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    Summary
    EudraCT Number:2008-003906-32
    Sponsor's Protocol Code Number:V060.08
    National Competent Authority:Czechia - SUKL
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2008-09-04
    Trial 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 ConcernedCzechia - SUKL
    A.2EudraCT number2008-003906-32
    A.3Full title of the trial
    A randomised, double-blind, placebo-controlled, multi national, Phase III study of the efficacy and safety of 300 IR sublingual immunotherapy (SLIT), starting 2 months before the grass pollen season, administered as allergen based tablets once daily to patients suffering from grass pollen rhinoconjunctivitis (with or without asthma)
    A.4.1Sponsor's protocol code numberV060.08
    A.5.1ISRCTN (International Standard Randomised Controlled Trial) NumberN/A
    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 SponsorStallergenes S.A.
    B.1.3.4CountryFrance
    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 ORALAIR Grasses 300 IR sublingual tablets
    D.2.1.1.2Name of the Marketing Authorisation holderStallergenes S.A.
    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 Sublingual tablet
    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.3.8INN - Proposed INNGrass pollen allergen extract (cocksfoot, meadow grass, rye grass, sweet vernal grass and timothy grass)
    D.3.10 Strength
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number300 IR units
    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 Yes
    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 Yes
    D.3.11.13.1Other medicinal product typeGrass pollen allergen extract (cocksfoot, meadow grass, rye grass, sweet vernal grass and timothy grass)
    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 placeboSublingual tablet
    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
    Grass pollen allergic rhinoconjunctivitis
    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 PT
    E.1.2Classification code 10039085
    E.1.2Term Rhinitis allergic
    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 efficacy and safety of sublingual tablets of grass pollen allergen extract when initiated 2 months before the grass pollen season compared with placebo for reduction of rhinoconjunctivitis symptoms and rescue medication usage.

    Primary Efficacy Objective
    To assess the efficacy of sublingual tablets of grass pollen allergen extract when initiated 2 months before the grass pollen season on:
    ­
    -The Average Adjusted Symptom Score (AASS). A score taking into account the Rhinoconjunctivitis Total Symptom Score (RTSS) and rescue medication use.
    E.2.2Secondary objectives of the trial
    Secondary Efficacy Objectives:
    To assess the efficacy of sublingual tablets of grass pollen allergen extract when initiated 2 months before the grass pollen season on:
    -The Average Rhinoconjunctivitis Total Symptom Score (ARTSS) of the six rhinoconjunctivitis symptoms sneezing, rhinorrhoea, nasal pruritus, nasal congestion, ocular pruritus and watery eyes.
    -The Average Rescue Medication Score (ARMS) and use of rescue medication (antihistamine [oral form or / and eye drops], nasal corticosteroid and oral corticosteroid).
    -The Average Combined Score (ACS). A score taking into account the RTSS and Rescue Medication Score (RMS).
    -Each of the six individual Average Rhinoconjunctivitis Symptom Scores (ARSS).
    -The proportion of symptom-controlled days (PSCD).
    -The global evaluation of the efficacy of sublingual tablets of grass pollen allergen extract by the patient.

    To document the safety of the treatment.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Patients must meet all of the following inclusion criteria in order to participate in this study:
    1. Written consent.
    2. Male or female outpatients aged 18 to 65 years (inclusive).
    3. Patients with grass pollen-related allergic rhinoconjunctivitis for at least the last two grass pollen seasons.
    4. Positive SPT (wheal diameter greater than 3 mm) and grass pollen-specific IgE values of at least 0.70 kU/L.
    5. An RRTSS during the previous pollen season of greater than or equal to 12 out of a possible 18. The RRTSS is an evaluation (by the patient) of the most severe symptoms during the previous pollen season.
    6. Patients in general good health as determined by the medical history, physical examination (including vital signs) and safety laboratory tests.
    7. Patients with FEV1 ≥ 80% of the predicted value.
    8. Female patients are eligible if they do not have child bearing potential. Female patients are considered not to have child-bearing potential before their menarche, at least 2 years after menopause or if they have had a total hysterectomy or bilateral oophorectomy.
    9. Female patients of child-bearing potential are eligible if they are not sexually active or if they:
    ­ Use a medically accepted contraceptive method (hormonal birth control [orally, injectable or by implant, for at least 2 months before enrolment], intrauterine device, spermicide used with a male condom, bilateral tubal ligation, diaphragm with spermicide, female condom, monogamous relationship with a vasectomised partner), and
    ­ Have a negative urine pregnancy test.
    10. Patients who are able to understand the information given, and will be compliant with the protocol including investigational product administration and visit schedules. Patients should also be able to complete the daily record card.
    E.4Principal exclusion criteria
    Patients must not meet any of the following exclusion criteria in order to participate in this study:

    1. Positive SPT to any other seasonal allergens present during the grass pollen season including olive and cypress pollen if these allergens are endemic to the region.
    2. Patients with clinically significant confounding symptoms of allergy to other allergens potentially overlapping the grass pollen season (for example, tree allergens).
    3. Significant symptomatic perennial allergy due to an allergen to which the patient is regularly exposed.
    4. Patients with moderate or severe persistent asthma (GINA 3 or 4).
    5. Patients with seasonal mild persistent asthma (GINA 2) necessitating treatment with inhaled glucocorticosteroids at a dose level greater than 400 mcg budesonide dose-equivalents.
    6. Patients who have received any desensitisation treatment for grass pollen in the last 5 years.
    7. Patients with ongoing treatment by immunotherapy with any other allergen.
    8. Patients with any nasal or oral condition that could confound the efficacy or safety assessments such as nasal polyposis, chronic sinusitis or oral inflammation (for example oral lichen planus, oral ulceration or oral mycosis).
    9. Patients with a known history of hypersensitivity or intolerance to any of the excipients in the investigational product (such as galactose intolerance).
    10. Patients with any past or current clinically significant condition which as judged by the investigator, may affect the patient's participation or the outcome of the study. These may include, but are not limited to, anaphylaxis with cardio-respiratory symptoms, chronic urticaria and angioedema, severe atopic dermatitis, malignancy, and cardiovascular, hepatic, renal, haematological, neurological, immunological and endocrine diseases.
    11. Patients treated with systemic, nasal or inhaled corticosteroids within 4 weeks before Visit 1 or with long acting systemic corticosteroids within 12 weeks before Visit 1, whatever the indication.
    12. Patients treated or under treatment with beta-blockers, continuous systemic corticotherapy or immunosuppressive drugs.
    13. Pregnant, breastfeeding, or sexually active females who are not using a medically accepted contraceptive method as listed above.
    14. Patients participating or having participated within 12 weeks before Visit 1 in any clinical study.
    15. Patients who are likely to be unable to complete the study for any reason, or patients who have to travel for extended periods of time during the grass pollen season which in the opinion of the investigator will compromise the data.
    16. Patients with a history of drug or alcohol abuse.
    17. Investigators, sub-investigators and study staff as well as their children or spouses and family members should not be enrolled in the study.
    18. Patients must not be randomised in this study more than once.
    E.5 End points
    E.5.1Primary end point(s)
    The primary efficacy variable is the Average Adjusted Symptom Score (AASS) during the pollen period while on treatment. The AASS score takes into account the Rhinoconjunctivitis Total Symptom Score (RTSS) and rescue medication use

    The study assess the efficacy of sublingual tablets of grass pollen allergen extract when initiated 2 months before the grass pollen season on:
    - The Average Adjusted Symptom Score (AASS). A score taking into account the Rhinoconjunctivitis Total Symptom Score (RTSS) and rescue medication use.
    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) 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 concerned10
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA49
    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 years
    E.8.9.1In the Member State concerned months8
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial months8
    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 Information not present in EudraCT
    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 state153
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 336
    F.4.2.2In the whole clinical trial 336
    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 Decision2008-11-26
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2008-09-24
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2009-08-31
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