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    Summary
    EudraCT Number:2007-003208-37
    Sponsor's Protocol Code Number:AL0704rP
    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:2007-09-24
    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 number2007-003208-37
    A.3Full title of the trial
    A multicentre multinational randomised, placebo-controlled, double-blind pivotal trial for the evaluation of safety and efficacy of specific immunotherapy with a cocktail of recombinant major allergens of Timothy Grass Pollen (Phleum pratense) adsorbed onto aluminium-hydroxide in patients with IgE-mediated allergic rhinoconjunctivitis with/without controlled asthma (AMETHYST)
    A.3.2Name or abbreviated title of the trial where available
    (AMETHYST)
    A.4.1Sponsor's protocol code numberAL0704rP
    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 SponsorAllergopharma Joachim Ganzer 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 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 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 nameCocktail of recombinant major allergens of Phleum pratense
    D.3.2Product code rPhleum - Strength 1
    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.3.9.3Other descriptive namerecombinant Phleum pratense allergen cocktail - Strength 1
    D.3.10 Strength
    D.3.10.1Concentration unit µg/ml microgram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0.78 µg/ml
    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 Yes
    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 nameCocktail of recombinant major allergens of Phleum pratense
    D.3.2Product code rPhleum Strength 2
    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.3.9.3Other descriptive namerecombinant major allergens of Phleum pratense - Strength 2
    D.3.10 Strength
    D.3.10.1Concentration unit µg/ml microgram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number6,25 µg/ml
    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 Yes
    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: 3
    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 nameCocktail of recombinant major allergens of Phleum pratense
    D.3.2Product code rPhleum - Strength 3
    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.3.9.3Other descriptive namerecombinant Phleum pratense allergen cocktail - Strength 3
    D.3.10 Strength
    D.3.10.1Concentration unit µg/ml microgram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number50
    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 Yes
    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: 4
    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 nameCocktail of recombinant major allergens of Phleum pratense
    D.3.2Product code rPhleum Strength 4
    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.3.9.3Other descriptive namerecombinant Phleum pratense allergen cocktail - Strength 4
    D.3.10 Strength
    D.3.10.1Concentration unit µg/ml microgram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number200 µg/ml
    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 Yes
    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
    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
    ICD classification code: J45.0 and J 30.1

    E.1.1.1Medical condition in easily understood language
    Allergic rhinoconjunctivitis with/without controlled asthma
    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 14.0
    E.1.2Level LLT
    E.1.2Classification code 10001728
    E.1.2Term Allergic rhinoconjunctivitis
    E.1.2System Organ Class 10015919 - Eye disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.0
    E.1.2Level LLT
    E.1.2Classification code 10001705
    E.1.2Term Allergic asthma
    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
    The aim of this study is to establish superiority of perennial specific immunotherapy with an aluminium-hydroxide-adsorbed cocktail of re-combinant major allergens of Timothy Grass (Phleum pratense) over placebo. Changes of the Rhinoconjunctivitis Symptom Medication Score (RC-SMS) from the baseline season to the season after 2 years of double-blind treat-ment will be evaluated.

    The RC-SMS will be calculated by the daily sum of symptoms and the use of anti-allergic medication documented in patient diaries dur-ing grass pollen season. Documentation period of patient diaries covers 12 weeks. The exact period of analysis of clinical efficacy (AUC) will be defined at the Blind Review Meeting (BRM) before data base lock and unblinding on the basis of the real pollen counts occurred in each study year and region.
    E.2.2Secondary objectives of the trial
    Changes of rhinoconjunctivitis specific Quality of Life at peak pollen season.

    Changes of specific conjunctival reactivity to grass pollen allergens.

    Changes of RC-SMS after the first treatment year.

    Changes of overall symptom medication score of rhinoconjunctivitis and asthma (SMS)

    Response (Improvement of AUC of RC-SMS of at least 40% after 2 years of treatment)

    Immunologic changes specific IgE, IgG1, IgG4.

    Safety of treatments during the entire study period.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    -Written Informed Consent
    - Male and female outpatients, 18-60 years legally competent
    - 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 pollen
    - In the course of the year: Major allergy symptoms during grass pollen season
    - Symptoms of allergic rhinoconjunctivitis against grass pollen allergens requiring
    medication during the last grass pollen season
    - Proven clinical relevance of grass pollen allergy by positive conjunctival
    provocation test (CPT) result using natural grass pollen cocktail.
    - Positive skin prick test reaction to natural grass pollen allergens demonstsrated by
    grass pollen allergen weal diameter >= 5mm (to be demonsstrated in a valid skin
    prick test: Negative NaCl control weal < 3 mm, positive Histamine (o.1%)L control
    weal >= 3 mm)
    - Positive EAST to grass pollen >= 1.5 kU/l to be determined in central laboratory
    - For female patients: effective contracetption and negative pregnancy test result.
    Highly effective methods of birth control are defined as those which result in a low
    failure rate (i.e. less than 1% per year) when used consistently and correctly such
    as implants, injectibles, combined or oral contraceptives, some IUDs, sexual
    abstinence or vasectomised partner. No pharmacological interactins are known for
    hormonal contraceptives and specific immunotherapeutic preparations.

    At the Beginning of the Treatment Phase (November 2009):
    Patients must have demonstrated moderate to severe symptoms of allergic grass pollen disease during the baseline season. Details are described in section 10.1.1 of Trial Protocol
    E.4Principal exclusion criteria
    - Previous course of hyposensitisation against grass pollen or unknown other
    allergens in any pharmaceutical form
    - Patients who have undergone an unsuccessful course of specific immunotherapy
    with any allergen
    - For allergens which interfere with the grass pollen season during May to August
    (Plantain, Nettle, Cypressus where appropriate, Olive tree, Parietaria officinalis, Alternaria alternata, Cat
    epithelia, Dermatophagoides farinae, Dermatophagoides pteronyssinus):
    sensitisation in the Skin Prick Test:
    ° Weal diameter of respective interfering allergen >= weal diameter of grass pollen
    allergen
    ° Sensitisation as determined by serum EAST > 1,5 kU/l
    - Clinical.y relevant sensitisation has to be excluded in a provocation test
    - Clinically relevant rhinoconjunctival or respiratory symptoms related to other
    reasons than allergy
    - PEF or FEV1 < 80% of predicted normal (ECCS) or uncontrolled/partly controlled
    bronchial asthma according to the GINA Guidelines (2006)
    - Febrile infections or inflammation of the respiratory tract at the time of inclusion
    - Irreversible secondary alternations of the reactive organ (emphysema,
    bronchiectasis etc.)
    - Severe acute or chronic diseases, severe inflammatory diseases
    - Other severe generalised diseases (liver, kidneys, metabolic diseases)
    - Autoimmune diseases, immune defects including immuno-suppression, immune-
    complex-induced immunopathies
    - Severe psychiatric and psychological disorders including impairment of cooperation
    (i.g. alcohol or drug abuse)
    - Completed or ongoing long-term treatment with tranquillizer psycho active drug

    Allergy treatment according to severity of symptoms with other than the following medication during the baseline grass pollen season:

    ° Levocabastine nasal spray/eye drops (0.5 mg/ml each),
    ° Loratadine/Cetrizine tablets (10 mg), Salbutamol 100 µg/puff), inhaled
    steroid in higher doses than 500µg/d Beclomethasonedipropionate/equivalent
    Treatment of exacerbation of allergic rhinoconjunctivitis and bronchial asthma with
    a short course oforal corticosteroids permitted. Treatment with or other
    medication must be stopped 2 weeks prior to start of this study

    ° Basic asthma treatment with other medication than short acting bronchodilatators and inhaled corticosteroids higher than 500µg Beclomethasonedipropionate or equivalent

    Any prophylactic and any treatment with antiallergic medication in fixed (constant) dosage during the baselilne and any grass pollen seasons during the study

    - Pregnancy and location period
    - Female patients seeking to become pregnant
    - 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 committed to a mental hospital by government or court
    - completed or ongoing treatment with Anti-EgE antibody
    - Patients being in any relationship of dependence with the sponsor and/or
    investigator
    - Contraindication for adrenaline, (e.g. acute or chronic symptomatic coronary heart
    disease, severe arterial hypertension)
    - Treatment with beta-Blockers, locally and systemically





    E.5 End points
    E.5.1Primary end point(s)
    The aim of this study is to establish superiority of perennial specific immunotherapy with an aluminium-hydroxide-adsorbed cocktail of re-combinant major allergens of Timothy Grass (Phleum pratense) over placebo. Changes of the Rhinoconjunctivitis Symptom Medication Score (RC-SMS) from the baseline season to the season after 2 years of double-blind treat-ment will be evaluated.

    The RC-SMS will be calculated by the daily sum of symptoms and the use of anti-allergic medication documented in patient diaries dur-ing grass pollen season. Documentation period of patient diaries covers 12 weeks. The exact period of analysis of clinical efficacy (AUC) will be defined at the Blind Review Meeting (BRM) before data base lock and unblinding on the basis of the real pollen counts occurred in each study year and region.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Study evaluation after 2 years treatment.
    E.5.2Secondary end point(s)
    Changes of rhinoconjunctivitis specific Quality of Life at peak pollen season.

    Changes of specific conjunctival reactivity to grass pollen allergens.

    Changes of RC-SMS after the first treatment year.

    Changes of overall symptom medication score of rhinoconjunctivitis and asthma (SMS)

    Response (Improvement of AUC of RC-SMS of at least 40% after 2 years of treatment)

    Immunologic changes specific IgE, IgG1, IgG4.

    Safety of treatments during the entire study period.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Safety: interim analysis

    Study evaluation after 2 years treatment.
    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 concerned40
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA61
    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
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years4
    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 years4
    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 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.1.3Elderly (>=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 state350
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 750
    F.4.2.2In the whole clinical trial 750
    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)
    Patients will be followed up according to GCP-, ICH- and WHO-Guidlines. See also Trial Protocol Chapter 12.10.
    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 Decision2008-01-18
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2008-01-16
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2012-03-29
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