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    Summary
    EudraCT Number:2020-004372-17
    Sponsor's Protocol Code Number:TT-06
    National Competent Authority:Slovakia - SIDC (Slovak)
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2021-01-11
    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 ConcernedSlovakia - SIDC (Slovak)
    A.2EudraCT number2020-004372-17
    A.3Full title of the trial
    Efficacy and safety of the SQ tree sublingual immunotherapy tablet in children and adolescents (5 through 17 years of age) with moderate to severe allergic rhinitis and/or conjunctivitis induced by pollen from birch and trees belonging to the birch homologous group.
    Účinnosť a bezpečnosť sublingválnej alergénovej imunoterapie podávanej vo forme SQ tabliet deťom a dospievajúcim (vo veku od 5 do 17 rokov) so stredne závažnou až závažnou alergickou rinitídou a/alebo konjunktivitídou vyvolanou peľom z brezy a stromov patriacich do homológnej skupiny brezy
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Clinical study to investigate the effect and safety of a tree pollen immunotherapy tablet in children and teenagers with a birch pollen allergy
    Klinická štúdia skúmajúca účinok a bezpečnosť tablety na imunoterapiu stromovým peľom u detí a dospievajúcich s alergiou na peľ brezy
    A.4.1Sponsor's protocol code numberTT-06
    A.7Trial is part of a Paediatric Investigation Plan Yes
    A.8EMA Decision number of Paediatric Investigation PlanP/434/2020
    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 pointHead of Clinical Project Management
    B.5.3 Address:
    B.5.3.1Street AddressBøge Allé 6-8
    B.5.3.2Town/ cityHørsholm
    B.5.3.3Post codeDK-2970
    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 ITULAZAX
    D.2.1.1.2Name of the Marketing Authorisation holderALK-Abelló A/S
    D.2.1.2Country which granted the Marketing AuthorisationSlovakia
    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 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 INNBETULA VERRUCOSA (108) POLLEN EXTRACT
    D.3.9.3Other descriptive nameBETULA VERRUCOSA (108)
    D.3.9.4EV Substance CodeSUB124948
    D.3.10 Strength
    D.3.10.1Concentration unit SQU Standardised Quality 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
    Tree pollen induced allergic rhinitis and/or conjuctivitis.
    E.1.1.1Medical condition in easily understood language
    Rhinitis and/or conjuctivitis induced due to allergy to tree pollen.
    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 10001726
    E.1.2Term Allergic rhinitis due to pollen
    E.1.2System Organ Class 100000004870
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10001709
    E.1.2Term Allergic conjunctivitis
    E.1.2System Organ Class 100000004853
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To compare the efficacy of the SQ tree SLIT-tablet to placebo in the treatment of moderate to severe allergic rhinitis and/or conjunctivitis induced by pollen from birch and trees belonging to the birch homologous group in children and adolescents (5 through 17 years of age) based on the average allergic rhinoconjunctivitis daily total combined score (average TCS) during the birch pollen season (BPS)
    E.2.2Secondary objectives of the trial
    Key secondary objectives:
    To compare the efficacy of the SQ tree SLIT-tablet to placebo based on:
    •The average TCS during the tree pollen season (TPS)
    •The average allergic rhinoconjunctivitis daily symptom score (average DSS) during the BPS and TPS
    •The average allergic rhinoconjunctivitis daily medication score (average DMS) during the BPS and TPS
    Secondary objectives:
    •To compare the safety and tolerability of the SQ tree SLIT-tablet to placebo
    •To compare the efficacy of the SQ tree SLIT-tablet to placebo using additional endpoints based on daily allergic rhinoconjunctivitis symptoms and rescue medication use
    •To compare the efficacy of the SQ tree SLIT-tablet to placebo based on assessments of quality of life
    •To compare the efficacy of the SQ tree SLIT-tablet to placebo based on patient treatment satisfaction
    •To compare the effect of the SQ tree SLIT-tablet to placebo on immunological parameters to birch, alder, hazel and oak pollen
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Subjects are eligible to be included in the trial only if all the following criteria apply:
    •Male or female of any race/ethnicity aged ≥4 to <18 years on the day informed consent is obtained from the parent/caregiver; the subject must be ≥5 to <18 years old at the randomisation visit
    •A documented, physician diagnosed, clinically relevant history of moderate to severe AR/C induced by birch pollen (with or without asthma) despite having received treatment with symptom-relieving medication during at least 1 previous tree pollen season for ages 4 through 6 years at screening or at least 2 previous tree pollen seasons for ages 7 through 17 years at screening
    •Positive skin prick test (SPT) to Betula verrucosa at screening
    •Positive specific IgE to Bet v at screening
    •Presence of 1 or more of the following Allergic Rhinitis Impact on Asthma (ARIA) quality of life items due to AR/C during the previous BPS:
    a.Sleep disturbance
    b.Impairment of daily activities, leisure and/or sport
    c.Impairment of school or work
    d.Troublesome symptoms
    E.4Principal exclusion criteria
    Subjects are excluded from the trial if any of the following criteria apply:
    •A clinically relevant history of symptomatic seasonal AR/C caused by an allergen source, other than tree pollen from the birch homologous group, with a season overlapping the TPS
    •A clinically relevant history of symptomatic perennial AR/C caused by an allergen source such as animal hair and dander to which the subject is exposed during the TPS
    •Any clinical deterioration of asthma (i.e. asthma exacerbation) that resulted in emergency treatment, hospitalisation or treatment with systemic corticosteroids within 3 months prior to randomisation
    •Reduced lung function at randomisation defined as forced expiratory volume in 1 second (FEV1) <70% of predicted value. For subjects with asthma, this is assessed on subject’s usual asthma medication following at least a 6-hour wash-out of SABA. This criterion does not need to be fulfilled if the subject is <7 years old, cannot perform reproducible FEV1 manoeuvres despite coaching and is not considered as having a diagnosis of asthma
    •Ongoing treatment with any allergy immunotherapy product
    •Severe chronic oral inflammation
    •A diagnosis of eosinophilic oesophagitis
    •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
    •Immunosuppressive treatment (ATC code L04 or L01) within 3 months prior to the screening visit
    E.5 End points
    E.5.1Primary end point(s)
    Average TCS during the BPS
    E.5.1.1Timepoint(s) of evaluation of this end point
    During the Birch Pollen Season (BPS)
    E.5.2Secondary end point(s)
    •Average TCS during the TPS
    •Average DSS during the BPS
    •Average DSS during the TPS
    •Average DMS during the BPS
    •Average DMS during the TPS
    E.5.2.1Timepoint(s) of evaluation of this end point
    During either Birch Pollen Season (BPS) or Tree Pollen Season (TPS), respectively.
    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 concerned11
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA68
    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
    Austria
    Lithuania
    Poland
    Netherlands
    Germany
    Belgium
    Denmark
    Hungary
    Russian Federation
    Slovakia
    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
    Date of the last follow-up phone visit (TC4) for the last subject in 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 months4
    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 months4
    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.1.1Number of subjects for this age range: 1000
    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: 450
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 550
    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 Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    Children and adolescents in age range 5-17 years.
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state65
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 880
    F.4.2.2In the whole clinical trial 1000
    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 must advise trial subjects on access to appropriate and available treatment. Post-trial treatment will not be sponsored by ALK.
    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 Decision2021-04-09
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-01-21
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2023-07-31
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