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    Summary
    EudraCT Number:2009-014923-22
    Sponsor's Protocol Code Number:GT-23
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2009-12-02
    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 ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2009-014923-22
    A.3Full title of the trial
    A phase IIIB trial investigating 3-year treatment efficacy, tolerability and safety of Grazax in children aged 5-18 years with grass pollen induced rhinoconjunctivitis with/without controlled controlled asthma ( three consecutive pollen seasons treatment)
    A.3.2Name or abbreviated title of the trial where available
    GT-23
    A.4.1Sponsor's protocol code numberGT-23
    A.5.1ISRCTN (International Standard Randomised Controlled Trial) NumberND
    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 SponsorALK-ABELLO`
    B.1.3.4CountryItaly
    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 GRAZAX
    D.2.1.1.2Name of the Marketing Authorisation holderALK-ABELLO` A/S
    D.2.1.2Country which granted the Marketing AuthorisationItaly
    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 Oral lyophilisate
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNGrass pollen
    D.3.10 Strength
    D.3.10.1Concentration unit SQU Standardised Quality Unit(s) (Deprecated)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number75000
    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 placeboOral lyophilisate
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    children from 5 to 18 years with
    grass pollen induced rhinoconjunctivitis with/without controlled asthma
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10054928
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To evaluate the 3 years efficacy, tolerability, safety of specific immunotherapy with Grazax compared to placebo on the top of rescue allergic symptomatic drugs in children with grass pollen induced rhinoconjunctivitis with or without controlled or partly controlled asthma.
    E.2.2Secondary objectives of the trial
    total number of days with severe symptoms during the 1, 2 and 3rd years of treatment (pollen season 2010, 2011 and 2012)
    -the average rhinoconjunctivitis symptom score and medication score in the entire grass pollen season during 1, 2 and 3 years
    - the average rhinoconjunctivitis symptoms in the peak grass pollen season by VAS during 1,2 and 3 years of treatment
    -recording of all adverse events and all SAE
    -the average asthma medication symptom score in the entire grass pollen season and in the peak pollen season. A total of 4 asthma symptoms should be measured on a scale from 0 to 3.
    -findings from physical examination, vital signs and FEV1 as well as monitoring of hematology, blood chemistry and urine values.
    -Profilin sensitization with SPT with Palm profiling
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Boys and girls 5-18 years of age
    2. Written informed consent obtained from parents/guardians and from subjects if the level of intellectual maturity makes it appropriate.
    Assent will be obtained from subjects turning 18 during the trial.
    3. A clinical history of grass pollen induced allergic rhinoconjunctivitis with controlled or partly controlled asthma having received treatment during the previous grass pollen season.
    4. Positive Skin Prick Test (SPT) response (wheal diameter > 3 mm) to Phleum pratense
    5. Positive specific IgE against Phleum pratense( >IgE Class 2 )
    6. Female subject who are fertile, must have a negative pregnancy test. In case of female subjects adequate methods to avoid pregnancy should be used. (in case of pregnancy the subject will stop to take study medication and will be followed until delivery)
    7. Subject and parent/guardian willing and able to comply with trial protocol regimens.
    E.4Principal exclusion criteria
    1. A clinical history of symptomatic seasonal allergic rhinitis and asthma, having received regular medication, due to another allergen during-or potentially overlapping- the grass pollen season
    2. A clinical history of perennial allergic rhinitis and asthma having received regular medication due to an allergen to which the subject is regular exposed.
    3. A clinical history of chronic sinusitis during the last 2 years.
    4. A clinical history of severe asthma and/or a FEV1 <80%
    5. Any clinical relevant chronic disease such as hepatic or renal insufficiency, immunological diseases (Rheumatoid arthritis, lymphoma ect)
    6. Current severe atopic dermatitis
    7. Previous treatment by immunotherapy with grass pollen allergen or any other allergen within the previous 5 years
    8. History of anaphylaxis
    9. Chronic urticaria and angioedema.
    10. Immunosuppressive treatments (cyclosporine and other immunomodulating drugs such as metothrexate, azathioprine ) (except for steroids for allergic symptoms)
    11. History of allergy, hypersensitivity or intolerance to investigational medicinal product ( except for Phleum pratense) or rescue medications
    12. Unlike to be able to complete the trial, for any reason, or likely to move, or travel for extended periods of time during the trial period.
    13. Being immediate family of the Investigator or trial staff, defined as the investigators/staffs child or grandchild.
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint will be the comparison between the two groups of the total number of days with severe symptoms during the pollen season after 3 years of treatment (pollen season 2012). A total of 6 rhinoconjunctivitis symptoms should be measured on a scale from 0-3 (patients diary).According to Durham et al, (EAACI 2008) and Bufe et al (JACI 2009) using therefore a symptom score (SS) with a scale ranging from 0 to 18, (6 items) a day with severe symptom will be defined as a day with a SS &#8805;10, despite the use of rescue medications.
    SS would be measured with a patient diary card during the entire pollen season.
    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 Yes
    E.6.13.1Other scope of the trial description
    tolllerabilita`
    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.8.3 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 concerned11
    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
    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 months0
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 Yes
    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.1.1.6Adolescents (12-17 years) Yes
    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 For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2009-12-02. Yes
    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 state110
    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 Decision2009-11-03
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2009-11-27
    P. End of Trial
    P.End of Trial StatusCompleted
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