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    Summary
    EudraCT Number:2020-005389-32
    Sponsor's Protocol Code Number:T521-STD-044
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2022-08-05
    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 number2020-005389-32
    A.3Full title of the trial
    Juniperus oxycedrus and Cupressus arizonica allergen extracts. Determination of the in vivo allergenic potency in histamine equivalent units (HEP).
    Extracto alergénico de Juniperus oxycedrus y Cupressus arizonica. Determinación de la potencia alergénica in vivo en unidades equivalentes de histamina (HEP)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    To determine the minimum amount of allergenic extract from Juniperus oxycedrus and Cupressus arizonica that produces a positive skin reaction.
    Determinar la cantidad mínima de extracto alergénico de Juniperus oxycedrus y Cupressus arizonica que produce una reacción cutánea positiva.
    A.4.1Sponsor's protocol code numberT521-STD-044
    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 SponsorInmunotek, S.L.
    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 supportInmunotek S.L.
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationInmunotek, S.L.
    B.5.2Functional name of contact pointMiguel Casanovas; Medical Director
    B.5.3 Address:
    B.5.3.1Street AddressC/ Punto Mobi, 5
    B.5.3.2Town/ cityAlcalá de Henares
    B.5.3.3Post code28805
    B.5.3.4CountrySpain
    B.5.4Telephone number34912908942110
    B.5.5Fax number34916639732
    B.5.6E-mailmcasanovas@inmunotek.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 nameJuniperus oxycedrus 300 µg /mL allergen extract
    D.3.2Product code T521
    D.3.4Pharmaceutical form 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 INNN/A
    D.3.9.1CAS number N/A
    D.3.9.2Current sponsor codeT521
    D.3.9.3Other descriptive nameAllergen extract of Juniperus oxycedrus pollen
    D.3.10 Strength
    D.3.10.1Concentration unit µg/ml microgram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number300
    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 Yes
    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 nameCupressus arizonica 100 µg /mL allergen extract
    D.3.2Product code T523
    D.3.4Pharmaceutical form 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 INNN/A
    D.3.9.1CAS number N/A
    D.3.9.2Current sponsor codeT521
    D.3.9.3Other descriptive nameAllergen extract of Cupressus arizonica pollen
    D.3.10 Strength
    D.3.10.1Concentration unit µg/ml microgram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    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 Yes
    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
    Allergy to Cupressaceae: Juniperus oxycedrus and Cupressus arizonica
    Alergia a cupresáceas: Juniperus oxycedrus y Cupressus arizonica
    E.1.1.1Medical condition in easily understood language
    Allergy to Cupressaceae
    Alergia a cupresáceas
    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 20.0
    E.1.2Level LLT
    E.1.2Classification code 10036019
    E.1.2Term Pollen allergy
    E.1.2System Organ Class 100000004870
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The main objective is to evaluate the concentration of allergenic extract of Juniperus oxycedrus and Cupressus arizonica that elicits a wheal of a equivalent size to that produced by a solution of histamine dihydrochlorohydrochloride at 10 mg/mL.
    El objetivo principal consiste en evaluar la concentración de extracto alergénico de Juniperus oxycedrus y Cupressus arizonica que provoca una pápula de un tamaño equivalente a la producida por una solución de dihidroclorhidrato de histamina a 10 mg/mL.
    E.2.2Secondary objectives of the trial
    N/A
    N/A
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Positive clinical history of inhalant allergy (rhinitis and/or rhinoconjunctivitis and/or asthma) to Juniperus oxycedrus and Cupressus arizonica.
    - A positive prick-test (mean diameter of the wheal greater than or equal to 3 mm) with an extract of the same allergen and/or presence of specific IgE against that allergen.
    - The mean area of the wheal obtained with Histamine dichlorohydrate at 10 mg/mL must be greater than or equal to 7 mm2.
    - Age: Between 18 and 64 years old.
    -Male or female
    - Must be able to give informed consent.
    - Historia clínica positiva de alergia inhalatoria (rinitis y/o rinoconjuntivitis y/o asma) frente a Juniperus oxycedrus y Cupressus arizonica.
    - Un prick-test positivo (diámetro medio de la pápula mayor o igual a 3 mm) con un extracto del mismo alérgeno y/o presencia de IgE específica frente a dicho alérgeno.
    - La media del área de la pápula obtenida con diclorhidrato de Histamina a 10 mg/mL debe ser mayor o igual a 7 mm2.
    - Edad: Comprendida entre 18 y 64 años.
    - Hombre o mujer
    - Deben ser capaces de otorgar el consentimiento informado.
    E.4Principal exclusion criteria
    Subjects outside the age range.
    - Subjects who have previously received immunotherapy in the last 5 years for the treatment of allergen-induced allergic rhinoconjunctivitis or asthma that may interfere with the mixed extract of Juniperus oxycedrus and/or Cupressus arizonica.
    - Subjects with significant symptoms of rhinoconjunctivitis and/or bronchial asthma in whom the suspension of systemic antihistamine treatment is contraindicated.
    - Subjects who have previously presented a severe secondary reaction during the performance of diagnostic skin tests by prick test.
    - Subjects under treatment with ß-blockers.
    - Subjects clinically unstable (acute asthma, febrile, etc.).
    - Subjects with active urticaria lesions, severe active dermographism, severe atopic dermatitis, sunburn, eczema, psoriasis lesions in the area where the prick test is performed (risk of false positives).
    - Subjects with active viral infection by herpes simplex or herpes varicella zoster in the area where the prick test is performed.
    - Subjects with any pathology in which the administration of adrenaline is contraindicated (hyperthyroidism, hypertension, heart disease, etc.).
    - Subjects in a state in which they are unable to cooperate and severe psychiatric disorders.
    - Pregnant women or women at risk of pregnancy and lactating women.
    Sujetos fuera del rango de edad.
    - Sujetos que hayan recibido previamente inmunoterapia en los últimos 5 años para el tratamiento del asma o de la rinoconjuntivitis alérgicas inducidas por alérgenos que pueda interferir con el extracto mezcla de Juniperus oxycedrus y/o Cupressus arizonica.
    - Sujetos con síntomas importantes de rinoconjuntivitis y/o asma bronquial en los cuales la suspensión del tratamiento antihistamínico por vía sistémica sea contraindicada
    - Sujetos que hayan presentado previamente una reacción secundaria grave durante la realización de pruebas cutáneas de diagnóstico mediante prick test.
    - Sujetos en tratamiento con ß-bloqueantes.
    - Sujetos inestables de punto de vista clínico (asma agudo, febril, etc.).
    - Sujetos con lesiones de urticaria activa, dermografismo activo severo, dermatitis atópica severa, quemaduras solares, eczema, lesiones de psoriasis en la zona de realización del prick-test (riesgo de falsos positivos).
    - Sujetos con infección vírica activa por el herpes simplex, o herpes varicela zoster en la zona de realización del prick-test.
    - Sujetos que tengan alguna patología en la que esté contraindicada la administración de adrenalina (hipertiroidismo, HTA, cardiopatía, etc.).
    - Estados del sujeto en que no pueda ofrecer cooperación y trastornos psiquiátricos severos.
    - Mujeres embarazadas o con riesgo de embarazo y mujeres lactantes.
    E.5 End points
    E.5.1Primary end point(s)
    The primary efficacy variable consists of the measurement of the skin wheal area induced after the application of each of the 3 concentrations of the allergenic extract, as well as those induced by the positive (histamine) and negative controls, by using prick test.
    La variable de eficacia primaria consiste la medición del área de la pápula inducida en la piel al aplicar cada una de las 3 concentraciones del extracto alergénico, así como los inducidos por los controles positivos (histamina) y negativo, mediante la prueba del prick test.
    E.5.1.1Timepoint(s) of evaluation of this end point
    The size of the wheal shall be measured 30 minutes after application of the allergen extracts. The data shall be collected on the CRF of each subject and recorded in the database.
    El tamaño de la pápula se medirá transcurridos 30 minutos después de la aplicación de los extractos alergénicos. El dato se recogerá el el CRD de cada sujeto y se registrará en la base de datos
    E.5.2Secondary end point(s)
    N/A
    N/A
    E.5.2.1Timepoint(s) of evaluation of this end point
    30 minutes after the administration of the allergen extract
    30 minutos después de la aplicación del extracto alergénico
    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 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 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
    Diclorhidrato de histamina
    Histamine dichlorohydrate
    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
    The trial will end once the database has been locked.
    El ensayo finalizará una vez se haya cerrado la base de datos
    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 months12
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial months12
    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: 20
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 10
    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 Yes
    F.3.3.7.1Details of other specific vulnerable populations
    Women of childbearing age using contraception and negative pregnancy test
    Mujeres en edad fértil usando contracepción y test de embarazo negativo
    F.4 Planned number of subjects to be included
    F.4.1In the member state30
    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)
    Nonw
    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 Decision2023-03-13
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2022-10-11
    P. End of Trial
    P.End of Trial StatusOngoing
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