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    Summary
    EudraCT Number:2015-002105-11
    Sponsor's Protocol Code Number:BTT-gpASIT009
    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:2015-07-31
    Trial 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 number2015-002105-11
    A.3Full title of the trial
    A multicenter, international, randomised, double-blind, placebo controlled study to demonstrate the clinical efficacy and safety of a subcutaneous immunotherapy with gpASIT+TM in patients with grass pollen-induced allergic rhinoconjunctivitis
    Un estudio internacional, multicéntrico, aleatorio, doble ciego y controlado por placebo para demostrar la eficacia y seguridad clínica de la inmunoterapia subcutánea con gpASIT+TM, en pacientes con rinoconjuntivitis alérgica inducida por polen de gramíneas
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A clinical study where patients will receive either a new medication (grass pollen -ASIT+TM of gpASIT+TM) either placebo (an inert substance) to treat patients with grass pollen-induced allergic rhinoconjunctivitis. Both products will administered in a subcutaneous way.
    A.3.2Name or abbreviated title of the trial where available
    BTT-gpASIT009_phase III
    A.4.1Sponsor's protocol code numberBTT-gpASIT009
    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 SponsorBioTech Tools S.A.
    B.1.3.4CountryBelgium
    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 supportBioTech Tools S.A.
    B.4.2CountryBelgium
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationBioTech Tools S.A.
    B.5.2Functional name of contact pointPirotton Sabine
    B.5.3 Address:
    B.5.3.1Street AddressAv. Ariane 5
    B.5.3.2Town/ cityBrussels
    B.5.3.3Post code1200
    B.5.3.4CountryBelgium
    B.5.4Telephone number3222640395
    B.5.5Fax number3222640399
    B.5.6E-mailsabine.pirotton@biotech.be
    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 namegpASIT+TM
    D.3.4Pharmaceutical form 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 INNgpASIT+TM
    D.3.9.3Other descriptive namePOLLEN PEPTIDES
    D.3.9.4EV Substance CodeSUB168148
    D.3.10 Strength
    D.3.10.1Concentration unit µg/ml microgram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) Yes
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product Yes
    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 placeboInjection
    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
    Treatment of seasonal grass pollen rhinoconjunctivitis
    Rinoconjuntivitis alérgica inducida por polen de gramíneas
    E.1.1.1Medical condition in easily understood language
    Treatment of hay fever
    Tratamiento de la fiebre del heno
    E.1.1.2Therapeutic area Diseases [C] - Ear, nose and throat diseases [C09]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 18.0
    E.1.2Level LLT
    E.1.2Classification code 10019170
    E.1.2Term Hay fever
    E.1.2System Organ Class 100000004870
    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 clinical trial is to demonstrate the clinical efficacy of gpASIT+™ during the peak of the grass pollen season following subcutaneous administration to patients suffering from hay fever.
    El objetivo principal de este estudio es demostrar la eficacia clinica de gpASIT+™ durante el pico de la estación del polen de gramíneas, cuando administrado con una inyección subcutánea, en pacientes sufriendo de la fiebre del heno.
    E.2.2Secondary objectives of the trial
    The secondary objectives are
    - To assess individual symptom and medication scores over the peak and entire pollen season after treatment with gpASIT+™ compared to placebo,
    - To assess changes in allergic reactivity to Conjunctival Provocation Test (CPT) after treatment with gpASIT+™ compared to placebo,
    - To assess the Quality-of-Life of patients and health economic aspects after treatment with gpASIT+™ compared to placebo,
    - To assess the safety and clinical tolerability of gpASIT+™ treatment.
    Los objetivos secundarios son:
    - conocer los síntomas individuales e la puntuación de la medicación durante el pico y toda la estación del polen, después del tratamiento con gpASIT+™, cuando comparado con placebo;
    - conocer los cambios en la reactividad alérgica al Teste de Provocación Conjuntival (CPT, de sus siglas en inglés), después del tratamiento con gpASIT+™, cuando comparado con placebo;
    - conocer la cualidad de vida de los pacientes y los aspectos económicos de salud, después del tratamiento con gpASIT+™, cuando comparado con placebo;
    - conocer la seguridad y tolerabilidad clínicas del tratamiento con gpASIT+™.
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    The impact of gpASIT+™ treatment on the immunological status of the patients in comparison with placebo will be assessed in two Belgian sites.
    El impacto del tratamiento con gpASIT+™ en el estado inmunológico de los pacientes, en comparación con el placebo, será evaluado en dos centros Belgas.
    E.3Principal inclusion criteria
    - Signed and dated Informed Consent Form by a legally competent patient
    - Female or male patients aged 18-64 years
    - The patients are in good physical and mental health according to his/her medical history and vital signs
    - For Females: non-pregnant, non-lactating females with adequate contraception or females unable to bear children (i.e. tubul ligation, hysterectomy, or post-menopausal (defined as a minimum of one year since the last menstrual period))
    - Allergy diagnosis:
    o A medical history of moderate to severe seasonal allergic rhinoconjunctivitis (SARC) for the grass pollen season during at least the two previous seasons (definition of allergy severity according to ARIA (Bousquet et al 2001))
    o A positive skin prick test (SPT - wheal diameter ? 3 mm) to grass pollen mixture, histamine wheal ? 3 mm, NaCl control reaction < 2 mm
    o Specific IgE against grass pollen (with recombinant allergens - g213) > 0.7 kU/L.
    o Positive response to CPT with at least 10,000 SQ-E/mL of grass allergens
    - Patients treated with anti-allergic medication for at least 2 grass pollen seasons prior to enrollment
    - For asthmatic patients: confirmed diagnosis of controlled asthma according to Global Initiative for Asthma (GINA) guidelines (steps 1-3, GINA 2014)
    - For patients with co-sensitisation to birch and parietaria pollen allergens, all of the following criteria must be fulfilled:
    o The result of the SPT to birch and parietaria pollen has to be less than the result to grass pollen
    o The specific-IgE level to birch and parietaria pollen allergens has to be less than the specific-IgE level to grass (the CAP RAST class for birch and parietaria has to be at least 1 CAP RAST class less than the CAP RAST class for grass)
    - El paciente legalmente competente debe firmar y fechar el formulario de consentimiento informado
    - Los pacientes femeninos o masculinos deben tener entre 18 y 64 años
    - Los pacientes deben gozar de buena salud física y mental de acuerdo a su historial médico y señales vitales
    - Para las mujeres: no deben estar embarazadas ni amamantando. Deben utilizar los anticonceptivos adecuados. Se aceptan mujeres incapaces de quedar embarazadas (trompas ligadas, histerectomía o mujeres posmenopáusicas (debe haber pasado un año como mínimo desde la última menstruación))
    - Diagnóstico de la alergia:
    o Historial médico de Rinoconjuntivitis Alérgica Estacional (SARC por sus siglas en inglés) de moderada a grave durante la temporada del polen de gramíneas, al menos en las últimas dos temporadas previas (definición de la gravedad de la alergia según ARIA (Bousquet et al 2001))
    o Prueba de Escarificación positiva (SPT (por sus siglas en inglés) - diámetro de la pápula ≥ 3 mm) a la mezcla de polen de gramíneas, pápula de histamina ≥ 3 mm, reacción de control NaCl < 2 mm
    o IgE específica cuando deparado con el polen de gramíneas (con alérgenos preparados en el laboratorio - g213) > 0.7 kU/L.
    o Respuesta positiva a la CPT con por lo menos 10 000 SQ-E/mL de alérgenos de pasto
    - Pacientes tratados con medicamentos antialérgicos por al menos 2 temporadas de polen de gramíneas, antes de su aleatorización
    - Para los pacientes asmáticos: diagnóstico confirmado de asma controlada según la guía de la Iniciativa Global para el Asma (GINA por sus siglas en inglés) (pasos 1-3, GINA 2014)
    - En el caso de los pacientes con cosensibilización a los alérgenos del polen de abedul y parietaria, se deben cumplir todos los siguientes criterios:
    o El resultado de la SPT al polen de abedul y parietaria debe ser menor al resultado del polen de gramíneas
    o El nivel de IgE específico a los alérgenos del polen de abedul y parietaria tiene que ser menor al nivel de IgE específico del polen de gramíneas (la clase CAP RAST para el abedul y la parietaria tiene que ser al menos 1 clase CAP RAST menor al de la clase CAP RAST del polen de gramíneas)
    E.4Principal exclusion criteria
    - Simultaneous participation in other clinical trials or previous participation within 30 days before inclusion
    - Previous immunotherapy with grass allergens within the last 5 years
    - Ongoing immunotherapy with grass allergens or any other allergens
    - Patients being in any relationship or dependence with the Sponsor, CRO and/or Investigator
    - Inability to understand instructions/study documents
    - Patients with a history of anaphylaxis, including food (e.g. peanut or marine animals) or hymenoptera venom (e.g. bee or wasp stings) or medication (e.g. penicillin)
    - Patients with a history of hypersensitivity to the excipients of the investigational product (gpASIT+TM or placebo)
    - Patients with partly controlled or uncontrolled asthma according to GINA guidelines (GINA 2014).
    - Patients with chronic asthma or emphysema, particularly with a forced expiratory volume in 1 second (FEV1) < 80% of the predicted value (ECSC) or with a peak expiratory flow (PEF) < 70% of the individual optimum value
    - Patients symptomatic to inhaled allergens circulating during the grass pollen season (specific to each country: e.g. birch, hazel, mugwort, ragweed, olive, Alternaria alternata)
    - Patients symptomatic to perennial inhaled allergens (house dust mites, cat, dog) to which the patients are regularly exposed
    - Patients with a history of significant renal disease or chronic hepatic disease
    - Patients with malignant disease
    - Patients with a known severe autoimmune disease
    - Patients with any chronic disease which may impair the patient?s ability to participate in the trial (e.g. severe congestive heart failure, active gastric ulcer, inflammatory bowel disease, uncontrolled diabetes mellitus, etc.)
    - Patients requiring beta-blockers/acetylcholinesterase inhibitors medication
    - Patients requiring antidepressant drugs with potent antihistamine properties i.e. tricyclic antidepressants (e.g. doxepin, amitriptyline, desipramine, imipramine, etc.)
    - Patients requiring anti-IgE antibodies, mast cell stabilizers or anti-leukotriene agents
    - Patients with any contraindication for the use of adrenaline
    - Patients with a known positive serology for Human Immunodeficiency Virus-1/2, Hepatitis B Virus or Hepatitis C Virus
    - Patients who are immunocompromised by medication or illness, have received a vaccine, corticoids or immunosuppressive medications within 1 month before study entry
    - Female patients who are pregnant, lactating, or of child-bearing potential and not protected from pregnancy by a sufficiently reliable method
    - Consumption of corticosteroids (oral, topic or nasal) or of anti-histaminic drugs within time period preceding the trial (screening visit), as defined in Chapter VIII.6 of the protocol
    - Patients with laboratory values greater than grade 2 according to the FDA Guidance for Industry for preventive Vaccine Trials (FDA 2007) at screening visit *
    - Unreliable patients including non-compliant patients, patients with known alcoholism or drug abuse or with a history of a serious psychiatric disorder as well as patients unwilling to give informed consent or to abide by the requirements of the protocol

    *Patients with laboratory values greater than grade 1 according to the FDA Guidance for Industry for preventive Vaccine Trials (FDA 2007) at screening visit will require a retest and only if normalising, the patient will be eligible.
    - Participación simultánea en otros ensayos clínicos o previa participación en los 30 días previos a la inclusión
    - Inmunoterapia previa con alérgenos de polen de gramíneas en los últimos 5 años
    - Inmunoterapia continua con alérgenos de polen de gramíneas o cualquier otro alérgeno.
    - Que los pacientes se encuentren en alguna relación o dependencia con el promotor, CRO y/o investigador
    - Que los pacientes sean incapaces de entender las instrucciones/documentos del estudio
    - Que los pacientes tengan un historial de anafilaxia, sea alimentaria (por ejemplo, cacahuete o animales marinos), por veneno de himenópteros (por ejemplo, de picadura de abejas o avispas) o por un medicamento (por ejemplo, penicilina)
    - Que los pacientes tengan un historial de hipersensibilidad a los excipientes del medicamento en investigación ((gpASIT+TM o placebo)
    - Que los pacientes padezcan del asma no controlado o parcialmente controlado según la guía de GINA (GINA 2014).
    - Que los pacientes padezcan del asma o enfisema crónico, particularmente con un volumen espiratorio forzado en 1 segundo (FEV1) < 80% del valor pronosticado (ECSC) o con un flujo espiratorio máximo (PEF) < 70% del valor óptimo individual
    - Que los pacientes padezcan síntomas al inhalar los alérgenos que circulan durante la temporada del polen de gramíneas (específico a cada país: por ejemplo, abedul, avellana, artemisa, ambrosía, olivo, Alternaria alternata)
    - Que los pacientes padezcan síntomas al inhalar los alérgenos de la planta perenne (ácaros del polvo, gatos, perros) a la cual se exponen con regularidad
    - Que los pacientes tengan un historial importante de enfermedades renales o enfermedades hepáticas crónicas
    - Que los pacientes sufran una enfermedad maligna
    - Que los pacientes sufran una conocida enfermedad autoinmune grave
    - Que los pacientes padezcan cualquier enfermedad crónica que pueda perjudicar la capacidad del paciente de participar en el ensayo (por ejemplo, insuficiencia cardíaca congestiva grave, úlcera gástrica activa, enfermedad inflamatoria intestinal, diabetes mellitus incontrolada, etc.)
    - Que los pacientes necesiten betabloqueantes/inhibidores de la acetilcolinesterasa
    - Que los pacientes necesiten antidepresivos con propiedades antihistamínicas potentes, es decir, antidepresivos tricíclicos (por ejemplo, doxepin, amitriptilina, desipramina, imipramina, etc.)
    - Que los pacientes necesiten anticuerpos anti IgE, estabilizadores de mastocitos o agentes antileucotrienos
    - Que los pacientes presenten alguna contraindicación al uso de la adrenalina
    - Que los pacientes presenten serología positiva para el Virus de Inmunodeficiencia Humano -1/2, Virus de la Hepatitis B o Virus de la Hepatitis C.
    - Los pacientes que están inmunocomprometidos por medicamentos o enfermedades, que hayan recibido una vacuna, corticoides o inmunosupresores durante el mes antes de ingresar al ensayo.
    - Que las pacientes estén embarazadas, amamantando o que tengan potencial para quedar embarazadas y no se protejan del embarazo con un método suficientemente fiable
    - Consumo de corticosteroides (orales, tópicos o nasales) o de antihistamínicos el período previo al ensayo (visita de investigación), tal y como se define en el Capítulo VIII.6 del protocolo
    - Que los pacientes presenten valores de laboratorio superiores al grado 2 según la guía para la industria de la FDA para ensayos clínicos con vacunas preventivas (FDA 2007) en la visita de la investigación*
    - Que los pacientes no sean confiables: incumplidores, con consumo sabido de alcohol o drogas o enfermedades psiquiátricas graves, así como también los pacientes que no estén dispuestos a dar el consentimiento informado o a acatar los requisitos del protocolo

    *Los pacientes con valores de laboratorio superiores al grado 1, según la guía para la industria de la FDA para ensayos clínicos con vacunas preventivas (FDA 2007), en la visita de la investigación, necesitarán volver a realizar la prueba, y solo si los valores se normalizan el paciente será elegible.
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint will be the reduction - in the treated group compared to the placebo group - of the Combined Symptom and Medication Score (CSMS) taking into account the daily Rhinoconjunctivitis Total Symptom Score (RTSS) and the daily Rescue Medication Score (RMS) over the peak of grass pollen season subsequent to treatment.
    El criterio principal será la reducción – en el grupo de tratamiento comparado con el grupo placebo – de la Puntuación de Síntomas y Medicación Combinados (CSMS, de sus siglas en inglés), teniendo en cuenta la Puntuación de los Síntomas Totales de Rinoconjuntivitis (RTSS, de sus siglas en inglés) y la Puntuación Diaria de la Medicación de Rescate (RMS, de sus siglas en inglés), durante el pico de la estación del polen de gramíneas subsecuente al tratamiento.
    E.5.1.1Timepoint(s) of evaluation of this end point
    reduction of the Combined Symptom and Medication Score (CSMS): during the peak of the grass pollen season.
    reducción de la Puntuación de Síntomas y Medicación Combinados (CSMS, de sus siglas en inglés): durante el pico de la estación del polen de gramíneas.
    E.5.2Secondary end point(s)
    1. Clinical efficacy endpoints will include:
    - Combined Symptom and Medication Score (CSMS) over the entire grass pollen season
    - Rhinoconjunctivitis Total Symptom Score (RTSS) over the peak period and the pollen season
    - Rescue Medication Score (RMS) over the peak period and the pollen season
    - Symptom sub-scores (Eyes, Nose) over the peak period and the pollen season
    - Well days over the peak period and the pollen season
    - In asthmatic patients
    * Lung symptoms over the peak period and the pollen season
    * Total Symptom Score (TSS; the sum of the nose, eye and lung scores) over the peak period and the pollen season
    * Use of rescue medication to relief asthma symptoms over the peak period and the pollen season

    2. Conjunctival Provocation Test (CPT) outcomes

    3. Quality-of-Life Questionnaires:
    - Standardised Rhinoconjunctivitis Quality-of-Life Questionnaire (RQLQ(S)) and Nocturnal Rhinoconjunctivitis
    Quality-of-Life Questionnaire (NRQLQ) in all patients
    - Standardised Asthma Quality-of-Life Questionnaire (AQLQ(S)) in asthmatic patients

    4. Health economic endpoints:
    - Number of working days lost due to grass pollen-induced allergy symptoms
    - Loss of productivity at work due to grass pollen induced-allergy symptoms, using a visual analog scale (VAS)

    5. Responder analysis on
    - Reactivity to CPT: one patient will be considered as a responder if the reactivity to CPT decreases between V1 and V6
    - CSMS over the peak pollen period and entire pollen season: one patient will be considered as a responder if the score is lower of at least 20% with respect to the median score observed in the placebo group

    6. Safety and clinical tolerability endpoints will include:
    - Solicited adverse events:
    * Local reactions at the injection site (swelling and redness) after investigational product administration
    * Allergic systemic reactions after investigational product administration
    - Unsolicited adverse events and serious adverse events
    - Physical examinations and vital signs
    - Laboratory investigations (haematology, clinical biochemistry, immunological parameters)
    - Use of rescue mediction during treatment phase
    1. Los criterios de valoración de eficacia clínica incluyen:
    - Los CSMS durante la temporada completa del polen de gramíneas
    - Los RTSS durante la temporada del polen y su pico
    - Los RMS durante la temporada del polen y su pico
    - La sub-calificación de los síntomas (oculares, nasales) durante y la temporada del polen y su pico
    - Los días buenos durante la temporada del polen y su pico
    - En pacientes asmáticos
    * Síntomas pulmonares durante la temporada del polen y su pico
    * La Calificación de los Síntomas Totales (TSS por sus siglas en inglés; la suma los resultados nasales, oculares y pulmonares) durante la temporada del polen y su pico
    * El uso de medicamentos de rescate para aliviar los síntomas de asma durante la temporada del polen y su pico

    2. Los resultados de la Prueba de Provocación Conjuntival (CPT por sus siglas en inglés)

    3. Los cuestionarios de calidad de vida:
    - Cuestionario Estandarizado de Calidad de Vida para la Rinoconjuntivitis (RQLQ(S) por sus siglas en inglés) y Cuestionario de Calidad de Vida para la Rinoconjuntivitis Nocturna (NRQLQ por sus siglas en inglés), para todos los pacientes
    - Cuestionario Estandarizado de Calidad de Vida para el Asma (AQLQ(S) por sus siglas en inglés), para pacientes asmáticos

    4. Los criterios económicos de valoración de salud:
    - La cantidad de días laborales perdidos debido a los síntomas de alergia inducidos por el polen de gramíneas
    - La pérdida de productividad en el trabajo debido a los síntomas de alergia inducidos por el polen de gramíneas, utilizando una Escala Visual Analógica (VAS por sus siglas en inglés)

    5. Análisis respondiente de
    - La reactividad en la CPT: el paciente será considerado un respondiente si la reactividad de la CPT disminuye entre la V1 y la V6
    - CSMS durante la temporada completa del polen y el pico de la misma: el paciente será considerado un respondiente si el resultado es menor por lo menos en un 20% con respecto al resultado promedio observado en el grupo tratado con placebo

    6. Los criterios de valoración de la seguridad y tolerabilidad clínica incluyen:
    - Los hechos adversos solicitados
    *Las reacciones locales en el área de inyección (hinchazón y enrojecimiento) luego de la administración del medicamento en investigación
    *Las reacciones alérgicas sistémicas luego de la administración del medicamento en investigación
    - Los hechos adversos no esperados y los hechos adversos graves
    - Los exámenes físicos y señales vitales
    - Las investigaciones en el laboratorio (hematología, bioquímica clínica, parámetros inmunológicos)
    - El uso de los medicamentos de rescate durante la fase de tratamiento
    E.5.2.1Timepoint(s) of evaluation of this end point
    - Clinical efficacy endpoints: during the peak and entire pollen season
    - Conjunctival Provocation Test (CPT) outcomes: at visit 1 and 6
    - Quality-of-Life Questionnaires: at visit 6, 7 and 8
    - Health economic endpoints: at visit 6, 7 and 8
    - Responder analysis on
    - Reactivity to CPT: at visit 6
    - CSMS: during peak and entire season
    - Safety and clinical tolerability endpoints
    - Solicited adverse events: visit 2, 3, 4 and 5
    - Unsolicited adverse events and serious adverse events: visit 2 to visit 8
    - Physical examinations and vital signs: visit 1 to visit 8
    - Laboratory investigations (haematology, clinical biochemistry, immunological parameters): visit 1, 6 and 8
    - Use of rescue mediction during treatment phase: visit 2, 3, 4 and 5
    - Criterios de eficacia clinica: durante el pico y la estación del polen entera
    - Resultados del CPT : visitas 1 y 6
    - Cuestionarios de Cualidad de Vida: visitas 6,7 y 8
    - Objetivos Económicos de Salud: visitas 6, 7 y 8
    - Análisis del Respondedor en
    - Reactividad al CPT: en la visita 6
    - CSMS: durante el pico y estación entera
    - Objetivos de seguridad y tolerabilidad clínicas
    - Eventos adversos esperados: visitas 2, 3, 4 y 5
    - Eventos adversos no esperados y eventos adversos graves: visita 2 a visita 8
    - Exanimación física y señales vitales: visita 1 a visita 8
    - Laboratorio de investigaciones (hematología, bioquímica clinica, parámetros inmunológicos): visitas 1, 6 y 8
    - Uso de medicación de rescate durante la fase de tratamiento: visitas 2, 3, 4 y 5
    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 Yes
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    immunogenicity
    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 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 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 concerned5
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA75
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.7Trial has a data monitoring committee Yes
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years0
    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 years0
    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 No
    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) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 654
    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 state50
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 654
    F.4.2.2In the whole clinical trial 654
    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
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2015-10-29
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-09-11
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2016-09-15
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