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    Summary
    EudraCT Number:2014-001459-22
    Sponsor's Protocol Code Number:BIA-PAR-DEPOT
    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:2014-11-11
    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 number2014-001459-22
    A.3Full title of the trial
    OPEN CLINICAL TRIAL, MULTICENTER, WITH SUBCUTANEOUS IMMUNOTHERAPY IN DEPOT PRESENTATION, IN PATIENTS WITH ALLERGY RHINOCONJUNCTIVITIS SENSITIZED TO PARIETARIA JUDAICA
    ENSAYO CLÍNICO ABIERTO, MULTICÉNTRICO CON INMUNOTERAPIA SUBCUTÁNEA EN PRESENTACION DEPOT EN PACIENTES CON RINOCONJUNTIVITIS ALÉRGICAS ENSIBILIZADOS A PARIETARIA JUDAICA.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    CLINICAL TRIAL IN THE EXPLORATION PHASE FOR TO EVALUATE SAFETY AND TOLERABILITY, OF SUBCUTANEOUS IMMUNOTHERAPY COMPARED TO PLACEBO IN PATIENTS WITH ALLERGY RHINOCONJUNCTIVITIS SENSITISED TO PARIETARIA JUDAICA, WITH AGES COMPRISED BETWEEN 18 AND 60 YEARS.
    ENSAYO CLÍNICO EN FASE DE EXPLORACIÓN PARA EVALUAR LA SEGURIDAD Y TOLERABILIDAD , DE LA INMUNOTERAPIA SUBCUTÁNEA, EN PACIENTES CON RINOCONJUNTIVITIS ALERGICA SENSIBILIZADOS A PARIETARIA JUDAICA, CON EDADES COMPRENDIDAS ENTRE 18 Y 60 AÑOS
    A.3.2Name or abbreviated title of the trial where available
    BIA-PAR-DEPOT
    BIA-PAR-DEPOT
    A.4.1Sponsor's protocol code numberBIA-PAR-DEPOT
    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 Farmacéutica S.A.
    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 Farmacéutica S.A.
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationBial Industrial Farmacéutica S.A.
    B.5.2Functional name of contact pointClinical Project Manager
    B.5.3 Address:
    B.5.3.1Street AddressParque Tecnológico de Vizcaya. Edificio 401
    B.5.3.2Town/ cityZamudio
    B.5.3.3Post code48170
    B.5.3.4CountrySpain
    B.5.4Telephone number+3494443 80 00
    B.5.5Fax number+3494443 80 16
    B.5.6E-mailAraitz.Landeta@bial.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.2.1.1.1Trade name Allergovac depot
    D.2.1.1.2Name of the Marketing Authorisation holderBial Industrial Farmacéutica S.A.
    D.2.1.2Country which granted the Marketing AuthorisationSpain
    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 nameAllergovac depot
    D.3.4Pharmaceutical form Suspension for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSubcutaneous use
    D.3.11 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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    PATIENTS WITH RHINOCONJUNCTIVITIS SENSITISED TO PARIETARIA JUDAICA
    Pacientes con rinoconjuntivitis sensibilizados a Parietaria judaica
    E.1.1.1Medical condition in easily understood language
    PATIENTS WITH ALLERGY SENSITISED TO PARIETARIA JUDAICA
    Pacientes con alergia sensibilizados a Parietaria judaica
    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
    To evaluate the safety and tolerability of subcutaneous immunotherapy in depot presentation and guideline fast in patients with rhinoconjunctivitis with or without asthma sensitized to Parietaria judaica, aged between 18 and 60 through the identification and classification of adverse reactions throughout the duration of the clinical trial
    Evaluar la seguridad y tolerabilidad de la inmunoterapia subcutánea en presentación depot y pauta rápida en pacientes con rinoconjuntivitis con o sin asma leve sensibilizados a Parietaria judaica, de edades comprendidas entre 18 y 60 años a través de la identificación y clasificación de reacciones adversas a lo largo de la duración del ensayo.
    E.2.2Secondary objectives of the trial
    To evaluate the indirect efficacy of subcutaneous immunotherapy through of measurement of changes in the levels of specific IgE, total IgG and IgG4 and the realization of the dose-response prick test
    Evaluar la eficacia indirecta de la inmunoterapia a través de la medida de los cambios en los niveles de IgE específica, IgG total e IgG4 y la realización del prick test dosis respuesta
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Signed informed consent
    2. Aged between 18 and 60
    3. Patients with seasonal allergic rhinoconjunctivitis caused by Parietaria judaica for at least 2 years before participating in the study. Allergic rhinoconjunctivitis is the main pathology under study but patients with concomitant mild asthma may also be included.
    4. Prick test results > 3 mm against Parietaria judaica. The positive and negative control tests should give consistent results.
    5. Patients with allergen specific IgE value ≥ class 2 (CAP / PHADIA) against Parietaria judaica. 6. Patients sensitized to Parietaria judaica with clinically relevant symptoms and, according to medical criteria, 100% eligible for the type of immunotherapy used in this trial.
    7. Women of childbearing potential must provide a negative pregnancy test and agree to use adequate contraception during the study if they are sexually active.
    1.Pacientes que firmen el consentimiento informado.
    2.Pacientes entre 18 y 60 años de edad.
    3.Pacientes con rinoconjuntivitis alérgica estacional producida por Parietaria judaica durante al menos 2 años antes de participar en el estudio. Pese a que la patología en estudio es la rinoconjuntivitis alérgica, se permite la inclusión de pacientes con patología asmática leve concomitante.
    4.Pacientes que han presentado un resultado de prick test > 3 mm de diámetro para Parietaria judaica. El control positivo y negativo del test deben dar resultados consistentes.
    5.Pacientes con un valor de IgE específica de ≥ clase 2 (CAP/PHADIA) para Parietaria judaica.
    6.Pacientes sensibilizados a Parietaria judaica con síntomas clínicamente relevantes a su exposición, en los que a juicio del investigador clínico esté indicado el tratamiento con una vacuna de Parietaria judaica 100%.
    7.Las mujeres en edad fértil deben presentar una prueba de embarazo en orina con resultado negativo en el momento de su incorporación al estudio.
    8.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
    1. Patients who have received prior immunotherapy anytime during the 5 years prior to the tested for the allergen under study or allergens with cross- reactivity, as well as patients currently receiving any allergen specific immunotherapy.
    2. Patients with severe asthma or FEV1 <70 % or so with asthma requiring treatment with inhaled or systemic corticosteroids at the time of study entry or within 8 weeks of the start of treatment.
    3. Patients with immune, heart, kidney or liver or any other disease with sufficient relevance to interfere with the study disease (as per medical criteria).
    4. Patients with a history of anaphylaxis.
    5. Patients with chronic urticaria.
    6. Patients with moderate/severe atopic dermatitis
    7. Patients with clinically relevant malformations of the upper respiratory tract.
    8. Patients who have participated in another clinical trial three months ago .
    9. Pregnant or breastfeeding women.
    10. Patients treated with tricyclic antidepressants, phenothiazines, β -blockers, and angiotensin converting enzyme inhibitors (ACEIs) .
    11. Difficulty/Impossibility to attend the visits.
    12.Lack of collaboration or refusal to participate in the study.
    1.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.
    2.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.
    3.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.
    4.Pacientes con historia previa de anafilaxias.
    5.Pacientes con urticaria crónica.
    6.Pacientes con dermatitis atópica moderada-severa
    7.Pacientes con malformaciones del tracto respiratorio superior con clínica relevante.
    8.Pacientes que hayan participado en otro ensayo clínico 3 meses antes.
    9.Mujeres embarazadas o en período de lactancia.
    10.Pacientes en tratamiento con antidepresivos tricíclicos, fenotiazinas, beta-bloqueantes, e inhibidores del enzima convertidor de angiotensina (IECAs).
    11.Paciente que no pueda acudir a las visitas.
    12.Falta de colaboración o negativa a participar por parte del paciente.
    E.5 End points
    E.5.1Primary end point(s)
    The number, rate and severity of adverse reactions with reference to
    the number of patients and number of administrations received in the
    study
    Número, porcentaje y severidad de las reacciones adversas con
    referencia al número de pacientes y número de administraciones
    recibidas por cada uno de ellos en el estudio
    E.5.1.1Timepoint(s) of evaluation of this end point
    -throughout the study
    -Durante la vigencia del estudio
    E.5.2Secondary end point(s)
    -Difference in the immunoglobulins levels: specific IgE, total IgG and
    IgG4 in each group, between V0 and VF.
    -Difference in the immunoglobulins levels: specific IgE, total IgG and
    IgG4 obtained in VF comparing treatment versus placebo group.
    diferencia obtenida en los niveles de
    inmunoglobulinas: IgE específica, IgG total e IgG4 entre V0 y VF
    intragrupo.
    -Diferencia en los niveles de inmunoglobulinas: IgE específica, IgG total
    e IgG4 obtenidos en la VF entre el grupo de tratamiento y el grupo
    control.
    E.5.2.1Timepoint(s) of evaluation of this end point
    At the end of the clinical trial
    Al finalizar el ensayo clínico
    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 No
    E.8.1.1Randomised No
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial1
    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 concerned4
    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
    1 week after LVLS
    1 semana después del LPLV
    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 months5
    E.8.9.1In the Member State concerned days15
    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: 52
    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 No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    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 state52
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    Patients will have the chance to continue with the inmunotherapy once the trial is over, when this is advisable for medical criterion.
    Los pacientes tendrán la posibilidad de continuar con la inmunoterapia una vez finalizado el ensayo, cuando esto sea aconsejable por criterio médico.
    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 Decision2015-02-20
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-07-09
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2016-03-11
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    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
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