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    The EU Clinical Trials Register currently displays   43861   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).

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    Summary
    EudraCT Number:2012-005092-14
    Sponsor's Protocol Code Number:GT-24
    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:2013-01-11
    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 number2012-005092-14
    A.3Full title of the trial
    Molecular and Cellular Mechanism in the course of Immunotherapy with a Phleum pratense oral lyophilisate
    Mecanismos moleculares y celulares implicados en la inmunoterapia con un liofilizado oral de Phleum pratense
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Not applicable
    No aplica
    A.4.1Sponsor's protocol code numberGT-24
    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 SponsorALK-Abelló 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 supportALK-Abelló S. A.
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationALK-Abelló S. A.
    B.5.2Functional name of contact pointClinical Trial Assistant
    B.5.3 Address:
    B.5.3.1Street AddressC/ Miguel Fleta, 19
    B.5.3.2Town/ cityMadrid
    B.5.3.3Post code28037
    B.5.3.4CountrySpain
    B.5.4Telephone number0034913276127348
    B.5.5Fax number0034913276128NA
    B.5.6E-mailSonia.deOrte@alk.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 Yes
    D.2.1.1.1Trade name GRAZAX 75000 SQ-T liofilizado oral
    D.2.1.1.2Name of the Marketing Authorisation holderALK Abello A/S
    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 nameGrazax
    D.3.4Pharmaceutical form Orodispersible tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSublingual use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNExtracto alergénico de polen de Phleum pratense
    D.3.9.3Other descriptive namePHLEUM PRATENSE POLLEN
    D.3.9.4EV Substance CodeSUB35149
    D.3.10 Strength
    D.3.10.1Concentration unit SQU Standardised Quality Unit(s) (Deprecated)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number75000
    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 placeboOrodispersible tablet
    D.8.4Route of administration of the placeboSublingual use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Treatment of grass pollen induced rhinitis and conjunctivitis in adult patients with clinically relevant symptoms and diagnosed witha positive skin-prick test and / or specific IgE test to grass pollen.
    Tratamiento de la rinitis y de la rinoconjuntivitis inducida por polen de gramíneas en pacientes adultos con síntomas clínicamente relevantes y diagnosticados mediante prueba cutánea de prick positiva y / o test de IgE específica a polen de gramíneas.
    E.1.1.1Medical condition in easily understood language
    Ocular and nasal symptoms caused by grass allergy in adult patients with relevant symptoms and diagnosed by specific testing.
    Tratamiento de lo síntomas oculares y nasales causados por la alergia al polen de gramíneas en pacientes adultos con síntomas relevantes y diagnosticados mediante pruebas específicas.
    E.1.1.2Therapeutic area Diseases [C] - Respiratory Tract Diseases [C08]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 15.1
    E.1.2Level LLT
    E.1.2Classification code 10001726
    E.1.2Term Allergic rhinitis due to pollen
    E.1.2System Organ Class 100000004855
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To identify changes in immunological markers measured in grass allergic subjects during treatment with Grazax.
    Identificar cambios en los marcadores inmunológicos medidos en sujetos alérgicos al polen de gramíneas durante el tratamiento con Grazax.
    E.2.2Secondary objectives of the trial
    To identify changes in immunological markers occurring at early time points during immunotherapy treatment.
    To identify markers which correlate with safety parameters.
    To identify markers which correlate with perceived efficacy as assessed by a visual analogical scale (VAS).
    Identificar cambios en los marcadores inmunológicos que ocurren durante el inicio del tratamiento con inmunoterapia.
    Identificar los marcadores que se correlacionan con parámetros de seguridad.
    Identificar los marcadores que se correlacionan con la eficacia percibida según la evaluación de una escala análogica visual (VAS).
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1.A history of relevant rhinitis or rhinoconjunctivitis with or without asthma due to grass pollen since at least the pollen season prior to trial entry (GPS 2012).
    2.Documented positive specific IgE against Phl p 5 (above or equal to IgE Class 2, above or equal to 0.70 kU/l).
    3.Positive Skin Prick Test (SPT) response (wheal diameter above or equal 3 mm) to Phleum pratense (ALK-Abelló).
    1.Historia clínica de alergia (rinoconjuntivitis y / o asma) por sensibilización al polen de gramíneas desde al menos la estación polínica previa (2012).
    2.IgE sérica positiva al polen de gramíneas (CAP clase 2 o superior o equivalente).
    3.Prueba cutánea positiva a Phleum pratense mediante skin prick test (SPT) con un diámetro de la pápula mayor o igual a 3 mm.
    E.4Principal exclusion criteria
    1.Previous treatment by immunotherapy with grass allergen extracts.
    2.Ongoing treatment with any allergen specific immunotherapy product.
    3.Previous or ongoing treatment with Omalizumab, mono amine oxidase (MAO) inhibitors or tricyclic antidepressant medication.
    1.Inmunoterapia previa con polen de gramíneas.
    2.Estar recibiendo algún tratamiento alérgeno-específico en el momento de la inclusión.
    3.Tratamientos previos o en curso con Omazilumab, inhibidores de la enzima mono amino oxidasa (MAO) o antidepresivos tricíclicos.
    E.5 End points
    E.5.1Primary end point(s)
    Immunological markers:
    Pre to post treatment change in immunological markers and differences versus placebo.
    Marcadores inmunológicos:
    Cambio en los marcadores inmunológicos antes y despues del tratamiento y diferencias frente a placebo.
    E.5.1.1Timepoint(s) of evaluation of this end point
    The control time is defined as: Visit 8 (2 years after treatment initiation)
    El momento de evaluación del ensayo se define como: Visita 8 (2 años después del inicio del tratamiento)
    E.5.2Secondary end point(s)
    Pre to 1 month treatment changes in immunological markers.
    Group comparison in changes in immunological markers in relation to (systemic) adverse reactions and VAS.
    Safety endpoints:
    Frequency of: AEs and SAEs.
    ESIs
    Vital signs
    Cambio en los marcadores inmunológicos antes y hasta un mes del tratamiento.
    Comparación en los marcadores inmunológicos en relación a reacciones adversas (sistémicas) y escala visual analógica (EVA)
    Criterios de valoración de seguridad:
    Frecuencia de: Efectos adversos y eventos adversos graves.
    ESIs.
    Signos vitales
    E.5.2.1Timepoint(s) of evaluation of this end point
    1, 4, 9, 12, 21, 24, 25, 28, 33 and 36 months after treatment initiation.
    Después de: 1, 4, 9, 12, 21, 24, 25, 28, 33 y 36 meses del inicio del 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 No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    Inmunological mechanisms of Grazax.
    Mecanismos inmunológicos de Grazax.
    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) No
    E.7.4Therapeutic use (Phase IV) Yes
    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 Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    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
    End of trial is defined as database closure: Approximately 3 months after Last Subject Last Visit.
    El final del ensayo se define como el cierre de la base de datos: aproximadamente 3 meses después de la ultima visita del último paciente.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    E.8.9.1In the Member State concerned months7
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months7
    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: 50
    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 50
    F.4.2.2In the whole clinical trial 50
    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
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2013-03-12
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-01-10
    P. End of Trial
    P.End of Trial StatusCompleted
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