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    Summary
    EudraCT Number:2006-005911-82
    Sponsor's Protocol Code Number:AL0506st
    National Competent Authority:Germany - PEI
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2006-12-21
    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 ConcernedGermany - PEI
    A.2EudraCT number2006-005911-82
    A.3Full title of the trial
    A multicenter, placebo-controlled, double-blind study to evaluate efficacy and safety of a perennial sublingual specific immunotherapy with a solution of grass pollen allergen extract in children with clinically relevant grass pollen sensitivity in comparison to a symptomatic standard treatment with add on placebo
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A multicenter, placebo-controlled, double-blind study to evaluate efficacy and safety of a perennial sublingual specific immunotherapy with a solution of grass pollen allergen extract in children with clinically relevant grass pollen sensitivity in comparison to a symptomatic standard treatment with add on placebo
    A.4.1Sponsor's protocol code numberAL0506st
    A.5.4Other Identifiers
    Name:Amendment 07Number:Amendment 07
    A.7Trial is part of a Paediatric Investigation Plan Yes
    A.8EMA Decision number of Paediatric Investigation PlanP/147/2009
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorAllergopharma GmbH & Co. KG
    B.1.3.4CountryGermany
    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 supportAllergopharma GmbH & Co. KG
    B.4.2CountryGermany
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAllergopharma GmbH & Co. KG
    B.5.2Functional name of contact pointDepartment of Clinical Trials
    B.5.3 Address:
    B.5.3.1Street AddressHermann-Koerner-Strasse 52
    B.5.3.2Town/ cityReinbek
    B.5.3.3Post code21465
    B.5.3.4CountryGermany
    B.5.4Telephone number0049040427650
    D. IMP Identification
    D.IMP: 1
    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 name6-Grass-Preparation
    D.3.2Product code AL0506st
    D.3.4Pharmaceutical form Oral drops, solution
    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.3.10 Strength
    D.3.10.1Concentration unit µg/ml microgram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number40
    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 placeboOral drops, solution
    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
    IgE-mediated allergic disease manifested as symptoms of allergic rhinitis/rhinoconjunctivitis with or without allergic bronchial asthma (GINA I und II)
    triggered by grass pollen allergens.
    E.1.1.1Medical condition in easily understood language
    IgE-mediated allergic disease manifested as symptoms of allergic rhinitis/rhinoconjunctivitis with or without allergic bronchial asthma (GINA I und II)
    triggered by grass pollen allergens.
    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 18.1
    E.1.2Level PT
    E.1.2Classification code 10048908
    E.1.2Term Seasonal allergy
    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 primary endpoint of this study is to establish superiority of sublingual perennial specific immunotherapy with the liquid preparation of grass pollen over symptomatic standard treatment with add on placebo by evaluation of the change of the area under the curve of the symptom and medication score (SMS) from the baseline season to the season after 1 year of treatment. The SMS will be calculated by the daily sum of symptoms and the use of anti-allergic medication documented in patients diaries during grass pollen seasons.
    E.2.2Secondary objectives of the trial
    - Immunological changes: Allergen-specific IgE, IgG1 and IgG4 at start of therapy compared to end of pollen season 2009 (2010 for patients from the 2nd screening period)
    - Safety of treatments during the entire treatment period
    - Changes in specific conjunctival provocation test
    - Efficacy of SIT over time by evaluation of the change of the area under the curve of the SMS after 2 years and after the full course of 3 years of treatment
    - Response

    For the treatment free follow-up investigation:
    • AUC of SMS during the 1st and 2nd year after the end of the full 3 years treatment course compared to previous years.
    • Well Days: No. of days with Symptom Score ≤ 4 and Medication Score = 0 within the analysis period (42 days) of the 1st and 2nd year after the end of the full 3 years treatment.
    • Cured Allergy: % of patients with at most one mild symptom in mean during the analysis period (42 days) of the 1st and 2nd year after the end of the full 3 years treatment.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    •Male and female outpatients
    •Age 4 – < 12 years
    •IgE-mediated seasonal allergic rhinitis/rhinoconjunctivitis with or without asthma bronchiale (GINA stage I or II), attributable to grass pollen allergens, documented by
    positive skin prick test weal for grass pollen at least as large as histaminedihydrochloride (1 %) control reaction or > 5 mm in diameter and
    positive EAST > class 2 to grass pollens and
    proven clinical relevance of grass pollen allergy by positive conjunctival provocation testing with grass pollen allergens
    •For female patients with childbearing potential: Negative pregnancy test and effective contraception
    •For patients with Asthma bronchiale at entry: specialist confirmed diagnosis and asthma classification as GINA grade I or II
    •Written informed consent

    At the beginning of the treatment phase:
    •Patients must have demonstrated a symptom score of at least 4 every day during the week following the peak pollen count in the baseline season (patients with less symptoms in the baseline season 2008 can repeat the baseline season in 2009)
    •Rhinitis / Rhinoconjunctivitis symptoms documented in the patients’ diary during the baseline season

    For the treatment free follow-up investigation:
    • Male and female outpatients, previously participating in and completed treatment phase of the clinical trial AL0506st
    • For female patients with childbearing potential: Negative pregnancy test and effective contraception
    • Written informed re-consent for follow-up investigation

    E.4Principal exclusion criteria
    •Previous or other current specific immunotherapy with grass pollen allergens in any formulation
    •Symptoms related to or strong skin test positivity to other seasonal or perennial allergens (skin prick test weal > 5 mm and/or as large as histaminedihydrochloride (1%) control reaction, if clinical relevance cannot be excluded), which are effective in the same period as the relevant grass pollens (June – August)
    •Previous course of hyposensitisation against grass pollen or other allergens that are not known
    •Specific immunotherapy with any other allergens during the course of the study
    •Patients that have undergone an unsuccessful course of specific immunotherapy with any allergen
    •Clinically relevant rhinoconjunctival or respiratory symptoms related to other reasons
    •Peak Flow < 80% of predicted normal
    •Severe bronchial asthma (GINA grade III and IV)
    •Allergy treatment according to severity of symptoms with other than the following medication during the grass pollen season: Levocabastine nasal spray/eye drops, Loratadine tablets, Cetirizine juice / tablets, Salbutamol and short course treatments on prescription with nasal corticosteroids or oral corticosteroids.
    •Febrile infections or inflammation of the respiratory tract at the time of inclusion
    •Severe acute or chronic diseases, severe inflammatory diseases (liver, kidneys, metabolic diseases)
    •Autoimmune diseases, immune-defects including immuno-suppression, immune-complex-induced immunopathies
    •Previous or ongoing use of anti-IGE antibodies, tranquilizers or psychoactive medicine
    •Severe psychiatric and psychological disorders including impairment of cooperation (e.g. alcohol or drug abuse)
    •Treatment with β-blockers
    •Recurrent seizures
    •Pregnancy and lactation period
    •Concurrent participation in any other clinical trial or participation in any other clinical trial during the previous 30 days
    •Low compliance or inability to understand instructions/study documents
    •Patients being in any relationship of dependence with the sponsor and/or with the investigator
    •Patients, who are institutionalised due to a official or judicial order
    •Mentally disabled minors
    •Contra-indications for application of adrenaline (e.g. severe acute or chronic symptomatic coronary heart disease, severe arterial hypertension)

    For the treatment free follow-up investigation:
    • Specific immunotherapy with grass pollens or any other allergens after the last dose of study drug.
    • Allergy treatment according to severity of symptoms with other than the following medication during the grass pollen season: Levocabastine nasal spray/eye drops, Loratadine tablets, Cetirizine juice/tablets, Salbutamol and short course treatments on prescription with nasal corticosteroids or oral corticosteroids.
    • Previous or ongoing use of anti-IgE antibodies, tranquilizers or psychoactive medicine
    • Severe psychiatric and psychological disorders including impairment of cooperation (e.g. alcohol or drug abuse)
    • Recurrent seizures
    • Pregnancy and lactation period
    • Concurrent participation in any other clinical trial or participation in any other clinical trial during the previous 30 days
    • Low compliance or inability to understand instructions/study documents
    • Patients being in any relationship of dependence with the sponsor and/or with the investigator
    • Patients, who are institutionalised due to a official or judicial order
    • Mentally disabled minors

    E.5 End points
    E.5.1Primary end point(s)
    This is a confirmatory phase III pivotal study. The primary endpoint is the change of the area under the curve (AUC) of the SMS (cf. chapter 7). The primary analysis will be the comparison of the change of the AUC at baseline to the measurement after 1 year treatment. That means that the primary analysis will be done with combined data from 2009 (patients of screening phase 1) and 2010 (patients of screening phase 2). The data after the second treatment year from patients of screening phase 1 will not be considered in the primary analysis. Based on the actual pollen count in the respective year, the AUC of the daily SMS-scores will be calculated over a certain time period to be defined at the Blind Review Meeting. The statistical null-hypothesis of no difference between the change of AUC of both treatment groups will be tested in a confirmatory sense within the Full Analysis Set with an analysis of variance (ANOVA) model adjusting for gender, year of baseline and center, the treatment effect will be tested at a two-sided significance level of 0.05. The ANOVA model will be used to estimate the mean adjusted treatment effect and the corresponding 95% confidence interval. All further statistical tests will be performed in an exploratory sense only. In addition, the treatment effect by gender, year of baseline and center will be described univariately and estimated with corresponding ANOVA models with the corresponding covariate in addition to treatment. A univariate, descriptive analysis of the change of AUC after 1 year will be performed- overall as well as by gender, year of baseline and center.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Primary analysis will be done with combined data from 2009 (patients of screening phase 1) and 2010 (patients of screening phase 2)
    E.5.2Secondary end point(s)
    Changes in IgE, IgG1 and IgG4 from start of the therapy to end of pollen season
    Occurrence of Adverse Events after treatment start
    Changes in specific conjunctival provocation test
    Symptom and medication score (SMS) after 1, 2 and 3 years of treatment
    Changes of the area under the curve of the SMS after 2 years and after the full course of 3 years of treatment will be analysed descriptively by treatment and in an exploratory sense also by strata of AUC of SMS at baseline
    Response

    For the treatment free follow-up:
    • AUC of SMS during the 1st and 2nd (= 4th and 5th grass pollen season) year after the end of the full 3 years treatment course compared to previous years.
    • Well Days: Number of days with Symptom Score ≤ 4 and Medication Score = 0 within the analysis period (42 days) of the 1st and 2nd (= 4th and 5th grass pollen season) year after the end of the full 3 years treatment course.
    • Cured Allergy: Percentage of patients with at most one mild symptom in mean during the analysis period (42 days) of the 1st and 2nd (= 4th and 5th grass pollen season) year after the end of the full 3 years treatment course.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Depending on the availablity of data, after end of double blind phase 2010 and/or after the end of the study in autumn 2013

    The data of the treatment free follow-up investigation will be analysed depending from the further treatment group after the 4th and 5th grass pollen season in autumn 2014 and 2015
    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 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) 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 trial2
    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 concerned34
    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
    Data base lock after end of treatment free follow-up
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years6
    E.8.9.1In the Member State concerned months10
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years7
    E.8.9.2In all countries concerned by the trial months10
    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: 230
    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) Yes
    F.1.1.5.1Number of subjects for this age range: 230
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) No
    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 Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    Age span of children: 4 - < 12, written informed consent by parents/legal guardian if necessary.
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state80
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 150
    F.4.2.2In the whole clinical trial 230
    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
    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 Decision2007-03-12
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2007-04-02
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2015-08-17
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