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    Summary
    EudraCT Number:2016-004661-23
    Sponsor's Protocol Code Number:C38072-AS-30066
    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:2017-03-10
    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 number2016-004661-23
    A.3Full title of the trial
    An Open-Label Extension Study of Reslizumab 110-mg Fixed, Subcutaneous Dosing in Patients 12 Years of Age and Older with Severe Eosinophilic Asthma
    Estudio de extensión abierto en una dosis fija de 110 mg de reslizumab, administrada por vía subcutánea en pacientes de 12 años o más con asma eosinofílica grave
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Study of Reslizumab Subcutaneous Dosing in Patients 12 Years of Age and Older with Severe Eosinophilic Asthma
    Estudio de reslizumab, administrado por vía subcutánea en pacientes de 12 años o más con asma eosinofílica grave
    A.4.1Sponsor's protocol code numberC38072-AS-30066
    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 pointVanessa Miranda
    B.5.3 Address:
    B.5.3.1Street Address929 N.Front Street
    B.5.3.2Town/ cityWilmington, NC
    B.5.3.3Post code28401
    B.5.3.4CountryUnited States
    B.5.4Telephone number+34900834223
    B.5.6E-mailRegistroEspanolDeEstudiosClinicos@druginfo.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 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.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
    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 grave y fenotipo eosinofílico.
    E.1.1.1Medical condition in easily understood language
    Asthma
    Asma
    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 19.1
    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 support the long-term safety of reslizumab 110 mg administered sc once every 4 weeks in patients 12 years of age and older with severe eosinophilic asthma whose asthma is inadequately controlled on standard-of-care treatment.
    El objetivo principal de este estudio es respaldar la seguridad a largo plazo de reslizumab 110 mg administrado por vía SC cada 4 semanas en pacientes de 12 años de edad o más con asma eosinofílica grave insuficientemente controlada con el tratamiento convencional
    E.2.2Secondary objectives of the trial
    The secondary objective of this study is to evaluate the efficacy of reslizumab 110 mg administered sc once every 4 weeks in patients 12 years of age and older with severe eosinophilic asthma that is inadequately controlled on standard-of-care treatment.
    El objetivo secundario de este estudio es evaluar la eficacia de reslizumab 110 mg administrado por vía SC cada 4 semanas en pacientes de 12 años de edad o más con asma eosinofílica grave insuficientemente controlada con el tratamiento convencional.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Patients may only be included in the study 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. Male or female patient 12 years or older with eosinophilic asthma who was previously randomized and completed the treatment period in either of the double-blind, placebocontrolled studies (Study 30025 or 30027) for sc reslizumab and who by the assessment of the Principal Investigator can safely participate in this study.

    Adolescents from Study 30025 must also complete the early follow-up visit before being eligible for this study.

    c. Unless surgically sterile or postmenopausal, female patients must have a negative urine pregnancy test at baseline. Definitions of sterile and postmenopausal are given in Protocol Appendix E.

    d. Females of childbearing potential (not surgically sterile or postmenopausal) must have an exclusively same-sex partner or use a medically acceptable method of contraception and must agree to continue the use of this method for the duration of the study and for 5 months after discontinuation of the study drug. Acceptable methods of contraception include intrauterine device, steroidal contraceptive (oral, implanted, transdermal, or injected), barrier method with spermicide, abstinence, bilateral tubal occlusion, and partner vasectomy.

    e. The patient must be willing and able to comply with study restrictions and willing to return to the investigational center for the follow-up procedures and assessments as specified in this protocol.
    Los pacientes podrán participar en el estudio solo si cumplen todos los criterios de inclusión siguientes:
    a. Se ha obtenido el consentimiento informado por escrito. Los pacientes entre 12 y <18 años de edad deberán dar su asentimiento, y sus padres o tutores legales deberán dar su consentimiento.
    b. Paciente hombre o mujer, de 12 años de edad o más, con asma eosinofílica, que haya sido aleatorizado y completado el período de tratamiento en uno de los estudios doble ciego y controlados con placebo de reslizumab SC (estudio 30025 o 30027), y que pueda participar de forma segura en este estudio según la evaluación del investigador principal.
    Los adolescentes del estudio 30025 deberán haber completado también la visita de seguimiento temprano para poder participar en este estudio.
    c. Salvo si son posmenopáusicas o quirúrgicamente estériles, las pacientes mujeres deberán tener un resultado negativo en una prueba de embarazo en orina en el momento basal. Las definiciones de posmenopáusica y estéril se recogen en el apéndice E del protocolo.
    d. Las mujeres con capacidad de procrear (no esterilizadas quirúrgicamente o que no sean posmenopáusicas) deberán tener exclusivamente una pareja del mismo sexo o utilizar un método anticonceptivo médicamente aceptable, y deberán comprometerse a seguir utilizando dicho método durante todo el tiempo que dure el estudio y hasta 5 meses después de la suspensión del fármaco del estudio. Los métodos anticonceptivos aceptables son dispositivo intrauterino, anticonceptivos esteroideos (orales, implantados, transdérmicos o inyectados), método de barrera con espermicida, abstinencia, oclusión de trompas bilateral y vasectomía de la pareja.
    e. El paciente ha de estar dispuesto y ser capaz de cumplir las restricciones del estudio y de acudir al centro para las evaluaciones y los procedimientos de seguimiento que se especifican en este protocolo.
    E.4Principal exclusion criteria
    Patients will be excluded from participating in this study if they meet any of the following criteria:

    a. Patient has received any intravenous or sc reslizumab administration in any previous clinical trial other than Studies 30025 and 30027.

    b. Patient withdrew early (discontinued from treatment) from either of the placebocontrolled reslizumab studies, Studies 30025 and 30027, for any reason.

    c. 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.

    d. 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).

    e. The patient has a known/diagnosed hypereosinophilic syndrome.

    f. The patient has a diagnosis of malignancy within 5 years of the screening visit, except for treated and cured non-melanoma skin cancers.

    g. The patient is a pregnant or lactating woman or intends to become pregnant during the study or within 5 months after the last dose of study drug. Administration of IMP will be discontinued for any female patient who becomes pregnant during the study.

    h. The patient required treatment for an asthma exacerbation within 4 weeks of screening or during the screening. (Note: This is required only in patients who did not rollover seamlessly from Study 30025 or 30027, ie, had a gap between placebo-controlled study
    EOT and screening for Study 30066 [including adolescents from Study 30025 who must also complete the early follow-up visit].)

    Patients who did not rollover seamlessly from Study 30025 or 30027 may be considered for rescreening if they are excluded from study participation for not satisfying this criterion. A patient may be rescreened for this reason 1 time only. The duration between
    the first visit during the screening period and the rescreening must be >30 days.

    i. The patient is a current smoker (ie, has smoked within the last 6 months before screening) or has a smoking history ≥10 pack-years.

    j. The patient is currently using any systemic immunosuppressive or immunomodulatory biologic (eg, anti-immunoglobulin E monoclonal antibody [mAb] or other mAb [eg, mepolizumab, benralizumab, dupilumab] or soluble receptors) or non-biologic (eg, methotrexate or cyclosporine), except maintenance oral corticosteroids for the treatment of asthma (up to and including 40 mg of prednisone daily or equivalent every-other-day dosing). Note: Previous use of such agents that occurred >5 half-lives from the initial screening visit may be allowed.

    k. The patient participated in a clinical study other than approved Teva reslizumab studies within 30 days or 5 half-lives of the investigational drug before screening, whichever is longer.

    l. The patient has a history of an immunodeficiency disorder including human immunodeficiency virus (HIV).

    m. The patient has current or suspected drug and/or 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 is expected to be poorly compliant with study procedures or visits.

    q. The patient is a vulnerable patient (eg, a patient who is or may be for any reason unable to take care of himself or herself, unable to protect himself or herself against significant harm or exploitation, or kept in detention).
    No podrán participar en este estudio los pacientes que cumplan cualquiera de los criterios siguientes:
    a. El paciente ha recibido reslizumab intravenoso o subcutáneo en un ensayo clínico previo diferente de los estudios 30025 y 30027.
    b. El paciente se retiró prematuramente (suspendió el tratamiento) de uno de los estudios doble ciego y controlados con placebo de reslizumab SC (estudio 30025 o 30027), por cualquier motivo.
    c. 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 la interpretación de los resultados de eficacia o que podría comprometer la seguridad del paciente.
    d. 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]).
    e. El paciente tiene un síndrome hipereosinófilo conocido/diagnosticado.
    f. El paciente ha tenido 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.
    g. El paciente es una mujer embarazada, en período de lactancia o que pretende quedarse embarazada durante el estudio o los 5 meses siguientes a la última dosis de fármaco del estudio. Se suspenderá la administración del MEI a las mujeres que se queden embarazadas durante el estudio.
    h. El paciente precisa tratamiento por una exacerbación del asma durante las 4 semanas previas a la selección o durante esta. (Nota: Esto se aplica solo a los pacientes no transferidos directamente desde los estudios 30025 o 30027, es decir, que hayan tenido una interrupción entre el FDE del estudio controlado con placebo y la selección para el estudio 30066 [incluidos los pacientes adolescentes del estudio 30025, que deberán haber completado también la visita de seguimiento temprano]).
    En los pacientes no transferidos directamente desde los estudios 30025 o 30027, podrá considerarse repetir el proceso de selección si son excluidos de la participación en este estudio por no cumplir este criterio Los pacientes podrán repetir el proceso de selección solo una vez. El intervalo entre la primera visita del período de selección y la repetición de la selección deberá ser > 30 días.
    i. El paciente es actualmente fumador (es decir, ha fumado en los 6 meses previos a la selección) o ha fumado en el pasado ≥ 10 paquetes-año.
    j. El paciente recibe actualmente un inmunosupresor o inmunomodulador sistémico biológico (p. ej., anticuerpo monoclonal [mAb] anti-inmunogloblina E u otro mAb [p. ej., mepolizumab, benralizumab, dupilumab] o receptores solubles) o no biológico (p. ej., metotrexato o ciclosporina), salvo corticosteroides orales de mantenimiento para el tratamiento del asma (hasta 40 mg diarios de prednisona o dosis equivalente en días alternos). Nota: Puede permitirse el uso previo de estos fármacos si tuvo lugar > 5 semividas antes de la visita de selección inicial.
    k. El paciente ha participado en un estudio clínico, aparte de los estudios de reslizumab de Teva aprobados, en los 30 días o 5 semividas del fármaco en investigación anteriores a la selección, lo que suponga más tiempo.
    l. El paciente tiene antecedentes de un trastorno de inmunodeficiencia, incluida la infección por el virus de la inmunodeficiencia humana (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. Se prevé que el paciente no cumplirá adecuadamente los procedimientos o visitas del estudio.
    q. El paciente está en situación de vulnerabilidad (p. ej., un paciente que por cualquier motivo sea o pueda ser incapaz de cuidar de sí mismo, incapaz de defenderse frente a daños importantes o explotación, o que esté bajo arresto).
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint is the frequency of adverse events including serious adverse events.
    El criterio de valoración principal es la frecuencia de acontecimientos adversos, incluidos acontecimientos adversos graves
    E.5.1.1Timepoint(s) of evaluation of this end point
    Patient counts and percentages will be provided for the frequency of patients with at least 1 adverse event.
    La frecuencia de pacientes con al menos 1 acontecimiento adverso se presentará por números de pacientes y porcentajes.
    E.5.2Secondary end point(s)
    The secondary safety endpoints for this study include the following:
    - clinical laboratory test results
     - hematology and chemistry results at baseline and at weeks 4 (chemistry only), 8, 24, and 36 or early withdrawal visit
    - local tolerability at the injection site at approximately 1 hour after study drug administration every 4 weeks throughout the study
    - vital signs measurements every 4 weeks throughout the study
    - concomitant medication usage every 4 weeks throughout the study

    The secondary efficacy endpoints for this study include the following:
    - clinical asthma exacerbation (CAE) and healthcare utilization (HCU)-related endpoints
     - frequency of CAEs
     - frequency of asthma-specific hospital admissions
     - length of hospital stay and number of ICU days
     - frequency of asthma-specific emergency department visits
     - frequency of school/work days missed due to asthma
    - change from baseline in pre-bronchodilator FEV1 measured using spirometry at weeks 0, 8, 24, and 36 or early withdrawal visit
    - change in daily morning ambulatory FEV1 from baseline at each week through week 36 or early withdrawal, as measured by the handheld spirometry device
    - absolute and percent reduction in the daily OCS dose at weeks 20 and 36 or early withdrawal visit as compared with the dose at baseline (for patients on daily OCS at baseline)
    - change from baseline in total inhalations of reliever bronchodilator medication (eg, short-acting beta-agonist) measured using weekly averages until week 36 or early withdrawal visit
    - change from baseline in ACQ-6 score performed at weeks 0, 8, 24, and 36 or early withdrawal visit
    - change from baseline in AQLQ12+ score performed at weeks 0, 8, 24, and 36 or early withdrawal visit
    Los criterios de valoración secundarios de la seguridad de este estudio son los siguientes:
    • Resultados de los análisis clínicos: resultados de hematología y bioquímica en el momento basal y en las semanas 4 (bioquímica solo), 8, 24 y 36 o en la visita de retirada prematura.
    • tolerabilidad local en el punto de inyección aproximadamente 1 hora después de la administración del fármaco del estudio, cada 4 semanas durante todo el estudio (véase la sección 7.8 del protocolo).)
    • mediciones de las constantes vitales cada 4 semanas durante todo el estudio.
    • uso de medicamentos concomitantes cada 4 semanas durante todo el estudio.
    Los criterios de valoración secundarios de la eficacia de este estudio son los siguientes:
    • exacerbación clínica del asma (ECA) criterios de valoración relacionados con la utilización de recursos sanitarios (URS).
    - frecuencia de ECA.
    - frecuencia de ingresos hospitalarios específicamente por asma.
    -duración de la estancia hospitalaria y número de días en la unidad de cuidados intensivos.
    - frecuencia de visitas a un servicio de urgencias específicamente por asma.
    -Frecuencia de días de absentismo escolar o laboral.
    • variación respecto al momento basal del volumen espiratorio forzado en 1 segundo (FEV1) antes del broncodilatador, medido mediante espirometría en las semanas 0, 8, 24 y 36 o en la visita de retirada prematura.
    • variación respecto al momento basal del FEV1 en consulta ambulatoria en cada semana hasta la semana 36 o en la visita de retirada prematura, medido con un dispositivo de espirometría manual.
    • reducción absoluta y porcentual de la dosis de corticosteroides orales (CO) en las semanas 20 y 36 o en la visita de retirada prematura, en comparación con la dosis basal (para pacientes en tratamiento con CO en el momento basal).
    • variación respecto al período basal del total de inhalaciones de medicamento broncodilatador para alivio de los síntomas (p. ej., agonistas beta de acción corta [ABAC]), determinada usando las medias semanales hasta la visita 36 o la visita de retirada prematura.
    • variación respecto al período basal de la puntuación en el cuestionario sobre el control del asma (ACQ-6) administrado en las semanas 0, 8, 24 y 36 o en la visita de retirada prematura.
    • variación respecto al período basal en la puntuación en el cuestionario de calidad de vida en el asma (AQLQ12+) administrado en las semanas 0, 8, 24 y 36 o en la visita de retirada prematura.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Secondary safety endpoints include clinical laboratory tests, local site reactions, vital signs measurements, and concomitant medication usage. Secondary efficacy endpoints include CAE and HCU-related events, change from baseline in pulmonary function tests, absolute and percent reduction in the daily OCS dose (for patients on daily OCS at baseline), change from baseline in total inhalations of reliever bronchodilator medication (eg, SABA), and change from baseline in patient-reported outcome questionnaires (ACQ-6 and AQLQ12+).
    Los criterios secundarios de valoración de la seguridad son los análisis clínicos, reacciones en el punto de inyección, mediciones de las constantes vitales y uso de medicamentos concomitantes. Los criterios secundarios de valoración de la eficacia son las ECA, los acontecimientos relacionados con el URS, la variación con respecto al momento basal de las pruebas de la función pulmonar, la reducción absoluta y porcentual de la dosis diaria de CO (en pacientes en tratamiento con CO orales en el momento basal), la variación respecto al momento basal de las inhalaciones de broncodilatador para alivio de los síntomas (p. ej., ABAC) y la variación respecto al momento basal en los cuestionarios de resultados comunicados por el paciente (ACQ-6 y AQLQ12+)
    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 Yes
    E.6.13.1Other scope of the trial description
    Immunogenicity
    Inmunogenicidad
    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 No
    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.8.3 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 EEA91
    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
    Belgium
    Canada
    Czech Republic
    France
    Germany
    Hungary
    Israel
    Poland
    Romania
    Russian Federation
    Spain
    Ukraine
    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 Patient Last Visit (LPLV) of the treatment period is defined as the EOT. The EOS visit for immunogenicity testing only will be performed 19 weeks (±2 weeks) after the final dose of study drug (approximately week 51). This will be considered the end of the trial for the purposes of end of trial notification
    Ultima Visita Ultimo Paciente (UVUP) del periodo de tratamient se define como FDE. El FDE para prueba de Inmonogenicidad solo se realizará en la semana 19 (±2 semanas ) después de la dosis del final de la medicación en estudio ( approx. semana 51). Esto será considerado FDE con el proposito de final de 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 days
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months0
    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: 25
    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.1.1.6.1Number of subjects for this age range: 25
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 320
    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 state6
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 276
    F.4.2.2In the whole clinical trial 360
    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)
    Patients should be treated with standard-of-care treatment after withdrawal from or withdrawal of the study, as appropriate.

    Patients will return to the care of their primary physician and/or asthma specialist after the end of this study.
    Los pacientes deben ser tratados con el tratamiento estándar de atención después de la retirada o la retirada del estudio, según corresponda.

    Los pacientes volverán al cuidado de su médico de cabecera y / o especialista en asma después del final de este 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 Decision2017-05-16
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-05-02
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2018-02-12
    As of 1.2.2020, the UK is no longer an EU Member State. However, EU law still applies to the UK during the transition period
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