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    Summary
    EudraCT Number:2021-003771-34
    Sponsor's Protocol Code Number:D9180C00004
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2022-01-04
    Trial 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 ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2021-003771-34
    A.3Full title of the trial
    A Phase III, Multicentre, Randomised, Double-blind, Chronic-dosing, Parallel-group, Placebo-controlled Study to Evaluate the Efficacy and Safety of Two Dose Regimens of MEDI3506 in Participants with Symptomatic Chronic Obstructive Pulmonary Disease (COPD) with a History of COPD Exacerbations (TITANIA)
    Studio di fase III, multicentrico, randomizzato, in doppio cieco, a dosaggio cronico, a gruppi paralleli, controllato verso placebo per valutare l’efficacia e la sicurezza di due posologie di MEDI3506 in partecipanti affetti da malattia polmonare ostruttiva cronica (BPCO) sintomatica con anamnesi di riacutizzazioni della BPCO (TITANIA)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Study to assess efficacy, safety, and tolerability of MEDI3506 in symptomatic chronic obstructive pulmonary disease (COPD) with a history of exacerbations.
    Studio per valutare l'efficacia, la sicurezza e la tollerabilità di MEDI3506 nella broncopneumopatia cronica ostruttiva sintomatica con anamnesi di esacerbazioni
    A.3.2Name or abbreviated title of the trial where available
    TITANIA
    TITANIA
    A.4.1Sponsor's protocol code numberD9180C00004
    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 SponsorASTRAZENECA AB
    B.1.3.4CountrySweden
    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.4.2CountrySweden
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAstraZeneca
    B.5.2Functional name of contact pointClinical Study Information Center
    B.5.3 Address:
    B.5.3.1Street AddressNA
    B.5.3.2Town/ cityNA
    B.5.3.3Post codeNA
    B.5.3.4CountryUnited States
    B.5.4Telephone number+18772409479
    B.5.6E-mailinformation.center@astrazeneca.com
    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 nameMEDI3506
    D.3.2Product code [na]
    D.3.4Pharmaceutical form Solution for injection/infusion
    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 INNMEDI3506
    D.3.9.1CAS number 2376858-66-9
    D.3.9.2Current sponsor codeMEDI3506
    D.3.9.3Other descriptive namehuman immunoglobulin (Ig) G1 monoclonal antibody (mAb)
    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.3.11.3.1Somatic cell therapy medicinal product Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    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/infusion
    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
    Chronic Obstructive Pulmonary Disease (COPD)
    Broncopneumopatia cronica ostruttiva (BPCO)
    E.1.1.1Medical condition in easily understood language
    Chronic Obstructive Pulmonary Disease (COPD)
    Broncopneumopatia cronica ostruttiva (BPCO)
    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.1.3Condition 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 2 dose regimens of MEDI3506 as add on to standard of care compared with standard of care plus placebo on the rate of moderate to severe exacerbations in former smokers.
    Valutare l’effetto di 2 regimi posologici di MEDI3506 come aggiunta allo standard of care (SoC) rispetto allo SoC più placebo sul tasso di riacutizzazioni della BPCO da moderate a gravi negli ex-fumatori.
    E.2.2Secondary objectives of the trial
    1. To evaluate the effect of 2 dose regimens of MEDI3506 as add on to standard of care compared with standard of care plus placebo on:
    a) the rate of moderate to severe COPD exacerbation in former and current smokers
    b) time to moderate to severe COPD exacerbations in former smokers
    c) change in pre-bronchodilator lung function in former smokers
    d) respiratory symptoms in former smokers
    e) respiratory health status/health related quality of life in former smokers
    f) severe COPD exacerbations in former smokers
    g) health status/health-related quality of life in former smokers
    h) COPD-related healthcare resource utilization in former smokers
    i) daily rescue medication use in former smokers
    2.To evaluate the pharmacokinetics and immunogenicity of 2 dose regimens of MEDI3506.
    3. To assess the safety and tolerability of two dose regiments of MEDI3506 as add on to standard of care compared with standard of care plus placebo
    1. Valut l’effetto di 2 regimi posologici di MEDI3506 come aggiunta allo SoC rispetto allo SoC più placebo su:
    a) tasso di riacutiz della BPCO da moderata a grave negli ex-fumatori e nei fumatori attuali
    b) tempo alle riacutizzazioni della BPCO da moderate a gravi negli ex-fumatori
    c) variaz della funzione polmonare pre-broncodilatatore negli ex-fumatori
    d) sintomi respiratori negli ex-fumatori
    e) stato di salute respiratorio/qualità della vita correlata alla salute negli ex-fumatori.
    f) riacutizzazioni gravi della BPCO negli ex-fumatori
    g) stato di salute legato alla BPCO/qualità della vita correlata alla salute negli ex-fumatori
    h) utilizzo delle risorse sanitarie (HRU) correlato alla BPCO negli ex-fumatori
    i) sull’uso giornaliero di farmaci di soccorso negli ex-fumatori
    2. Valutare la farmacocinetica e l’immunogenicità di 2 regimi posologici di MEDI3506.
    3. Valutare la sicurezza e tollerabilità di 2 regimi posologici di MEDI3506 in aggiunta allo SoC rispetto allo SoC più placebo.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Participant must be >= 40 years of age and capable of giving signed informed consent.
    2. Documented diagnosis of COPD for at least one year prior to enrolment.
    3. Post BD FEV1/FVC < 0.70 and post-BD FEV1 >20% of predicted normal value.
    4. Documented history of >= 2 moderate or >= 1 severe COPD exacerbations within 12 months prior to enrolment.
    5. Documented optimized dual or triple treatment with COPD and at a stable dose for at least 3 months prior to enrolment.
    6. Smoking history of >= 10 pack-years.
    7. CAT total score >=10, and each of the phlegm (sputum) and cough items >= 2.
    1. I partecipanti devono avere un’età => 40 anni e devono essere in grado di dare il consenso informato firmato.
    2. Diagnosi di BPCO documentata da almeno un anno prima del reclutamento.
    3. FEV1/FVC < 0.70 e FEV1 > 20% post-broncodilatatore di valore normale predetto.
    4. Storia clinica documentata di >= 2 riacutizzazioni moderate o >= 1 riacutizzazione grave della BPCO nei 12 mesi precedenti il reclutamento.
    5. Doppio o triplo trattamento ottimizzato documentato con BPCO e a una dose stabile per almeno 3 mesi prima dell'arruolamento.
    6. Storia con >= 10 pacchetti di sigarette/anno
    7. Punteggio totale CAT >=10, espettorato e tosse >= 2 ciascuno.
    E.4Principal exclusion criteria
    1. Clinically important pulmonary disease other than COPD.
    2. Radiological findings suggestive of a respiratory disease other than COPD that is contributing to the participant's respiratory symptoms.
    3. Current diagnosis of asthma, prior history of asthma, or asthma-COPD overlap. Childhood history of asthma is allowed and defined as asthma diagnosed and resolved before the age of 18.
    4. Any unstable disorder, including, but not limited to, cardiovascular, gastrointestinal, hepatic, renal, neurological, musculoskeletal, infectious, endocrine, metabolic, haematological, psychiatric disorder, major physical and/or cognitive impairment that could affect safety, study findings or participants ability to complete the study.
    5. COPD exacerbation, within 2 weeks prior to randomization, that was treated with systemic corticosteroids and/or antibiotics, and/or led to hospitalization.
    6. Active significant infection within the 4 weeks prior to randomization, pneumonia within 6 weeks prior to randomization, or medical condition that predisposes the participant to infection.
    7. Suspicion of, or confirmed, ongoing SARS-CoV-2 infection.
    8. Significant COVID-19 illness within the 6 months prior to enrolment.
    9. Unstable cardiovascular disorder.
    10. Diagnosis of cor pulmonale, pulmonary arterial hypertension and/or right ventricular failure.
    11. History of known immunodeficiency disorder, including a positive test for HIV-1 or HIV 2.
    12. History of positive test or treatment for hepatitis B or hepatitis C.
    13. Evidence of active liver disease, including jaundice during screening.
    14. Malignancy, current or within the past 5 years, except for adequately treated non-invasive basal cell and squamous cell carcinoma of the skin and cervical carcinoma-in-situ treated with apparent success more than one year prior to enrolment. Suspected malignancy or undefined neoplasms.
    15. Participants who have evidence of active TB.
    16. Participants that have previously received MEDI3506.
    17. Any clinically significant abnormal findings in physical examination, vital signs, ECG, or laboratory testing during the screening period, which in the opinion of the investigator may put the participant at risk because of their participation in the study, or may influence the results of the study, or the participant's ability to complete the entire duration of the study.
    18. Active vaping of any products within the 6 months prior to randomization and during the study.
    1. Altre malattie polmonari clinicamente rilevanti, oltre alla BPCO.
    2. Risultati radiologici che suggeriscono una malattia respiratoria, oltre alla BPCO, ce contribuisce ai sintomi respiratori del partecipante.
    3. Diagnosi attuale di asma, precedente storia clinica di asma o sovrapposizione di asma e BPCO. È consentita una storia clinica infantile di asma definita come asma diagnosticata e risolta prima dell’età di 18 anni.
    4. Qualsiasi malattia instabile, incluse, ma non limitate a malattie cardiovascolari, gastrointestinali, epatiche, renali, neurologiche, muscoloscheletriche, infettive, endocrine, metaboliche, ematologiche, psichiatriche, decadimento fisico e/o cognitivo che possa influenzare la sicurezza, le conclusioni dello studio o la capacità del partecipante di completare lo studio.
    5. Riacutizzazione della BPCO nelle 2 settimane prima della randomizzazione, che è stata trattata con corticosteroidi sistemici e/o antibiotici e/o ha portato a ospedalizzazione.
    6. Infezione attiva significante nelle 4 settimane precedenti la randomizzazione, polmonite nelle 6 settimane precedenti la randomizzazione o condizione medica che predispone il partecipante a infezioni.
    7. Infezione da SARS-CoV-2 sospetta, confermata o in corso.
    8. Malattia COVID-19 significante nei 6 mesi precedenti il reclutamento.
    9. Malattia cardiovascolare instabile.
    10. Diagnosi di cor pulmonale, ipertensione arteriosa polmonare e/o insufficienza ventricolare destra.
    11. Storia clinica di malattia da immunodeficienza conosciuta, incluso un test positivo per HIV-1 e HIV-2.
    12. Storia di un test positivo o trattamento per l’epatite B o C.
    13. Prova di malattia al fegato attiva, inclusa l’itterizia, durante lo screening.
    14. Tumore maligno, corrente o nei 5 anni precedenti, a eccezione di carcinoma basocellulare e carcinoma squamocellulare non invasivi della pelle e carcinoma della cervice uterina in situ trattati con apparente successo più di un anno prima del reclutamento. Sospetto tumore maligno o neoplasia non definita.
    15. Partecipanti con prove di tubercolosi attiva.
    16. Partecipanti che hanno precedentemente ricevuto MEDI3506.
    17. Qualsiasi risultanza anomala significativa nell’esame fisico, segni vitali, ECG e test di laboratorio durante il periodo di screening, che, nell’opinione del ricercatore, possa mettere il partecipante a rischio per via della partecipazione allo studio stesso, o possa influenzare i risultati dello studio o l’abilità del partecipante di completare l’intero studio.
    18. Uso attivo di qualsiasi prodotto per sigaretta elettronica nei 6 mesi precedenti la randomizzazione e durante lo studio.
    E.5 End points
    E.5.1Primary end point(s)
    Annualized rate of moderate to severe COPD exacerbations in participants who are former smokers.
    Tasso annualizzato di riacutizzazioni della BPCO da moderate a gravi in partecipanti ex-fumatori.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Week 52
    Settimana 52
    E.5.2Secondary end point(s)
    1. Annualized rate of moderate to severe COPD exacerbations in former or current smokers.
    2. Time to first moderate to severe COPD exacerbation in former smokers.
    3. Change from baseline in pre-bronchodilator, pre dose trough FEV1 (mL) in former smokers.
    4. Change from baseline in E-RS:COPD total score in former smokers.
    5. Change from baseline in SGRQ total score in former smokers.
    6. Time to first severe COPD exacerbation in former smokers.
    7. Annualized rate of severe COPD exacerbations in former smokers.
    8. Change from baseline in CAT total score in former smokers.
    9. Proportion of participants achieving MCID in CAT score in former smokers.
    10. Proportion of participants having = 1 healthcare resource utilization type in former smokers.
    11. Annualized rate of healthcare resource utilization in former smokers.
    12. Change from baseline in rescue medication in former smokers.
    13. Trough serum concentrations of MEDI3506.
    14. Presence of anti-drug antibodies.
    15. Safety and tolerability.
    1. Tasso annuale di riacutizzazioni della BPCO da moderate a gravi negli ex-fumatori e nei fumatori attuali.
    2. Tempo alla prima riacutizzazione della BPCO da moderata a grave negli ex-fumatori.
    3. Variazione rispetto al basale pre-brochiodilatatore, nel FEV1 pre-dose minima (ml) negli ex-fumatori.
    4. Variazione rispetto al basale nel puntaggio totale E-RS:COPD negli ex-fumatori.
    5. Variazione rispetto al basale nel punteggio dell’SGRQ negli ex-fumatori.
    6. Tempo alla prima riacutizzazione grave correlata alla BPCO negli ex-fumatori.
    7. Tasso annuale di riacutizzazioni gravi correlate alla BPCO negli ex-fumatori.
    8. Variazione rispetto al basale nel punteggio totale del CAT negli ex-fumatori.
    9. Percentuale di pazienti che ottiene una MCID nel punteggio del CAT negli ex-fumatori.
    10. Percentuale di pazienti con =1 tipo di utilizzo delle risorse sanitarie (HRU) negli ex-fumatori.
    11. Tasso annualizzato di utilizzo delle risorse sanitarie (HRU) negli ex-fumatori.
    12. Variazione rispetto al basale nell’uso di farmaci di soccorso negli ex-fumatori.
    13. Concentrazioni sieriche minime di MEDI3506.
    14. Presenza di anticorpi anti-farmaco.
    15. Efficacia e tollerabilità.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Over 52 weeks
    Oltre la settimana 52
    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 Yes
    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 trial3
    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 concerned14
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA77
    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 Information not present in EudraCT
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Australia
    Chile
    Colombia
    Peru
    Philippines
    Thailand
    Brazil
    China
    Germany
    Greece
    Israel
    Italy
    Poland
    Romania
    Russian Federation
    Taiwan
    United Kingdom
    United States
    France
    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
    LSLV
    LSLV
    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 months6
    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 months6
    E.8.9.2In all countries concerned by the trial days20
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    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) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 622
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 650
    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 state8
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 349
    F.4.2.2In the whole clinical trial 1272
    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)
    Participants who complete a 52-week study treatment period, and have not been prematurely discontinued from IP, may be offered an opportunity to enter a controlled long term extension study.
    I partecipanti che completano il periodo di trattamento di 52 settimane e che non hanno prematuramente interrotto il trattamento, potrà essere offerto i entrare in uno studio di estensione a lungo termine controllato
    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 Decision2022-03-21
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2022-01-26
    P. End of Trial
    P.End of Trial StatusOngoing
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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