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   43871   clinical trials with a EudraCT protocol, of which   7290   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:2011-000870-79
    Sponsor's Protocol Code Number:101-PG-PSC-186
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2012-01-11
    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 number2011-000870-79
    A.3Full title of the trial
    Prospective study to evaluate the safety of a 4-month treatment with Depigoid® Dermatophagoides pteronyssinus or 50% Dermatophagoides pteronyssinus / 50% Dermatophagoides farinae (500 DPP/ml) in patients with allergic rhinitis or rhinoconjunctivitis with or without mild persistent or intermittent asthma.
    ? Estudio prospectivo para evaluar la seguridad de un tratamiento de 4 meses de duración con Depigoid® Dermatophagoides pteronyssinus o Dermatophagoides pteronyssinus 50%/Dermatophagoides farinae 50% (500 DPP/ml) en pacientes con rinitis o rinoconjuntivitis alérgica, con o sin asma intermitente o persistente leve?
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Safety clinical trial with depigmented and polymerized allergenic extracts of Dermatophagoides pteronyssinus or Dermatophagoides pteronyssinus 50%/Dermatophagoides farinae 50% (500 DPP/ml)
    Ensayo clínico de seguridad con extractos alergénicos despigmentados y polimerizados de Dermatophagoides pteronyssinus o Dermatophagoides pteronyssinus 50%/Dermatophagoides farinae 50% (500 DPP/ml)
    A.4.1Sponsor's protocol code number101-PG-PSC-186
    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 SponsorLaboratorios LETI, S.L.U.
    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 supportLaboratorios LETI, S.L.U.
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationHarrison Clinical Research Iberica, SL
    B.5.2Functional name of contact pointElvira Lara
    B.5.3 Address:
    B.5.3.1Street Addressc/Príncep Jordi, 21-23, esc B, entlo 1ªB
    B.5.3.2Town/ cityBarcelona
    B.5.3.3Post code08014
    B.5.3.4CountrySpain
    B.5.4Telephone number0034932266964--
    B.5.5Fax number0034932265833--
    B.5.6E-mailelara@hcrib.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 nameDepigmented and polymerized allergen extract of D.pteronyssinus 100%
    D.3.2Product code 186
    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 INNDepigmented and polimerized allergen extract of D.pteronyssinus 100%
    D.3.10 Strength
    D.3.10.1Concentration unit Other
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number500
    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) No
    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 nameDepigmented and polymerized allergen extract of D.pteronyssinus 50% + D. farinae 50%
    D.3.2Product code 186
    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 INNDepigmented and polymerized allergen extract of D.pteronyssinus 50% + D. farinae 50%
    D.3.10 Strength
    D.3.10.1Concentration unit Other
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number500
    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) No
    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
    Allergic rhinitis or rhinoconjunctivitis with or without mild persistent or intermittent asthma, to Dermatophagoides pteronyssinus or Dermatophagoides pteronyssinus and Dermatophagoides farinae.
    Rinitis o rinoconjuntivitis alérgica, con o sin asma intermitente o persistente leve, a Dermatophagoides pteronyssinus o Dermatophagoides pteronyssinus y Dermatophagoides farinae.
    E.1.1.1Medical condition in easily understood language
    Allergic rhinitis or rhinoconjunctivitis without asthma , or with mild intermittent or persistent asthma, sensitized to house dust mites.
    Rinitis o rinoconjuntivitis alérgica sin asma, o bien con asma intermitente o persistente leve, por sensibilización a los ácaros del polvo doméstico.
    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 14.1
    E.1.2Level LLT
    E.1.2Classification code 10020419
    E.1.2Term House dust mite allergy
    E.1.2System Organ Class 10021428 - Immune system disorders
    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 of a 4-month treatment with an extract of Depigoid® Dermatophagoides pteronyssinus 100% or a mixture of 50% Dermatophagoides pteronyssinus and 50% Dermatophagoides farinae at a concentration of 500 DPP/ml administered following a rush build-up regimen.
    Evaluar la seguridad de un tratamiento de 4 meses de duración con un extracto de Depigoid® Dermatophagoides pteronyssinus 100% o una mezcla 50% Dermatophagoides pteronyssinus y 50% Dermatophagoides farinae, administrado a una concentración de 500 DPP/ml en una pauta de escalado rápida.
    E.2.2Secondary objectives of the trial
    To assess the subjects' immunologic responses to the above treatment
    Valorar la respuesta inmunológica de los pacientes al tratamiento mencionado arriba.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    (1) Men and women between 18 and 55 years of age (both inclusive).
    (2) Individuals suffering symptoms of allergic rhinoconjunctivitis or rhinitis during at least the preceding year -- with or without symptoms of mild persistent or intermittent allergic asthma which is controlled with a dose < or = 400 µg/day budesonide or an equivalent -- caused by a clinically relevant sensitization to house dust mites (Dermatophagoides pteronyssinus or Dermatophagoides pteronyssinus and Dermatophagoides farinae).
    The IgE-mediated sensitization will be demonstrated by means of the following : medical history and IgE specific to house dust mites (D. pteronyssinus or D. pteronyssinus and D. farinae) CAP RAST ? 2 and positive skin prick test. A skin prick test will be considered positive when it produces a wheal of at least 3 mm according to the largest diameter.
    (3) Asthmatic patients must be stable and on a stable inhaled steroid dose within 6 weeks prior to visit 1 and throughout the study.
    (1) Hombres y mujeres de entre 18 y 55 años de edad (ambos incluidos).
    (2) Individuos que padecen síntomas de rinoconjuntivitis o rinitis alérgica durante al menos el año anterior (con o sin síntomas de asma alérgico intermitente o persistente leve controlada con una dosis < ó = 400 µg/día de budesonida o un equivalente ) producidos por una sensibilización a ácaros del polvo doméstico (Dermatophagoides pteronyssinus o Dermatophagoides pteronyssinus y Dermatophagoides farinae) clínicamente relevante.
    La sensibilización mediada por IgE se demostrará teniendo en cuenta:: historia clínica e IgE específica para los ácaros del polvo doméstico (D. pteronyssinus o D. pteronyssinus y D. farinae) CAP RAST ? 2 y prick test positivo. Una prick test se considerará positiva cuando produzca una pápula de al menos 3 mm según el diámetro mayor.
    (3) Los pacientes asmáticos deben estar estables y estar tomando una dosis estable de esteroides inhalada en el plazo de 6 semanas antes de la visita 1 y durante todo el estudio.
    E.4Principal exclusion criteria
    - Any contraindication for treatment with allergen specific immunotherapy
    - Forced expiratory volume in 1 s (FEV1) or peak expiratory flow (PEF) value < 80% of the predicted normal value
    - Allergy symptoms due to sensitization to pollens or other perennial allergens (molds, epithelia)
    - Asthma requiring a dose > 400 µg/day of Budesonide or an equivalent, without long-lasting beta-2 agonists, to reach control according to the Global Initiative for Asthma (GINA 2010)
    - Patients with non controlled bronchial asthma within 3 months prior to Visit 1
    - Patients with asthma who have been treated with systemic steroids within 3 months prior to V1
    - Patients with hospital admission due to asthma exacerbations within 1 year prior to V1
    - Acute or chronic inflammatory or infectious diseases of the airways
    - Chronic structural diseases of the respiratory system
    - Immune system diseases, both autoimmune diseases and immunodeficiency
    - Any disease involving a contraindication for the use of adrenaline
    - Serious uncontrolled diseases
    - Malignant disease with activity in the last 5 years
    - Use of immunotherapy with allergenic extracts of storage or house dust mites in the last 5 years
    - Systemic or topical treatment with beta-blocker drugs 1 week before visit 2
    - Treatment with substances interfering with the immune system 2 weeks before visit 2
    - Use of psychotropic or antidepressants substances 1 week before visit 2
    - Use of systemic corticosteroids 3 months before visit 1
    - Immunization with prophylactic (bacterial or viral) vaccines within 7 days before visit 2
    - Female subjects who are pregnant or nursing and women with a positive pregnancy test at visit 1 or 2
    - Women of childbearing potential not using highly effective methods of birth control
    -Cualquier contraindicación para el tratamiento con inmunoterapia específica de alergeno.
    - Valor de volumen espiratorio forzado en 1 s (VEF1) o flujo espiratorio pico (FEP) < 80 % del valor normal previsto.
    - Síntomas de alergia debido a la sensibilización a pólenes u otros alergenos perennes (mohos, epitelios)
    - Asma que requiere una dosis > 400 ?g/día de budesonida o un equivalente, sin beta-2 agonistas de larga duración, para alcanzar un control según la Global Initiative for Asthma (GINA 2010)
    -Pacientes con asma bronquial no controlada en el plazo de 3 meses antes de la visita 1
    - Pacientes con asma que se han tratado con esteroides sistémicos en el plazo de 3 meses antes de V1
    - Pacientes con ingreso hospitalario debido a agravamiento del asma en el plazo de 1 año antes de V1
    - Enfermedades inflamatorias o infecciosas agudas o crónicas de las vías respiratorias
    - Enfermedades estructurales crónicas del sistema respiratorio
    - Enfermedades del sistema inmunitario, tanto enfermedades autoinmunitarias como inmunodeficiencia.
    - Cualquier enfermedad que implique una contraindicación para el uso de adrenalina
    - Enfermedades graves no controladas
    - Enfermedad maligna con actividad en los últimos 5 años
    - Uso de inmunoterapia con extractos alergénicos de ácaros del polvo doméstico o de almacén en los últimos 5 años
    - Tratamiento sistémico o tópico con fármacos beta bloqueantes 1 semana antes de la visita 2
    - Tratamiento con sustancias que interfieren con el sistema inmunitario 2 semanas antes de la visita 2
    - Uso de sustancias psicotrópicas o antidepresivas 1 semana antes de la visita 2
    - Uso de corticosteroides sistémicos 3 meses antes de la visita 1
    - Inmunización con vacunas profilácticas (bacterianas o virales) en el plazo de 7 días antes de la visita 2
    - Mujeres que están embarazadas o en periodo de lactancia y mujeres con una prueba de embarazo positiva en la visita 1 ó 2
    - Mujeres que puedan tener hijos que no usen métodos altamente eficaces de control de natalidad
    E.5 End points
    E.5.1Primary end point(s)
    Safety:
    Local and systemic adverse reactions (EAACI classification); adverse events.
    Seguridad:
    reacciones adversas locales y sistémicas (clasificación EAACI); acontecimientos adversos.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Safety: Reactions within 48h after treatment; Adverse events during study plus 1 week follow-up.
    Seguridad: Reacciones durante las primeras 48h tras el tratamiento; Acontecimientos adversos durante el estudio más una semana de seguimiento.
    E.5.2Secondary end point(s)
    Efficacy:
    Immunologic response measured by immunological parameters
    Eficacia:
    Respuesta inmune medida mediante parametros inmunológicos.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Efficacy: At screening and 1 week after end of treatment (follow-up visit)
    Eficacia: En la visita de selección y 1 semana tras terminar el tratamiento.
    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 Yes
    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 No
    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 concerned10
    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
    Last visit of the last subject participating in the trial
    Última visita del último paciente que participa en el ensayo.
    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 months11
    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 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: 103
    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 state103
    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)
    Those patients who finish all the procedures of this Clincal Trial will be given the option to continue treatment until its completion (a total of 3 years) in a maintenance regimen of Depigoid at the marketed concentration (100 DPP/ml).
    Aquellos pacientes que terminen todos los procedimientos del ensayo clínico se les dará la opción de continuar el tratamiento hasta su finalización (un total de 3 años) con un régimen de mantenimiento de Depigoid a la concentración comercializada (100 DPP/ml).
    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 Decision2012-02-17
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-02-10
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    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-Sat May 04 15:18:48 CEST 2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA