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    Summary
    EudraCT Number:2008-006258-16
    Sponsor's Protocol Code Number:AL0801rB
    National Competent Authority:Sweden - MPA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2008-11-19
    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 ConcernedSweden - MPA
    A.2EudraCT number2008-006258-16
    A.3Full title of the trial
    A multicentre randomised placebo-controlled double-blind clinical trial for the immunological and histological evaluation of specific immunotherapy with an aluminium hydroxide-adsorbed recombinant hypoallergenic derivative of the major birch pollen allergen, rBet v1-FV
    A.3.2Name or abbreviated title of the trial where available
    Specific immunotherapy with a recombinant birch pollen allergen
    A.4.1Sponsor's protocol code numberAL0801rB
    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
    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 namefolding variant of recombinant major birch pollen allergen
    D.3.2Product code rBet v1-FV
    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.3.11 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
    ICD classification code: J45.0 and J30.1
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10039085
    E.1.2Term Rhinitis allergic
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10001705
    E.1.2Term Allergic asthma
    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 evaluate immunohistological changes and tolerability of specific immunotherapy with rBet v1-FV.
    E.2.2Secondary objectives of the trial
    To evaluate the safety of the preparation of the folding variant of recombinant major allergen of birch pollen (rBet v1-FV) for perennial treatment.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Male and female outpatients, 18 - 60 years
    - Patients suffering from IgE-mediated, seasonal allergic rhinitis with or without
    controlled bronchial asthma (PEF and/or FEV1 at least 80% predicted normal)
    attributable to birch pollen and
    - In the course of the year: major allergy symptoms during birch pollen season and
    - symptoms of allergic rhinoconjunctivitis against birch pollen allergens requiring
    medication during the last birch pollen season and
    - proven clinical relevance of birch pollen allergy by positive conjunctival provocation
    test result using natural birch pollen extract and
    - positive skin prick test reaction to natural birch pollen allergens demonstrated by
    birch pollen allergen wheal diameter > 5mm (to be demonstrated in a valid skin prick
    test: negative NaCl control wheal < 3mm, positive Histamine (0.1%) control wheal >
    3mm) and
    - positive EAST to birch pollen ≥ 1.5 kU/L to be determined in central laboratory
    - For female patients: effective contraception and negative pregnancy test result.
    E.4Principal exclusion criteria
    - Previous course of hyposensitation against tree pollens 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 birch pollen season: alder, hazel, beech, Dermatophagoides
    farinae, Dermatophagoides pteronyssinus, dog, cat:
    • Sensitisation in the Skin Prick Test: wheal diameter of respective interfering
    allergen ≥ wheal diameter of birch pollen allergen
    • Sensitisation as determined by serum EAST
    - Clinically relevant rhinoconjunctival or respiratory symptoms related to other reasons
    than allergy
    - PEF or FEV1 < 80% of predicted normal (ECSC) or uncontrolled bronchial asthma
    according to the GINA Guidelines (2006)
    - Febrile infections or inflammation of the respiratory tract at the time of inclusion
    - Irreversible secondary alterations 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, immunocomplex-
    induced immunopathies
    - Severe psychiatric and psychological disorders including impairment of cooperation
    (e.g. alcohol or drug abuse)
    - Allergy treatment according to severity of symptoms with other than the following
    medication during the baseline birch pollen season:
    • Levocabastine nasal spray/eye drops (0.5mg/mL each), Loratadine/Cetirizine
    tablets (10mg), Salbutamol (100μg/puff).
    • Treatment of exacerbation of allergic rhinoconjunctivitis and bronchial asthma
    with a short course of oral corticosteroids is permitted. Treatment with other
    medication must be stopped 2 weeks prior to start of this study.
    • Basic asthma treatment with other medication than short acting bronchodilators
    - Any prophylactic and any treatment with antiallergic medication in fixed (constant)
    dosage during the baseline and any birch pollen seasons during the study
    - Treatment with β-blockers (locally and systemically)
    - Pregnancy and lactation 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
    - Completed or ongoing treatment with anti-IgE-antibody
    - Possible dependence of patients on sponsor or investigator
    - Completed or ongoing long-term treatment with tranquilizer or psychoactive drugs
    - Contra-indication for adrenalin (for example, acute or chronic symptomatic coronary
    heart disease, severe hypertension)
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint is the descriptive evaluation of the changes in populations of
    inflammatory cells and subpopulations of immunologically active cells.
    The subpopulations which will be evaluated are cells considered central in allergic
    inflammation. All these cells will be evaluated in nasal biopsies obtained before the start of the treatment (outside the birch pollen season) and during treatment and
    at the birch 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 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) 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 concerned2
    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 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 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 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 2008-11-19. 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 state20
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 20
    F.4.2.2In the whole clinical trial 20
    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 Decision2008-11-19
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2008-10-20
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2011-04-26
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