Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

  • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   43607   clinical trials with a EudraCT protocol, of which   7207   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools

    < Back to search results

    Print Download

    EudraCT Number:2015-001580-39
    Sponsor's Protocol Code Number:C38072-AS-30027
    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:2015-10-05
    Trial results View results
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedSpain - AEMPS
    A.2EudraCT number2015-001580-39
    A.3Full title of the trial
    A Phase 3, 24-Week Double-Blind, Placebo-Controlled, Parallel-Group, Efficacy and Safety Study of Reslizumab Subcutaneous Dosing (110 mg Every 4 weeks) in Patients with Oral Corticosteroid Dependent Asthma and Elevated Blood Eosinophils
    Estudio de fase 3, doble ciego, controlado con placebo y de grupos paralelos de 24 semanas de duración para evaluar la eficacia y la seguridad de reslizumab administrado por vía subcutánea (110 mg cada 4 semanas) en pacientes con asma dependiente de corticosteroides orales 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 24-Week Efficacy and Safety Study of Reslizumab Subcutaneous Dosing in Patients with Oral Corticosteroid Dependent Asthma and Elevated Blood Eosinophils
    Estudio de 24 semanas de duración para evaluar la eficacia y la seguridad de reslizumab administrado por vía subcutánea en pacientes con asma dependiente de corticosteroides orales y concentración elevada de eosinófilos en sangre.
    A.4.1Sponsor's protocol code numberC38072-AS-30027
    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 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
    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
    Asthma & elevated blood Eosinophils
    Asma 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 ability of reslizumab (110 mg) administered subcutaneously (sc) once every 4 weeks to produce a corticosteroid-sparing effect (as demonstrated by percent reduction in daily OCS use) in patients with OCS-dependent asthma and elevated blood eosinophils, without loss of asthma control.
    El objetivo principal de este estudio es determinar la capacidad de reslizumab (110 mg) administrado por vía subcutánea (SC) una vez cada 4 semanas para conseguir un efecto de ahorro de corticosteroides(según lo demostrado por la reducción porcentual del uso diario de CCO) en pacientes con asma dependiente de CCO y concentración elevada de eosinófilos en sangre, sin perder el control del asma.
    E.2.2Secondary objectives of the trial
    The secondary objective of this study is to evaluate the clinical benefits of reslizumab in the context of OCS reduction.
    El objetivo secundario de este estudio es evaluar los beneficios clínicos de reslizumab en el contexto de la reducción de CCO.
    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. The patient is male or female, 12 years of age and older, with a previous 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.
    b. Written informed consent is obtained. A patient 12 through <18 years of age must provide assent and his/her parent(s) or legal guardian(s) must provide consent.
    c. The patient continues to require an average daily maintenance dose of OCS or equivalent for asthma of between 5 and 40 mg during the 3 months prior to screening. Patients on an OCS dose of >40 mg at screening who the investigator believes may be able to decrease OCS dose tominor or equal 40 mg during the optimization period may also be enrolled. Note: every-other-day dosing that is within this daily average (ie, 10 to 80 mg) is allowed.
    d. The patient has a documented blood eosinophil level of at least 300/µL during the previous 12 months while on at least medium dose inhaled corticosteroid (ICS) (eg, maior or equal 440 µg/day of fluticasone propionate or equivalent daily), or maior or equal 300/µL at screening while on chronic OCS or that becomes manifest during the OCS optimization period or at the week -2 visit (end of optimization period/beginning of run-in period).
    e. The patient has required at least 880 µg of inhaled fluticasone propionate or equivalent daily PLUS another controller(s) (eg, long-acting beta-adrenergic agonist [LABA], long-acting anti-muscarinic antagonist [LAMA], leukotriene inhibitor, or theophylline), or documented intolerance to another controller, for at least 6 months prior to the screening visit. For a fixed-dose ICS/LABA preparation, the highest labeled dose in that region will satisfy this criterion. For patients 12 through <18years of age, the ICS dose must be maior or equal 440 µg/day of fluticasone propionate or equivalent daily. Note: the dose and regimen of asthma controllers and any allergen immunotherapy should have been stable during the 30 days prior to signing the Informed Assent Form/Informed Consent Form (ICF).
    f. The patient has FEV1 reversibility of at least 12% and an absolute change of at least 200 mL after administration of inhaled SABA according to the standard American Thoracic Society (ATS) or European Respiratory Society (ERS) protocol. Given the refractory nature of the disease in this population and the influence of high background controller medications on reversibility testing, documented FEV1 reversibility of 12% or a provocation concentration producing a 20% fall in FEV1 for methacholine of minor or equal to 8 mg/mL within 24 months of the screening visit, and performed according to the standard ATS/ERS procedures, would fulfill this criterion.
    g. Females of childbearing potential (not surgically sterile or 2 years postmenopausal) must have exclusively same-sex partners or use medically acceptable methods of birth control and must agree to continue use of this method for the duration of the study and for 5 months after the last study drug dose. Acceptable methods of birth control include intrauterine device, systemic hormonal contraceptive (oral, implanted, transdermal, or injected), barrier method with spermicide, abstinence, and partner vasectomy.
    h. The patient must be willing and able to comply with study restrictions, willing and able to perform requisite procedures and to remain at the clinic for the required duration during the study period, and willing to return to the clinic for the follow up evaluation as specified in this protocol.
    i. Except for the OCS, which will be adjusted per protocol, the patient must maintain his/her usual asthma controller regimen without change throughout the screening, optimization, run-in, and treatment periods.
    Únicamente podrán participar en el estudio los pacientes que cumplan todos los criterios de inclusión siguientes:
    a. El paciente es un varón o una mujer, de 12 o más años de edad, con diagnóstico previo de asma. En Corea del Sur y Argentina no podrán participar en el estudio pacientes de 12 a < 18 años de edad y en
    Corea del Sur tampoco podrán participar pacientes de 66 o más años de edad.
    b. Se ha obtenido el consentimiento informado por escrito. Los pacientes entre 12 y <18 años de edad deben dar su asentimiento, y sus padres o tutores legales deben dar su consentimiento.
    c. El paciente sigue necesitando una dosis diaria media de mantenimiento de CCO o equivalente para el asma de entre 5 y 40 mg durante los 3 meses previos a la selección. Podrán participar también
    pacientes con una dosis de CCO > 40 mg en la selección cuando el investigador considere que podrán reducir la dosis de CCO a ? 40 mg durante el período de optimización. Nota: se permite la
    administración en días alternos siempre que se alcance esa dosis diaria media (es decir, entre 10 y 80 mg).
    d. El paciente tiene una concentración documentada de eosinófilos en sangre de al menos 300/µL durante los 12 meses previos con la administración de al menos la dosis media de corticosteroides inhalados
    (CCI) (por ejemplo, ?440 ?g/día de propionato de fluticasona o equivalente diario), o ?300/µL en laselección durante el tratamiento crónico con CCO, o que se manifiesta por primera vez durante el
    período de optimización de CCO o en la visita de la semana -2 (final del período de optimización/inicio del período de preinclusión).
    e. El paciente ha necesitado al menos 880 ?g de propionato de fluticasona inhalado o un equivalente diario MÁS otro(s) medicamento(s) para el control del asma (como agonista beta de acción prolongada
    [ABAP], antagonista antimuscarínico de acción prolongada, inhibidor de leucotrienos o teofilina), o intolerancia documentada a otro medicamento para el control del asma, desde por lo menos 6 meses
    antes de la visita de selección. En el caso de un preparado que combine CCI/ABAP en dosis fijas, la dosis más alta aprobada en la región en cuestión cumplirá este criterio. En los pacientes de 12 a < 18 años de edad, la dosis de CCI debe ser ?440 ?g/día de propionato de fluticasona o el equivalente diario. Nota: la dosis y la pauta de medicamentos utilizados para el control del asma y de cualquier inmunoterapia con alergenos deberán mantenerse estables desde 30 días antes de la firma del documento de asentimiento/consentimiento informado (DCI).
    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). Dada la naturaleza resistente de la enfermedad en esta población y la influencia
    de la medicación de base utilizada anteriormente para el control del asma en la prueba de la reversibilidad, este criterio se cumplirá con una reversibilidad documentada del FEV1 del 12 % o una
    disminución del 20 % en el FEV1 con una concentración de provocación para la metacolina de ?8 mg/ml en los 24 meses previos a la visita de selección y realizada conforme a los procedimientos
    normalizados de ATS/ERS.
    g. Las mujeres con capacidad de procrear (que no se hayan esterilizado quirúrgicamente o que no lleven dos años de posmenopausia) deberá tener exclusivamente parejas del mismo sexo o utilizar métodos
    anticonceptivos que sea médicamente aceptables, 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 hormonales sistémicos (orales, implantados, transdérmicos o inyectados), un método de barrera con espermicida, abstinencia y vasectomía de la pareja.
    h. 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 según se especifica en este protocolo.
    i. A excepción del CCO, que se ajustará como se indica en el protocolo, el paciente debe mantener su tratamiento habitual para el control del asma sin cambios durante los períodos de selección,
    optimización, preinclusión y tratamiento.
    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 and interpretation of efficacy results or would 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 [also known as Churg-Strauss syndrome], or allergic bronchopulmonary aspergillosis).
    c. The patient has a known hypereosinophilic syndrome.
    d. The patient has a history of any malignancy within 5 years of the screening visit, except for treated and cured non-melanoma skin cancers.
    e. The patient is pregnant or intends to become pregnant during the study or is a lactating woman. Any woman becoming pregnant will be withdrawn from the study.
    f. The patient required treatment for an asthma exacerbation within 4 weeks of screening.
    g. The patient is a current smoker (ie, has smoked within the last 6 months prior to screening) or has a smoking history maior or equal 10 pack-years.
    h. The patient is currently using any systemic immunosuppressive or immunomodulatory biologic (eg, anti immunoglobulin E monoclonal antibody [mAb] or other mAb [eg, mepolizumab] or soluble receptor) or non-biologic (eg, methotrexate, cyclosporine), except maintenance OCS for the treatment of asthma. Previous use of such agents that occurred >5 half-lives from the screening visit may be allowed, if approved by the medical monitor.
    i. The patient participated in a clinical study 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 immunodeficiency disorder including human immunodeficiency virus.
    m. The patient has current suspected drug and/or alcohol abuse.
    n. The patient has had an active helminthic parasitic infection or was treated for one within 6 months of screening.
    o. The patient has a history of allergic reactions 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.)
    No podrán participar en este estudio los pacientes que cumplan cualquiera de los criterios
    a. El paciente tiene un trastorno médico clínicamente significativo no controlado (tratado o no tratado) que podría interferir con el calendario o los procedimientos del estudio y con la interpretación de los resultados de la eficacia, o que podría comprometer la seguridad del paciente.
    b. El paciente tiene otro trastorno pulmonar subyacente que puede confundir (p. ej., enfermedad pulmonar obstructiva crónica, enfermedad pulmonar intersticial, bronquiectasia, granulomatosis eosinofílica con poliangiitis [también conocido como síndrome de Churg-Strauss], o aspergilosis broncopulmonar alérgica [ABPA]).
    c. El paciente presenta un síndrome hipereosinófilo conocido.
    d. El paciente tiene antecedentes 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 o que pretende quedarse embarazada durante el estudio, o está en período de lactancia. Se retirará del estudio a todas las mujeres que se queden embarazadas.
    f. El paciente precisa tratamiento por una exacerbación del asma durante las 4 semanas de la selección.
    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 que 10 paquetes año.
    h. El paciente está usando actualmente algún tratamiento inmunosupresor o inmunomodulador sistémico con un
    producto biológico (por ejemplo, anticuerpo monoclonal [AmC] contra la inmunoglobulina E u otros AmC [como mepolizumab] o receptores solubles) o no biológico (por ejemplo, metotrexato o ciclosporina),
    excepto CCO de mantenimiento para el tratamiento del asma. Nota: Se permitirá el uso previo de esos fármacos desde >5 semividas antes de la visita de selección, siempre que así lo apruebe el monitor médico.
    i. El paciente ha participado en un estudio clínico en los 30 días o 5 semividas del fármaco de investigación anteriores a 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 el virus de la
    inmunodeficiencia humana.
    m. El paciente presenta actualmente o se sospecha que presenta un problema de abuso de drogas o alcohol.
    n. El paciente ha presentado 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 reacciones alérgicas 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 variable and endpoint for this study is the categorized percent reduction in the daily OCS dose during weeks 20 to 24 as compared with the dose at the end of the optimization phase. Percent reduction will be categorized as follows:
    - 90% to 100%
    - 75% to <90%
    - 50% to <75%
    - >0% to <50%
    - No decrease in OCS, or loss of baseline asthma control during weeks 20 through 24, or discontinuation from study drug
    Loss of baseline asthma control will be defined as FEV1 value of less than 80% of baseline at the week 24 visit, or clinically significant worsening in ACQ-6 score (change in score of 0.5) at the week 24 visit compared with baseline, and/or clinical asthma exacerbation during weeks 20 through 24.
    La variable y el criterio de valoración principal de la eficacia en este estudio es la reducción porcentual de la dosis diaria de CCO durante las semanas 20 a 24 frente a la dosis administrada al final de la fase de optimización.La reducción porcentual se
    clasificará de la forma siguiente:
    - entre el 90 % y el 100 %
    - entre el 75 % y <90 %
    - entre el 50 % y <75 %
    - entre >0 % y <50 %
    - sin reducción de la dosis de CCO, o pérdida del control basal del asma durante las semanas 20 a 24 o interrupción del tratamiento con el fármaco del estudio
    La pérdida del control basal del asma se definirá como un valor del FEV1 inferior al 80 % del valor basal en la visita de la semana 24, o un empeoramiento clínicamente significativo de la puntuación obtenida en el Cuestionario sobre el control del asma (ACQ)-6 (variación de la
    puntuación de 0,5) en la visita de la semana 24, en comparación con el momento basal, y/o exacerbación clínica del asma (según se define en la sección 6.7) durante las semanas 20 a 24).
    E.5.1.1Timepoint(s) of evaluation of this end point
    during the 20-24-week treatment period
    Durante el periodo de tratamiento entre las semanas 20-24
    E.5.2Secondary end point(s)
    The secondary efficacy endpoints are as follows:
    - Proportion of patients achieving ?50% reduction in OCS dose at eeks 20 to 24 relative to the OCS dose at DoR/baseline, while maintaining asthma control
    - Proportion of patients achieving dose reduction to ?5 mg daily dose at weeks 20 to 24, while maintaining asthma control
    - Percent change from DoR/baseline in OCS dose at weeks 20 to 24
    - Proportion of patients achieving less than 5 mg decrement in OCS dose (ie, the minimal and non-responders) at weeks 20 to 24 compared with the OCS dose at DoR/baseline, while maintaining asthma control
    - Clinical asthma exacerbation related:
    - Annualized rate of clinical asthma exacerbations requiring a burst of systemic corticosteroid (injection, or if oral, at least a doubling from the current OCS dose for at least 3 days); an asthma-specific hospital admission; or an asthma-specific emergency department visit during the treatment period (weeks 0 to 24)
    - Proportion of patients discontinuing OCS at weeks 20 to 24, while maintaining asthma control
    Los criterios de valoración secundarios de la eficacia de este estudio son:
    - Proporción de pacientes que logran una reducción ?50 % en la dosis de CCO entre las semanas 20 y 24 en relación con la dosis de CCO en el día de la aleatorización (DdA)/momento basal, con mantenimiento del control del asma
    - Proporción de pacientes que logran una reducción de la dosis a ?5 mg diarios entre las semanas 20 y 24, con mantenimiento del control del asma
    - Variación porcentual de la dosis de CCO con respecto al DdA/momento basal entre las semanas 20 y 24
    - Proporción de pacientes que logran una reducción inferior a 5 mg en la dosis de CCO (esto es, respuesta mínima o ausencia de respuesta) entre las semanas 20 y 24 en comparación con la dosis de CCO en el DdA/momento basal, con mantenimiento del control del asma
    - Relacionados con la exacerbación clínica del asma:
    - Tasa anualizada de exacerbaciones clínicas del asma que precisan tratamiento agudo con corticosteroides sistémicos (inyectables o, si son orales, al menos el doble de la dosis de CCO que ya esté recibiendo durante un mínimo de 3 días); hospitalización específicamente por asma; o visita a un servicio de urgencias específicamente por asma durante el período de tratamiento (entre las semanas 0 y 24)
    - Proporción de pacientes que suspenden la administración de CCO entre las semanas 20 y 24, con mantenimiento del control del asma
    E.5.2.1Timepoint(s) of evaluation of this end point
    during the 24-week treatment period.
    durante el periodo de tratamiento en la semana 24
    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 EEA51
    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, Democratic People's Republic of
    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 (approximately week 24). LSLV late follow up, for immunogenicity testing only, will be performed after the treatment period (approximately week 48). 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 sujeto (UVUS) se define como el final del tratamiento (aproximadamente en la semana 24). Se realizará un seguimiento tardío en la UVUS únicamente para pruebas de inmunogenicidad después del período de tratamiento (aproximadamente en la semana 48). 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 years2
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months0
    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: 8
    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: 8
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 129
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 15
    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 state12
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 57
    F.4.2.2In the whole clinical trial 152
    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 Decision2015-11-24
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-11-11
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2017-12-04
    For support, Contact us.
    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
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

    European Medicines Agency © 1995-2023 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands