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    The EU Clinical Trials Register currently displays   43974   clinical trials with a EudraCT protocol, of which   7311   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:2017-001040-35
    Sponsor's Protocol Code Number:D3250C00045
    National Competent Authority:Austria - BASG
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2017-09-18
    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 ConcernedAustria - BASG
    A.2EudraCT number2017-001040-35
    A.3Full title of the trial
    A Multicenter, Randomized, Double-blind, Parallel Group, Placebo controlled, Phase 3b Study to Evaluate the Safety and Efficacy of Benralizumab 30 mg sc in Patients with Severe Asthma Uncontrolled on Standard of Care Treatment (ANDHI)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study to evaluate the effect of Benralizumab in Patients with Severe Asthma Uncontrolled.
    A.3.2Name or abbreviated title of the trial where available
    ANDHI
    A.4.1Sponsor's protocol code numberD3250C00045
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT03170271
    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 AB
    B.5.2Functional name of contact pointInformation Center
    B.5.3 Address:
    B.5.3.1Street AddressVastra Malarehamnen 9
    B.5.3.2Town/ citySödertälje
    B.5.3.3Post code151 85
    B.5.3.4CountrySweden
    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 namebenralizumab
    D.3.2Product code MEDI-563
    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 INNbenralizumab
    D.3.9.1CAS number 1044511-01-4
    D.3.9.2Current sponsor codeMEDI-563
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number30
    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 Yes
    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
    severe uncontrolled asthma
    E.1.1.1Medical condition in easily understood language
    Asthma (an illness that causes breathing difficulty) that is not fully controlled, so that episodes of breathing difficulty are still occurring despite the use of other available treatments.
    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.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10049106
    E.1.2Term Asthma chronic
    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 determine the effect of benralizumab on the rate of asthma exacerbations
    E.2.2Secondary objectives of the trial
    To determine the effect of benralizumab on:
    - patient-reported disease-specific quality of life.
    - lung function.
    - patient-reported asthma control.
    - time to first asthma exacerbation.
    - lung function at home.
    - general quality of life and health status.
    To evaluate patient impression of overall asthma severity and change in the overall asthma status.
    To determine the effect of benralizumab on the patient’s predominant symptoms and disease specific health-related quality of life in patients with doctor diagnosed chronic sinusitis with nasal polyposis.
    Safety Objective: To assess the safety and tolerability of benralizumab
    Exploratory Objectives:
    To determine the effect of:
    -eosinophil depletion with benralizumab on Biomarker components of known asthma inflammatory pathways or airway remodeling and Biomarker surrogates of eosinophilic inflammation/activation
    -benralizumab on the patient’s level of asthma control based on standard asthma guidance recommendations
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    ANDHI in Practice [ANDHI IP] substudy included within study and Protocol Amendment 4.0, 01 May 2020.

    Main objective: To assess the potential for benralizumab treated patients to reduce their standard of care asthma controller regimen while maintaining asthma control.
    Main outcome variables:
    - Number of reductions in asthma controller medications from Visit 15 to the end of study (EOS) Visit 27 (Day 560/Week 80).
    - Number of adapted GINA step category reductions from baseline at Visit 15 to the EOS Visit 27 (Day 560/Week 80).
    Main outcome measures:
    - Proportion of patients with at least one reduction in asthma controller medication from Visit 15 to EOS (Visit 27);
    - Proportions of patients with the number of adapted GINA step category reductions from Visit 15 to EOS (Visit 27) ≥ X, where X is ranging from 1 to 4.
    - Distribution of the number of adapted GINA step reductions from Visit 15 to EOS (Visit 27) (X) where X is ranging from 0c to 4.

    Other Objectives: To assess standard asthma efficacy measures for benralizumab treated patients when reducing their standard of care asthma controller regimen.
    Supportive Measures:
    - Change in continuous asthma efficacy measures (including ACQ6, SGRQ, pre-bronchodilator forced expiratory volume [pre-BD FEV1] and weekly mean morning peak expiratory flow [PEF]) from Visit 15 to the EOS Visit 27 (Day 560/Week 80).
    - Change in continuous asthma efficacy measures(including ACQ6, SGRQ, FEV1 and morning PEF) from Visit 4 to the EOS Visit 27 (Day 560/Week 80).
    - Degree of change reported by the patient (PGI-C) from Visit 13 and Investigator (CGI-C) from Visit 4 to the EOS Visit 27 (Day 560/Week 80).
    - Clinically significant asthma exacerbations from Visit 15 to the EOS Visit 27 (exacerbation count and time to first exacerbation).
    Safety Objective: To assess the safety and tolerability of benralizumab during treatment period.

    Endpoint: AEs, physical examination, vital signs during the open label benralizumab treatment period (Visit 13 to Visit 27).
    E.3Principal inclusion criteria
    1.Written informed consent for study participation must be obtained prior to any study related procedures being performed and according to international guidelines and/or applicable European Union (EU) guidelines.
    2.Female and male patients aged 18 to 75 years inclusively at the time of Visit 1 with a history of physician-diagnosed asthma requiring treatment with medium-to-high dose ICS plus asthma controller, for at least 12 months prior to Visit 1. Other acceptable asthma controllers include a long acting bronchodilator (LABA or long-acting muscarinic antagonists [LAMA]), a leukotriene inhibitor, theophylline preparations or maintenance OCS (daily or every other day OCS requirement in order to maintain asthma control; maximum total daily dose 20 mg prednisone or equivalent).
    3.Documented current treatment with high daily doses of ICS plus at least one other asthma controller for at least 3 months prior to Visit 1; see inclusion criterion 2 for acceptable other asthma controllers.
    - For ICS/LABA combination preparations, highest-strength maintenance doses approved in the given country will meet this criterion.
    - If the ICS and the other asthma controller therapies are given by separate inhalers, then the patient must be on a high daily ICS dose.
    4.History of at least 2 asthma exacerbations while on ICS plus another asthma controller (see inclusion criterion 2 for examples) that required treatment with systemic corticosteroids (IM, IV, or oral) in the 12 months prior to Visit 1. For patients receiving corticosteroids as a maintenance therapy, the corticosteroid treatment for the exacerbation is defined as a temporary increase of their maintenance dose.
    5.ACQ6 score ≥1.5 at Visit 1.
    6.Screening pre-bronchodilator (pre-BD) FEV1 of <80% predicted at Visit 2
    Note: Spirometry testing should only be performed if the patient meets the asthma medication hold for lung function testing, the test should be postponed to another day prior to Visit 3 to improve the chances of achieving a qualifying FEV1 that is not affected by bronchodilator medication.
    7. Evidence of asthma as documented by excessive variability in lung function by satisfying ≥1 of the criteria below: a) Airway reversibility (FEV1 ≥12%) using a short-acting bronchodilator demonstrated at Visit 2 or Visit 3. b) Airway reversibility to short-acting bronchodilator (FEV1 ≥12%) documented* during the 12 months prior to enrolment Visit 1. c) Daily diurnal peak flow variability of >10% when averaged over 7 continuous days during the study run-in period. d) An increase in FEV1 of ≥12% and 200 mL after a therapeutic trial of systemic corticosteroid (eg, OCS), given outside of an asthma exacerbation, documented in the 12 months prior enrolment Visit 1. e) Airway hyper-responsiveness documented in the 24 months prior to randomization Visit 4.
    8. Peripheral blood eosinophil count either: ≥300 cells/μL assessed by central laboratory at either Visit 1 or Visit 2 OR ≥150 to <300 cells/μL assessed by central laboratory at either Visit 1 or Visit 2, IF ≥1 of the following 5 clinical criteria (a to e) is met: a) Using maintenance OCS (daily or every other day OCS requirement in order to maintain asthma control; maximum total daily dose 20 mg prednisone or equivalent) at screening. b) History of nasal polyposis. c) Age of asthma onset ≥18 years. d) Three or more documented exacerbations requiring systemic corticosteroid treatment during the 12 months prior to screening. e) Pre-bronchodilator forced vital capacity <65% of predicted, as assessed at Visit 2.
    9. Women of childbearing potential (WOCBP) must use at least one acceptable and effective form of birth control (confirmed by the Investigator). Women of childbearing potential must agree to use birth control from enrolment, throughout the study duration and until 16 weeks (approximately 5 half-lives) after last dose of investigational product (IP). Women of childbearing potential must also have negative serum pregnancy test result on Visit 1.
    10.Women not of childbearing potential are defined as women who are either permanently sterilized (hysterectomy, bilateral oophorectomy, or bilateral salpingectomy), or who are postmenopausal. Women will be considered postmenopausal if they have been amenorrheic for 12 months prior to the planned date of randomization without an alternative medical cause. 11.All male patients who are sexually active must agree to use a double barrier method of contraception (condom with spermicide) from the first dose of IP until 16 weeks after their last dose.
    12.Weight of ≥40 kg.
    For Inclusion Criteria for ANDHI in Practice Sub Study please see Page 47 of protocol.
    E.4Principal exclusion criteria
    1.Clinically important pulmonary disease other than asthma (eg, active lung infection, chronic obstructive pulmonary disease [COPD], bronchiectasis, pulmonary fibrosis, cystic fibrosis), or ever been diagnosed with pulmonary or systemic disease, other than asthma, that are associated with elevated peripheral eosinophil counts (eg, allergic bronchopulmonary aspergillosis/mycosis, Churg-Strauss syndrome, hypereosinophilic syndrome).
    2.Acute upper or lower respiratory infections within 30 days prior to the date informed consent is obtained or during the screening/run-in period.
    3.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 patient throughout the study.
    Influence the findings of the studies or their interpretations.
    Impede the patient’s ability to complete the entire duration of study.
    4.Known history of allergy or reaction to any component of the IP formulation.
    5.A helminth parasitic infection diagnosed within 24 weeks prior to the date informed consent is obtained that has not been treated with, or has failed to respond to, standard of care therapy.
    6.Any clinically significant abnormal findings in physical examination, vital signs, hematology, or clinical chemistry during screening period, which in the opinion of the Investigator may put the patient at risk because of his/her participation in the study, or may influence the results of the study, or the patient’s ability to complete entire duration of the study.
    7.Any clinically significant cardiac disease or any electrocardiogram (ECG) abnormality obtained during the screening/run-in period, which in the opinion of the Investigator may put the patient at risk or interfere with study assessments.
    8.History of alcohol or drug abuse within 12 months prior to the date informed consent is obtained.
    9.A history of known immunodeficiency disorder including a positive human immunodeficiency virus (HIV) test.
    10.Current smokers or former smokers with a smoking history of ≥10 pack years. A former smoker is defined as a patient who quit smoking 6 months prior to Visit 1.
    11.Current malignancy, or history of malignancy, except for:
    Patients who have had non-melanoma skin cancers or in situ carcinoma of the cervix are eligible provided that the patient is in remission and curative therapy was completed at least 12 months prior to the date informed consent is obtained.
    Patients who have had other malignancies are eligible provided that the patient is in remission and curative therapy was completed at least 5 years prior to the date informed consent is obtained.
    12.Approved or off-label use of systemic immunosuppressive medications within 3 months prior to the date informed consent is obtained. These include but are not limited to small molecules such as methotrexate, cyclosporine, azathioprine, and immunosuppressive/immunomodulating biologics such as tumor necrosis factor (TNF) blockers. Regular use of systemic (oral) corticosteroids is also excluded except for the indication of asthma.
    13.Concurrent biologics for asthma are not allowed except for stable allergen immunotherapy (defined as a stable dose and regimen at the time of Visit 1). Acceptable washout periods for other asthma biologics: Other eosinophil lowering products indicated for asthma (including mepolizumab or reslizumab): at least 4 months.Prior omalizumab use: at least 1 month.
    14.Previously received benralizumab (MEDI-563).
    15.Receipt of any investigational medication as part of a research study within approximately 5 half-lives prior to randomization.
    16.ALT or AST level >3 times the upper limit of normal (ULN) confirmed during screening period.
    17.Receipt of immunoglobulin or blood products within 30 days prior to the date informed consent is obtained.
    18.Receipt of live attenuated vaccines 30 days prior to the date of randomization; other types of vaccines are allowed.
    19.Planned surgical procedures during the conduct of the study.
    20.Currently breastfeeding or lactating women.
    21.Pevious randomization in the present study.
    22.Concurrent enrolment in another interventional or post-authorization safety study.
    23.AstraZeneca staff involved in the planning and/or conduct of the study.
    24.Employees of the study center or any other individuals involved with the conduct of the study or immediate family members of such individuals.
    For Exclusion Criteria for ANDHI in Practice Sub Study please see Page 50 of protocol.
    E.5 End points
    E.5.1Primary end point(s)
    The annualized rate of asthma exacerbations between benralizumab and placebo.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Treatment period of 24 weeks.
    E.5.2Secondary end point(s)
    The change from baseline (Visit 4) in Saint George Respiratory Questionnaire (SGRQ) to the EOT (Day 168/Week 24).
    The change from baseline (Visit 4) in forced expiratory volume in first second (FEV1) over the treatment period (up to and including Day 168/Week 24).
    The change from baseline (Visit 4) in Asthma Control Questionnaire 6 (ACQ6) to the EOT (Day 168/Week 24).
    Time to first asthma exacerbation (treatment period 24 weeks).
    The change from run-in baseline morning peak expiratory flow (PEF) to the EOT (Day 168/Week 24).
    The change from baseline (Visit 4) SF 36v2 to the EOT (Day 168/Week 24).
    The change from baseline (Visit 4) in PGI-S to the EOT (Day 168/Week 24).
    The degree of change reported by the patient (PGI-C) and Investigator (CGI-C) expressed as a proportion of each of the 7 possible responses to the EOT (Day 168/Week 24).
    The degree of change reported by the patient in their predominant symptom to the EOT (Day 168/Week 24).
    The change from baseline (Visit 3) in the sino-nasal outcome test (SNOT-22) score to the EOT (Day 168/Week 24).
    Safety: Adverse events (AEs), laboratory variables, physical examination.
    Exploratory:
    The change from baseline (Visit 4) in circulating biomarkers to each pre-specified scheduled assessment during the treatment period.
    The proportion of time that that the patient’s asthma is well-controlled based on composite diary measures.
    E.5.2.1Timepoint(s) of evaluation of this end point
    From Baseline (Visit 4) to EOT (Day 168/ Week 24).
    Throughout 24 week treatment period.
    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 No
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    Exploratory Biomarkers.
    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 Yes
    E.8.1.7.1Other trial design description
    Double blind for 24 week period. Patients can then be enrolled in 56 week open label sub study.
    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 concerned3
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA118
    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
    Austria
    Belgium
    Canada
    Denmark
    Finland
    France
    Germany
    Italy
    Netherlands
    Norway
    Spain
    Sweden
    Switzerland
    United Kingdom
    United States
    E.8.7Trial has a data monitoring committee No
    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
    The last visit of the last patient undergoing the study. The final study visit will be the telephone FU Visit.
    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 months0
    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 months0
    E.8.9.2In all countries concerned by the trial days0
    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: 567
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 63
    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 state18
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 360
    F.4.2.2In the whole clinical trial 630
    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)
    See protocol. Patient will return to Standard of Care.
    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 Decision2017-10-27
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-10-27
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2020-10-21
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