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    The EU Clinical Trials Register currently displays   36859   clinical trials with a EudraCT protocol, of which   6085   are clinical trials conducted with subjects less than 18 years old.
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    EudraCT Number:2013-005614-35
    Sponsor's Protocol Code Number:D2210C00007
    National Competent Authority:Poland - Office for Medicinal Products
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2014-07-22
    Trial results View results
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    A. Protocol Information
    A.1Member State ConcernedPoland - Office for Medicinal Products
    A.2EudraCT number2013-005614-35
    A.3Full title of the trial
    A 52-Week, Multicentre, Randomized, Double-Blind, Parallel Group, Placebo Controlled, Phase 3 Study to Evaluate the Efficacy and Safety of Tralokinumab in Adults and Adolescents with Asthma Inadequately Controlled on Inhaled Corticosteroid Plus Long-Acting β2-Agonist
    52- tygodniowe, wieloośrodkowe, randomizowane, prowadzone w grupach równoległych z zastosowaniem metodyki podwójnie ślepej próby, kontrolowane placebo, badanie fazy III oceniające skuteczność i bezpieczeństwo stosowania Tralokinumabu u pacjentów dorosłych oraz młodocianych z rozpoznaniem astmy oskrzelowej źle kontrolowanej, leczonych kortykosteroidami wziewnymi w połączeniu z długo działającymi β2- agonistami
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Phase 3 study to evaluate the Efficacy and Safety of Tralokinumab in Adults and Adolescents with asthma that is not controlled.
    Badanie fazy 3 oceniające skuteczność i bezpieczeństwo stosowania Tralokinumabu u pacjentów dorosłych oraz młodocianych z astma oskrzelowąj źle kontrolowaną
    A.3.2Name or abbreviated title of the trial where available
    A.4.1Sponsor's protocol code numberD2210C00007
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT02161757
    A.5.3WHO Universal Trial Reference Number (UTRN)U1111-1156-7437
    A.7Trial is part of a Paediatric Investigation Plan Yes
    A.8EMA Decision number of Paediatric Investigation PlanP/198/2011
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorAstraZeneca AB
    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 supportAstraZeneca AB
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAstraZeneca AB
    B.5.2Functional name of contact pointEva Augurell
    B.5.3 Address:
    B.5.3.2Town/ citySodertalje
    B.5.3.3Post code151 85
    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 nameTralokinumab
    D.3.2Product code CAT-354
    D.3.4Pharmaceutical form Solution for injection in pre-filled syringe
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSubcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNTralokinumab
    D.3.9.1CAS number 1044515-88-9
    D.3.9.2Current sponsor codeCAT-354
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number150
    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. cell therapy medicinal product No
    D. therapy medical product No
    D. Engineered Product No
    D. ATIMP (i.e. one involving a medical device) No
    D. 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) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product Yes
    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 placeboSolution for injection in pre-filled syringe
    D.8.4Route of administration of the placeboSubcutaneous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    E.1.1.1Medical condition in easily understood language
    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 PT
    E.1.2Classification code 10003553
    E.1.2Term 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
    To evaluate the effect of tralokinumab compared with placebo on the annualised asthma exacerbation rate in adult and adolescent subjects with asthma that is inadequately controlled with inhaled corticosteroid plus long-acting β2-agonist
    Ocena wpływu tralokinumabu w porównaniu z placebo, na roczną częstość występowania zaostrzeń astmy u pacjentów dorosłych i nieletnich z astmą niedostatecznie kontrolowaną, leczonych wziewnymi kortykosteroidami oraz długo działającego β2-mimetykiem
    E.2.2Secondary objectives of the trial
    To assess the effect of tralokinumab with regards to lung function
    To assess the effect of tralokinumab with regards to asthma symptoms
    To assess the effect of tralokinumab with regards to asthma specific health-related quality of life
    To assess the effect of tralokinumab with regards to ACQ-6 defined asthma control
    To assess the effect of tralokinumab with regards to ER and urgent care visits and hospitalizations due to asthma
    To assess the effect of tralokinumab with regards to health care resource utilization and productivity loss due to asthma
    To assess the effect of tralokinumab with regards to health related quality of life
    To assess the effect of tralokinumab with regards to asthma symptoms and asthma control
    To evaluate the PK and immunogenicity of tralokinumab
    To evaluate the safety and tolerability tralokinumab

    Ocena stosowania tralokinumabu pod względem wpływu na czynności płuc
    Ocena stosowania tralokinumabu pod względem wpływu na objawy astmy
    Ocena stosowania tralokinumabu pod względem wpływu na jakości życia uwarunkowaną stanem zdrowia w kontekście astmy
    Ocena stosowania tralokinumabu pod względem wpływu na kontrolę astmy określanej kwestionariuszem kontroli astmy-6
    Ocena stosowania tralokinumabu pod względem wpływu na ilość wizyt związanych z astmą na oddziałach ratunkowych i oddziałach pomocy doraźnej oraz na ilość hospitalizacji
    Ocena wpływu stosowania tralokinumabu pod względem wykorzystywania zasobów opieki zdrowotnej oraz utraty produktywności w związku z astmą
    Ocena stosowania tralokinumabu pod względem wpływu na jakość życia uwarunkowaną stanem zdrowia
    Ocena stosowania tralokinumabu pod względem wpływu na inne kryteria dotyczące objawów astmy i kontroli astmy
    Ocena farmakokinetyki i immunogenności tralokinumabu
    Ocena bezpieczeństwa i tolerancji stosowania tralokinumabu
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Age 12 -75
    2. Documented physician-diagnosed asthma.
    3. Documented treatment with ICS at a total daily dose corresponding to ≥500μg fluticasone propionate dry powder formulation equivalents) and a LABA
    4. Morning pre-BD FEV1 value of ≥40 and <80% value (<90% for patients 12 to 17 years of age) of their PNV.
    5. Post-BD reversibility of ≥12% and ≥200 mL in FEV1
    6. ACQ-6 score ≥1.5
    1.Kobiety i mężczyźni w wieku od 12 do 75 roku życia włącznie;
    2.Udokumentowane rozpoznanie przez lekarza astmy;
    3.Udokumentowane leczenie lekiem z klasy ICS w całkowitej dawce dobowe;j równoważnej ≥500 μg propionianu flutykazonu w postaci preparatu suchego proszku oraz lekiem z klasy LABA;
    4.Poranna wartość FEV1 przed przyjęciem leku rozszerzającego oskrzela ≥40 i <80% (<90% w przypadku pacjentów w wieku od 12 do 17 lat) wartości PNV;
    5.Odwracalność FEV1 po podaniu leku rozszerzającego oskrzela wynosząca ≥12% i ≥200 ml;
    6.Wynik ACQ-6 ≥1,5
    E.4Principal exclusion criteria
    1. Pulmonary disease other than asthma
    2. History of anaphylaxis following any biologic therapy
    3. Hepatitis B, C or HIV
    4. Pregnant or breastfeeding
    5. History of cancer
    6. Current tobacco smoking or a history of tobacco smoking for ≥ 10 pack-years
    7. Previous receipt of tralokinumab
    1.Klinicznie istotna choroba płuc inna niż astma;
    2.Reakcja anafilaktyczna na jakiekolwiek leczenie biologiczne w wywiadzie;
    3.Dodatni wynik badania serologicznego w kierunku obecności antygenu powierzchniowego wirusa zapalenia wątroby typu B, typu C lub HIV;
    4.Kobiety w ciąży, karmiące piersią, lub w okresie laktacji;
    5.Nowotwór złośliwy w wywiadzie;
    6.Osoba aktualnie paląca tytoń lub palenie tytoniu w przeszłości w ilości ≥10 paczkolat;
    7.Wcześniejsze otrzymywanie tralokinumabu
    E.5 End points
    E.5.1Primary end point(s)
    Annual asthma exacerbation rate
    Roczna częstość występowania zaostrzeń astmy
    E.5.1.1Timepoint(s) of evaluation of this end point
    Week 0 to Week 52
    tygodnie od „0” do „52”
    E.5.2Secondary end point(s)
    1.Percent change from baseline to Week 52 in pre-dose/pre-bronchodilator forced expiratory volume in 1 second
    2. Change from baseline to Week 52 in daily asthma symptom score
    3. Change from baseline to Week 52 in Asthma Quality of Life Questionnaire for 12 Years and Older total score
    4. Change from baseline to Week 52 in Asthma Control Questionnaire-6 defined asthma control
    5. Time to first asthma exacerbation and proportion of subjects with ≥1 asthma exacerbation
    6. Annualised asthma exacerbation rate that is associated with an ER or urgent care visit, or a hospitalization
    7. Work Productivity and Activity Impairment Questionnaire and Classroom Impairment Questionnaire and European Quality of Life - 5 Dimension 5 Level Daily Living Questionnaire
    8. Rescue medication use, Home peak expiratory flow (morning and evening)
    9. Night-time awakening due to asthma
    10. Pharmacokinetic parameters and Anti-Drug Antibodies
    11. Safety and Tolerability of tralokinumab assessed by the reporting of adverse events/serious adverse events and assessments for physical examination, electrocardiogram, laboratory values and vital signs
    1.Procentowa zmiana wyjściowej natężonej objętości wydechowej pierwszosekundowej przed podaniem badanego leku/przed podaniem leku rozszerzającego oskrzela w odniesieniu do wartości wyjściowej;
    2.Zmiana wartości wyjściowej średniego wyniku oceny objawów astmy w ciągu doby vs tydzień 52;
    3. Zmiana wyjściowego wyniku standaryzowanego kwestionariusza oceny jakości życia w astmie dla osób w wieku od 12 roku życia vs tydzień 52;
    4.Zmiana wyjściowego wyniku kwestionariusza kontroli astmy-6 vs tydzień 52;
    5.Czas do wystąpienia pierwszego zaostrzenia astmy i odsetek pacjentów z ≥1 zaostrzeniem astmy;
    6.Roczna częstość występowania zaostrzeń astmy, które są związane z wizytą na oddziale ratunkowym lub oddziale pomocy doraźnej bądź z hospitalizacją;
    7.Ocena wykorzystywania zasobów opieki zdrowotnej oraz utraty produktywności w związku z astmą i jakość życia uwarunkowanej stanem zdrowia przy użyciu europejskiego kwestionariusza jakości życia EQ-5D-5L;
    8.Stosowanie leku doraźnego. Mierzony w domu szczytowy przepływ wydechowy (rano i wieczorem);
    9.Wybudzanie się w nocy z powodu astmy;
    10.Parametry farmakokinetyczne i przeciwciał przeciwko lekowi(ADA);
    11.Ocena bezpieczeństwa i tolerancji tralokinumabu na podstawie występowania zdarzeń niepożądanych/poważnych zdarzeń niepożądanych, podstawowych parametrów życiowych, elektrokardiogramu cyfrowego, klinicznych badań biochemicznych/hematologicznych/badań ogólnych moczu i badań przedmiotowych
    E.5.2.1Timepoint(s) of evaluation of this end point
    Week 0 to Week 52

    - endpoints 1-9

    Week 0 to Week 72

    - endpoints 10-11
    tygodnie od „0” do „52”
    punkty końcowe 1-9

    tygodnie od „0” do „72”
    punkty końcowe 10-11
    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 Yes
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    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. 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 trial4
    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 concerned30
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA82
    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
    Korea, Republic of
    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
    „LVLS” (Last Visit Last Subject)
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    E.8.9.1In the Member State concerned months1
    E.8.9.1In the Member State concerned days28
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months4
    E.8.9.2In all countries concerned by the trial days28
    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: 100
    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) Yes
    F. of subjects for this age range: 100
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 960
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 60
    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. of subjects incapable of giving consent
    Adolescents (12-17 years
    Małoletni pacjenci w wieku 12–17 lat
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state135
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 266
    F.4.2.2In the whole clinical trial 1140
    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)
    Nie dotyczy
    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 Decision2014-09-10
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-07-15
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2017-07-18
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