Flag of the European Union EU Clinical Trials Register Help

Clinical trials

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

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

    The EU Clinical Trials Register currently displays   43857   clinical trials with a EudraCT protocol, of which   7284   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

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

    < Back to search results

    Print Download

    Summary
    EudraCT Number:2011-004583-30
    Sponsor's Protocol Code Number:BIA-DPT-P2-001
    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:2011-11-07
    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 number2011-004583-30
    A.3Full title of the trial
    A MULTICENTER, PHASE II, RANDOMISED, DOUBLE?BLIND, PLACEBO CONTROLED CLINICAL TRIAL OF THE SUBCUTANEOUS IMMUNOTHERAPY IN DIFFERENT DOSES WITH PARALLEL GROUPS IN SUBJECTS WITH ALLERGIC RHINOCONJUNCTIVITIS +/- ASTHMA SENSITIZED TO DERMATOPHAGOIDES PTERONYSSINUS.
    Ensayo clínico fase II, multicéntrico, aleatorizado, doble ciego, con inmunoterapia subcutánea a diferentes dosis, en grupos paralelos y controlado con placebo, en pacientes con rinoconjuntivitis ± asma sensibilizados a Dermatophagoides pteronyssinus
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A MULTICENTER, PHASE II, RANDOMISED, DOUBLE?BLIND, PLACEBO CONTROLED CLINICAL TRIAL OF THE SUBCUTANEOUS IMMUNOTHERAPY IN DIFFERENT DOSES WITH PARALLEL GROUPS IN SUBJECTS WITH ALLERGIC RHINOCONJUNCTIVITIS +/- ASTHMA SENSITIZED TO DERMATOPHAGOIDES PTERONYSSINUS.
    Ensayo clínico fase II, multicéntrico, aleatorizado, doble ciego, con inmunoterapia subcutánea a diferentes dosis, en grupos paralelos y controlado con placebo, en pacientes con rinoconjuntivitis ± asma sensibilizados a Dermatophagoides pteronyssinus
    A.3.2Name or abbreviated title of the trial where available
    BIAL
    BIAL
    A.4.1Sponsor's protocol code numberBIA-DPT-P2-001
    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 SponsorBIAL Industrial Farmaceutica
    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 supportBIAL Industrial Farmaceutica
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationCAIBER
    B.5.2Functional name of contact pointCAIBER
    B.5.3 Address:
    B.5.3.1Street AddressMelchor Fernandez Almagro, 3
    B.5.3.2Town/ cityMadrid
    B.5.3.3Post code28029
    B.5.3.4CountrySpain
    B.5.4Telephone number003491822249400
    B.5.5Fax number003491387755100
    B.5.6E-mailugoicoechea@caiber.net
    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 nameAllegovac depot.
    D.3.2Product code V01AA
    D.3.4Pharmaceutical form Suspension 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.3.9.1CAS number 8000045207
    D.3.9.3Other descriptive nameAllergens, house dust and mite
    D.3.10 Strength
    D.3.10.1Concentration unit SU/ml Standardised Unit(s)/millilitre (Deprecated)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0.125
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.1CAS number 8000045207
    D.3.9.3Other descriptive nameAllergens, house dust and mite
    D.3.10 Strength
    D.3.10.1Concentration unit SU/ml Standardised Unit(s)/millilitre (Deprecated)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0.25
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.1CAS number 8000045207
    D.3.9.3Other descriptive nameAllergens, house dust and mite
    D.3.10 Strength
    D.3.10.1Concentration unit SU/ml Standardised Unit(s)/millilitre (Deprecated)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0.5
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.1CAS number 8000045207
    D.3.9.3Other descriptive nameAllergens, house dust and mite
    D.3.10 Strength
    D.3.10.1Concentration unit SU/ml Standardised Unit(s)/millilitre (Deprecated)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.1CAS number 8000045207
    D.3.9.3Other descriptive nameAllergens, house dust and mite
    D.3.10 Strength
    D.3.10.1Concentration unit SU/ml Standardised Unit(s)/millilitre (Deprecated)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1.5
    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 rhinoconjunctivitis with or without associated asthma.
    Rinoconjuntivitis alérgica estacional con o sin asma asociada.
    E.1.1.1Medical condition in easily understood language
    Allergic rhinoconjunctivitis with or without associated asthma.
    Rinoconjuntivitis alérgica estacional con o sin asma asociada.
    E.1.1.2Therapeutic area Body processes [G] - Immune system processes [G12]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Compare the efficacy of subcutaneous immunotherapy in depot presentation in five different doses in sensitive patients to Dermatophagoides pteronyssinus with asthma +/- allergic rhinoconjunctivitis, between 18 and 60 years old.
    Comparar la eficacia de la inmunoterapia subcutánea en presentación depot, en 5 dosis diferentes en pacientes con rinoconjuntivitis alérgica ± asma sensibilizados a DPT, de edades comprendidas entre 18 y 60 años.
    E.2.2Secondary objectives of the trial
    Not applicable
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    -Los pacientes deben firmar un consentimiento informado.
    -Pacientes con edad entre 18 y 60 años.
    -Pacientes con rinoconjuntivitis alérgica estacional producida por DPT durante al menos 2 años antes de participar en el estudio y en los que a juicio del investigador esté indicado el tratamiento con inmunoterapia. Pese a que la patología en estudio es la rinoconjuntivitis alérgica, se permite la inclusión de pacientes con patología asmática leve concomitante.
    -Pacientes que hayan obtenido un resultado de prick test ? 3 mm de diámetro para DPT.
    -Pacientes que hayan obtenido una valoración de IgE específica ? clase 2 (CAP/PHADIA) a DPT.
    -Los pacientes serán preferiblemente monosensibilizados a DPT. En el caso de pacientes polisensibilizados sólo se podrán incluir en el estudio si el resto de sensibilizaciones están producidas por alérgenos estacionales cuyo período de polinización no coincida con el período de tratamiento del estudio.
    -Las mujeres en edad fértil deben presentar una prueba de embarazo en orina con resultado negativo en el momento de su incorporación al estudio.
    -Además, las mujeres en edad fértil, deben comprometerse a utilizar un método anticonceptivo adecuado durante el estudio si son sexualmente activas.
    E.4Principal exclusion criteria
    -Uso estable y continuado de medicación para la patología alérgica durante las 2 semanas previas a su inclusión.
    -Pacientes sensibilizados a otros alérgenos perennes clínicamente relevantes y con niveles de IgE específica ? clase 2 CAP/PHADIA.
    -Pacientes que hayan recibido inmunoterapia previa en los 5 años precedentes para el alérgeno testado o un alérgeno con reactividad cruzada o estén actualmente recibiendo inmunoterapia con cualquier alérgeno.
    -Pacientes con asma severo o FEV1< 70% o con asma tal que precisen tratamiento con corticoides inhalados o sistémicos en el momento de entrada en el estudio o en las 8 semanas previas al inicio del tratamiento.
    -Pacientes con enfermedades inmunológicas, cardíacas, renales o hepáticas o de otro tipo que a juicio del investigador tengan relevancia suficiente como para interferir con el estudio.
    -Pacientes con historia previa de anafilaxias.
    -Pacientes con urticaria crónica.
    -Pacientes con dermatitis atópica moderada-severa.
    -Pacientes con malformaciones del tracto respiratorio superior con clínica relevante.
    -Pacientes que hayan participado en otro ensayo clínico 3 meses antes.
    -Pacientes en tratamiento con antidepresivos tricíclicos, psicótropos (psicofármacos), B-bloqueantes, e inhibidores del enzima convertidor de angiotensina (IECAs).
    -Mujeres embarazadas o en período de lactancia o mujeres en edad fértil que no se comprometan a utilizar un método anticonceptivo adecuado si son sexualmente activas y no hayan demostrado haber sido esterilizadas quirúrgicamente o que presenten alguna otra forma de incapacidad para tener descendencia.
    -Pacientes con alguna condición que imposibilite o interfiera con la validez de las pruebas a realizar durante el estudio.
    -Pacientes que no puedan acudir a las visitas o falta de colaboración o negativa a participar por parte del paciente.
    E.5 End points
    E.5.1Primary end point(s)
    La variable principal de valoración del estudio es la variación en la concentración del alérgeno (DPT) necesaria para producir una respuesta positiva en el test de provocación nasal entre la visita de selección (V0) y la visita final (VF) del estudio. Se compararán las diferencias en dicha variación entre los diferentes grupos de tratamiento y frente al placebo
    E.5.1.1Timepoint(s) of evaluation of this end point
    Entre la visita de selección (V0) y la visita final del estudio (VF) con una duración de 19 semanas.
    E.5.2Secondary end point(s)
    ?Diferencias de la concentración necesaria del extracto alergénico de DPT para producir un resultado positivo en el test de provocación nasal en la visita final entre los diferentes grupos.
    ?Comparación de las diferencias obtenidas entre V0 y VF en las puntuaciones del prurito y secreción nasal obtenidas en la prueba de provocación nasal entre los diferentes grupos del estudio.
    ?Diferencias obtenidas en las puntuaciones del prurito y secreción nasal obtenidas en la prueba de provocación nasal entre los diferentes grupos del estudio en la VF.
    ?Comparación de la diferencia obtenida en los niveles de inmunoglobulinas: IgE específica, IgG total e IgG4 entre V0 y VF entre los diferentes grupos del estudio.
    ?Diferencia en los niveles de inmunoglobulinas: IgE específica, IgG total e IgG4 obtenidos en la VF entre lo diferentes grupos del estudio.
    ?Pruebas cutáneas (prick test dosis respuesta): comparación de las diferencias obtenidas entre la V0 y la VF entre los diferentes grupos del estudio.
    ?Diferencias en los resultados obtenidos en el prick test dosis respuesta en la VF entre los diferentes grupos de tratamiento.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Entre la visita de selección (V0) y la visita final del estudio (VF) con una duración de 19 semanas
    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) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    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 trial6
    E.8.3 The trial involves single site in the Member State concerned Yes
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned12
    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
    Última visita al centro del último paciente participante en el estudio.
    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 months8
    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 months0
    E.8.9.2In all countries concerned by the trial days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 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: 150
    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 state150
    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)
    Not Applicable
    No aplica
    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 Decision2012-01-16
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-12-12
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2012-11-30
    For support, Contact us.
    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

    European Medicines Agency © 1995-Thu Apr 25 05:53:35 CEST 2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA