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    Summary
    EudraCT Number:2011-002277-38
    Sponsor's Protocol Code Number:MT-06
    National Competent Authority:Denmark - DHMA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2011-08-19
    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 ConcernedDenmark - DHMA
    A.2EudraCT number2011-002277-38
    A.3Full title of the trial
    A one-year trial evaluating the efficacy and safety of the ALK house dust mite allergy immunotherapy tablet in adult subjects with house dust mite allergic rhinitis
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A one year study to look at the efficacy and safety of tablets to treat adults allergic to house dust mite
    A.4.1Sponsor's protocol code numberMT-06
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorALK-Abelló A/S
    B.1.3.4CountryDenmark
    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 supportALK-Abelló A/S
    B.4.2CountryDenmark
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationALK-Abelló A/S
    B.5.2Functional name of contact pointMedical expert
    B.5.3 Address:
    B.5.3.1Street AddressBøge Aile 6-8
    B.5.3.2Town/ cityHørsholm
    B.5.3.3Post code2970
    B.5.3.4CountryDenmark
    B.5.4Telephone number+4545747576
    B.5.5Fax number+4545748690
    B.5.6E-mailMWIDK@alk-abello.com
    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 nameALK house dust mite (HDM) allergy immunotherapy tablet (AIT)
    D.3.2Product code ALK HDM AIT
    D.3.4Pharmaceutical form Oral lyophilisate
    D.3.4.1Specific paediatric formulation No
    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 INNN/A
    D.3.9.2Current sponsor codeALK HDM AIT
    D.3.9.3Other descriptive nameAllergen extract from Dermatophagoides pteronyssinus and Dermatophagoides farinae
    D.3.10 Strength
    D.3.10.1Concentration unit SU Standardised Unit(s) (Deprecated)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number6
    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) No
    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 No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    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 No
    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 nameALK house dust mite (HDM) allergy immunotherapy tablet (AIT)
    D.3.2Product code ALK HDM AIT
    D.3.4Pharmaceutical form Oral lyophilisate
    D.3.4.1Specific paediatric formulation No
    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 INNN/A
    D.3.9.2Current sponsor codeALK HDM AIT
    D.3.9.3Other descriptive nameAllergen extract from Dermatophagoides pteronyssinus and Dermatophagoides farinae
    D.3.10 Strength
    D.3.10.1Concentration unit SU Standardised Unit(s) (Deprecated)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number12
    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) No
    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 No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    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 No
    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 placeboSublingual use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    allergic rhinitis
    E.1.1.1Medical condition in easily understood language
    allergy to house dust mite
    E.1.1.2Therapeutic area Body processes [G] - Immune system processes [G12]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level LLT
    E.1.2Classification code 10034382
    E.1.2Term Perennial allergic rhinitis
    E.1.2System Organ Class 10038738 - Respiratory, thoracic and mediastinal disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level LLT
    E.1.2Classification code 10001723
    E.1.2Term Allergic rhinitis
    E.1.2System Organ Class 10038738 - Respiratory, thoracic and mediastinal disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level LLT
    E.1.2Classification code 10001724
    E.1.2Term Allergic rhinitis (excl hay fever)
    E.1.2System Organ Class 10038738 - Respiratory, thoracic and mediastinal disorders
    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 of ALK HDM AIT given once daily compared to placebo in the treatment of HDM allergic rhinitis. The primary endpoint is the average total combined rhinitis score (TCRS) during the last 8 weeks of treatment. The TCRS is the sum of the allergic rhinitis daily symptom score (DSS) and the allergic rhinitis daily medication score (DMS) averaged over the last 8 weeks of treatment.
    E.2.2Secondary objectives of the trial
    To determine the effect of the ALK HDM AIT on average allergic rhinitis DSS, average allergic rhinitis DMS and average total combined rhinoconjunctivitis score.

    Additional secondary objectives of the trial are:

    To evaluate the safety and tolerability of ALK HDM AIT treatment

    To determine the effect of the ALK HDM AIT on individual rhinitis and conjunctivitis symptoms, medication use, onset of action, treatment satisfaction, and generic and disease-specific quality of life. Immunological parameters will be investigated for a subset of the subjects.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    I1. Written informed consent obtained before entering the trial.
    I2. Subject 18-65 years of age, with a clinical history consistent with moderate to severe persistent HDM allergic rhinitis (with or without asthma) for at least one year prior to trial entry, with allergic rhinitis symptoms despite having received symptomatic treatment.
    I3. Moderate to severe HDM allergic rhinitis symptoms during the baseline period defined as a daily total rhinitis symptom score of at least 6, or a score of at least 5 with one symptom being severe, during at least 8 days of the 15-days baseline period.
    I4. Use of symptomatic medication for treatment of HDM allergic rhinitis during at least 8 days of the 15-days baseline period.
    I5. Presence of one or more of the following ARIA quality of life items due to HDM allergic rhinitis during the baseline period:
    1) Sleep disturbance
    2) Impairment of daily activities, leisure and/or sport
    3) Impairment of school or work
    I6. If asthma, daily use of ICS should be ≤400mcg budesonide or equivalent3 (i.e. corresponding to GINA treatment steps 1 or 2).
    I7. Positive skin prick test response (wheal diameter ≥3 mm) to Dermatophagoides pteronyssinus and/or Dermatophagoides farinae.
    I8. Positive specific IgE against Dermatophagoides pteronyssinus and/or Dermatophagoides farinae (defined as ≥IgE Class 2; or ≥0.70 kU/L).
    I9. Male, Female (infertile), Female, with a negative pregnancy test and willingness to practise appropriate6 contraceptive methods until treatment with IMP has been discontinued.
    I10.
    Subject willing and able to comply with trial protocol
    E.4Principal exclusion criteria
    E1. A clinically relevant history of symptomatic seasonal allergic rhinoconjunctivitis and/or asthma caused by an allergen to which the subject regularly exposed and overlapping with the 8-week efficacy assessment period.
    E2. A clinically relevant history of symptomatic allergic rhinoconjunctivitis caused by mould or by animal hair and dander to which the subject is regularly exposed.
    E3. Reduced lung function (defined as FEV1<70% of predicted value after adequate pharmacologic treatment).
    E4. A clinical history of uncontrolled asthma7 within 3 months prior to screening.
    E5. Symptoms of or treatment for upper respiratory tract infection, acute sinusitis, acute otitis media or other relevant infectious process at randomisation.
    E6. Any nasal condition that could confound the efficacy or safety assessments (e.g. nasal polyposis).
    E7. Inflammatory conditions in the oral cavity with severe symptoms such as oral lichen planus with ulcerations or severe oral mycosis at randomisation.
    E8. Previous treatment with immunotherapy with HDM allergen or a cross-reacting allergen for more than 1 month within the last 5 years. Initiation of subcutaneous immunotherapy is acceptable, if treatment has been discontinued before reaching maintenance dose.
    E9. Ongoing treatment with any specific immunotherapy.
    E10. History of anaphylaxis with cardio-respiratory symptoms (food allergy, drugs or an idiopathic reaction).
    E11. History of 2 or more episodes of generalised urticaria during the last 2 years.
    E12. History of drug induced (incl. immunotherapy) facial angioedema or a familiy (parents and siblings) history of hereditary angioedema.
    E13. Any clinically relevant chronic disease (≥3 months duration) (e.g. cystic fibrosis, malignancy, type I diabetes mellitus, malabsorption or malnutrition, renal or hepatic insufficiency).
    E14. Systemic disease affecting the immune system (e.g. autoimmune disease, immune complex disease, or immune deficiency disease).
    E15. Severe inflammatory disease (e.g. rheumatoid arthritis, systemic lupus erythematosus, immune deficiency diseases or multiple sclerosis).
    E16. Immunosuppressive treatment (ATC code L04 or L01) within 3 months prior to the screening visit (except steroids for allergic rhinitis and asthma).
    E17. Current treatment with ACE inhibitors, tricyclic antidepressants; catechol-O-methyl transferase inhibitors (COMT inhibitors) and mono amine oxidase inhibitors (MAOIs).
    E18. Use of medication listed in the table of "Prohibited Concomitant Medication" (Table 2) within the specified timeframes.
    E19. Use of any IMP within 30 days/5 half-lives of the product (which ever longest) prior to randomisation.
    E20. History of allergy, hypersensitivity or intolerance to the excipients of the IMP or to the symptomatic medications.
    E21. History of alcohol or drug abuse within the past 2 years.
    E22. Being immediate family of the investigator or trial staff, defined as the investigator's/staff’s spouse, parent, child, grandparent or grandchild.
    E.5 End points
    E.5.1Primary end point(s)
    The average total combined rhinitis score (TCRS) during the last 8 weeks of the 12 months period of treatment.

    The TCRS is the sum of the total allergic rhinitis daily symptom score (DSS) and the allergic rhinitis daily medication score (DMS) averaged over the last 8 weeks of the 12 months period of treatment.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Measured over the last 8 weeks of the 12 months period of treatment
    E.5.2Secondary end point(s)
    The average total allergic rhinitis DSS during the last 8 weeks of 12 months treatment.
    The average total allergic rhinitis DMS during the last 8 weeks of 12 months treatment.
    The average total combined allergic rhinoconjunctivitis score during the last 8 weeks of 12 months treatment

    Other efficacy endpoints include:
    The average total allergic rhinoconjunctivitis DSS during the last 8 weeks of 12 months treatment.
    The average total allergic rhinoconjunctivitis DMS during the last 8 weeks of 12 months treatment.
    The average total allergic conjunctivitis DSS, allergic conjunctivitis DMS and combined conjunctivitis score during the last 8 weeks of 12 months treatment.
    Onset of efficacy, based on DSS and DMS during all one week diary periods.
    The average individual allergic DSS during the last 8 weeks of 12 months treatment
    RQLQ.
    Global evaluation for efficacy.
    Immunology markers.
    Symptom free days.
    EQ-5D.
    TSQM II.
    WPAI-AS.
    Health care utilisation based on GP/specialist visits

    The safety endpoints for the trial include
    Local AEs including oral pruritus, ear pruritus, throat irritation and mouth oedema.
    AEs, SAEs, AE withdrawals, clinical laboratory tests, vital signs, physical examination
    E.5.2.1Timepoint(s) of evaluation of this end point
    Measured over the last 8 weeks of the 12 months period of treatment
    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 No
    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.8.2.4Number of treatment arms in the trial2
    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 concerned6
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA78
    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 No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Bosnia and Herzegovina
    Croatia
    Serbia
    Ukraine
    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
    2 months after last patient last visit
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    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 years1
    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 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.1.2.1Number of subjects for this age range: 900
    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 state60
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 939
    F.4.2.2In the whole clinical trial 1163
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    After the end of the trial, the investigator will ensure trial subjects have access to appropriate and available treatment.
    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 Decision2011-09-12
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-10-12
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2013-04-04
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