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    Summary
    EudraCT Number:2019-000560-22
    Sponsor's Protocol Code Number:MT-12
    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:2020-04-28
    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 number2019-000560-22
    A.3Full title of the trial
    A one-year placebo-controlled phase III trial evaluating the efficacy and safety of the house dust mite (HDM) SLIT-tablet in children (5-11 years of age) with HDM allergic rhinitis/rhinoconjunctivitis with or without asthma
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A clinical trial studying the effect of the house dust mite tablet on children with allergic rhinitis/rhinoconjunctivitis
    A.4.1Sponsor's protocol code numberMT-12
    A.5.4Other Identifiers
    Name:IND numberNumber:015015
    A.7Trial is part of a Paediatric Investigation Plan Yes
    A.8EMA Decision number of Paediatric Investigation PlanP/328/2019
    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 Global Clinical Development
    B.5.2Functional name of contact pointClinical Trials Information
    B.5.3 Address:
    B.5.3.1Street AddressBøge Allé 6-8
    B.5.3.2Town/ cityHørsholm
    B.5.3.3Post code2970
    B.5.3.4CountryDenmark
    B.5.6E-mailClinicalTrials@alk.net
    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 ACARIZAX
    D.2.1.1.2Name of the Marketing Authorisation holderALK-Abello A/S
    D.2.1.2Country which granted the Marketing AuthorisationCzechia
    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 nameHDM SLIT-tablet
    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 INNDERMATOPHAGOIDES PTERONYSSINUS EXTRACT
    D.3.9.3Other descriptive nameDERMATOPHAGOIDES PTERONYSSINUS EXTRACT
    D.3.9.4EV Substance CodeSUB84531
    D.3.10 Strength
    D.3.10.1Concentration unit SQU Standardised Quality Unit(s) (Deprecated)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number6
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNDERMATOPHAGOIDES FARINAE EXTRACT
    D.3.9.3Other descriptive nameDERMATOPHAGOIDES FARINAE EXTRACT
    D.3.9.4EV Substance CodeSUB84530
    D.3.10 Strength
    D.3.10.1Concentration unit SQU Standardised Quality 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.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/rhinoconjunctivitis induced by house dust mites
    E.1.1.1Medical condition in easily understood language
    House dust mite allergy
    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 20.0
    E.1.2Level LLT
    E.1.2Classification code 10020419
    E.1.2Term House dust mite allergy
    E.1.2System Organ Class 100000004870
    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 demonstrate the efficacy of the HDM SLIT-tablet compared to placebo in the treatment of HDM allergic rhinitis (AR)
    in children (5-11 years of age) based on total combined rhinitis symptoms and medication use (TCRS) during the primary efficacy assessment period.
    E.2.2Secondary objectives of the trial
    The key secondary objectives are to demonstrate the efficacy of the HDM SLIT-tablet compared to placebo during the primary efficacy assessment
    period based on:
    1. Rhinitis symptoms (based on DSS)
    2. Rhinitis medication use (based on DMS)
    3. Combined rhinoconjunctivitis symptoms and medication use (based on TCS)

    The additional secondary objectives are to evaluate the HDM SLIT-tablet compared to placebo during the primary efficacy assessment period with
    respect to:
    - Safety and tolerability
    - Rhinoconjunctivitis symptoms
    - Rhinoconjunctivitis medication use
    - Rhinoconjunctivitis quality of life (QoL)
    - Asthma symptoms and medication use
    -Changes in immunological parameters
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Male or female, aged 5-11 years old at randomisation, of any race/ethnicity and weighing 15 kg or more on the day of screening
    - A clinical history of AR/C when exposed to HDM (diagnosed by a physician) of 1 year duration or more (with or without asthma) and with
    allergic rhinitis symptoms despite having received allergy pharmacotherapy during the previous year prior to the screening visit
    - Have a rhinitis DSS of at least 6, or a score of at least 5 with one symptom being severe, on at least 8 of the last 14 days of the baseline period
    - Use symptomatic medication for treatment of HDM allergic rhinitis during at least 8 of the last 14 days of the baseline period
    - Presence of one or more of the Allergic Rhinitis Impact on Asthma (ARIA) quality of life items due to HDM AR/C during the last 14 days of
    the baseline period
    - Positive skin prick test (SPT) to D. pteronyssinus or D. farinae at screening
    - Positive D. pteronyssinus or D. farinae specific IgE (defined as ≥class 3, ≥3.5 kU/l) at screening
    - Lung function measured by FEV1 ≥ 70% of predicted value or according to local requirements at randomisation (visit 3). For subjects having a diagnosis of asthma, FEV1 is measured while on subject's usual asthma medication following at least a 6-hour washout of SABA. The criteria must be fulfilled, unless subject is ≤7 years old and not able to perform reproducible FEV1 manoeuvres despite coaching and is not considered as having a diagnosis of asthma as defined in section 11.5 of this protocol.
    E.4Principal exclusion criteria
    -A clinically relevant history of symptomatic perennial AR/C caused by a perennial allergen source such as animal hair and dander and/or mould,
    or symptomatic seasonal AR/C and/or asthma caused by an allergen to which the subject is exposed in the baseline and/or efficacy assessment
    period.
    - SLIT or SCIT treatment reaching the maintenance dose, with D. pteronyssinus or D. farinae for more than 1 month within the last 5
    years. In addition, any SLIT or SCIT treatment with D. pteronyssinus or D. farinae within the previous 12 months
    - Treatment with medications with potential impact on efficacy endpoints (e.g. treatment with anti-IgE drugs within 130 days/5 halflives
    of the drug (which ever longest) or treatment with antidepressant or antipsychotic medications with antihistaminergic effect)
    - Asthma requiring daily use of more than 400 mcg budesonide or equivalent at screening or any clinical deterioration of asthma that resulted in emergency treatment, hospitalisation or treatment with systemic corticosteroids within 3 months prior to randomisation
    - Any systemic immunosuppressive treatment, other than glucocorticosteroids, within 130 days prior to screening. Any oral
    glucocorticosteroids from 60 days prior to baseline. Any other systemic glucocorticosteroids (depot or parenteral) from 90 days prior to baseline,
    - A history of chronic urticaria (> 6 weeks) and/or chronic angioedema (> 6 weeks) within the last 2 years prior to screening that in the opinion
    of the investigator may constitute an increased safety concern.
    - A relevant history of systemic allergic reaction e.g. anaphylaxis with cardiorespiratory symptoms, generalised urticaria or severe facial
    angioedema that in the opinion of the investigator may constitute an increased safety concern
    - Severe chronic oral inflammation
    - A diagnosis or history of eosinophilic oesophagitis
    - Active or poorly controlled autoimmune diseases, immune defects, immunodeficiencies, immunosuppression or malignant neoplastic
    diseases with current disease relevance or any immunosuppressive treatment within 3 months prior to screening
    - Known history of allergy, hypersensitivity or intolerance to any of the excipients or active substances of the IMP (except for D. pteronyssinus
    and/or D. farinae) or to any excipient of the rescue medication provided in this trial
    - May be at greater risk of developing severe adverse reactions after adrenaline/epinephrine administration
    E.5 End points
    E.5.1Primary end point(s)
    Primary efficacy endpoint during the efficacy assessment period is:
    The average daily TCRS

    The daily TCRS is the sum of the rhinitis daily symptoms score (DSS) and the rhinitis daily medication score (DMS).
    E.5.1.1Timepoint(s) of evaluation of this end point
    During the efficacy assessment period which is the last 8 weeks (period 4) of the approximately 12 months IMP treatment.
    E.5.2Secondary end point(s)
    Key secondary efficacy endpoints during the efficacy assessment period are:
    - The average rhinitis DSS
    - The average rhinitis DMS
    - The average total combined score (TCS)
    The daily TCS is the sum of the rhinoconjunctivitis DSS (rhinitis DSS + conjunctivitis DSS) and the rhinoconjunctivitis DMS (rhinitis DMS +
    conjunctivitis DMS).
    The safety and tolerability endpoints are:
    - Treatment-emergent adverse events (TEAEs), solicited AEs, IMP related AEs, treatment-emergent serious adverse events (SAEs), event
    of special interest (ESI), TEAEs leading to discontinuation, time to discontinuation due to TEAEs
    - Vital signs, physical examination, FEV1 and clinical laboratory values during treatment and at the final visit (visit 7)
    Additional secondary efficacy endpoints during the efficacy assessment period are:
    - Average rhinoconjunctivitis DSS
    - Average rhinoconjunctivitis DMS
    - Paediatric rhinoconjunctivitis quality of life questionnaire (PRQLQ)
    - Average asthma DSS
    - Average daily use of short-acting β2-agonist (SABA)
    - Rhinitis mild days
    - Rhinitis exacerbation days (days with a rhinitis DSS of 6 or of 5 with
    one individual symptom scored 3 (symptom that is hard to tolerate; causes interference with activities of daily living and/or sleeping))
    - Average rhinitis combined symptom and medication score (CSMS)
    The immunologic endpoints are:
    - Change from baseline in specific IgE and IgG4 to D. pteronyssinus and D. farina, change in baseline for HDM IgE-Blocking factor (IgE-BF) and
    change in baseline for total IgE measured at end of trial (visit 7)
    E.5.2.1Timepoint(s) of evaluation of this end point
    Secondary endpoints will be evaluated during the efficacy asessment period, as specified for applicable endpoints, or througout the trial (safety and tolerability as well as immunologic endpoints).
    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 Yes
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    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 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 EEA46
    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
    Canada
    Russian Federation
    Ukraine
    United States
    Bulgaria
    France
    Germany
    Lithuania
    Poland
    Slovakia
    Spain
    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
    LVLS
    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 months10
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years3
    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 Yes
    F.1.1Number of subjects for this age range: 1370
    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.1.1.5.1Number of subjects for this age range: 1370
    F.1.1.6Adolescents (12-17 years) No
    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 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 state100
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 805
    F.4.2.2In the whole clinical trial 1370
    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)
    None
    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 Decision2020-06-04
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-05-27
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2023-04-21
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