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    Summary
    EudraCT Number:2007-005452-16
    Sponsor's Protocol Code Number:AL0705AV
    National Competent Authority:Portugal - INFARMED
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2007-11-30
    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 ConcernedPortugal - INFARMED
    A.2EudraCT number2007-005452-16
    A.3Full title of the trial
    A multicentre randomised placebo-controlled, double-blind clinical trial for eval¬ua¬tion of safety and efficacy of pre-seasonal specific immunotherapy with a hypoallergenic extract of a 6 grass and rye (Grasses plus Rye) pollen mixture in patients with rhinoconjunctivitis +/- asthma bronchiale
    A.4.1Sponsor's protocol code numberAL0705AV
    A.7Trial is part of a Paediatric Investigation Plan Information not present in EudraCT
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorAllergopharma Joachim Ganzer KG an afilliate of Merck KGaA, Darmstadt
    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 support
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisation
    B.5.2Functional name of contact point
    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 Yes
    D.2.1.1.1Trade name Allergovit
    D.2.1.1.2Name of the Marketing Authorisation holderAllergopharma Joachim Ganzer KG
    D.2.1.2Country which granted the Marketing AuthorisationGermany
    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.3.4Pharmaceutical form Suspension for injection
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    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 INN6 Gramíneas (80%) + Centeio (20%)
    D.3.9.1CAS number NA
    D.3.10 Strength
    D.3.10.1Concentration unit U/ml unit(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1000
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INN6 Gramíneas (80%) + Centeio (20%)
    D.3.9.1CAS number Na
    D.3.10 Strength
    D.3.10.1Concentration unit U/ml unit(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10000
    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) Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    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 Information not present in EudraCT
    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 placeboSuspension for injection
    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
    IgE-mediated allergic diseases including symptoms of allergic rhinoconjunctivitis, controlled allergic bronchial asthma, triggered by grass/rye pollen allergens
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The aim of this CT is to prove the hypothesis that the allergoid preparation of an extract of a grasses plus rye pollen mixture is suitable for an efficacious treatment of grass pollen allergic patients with SIT and that the trial preparation is sufficient to suppress allergic symptoms caused by natural grass pollen exposure.

    A quantitative Conjunctival Provocation Test (CPT) will be performed before treatment to determine the individual threshold concentration defined by the lowest concentration of a grass plus rye pollen extract eliciting a positive allergic reaction (irritation/pruritus and redness/hyperemia) in the conjunctiva of a patient.
    Primary endpoint is o determine the number of patients with an improvement of the threshold concentration in October 2009 after 2 years of treatment a CPT with the individual threshold concentration only will be performed.
    E.2.2Secondary objectives of the trial
    • Changes in patients´ assessment of rhinoconjunctivitis at the end of the grass pollen season accor¬¬ding to a Visual Rating Scale after 1, 2, and 3 years
    • Number of patients with an improvement of the conjunctival provocation threshold concentration after 1 and 3 years
    • Immunologic changes: Allergen specific IgG4.
    • Tolerability and safety will be assessed during the initial treatment phase and after each injection by evaluating the documentation of adverse events and other para¬meters.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Patients suffering from IgE-mediated, moderate to severe seasonal allergic rhinitis with or without controlled bronchial asthma (PEF and/or FEV1 at least 80% predicted normal), attributable to grass/Secale pollen;
    - In the course of the year: major allergy symptoms during grass/Secale pollen season;
    - Symptoms of allergic rhinoconjunctivitis against grass/Secale pollen allergens requiring medication during the last grass pollen season;
    - Proven clinical relevance of grass pollen allergy by positive conjunctival provocation test result using a natural grass pollen extract;
    - Positive Prick Test reaction to grass pollen allergens demonstrated by allergen wheal diameter > 3mm (to be demonstrated in a valid skin prick test: nega¬tive NaCl control wheal < 3mm, positive Histamine (0.1% control wheal > 3mm);
    - Positive EAST to grass pollen  1.5 kU/L to be determined in central laboratory;
    E.4Principal exclusion criteria
    - Previous course of hyposensitisation against grass pollen or any unknown allergen
    - Patients that have undergone an unsuccessful course of specific immunotherapy with any allergen
    - Symptoms related to or strong skin test positivity (weal diameter  than diameter of the grass pollen weal) to birch, parietaria, mugwort, oak, olive tree, plane tree
    - PEF or FEV1 < 80 % of predicted normal (ECCS) or uncontrolled bronchial asthma
    Contra-indications for application of adrenaline:
    - Severe acute or chronic diseases, severe inflammatory diseases ary heart disease
    - Severe arterial hypertension
    - Treatment with -Blockers, locally and systemically
    - Completed or ongoing treatment with anti-IgE-antibody
    -
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint of the study is the number of patients with an improvement of the theshold concentration eliciting a positive Conjunctival Provocation Test (CPT) with grass plus rye allergens after 2 pre-seasonal short treatment courses with the allergoid preparation compared to placebo under double-blind conditions.
    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 No
    E.6.4Safety No
    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 Yes
    E.6.13.1Other scope of the trial description
    Tolerability
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans Information not present in EudraCT
    E.7.1.2Bioequivalence study Information not present in EudraCT
    E.7.1.3Other Information not present in EudraCT
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) Yes
    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.8.3 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 concerned4
    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 Information not present in EudraCT
    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
    date of the final clinical database lock
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    E.8.9.1In the Member State concerned months
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years3
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero Information not present in EudraCT
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) Information not present in EudraCT
    F.1.1.3Newborns (0-27 days) Information not present in EudraCT
    F.1.1.4Infants and toddlers (28 days-23 months) Information not present in EudraCT
    F.1.1.5Children (2-11years) Information not present in EudraCT
    F.1.1.6Adolescents (12-17 years) Information not present in EudraCT
    F.1.2Adults (18-64 years) Yes
    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 No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    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 Information not present in EudraCT
    F.4 Planned number of subjects to be included
    F.4.1In the member state75
    F.4.2 For a multinational trial
    F.4.2.2In the whole clinical trial 75
    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 Decision2008-02-06
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2008-03-10
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2009-11-23
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