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    Summary
    EudraCT Number:2014-004223-46
    Sponsor's Protocol Code Number:SL75.14
    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:2015-08-25
    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 number2014-004223-46
    A.3Full title of the trial
    A randomized, double-blind, placebo-controlled, multi-center study of the efficacy and safety of STG320 sublingual tablets of house dust mite (HDM) allergen extracts in adults and adolescents with HDM-associated allergic rhinitis
    Estudio multicéntrico, aleatorizado, doble ciego y controlado con placebo para
    evaluar la eficacia y seguridad de los comprimidos sublinguales STG320 de extractos alergénicos del ácaro del polvo doméstico en adultos y adolescentes con rinitis alérgica a los ácaros del polvo doméstico.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Efficacy and safety study evaluating a new sublingual treatment in HDM allergic rhinitis
    Estudio para evaluar la eficacia y seguridad de un nuevo tratamiento sublingual en
    rinitis alérgica a los acaros de polvol polvo domestico
    A.4.1Sponsor's protocol code numberSL75.14
    A.5.4Other Identifiers
    Name:16252Number:IND Number
    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 SponsorStallergenes S.A.
    B.1.3.4CountryFrance
    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 supportStallergenes S.A.
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationStallergenes S.A.
    B.5.2Functional name of contact pointRegulatory Affairs
    B.5.3 Address:
    B.5.3.1Street Address6 rue Alexis de Tocqueville
    B.5.3.2Town/ cityAntony Cedex
    B.5.3.3Post code93183
    B.5.3.4CountryFrance
    B.5.4Telephone number0033155592875
    B.5.5Fax number0033155590358
    B.5.6E-mailcsegond@stallergenes.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 Yes
    D.2.1.1.2Name of the Marketing Authorisation holderShionogi Co., Ltd
    D.2.1.2Country which granted the Marketing AuthorisationJapan
    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 nameHouse dust mite allergen extracts
    D.3.2Product code STG320
    D.3.4Pharmaceutical form Sublingual tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSublingual use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNDermatophagoides pteronyssinus allergen extract
    D.3.9.3Other descriptive nameDERMATOPHAGOIDES PTERONYSSINUS EXTRACT
    D.3.9.4EV Substance CodeSUB84531
    D.3.10 Strength
    D.3.10.1Concentration unit BAU Bioequivalent Allergy Unit(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number50
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNDermatophagoides farinae allergen extract
    D.3.9.3Other descriptive nameDERMATOPHAGOIDES FARINAE EXTRACT
    D.3.9.4EV Substance CodeSUB84530
    D.3.10 Strength
    D.3.10.1Concentration unit BAU Bioequivalent Allergy Unit(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number50
    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) Yes
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    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.IMP: 2
    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 Yes
    D.2.1.1.2Name of the Marketing Authorisation holderShionogi Co., Ltd
    D.2.1.2Country which granted the Marketing AuthorisationJapan
    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 nameHouse dust mite allergen extracts
    D.3.2Product code STG320
    D.3.4Pharmaceutical form Sublingual tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSublingual use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNDermatophagoides pteronyssinus allergen extract
    D.3.9.3Other descriptive nameDERMATOPHAGOIDES PTERONYSSINUS EXTRACT
    D.3.9.4EV Substance CodeSUB84531
    D.3.10 Strength
    D.3.10.1Concentration unit BAU Bioequivalent Allergy Unit(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number150
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNDermatophagoides farinae allergen extract
    D.3.9.3Other descriptive nameDERMATOPHAGOIDES FARINAE EXTRACT
    D.3.9.4EV Substance CodeSUB84530
    D.3.10 Strength
    D.3.10.1Concentration unit BAU Bioequivalent Allergy Unit(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number150
    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) Yes
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    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 placeboSublingual tablet
    D.8.4Route of administration of the placeboSublingual use
    D.8 Placebo: 2
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboSublingual tablet
    D.8.4Route of administration of the placeboSublingual use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    House dust mite allergic rhinitis
    Rinitis alergica al polvo domestico
    E.1.1.1Medical condition in easily understood language
    Allergic rhinitis due to house dust mite
    Rinitis alérgica debido a acaros del polvo domestico
    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 LLT
    E.1.2Classification code 10001725
    E.1.2Term Allergic rhinitis due to other allergen
    E.1.2System Organ Class 100000004855
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To evaluate the efficacy of STG320 sublingual tablets at a daily dosage of 300 IR when administered for 12 months to adults and adolescents with HDM-associated allergic rhinitis.
    Evaluar la eficacia de los comprimidos sublinguales STG320 a una dosis diaria de
    300 IR administrados durante 12 meses a adultos y adolescentes con RA asociada
    a los ácaros del polvo doméstico.
    E.2.2Secondary objectives of the trial
    - To assess the efficacy of STG320 sublingual tablets at dosage of 300 IR
    - Rhinoconjunctivitis symptom evaluation and rescue medication use will also be evaluated during the 2-week secondary evalutation period
    - To assess the effect of STG320 on other variables at the end of treatment (work productivity and activity impairment, immunological markers)
    -Evaluar la eficacia de los comprimidos sublinguales STG320 a una dosis de 300 IR
    -La evaluación de los síntomas de rinoconjuntivitis y del uso de medicación de
    rescate también se valorará durante los periodos de evaluación secundaria de 2
    semanas.
    -Evaluar el efecto de STG320 sobre otras variables al finalizar el tratamiento (a productividad del trabajo y el deterioro actividad, marcadores inmunológicos)
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Have house dust mite (HDM)-associated allergic rhinitis (AR) (with or without asthma) for at least 1 year based on the presence of:
    ? Symptoms for 4 or more consecutive weeks in the previous year and for at least 4 days per week during those weeks.
    ? Symptoms requiring regular intake of symptomatic treatment(s).
    ? Symptoms evaluated as ?troublesome? by the patients or impairing their daily activities, leisure or sport, school or work or involving sleep disturbance.
    2. Have given signed informed consent to participate, after having been informed of the nature and aims of the study, in accordance with local regulation and requirements.
    3. Male or female outpatients 12 to 65 years of age.
    4. Sensitized to D. pteronyssinus (D. pte) and/or D. farinae (D. far) defined as skin prick test wheal diameter at least 5 mm greater than the negative control and HDM-specific serum IgE ?3.5 kU/L.
    5. Willing to and capable of completing the e-diary, study questionnaires and scales.
    1. Padecer rinitis alérgica (RA) a los ácaros del polvo doméstico (con o sin asma)
    durante al menos 1 año basándose en la presencia de: ? Síntomas durante 4
    semanas consecutivas o más en el año anterior y durante al menos 4 días por
    semana esas semanas. ? Síntomas que requieran el consumo habitual de uno o
    varios tratamientos sintomáticos. ? Síntomas evaluados como ?molestos? por los
    pacientes o que afecten a sus actividades cotidianas, de ocio o deporte, escolares
    o laborales, o que impliquen trastornos del sueño. 2. Haber firmado un
    consentimiento informado para participar, después de haber sido informado de la
    naturaleza y los objetivos del estudio, conforme a las normativas y requisitos
    locales. 3. Pacientes ambulatorios de ambos sexos de 12 a 65 años de edad. 4.
    Presentar sensibilización a D. pteronyssinus (D. pte) o D. farinae (D. far)
    determinada por una prueba de punción cutánea cuyo resultado sean habones de
    un diámetro al menos 5 mm mayor a los producidos en el control negativo y una
    IgE específica en suero frente a los ácaros del polvo doméstico ? 3,5 kU/l. 5. Estar
    dispuesto y poder completar el diario electrónico, los cuestionarios del estudio y las
    escalas.
    E.4Principal exclusion criteria
    1. A history of rhinitis, rhino-conjunctivitis or asthma to allergens other than HDM, likely to result in rhinitis symptoms during the baseline and primary evaluation periods (i.e., 4 weeks of evaluation between September and January).
    Specifically, when the following are present:
    ? documented sensitization (positive Skin Prick Test or allergen specific serum IgE >3.5kU/L) and history of clinically relevant symptoms to allergen(s) other than HDM
    ? anticipated exposure to such allergen(s) during the baseline and primary evaluation periods (i.e., the 4 weeks of evaluation between September and January)
    For example, the following patients are to be excluded:
    - patients sensitized to cat or dog allergens and regularly exposed to these animals
    - patients sensitized to perennial allergens, such as aspergillus, cladosporium, alternaria, cockroach
    - patients sensitized to seasonal allergens such as parietaria, ragweed or mugwort, if these allergens are endemic in the region during the baseline and primary evaluation periods.
    2. Any diagnosed nasal (other than HDM allergic rhinitis) or oral disease that could interfere with the efficacy or safety assessments, such as nasal polyposis, recurrent chronic rhino-sinusitis (at least 2 isolated episodes per year in the 2 previous years, each episode lasting more than 8 weeks) or a history of chronic oral inflammation or current active oral inflammation from any etiology (e.g., oral lichen planus, oral ulceration or oral mycosis) and/or oral wounds.
    3. Recent nasal surgery (i.e., within the previous 6 months).
    4. Partially controlled or uncontrolled asthma defined in the Global Initiative for Asthma 2014 guidelines (GINA 2014) as the presence of daytime asthma symptoms more than twice/week or nocturnal symptoms/awakening or need for reliever/rescue treatment more than twice/week or FEV1 <80% of predicted or personal best value.
    5. Asthma therapies consistent with GINA treatment Step 3, Step 4 and Step 5 i.e., the preferred controller medication consists of inhaled corticosteroid (ICS) combined with long-acting beta (?)-2 agonist (LABA) according to GINA classification 2014 (refer to Appendix II for the full details of other controller options).
    6. Experienced a life-threatening asthma attack or an asthma exacerbation that resulted in Intensive Care Unit (ICU) hospitalization.
    7. Requiring continuous treatment with systemic corticosteroids for any indication.
    8. Requiring continuous treatment with ?-blockers or with Monoamine Oxidase Inhibitors (MAOIs).
    9. Received an immunosuppressive treatment within 3 months prior to screening.
    10. Received allergen specific immunotherapy (AIT) by any route:
    - for house dust mites: AIT for more than 1 month within the 5 years before screening
    - for other allergen(s): ongoing or recently stopped (within 6 months) AIT.
    11. Any history of anaphylaxis after previous allergen immunotherapy, exposure to allergen(s) or of unknown cause.
    12. Any history of hypersensitivity to STG320 or its excipients or contraindication to the use of rescue medications
    13. Female with positive urine pregnancy test or lactating or expecting to conceive within the duration of the study.
    14. Sexually active female of child-bearing potential without medically accepted contraceptive method
    15. Unable or unwilling to comply with the study protocol requirements, including those who anticipate significant changes in their daily environment in relation to HDM exposure or who are likely to travel for extended periods of time during the main efficacy assessment period.
    16. Patients with past or current disease(s) which, as judged by the Investigator, may affect the patient?s participation in or the outcome of this study. These diseases include, but are not limited to, cardiovascular disease, malignancy, active tuberculosis, hepatic disease, renal disease, hematologic disease, neurologic or psychiatric disease, severe autoimmune disorder, immunodeficiency or immunologic disease and endocrine disease.
    17. Patients with a history of eosinophilic esophagitis or with current severe or persistent gastroesophageal symptoms including dysphagia or chest pain.
    18. Contraindications to allergen specific immunotherapy.
    19. Patients with history of drug or alcohol abuse.
    20. Participation in any clinical study within 30 days prior to the selection visit.
    21. Possible dependency of the patient on sponsor or investigators/subinvestigators or study personnel.
    1.-Antecedentes de rinitis, rinoconjuntivitis o asma a alérgenos distintos de los ácaros del polvo doméstico, con probabilidades de producir síntomas de rinitis durante los periodos de evaluación inicial y principal (es decir, las 4 semanas de evaluación,entre septiembre y enero). En concreto, cuando presente lo siguiente: sensibilización documentada (prueba de punción cutánea positiva [diámetro del habón al menos 5 mm mayor que el control negativo] o IgE específica en suero frente al alérgeno > 3,5kU/l) y antecedentes de síntomas clínicamente relevantes a alérgeno(s) distinto(s) a los ácaros del polvo doméstico; ? exposición prevista a dicho(s) alérgeno(s) durante los periodos de evaluación inicial y principal (es decir, las 4 semanas de evaluación entre septiembre y enero). Por ejemplo, deben ser excluidos los siguientes pacientes: - pacientes sensibilizados a los alérgenos de gato o perro y que estén habitualmente expuestos a estos animales; - pacientes sensibilizados a alérgenos perennes, tales como aspergillus, cladosporium, alternaria o cucaracha; - pacientes sensibilizados a alérgenos estacionales, tales
    como parietaria, ambrosía o artemisa, si estos alérgenos son endémicos en la
    región durante los periodos de evaluación inicial y principal.
    2. Cualquier enfermedad nasal (excepto la rinitis alérgica asociada a los ácaros del polvo doméstico) o bucal diagnosticada que pueda obstaculizar las evaluaciones de eficacia o seguridad, como, por ejemplo, la poliposis nasal, la rinosinusitis crónica recurrente (al menos 2 episodios aislados por año en los 2 años anteriores, y que cada episodio durase más de 8 semanas) o antecedentes de inflamación bucal crónica o actualmente activa de cualquier etiología (p. ej., liquen plano oral, ulceración bucal o micosis bucal) o heridas bucales. 3. Cirugía nasal reciente (es decir, en los 6 meses previos).
    4. Asma parcialmente controlada o no controlada definida en las directrices 2014 de la Iniciativa Global para el Asma (GINA 2014)
    como la presencia de síntomas diurnos de asma más de dos veces por semana, síntomas nocturnos/despertares o necesidad de tratamiento calmante/de rescate más de dos veces por semana o VEF1 < 80 % del mejor valor previsto o personal.
    5. Terapias de tratamiento del asma GINA que consisten en el paso 3, los pasos 4 y 5, es decir, el medicamento de control preferido que consiste en corticosteroides inhalados (ICS) en combinación con Agonista Beta (?)2 de acción prolongada (LABA) según la clasificación GINA de 2014 (consulte Apéndice II para los detalles completos de otras opciones del controlador.
    6. Haber sufrido una crisis asmática o una reagudización del asma potencialmente mortales que provocasen su hospitalización en la unidad de
    cuidados intensivos (UCI). 7. Requerir tratamiento continuo con corticoesteroides
    sistémicos para cualquier indicación. 8. Requerir tratamiento continuo con
    ?-bloqueantes o con inhibidores de la monoaminooxidasa (IMAO). 9. Haber recibido un tratamiento inmunodepresor en los 3 meses previos a la selección. 10. Haber recibido inmunoterapia específica con alérgenos (ITA) por cualquier vía: - para los ácaros del polvo doméstico: ITA durante más de un mes en los 5 años anteriores a la selección; - para otro(s) alérgeno(s): ITA en curso o interrumpida recientemente (hace menos de 6 meses). 11. Cualquier antecedente de anafilaxia tras la inmunoterapia con alérgenos previa, exposición a alérgeno(s) o de causa desconocida. 12. Antecedentes de hipersensibilidad al STG320 o a sus excipientes o contraindicaciones de uso de medicamentos de rescate (es decir, antihistamínicos y corticoesteroides). 13. Mujer con prueba de embarazo en orina positiva, en periodo de lactancia o que espera concebir durante el transcurso del estudio. (por favor ver el protocolo)
    E.5 End points
    E.5.1Primary end point(s)
    Total Combined Score (TCS). The average TCS is calculated for each patient as the average of the non-missing daily TCSs.
    The daily TCS (scale 0-15) is the sum of the patient?s daily Rhinitis Total Symptom Score (RTSS, scale 0-12) and daily Rescue Medication Score (RMS, scale 0-3).
    Puntuación combinada total (TCS). La TCS promedio se calcula para cada paciente
    como el promedio de las TCS diarias disponibles. La TCS diaria (escala 0-15) es la
    suma de la puntuación total de los síntomas de rinitis (RTSS, escala 0-12) y de la
    puntuación de la medicación de rescate (RMS, escala 0-3) diarias del paciente.
    E.5.1.1Timepoint(s) of evaluation of this end point
    All along the study
    A lo largo del estudio
    E.5.2Secondary end point(s)
    Rhinitis Total Symptom Score (RTSS)
    Rescue Medication Score (RMS)
    Adjusted Symptom Score (ASS, scale 0-12)
    Total Ocular Symptom Score (TOSS, scale 0-6)
    Six Individual Rhinoconjunctivitis Symptom Scores (RSSs)
    Rhinoconjunctivitis rescue medication usage
    Visual Analogue Scale (VAS)
    Proportion of Symptom-Controlled Days (PSCD)
    Controlled patients (CP)
    Overall Standardized Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ(S)?12) scores
    EQ-5D-5L Generic health-related quality of life questionnaire
    Global Rating of Change Score (GRCS)
    Puntuación total de los síntomas de rinitis (RTSS)
    Puntuación de la medicación de rescate (RMS)
    Puntuación total de los síntomas de rinitis (RTSS, escala 0-12). Puntuación total de los síntomas oculares (TOSS, escala 0-6).
    Cada una de las seis puntuaciones de los síntomas de rinoconjuntivitis (RSS).
    Uso de medicación de rescate de rinoconjuntivitis.
    Escala visual análogica(EVA)
    Porcentaje de días con síntomas controlados (PSCD).
    Pacientes controlados (PC).
    Cuestionario de calidad de vida para pacientes con rinoconjuntivitis (RQLQ(S)?12)
    Cuestionario de salud EQ-5D-5L

    Puntuación de la escala de percepción de mejoría (GRCS)
    E.5.2.1Timepoint(s) of evaluation of this end point
    All along the study
    A lo largo del estudio
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy No
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) 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 concerned15
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA100
    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
    Bulgaria
    Canada
    Czech Republic
    France
    Germany
    Israel
    Italy
    Poland
    Russian Federation
    Slovakia
    Spain
    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 Visit of the Last Patient
    Ultima visita del ultimo paciente
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months8
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months8
    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: 100
    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: 100
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 890
    F.1.3Elderly (>=65 years) No
    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 state70
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 660
    F.4.2.2In the whole clinical trial 990
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    None
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2015-10-26
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-10-15
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2018-06-21
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