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    Summary
    EudraCT Number:2019-002811-25
    Sponsor's Protocol Code Number:DMV03-SIT-027
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2020-11-25
    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 number2019-002811-25
    A.3Full title of the trial
    Prospective, multicenter, randomized, double-blind, placebo-controlled clinical trial of efficacy and safety with subcutaneous immunotherapy in patients with mild to moderate rhinitis / rhinoconjunctivitis sensitized to grasses and olive
    Ensayo clínico de eficacia y seguridad, prospectivo, multicéntrico, aleatorizado, doble ciego controlado con placebo, con inmunoterapia subcutánea en pacientes con rinitis/rinoconjuntivitis con o sin asma de leve a moderada sensibilizados a gramíneas y olivo
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Prospective, multicenter, randomized, double-blind, placebo-controlled clinical trial of efficacy and safety with subcutaneous immunotherapy in patients with mild to moderate rhinitis / rhinoconjunctivitis sensitized to grass and olive pollen
    Ensayo clínico de eficacia y seguridad, prospectivo, multicéntrico, aleatorizado, doble ciego controlado con placebo, con inmunoterapia subcutánea en pacientes con rinitis/rinoconjuntivitis con o sin asma de leve a moderada sensibilizados a gramíneas y olivo
    A.4.1Sponsor's protocol code numberDMV03-SIT-027
    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 SponsorInmunotek, S.L.
    B.1.3.4CountrySpain
    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 supportINMUNOTEK, S.L.
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationINMUNOTEK, S.L.
    B.5.2Functional name of contact pointMiguel Casanovas
    B.5.3 Address:
    B.5.3.1Street AddressPunto Mobi, 5
    B.5.3.2Town/ cityAlcalá de Henares
    B.5.3.3Post code28805
    B.5.3.4CountrySpain
    B.5.4Telephone number34912908942110
    B.5.5Fax number34916639732
    B.5.6E-mailmcasanovas@inmunotek.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 nameMG01-T517 (10.000-10.000)
    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 INNN/A
    D.3.9.2Current sponsor codeMG01
    D.3.9.3Other descriptive nameMixture of polymerized with glutaraldehyde allergen extracts of Phleum pratense, Dactylis glomerata, Poa pratensis, Holcus lanatus, Festuca elatior and Lolium perenne
    D.3.9.4EV Substance CodeSUB207678
    D.3.10 Strength
    D.3.10.1Concentration unit AU/ml allergy unit(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10.000
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNN/A
    D.3.9.3Other descriptive nameAllergenic extract of Olea europaea pollen polymerized with glutaraldehyde
    D.3.9.4EV Substance CodeSUB207680
    D.3.10 Strength
    D.3.10.1Concentration unit AU/ml allergy unit(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10.000
    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 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 nameMG01-T517-(30.000-10.000)
    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 INNN/A
    D.3.9.2Current sponsor codeMG01
    D.3.9.3Other descriptive nameMixture of polymerized with glutaraldehyde allergen extracts of Phleum pratense, Dactylis glomerata, Poa pratensis, Holcus lanatus, Festuca elatior and Lolium perenne
    D.3.9.4EV Substance CodeSUB207678
    D.3.10 Strength
    D.3.10.1Concentration unit AU/ml allergy unit(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number30.000
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNN/A
    D.3.9.2Current sponsor codeT517
    D.3.9.3Other descriptive nameAllergenic extract of Olea europaea pollen polymerized with glutaraldehyde
    D.3.9.4EV Substance CodeSUB207680
    D.3.10 Strength
    D.3.10.1Concentration unit AU/ml allergy unit(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10.000
    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 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
    Allergic rhinitis / rhinoconjunctivitis with or without mild to moderate asthma due to sensitization to grass and olive pollen
    Rinitis alérgica / rinoconjuntivitis con o sin asma leve a moderada por sensibilización a pólen de gramineas y olivo
    E.1.1.1Medical condition in easily understood language
    Grasses and olive tree allergy
    Alergia frente a Gramíneas y Olivo
    E.1.1.2Therapeutic area Diseases [C] - Immune System Diseases [C20]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10036019
    E.1.2Term Pollen allergy
    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 main objective of this trial is to evaluate the clinical efficacy of subcutaneously administered polymerized allergenic extracts, comparing with placebo in subjects with rhinitis / rhinoconjunctivitis according to the ARIA classification, with or without controlled intermittent or persistent (mild-moderate) asthma, according to the definition of GEMA 5.0, by the combined score of symptoms and medication consumption for rhinitis / rhinoconjunctivitis and asthma for each trial subject.
    El objetivo principal de este ensayo es evaluar la eficacia clínica de los extractos alergénicos polimerizados administrados por vía subcutánea, comparando con placebo en sujetos con rinitis/rinoconjuntivitis según la clasificación ARIA, con o sin asma intermitente o persistente (leve-moderada) controlada, según la definición de GEMA 5.0, mediante la puntuación combinada de síntomas y consumo de medicación para rinitis/rinoconjuntivitis y asma para cada sujeto del ensayo.
    E.2.2Secondary objectives of the trial
    As secondary objectives will be assessed the tolerance, changes in immunological parameters, the subject quality of life, after the treatment and the safety of the subcutaneous immunotherapy
    Como objetivos secundarios se evaluarán la tolerancia, cambios en parámetros inmunológicos, la calidad de vida del sujeto tras el tratamiento y la seguridad de la inmunoterapia subcutánea
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Subject who has signed the informed consent.
    - Subjects of both sexes aged between 14 and 65 years.
    - Subjects with confirmed clinical history of inhalational allergy (rhinitis and / or moderate-severe intermittent or persistent rhinoconjunctivitis according to the ARIA classification with or without intermittent or persistent controlled mild-moderate asthma according to the GEMA 5.0 classification caused by grass and olive allergy.
    - Subjects with a positive prick test (papule diameter ≥ 5 mm) to a standardized extract of pollen from grasses (Phleum pratense, Holcus lanatus, Dactylis glomerata, Poa pratensis, Festuca elatior, Lolium perenne), or one of the components of the mixture and an olive extract, made within 12 months prior to signing the informed consent.
    - Specific IgE (CAP or Immulite) against one of the components of the mixture of grasses, preferably Phleum pratense and olive or one of the molecular components of allergenic sources with a value ≥ 3 KU / L, determined within the 12 months prior to signing the informed consent.
    - Women of childbearing age (from menarche) should submit a urine pregnancy test with a negative result at the time of joining the trial.
    - Women of childbearing potential, and men participating in the trial, should commit to using an appropriate method of contraception. Medically acceptable methods of contraception are intrauterine devices placed at least 3 months in advance, surgical sterilization (for example, tubal ligation), barrier methods, or the use of oral contraceptives.
    - Subjects diagnosed with asthma according to the GEMA 5.0 guide.
    - Subjects capable of complying with the dosage regimen.
    - Subjects who have a smartphone to record symptoms and medication.
    - Sujeto que haya firmado el consentimiento informado.
    - Sujetos de ambos sexos con edad comprendida entre 14 y 65 años.
    - Sujetos con historia clínica confirmada de alergia inhalatoria (rinitis y/o rinoconjuntivitis intermitente o persistente moderada-grave según la clasificación ARIA con o sin asma intermitente o persistente controlada leve-moderada según la clasificación GEMA 5.0 causada por alergia a gramíneas y olivo.
    - Sujetos con un prick test positivo (diámetro de la pápula ≥ 5 mm) a un extracto estandarizado mezcla de polen de gramíneas (Phleum pratense, Holcus lanatus, Dactylis glomerata, Poa pratensis, Festuca elatior, Lolium perenne), o a uno de los componentes de la mezcla y a un extracto de olivo, realizados dentro de los 12 meses anteriores a la firma del consentimiento informado.
    - IgE específica (CAP o Immulite) frente a uno de los componentes de la mezcla de gramíneas, preferiblemente a Phleum pratense y olivo o a uno de los componentes moleculares de las fuentes alergénicas con un valor ≥ 3 KU/L, determinados dentro de los 12 meses anteriores a la firma del consentimiento informado.
    - Las mujeres en edad fértil (desde menarquía) deben presentar una prueba de embarazo en orina con resultado negativo en el momento de su incorporación al ensayo.
    - Las mujeres en edad fértil, y los hombres que participen en el ensayo, deben comprometerse a utilizar un método anticonceptivo adecuado. Los métodos anticonceptivos médicamente aceptables son dispositivos intrauterinos colocados con, al menos, 3 meses de antelación, la esterilización quirúrgica (por ejemplo, ligadura de trompas), métodos de barrera o el uso de anticonceptivos orales.
    - Sujetos diagnosticados de asma según la guía GEMA 5.0.
    - Sujetos capaces de cumplir con el régimen de dosificación.
    - Sujetos que posean un smartphone para el registro de síntomas y medicación.
    E.4Principal exclusion criteria
    - Subjects polisensitized to other aeroallergens with the exception of epithelia with exposure and occasional symptoms and non-seasonal pollens with grasses and olive
    - Subjects who have received prior immunotherapy in the preceding 5 years for any of the allergens tested or a cross-reactive allergen or are currently receiving immunotherapy with any allergen.
    - Subjects in which immunotherapy may be subject to an absolute general contraindication according to the criteria of the Immunotherapy Committee of the Spanish Society of Allergy and Clinical Immunology and the European Allergy and Clinical Immunology Immunotherapy Subcommittee.
    - Subjects with severe or uncontrolled persistent asthma, with an FEV1 <70% with respect to the reference value despite adequate pharmacological treatment at the time of inclusion in the trial. Likewise, subjects with intermittent or persistent rhinitis / rhinoconjunctivitis with severe symptoms in which the suspension of oral or systemic antihistamine treatment is contraindicated.
    - Subjects who have previously presented a serious secondary reaction during the performance of diagnostic skin tests using the prick test.
    - Subjects under treatment with ß-blockers.
    - Clinically unstable subjects at the time of enrollment in the trial (acute asthma exacerbation, respiratory infection, feverish process, acute urticaria, etc.).
    - Subjects with active chronic urticaria, severe dermographism, severe atopic dermatitis, sunburns, active psoriasis with lesions in areas where skin tests will be performed, or a history of hereditary angioedema.
    - Subjects who have any pathology in which the administration of adrenaline is contraindicated (hyperthyroidism, HT, heart disease, etc.).
    - Subjects with some other disease not related to moderate rhinoconjunctivitis or asthma, but of potential severity and that may interfere with treatment and follow-up (epilepsy, psychomotor disorder, uncontrolled diabetes, malformations, multiple operations, kidney disease,).
    - Subjects with autoimmune disease (thyroiditis, lupus, etc.), tumor diseases or with a diagnosis of immunodeficiencies.
    - Subject whose condition prevents him / her from offering cooperation and who has severe psychiatric disorders.
    - Subjects with a known allergy to other investigational drug components other than the allergen.
    - Subjects with diseases of the lower respiratory tract other than asthma such as emphysema or bronchiectasis.
    - Subjects who are direct relatives of the researchers.
    - Pregnant or lactating women.
    - Sujetos polisensibilizados a otros aeroalérgenos a excepción de epitelios con exposición y sintomatología ocasional y pólenes no coestacionales con gramíneas y olivo.
    - Sujetos que hayan recibido inmunoterapia previa en los 5 años precedentes para cualquiera de los alérgenos testados o un alérgeno con reactividad cruzada o estén actualmente recibiendo inmunoterapia con cualquier alérgeno.
    - Sujetos en los que la inmunoterapia pueda ser objeto de contraindicación general absoluta según los criterios del Comité de Inmunoterapia de la Sociedad Española de Alergia e Inmunología Clínica y del European Allergy and Clinical Immunology Immunotherapy Subcommittee.
    - Sujetos con asma persistente grave o no controlada, con un FEV1 < 70% con respecto al valor de referencia a pesar de un tratamiento farmacológico adecuado en el momento de la inclusión en el ensayo. Así mismos sujetos con rinitis / rinoconjuntivitis intermitente o persistente con síntomas severos en los cuales la suspensión del tratamiento antihistamínico por vía oral o sistémica sea contraindicado.
    - Sujetos que hayan presentado previamente una reacción secundaria grave durante la realización de pruebas cutáneas de diagnóstico mediante prick test.
    - Sujetos en tratamiento con ß-bloqueantes.
    - Sujetos inestables desde el punto de vista clínico en el momento de la inclusión en el ensayo (exacerbación asmática aguda, infección respiratoria, proceso febril, urticaria aguda, etc.).
    - Sujetos con urticaria crónica activa, dermografismo severo, dermatitis atópica severa, quemaduras solares, psoriasis activa con lesiones en zonas donde se realizarán pruebas cutáneas, o antecedentes de angioedema hereditario.
    - Sujetos que tengan alguna patología en la que esté contraindicada la administración de adrenalina (hipertiroidismo, HTA, cardiopatía, etc.).
    - Sujetos con alguna otra enfermedad no relacionada con la rinoconjuntivitis moderada o con el asma, pero de potencial gravedad y que pueda interferir con el tratamiento y seguimiento (epilepsia, alteración psicomotora, diabetes no controlada, malformaciones, multioperados, nefropatías,).
    - Sujetos con enfermedad autoinmune (tiroiditis, lupus, etc.), enfermedades tumorales o con diagnóstico de inmunodeficiencias.
    - Sujeto cuyo estado le impide ofrecer cooperación y o que presente trastornos psiquiátricos severos.
    - Sujetos con alergia conocida a otros componentes del medicamento en investigación diferentes del alérgeno.
    - Sujetos con enfermedades de la vía respiratoria inferior diferentes al asma como el enfisema o las bronquiectasias.
    - Sujetos que sean familiares directos de los investigadores.
    - Mujeres embarazadas o en período de lactancia.
    E.5 End points
    E.5.1Primary end point(s)
    Overall score of symptoms and medication throughout the trial.
    Puntuación global de síntomas y medicación durante todo el ensayo.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Begining and end of the clinical trial
    Principio y final del ensayo
    E.5.2Secondary end point(s)
    - Symptom free days
    - Days off medication
    - Asthmatic exacerbations
    - Analog visual scale (EVA)
    - Immunological parameters: total IgE, specific IgE, specific IgG, specific IgG4
    - ACT Asthma Control Questionnaire
    - Quality of life questionnaire in rhinitis ESPRINT-15
    - Consumption of health resources
    - Safety of specific immunotherapy
    - Días libres de síntomas
    - Días libres de medicación
    - Exacerbaciones asmáticas
    - Escala visual analógica (EVA)
    - Parámetros inmunológicos: IgE total, IgE específica, IgG específica, IgG4 específica
    - Cuestionario de control de asma ACT
    - Cuestionario de calidad de vida en rinitis ESPRINT-15
    - Consumo de recursos sanitarios
    - Seguridad de la inmunoterapia específica
    E.5.2.1Timepoint(s) of evaluation of this end point
    Begining and end of the clinical trial
    Principio y final del ensayo
    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 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 Yes
    E.8.1.7.1Other trial design description
    Nada
    None
    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 trial3
    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 concerned13
    E.8.5The trial involves multiple Member States No
    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 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
    The trial will finished with the database closed out.
    El ensayo finalizará con el cierre de la base de datos de los resultados del ensayo.
    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 months6
    E.8.9.1In the Member State concerned 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: 20
    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: 20
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 130
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 30
    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 state180
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 180
    F.4.2.2In the whole clinical trial 180
    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
    Ninguno
    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 Decision2020-11-13
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-11-06
    P. End of Trial
    P.End of Trial StatusOngoing
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    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.

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