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    Summary
    EudraCT Number:2010-018621-19
    Sponsor's Protocol Code Number:MT-04
    National Competent Authority:Lithuania - SMCA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2010-06-02
    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 ConcernedLithuania - SMCA
    A.2EudraCT number2010-018621-19
    A.3Full title of the trial
    Efficacy of ALK house dust mite allergy immunotherapy tablet in subjects with house dust mite induced asthma. The MITRA Trial.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    To find out if people with allergic asthma caused by house dust mites will benefit from allergy vaccine given as a tablet.
    A.3.2Name or abbreviated title of the trial where available
    MITRA
    A.4.1Sponsor's protocol code numberMT-04
    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-abello
    B.4.2CountryDenmark
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationALK-abello
    B.5.2Functional name of contact pointClinical Project Manager
    B.5.3 Address:
    B.5.3.1Street AddressBøge Alle 6-8
    B.5.3.2Town/ cityHørsholm
    B.5.3.3Post code2970
    B.5.3.4CountryDenmark
    B.5.4Telephone number4545747995
    B.5.5Fax number454545748697
    B.5.6E-mailbmt@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.3.9.1CAS number N/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 AgU antigen unit(s)
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number6 to 12
    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.3.9.1CAS number N/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 AgU antigen unit(s)
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number6 to 12
    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
    House dust mite induced allergic asthma
    E.1.1.1Medical condition in easily understood language
    suffer from asthma and are allergic to house dust mites
    E.1.1.2Therapeutic area Diseases [C] - Immune System Diseases [C20]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level LLT
    E.1.2Classification code 10001705
    E.1.2Term Allergic asthma
    E.1.2System Organ Class 100000004855
    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 the ALK house dust mite (HDM) allergy immunotherapy tablet (AIT) (6 Development Unit (DU) and 12 DU) given once daily compared to placebo in subjects with HDM induced asthma, as measured by time to first asthma exacerbation after inhaled corticosteroid (ICS) reduction.
    E.2.2Secondary objectives of the trial
    To determine the effects of ALK HDM AIT on asthma symptoms and immunology.

    To evaluate the effects of ALK HDM AIT on lung function, asthma control, safety, symptomatic medication, asthma quality of life, and pharmacoeconomics.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Male or female ≥ 18 years.
    • A clinical relevant history consistent with HDM-induced asthma of at least 1 year prior to trial entry.
    • Use of an appropriate amount of inhaled corticosteroid (incl. combination products) in accordance with the GINA Guideline step 2-4 for the control of the asthma symptoms for a period of at least 6 months within the past year.
    • Dose of ICS after switching should at randomisation be in a range of budesonide 400-1200 mcg.
    • Documented reversible airway obstruction.
    • Asthma control level above or equal to 1.0 (asthma control questionnaire (ACQ) ≥ 1.0) at screening.
    • Asthma control level between 1.0 and 1.5 (1.0 ≤ ACQ ≤ 1.5) at visit 3 (randomisation).
    • FEV1 > 70% of predicted value.
    • A clinical history consistent with mild to severe HDM-induced allergic rhinitis for at least 1 year.
    • Positive SPT response (wheal diameter ≥ 3 mm larger than the negative control) to Der pte and/or Der far.
    • Positive specific IgE against Der pte and/or Der far (≥ IgE Class 2; ≥ 0.70 KU/L).
    E.4Principal exclusion criteria
    • A clinical history of persistent allergic asthma and/or rhinitis caused by an allergen to which the subject is regularly exposed and sensitized (except HDM).
    • A clinical history of intermittent allergic asthma and/or rhinitis if the seasonal allergen that may cause symptoms in the ICS reduction period (period 3).
    • Previous treatment with immunotherapy with HDM allergen for more than 1 month within the last 5 years.
    • Hospitalisation for more than 12 hours due to asthma exacerbation within the last 3 months prior to screening visit.
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint is the time to first asthma exacerbation during period 3 (ICS reduction).

    Time to first asthma exacerbation is measured in days from start of period 3 (ICS reduction). The definition of asthma exacerbation used is that the subject must experience one or more of the 9 criteria a)-i) listed below.

    The definition of asthma exacerbation used in this trial is based on the recommendations given in the joint statement from the American Thoracic Society and the European Respiratory Society 2009. The clinical interpretation presented below is based on recommendations from GINA (9), the joint statement from the American Thoracic Society and the European Respiratory Society 2009 (12) as well as publications covering asthma exacerbations (18;19). The cut-off for daytime symptoms is based on recommendations from a multinational board of clinical experts within asthma treatment.
    In order to fulfil the criteria for a moderate asthma exacerbation in practice, the subject must experience one or more of the following criteria leading to a change in treatment:
    a) Nocturnal awakening(s) due to asthma requiring SABA use for at least 2 consecutive nights or an increase of minimum 0.75 in daily symptom score from baseline value on at least 2 consecutive days.
    b) An increase from baseline value in occasions of SABA use on at least 2 consecutive days (a minimum increase of 4 puffs per day).
    c) ≥ 20% decrease in PEF from baseline value on at least 2 consecutive mornings or evenings or ≥ 20% decrease in FEV1 from baseline value.
    d) Visit to the emergency room or unscheduled visit to the trial centre for asthma treatment not requiring systemic corticosteroids.

    The baseline value is the mean values during the last 14 days of the screening period.

    If the subject experience one of the following events, this will be characterised as a severe asthma exacerbation:
    e) Need of systemic corticosteroids for treatment of asthma symptoms for at least 3 days.
    f) Emergency room visit because of asthma, requiring systemic corticosteroids or hospitalisation for more than 12 hours because of asthma.

    E.5.1.1Timepoint(s) of evaluation of this end point
    end of trial - May 2013
    E.5.2Secondary end point(s)
    Key Secondary Endpoints
    Key secondary endpoints are:
    • Time to first deterioration in asthma symptoms.
    Time in days from start of period 3 (ICS reduction) to the first asthma exacerbation fulfilling criterion a), see section 8.6.1.
    • Immunology measured at end of trial in terms of specific IgE-blocking factor against HDM allergens.
    8.6.3 Other Secondary Endpoints
    • Severe asthma exacerbation.
     Time to first severe asthma exacerbation.
    Time in days from start of period 3 to the first severe asthma exacerbation fulfilling criterion e) or f), see section 8.6.1.
    • Asthma exacerbations during period 3.
     The frequency of asthma exacerbations (number/percentage of subjects) during period 3.
    • Asthma symptoms.
     The average overall symptom score over the first asthma exacerbation free period during the first 3 months of period 3.
     The average overall symptom score over the first asthma exacerbation free period during entire period 3.
     Symptom free days during period 3.
    A symptom free day is defined as a day with:
    o No asthma symptoms (symptom score =0).
    o No need for SABA.
    o No increase in ICS or use of oral steroid.
    • Symptomatic medication.
     Time to first increased use of SABA.
    Time in days from start of period 3 to the first asthma exacerbation fulfilling criterion b), see section 8.6.1.
    • Lung function.
     The average morning PEF and diurnal variability over the first asthma exacerbation free period during first 3 months of period 3.
     The average morning PEF and diurnal variability over the first asthma exacerbation free period during entire period 3.
     Time to first deterioration in lung function.
    Time in days from start of period 3 to the first asthma exacerbation fulfilling criterion c), see section 8.6.1.
     Change in FEV1 from baseline to visit 9 (ICS reduction).
    • Asthma control.
     The overall ACQ for the last week of period 2 (treatment maintenance) before period 3 (assessed at visit 9).
    • Asthma quality of life.
     The overall AQLQ(s) for the last week of period 2 (treatment maintenance) before period 3 (assessed at visit 9).
    • Immunology.
     Specific IgE, IgG4, and other immunological assessments.
    • Quality of Life and Pharmacoeconomics Assessments.
     Development and changes in ACQ, AQLQ(s), SF-36, TSQM II, and WPAI:ASTHMA.
     Health care resource use and rate of hospitalisation.
    • Safety.
     AEs, SAEs, AE withdrawals, clinical lab tests, vital signs, physical examination
    E.5.2.1Timepoint(s) of evaluation of this end point
    end of trial - May 2013
    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 Yes
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic Yes
    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 trial3
    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 concerned5
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA90
    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
    Austria
    Croatia
    Denmark
    France
    Germany
    Lithuania
    Netherlands
    Poland
    Serbia
    Slovakia
    Spain
    United Kingdom
    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
    the end of the trial is defined in the protocol as database closure
    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 months7
    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 months7
    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.1.1Number of subjects for this age range: 0
    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: 750
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 50
    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 No
    F.3.3.1Women of childbearing potential not using contraception Information not present in EudraCT
    F.3.3.2Women of child-bearing potential using contraception Information not present in EudraCT
    F.3.3.3Pregnant women Information not present in EudraCT
    F.3.3.4Nursing women Information not present in EudraCT
    F.3.3.5Emergency situation Information not present in EudraCT
    F.3.3.6Subjects incapable of giving consent personally Information not present in EudraCT
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state82
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 750
    F.4.2.2In the whole clinical trial 800
    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)
    There are no plans for treatment of the subject after the subject has ended participation in the trial
    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 Decision2010-11-02
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2010-10-14
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2013-06-25
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