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    EudraCT Number:2015-000865-29
    Sponsor's Protocol Code Number:C38072-AS-30025
    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:2015-08-10
    Trial results View results
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    A. Protocol Information
    A.1Member State ConcernedSpain - AEMPS
    A.2EudraCT number2015-000865-29
    A.3Full title of the trial
    A 52-Week Double-Blind, Placebo-Controlled, Parallel-Group Efficacy and Safety Study of Reslizumab 110 mg Fixed, Subcutaneous Dosing in Patients with Uncontrolled Asthma and Elevated Blood Eosinophils
    Estudio doble ciego, controlado con placebo y de grupos paralelos de 52 semanas de duración para evaluar la eficacia y la seguridad de una dosis fija de 110 mg de reslizumab por vía subcutánea en pacientes con asma no controlada y concentración elevada de eosinófilos en sangre
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A 52-Week Efficacy and Safety Study of Reslizumab Subcutaneous Dosing in Patients with Uncontrolled Asthma and Elevated Blood Eosinophils
    Estudio de 52 semanas de duración para evaluar la eficacia y la seguridad de una dosis de reslizumab por vía subcutánea en pacientes con asma no controlada y concentración elevada de eosinófilos en sangre
    A.4.1Sponsor's protocol code numberC38072-AS-30025
    A.7Trial is part of a Paediatric Investigation Plan Yes
    A.8EMA Decision number of Paediatric Investigation PlanP/017/2015
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorTeva Branded Pharmaceutical Products R&D, 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 supportTeva Branded Pharmaceutical Products R&D, Inc
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationPPD Global
    B.5.2Functional name of contact pointPip Majerski
    B.5.3 Address:
    B.5.3.1Street AddressGranta Park
    B.5.3.2Town/ cityCambridge
    B.5.3.3Post codeCB21 5AE
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number+34 900 834223
    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 nameReslizumab
    D.3.2Product code CEP-38072
    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 INNReslizumab
    D.3.9.1CAS number 241473-69-8
    D.3.9.2Current sponsor codeCEP-38072
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number110
    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. cell therapy medicinal product No
    D. therapy medical product No
    D. Engineered Product No
    D. ATIMP (i.e. one involving a medical device) No
    D. 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 injection in pre-filled syringe
    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
    Uncontrolled Asthma & elevated blood Eosinophils
    asma no controlada y concentración elevada de eosinófilos en sangre
    E.1.1.1Medical condition in easily understood language
    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 18.0
    E.1.2Level PT
    E.1.2Classification code 10003553
    E.1.2Term Asthma
    E.1.2System Organ Class 10038738 - Respiratory, thoracic and mediastinal 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 determine the effect of reslizumab (110 mg) administered subcutaneously every 4 weeks on clinical asthma exacerbations in adults and adolescents with asthma and elevated blood eosinophils who are inadequately controlled on standard-of-care asthma therapy.
    El objetivo principal de este estudio es determinar el efecto de reslizumab (110 mg) administrado por vía subcutánea cada 4 semanas en las exacerbaciones clínicas del asma en adultos y adolescentes con asma y concentración elevada de eosinófilos en sangre que no logran un control adecuado del asma con el tratamiento habitual.
    E.2.2Secondary objectives of the trial
    Secondary efficacy objectives are to evaluate the effects of reslizumab compared with placebo on a range of clinical markers of asthma control including pulmonary function (forced expiratory volume in 1 second [FEV1]).
    Los objetivos secundarios de la eficacia son evaluar los efectos de reslizumab en comparación con placebo en una serie de marcadores clínicos de control del asma, entre ellos la función pulmonar (volumen espiratorio forzado en 1 segundo [FEV1]).
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Patients may be included in the study only if they meet all of the following criteria:
    a. Written informed consent is obtained. A patient 12 through <18 years of age must provide assent, and their parent(s) or legal guardian(s) must provide consent.
    b. The patient is male or female, 12 years of age and older, with a diagnosis of asthma. (Patients 12 to <18 years of age are excluded from participating in South Korea and Argentina, and patients 66 years of age and older are excluded from participating in South Korea.)
    c. The patient has had at least 2 documented asthma exacerbations requiring the use of systemic (oral, intramuscular, or intravenous) corticosteroids within 12 months of signing the Informed Assent Form/Informed Consent Form.
    d. The patient has an ACQ-6 score of at least 1.5 at screening (visit 1).
    e. The patient has a blood eosinophil level of at least 300/microL during the screening period (ie, prior to visit 2).(A maximum of 30% of the patients with blood eosinophil levels of 300/microL to <400/microL will be enrolled. When this 30% threshold has been reached, only patients with blood eosinophil levels of maior or equal 400/microL will then be enrolled).
    f. The patient has an FEV1 reversibility of at least 12%and an absolute change of at least 200 mL after administration of inhaled SABA according to standard American Thoracic Society (ATS) or European Respiratory Society (ERS) protocol. Documented historical reversibility within 12 months of signing the Informed Assent Form/Informed Consent Form is acceptable.
    g. The patient has required at least 440 microg of inhaled fluticasone propionate or equivalent total daily dose for at least 3 months. For ICS/LABA combination preparations, the mid-strength approved maintenance dose in the local country will meet this ICS criterion.
    h. The patient has required an additional asthma controller medication (eg, long-acting beta-2-agonist[LABA], long-acting muscarinic antagonist [LAMA], leukotriene receptor antagonist [LTRA], or theophylline preparations), besides inhaled corticosteroids, for at least 3 months or a documented failure in the past 12 months of an additional asthma controller medication for at least 3 successive months.
    i. Females of childbearing potential (not surgically sterile or 2 years postmenopausal) must have an exclusively same-sex partner or use a medically acceptable method of contraception, and must agree to continue use of this method for the duration of the study and for 5 months after last study drug dose. Acceptable methods of contraception include intrauterine device, steroidal contraceptive (oral, implanted, transdermal, or injected), barrier method with spermicide, abstinence, and partner vasectomy.
    j. The patient must be willing and able to comply with study restrictions, perform requisite procedures and remain at the clinic for the required duration during the study period, and be willing to return to the clinic for the follow-up evaluation as specified in this protocol.
    k. The patient must maintain their usual asthma controller regimen without change throughout the screening and run-in periods. A patient who experiences an asthma exacerbation during this time that requires additional medication, beyond increased SABA use, will be considered to have failed screening/run-in and cannot undergo randomization. A patient may be rescreened for this reason 1 time only.
    I. In order to be randomized, a patient must demonstrate the following:
    -- inadequate asthma control at baseline/DoR as evidenced by:
    - daytime asthma symptom score >0 on >2 of the previous 7 days based on the asthma control diary received at run-in OR
    i) need for reliever SABA use on >2 of the previous 7 days OR
    ii) maio or equal 1 nighttime awakening due to asthma over the previous 7 days OR
    - pre-bronchodilator FEV1 <80% predicted at baseline/DoR
    -- completion of at least 4 days of diary entries or equivalent during the last 7 days of run-in. A patient may be rescreened for this reason 1 time only.
    Los pacientes podrán participar en el estudio únicamente si cumplen todos los criterios de inclusión siguientes:
    a.Se ha obtenido el consentimiento informado por escrito. Los pacientes entre 12 y menores de 18 años deberán dar su asentimiento, y sus padres o tutores legales deberán dar su consentimiento.
    b.El paciente es un varón o una mujer, de 12 o más años de edad, con diagnóstico de asma. (En Corea del Sur y Argentina no podrán participar en el estudio pacientes de 12 a <18 años de edad y e Corea del Sur tampoco podrán participar pacientes de 66 o más años de edad.)
    c. El paciente ha tenido al menos 2 exacerbaciones de asma documentadas que han precisado el uso de corticosteroides sistémicos (administrados por vía oral, intramuscular o intravenosa) en los 12 meses previos a la firma del documento de asentimiento informado/documento de consentimiento informado.
    d. Paciente con una puntuación ACQ-6 de al menos 1,5 en la selección (visita 1).
    e.El paciente tiene una concentración de eosinófilos en sangre de al menos 300/microl durante el período de selección (antes de la visita 2). (El 30% como máximo de los pacientes reclutados tendrán concentraciones de eosinófilos en sangre de entre 300/microl y menor a 400/microl. Cuando se haya alcanzado ese umbral del 30%, se reclutará únicamente a pacientes con concentraciones de eosinófilos en sangre mayor o igual 400/microl)
    f.El paciente presenta una reversibilidad del FEV1 de al menos el 12% y un variación absoluta de al menos 200 ml tras la administración de ABAC inhalados, de conformidad con el protocolo normalizado de la American Thoracic Society (ATS) o la Sociedad Europea de Enfermedades Respiratorias (ERS). Se acepta una reversibilidad histórica documentada en los 12 meses anteriores a la firma del documento de asentimiento informado/documento de consentimiento informado.
    g.El paciente ha requerido al menos 440 microg de propionato de fluticasona inhalado o una dosis diaria total equivalente durante al menos 3 meses. Para preparar las combinaciones de CI/ABAP, la dosis de mantenimiento aprobada con la concentración intermedia en el país en cuestión cumplirá este criterio para los CI.
    h.El paciente ha requerido medicación adicional para el control del asma (por ejemplo, agonista beta 2 de acción prolongada [ABAP], antagonista muscarínico de acción prolongada [AMAP], antagonista de receptores de leucotrienos [ARLT], o preparado de teofilina), además de corticosteroides inhalados, durante al menos 3 meses o se ha documentado en los últimos 12 meses el fracaso de otra medicación para el control del asma durante un mínimo de 3 meses sucesivos.
    i.Las mujeres con capacidad de procrear (que no se hayan esterilizado quirúrgicamente o que no lleven dos años de posmenopausia) deberá tener exclusivamente una pareja del mismo sexo o utilizar un método anticonceptivo que sea médicamente aceptable, y deberán comprometerse a seguir utilizando dicho método durante todo el tiempo que dure el estudio y hasta 5 meses después de recibir la última dosis del fármaco del estudio. Los métodos anticonceptivos aceptables son dispositivo intrauterino (DIU), anticonceptivos esteroideos (orales, implantados, transdérmicos o inyectados), un método de barrera con espermicida, abstinencia y vasectomía de la pareja.
    j.El paciente ha de estar dispuesto y ser capaz de cumplir las restricciones del estudio, realizar los procedimientos exigidos, permanecer en el centro el tiempo necesario durante el período de estudio y acudir al centro para la evaluación de seguimiento que se especifica en este protocolo.
    k.El paciente debe mantener su tratamiento habitual para el control del asma sin cambiarlo durante los períodos de selección y preinclusión. El paciente que experimente una exacerbación del asma durante este tiempo y que precise medicación adicional, además de aumentar el uso de ABAC, se considerará un fracaso de la selección/preinclusión y no podrá ser aleatorizado a un grupo de tratamiento. Los pacientes podrán someterse a selección nuevamente en una ocasión. (La duración entre la primera visita del período de selección y la repetición de la selección deberá ser >30 días.)
    l.Para poder ser aleatorizado, el paciente tiene que demostrar lo siguiente:
    -control inadecuado del asma en el momento basal/DdA documentado por:
    i. puntuación de síntomas asmáticos diurnos >0 en >2 de los 7 días anteriores, basada en el diario de control del asma recibido en la preinclusión O
    ii. necesidad de utilizar ABAC para alivio de los síntomas en >2 de los 7 días previos O
    iii. mayor o igual a 1 despertares nocturnos debidos al asma durante los 7 días anteriores O
    iv. FEV1 antes del broncodilatador <80% del valor previsto en el momento basal/DdA
    v. finalización de al menos 4 días de entradas en el diario o equivalente durante los últimos 7 días de preinclusión. Los pacientes podrán someterse a selección nuevamente en una ocasión.
    E.4Principal exclusion criteria
    Patients will be excluded from participating in this study if they meet any of the following criteria:
    a. The patient has any clinically significant, uncontrolled medical condition (treated or untreated) that would interfere with the study schedule or procedures, interpretation of efficacy results, or compromise the patient?s safety.
    b. The patient has another confounding underlying lung disorder (eg, chronic obstructive pulmonary disease, interstitial lung disease, bronchiectasis, eosinophilic granulomatosis with polyangiitis [EGPA, also known as Churg-Strauss syndrome], or allergic bronchopulmonary aspergillosis [ABPA]).
    c. The patient has a known hypereosinophilic syndrome.
    d. The patient has a diagnosis of malignancy within 5 years of the screening visit, except for treated and cured non-melanoma skin cancers.
    e. The patient is a pregnant or lactating woman, or intends to become pregnant during the study. Any woman becoming pregnant during the study will be withdrawn from the study.
    f. The patient required treatment for an asthma exacerbation within 4 weeks of screening or during the screening/run-in period.
    g. The patient is a current smoker (ie, has smoked within the last 6 months prior to screening) or has a smoking history ?10 pack years.
    h. The patient is currently using any systemic immunosuppressive or immunomodulatory biologic (eg, anti-immunoglobulin E monoclonal antibody or other monoclonal antibody [eg, mepolizumab] or soluble receptors) or non-biologic (eg, methotrexate or cyclosporine), except maintenance oral corticosteroids for the treatment of asthma (up to and including 10 mg of prednisone daily or equivalent). Note: Previous use of such agents that occurred >5 half-lives from the initial screening visit may be allowed, if approved by the medical monitor.
    i. The patient participated in a clinical trial within 30 days or 5 half-lives of the investigational drug before screening, whichever is longer.
    j. The patient was previously exposed to benralizumab within 12 months of screening.
    k. The patient was previously exposed to reslizumab.
    l. The patient has a history of an immunodeficiency disorder including HIV.
    m. The patient has current or suspected drug and alcohol abuse.
    n. The patient has an active helminthic parasitic infection or was treated for one within 6 months of screening.
    o. The patient has a history of allergic reaction or hypersensitivity to any component of the study drug.
    p. The patient has a history of latex allergy. (The current prefilled syringe device has a natural rubber component to the needle shield.)
    Se excluirá del estudio a los pacientes que cumplan alguno de los criterios siguientes:
    a.El paciente tiene un trastorno médico clínicamente significativo o no controlado (tratado o no tratado) que puede interferir con el calendario o los procedimientos del estudio, la interpretación de los resultados de eficacia o el compromiso con la seguridad del paciente.
    b.El paciente presenta otro trastorno pulmonar subyacente que puede confundir los resultados (p. ej., enfermedad pulmonar obstructiva crónica, enfermedad pulmonar intersticial, bronquiectasia, granulomatosis eosinofílica con poliangiitis [GEPA], también conocido como síndrome de Churg-Strauss], o aspergilosis broncopulmonar alérgica [ABPA]).
    c.El paciente presenta un síndrome hipereosinófilo conocido.
    d.El paciente ha recibido un diagnóstico de neoplasia maligna en los 5 años previos a la visita de selección, excepto cánceres de piel distintos de melanoma que hayan sido tratados y curados.
    e.El paciente es una mujer embarazada, en período de lactancia o que pretende quedarse embarazada durante el estudio. Se retirará del estudio a todas las mujeres que se queden embarazadas durante el estudio.
    f.El paciente ha precisado tratamiento por una exacerbación del asma en las 4 semanas previas a la selección o durante el período de selección/preinclusión.
    g.El paciente es actualmente fumador (es decir, ha fumado en los 6 meses previos a la selección) o ha fumado en el pasado mayor o igual a 10 paquetes año.
    h.El paciente está usando actualmente algún tratamiento inmunosupresor o inmunomodulador sistémico con un producto biológico (por ejemplo, anticuerpo monoclonal contra la inmunoglobulina E u otros anticuerpos monoclonales [como mepolizumab] o receptores solubles) o no biológico (por ejemplo, metotrexato o ciclosporina), excepto corticosteroides orales de mantenimiento para el tratamiento del asma (hasta 10 mg inclusive de prednisona diarios o equivalente). Nota: Se permitirá el uso previo de esos fármacos desde >5 semividas antes de la visita inicial de selección, siempre que así lo apruebe el monitor médico.
    i.El paciente ha participado en un ensayo clínico en los 30 días o 5 semividas del fármaco de investigación antes de la selección, lo que más largo sea.
    j.El paciente ha estado anteriormente expuesto a benralizumab en los 12 meses previos a la selección.
    k.El paciente ha estado anteriormente expuesto a reslizumab.
    l.El paciente tiene antecedentes de un trastorno de inmunodeficiencia, incluida la infección por VIH.
    m.El paciente presenta actualmente o se sospecha que presenta un problema de abuso de drogas o alcohol.
    n.El paciente presenta una infección parasitaria helmíntica activa o ha sido tratado por esa causa en los 6 meses previos a la selección.
    o.El paciente tiene antecedentes de reacción alérgica o hipersensibilidad a cualquiera de los componentes del fármaco del estudio.
    p.El paciente tiene antecedentes de alergia al látex. (El dispositivo actual de la jeringa precargada tiene un componente de caucho natural en el capuchón de la aguja.)
    E.5 End points
    E.5.1Primary end point(s)
    The primary efficacy endpoint is the frequency of clinical asthma exacerbations (CAEs) per patient during the 52-week treatment period.
    For this study, a CAE is defined as a clinically judged deterioration in asthma control as determined by the
    investigator and as evidenced by new or worsening asthma signs or symptoms based on the patient history, asthma control diary, physical examination, and/or ambulatory or clinic visit assessment of lung function and that results in a medical intervention, including at least 1 of the following:
    -- use of systemic corticosteroids (oral or injection) or at least a doubling from a stable maintenance oral
    corticosteroid dose for at least 3 days
    -- asthma-specific hospital admission
    -- asthma-specific emergency department visit
    Additional medication and/or medical intervention that would satisfy the CAE definition occurring within 7 days of the last day of a prior CAE event will be considered as part of the same event for analysis purposes.
    La variable principal de la eficacia de este estudio es la frecuencia de ECA en cada paciente durante el período de tratamiento de 52 semanas. A los efectos de este estudio, una ECA se define como un deterioro desde el punto de vista clínico en el control del asma, según lo determinado por el investigador y manifestado por la aparición o el empeoramiento de signos o síntomas de asma en base a los antecedentes médicos del paciente, el diario de control del asma, la exploración física o la evaluación de la función pulmonar realizada en una visita al centro del estudio o a una consulta ambulatoria y que precisa una intervención médica, incluida al menos una de las siguientes:
    -- uso de corticosteroides sistémicos (orales o inyectables) o necesidad de aumentar como mínimo al doble la dosis estable del corticosteroide oral de mantenimiento durante al menos 3 días.
    -- ingreso hospitalario específicamente por asma
    -- visita a un servicio de urgencias específicamente por asma
    A los efectos del análisis, se considerará como parte del mismo episodio cualquier medicación o intervención médica adicional que cumpla la definición de ECA y que ocurra en los 7 días siguientes al último día de un episodio previo de ECA.
    E.5.1.1Timepoint(s) of evaluation of this end point
    during the 52-week treatment period
    durante el período de tratamiento de 52 semanas
    E.5.2Secondary end point(s)
    The secondary efficacy endpoints are as follows:
    -- change in pre-bronchodilator FEV1 from baseline/the day of randomization (DoR) at week 52
    -- change in Asthma Quality of Life Questionnaire for patients 12 years and older (AQLQ +12) score from baseline/DoR at week 52
    --change in 6-item Asthma Control Questionnaire (ACQ-6) score from baseline/DoR at week 52
    -- change in total asthma symptom scores (day and night) from baseline/DoR at week 52
    -- change in percentage of asthma control days from baseline/DoR at week 52
    -- change in St. George?s Respiratory Questionnaire (SGRQ) score from baseline/DoR at week 32
    -- time to first clinical asthma exacerbation during the 52-week treatment period
    -- frequency of exacerbations requiring hospitalization or emergency department visits per patient during
    the 52-week treatment period
    -- frequency of moderate exacerbations defined as exacerbations requiring additional asthma controller
    medication that was not a systemic corticosteroid and that did not result in an asthma-specific hospitalization or emergency department visit during the 52-week treatment period
    Los criterios secundarios de valoración de la eficacia son los siguientes:
    -- variación del FEV1 antes del broncodilatador respecto al momento basal/día de la aleatorización (DdA) en la semana 52
    -- variación de la puntuación obtenida en el Cuestionario de calidad de vida en el asma en pacientes de 12 o más años de edad (AQLQ +12) respecto al momento basal/DdA en la semana 52
    -- variación de la puntuación obtenida en el Cuestionario sobre el control del asma con 6 apartados (ACQ-6) respecto al momento basal/DdA en la semana 52
    -- variación de las puntuaciones totales de los síntomas de asma (diurnos y nocturnos) respecto al momento basal/DdA en la semana 52
    -- variación del porcentaje de días de control del asma respecto al momento basal/DdA en la semana 52
    -- variación de la puntuación obtenida en el Cuestionario Respiratorio de St. George (SGRQ) respecto al momento basal/DdA en la semana 32
    -- tiempo hasta la primera exacerbación clínica del asma durante el período de tratamiento de 52 semanas
    -- frecuencia de exacerbaciones que requieren hospitalización o visitas del paciente a un servicio de urgencias durante el período de tratamiento de 52 semanas
    -- frecuencia de exacerbaciones moderadas, definidas estas como exacerbaciones que requieren medicación adicional para el control del asma distinta de un corticosteroide sistémico, pero que no tienen como resultado la hospitalización del paciente o su visita a un servicio de urgencias específicamente por asma durante el período de tratamiento de 52 semanas.
    E.5.2.1Timepoint(s) of evaluation of this end point
    during the 52-week treatment period.
    durante el período de tratamiento de 52 semanas
    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 No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    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. 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 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 trial2
    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 EEA101
    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
    Czech Republic
    Korea, Republic of
    New Zealand
    Russian Federation
    South Africa
    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
    Last Subject Last Visit (LSLV) treatment period is defined as end of treatment (week 52). LSLV late follow up for immunogenicity testing only, will be performed 28 weeks (±2 weeks) after the last dose of study drug(approximately week 76). This will be considered the end of the trial for the purposes of end of trial notification.
    El período de tratamiento de la última visita del último paciente (UVUP) se define como el final del tratamiento (semana 52). Se realizará otro seguimiento tardío en la UVUP únicamente para pruebas de inmunogenicidad 28 semanas (±2 semanas) después de la última dosis del fármaco del estudio (aproximadamente en la semana 76). Ese momento se considerará el final del ensayo a los efectos de su notificación.
    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 months9
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months9
    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: 40
    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) Yes
    F. of subjects for this age range: 40
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 340
    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 state25
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 177
    F.4.2.2In the whole clinical trial 400
    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)
    Standard of Care
    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 Decision2015-10-09
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-07-27
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2018-01-31
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