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    EudraCT Number:2010-020127-52
    Sponsor's Protocol Code Number:MI-CP196 (D3251L00001)
    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:2010-09-23
    Trial results View results
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    A. Protocol Information
    A.1Member State ConcernedGermany - PEI
    A.2EudraCT number2010-020127-52
    A.3Full title of the trial
    A Phase 2a, double blind, placebo controlled study to evaluate the efficacy of MEDI-563 in subjects with moderate to severe COPD and sputum eosinophilia
    A.4.1Sponsor's protocol code numberMI-CP196 (D3251L00001)
    A.7Trial is part of a Paediatric Investigation Plan Information not present in EudraCT
    A.8EMA Decision number of Paediatric Investigation Plan
    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 support
    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
    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 nameMEDI-563
    D.3.2Product code MEDI-563
    D.3.4Pharmaceutical form Powder for solution for injection
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPSubcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.1CAS number 1044511-01-4
    D.3.9.2Current sponsor codeMEDI-563
    D.3.9.3Other descriptive namebenralizumab
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number50
    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) Information not present in EudraCT
    D. cell therapy medicinal product No
    D. therapy medical product No
    D. Engineered Product Information not present in EudraCT
    D. ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D. on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    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 Information not present in EudraCT
    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
    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
    Chronic obstructive pulmonary disease and Sputum Eosinophilia
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 13.1
    E.1.2Level LLT
    E.1.2Classification code 10010952
    E.1.2Term COPD
    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 primary objective of this study is to evaluate the effect of multiple subcutaneous (SC) doses of MEDI-563 on the rate of moderate-to-severe acute axacerbations in COPD (AECOPD) in adult subjects with moderate-to-severe COPD who exhibit eosinophilia (equal to or greater than 3% sputum eosinophilia in the previous 12 months or at screening) compared to placebo
    E.2.2Secondary objectives of the trial
    The secondary objectives of this study are:

    1. To evaluate the safety and tolerability of MEDI-563 in this subject population.

    2. To evaluate the reduction in hospitalization due to AECOPD.

    3. To assess the effect of MEDI-563 on health-related quality of life measurements such as the COPD-specific St. George's Respiratory Questionnnaire (SGRQ-C) and the Chronic Respiratory Questionnaire self-administered standardized format (CRQ-SAS).

    4. To describe the effect of MEDI-563 on the BODE (Body Mass Index, Airway Obstruction, Dyspnea, and exercise capacity) index
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Subjects aged 40 to 85 years old at the time of screening.

    2. Written informed consent obtained from the subject prior to
    performing any protocol-related procedures.

    3. Documented history of moderate to severe COPD with a
    post-bronchodilator FEV1/FVC < 0.70 and a
    post-bronchodilator FEV1 < 80% predicted at screening.

    4. Documented history of 1 or more AECOPD that required treatment
    with systemic corticosteroids and/or antibiotics, or hospitalization
    within 8 weeks - 52 weeks prior to Day 1.

    5. Eosinophilia: greater or same as 3.0% demonstrated on sputum
    within 12 months prior to, or at screening.

    6. Clinically stable and free from an acute exacerbation of COPD for
    8 weeks prior to Day 1.

    7. Current smoker or ex-smoker with a tobacco history of more than
    or equal to 10 pack-years (1 pack year = 20 cigarettes smoked per
    day for 1 year).

    8. Female subjects of childbearing potential who are sexually active
    with non-sterilized male partner must use adequate contraception
    from screening through the end of the study. An acceptable
    method of contraception is defined as one that has no higher than
    a 1% failure rate. In this study, where medications and devices
    containing hormones are included, the recommended methods of
    contraception are described in the protocol. Sustained abstinence is
    an acceptable practice; however, periodic abstinence, the rhythm
    method, and the withdrawal method are not acceptable methods
    of contraception.

    9. Non-sterilized males who are sexually active with a female of
    child-bearing potential must use adequate contraception
    (see protocol) from screening through the end of the study.

    10. Females not of childbearing potential must have been
    surgically sterilized (eg. hysterectomy, bilateral tubal ligation,
    or bilateral oophorectomy) or postmenopausal (defined as at
    least 1 year since last regular menses) and follicle stimulating
    hormone (FSH) > 23 IU/L according to a central

    11. Sterilized males must be at least one year post vasectomy or
    must use adequate contraception (see Table 4.2.1-1) if less than
    one year post vasectomy.

    12. Ability and willingness to complete follow-up period as required
    by the protocol.

    13. Subjects receiving allergy immunotherapy must be on a stable
    dose for the preceding 90 days prior to Day 1.

    14. Able to read and write.
    E.4Principal exclusion criteria
    1. Any condition that, in the opinion of the investigator, would interfere
    with evaluation of the investigational product or interpretation of
    subject safety or study results.

    2. Significant or unstable ischemic heart disease, arrhythmia,
    cardiomyopathy, heart failure, renal failure, uncontrolled
    hypertension as defined by the Investigator, or any other
    relevant cardiovascular disorder as judged by the Investigator.

    3. Pregnant, breastfeeding and lactating women.

    4. Known history of allergy or reaction to any component of the
    investigational product formulation, budesonide/formoterol
    preparations, tiotropium bromide or terbutaline sulphate or
    any of their excipients.

    5. History of anaphylaxis to any other biologic therapy.

    6. Donation or transfusion of blood, plasma or platelets within
    the past 90 days prior to screening.

    7. Other significant pulmonary disease as a primary diagnosis
    (eg, cystic fibrosis, bronchiecstasis, alpha-1 antitrypsin
    deficiency, interstitial lung disease; pulmonary hypertension
    other than cor pulmonale) if a subject is diagnosed with any
    other pulmonary disease as a secondary diagnosis, they may
    be included if, in the opinion of the investigator or medical monitor,
    the inclusion does not compromise the interpretation of the study.

    8. Receiving long-term oxygen therapy (LTOT) at entry into the study.
    LTOT is defined as use of oxygen for a minimum of 15 hours per day.

    9. Subjects who have a past or present disease or disorder, which is
    judged by the investigator and the medical monitor, may either put
    the subject at risk because of participation in the study, or may affect
    the outcome of the study. Subjects, who have epilepsy, must be on a
    stable dose of medication for 30 days prior to Day 1.

    10. Influenza vaccination within 3 weeks before sputum collection at
    screening (Day -56).

    11. Fever > 37.8 °C (100°F) measured using the tympanic temperature
    (or equivalent oral/rectal/axillary temperature) at Day 1.

    12. Use of immunosuppressive medication, including inhaled (other than
    Symbicort®), topical, ocular, nasal or rectal corticosteroids and
    systemic steroids within 28 days before randomization (Day 1)
    into the study.

    13. Receipt of immunoglobulin or blood products within 30 days before
    randomization into the study.

    14. Receipt of any novel investigational medicinal products within 3
    months before the first dose of investigational product in this study
    and through to study end.

    15. Seropositive for hepatitis B surface antigen, hepatitis C, or human
    immunodeficiency virus (HIV)-1 or HIV-2).

    16. Unexplained diarrhea within 30 days prior to screening; or a
    diagnosis of a helminth parasitic infestation within 6 months prior
    to screening; history of an untreated systemic helminth parasitic
    infection; history of living with a person known to have had a
    helminth parasitic infestation within 12 months prior to screening;
    history of recent travel to areas where parasite infestations are
    endemic within 3 months before screening.

    17. Any subjects that have positive serum serology during the
    screening/run-in period to Strongyloides stercoralis will be
    excluded. Subjects with a positive serology to Schistosoma mansoni,
    Taenia solium, or Ascaris lumbricoides will undergo a confirmatory
    stool sampling per local guidelines. If the stool sampling is positive
    for Schistosoma mansoni or Taenia solium the subject will be
    excluded. All subjects with a positive serology for Ascaris
    lumbricoides, whether stool sampling is positive or negative, must
    be administered a single oral dose of 400mg albendazole. If
    albendazole is not licensed, the subject will be treated per local
    standard of care.

    18. History of alcohol or drug abuse within the past year that required
    treatment that the investigator felt or medical monitor felt would
    compromise the study data interpretation.

    19. Past or present malignancy within the past 5 years except
    adequately treated non-invasive basal cell carcinoma and
    squamous cell carcinoma of the skin and cervical carcinoma-in-situ
    treated with apparent success more than 1 year prior to screening.
    E.5 End points
    E.5.1Primary end point(s)
    The primary objective of this study is to evaluate the effect of multiple SC doses of MEDI-563 on the rate of moderate-to-severe AECOPD in adult subjects with moderate-to-severe COPD. The primary endpoint will be the number of moderate-to-severe AECOPD experienced by subjects after their first dose of investigational product to their Day 393/Early Discontinuation visit.

    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 No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    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. trial type description
    E.7.2Therapeutic exploratory (Phase II) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    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.8.3 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 concerned1
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA26
    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 Information not present in EudraCT
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    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
    Date of the last protocol specified visit for the last subject in the study
    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 months7
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months7
    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.1.3Elderly (>=65 years) Yes
    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 state5
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 70
    F.4.2.2In the whole clinical trial 90
    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 Decision2011-03-03
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2010-12-14
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2013-07-11
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