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    The EU Clinical Trials Register currently displays   44020   clinical trials with a EudraCT protocol, of which   7318   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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    Summary
    EudraCT Number:2017-003078-15
    Sponsor's Protocol Code Number:D5180C00007
    National Competent Authority:Germany - PEI
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2017-11-20
    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 ConcernedGermany - PEI
    A.2EudraCT number2017-003078-15
    A.3Full title of the trial
    A Multicentre, Randomized, Double-Blind, Placebo Controlled, Parallel Group, Phase 3 Study to Evaluate the Efficacy and Safety of Tezepelumab in Adults and Adolescents with Severe Uncontrolled Asthma (NAVIGATOR)
    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 Tezepelumab in Adults and Adolescents with severe asthma that is not controlled.
    A.3.2Name or abbreviated title of the trial where available
    NAVIGATOR
    A.4.1Sponsor's protocol code numberD5180C00007
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT03347279
    A.7Trial is part of a Paediatric Investigation Plan Yes
    A.8EMA Decision number of Paediatric Investigation PlanP/316/2014
    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.4.1Name of organisation providing supportAmgen
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisation
    B.5.2Functional name of contact point
    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 nameTezepelumab
    D.3.2Product code MEDI9929 anti-TSLP mAb (AMG157)
    D.3.4Pharmaceutical form Solution for injection
    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 INNTezepelumab
    D.3.9.1CAS number 1572943-04-4
    D.3.9.2Current sponsor codeMEDI9929
    D.3.9.3Other descriptive nameAMG 157
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number99 to 121
    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
    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
    Severe uncontrolled 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.1.2 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 assess the effect of tezepelumab SC Q4W on asthma exacerbations in adult and adolescent subjects with severe uncontrolled asthma compared with placebo.
    E.2.2Secondary objectives of the trial
    1) To assess the effect of tezepelumab SC Q4W on:
    a) pulmonary function compared with placebo.
    b) health status/health related quality of life compared with placebo.
    c) asthma control compared with placebo.
    d) asthma symptoms compared with placebo.
    Other Secondary objectives:
    1) To assess the effect of tezepelumab SC Q4W on:
    a) other endpoints associated with asthma exacerbations.
    b) biomarkers.
    c) other asthma control metrics.
    d) general health-related quality of life.
    e) patient (PGI-C and PGI-S) and clinician impression of overall asthma severity (CGI-C).
    2) To evaluate the effect of tezepelumab SC Q4W compared with placebo on health resource utilization and productivity loss due to asthma.
    3) To evaluate the pharmacokinetics (PK) and immunogenicity of tezepelumab.
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    A Multcentre, Randomized, Double-Blind, Placebo Controlled, Parallel Group. Phase 3 Study to Evaluate the Efficacy and Safety of Tezepelumab in Adults and Adolescents with Severe Uncontrolled Asthma (NAVIGATOR)
    1) Exploratory Objective: To explore the effect of tezepelumab SC Q4W on disease activity.
    Endpoint/variable: Domiciliary FENO in a subset of subjects.
    2) Exploratory Objective: To explore the relationships between T helper cells in blood and exposure/response to tezepelumab.
    Endpoint/variable: Enumerate Th1, Th2, Th17 cells in whole blood by flow cytometry.
    E.3Principal inclusion criteria
    1) Provision of signed and dated informed consent prior to any mandatory study specific procedures, sampling and analyses.
    2) Subjects must be 12 to 80 years of age inclusive at the time of signing the informed consent form.
    3) Documented physician-diagnosed asthma for at least 12 months prior to Visit 1.
    4) Subjects who have received a physician-prescribed asthma controller medication with medium or high dose ICS for at least 12 months prior to Visit 1.
    5) Documented treatment with a total daily dose of either medium or high dose ICS (>= 500 ug fluticasone proprionate dry powder formulation equivalent total daily dose) for at least 3 months prior to Visit 1.
    6) At least one additional maintenance asthma controller medication is require according to standard practice of care, eg. LABA, LTRA, theophylline, LAMA, cromones etc. Use of additional asthma controller medications must be document for at least 3 months prior to Visit 1.
    7) Morning pre-BD FEV1 <80% predicted normal (<90% for subjects 12-17 years of age) at either Visit 2 or Visit 2a.
    8) Evidence of asthma as documented by either i) Documented historical reversibility of FEV1 >=12% and >=200 mL in the previous 12 months prior to Visit 1 OR ii) Post-BD (albuterol/salbutamol) reversibility of FEV1 >=12% and >=200 mL during screening at either Visit 2 or Visit 2a.
    9) ACQ-6 score >=1.5 at screening and randomization.
    10) Documented history of at least 2 asthma exacerbation events within 12 months prior to Visit 1.
    E.4Principal exclusion criteria
    1) Any clinically important pulmonary disease other than asthma.
    2) History of cancer.
    3) History of clinically significant infection, including upper (URTI) or lower respiratory tract infection (LRTI), requiring treatment with antibiotics or antiviral medications finalized <2 weeks before Visit 1 or during the run-in period.
    4) Current smokers or subjects with smoking history >=10 pack-years and subjects using vaping products, including electronic cigarettes. Former smokers with a smoking history of <10 pack years and users of vaping or e-cigarette products must have stopped for at least 6 months prior to Visit 1.
    5) History or chronic alcohol or drug abuse within 12 months prior to Visit 1.
    6) Tuberculosis requiring treatment within 12 months prior to Visit 1.
    7) History of known immunodeficiency disorder including a positive human immunodeficiency virus (HIV) test at Visit 1, or the subject taking antiretroviral medications as determined by medical history and/or subject's verbal report.
    8) History of anaphylaxis or documented immune complex disease (Type III hypersensitivity reactions) following any biological therapy.
    9) Subject randomized in the current study or previous tezepelumab studies.
    10) Treatment with the following medications within the last 12 weeks prior to randomization: Systemic immunosuppressive/immunomodulating drugs (e.g. methotrexate, cyclosporine, etc) except for OCS used in the treatment of asthma/asthma exacerbations.
    E.5 End points
    E.5.1Primary end point(s)
    Primary endpoint: Annualized asthma exacerbation rate (AAER).
    E.5.1.1Timepoint(s) of evaluation of this end point
    Baseline to Week 52.
    E.5.2Secondary end point(s)
    Key Secondary endpoints:
    1) Change from baseline in the pre-dose/pre-bronchodilator (pre-BD) forced expiratory volume in 1 second (FEV1).
    2) Change from baseline in Standardized Asthma Quality of Life Questionnaire for 12 years and older (AQLQ(S)+12) total score.
    3) Change from baseline in Asthma Control Questionnaire-6 (ACQ-6) score.
    4) Change from baseline in weekly mean daily Asthma Symptom Diary score.
    Other Secondary endpoints:
    1) Time to first asthma exacerbation. b) Proportion of subjects with >=1 asthma exacerbation. c) Annualized rate of exacerbations associated with emergency room visit, urgent care visit, or hospitalization.
    2) Change from baseline in fractional exhaled nitric oxide FENO (ppb), peripheral blood eosinophils and total serum IgE.
    3) Change from baseline in weekly mean rescue medication use, weekly mean morning and evening peak expiratory flow (PEF), and weekly mean number of night time awakenings.
    4) Asthma specific resource utilization (eg. unscheduled physician visits, unscheduled phone calls to physicians, use of other asthma medications). Work Productivity and Activity Impairment, Questionnaire and Classroom Impairment Questionnaire (WPAI+CIQ) score.
    5) PK: Serum trough concentrations; Immunogenicity: Incidence of antidrug antibodies.
    6) European Quality of Life - 5 Dimensions 5 Levels Questionnaire (EQ-5D-5L) score.
    7) Patient Global Impression of Change/Severity (PGI-C, PGI-S) and Clinician Global Impression of Change (CGI-C).
    E.5.2.1Timepoint(s) of evaluation of this end point
    Key Secondary endpoints:
    1) Baseline, Week 52
    2) Baseline, Week 52
    3) Baseline, Week 52
    4) Baseline, Week 52
    Other Secondary endpoints:
    1) Baseline to Week 52
    2) Baseline, Week 52
    3) Baseline, Week 52
    4) Week 52
    5) Baseline to Week 52
    6) Week 52
    7) Week 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 No
    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 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 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 concerned16
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA33
    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
    Australia
    Austria
    Brazil
    Canada
    China
    France
    Germany
    Israel
    Japan
    Korea, Republic of
    Russian Federation
    Saudi Arabia
    South Africa
    Taiwan
    Ukraine
    United Kingdom
    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
    LSLV
    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 months7
    E.8.9.1In the Member State concerned days16
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months11
    E.8.9.2In all countries concerned by the trial days19
    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: 80
    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: 80
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 845
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 135
    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 No
    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 state45
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 125
    F.4.2.2In the whole clinical trial 1060
    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 Decision2018-03-13
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-08-23
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2020-11-12
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