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    Summary
    EudraCT Number:2010-022510-11
    Sponsor's Protocol Code Number:MEA114092
    National Competent Authority:Estonia - SAM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2010-11-12
    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 ConcernedEstonia - SAM
    A.2EudraCT number2010-022510-11
    A.3Full title of the trial
    A multicenter, open-label, dose ranging study to determine the pharmacokinetics and pharmacodynamics of mepolizumab administered intravenously or subcutaneously to adult asthmatic subjects with elevated blood eosinophil levels
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Study of a mepolizumab in different administration forms in patients with asthma
    A.4.1Sponsor's protocol code numberMEA114092
    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 SponsorGlaxoSmithKline Research & Development Ltd
    B.1.3.4CountryUnited Kingdom
    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 supportGSK
    B.4.2CountryUnited Kingdom
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationGlaxoSmithKline
    B.5.2Functional name of contact pointClinical Trials Helpdesk
    B.5.3 Address:
    B.5.3.1Street AddressIron Bridge Road
    B.5.3.2Town/ cityUxbridge
    B.5.3.3Post codeUB11 1BU
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number+44 2089904466
    B.5.5Fax number+44208990134
    B.5.6E-mailGSKClinicalSupportHD@gsk.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 nameMepolizumab for Injection
    D.3.2Product code SB240563
    D.3.4Pharmaceutical form Injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    Subcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNMepolizumab
    D.3.9.1CAS number 196078-29-2
    D.3.9.2Current sponsor codeSB-240563
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number2.5
    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 No
    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.3.11.13.1Other medicinal product typeHumanised Monoclonal Antibody
    D.8 Information on Placebo
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Asthma
    E.1.1.1Medical condition in easily understood language
    Adult asthmatic subjects with elevated blood eosinophil levels.
    E.1.1.2Therapeutic area Body processes [G] - Circulatory and Respiratory Physiological Phenomena [G09]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.0
    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 demonstrate that the PK/PD relationship between the exposure of SC administered mepolizumab and a marker of response, plasma eosinophil, is comparable to that observed following IV administration
    E.2.2Secondary objectives of the trial
    • To assess the relative bioavailability of mepolizumab administered subcutaneously, as compared to mepolizumab administered intravenously, in asthmatic adult subjects with elevated blood eosinophil levels.

    • To assess the immunogenicity of repeat doses of mepolizumab.

    • To assess the safety and tolerability of repeat doses of mepolizumab when administered subcutaneously and intravenously to asthmatic adult subjects with elevated blood eosinophil levels
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Males or eligible females between 18 and 65 years of age inclusive, at the time of
    signing the informed consent; Non-childbearing potential is defined as pre menopausal females with a documented tubal ligation or hysterectomy; or postmenopausal defined as 12 months of spontaneous amenorrhea [in questionable cases a blood sample with simultaneous follicle stimulating hormone (FSH) > 40 MlU/ml and estradiol < 40 pg/ml (<147pmol/L) is confirmatory]. To be eligible for entry into the study, females of childbearing potential and females whose menopausal status is in question must commit to consistent and correct use of an acceptable method of birth control as defined in Section 7.1.1 of the protocol from one month prior to the first dose of investigational product until 4 months after the last dose of investigational product.
    2. History of asthma for at least one year.
    3. Subjects must be on a stable dose of an inhaled corticosteroid or combination (ICS+LABA) therapy for at least 12 weeks prior to screening.
    4. FEV1≥45% and <90 % of predicted normal value during screening (obtained between 6:00 AM and 1:00 PM).
    5. Evidence of airway reversibility (FEV1≥12%) within 30 minutes of inhalation of albuterol OR airway hyperresponsiveness (PC20 of <8mg/mL or PD20 of <7.8 μ mol methacholine/histamine) documented in the 12 months prior to randomization.
    6. Subjects with documented evidence of elevated blood eosinophilia levels (>0.2 cells 10^9/L) within 12 months of screening and evidence of elevated blood eosinophilia levels (>0.2 cells 10^9/L) at screening.
    7. Capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the consent form.
    E.4Principal exclusion criteria
    1. QTcF ≥450 msec; or QTcF ≥ 480 msec in subjects with Bundle Branch Block.
    2. AST, ALT, alkaline phosphatase and bilirubin ≥ 1.5xULN (isolated bilirubin
    <1.5xULN is acceptable if bilirubin is fractionated and direct bilirubin ≥35%).
    3. Subjects with elevated blood eosinophil levels which is not related to asthma
    4. Current smokers (any subject who has smoked within the six months prior to
    screening or has a positive urine cotinine at screening) or subjects with a smoking
    history of >10 pack years calculated as follows:view protocol for further information.
    5. Presence of a clinically important lung condition other than asthma including current infection, bronchiectasis, pulmonary fibrosis, bronchopulmonary aspergillosis,
    Churg-Strauss syndrome, or diagnoses of emphysema or chronic bronchitis (chronic
    obstructive pulmonary disease other than asthma) or a history of lung cancer.
    6. An asthma exacerbation or respiratory tract infection within six weeks prior to
    screening (an exacerbation is defined as worsening asthma requiring the use of
    systemic corticosteroids and/or emergency department visit, hospitalisation).
    7. Subjects with a parasitic infestation within six months of screening.
    8. A current malignancy or previous history of cancer in remission for less than five
    years prior screening (except for localized carcinoma of the skin that has been
    resected for cure).
    9. Subjects who have clinically significant cardiovascular, endocrine, autoimmune,
    metabolic, neurological, renal, gastrointestinal, hepatic, haematological or any other
    system abnormalities that are uncontrolled with standard treatment.
    10. Unstable liver disease (as defined by the presence of ascites, encephalopathy,
    coagulopathy, hypoalbuminaemia, esophageal or gastric varices or persistent
    jaundice), cirrhosis, and known biliary abnormalities (with the exception of Gilbert’s
    syndrome or asymptomatic gallstones).
    11. Subjects with a known immunodeficiency (e.g. human immunodeficiency virus –
    HIV).
    12. A positive pre-study Hepatitis B surface antigen or positive Hepatitis C antibody
    result within three months of screening.
    13. Subjects who have received omalizumab [Xolair] within 130 days of administration of the first dose of study medication.
    14. Subjects with recent history (within two years prior to screening) of alcohol misuse or substance abuse prior screening.
    15. A positive pre-study drug/alcohol test at screening.
    E.5 End points
    E.5.1Primary end point(s)
    • Change from baseline in blood eosinophil levels as assessed by the exposure-response relationship

    • Area under the blood eosinophil time curve (AUC), maximum change from baseline in blood eosinophils (Emax), time to maximum change in blood eosinohil levels (Tmaxeos), time to 50% eosinophil repletion (Trep)

    • Area under the plasma-concentration time curve (AUC), maximum plasma concentration (Cmax), time to Cmax (Tmax) and terminal half-life (t½) of mepolizumab
    E.5.1.1Timepoint(s) of evaluation of this end point
    Day1, Day 3, Day 7, Day 28, Day 56, Day 70, Day 84, Day 112 and Day 140.
    E.5.2Secondary end point(s)
    • AUC and Cmax of mepolizumab (Day1, Day 3, Day 7, Day 28, Day 56, Day 70, Day 84, Day 112 and Day 140)
    • Levels of anti-mepolizumab antibodies (Day 1, Day 112 and Day 140)
    • Spontaneous and elicited adverse
    events (AEs), (Day1, Day 3, Day 7, Day 28, Day 56, Day 70, Day 84, Day 112 and Day 140) vital signs,(Day-14, Day 1, Day 28, Day 56, Day 84, day 112 and Day 140) electrocardiograms (ECGs) (Day -14, Day 3)and clinical laboratory values (Day -14, Day1, Day 3, Day 7, Day 28, Day 56, Day 70, Day 84, Day 112 and Day 140)
    E.5.2.1Timepoint(s) of evaluation of this end point
    Day1, Day 3, Day 7, Day 28, Day 56, Day 70, Day 84, Day 112 and Day 140.
    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 No
    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.7.1.3.1Other 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 No
    E.8.1.1Randomised No
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    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 No
    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 concerned2
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA10
    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
    Last subject last visit
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years0
    E.8.9.1In the Member State concerned months11
    E.8.9.1In the Member State concerned days12
    E.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months11
    E.8.9.2In all countries concerned by the trial days12
    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: 58
    F.1.3Elderly (>=65 years) No
    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 state15
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 58
    F.4.2.2In the whole clinical trial 65
    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 not receive any additional treatment after completion of the study because other treatment options are available. Treatment after study completion will be at the discretion of the investigator.
    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 Decision2010-12-13
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2010-11-11
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2012-03-07
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