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    Summary
    EudraCT Number:2013-005614-35
    Sponsor's Protocol Code Number:D2210C00007
    National Competent Authority:Bulgarian Drug Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2014-09-29
    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 ConcernedBulgarian Drug Agency
    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
    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.
    A.3.2Name or abbreviated title of the trial where available
    STRATOS 1
    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/280/2011
    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 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.5.3.4CountrySweden
    B.5.6E-maileva.augurell@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 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.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) 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
    Asthma
    E.1.1.1Medical condition in easily understood language
    Asthma
    E.1.1.2Therapeutic area Diseases [C] - Respiratory Tract Diseases [C08]
    MedDRA Classification
    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
    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

    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
    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
    E.5 End points
    E.5.1Primary end point(s)
    Annual asthma exacerbation rate
    E.5.1.1Timepoint(s) of evaluation of this end point
    Week 0 to Week 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
    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
    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.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 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 concerned16
    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
    Argentina
    Belgium
    Brazil
    Bulgaria
    Colombia
    Germany
    Hungary
    Korea, Republic of
    Peru
    Poland
    Slovakia
    Spain
    United States
    Vietnam
    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
    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.1.1.6.1Number 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.3.3.6.1Details of subjects incapable of giving consent
    Adolescents (12-17 year's old)
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state130
    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)
    None
    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 Decision2015-02-24
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-11-20
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2017-07-18
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