes durante una de las últimas visitas de tratamiento del estudio MEA115588 o MEA115575:
    - ALT >= 2 x LSN (límite superior del valor normal).
    - AST >= 2 x LSN.
    - Fosfatasa alcalina >= 2 x LSN.
    - Bilirrubina > 1,5 x LSN (bilirrubina aislada > 1,5 x LSN es aceptable si la bilirrubina está fraccionada y la bilirrubina directa es < 35%) .
    2. Estado de la hepatitis: resultado positivo del antígeno de superficie de la hepatitis B (HBsAg) en visita 1.
    3. Revisión del ECG: anomalía clínicamente significativa al realizar la revisión centralizada del ECG durante una de las últimas visitas de tratamiento en el estudio MEA115588 o MEA115575.
    E.5 End points
    E.5.1Primary end point(s)
    Adverse Events
    Acontecimientos adversos.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Each clinic visit.
    En cada visita del estudio.
    E.5.2Secondary end point(s)
    - Frequency of positive anti-mepolizumab binding antibodies and neutralising antibodies.
    - Annualized rate of exacerbations
    - ACQ score
    - FEV1
    - # of withdrawals due to lack of efficacy
    - # of withdrawals due to adverse events
    - # of hospitalisations due to adverse events including asthma exacerbations
    - Frequency of both systemic (i.e. allergic/IgE-mediated and non-allergic) and local site reactions
    - 12-lead ECG parameters
    - Vital signs
    - Clinical Laboratory Parameters
    - Frecuencia de anticuerpos anti-mepolizumab positivos y anticuerpos neutralizantes
    - Tasa anual de exacerbaciones
    - Puntuación en el Cuestionario de Control del Asma
    - Valor de FEV1 obtenido en la espirometría clínica
    - Número de abandonos por falta de eficacia
    - Número de abandonos por acontecimientos adversos
    - Número de hospitalizaciones por acontecimientos adversos como, por ejemplo, exacerbaciones asmáticas
    - Frecuencia de reacciones sistémicas (alérgicas y no alérgicas) y reacciones locales en la zona de inyección
    - Parámetros del ECG de 12 derivaciones
    - Constantes vitales
    - Parámetros analíticos clínicos
    E.5.2.1Timepoint(s) of evaluation of this end point
    Each clinic visit
    En cada visita 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 Yes
    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) 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 Yes
    E.8.1.7.1Other trial design description
    Estudio de seguridad a largo plazo.
    Long term safety study
    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 concerned5
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA75
    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
    Argentina
    Australia
    Belgium
    Canada
    Chile
    Czech Republic
    France
    Germany
    Italy
    Japan
    Korea, Republic of
    Mexico
    Netherlands
    Poland
    Russian Federation
    Spain
    Ukraine
    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
    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 years1
    E.8.9.1In the Member State concerned months4
    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 months4
    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: 20
    F.1.1.1In Utero No
    F.1.1.1.1Number of subjects for this age range: 0
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.2.1Number of subjects for this age range: 0
    F.1.1.3Newborns (0-27 days) No
    F.1.1.3.1Number of subjects for this age range: 0
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.4.1Number of subjects for this age range: 0
    F.1.1.5Children (2-11years) No
    F.1.1.5.1Number of subjects for this age range: 0
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 20
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 620
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 20
    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 300
    F.4.2.2In the whole clinical trial 660
    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)
    The investigator is responsible for ensuring that consideration has been given to the post study care of the subject?s medical condition whether or not GSK is providing specific post study treatment. At the end of the study, subjects should be prescribed appropriate alternative asthma therapy if needed and as determined by the study Investigator.
    El Investigador es responsable de garantizar el tratamiento adecuado del paciente posterior al estudio, tanto si GSK está proporcionando un tratamiento específico como si no. Al final del estudio, se prescribirá a los sujetos un tratamiento alternativo adecuado contra el asma según lo determine el investigador 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 Decision2013-04-22
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-03-25
    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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