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    Summary
    EudraCT Number:2013-003270-28
    Sponsor's Protocol Code Number:VB-02-DFLOP
    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:2013-10-22
    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 number2013-003270-28
    A.3Full title of the trial
    Biological standardization of allergenic extracts of Dermatophagoides farinae and Lolium perenne. Open label. Single Center. Phase II Study.
    Estandarización biológica de extractos alergénicos de Dermatophagoides farinae y Lolium perenne.. Estudio clínico Fase II. Abierto. Monocéntrico.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Biological standardization of allergenic extracts of Dermatophagoides farinae and Lolium perenne.
    Estandarización biológica de extractos alergénicos de Dermatophagoides farinae y Lolium perenne.
    A.3.2Name or abbreviated title of the trial where available
    Biological standardization of Dermatophagoides farinae and Lolium perenne.
    Estandarización biológica de Dermatophagoides farinae y Lolium perenne.
    A.4.1Sponsor's protocol code numberVB-02-DFLOP
    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 SponsorInstituto de Inmunología y Alergia INMUNAL S.A..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 supportInstituto de Inmunología y Alergia INMUNAL S.A.U.
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationInstituto de Inmunología y Alergia INMUNAL S.A..U.
    B.5.2Functional name of contact pointIsabel Conde
    B.5.3 Address:
    B.5.3.1Street AddressAvda. Punto Es, 12
    B.5.3.2Town/ cityAlcalá de Henares (Madrid)
    B.5.3.3Post code28805
    B.5.3.4CountrySpain
    B.5.4Telephone number0034918305916
    B.5.5Fax number0034918305912
    B.5.6E-mailiconde@inmunal.es
    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 nameDermatophagoides farinae
    D.3.2Product code DF
    D.3.4Pharmaceutical form Concentrate and solvent for cutaneous solution
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPCutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNDermatophagoides farinae
    D.3.9.3Other descriptive nameDERMATOPHAGOIDES FARINAE
    D.3.9.4EV Substance CodeSUB29199
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeup to
    D.3.10.3Concentration number1.57
    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 nameLolium perenne
    D.3.2Product code LP
    D.3.4Pharmaceutical form Concentrate and solvent for cutaneous solution
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPCutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNLolium perenne
    D.3.9.3Other descriptive nameLOLIUM PERENNE POLLEN
    D.3.9.4EV Substance CodeSUB35900
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeup to
    D.3.10.3Concentration number0.67
    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: 3
    D.1.2 and D.1.3IMP RoleComparator
    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 nameHISTAMINE DIHYDROCHLORIDE
    D.3.2Product code HD
    D.3.4Pharmaceutical form Concentrate and solvent for cutaneous solution
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPCutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNHistamine dihydrochloride
    D.3.9.1CAS number 56-92-8
    D.3.9.2Current sponsor codeHD
    D.3.9.3Other descriptive nameHISTAMINE DIHYDROCHLORIDE
    D.3.9.4EV Substance CodeSUB12022MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    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
    Biological standardization for allergenic extracts in patients with
    hipersensibility to extracts.
    Estandarización biológica de extractos alergénicos en pacientes con
    hipersensibilidad a los extractos.
    E.1.1.1Medical condition in easily understood language
    Determination of biological activity of allergenic extracts in patients with
    hipersensibility.
    Determinacion de la actividad biológica de extractos alergénicos en
    pacientes con hipersensibilidad.
    E.1.1.2Therapeutic area Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Diagnosis [E01]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level HLGT
    E.1.2Classification code 10001708
    E.1.2Term Allergic conditions
    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
    The biological characterization of allergen extracts.
    La caracterización biológica de extractos alergénicos.
    E.2.2Secondary objectives of the trial
    - To determine the specificity of extracts in patients with hipersensibility.
    - To determine the optimal dose of the allergen extract on skin test.
    - Determinar la especificidad de los extractos en pacientes con
    hipersensibilidad.
    - Estimar la dosis óptima de extracto alergénico en el diagnóstico
    mediante prueba Prick test.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Informed consent signed and dated by the patient/witness.
    - Patients living in an area where the allergen is considered as a relevant
    health problem.
    - Medical history supporting the allergy to the allergen.
    - Positive diagnosis to the allergen
    - Specific IgE positive for any of the allergens
    - Age range between 18 and 64 years old for both genders
    -Negative pregnancy test for fertile women
    - Consentimiento informado firmado y fechado por el paciente.
    - Pacientes que residan en un área donde el alérgeno es un problema
    relevante de salud
    - Historia clínica previa que apoye el diagnostico de alergia
    - Diagnostico positivo al alérgeno
    - Prueba para IgE específica positiva para alguno de los 4 alérgenos a
    ensayar.
    - Edad entre 18 y 64 años, sin importar el sexo.
    - Test de embarazo negativo en orina para mujeres en edad fértil.
    E.4Principal exclusion criteria
    - Patients who had received previous immunotherapy within the previous
    2 years
    - Patients who had received within the previous 15 day sany intake of
    drugs able to interfere in the Skin Prick test (e.g. anti histaminic, topic
    corticoids, ? blockers or tryciclic antidepresives).
    - Pregnant women or breast feeding
    - Patients who has received systemic corticoids (dose greater than 30 mg
    prednisone/day) for longer than a week.
    - Patients with cutaneous reactions which can modify the response (e.g.
    Dermographism, dermatitis, severe asthma, hipersensibility to phenol or
    any of the components of the prick test)
    - Pacientes que hayan recibido inmunoterapia en los 2 años anteriores
    - Administracion en los 15 días anteriores al estudio de fármacos
    antihistaminicos, bloqueantes de receptores ?, corticoides tópicos o
    antidepresivos triciclicos
    - Administracion de corticoides sistemicos (dosis mayor de 30 mg
    prednisona/día) durante mas de 7 días
    - Cualquier proceso cutáneo que altere la respuesta (p.e. dermografismo,
    dermatitis, asma severa, hipersensibilidad al fenol o algun componente
    del prick test)
    - Mujeres embarazadas o lactantes
    E.5 End points
    E.5.1Primary end point(s)
    Cutaneous reaction to the extract
    Respuesta cutanea al extracto
    E.5.1.1Timepoint(s) of evaluation of this end point
    30 minutes
    30 minutos
    E.5.2Secondary end point(s)
    Not applicable
    No aplica
    E.5.2.1Timepoint(s) of evaluation of this end point
    Not applicable
    No aplica
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis Yes
    E.6.2Prophylaxis No
    E.6.3Therapy No
    E.6.4Safety No
    E.6.5Efficacy No
    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
    Standardization of the allergen extracts.
    Estandarizacion biológica de los extractos alergénicos
    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 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 Yes
    E.8.2.3.1Comparator description
    Control positivo de histamina
    Positive control of histamine
    E.8.2.4Number of treatment arms in the trial1
    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
    When the 50 patients have been included and received the allergen
    extracts.
    Cuando los 50 pacientes hayan sido incluidos y reciban los extractos.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    E.8.9.1In the Member State concerned months3
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial months3
    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.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 Decision2014-01-27
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-10-04
    P. End of Trial
    P.End of Trial StatusCompleted
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