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    Summary
    EudraCT Number:2017-003079-69
    Sponsor's Protocol Code Number:D5180C00009
    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:2017-12-04
    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 number2017-003079-69
    A.3Full title of the trial
    A Multicentre, Randomized, Double-Blind, Placebo Controlled, Phase 3 Study to Evaluate the Efficacy and Safety of Tezepelumab in Reducing Oral Corticosteroid Use in Adults with Oral Corticosteroid Dependent Asthma (SOURCE)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Phase 3 Study to Evaluate the Efficacy and Safety of Tezepelumab in Reducing Oral Corticosteroid Use in Adults with Oral Corticosteroid Dependent Asthma (SOURCE)
    A.3.2Name or abbreviated title of the trial where available
    SOURCE
    A.4.1Sponsor's protocol code numberD5180C00009
    A.7Trial is part of a Paediatric Investigation Plan No
    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 supportAmgen
    B.4.2CountryUnited States
    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 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 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 evaluate the effect of tezepelumab compared with placebo in reducing the prescribed OCS maintenance dose in patients with asthma requiring chronic treatment with maintenance OCS in addition to high dose ICS plus LABA
    E.2.2Secondary objectives of the trial
    Key Secondary Objective:

    1)To evaluate the effect of tezepelumab compared with placebo on asthma exacerbations

    Other Secondary Objectives:

    1) To evaluate the effect of tezepelumab compared with placebo on the prescribed, OCS daily maintenance dose

    2)To evaluate the effect of tezepelumab compared with placebo on Pre-BD lung function

    3)To assess the effect of tezepelumab compared with placebo with regards to asthma symptoms and other asthma control metrics

    4)To assess the effect of tezepelumab compared with placebo with regards to asthma related and general health-related quality of life

    5)To evaluate the efficacy of tezepelumab compared with placebo on health resource
    utilization and productivity loss due to asthma

    6)To assess the effect of tezepelumab on biomarkers

    7)To evaluate the pharmacokinetics (PK) and immunogenicity of tezepelumab
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1)Subject must be 18 to 80 years of age inclusive at the time of signing the informed consent form

    2)Subjects must have received a physician-prescribed medium- or highdose ICS as per GINA guideline for at least 12 months

    3)Subjects must have received physician prescribed LABA and high dose ICS (total daily dose >500μg fluticasone propionate dry powder
    formulation equivalent) for at least 3 months prior to visit 1. The ICS and LABA can be parts of a combination product, or given by separate
    inhalers.

    4)Additional maintenance asthma controller medications are allowed according to standard practice of care i.e., leukotriene receptor antagonists (LTRAs), theophylline, long-acting muscarinic antagonists (LAMAs), secondary ICS and cromones. The use of these medications must be documented for at least 3 months

    5)Subjects must have received OCS for the treatment of asthma for at least 6 months prior to visit 1 and on a stable dose of between ≥ 7.5 to ≤
    30mg (prednisone or prednisolone equivalent) daily or daily equivalent for at least 1 month. The OCS dose may be administered every other
    day(or different doses every other day); Average dose over two days = The daily dose.

    6)Morning pre-bronchodilator (BD) FEV1 must be < 80% predicted normal

    7)Subjects must have evidence of asthma as documented by post-BD (albuterol/salbutatomol) reversibility of FEV1 ≥12% and ≥200 mL (15-30 min after administration of 4 puffs of albuterol/salbutamol), documented either in the previous 12 months or at screening

    8)Subjects must have a history of at least 1 asthma exacerbation event within 12 months

    9)Subject must have received the optimized OCS dose for at least 2 weeks prior to randomization

    10)Minimum 10 days compliance with the morning and evening eDiary completion and OCS,ICS,LABA as well as other asthma controller medications as captured in the eDiary during the 14 days prior to randomization
    E.4Principal exclusion criteria
    1)Any clinically important pulmonary disease other than asthma (e.g. active lung infection, Chronic Obstructive Pulmonary Disease (COPD), bronchiectasis, pulmonary fibrosis, cystic fibrosis, hypoventilation syndrome associated with obesity, lung cancer, alpha 1 anti-trypsin deficiency, and primary ciliary dyskinesia) or ever diagnosed with pulmonary or systemic disease, other than asthma, that are associated with elevated peripheral eosinophil counts (e.g. allergic bronchopulmonary aspergillosis/mycosis, Churg-Strauss syndrome, hypereosinophilic syndrome).

    2)Any disorder, including, but not limited to, cardiovascular, gastrointestinal, hepatic, renal, neurological, musculoskeletal, infectious, endocrine, metabolic, hematological, psychiatric, or major physical impairment that is not stable in the opinion of the Investigator and could:
    Affect the safety of the subject throughout the study Influence the findings of the study or the interpretation Impede the subject's ability to complete the entire duration of study

    3)History of cancer: Subjects who have had basal cell carcinoma, localized squamous cell carcinoma of the skin or in situ carcinoma of the cervix are eligible to participate in the study provided that curative therapy was completed at least 12 months prior to visit 1.Subjects who have had other malignancies are eligible provided that curative therapy was completed at least 5 years prior to visit 1

    4)History of a clinically significant infection, including upper or lower respiratory tract infection (URTI and LRTI, respectively), requiring treatment with antibiotics or antiviral medications
    finalized < 2 weeks before screening or during the run-in period.

    5)A helminth parasitic infection diagnosed within 6 months prior to visit 1 that has not been treated with, or has failed to respond to, standard of care therapy.

    6)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 to be eligible.

    7)History of chronic alcohol or drug abuse within 12 months

    8)Tuberculosis requiring treatment within the 12 months

    9)History of any known immunodeficiency disorder including a positive human immunodeficiency virus (HIV) test.

    10)Major surgery within 8 weeks prior to visit 1 or planned surgical procedures requiring general anaesthesia or in-subject status for >1 day during the conduct of the study.

    11)Clinically significant asthma exacerbation, in the opinion of the Investigator, including those requiring use of systemic corticosteroids or increase in the maintenance dose of OCS within 30 days prior to to visit 1

    12) During the optimization period, asthma control reached at an OCS dose of <7.5mg or >30mg and/or 3 consecutive dose reductions after which asthma control was still obtained

    13)Evidence of clinically significant infection or subject receiving treatment with antibiotics or antiviral meidcations
    E.5 End points
    E.5.1Primary end point(s)
    Categorized percent reduction from baseline in the daily OCS dose at Week 48 while not losing asthma control

    The categories for percent change from baseline in daily OCS dose are defined as:
    1. ≥90% to ≤100% reduction
    2. ≥75% to <90% reduction
    3. ≥50% to <75% reduction
    4. >0% to <50% reduction
    5. no change or any increase
    E.5.1.1Timepoint(s) of evaluation of this end point
    Week 48
    E.5.2Secondary end point(s)
    Key Secondary Endpoint: Annualized asthma exacerbation rate (AAER)

    Other Secondary Endpoints:

    1a)Proportion of subjects with 100% reduction from baseline in daily OCS dose at Week 48

    1b)Proportion of subjects with daily OCS dose ≤5 mg at Week 48

    1c)Proportion of subjects with ≥50% reduction from baseline in daily OCS dose at Week 48

    2)Change from baseline in Pre-bronchodilator forced expiratory volume in 1 second (FEV1)

    3a)Change from baseline in weekly mean daily Asthma Symptom Score as captured in the daily Asthma Symptom Diary (ASD

    3b)Change from baseline in weekly mean rescue medication use

    3c) Change from baseline in weekly mean home peak expiratory flow (morning and evening)

    3d) Change from baseline in weekly mean number of night-time awakening due to asthma

    3e) Change from baseline in Asthma Control Questionnaire 6 (ACQ-6) score

    4a)Change from baseline in Standardized Asthma Quality of Life Questionnaire for 12 years and older (AQLQ(s)+12) total score

    4b)Change from baseline in European Quality of Life – 5 Dimensions 5 Levels Questionnaire (EQ-5D-5L) score


    5a) Number of asthma specific resource utilizations (e.g. unscheduled physician visits, unscheduled phone calls to physicians, use of other asthma medications)

    5b) Work Productivity and Activity Impairment Questionnaire and Classroom Impairment Questionnaire (WPAI+CIQ)

    6a)Change from baselin in FENO

    6b)Change from baseline peripheral blood eosinophils and total IgE

    7a) PK: Serum trough concentrations

    7b)Immunogenicity: Incidence of anti-drug antibodies (ADA)
    E.5.2.1Timepoint(s) of evaluation of this end point
    Key Secondary Endpoint: Baseline to Week 48

    Other Secondary Endpoints:

    1)Week 48

    2)Baseline, Week 48

    3)Baseline, Week 48

    4)Baseline, Week 48

    5)Week 48

    6)Baseline, Week 48

    7)Baseline to Week 48
    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 No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic Yes
    E.6.11Pharmacogenomic Yes
    E.6.12Pharmacoeconomic No
    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 concerned12
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA24
    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
    Germany
    Korea, Republic of
    Poland
    Turkey
    Ukraine
    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
    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 months8
    E.8.9.1In the Member State concerned days30
    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 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: 129
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 23
    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 state31
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 61
    F.4.2.2In the whole clinical trial 152
    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 Decision2018-03-19
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-04-26
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2020-09-25
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