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    Summary
    EudraCT Number:2009-011999-30
    Sponsor's Protocol Code Number:VO64.08
    National Competent Authority:Hungary - National Institute of Pharmacy
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2009-07-01
    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 ConcernedHungary - National Institute of Pharmacy
    A.2EudraCT number2009-011999-30
    A.3Full title of the trial
    A randomised, double-blind, placebo-controlled, multi-national, Phase III trial to assess the efficacy and safety of 300 IR sublingual immunotherapy (SLIT) administered as allergen-based tablets once daily to adolescents and children above the age of 5 years, suffering from house dust mite allergic rhinitis
    A.4.1Sponsor's protocol code numberVO64.08
    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 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 nameSublingual tablet of HDM Allergen Extracts
    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.3.9.3Other descriptive nameDermatophagoides pteronyssinus allergen extract
    D.3.10 Strength
    D.3.10.1Concentration unit BAU Bioequivalent Allergy Unit(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number50
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.3Other descriptive nameDermatophagoides farinae allergen extract
    D.3.10 Strength
    D.3.10.1Concentration unit BAU Bioequivalent Allergy Unit(s)
    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) 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.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 nameSublingual tablet of HDM Allergen Extracts
    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.3.9.3Other descriptive nameDermatophagoides pteronyssinus allergen extract
    D.3.10 Strength
    D.3.10.1Concentration unit BAU Bioequivalent Allergy Unit(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number150
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.3Other descriptive nameDermatophagoides farinae allergen extract
    D.3.10 Strength
    D.3.10.1Concentration unit BAU Bioequivalent Allergy Unit(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number150
    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 placeboSublingual tablet
    D.8.4Route of administration of the placeboSublingual use
    D.8 Placebo: 2
    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
    House Dust Mite Allergic Rhinitis
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10001723
    E.1.2Term Allergic rhinitis
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The primary objective is to assess efficacy after one year of treatment:
    To determine if sublingual tablet of HDM Allergen Extracts administered sublingually at a dosage of 300 IR to children and adolescents during approximately 12 months, is significantly better than placebo in relieving house dust mite allergic rhinitis symptoms, as assessed by the magnitude of response observed on the Average Adjusted Symptom Score (AASS). The AASS is a score assessing four rhinitis symptoms: sneezing, rhinorrhoea, nasal pruritis and nasal congestion, adjusted on the rescue medication intake.

    Post-treatment long-term efficacy objective:
    To assess the post treatment long-term efficacy (disease modifying effect) of 300IR sublingual tablet of HDM Allergen Extracts on the AASS after one treatment year and one follow-up year without treatment
    E.2.2Secondary objectives of the trial
    To assess efficacy after 1 treatment year & post treatment long-term efficacy of 300IR in rhinitis overall & overtime, assessed on different global or individual scores, improvement in allergic rhinitis life impact, & safety on:
    o Average Adjusted Symptom Score at different periods
    o Average Rhinitis Total Symptom Score of 4 rhinitis symptoms
    o Average Rescue Medication Score (see protocol p26).
    o Each of 5 individual Average Rhinoconjunctivitis Symptom Scores (see protocol p26).
    o Onset action of SLIT
    o Rescue medication usage (see protocol p45).
    o Average Combined Score – score combining Rhinitis Total Symptom Score & Rescue medication score.
    o Overall Rhinoconjunctivitis Quality of Life Questionnaire score.
    o Proportion of symptom-controlled days
    o Global evaluation of allergic rhinitis by patient
    o Asthma evaluation (Present / Absent), GINA classification and symptom score
    o Sensitisation status
    o Safety of treatment (see protocol p27)
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    Part of the same protocol. The sub-study will be performed in selected sites.

    Exploratory:
    • Immunological markers (immunoglobulin IgE, IgG4 and IgA) specific for house dust mite allergens.
    An ancillary study will be conducted in a sub-group of patients to evaluate the effect of 300 IR of sublingual tablet of Allergen Extracts on selected immunological markers from peripheral blood (circulating house dust mite-specific CD4+ T-cell responses)
    • Nasal provocation test in a sub-group of patients (the nasal provocation test will not be proposed to patients who are only sensitised to D. Farinae
    E.3Principal inclusion criteria
    1. Male or female outpatients, aged 5-17 years inclusive
    2. History of house dust mite-related allergic rhinitis for at least 1 year requiring regular intake of symptomatic treatment(s)
    3. Sensitised to D. pteronyssinus and/or D. farinae (positive skin prick test with wheal diameter greater than 3 mm and a specific IgE level ≥ 0.7 kU/L)
    4. Baseline ARTSS ≥ 5 after completion of the 7-day daily record card with at least 4 days of valid data
    5. General good condition as determined by past medical history, physical examination and safety laboratory tests
    6. Negative urine pregnancy test on all female patients who have had their menarche
    7. Patients and/or legal representative who are willing to comply with the protocol
    8. Patients and/or legal representative who are able to understand the information given and the text of the consent form, who are able to complete the daily record card and the RQLQ; patients who are able to understand the information of the RQLQ given by the interviewer (applicable only from 6 years on)
    9. Patient and/or legal representative having given his signed informed consent.
    10. Patient registered with the French Social Security System (for France only)
    E.4Principal exclusion criteria
    1. Co-sensitization associated with clinically relevant allergic rhinitis, sinusitis, conjunctivitis or asthma likely to significantly change the symptoms of the patient throughout the study (that means patient symptomatic to another allergen than house dust mites to which the patient will be exposed during the study; i.e. will notably be excluded
     patients sensitised to cat or dog allergens and regularly exposed to these allergens
     patients sensitised to aspergillus, cladosporium, alternaria
     patients sensitised to parietaria , ragweed, or mugwort, if this allergen is endemic to the region
    2. 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).
    3. Patients with moderate or severe persistent asthma (GINA 3 or 4)
    4. Patients with mild persistent asthma (GINA 2) necessitating treatment with inhaled glucocorticosteroids at a daily dose level greater than 400 mcg budesonide dose-equivalents [that is, patients with GINA 1 asthma or asthmatic patients necessitating treatment with inhaled corticosteroids at a daily dose level equal to or less than 400 mcg budesonide dose-equivalents at stable dose in the last 4 weeks may be included in the study]
    5. FEV1 < 80% of predicted value at visit V1
    6. Any change in environmental measures for allergen avoidance during the study.
    7. Patients treated with systemic steroids (whatever the indication) within 4 weeks before visit V1.
    8. Patients treated with long acting systemic steroids (whatever the indication) within 12 weeks before visit V1 or between visits V1 and V2.
    9. Patients treated with beta-blockers or continuous corticotherapy, other than a daily dose level equal to or less than 400 mcg of inhaled budesonide dose-equivalents for asthmatic patients.
    10. Patients treated with antihistamines for any reasons other than house dust mite allergic rhinitis symptoms
    11. Patients who received allergen specific immunotherapy for house dust mites in the last 5 years.
    12. Ongoing immunotherapy with any allergen.
    13. Patients with a past or current disease, which as judged by the investigator, may affect the patient's participation in or the outcome of this study. These diseases include, but are not limited to, cardiovascular disease, malignancy, hepatic disease, renal disease, haematological disease, neurological disease, immunological disease, psychiatric disease, dermatological disease, and endocrine disease.
    14. Usual contraindications of immunotherapy such as serious immunopathologic conditions or malignancies.
    15. Intolerance to any excipients (more specifically to lactose)
    16. Patients with a history of drug or alcohol abuse.
    17. Pregnant or breast-feeding women
    18. Sexually active female patients of childbearing potential who are not willing to use a medically accepted contraceptive method for the next two years (hormonal birth control [orally, injectable or by implant, for at least 2 months before enrolment], bilateral tubal ligation, monogamous relationship with a vasectomised partner)
    19. Patients likely to be non-compliant
    Patients who have already been included in this study or who are participating in another study
    20. Patients having participated in a study with an investigational drug in the 12 weeks preceding V1
    21. Children of Investigators, co-investigators and of all the study collaborators should not be enrolled in the study.

    Note: Patients with flue or with an upper respiratory track infection must be treated appropriately and can be re-evaluated for enrolment at visit 2.
    E.5 End points
    E.5.1Primary end point(s)
    The primary efficacy criterion is the Average Adjusted Symptom Score (AASS), average of the daily (non-missing) ASS during the period of assessment. AASS theoretically ranges from 0 to 12.
    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.8.3 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 concerned8
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA52
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA Information not present in EudraCT
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    E.8.7Trial has a data monitoring committee Yes
    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 years2
    E.8.9.1In the Member State concerned months6
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months6
    E.8.9.2In all countries concerned by the trial days0
    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 2009-07-01. 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 Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    Minors
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state140
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 415
    F.4.2.2In the whole clinical trial 454
    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 Decision2009-09-14
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2009-08-05
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2011-09-29
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