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    The EU Clinical Trials Register currently displays   43724   clinical trials with a EudraCT protocol, of which   7255   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

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    EudraCT Number:2013-005615-27
    Sponsor's Protocol Code Number:D2210C00008
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2014-09-05
    Trial results View results
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    A. Protocol Information
    A.1Member State ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2013-005615-27
    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
    Studio di Fase III, di 52 settimane, multicentrico, randomizzato, in doppio cieco, a gruppi paralleli, controllato verso placebo, per valutare l’efficacia e la sicurezza di Tralokinumab in pazienti adulti e adolescenti con asma non adeguatamente controllato da Corticosteroidi inalatori in aggiunta a β2-Agonisti a lunga durata d’azione
    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.
    Studio di Fase III per valutare l’efficacia e la sicurezza di Tralokinumab in pazienti adulti e adolescenti con asma non adeguatamente controllato.
    A.4.1Sponsor's protocol code numberD2210C00008
    A.5.3WHO Universal Trial Reference Number (UTRN)U1111-1158-7974
    A.7Trial is part of a Paediatric Investigation Plan Yes
    A.8EMA Decision number of Paediatric Investigation PlanP/280/2011
    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.5.3.1Street Address151 85
    B.5.3.2Town/ citySodertalje
    B.5.4Telephone number46317761315
    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.3.11 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 17.0
    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 longacting
    Valutare l’effetto della somministrazione di tralokinumab verso placebo sul tasso annuale di riacutizzazione dell’asma in soggetti adulti e adolescenti con asma inadeguatamente controllato in trattamento con corticosteroidi inalatori in aggiunta a β2-agonisti a lunga durata d’azione.
    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 of tralokinumab.
    Valutare l’effetto di tralokinumab sulla funzionalità polmonare.
    Valutare l’effetto di tralokinumab sui sintomi dell’asma.
    Valutare l’effetto di tralokinumab sulla qualità della vita correlata specificatamente all’asma.
    Valutare l’effetto di tralokinumab sul controllo dell’asma classificato secondo l’Asthma Control Questionnaire-6.
    Valutare l’effetto del tralokinumab sugli accessi in pronto soccorso, visite mediche urgenti e sulle ospedalizzazioni dovute all’asma.
    Valutare l’effetto del tralokinumab sull’utilizzo delle risorse sanitarie e sulla perdita di produttività causata dall’asma.
    Valutare l’effetto del tralokinumab sullo stato di salute correlato alla qualità della vita.
    Valutare l’effetto del tralokinumab sui sintomi dell'asma e il controllo dell'asma.
    Valutare la farmacocinetica e immunogenicità di tralokinumab.
    Valutare la sicurezza e la tollerabilità di tralokinumab.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Age 12 -75 years
    2. Documented physician-diagnosed asthma at least 12 months prior to enrollment.
    3. Documented treatment with ICS at a total daily dose corresponding to ≥500μg fluticasone
    propionate dry powder formulation equivalents and a LABA for at least 3 months.
    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
    7. At least 2 documented asthma exacerbations in the 12 months prior to the date of informed consent.
    1. Età compresa tra i 18 e i 75 anni (in Italia), 12 e 75 anni (internazionale).
    2. Asma documentato e diagnosticato da un medico almeno 12 mesi prima dell’arruolamento.
    3. Trattamento documentato con ICS corrispondente alla dose totale giornaliera ≥ 500μg di fluticasone propinato in formulazione di polvere secca in aggiunta a un β2-agonista a lunga durata d’azione (LABA) da almeno 3 mesi.
    4. Valore mattutino pre-BD di FEV1 ≥40 e <80% (<90% per i pazienti dai 12 ai 17 anni di età se applicabile) dal valore normale predetto PNV.
    5. Reversibilità in FEV1 nel post-broncodilatatore ≥12% e ≥200 mL.
    6. Punteggio dell’ACQ-6 ≥1.5
    7. Almeno 2 riacutizzazioni di asma documentate nei 12 mesi precedenti la data della firma del consenso informato.
    E.4Principal exclusion criteria
    1. Clinically important 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. Patologie polmonari clinicamente importanti oltre l’asma
    2. Storia di anafilassi a qualunque terapia biologica
    3. Epatite B, C o HIV
    4. gravidanza o allattamento
    5. storia di tumore
    6. Paziente fumatore o ex fumatore con un consumo ≥ 10 pack-years
    7. Precedente trattamento con tralokinumab
    E.5 End points
    E.5.1Primary end point(s)
    Annual asthma exacerbation rate
    tasso annuale di riacutizzazione dell’asma
    E.5.1.1Timepoint(s) of evaluation of this end point
    Week 0 to Week 52
    da settimana 0 a settimana 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 Dimensions - 5 Levels Daily Living Quesitonnaire.
    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, electocardiogram, laboratory values and vital signs.

    1. Percentuale di cambiamento rispetto al basale alla settimana 52 del volume espiratorio massimo nel primo secondo pre-dose/pre-broncodilatatore.
    2. Cambiamento dal baseline alla settimana 52 nel punteggio giornaliero dei sintomi dell'asma.
    3. Cambiamento dal baseline alla settimana 52 nel punteggio totale del Standardised Asthma Quality of Life Questionnaire for 12 Years and Older
    4. Cambiamento dal baseline alla settimana 52 nel controllo dell'asma definito dall'Asthma Control Questionnaire-6.
    5. Tempo alla prima riacutizzazione d’asma e proporzione di pazienti ≥1 riacutizzazioni di asma.
    6. Tasso annuale di riacutizzazioni d’asma che sono associati ad accessi al pronto soccorso, a visite mediche urgenti o a ospedalizzazione.
    7. Questionari: Work Productivity, Activity Impairment, Classroom Impairment e European Quality of Life -5 Dimensions - 5 Levels Daily Living.
    8. Uso di farmaci d’emergenza, picco di flusso espiratorio monitorato da casa (mattino e sera).
    9. Risveglio notturno dovuto all’asma.
    10. Parametri farmacocinetici e anticorpi anti-farmaco.
    11. Sicurezza e tollerabilità di tralokinumab valutata sulla reportistica di eventi avversi/eventi avversi seri e la valutazione di esami fisici, elettrocardiogramma, valori di laboratorio e segni vitali.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Week 0 to Week 52 (except PK and ADA, 0 to Week 72 weeks)
    dalla settimana 0 alla settimana 52 (eccetto PK e ADA, da settimana 0 a settimana 72)
    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 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. 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 concerned18
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA53
    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
    Hong Kong
    Russian Federation
    South Africa
    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
    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 months11
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months1
    E.8.9.2In all countries concerned by the trial days15
    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: 77
    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: 77
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 653
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 40
    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 state34
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 245
    F.4.2.2In the whole clinical trial 770
    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)
    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 Decision2014-10-21
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-09-11
    P. End of Trial
    P.End of Trial StatusCompleted
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