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    The EU Clinical Trials Register currently displays   43865   clinical trials with a EudraCT protocol, of which   7286   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

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    Summary
    EudraCT Number:2007-000823-16
    Sponsor's Protocol Code Number:AL0703st
    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:2007-06-12
    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 number2007-000823-16
    A.3Full title of the trial
    A multicenter, multinational, placebo-controlled, double-blind, randomized study to evaluate efficacy and safety of a perennial, sublingual specific immunotherapy in patielnts with rhinoconjunctivitis with/without controlled asthma caused by grass pollen (Allegra-6)
    A.3.2Name or abbreviated title of the trial where available
    ALLEGRA6
    A.4.1Sponsor's protocol code numberAL0703st
    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 nameSolution of grass pollen allergen extract in a water/glycerol solution with phosphate buffered salin
    D.3.4Pharmaceutical form Oral drops, solution
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    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 microgram(s)
    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) 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 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 rhinoconjunctivitis with or without controlled asthma caused by grass pollen.

    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10048908
    E.1.2Term Seasonal allergy
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Demonstrating safety and efficacy of a sublingual administration of grass pollen allergen in patients with allergic rhinitis (due to grass pollen allergy) with or without asthma.

    Measurement includes symptom-medication-score between IMP and placebo group, respectively between baseline pollen season and first pollen season.
    E.2.2Secondary objectives of the trial
    Efficacy in terms of immunologic blood parameters: allergen-specific IgE, IgG1 and IgG4, measured at start and end of IMP-season.

    Long-term efficacy, measured by change in symptom-medication-score after two, respectively three years of treatment with IMP.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    •Male and female outpatients
    •Age18 - 65 years
    •IgE-mediated seasonal allergic rhinoconjunctivitis with or without controlled asthma caused by grass pollen documented by
    •Positive skin prick test wheal for grass pollen > 5mm in diameter and
    •Positive histamine (0.1% histamine free base) wheal >3mm and a negative NaCl control reaction <3mm
    •Positive EAST > 1.5kU/L to grass pollens and
    •Proven clinical relevance of grass pollen allergy by positive conjunctival provocation testing with grass pollen allergens and
    •Main discomfort in the months May, June, July of the year
    •For female patients with childbearing potential: (i.e., females are not chemically or surgically sterilised or females who are not post-menopausal) must have a negative serum pregnancy test before the baseline phase.
    •Female patients must have a negative serum pregnancy test at enrolment and be willing to use a reliable method of birth control (i.e., double barrier method, oral contraceptive, implant, dermal contraception, long-term inject able contraceptive, intrauterine device, or tubar ligation) during the study, as judged by the investigator.
    •Be able to understand and comply with the requirements of the study, as judged by the investigator
    •For patients with bronchial asthma at entry: confirmed diagnosis and asthma classification as controlled “according” GINA guidelines (version 2006).

    At the Beginning of the treatment phase:

    •Rhinoconjunctivitis symptoms documented in the patients diary during the baseline season
    •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.



    E.4Principal exclusion criteria
    •Previous or other current specific immunotherapy with grass pollen allergens in any formulation
    •For allergens which interfere with the grass pollen season: (Plantain, Nettle, Birch, Olive tree, Parietaria officinalis, Alternaria alternata, Cat epithelia, Dermatophagoides farinae, Dermatophagoides pteronyssinus):
    •Sensitisation in the Skin Prick Test: wheal diameter of respective interfering allergen ≥ wheal diameter of grass pollen allergen
    •Previous course of hyposensitisation against grass pollen or other allergens that are not known
    •Patients who have undergone an unsuccessful course of specific immunotherapy with any allergen
    •Clinically relevant rhinoconjunctival or respiratory symptoms related to other reasons
    •PEF or FEV1 < 80% of predicted normal (ECCS)
    •Uncontrolled or partly controlled asthma according GINA guidelines (version 2006)
    •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 immune-suppression, immune-complex-induced immunopathies
    •Severe psychiatric and psychological disorders including impairment of cooperation (e.g. alcohol or drug abuse)
    •Treatment with beta-blockers (locally and systemically)
    •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
    •Involvement in the planning and conduct of the study (applies to both) Allergopharma Joachim Ganzer KG staff or staff at the study site.
    •Patients being in any relationship of dependence with the Sponsor and/or with the Investigator
    •Previous enrolment or randomisation of treatment in the present study
    •Completed or ongoing treatment with anti-IgE-Antibody
    •Completed or ongoing long-term treatment with tranquilizer psychoactive drugs
    •Allergy treatment according to severity of symptoms with other than the following medication during the grass pollen season: Levocabastine nasal spray/eye drops, Loratadine/Cetirizin tablets, Salbutamol and exacerbation treatment with a short course of oral corticosteroids.
    •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 of this study is difference between active treatment and placebo in the change of the Area Under the Curve of the Symptom - 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 use of anti-allergic medication documented in patients’ diaries during the 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 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 Yes
    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 concerned16
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA3
    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
    1. End of trial if efficacy and safety shows in analysis of the first year of treatment: August 2011 (two more years of treatment with IMP, offer of open-label-treatment with IMP for members of placebo group)

    2. End of trial if efficacy and safety is not evident in analysis of the first year of treatment: August 2009. All patients will be offered two years of further treatment with Subcutaneous Immunotherapy or other current therapies for allergic rhinoconjunctivitis.
    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 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 state166
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 60
    F.4.2.2In the whole clinical trial 226
    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 Decision2007-09-10
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2007-11-20
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2011-10-20
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