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    Summary
    EudraCT Number:2016-004363-39
    Sponsor's Protocol Code Number:MT-11
    National Competent Authority:France - ANSM
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2017-12-27
    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 ConcernedFrance - ANSM
    A.2EudraCT number2016-004363-39
    A.3Full title of the trial
    A phase III trial evaluating the efficacy and safety of the house dust mite (HDM) sublingual immunotherapy (SLIT)-tablet in children and adolescents (5-17 years) with HDM allergic asthma
    Étude de Phase III évaluant l’efficacité et la bonne tolérance du comprimé d'immunothérapie sublinguale aux acariens (comprimé HDM-SLIT) chez des enfants et des adolescents âgés de 5 à 17 ans présentant un asthme allergique aux acariens de la poussière de maison.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A clinical trial to check efficacy and safety of house dust mite tablets in children and adolescents with allergic asthma
    Étude clinique évaluant l’efficacité et la bonne tolérance des comprimés chez des enfants et des adolescents présentant un asthme allergique aux acariens de la poussière de maison.
    A.4.1Sponsor's protocol code numberMT-11
    A.5.4Other Identifiers
    Name:IND Number Number:17691
    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 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 ACARIZAX
    D.2.1.1.2Name of the Marketing Authorisation holderALK-Abelló A/S
    D.2.1.2Country which granted the Marketing AuthorisationDenmark
    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 nameSQ HDM 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 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.3.8 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.3.11 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 (HDM) Allergic Asthma
    Asthme allergique aux acariens de la poussière de maison
    E.1.1.1Medical condition in easily understood language
    Asthma that is induced by House Dust Mite allergy
    Asthme allergique provoquée par des acariens de la poussière de maison
    E.1.1.2Therapeutic area Diseases [C] - Respiratory Tract Diseases [C08]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level SOC
    E.1.2Classification code 10038738
    E.1.2Term Respiratory, thoracic and mediastinal disorders
    E.1.2System Organ Class 10038738 - Respiratory, thoracic and mediastinal disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10001705
    E.1.2Term Allergic asthma
    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
    The primary objective is to demonstrate superiority of the HDM SLIT-tablet versus placebo as add-on treatment in children and adolescents (5-17 years) with HDM allergic asthma based on clinically relevant asthma exacerbations after at least 4 months of treatment.
    L’objectif principal est de démontrer la supériorité du comprimé HDM-ITSL comparativement au placebo en traitement additionnel chez les enfants et adolescents (âgés de 5 à 17 ans) présentant un asthme allergique aux acariens, sur la base des exacerbations cliniquement significatives de l’asthme après au moins 4 mois de traitement.
    E.2.2Secondary objectives of the trial
    The key secondary objectives are to demonstrate superiority of the HDM SLIT-tablet versus placebo after at least 4 months as add-on treatment in children and adolescents with HDM allergic asthma with respect to:
    • Nocturnal awakening due to asthma which require SABA rescue medication
    • Rescue medication use (SABA)
    • Lung function (FEV1)
    Les objectifs secondaires fondamentaux sont de démontrer la supériorité du comprimé HDM-ITSL par rapport au placebo après au moins 4 mois de traitement additionnel chez les enfants et adolescents présentant un asthme allergique aux acariens, en ce qui concerne les éléments suivants :
    • Réveils nocturnes dus à l’asthme nécessitant la prise de médicaments de secours de type β2-agoniste à action courte (SABA, short-acting β2-agonist)
    • Utilisation de médicaments de secours (SABA)
    • Fonction pulmonaire (VEMS)
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    I1. Written informed consent obtained from parents/caregivers before any trial related procedures are performed
    I2. Male or female of any race/ethnicity aged ≥4 to ≤17 years on the day informed consent is obtained from the parent/caregiver. The subject must be ≥5 to ≤17 years old at the randomisation visit
    I3. A female subject of childbearing potential must have a negative pregnancy test and be willing to practise appropriate contraceptive methods until the follow-up TC
    I4. A clinical history of HDM allergic asthma of at least 1 year duration diagnosed by a physician
    I5. Use of low daily dose of ICS plus LABA or medium/high daily dose of ICS with or without LABA for the control of asthma symptoms within the past year prior to randomisation. For definition of ICS doses, please see Table 3 and Table 4
    I6. ≥3 clinically relevant asthma exacerbations in the past two years or ≥2 clinically relevant asthma exacerbations in the past year or ≥1 severe asthma exacerbation in the past year prior to randomization while being on asthma controller medication (low dose ICS plus LABA or medium/high dose ICS with or without LABA) . The asthma controller medication at the screening visit must be at a dose equivalent to or below the dose the subject received before the last asthma exacerbation occurred
    I7. One or more of the following within the past 4 weeks prior to randomisation:
    a. Daytime asthma symptoms more than twice/week
    b. Any nocturnal awakening due to asthma which require use of SABA rescue medication
    c. SABA rescue medication needed for treatment of asthma symptoms more than twice/week
    d. Any activity limitation due to asthma
    I8. Lung function measured by FEV1 ≥ 70% of predicted value or according to local requirements while on background treatment following at least a 6-hour washout of SABA at screening and randomisation
    I9. Clinical history of HDM AR within the last year prior to randomisation
    I10. An average TCRS>0 during the baseline period (period 2)
    I11. Positive specific IgE (defined as ≥class 2, ≥0.70 kU/l) against D. pteronyssinus and/or D. farinae at screening
    I12. Positive SPT to D. pteronyssinus and/or D. farinae at screening
    I13. Subject willing and able to comply with trial protocol
    I1. Consentement éclairé écrit fourni par les parents/soignants avant toute procédure liée à l’étude
    I2. Patient de sexe masculin ou féminin de n’importe quelle origine ethnique, âgé(e) de ≥ 4 à ≤ 17 ans le jour de la fourniture du consentement éclairé par le parent/soignant. Le patient doit être âgé de ≥ 5 à ≤ 17 ans lors de la visite de randomisation
    I3. Chez une patiente en âge de procréer, test de grossesse négatif et volonté d’utiliser des moyens de contraception appropriés jusqu’à l’appel téléphonique (AT) de suivi
    I4. Antécédents cliniques d’asthme allergique aux acariens pendant au moins 1 an, diagnostiqué par un médecin
    I5. Utilisation de doses journalières faibles d’ICS plus LABA ou de doses journalières moyennes/fortes d’ICS avec ou sans LABA pour le contrôle des symptômes d’asthme au cours de l’année précédant la randomisation. Pour la définition des doses d’ICS, veuillez vous reporter au Tableau 1 et au Tableau 2
    I6. Présence de ≥ 3 exacerbations cliniquement significatives de l’asthme au cours des deux années précédentes ou de ≥ 2 exacerbations cliniquement significatives de l’asthme au cours de l’année précédente ou de ≥ 1 exacerbation sévère de l’asthme au cours de l’année précédant la randomisation pendant le traitement destiné à contrôler l’asthme (ICS à doses faibles plus LABA ou ICS à doses moyennes/fortes avec ou sans LABA). Le traitement de contrôle de l’asthme lors de la visite de sélection doit être à une dose équivalente ou inférieure à la dose reçue par le patient avant la survenue de la dernière exacerbation de l’asthme
    I7. Présence d’un ou plusieurs des critères suivants au cours des 4 semaines précédant la randomisation :
    a. Présence de symptômes diurnes de l’asthme plus de deux fois/semaine
    b. Tout réveil nocturne dû à l’asthme, nécessitant l’utilisation de médicament de secours de type SABA
    c. Médicament de secours de type SABA nécessaire pour le traitement des symptômes de l’asthme plus de deux fois par semaine
    d. Toute limitation d’activité due à l’asthme
    I8. Fonction pulmonaire mesurée par VEMS ≥ 70 % de la valeur prédite ou selon les exigences locales pendant le traitement de fond après au moins 6 heures de sevrage de SABA à la sélection et la randomisation
    I9. Antécédents cliniques de RA aux acariens au cours de l’année précédant la randomisation
    I10. Score combiné total moyen relatif à la rhinite (TCRS, total combined rhinitis score) > 0 pendant la période d’inclusion (période 2)
    I11. Dépistage positif d’immunoglobulines E (IgE) spécifiques (défini comme ≥ classe 2, ≥ 0,70 kU/l) contre Dermatophagoides pteronyssinus (D. pteronyssinus) et/ou Dermatophagoides farinae (D. farinae) à la sélection
    I12. Prick test cutané positif (SPT, skin prick test) contre D. pteronyssinus et/ou D. farinae à la sélection
    I13. Volonté et capacité du patient à respecter le protocole de l’étude
    E.4Principal exclusion criteria
    E1. Is sensitised and regularly exposed to animal dander, molds, and/or cockroach (e.g., present in the home, job, school, etc.) or other perennial allergen
    E2. Has experienced a life-threatening asthma attack defined for this protocol as an asthma episode that required intubation and/or was associated with hypercapnia requiring non-invasive ventilator support
    E3. Within the last month before the randomisation visit (visit 3), has had an occurrence of any clinical deterioration of asthma that resulted in emergency treatment, hospitalisation, or treatment with systemic corticosteroids
    E4. Within the last 3 months before the randomisation visit (visit 3) while on high dose ICS treatment, has had an occurrence of any clinical deterioration of asthma that resulted in emergency treatment, hospitalisation, or treatment with systemic corticosteroids
    E5. SLIT treatment with D. pteronyssinus or D. farinae for more than 1 month within the last 5 years. In addition, any SLIT treatment with D. pteronyssinus or D. farinae within the previous 12 months
    E6. SCIT treatment with D. pteronyssinus or D. farinae reaching the maintenance dose within the last 5 years. In addition, any SCIT treatment with D. pteronyssinus or D. farinae within the previous 12 months
    E7. Ongoing treatment with any allergy immunotherapy product
    E8. Severe chronic oral inflammation
    E9. Any nasal or naso/oropharyngeal condition that could confound the efficacy or safety assessments (e.g., hypertrophy of the pharyngeal/palatine tonsils, clinically relevant nasal polyps, a history of paranasal sinus surgery or surgery of nasal turbinates)
    E10. Any clinically relevant chronic disease incl. malignancy that in the opinion of the investigator would interfere with the trial evaluations or the safety of the subject
    E11. Has a diagnosis of eosinophilic oesophagitis
    E12. 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
    E13. Active or poorly controlled autoimmune diseases, immune defects, immunodeficiencies, immunosuppression or malignant neoplastic diseases with current disease relevance
    E14. Ongoing treatment with OCS
    E15. Treatment with restricted and prohibited concomitant medication listed in Table 2
    E16. Treatment with an investigational drug within 30 days/5 half-lives of the drug (which ever longest) prior to screening
    E17. A history of allergy, hypersensitivity or intolerance to any of the excipients or active substance of the IMP (except D. pteronyssinus and D. farinae) or to any excipient of the rescue medication provided in this trial
    E18. A business or personal relationship with trial staff or sponsor who is directly involved with the conduct of the trial
    E19. A history of alcohol or drug abuse
    E20. Has previously been randomised into this trial, is participating in this trial at another investigational site or is participating or planning to participate in any other clinical trial during the duration of this trial
    E21. Has a history or current evidence of any condition, treatment, laboratory values out of range or other circumstance that in the opinion of the investigator are clinically relevant and might expose the subject to risk by participating in the trial, confound the results of the trial, or interfere with the subject’s participation for the full duration of the trial
    E22. Has a condition or treatment that increase the risk of the subject developing severe adverse reactions after adrenaline/epinephrine administration
    E23. Is unable to or will not comply with the use of adrenaline/epinephrine auto-injectors for countries where this is a regulatory requirement
    E1. Sensibilisation et exposition régulière à des poils de chien, moisissures et/ou blattes (par exemple, présence dans le domicile, dans le milieu professionnel ou scolaire, etc.) ou à tout autre allergène pérenne
    E2. Antécédents de crise d’asthme menaçant le pronostic vital, définie pour ce protocole comme un épisode asthmatique ayant nécessité une intubation et/ou ayant été associé à une hypercapnie nécessitant une ventilation assistée non invasive
    E3. Au cours du mois précédant la visite de randomisation (visite 3), survenue d’une détérioration clinique de l’asthme ayant abouti à un traitement en urgence, une hospitalisation ou un traitement par corticoïdes systémiques
    E4. Au cours des 3 mois précédant la visite de randomisation (visite 3), pendant un traitement par ICS à forte dose, survenue d’une détérioration clinique de l’asthme ayant abouti à un traitement en urgence, une hospitalisation ou un traitement par corticoïdes systémiques
    E5. Traitement ITSL par D. pteronyssinus ou D. farinae pendant plus d’1 mois au cours des 5 dernières années. En outre, tout traitement ITSL par D. pteronyssinus ou D. farinae au cours des 12 mois précédents
    E6. Immunothérapie sous-cutanée (ITSC) par D. pteronyssinus ou D. farinae ayant atteint la dose d’entretien au cours des 5 dernières années. En outre, tout traitement ITSC par D. pteronyssinus ou D. farinae au cours des 12 mois précédents
    E7. Traitement en cours par un produit d’immunothérapie contre l’allergie
    E8. Inflammation orale chronique sévère
    E9. Toute pathologie nasale ou naso/oropharyngée susceptible d’interférer sur les évaluations d’efficacité ou de tolérance (par exemple, hypertrophie des amygdales pharyngées/palatines, polypes nasaux cliniquement significatifs, antécédents d’intervention chirurgicale sur les sinus paranasaux ou les cornets nasaux). En cas de doute, une endoscopie nasale est recommandée.
    E10. Toute pathologie chronique cliniquement significative, y compris cancer, qui est susceptible d’interférer sur les évaluations de l’étude ou la sécurité du patient, d’après l’investigateur
    E11. Antécédents de diagnostic d’oesophagite à éosinophiles
    E12. Antécédents significatifs de réactions allergiques systémiques, par exemple anaphylaxie avec symptômes cardiorespiratoires, urticaire généralisée ou angio-oedème facial sévère pouvant augmenter, d’après l’investigateur, les problèmes de sécurité
    E13. Pathologies auto-immunes actives ou mal contrôlées, anomalies immunitaires, immunodéficiences, immunosuppression ou maladies néoplasiques malignes significatives
    E14. Traitement en cours par corticoïdes oraux (OCS, oral corticosteroid)
    E15. Traitement par médicaments concomitants interdits ou à usage restreint, répertoriés dans le Tableau 4
    E16. Traitement par un médicament expérimental au cours des 30 jours/5 demi-vies du médicament (selon la période la plus longue) avant la sélection
    E17. Antécédents d’allergie, hypersensibilité ou intolérance à l’un des excipients ou à la substance active du ME (sauf D. pteronyssinus et D. farinae) ou à tout excipient des médicaments de secours fournis dans cette étude
    E18. Lien professionnel ou personnel avec le personnel de l’étude ou le promoteur directement impliqué avec la conduite de l’étude
    E19. Antécédents d’alcoolisme ou de toxicomanie
    E20. Antécédents de randomisation dans la présente étude, participation à la présente étude dans un autre centre d’étude ou participation ou prévision de participation à une autre étude clinique pendant la durée de la présente étude
    E21. Antécédents ou signes récents de pathologie, traitement, paramètre biologique en dehors des valeurs normales ou de toute autre circonstance jugée cliniquement significative par l’investigateur ou susceptible de présenter un risque pour le patient s’il participe à l’étude, ou de compromettre l’interprétation des résultats de l’étude ou d’interférer sur la participation du patient pendant toute la durée de l’étude
    E22. Pathologie ou traitement augmentant le risque de réactions indésirables sévères après administration d’adrénaline/épinéphrine
    E23. Incapacité ou refus de respecter les instructions relatives à l’utilisation des auto-injecteurs d’adrénaline/épinéphrine dans les pays disposant d’une norme réglementaire concernant cette utilisation
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint of the trial is the annualised rate of clinically relevant asthma exacerbations calculated as the number per year per subject during the efficacy evaluation period (period 4).
    A clinically relevant asthma exacerbation must be medically confirmed and is defined as asthma worsening leading to at least one of the following criteria:
    • Doubling of ICS dose compared to background treatment
    • Systemic corticosteroids for treatment of asthma symptoms for at least 3 days
    • Emergency room visit due to asthma, requiring systemic corticosteroids
    • Hospitalisation (admission not required) for more than 12 hours due to asthma.
    E.5.1.1Timepoint(s) of evaluation of this end point
    According to protocol.
    E.5.2Secondary end point(s)
    The key secondary endpoints are:
    • Proportion of days with nocturnal awakenings due to asthma requiring SABA rescue medication during the 14 days eDiary recording every 4 months after randomisation
    • The average daily dose of SABA during the 14 days eDiary recording every 4 months after randomisation
    • Percentage predicted FEV1 assessed every 4 months after randomisation

    Additional secondary efficacy endpoints are:
    • Time to first clinically relevant asthma exacerbation
    • Time to recurrent clinically relevant asthma exacerbation
    • Rate of severe asthma exacerbation during the efficacy period (period 4), defined as asthma worsening leading to at least one of the following criteria:
    o Systemic corticosteroids for treatment of asthma symptoms for at least 3 days
    o Emergency room visit due to asthma, requiring systemic corticosteroids
    o Hospitalisation (admission not required) for more than 12 hours due to asthma
    • Time to first severe asthma exacerbation
    • Time to recurrent severe asthma exacerbations
    • ACQ or ACQ-IA
    Endpoints derived from the two week daily diary collected every 4 months after treatment initiation include:
    • The average TCRS (TCRS is the sum of the rhinitis daily symptom score (DSS) and the rhinitis daily medication score (DMS)).
    • Average rhinitis DSS
    • Average rhinitis DMS
    • Average rhinoconjunctivitis total combined score (TCS)
    • Average rhinoconjunctivitis DSS
    • Average rhinoconjunctivitis DMS
    • The average combined symptom and medication score (CSMS)
    • Average asthma DSS
    • Global evaluation of allergic asthma
    • Global evaluation of AR
    E.5.2.1Timepoint(s) of evaluation of this end point
    According to protocol.
    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 No
    E.8.4.1Number of sites anticipated in Member State concerned9
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA76
    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
    Bulgaria
    Denmark
    France
    Germany
    Hungary
    Poland
    Russian Federation
    Spain
    United Kingdom
    United States
    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
    LPLV
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years4
    E.8.9.1In the Member State concerned months4
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years4
    E.8.9.2In all countries concerned by the trial months4
    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: 600
    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: 270
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 330
    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 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 state30
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 360
    F.4.2.2In the whole clinical trial 600
    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. Such 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 Decision2017-12-27
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-02-13
    P. End of Trial
    P.End of Trial StatusOngoing
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