Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

  • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   43724   clinical trials with a EudraCT protocol, of which   7255   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).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools

    < Back to search results

    Print Download

    EudraCT Number:2013-002523-42
    Sponsor's Protocol Code Number:D3250C00020
    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:2014-03-20
    Trial results View results
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedGermany - PEI
    A.2EudraCT number2013-002523-42
    A.3Full title of the trial
    A multicenter, randomized, double-blind, parallel group, placebo-controlled, Phase 3 efficacy and safety study of benralizumab (MEDI-563) to reduce oral corticosteroid use in patients with uncontrolled asthma on high dose inhaled corticosteroid plus long acting beta2 agonist and chronic oral corticosteroid therapy (ZONDA)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Efficacy and safety study of Benralizumab to reduce OCS use in patients with uncontrolled asthma on high dose inhaled corticosteroid plus LABA and chronic OCS therapy
    A.3.2Name or abbreviated title of the trial where available
    A.4.1Sponsor's protocol code numberD3250C00020
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT02075255
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation PlanP/020/2014
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorAstraZeneca AB
    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.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 pointClinical Trial Transparency
    B.5.3 Address:
    B.5.3.1Street AddressVastra Malarehamnen
    B.5.3.2Town/ citySodertalje
    B.5.3.3Post code151 85
    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.3.11 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. cell therapy medicinal product No
    D. therapy medical product No
    D. Engineered Product No
    D. ATIMP (i.e. one involving a medical device) No
    D. 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 Yes
    D. medicinal product typeMonoclonal antibody
    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
    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 occuring 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 18.1
    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
    The effect of 2 dosing regimens of benralizumab on percentage reduction of Oral Corticosteroid dose in the terms of percentage reduction in final Oral Corticosteroid dose
    compared with week 0, while maintaining asthma control
    E.2.2Secondary objectives of the trial
    To assess the effect of 2 dosing regimens of benralizumab on:
    -OCS dose in adult patients with uncontrolled asthma
    -parameters associated with asthma exacerbations
    -pulmonary function
    -asthma symptoms and other asthma control metrics
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1.Provision of informed consent prior to any study specific procedures
    2. Female and male aged from 18 to 75 years, inclusively
    3. History of physician-diagnosed asthma requiring treatment with medium dose ICS and a
    4. Elevated level of peripheral blood eosinophil
    5. Documented treatment with high-dose ICS and LABA for at least 6 months prior to Visit 1
    6. Chronic oral prednisone or prednisolone therapy for at least 6 continuous months
    directly preceding Visit 1, and on a stable dose for at least one month prior to Visit 1
    7.Patients with documented failures of OCS reduction within 6 months prior to Visit 1 will not be required to proceed through the dose optimization phase during run-in.
    8. Morning pre-bronchodilator (Pre-BD) FEV1 of <80% predicted
    9. Either documented post bronchodilator (post-BD) reversibility of ≥ 12% and ≥ 200 mL in FEV1 or PC20 FEV1
    10. At least 1 documented asthma exacerbation in the previous 12 months prior to the date informed consent is obtained
    11. Optimized OCS dose reached at least 2 weeks prior to randomization
    12. Additional asthma controller medication must not have been initiated during run-in
    13. At least 70% compliance with OCS use
    14. At least 70% compliance with usual asthma controller ICS-LABA
    15. Minimum 70% (i.e. 10 of 14 days) compliance with asthma daily diary (morning
    and evening diary)
    16. No documented asthma exacerbations during the screening/dose optimization period
    E.4Principal exclusion criteria
    1. Clinically important pulmonary disease other than asthma or ever been diagnosed with pulmonary or systemic disease, other than asthma, that are associated with elevated peripheral eosinophil counts.
    2. Any disorder, including, but not limited to, cardiovascular, gastrointestinal, hepatic, renal, neurological,musculoskeletal, infectious, endocrine, metabolic, haematological, 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
    3. Acute upper or lower respiratory infections requiring antibiotics or antiviral medication within 30 days prior to the date informed consent is obtained or during the screening/run-in period
    4. Any clinically significant abnormal findings in physical examination, vital signs, haematology, clinical chemistry, or urinalysis during screening/run-in 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
    5. History of life-threatening asthma
    6. Asthma control reached at an OCS dose of ≤5mg during
    run-in/OCS optimization phase
    7. Qualifies for 3 consecutive dose reductions at Visits 2-4 and continues to meet OCS dose reduction criteria at Visit 5
    8. Receipt of oral dexamethasone as the maintenance oral steroid controller for asthma symptoms
    E.5 End points
    E.5.1Primary end point(s)
    Percentage reduction in final OCS dose compared with baseline (Visit 6), while maintaining asthma control
    E.5.1.1Timepoint(s) of evaluation of this end point
    Week 28
    E.5.2Secondary end point(s)
    The effect of 2 dosing regimens of benralizumab on:
    -OCS dose in terms of proportion of patients with ≥50% reduction in average daily OCS dose at week 28 compared with dose at week 0 while maintaining asthma control average final OCS dose ≤5.0 mg daily at week 28, while maintaining asthma control.
    -OCS dose in terms of proportion of patients with ≤5.0 mg reduction on daily OCS dose at week 28 compared with dose at week 0, while maintaining asthma control.
    -Proportion of patients with ≥1 asthma exacerbation after randomization, time to the first
    asthma exacerbation after randomization and annual rate of asthma exacerbations that are associated with an emergency room visit or a hospitalization after randomization
    -pulmonary function in terms of change from week 0 in prebronchodilator Forced Expiratory Volume in 1 second (FEV1) and in prebronchodilator Inspiratory Capacity (IC), Expiratory Reserve Volume (ERV) and Inspiratory Reserve Volume (IRV).
    -asthma symptoms and other asthma control metrics in the terms of change from week 0 in asthma symptom score (total, daytime, and night time) and in rescue medication use.
    -asthma symptoms and other asthma control metrics in the terms of change from week 0 in the number of nights with awakening due to asthma requiring rescue medication.
    - asthma symptoms and other asthma control metrics in the terms of change from week 0 in Asthma Control Questionnaire 6 (ACQ-6).
    -asthma related health related quality of life in the terms of change from week 0 in Standardised Asthma Quality of Life Questionnaire for 12 Years and Older (AQLQ(S)+12).
    -The pharmacokinetics (PK) of 2 dosing regimens of benralizumab in the terms of PK parameters
    -The immunogenicity of 2 dosing regimens of benralizumab in the terms of
    Anti-drug antibodies (ADA) presence or absence
    -The safety and tolerability of 2 dosing regimens of benralizumab in terms of Adverse Event (AE)/Serious Adverse Event (SAE)
    -The safety and tolerability of 2 dosing regimens of benralizumab in terms of laboratory variables
    -The safety and tolerability of 2 dosing regimens of benralizumab in terms of electrocardiogram (ECG) evaluation
    -The safety and tolerability of 2 dosing regimens of benralizumab in terms of physical examination results
    -The impact of 2 dosing regimens of benralizumab on blood eosinophil count.
    - The impact of 2 dosing regimens of benralizumab on biomarkers (subset of patients) in terms of quantification of sputum cytokines and biomarkers
    E.5.2.1Timepoint(s) of evaluation of this end point
    week 28
    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 No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    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. 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 concerned5
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA31
    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
    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
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months6
    E.8.9.1In the Member State concerned days16
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months9
    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: 108
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 12
    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 state14
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 57
    F.4.2.2In the whole clinical trial 120
    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)
    Subjects will be offered participation in separate safety extension study
    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 Decision2014-06-24
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-05-06
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2016-07-06
    For support, Contact us.
    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.

    European Medicines Agency © 1995-2023 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands