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    Summary
    EudraCT Number:2013-001728-20
    Sponsor's Protocol Code Number:AV-X-02
    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:2013-09-05
    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 number2013-001728-20
    A.3Full title of the trial
    An open trial to assess the tolerability of AVANZ® Salsola immunotherapy
    Ensayo abierto para evaluar la tolerabilidad de la inmunoterapia con AVANZ® Salsola
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Assesment of the tolerability of AVANZ® Salsola immunotherapy
    Evaluación de la tolerabilidad de la inmunoterapia con AVANZ® Salsola
    A.4.1Sponsor's protocol code numberAV-X-02
    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 pointDepartamento Médico
    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 number+34913276127NA
    B.5.5Fax number+34913276128NA
    B.5.6E-mailPilar.Rico@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 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 nameAVANZ Salsola kali
    D.3.4Pharmaceutical form Suspension 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 INNSalsola kali
    D.3.9.3Other descriptive nameSALSOLA KALI L.
    D.3.9.4EV Substance CodeSUB29880
    D.3.10 Strength
    D.3.10.1Concentration unit SQU/ml Standardised Quality Unit(s)/millilitre (Deprecated)
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number600 to 3000
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Allergic rhinoconjunctivitis with or without asthma due to sensitisation to Salsola kali pollen
    Rinoconjuntivitis alérgica con o sin asma debido a la sensibilización al polen de Salsola kali
    E.1.1.1Medical condition in easily understood language
    Allergy to Salsola kali pollen
    Alergia al polen de Salsola kali
    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 16.1
    E.1.2Level PT
    E.1.2Classification code 10039085
    E.1.2Term Rhinitis allergic
    E.1.2System Organ Class 10038738 - Respiratory, thoracic and mediastinal 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 assess the tolerability of the up-dosing phase of AVANZ® Salsola kali. The frequency of patients with investigational medicinal product (IMP)-related adverse events (AEs) will be the primary endpoint.
    Valorar la tolerabilidad de la fase de incremento de dosis de AVANZ® Salsola kali. El criterio de valoración principal será la frecuencia de pacientes con acontecimientos adversos (AAs) relacionados con los productos en investigación.
    E.2.2Secondary objectives of the trial
    Frequency of patients with systemic reactions according to EAACI classification for the investigational medicinal procuct.
    Increase in IgG4 and IgE for Salsola kali
    Reduction in immediate skin reactivity for Salsola kali
    Frecuencia de pacientes con reacciones sistémicas de acuerdo a la clasificación de la EAACI con el producto en investigación.
    Aumento de IgG4 e IgE frente a Salsola kali.
    Reducción de la reactividad cutánea inmediata frente a Salsola kali.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1.Male and female patients 18-65 years of age.
    2.A clinical history of Salsola kali pollen induced allergic rhinoconjunctivitis with or without asthma at least one year prior to trial entry.
    3.Positive SPT to Salsola kali pollen (wheal diameter > 3 mm).
    4.Documenting in the last 5 years a positive specific IgE against Salsola kali pollen (>=Class 2; >=0.70 KU/L).
    1.Pacientes de ambos sexos con edades comprendidas entre 18 y 65 años.
    2.Antecedentes clínicos de rinoconjuntivitis inducida por el polen de Salsola kali, con o sin asma, desde al menos un año antes de su inclusión en el ensayo.
    3.SPT positivo al extracto alergénico de polen de Salsola kali (diámetro de la pápula > 3 mm).
    4.IgE específica positiva frente a Salsola kali (>= IgE Clase 2; >= 0.70 KU/L) documentada en los últimos 5 años.
    E.4Principal exclusion criteria
    1.FEV1 < 70% of predicted value at screening after adequate pharmacologic treatment.
    2.Uncontrolled or severe asthma.
    3.History of severe asthma exacerbation or emergency room visit or admission for asthma in the previous 12 months.
    4.At screening, current symptoms of, or treatment for, upper respiratory tract infection, acute sinusitis, acute otitis media or other relevant infection (serous otitis media is not an exclusion criterion).
    5.Treatment with parenteral corticosteroids, oral corticosteroids or anti-IgE in the previous 3 months or during the study (except for steroids if needed as rescue medication).
    6.Currently treated with angiotensin converting enzyme (ACE) inhibitors, tricyclic antidepressants, ?-blockers, mono amine oxidase inhibitors (MAOIs) and any other drug containing alum (e.g. antacids) taken on a daily basis.
    7.Immunotherapy with Salsola kali pollen extracts within the previous 5 years
    8.Concomitant immunotherapy with any other allergen
    1.FEV1 < 70% del valor teórico en la selección tras tratamiento farmacológico adecuado.
    2.Asma grave o no controlado.
    3.Antecedentes de exacerbación grave de asma o visita a urgencias por asma en los 12 meses anteriores
    4.En la selección, síntomas de, o tratamiento para: infección del tracto respiratorio superior, sinusitis aguda, otitis media aguda u otra infección importante (una otitis media serosa no constituye un criterio de exclusión).
    5.Tratamiento con corticosteroides parenterales, orales, o anti-IgE en los 3 meses anteriores o durante el ensayo (excepto en el caso de los esteroides que sean necesarios como medicación de rescate).
    6.Tratamiento concomitante con inhibidores de la enzima convertidora de la angiotensina (IECA), antidepresivos tricíclicos, betabloqueantes, inhibidores de la mono amino oxidasa (IMAO) y cualquier otro medicamento que contenga aluminio (por ejemplo, antiácidos) tomados diariamente.
    7.Inmunoterapia previa en los 5 años anteriores con extractos de polen de Salsola kali.
    8.Inmunoterapia concomitante con otro alérgeno
    E.5 End points
    E.5.1Primary end point(s)
    Incidence of adverse reactions to Salsola kali AVANZ® immunotherapy.
    Incidencia de reacciones adversas a la inmunoterapia con AVANZ® Salsola kali.
    E.5.1.1Timepoint(s) of evaluation of this end point
    After up-dosing phase and one maintenance dose (6 weeks)
    Después de la fase de inicio y de una dosis de mantenimiento (6 semanas)
    E.5.2Secondary end point(s)
    Difference in Salsola kali IgE and IgG4 levels from baseline to end of trial. Changes in immediate skin response to Salsola allergens from baseline to end of trial by parallel line assay.
    Diferencia entre los valores basales y los valores al final del tratamiento de los niveles de IgE e IgG4 específicos de Salsola kali. Cambio en la reactividad cutánea inmediata a Salsola desde antes de iniciar el tratamiento hasta el final del mismo, medida por ensayo de líneas paralelas.
    E.5.2.1Timepoint(s) of evaluation of this end point
    After up-dosing phase and one maintenance dose (6 weeks)
    Después de la fase de inicio y de una dosis de mantenimiento (6 semanas)
    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 No
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic Yes
    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) 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 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 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 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
    Database lock
    Cierre de la base de datos
    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 months6
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months6
    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.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 Decision2013-11-13
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-09-11
    P. End of Trial
    P.End of Trial StatusCompleted
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