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    Summary
    EudraCT Number:2022-000615-31
    Sponsor's Protocol Code Number:DIA-EC-Cupa1-01-22
    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:2022-02-24
    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 number2022-000615-31
    A.3Full title of the trial
    Multicenter, double-blind, randomized, placebo-controlled phase III clinical trial in parallel groups which evaluates the clinical efficacy and safety of immunotherapy with the purified major allergen Cup a 1, in patients with moderate/severe allergic rhino conjunctivitis with or without controlled asthma, sensitized to Cupressaceae
    Ensayo clínico fase III multicéntrico, doble ciego, aleatorizado y controlado con placebo, en grupos paralelos, que evalúa la eficacia clínica y seguridad de la inmunoterapia con el alérgeno mayor purificado Cup a 1, en pacientes con rinoconjuntivitis alérgica moderada/ grave con o sin asma controlado, sensibilizados a Cupresáceas
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Clinical trial developed at various hospitals where each patient randomly receive in parallel groups either placebo or treatment. Nor patients or investigators will know what the patient it's being given. This clinical trial evaluates efficacy and safety of the immunotherapy with allergen “Cup a 1” (major protein in Cupressus arizónica) in patients with allergic rhinoconjunctivitis with or without asthma sensitized to Cupressaceae pollen
    Ensayo clínico en varios centros, donde los pacientes reciben en paralelo aleatoriamente el tratamiento o el placebo (control). Ni investigadores ni pacientes sabrán qué tratamiento están recibiendo. El ensayo clínico evalúa eficacia clínica y seguridad de la inmunoterapia con el alérgeno “cup a 1” (proteína mayoritaria de Cupressus arizónica), en pacientes con rinoconjuntivitis alérgica con o sin asma, sensibilizados al polen de las Cupresáceas
    A.4.1Sponsor's protocol code numberDIA-EC-Cupa1-01-22
    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 SponsorDiater Laboratorio de Diagnósticos y Aplicaciones Terapéuticas
    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 supportDiater Laboratorio de Diagnósticos y Aplicaciones Terapéuticas
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationDiater Laboratorio de Diagnósticos y Aplicaciones Terapéuticas
    B.5.2Functional name of contact pointClinical Trial Departament
    B.5.3 Address:
    B.5.3.1Street AddressAv. Gregorio Peces Barba, 2, Parque Tecnológico de Leganés
    B.5.3.2Town/ cityLeganés, Madrid
    B.5.3.3Post code28918
    B.5.3.4CountrySpain
    B.5.4Telephone number0034914966013
    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 nameCup a 1 purified and isolated protein
    D.3.2Product code Cup a 1 MOL
    D.3.4Pharmaceutical form Solution for injection in vial
    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 INNCup a 1 purified an isolated protein
    D.3.9.3Other descriptive nameMajor allergen Cup a 1
    D.3.10 Strength
    D.3.10.1Concentration unit µg/ml microgram(s)/millilitre
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number3 to 7
    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 placeboSolution for injection in vial
    D.8.4Route of administration of the placeboSubcutaneous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Allergic patients to the Cupressaceae pollen with moderate/severe allergic rhino conjunctivitis with or without controlled asthma
    Pacientes alérgicos al polen de las Cupresáceas con rinoconjuntivitis alérgica moderada o grave, con o sin asma controlado
    E.1.1.1Medical condition in easily understood language
    Allergic patients to the Cupressaceae pollen with moderate/severe allergic rhino conjunctivitis with or without controlled asthma
    Pacientes alérgicos al polen de las Cupresáceas con rinoconjuntivitis alérgica moderada o grave, con o sin asma controlado
    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 10001728
    E.1.2Term Allergic rhinoconjunctivitis
    E.1.2System Organ Class 100000004853
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Assessment of efficacy of specific immunotherapy with the purified and isolated protein Cup a 1 administered subcutaneously in patients sensitized to the allergen under study.
    Evaluar la eficacia de la inmunoterapia específica con la proteína purificada y aislada Cup a 1 administrada subcutáneamente en pacientes sensibilizados al alérgeno en estudio.
    E.2.2Secondary objectives of the trial
    • Analysis of additional efficacy parameters to the combined index of symptom frequency and severity score together with rescue medication consumption score.
    • Evaluate the variation of follow-up skin tests with Cupressaceae and Cup a 1 extracts.
    • Control of asthma and allergic rhinitis assessment, using the ACT and the modified ARIA scale.
    • Patient's health status assessment using the VAS scale.
    • Quality of life evaluation according to rhinitis (ESPRINT-15).
    • Evaluate the immunological markers related to efficacy: IL-10, IL-13, INF-ƴ, IgG4, total IgE and specific IgE against Cupressus arizonica and Cup a 1.
    • Evaluate the degree of tolerance against conjunctival provocation with Cupressaceae extract.
    • Evaluation of the safety of the treatment, through the registry of AA and AAG.
    • Análisis de parámetros de eficacia adicionales al índice combinado de puntuación de frecuencia y gravedad de síntomas junto a puntuación de consumo de medicación de rescate
    • Evaluar la variación de las pruebas cutáneas de seguimiento con los extractos de Cupressaceae y Cup a 1.
    • Evaluar el control del asma y la rinitis alérgica, mediante ACT y escala ARIA modificada.
    • Evaluar el estado de salud del paciente mediante la escala EVA.
    • Evaluar la calidad de vida acorde a la Rinitis (ESPRINT-15).
    • Evaluar los marcadores inmunológicos relacionados con la eficacia: IL-10, IL-13, INF-ƴ, IgG4, IgE total e IgE específica frente a Cupressus arizónica y Cup a 1.
    • Evaluar el grado de tolerancia frente a provocación conjuntival con extracto de Cupresáceas.
    • Evaluación de la seguridad del tratamiento, mediante el registro de AA y AAG.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Male or female from 12 to 65 years of age included.
    2. Obtaining informed consent to participate in the study, as well as guardians or legal representatives, in case of minor.
    3. Moderate or severe allergic rhinitis or rhinoconjunctivitis, according to the modified ARIA classification, with or without controlled asthma, by demonstrated sensitization to Cupressaceae.
    4. Cupressus or Cup a 1 IgE levels greater or equal than 2 kU/l (classes 3 to 6).
    5. Positive skin prick test (≥3 mm in diameter) with Diater extract for Cupressaceae and Cup at 1.
    6. Clinically relevant symptoms against cupresaceae.
    7. Willingness to comply with all protocol requirements and availability for follow-up throughout the duration of the trial.
    8. Negative urine pregnancy test for women of childbearing potential (fertile from menarche to postmenopause, unless sterilized due to hysterectomy, bilateral salpingectomy, and bilateral oophorectomy) and willing to use effective contraception from 14 days before the first administration until 30 days after the last investigational product administration.
    1. Sujetos de ambos sexos, de edades entre 12 a 65 años inclusive.
    2. Obtención del consentimiento informado para participar en el estudio, así como los tutores o representantes legales, si es menor de edad
    3. Rinitis o Rinoconjuntivitis alérgica, moderada ó grave, de acuerdo con la clasificación ARIA modificada, con o sin asma controlada por sensibilización demostrada a Cupresáceas.
    4. Niveles de IgE Cupressus ó Cup a 1 mayor o igual que 2 kU/l (clases 3 a 6).
    5. Prueba cutánea Prick positiva (≥3 mm de diámetro) con extracto Diater para Cupressaceae y Cup a 1.
    6. Síntomas clínicamente relevantes frente a cupresáceas.
    7. Voluntad para cumplir con todos los requerimientos del protocolo y disponibilidad para el seguimiento mientras dure el ensayo.
    8. Test de embarazo negativo en orina para mujeres potencialmente fértiles (se entiende por fértil desde la menarquia hasta la posmenopausia, a menos que haya sido esterilizada debido a una histerectomía, salpingectomía bilateral y ooforectomía bilateral) y dispuestas a usar un método anticonceptivo efectivo desde 14 días antes de la primera administración hasta 30 días después de la última administración de producto en investigación
    E.4Principal exclusion criteria
    1. Clinically relevant polysensitization: epithelia if they coexist with animals, mites, fungi and pollens at the investigator's discretion.
    2. Nasal or paranasal recent or scheduled pathology or surgery that may interfere with the trial, such as polyposis, at the investigator's discretion.
    3. Uncontrolled serious systemic diseases, such as autoimmune, cardiovascular, hyperthyroidism, liver disease or kidney failure, malignant tumours or chronic infection.
    4. Uncontrolled asthma despite optimal pharmacological treatment.
    5. Having received immunotherapy to cupresaceae or phylogenetically related allergens in the 5 years prior to the start of the trial.
    6. Being in concomitant treatment with another immunotherapy against other allergens during the trial.
    7. Adrenaline use contraindication.
    8. Active tuberculosis.
    9. Severe atopic eczema.
    10. Dermographism, pathologies or skin alterations that interfere with the evaluation of skin tests.
    11. Psychiatric disorder that prevents adequate compliance with the immunotherapy program.
    12. Pregnant or lactating woman.
    13. Simultaneous participation in another clinical trial.
    14. Any disease that interferes with the absorption or elimination of the investigational products.
    15. Chronic abuse of alcohol or any other type of substance that, in the opinion of the investigator, may interfere with the trial
    1. Polisensibilización clínicamente relevante: epitelios si conviven con animales, ácaros, hongos y pólenes clínicamente relevantes a criterio del investigador.
    2. Patología o cirugía nasales ó paranasal reciente o programada que pueda interferir en el ensayo, como por ejemplo poliposis, a criterio del investigador.
    3. Enfermedades sistémicas graves no controladas, tales como autoinmunes, cardiovasculares, hipertiroidismo, enfermedad hepática o insuficiencia renal, tumores malignos o infección crónica.
    4. Asma no controlado a pesar de un tratamiento farmacológico óptimo.
    5. Haber recibido inmunoterapia a cupresáceas o alérgenos relacionados filogenéticamente en los 5 años previos al comienzo del ensayo.
    6. Estar en tratamiento concomitante con otra inmunoterapia frente otros alérgenos durante el ensayo.
    7. Contraindicación de uso de adrenalina.
    8. Tuberculosis activa.
    9. Eczema atópico severo.
    10. Dermografismo, patologías o alteraciones cutáneas que interfieran con la evaluación de las pruebas cutáneas.
    11. Trastorno psiquiátrico que impida el adecuado cumplimiento del programa de inmunoterapia.
    12. Mujer embarazada o en periodo de lactancia.
    13. Participación simultánea en otro ensayo clínico.
    14. Cualquier enfermedad que interfiera en la absorción o eliminación de los productos en investigación.
    15. Abuso crónico de alcohol o algún otro tipo de sustancia que, a criterio del investigador, pueda interferir en el ensayo
    E.5 End points
    E.5.1Primary end point(s)
    The efficacy of the treatment will be evaluated based on the symptom frequency and severity score together with the Combined Symptom and Medication Score (CSMS), which will be obtained through a questionnaire completed by the patient during 2 pollen seasons.
    La eficacia del tratamiento se evaluará en base a la puntuación de frecuencia y gravedad de síntomas junto a puntuación de consumo de medicación de rescate (CSMS, por sus siglas en inglés Combined Symptom and Medication Score), que se obtendrá mediante un cuestionario completado por el paciente durante 2 estaciones polínicas.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Visits V8, V9, V10, V20, V21 and V22 matching visits with January, February and march 2023 and 2024 (polinic season)
    Visitas V8, V9, V10, V20, V21 y V22 visitas coincidentes con enero, febrero y marzo de 2023 y 2024 (estaciones polínicas)
    E.5.2Secondary end point(s)
    1.Symptom frequency and severity score. Results are compared between treatment groups and between pollen seasons.
    2.Score for Rescue medication use.
    3.Symptom-free days.
    4.Medication-free days.
    5.Extra visits and/or emergencies during the period of the clinical trial related to the pathology under study.
    6.Skin follow-up skin test with Cupressaceae extract and Cup a 1.
    7.Asthma and allergic rhinitis control assessed by ACT and modified ARIA
    8.Visual Analog Scale (VAS) for the state of health performed by the patient.
    9.ESPRINT-15 questionnaire evaluation.
    10.Evaluation of immunological markers: IL-10, IL-13, INF-ƴ, specific IgE and specific IgG4 against Cupressus arizonica and Cup a 1.
    11.Conjunctival provocation against cupresaceae.
    12.Frequency of adverse events (AEs), serious AAs (SAEs) and ADRs, particularly systemic events according to the World Allergy Organization (WAO) 2010 classification.
    1.Puntuación de frecuencia y gravedad de los síntomas. Se comparan los resultados entre grupos de tratamiento y entre estaciones polínicas.
    2.Puntación de uso de medicación de rescate.
    3.Días libres de síntomas.
    4.Días libres de medicación.
    5.Visitas extras y/o urgencias durante el periodo del ensayo clínico relativo a la patología en estudio.
    6.Prueba cutánea de seguimiento con el extracto de Cupressaceae y Cup a 1.
    7.Control del asma y la rinitis alérgica, mediante ACT y escala ARIA modificada
    8.Escala Visual Analógica (EVA) para el estado de salud realizada por el paciente.
    9.Valoración del cuestionario ESPRINT-15.
    10.Evaluación de marcadores inmunológicos: IL-10, IL-13, INF-ƴ, IgE específica e IgG4 especificas frente a Cupressus arizónica y Cup a 1.
    11.Provocación conjuntival frente a cupresáceas.
    12.Frecuencia de acontecimientos adversos (AA)s, AA graves (AAG)s y de RAs, particularmente las sistémicas según graduación de la World Allergy Organization (WAO) 2010
    E.5.2.1Timepoint(s) of evaluation of this end point
    1.Visits V8, V9, V10, V20, V21 and V22 matching visits with January, February and march 2023 and 2024
    2.Visits V8, V9, V10, V20, V21 and V22 matching visits with January, February and march 2023 and 2024
    3.Daily during 50 days during the two pollen seasons
    4.Daily during 50 days during the two pollen seasons
    5.Throughout the study
    6.V0, V11 y V27
    7. SCR, V11 y V27
    8.SCR and Visits V8, V9, V10, V20, V21, V22 and matching visits with January, February and march 2023 and 2024
    9.SCR y Visitas V8, V9, V10, V20, V21, V22 and matching visits with January, February and march 2023 and 2024
    10.V0, V3, V7, V11 and V27
    11.SCR, V11( matching visit with April 2023) and V27
    12.Throughout the study
    1.Visitas V8, V9, V10, V20, V21 y V22 visitas coincidentes con enero, febrero y marzo de 2023 y 2024
    2. Visitas V8, V9, V10, V20, V21 y V22 visitas coincidentes con enero, febrero y marzo de 2023 y 2024
    3.50 días seguidos en dos estaciones polínicas
    4.50 días seguidos en dos estaciones polínicas
    5.Durante todo el estudio
    6.V0, V11 y V27
    7. SCR, V11 y V27
    8.SCR y Visitas V8, V9, V10, V20, V21 y V22 visitas coincidentes con enero, febrero y marzo de 2023 y 2024
    9.SCR y Visitas V8, V9, V10, V20, V21 y V22 visitas coincidentes con enero, febrero y marzo de 2023 y 2024
    10.V0, V3, V7, V11 y V27
    11.SCR, V11(visita coincidente con abril 2023) y V27
    12.Durante todo el estudio
    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 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) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    E.7.4Therapeutic use (Phase IV) No
    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 Yes
    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 trial3
    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 concerned13
    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 end date of the trial will be the Last Visit date or procedure of the Last Patient.
    La fecha de fin del ensayo será la fecha de última visita o
    procedimiento del último paciente.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months4
    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 Yes
    F.1.1Number of subjects for this age range: 10
    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) Yes
    F.1.1.6.1Number of subjects for this age range: 10
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 140
    F.1.3Elderly (>=65 years) No
    F.1.3.1Number of subjects for this age range: 0
    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 state150
    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 Decision2022-05-26
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2022-05-18
    P. End of Trial
    P.End of Trial StatusOngoing
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