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    Summary
    EudraCT Number:2014-000314-54
    Sponsor's Protocol Code Number:201312
    National Competent Authority:Czechia - SUKL
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2014-05-14
    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 ConcernedCzechia - SUKL
    A.2EudraCT number2014-000314-54
    A.3Full title of the trial
    Study 201312: A Multi-Centre, Open-Label, Study of Mepolizumab in a Subset of Subjects with a History of Life Threatening/Seriously Debilitating Asthma Who Participated in the MEA115661 Trial
    Multicentrické, otevřené klinické hodnocení mepolizumabu u podskupiny pacientů s anamnézou život ohrožujícího/těžce invalidizujícího astmatu, kteří se účastnili klinického hodnocení MEA115661
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    An Extension Study to MEA115661 for subjects who benefited from mepolizumab treatment
    A.4.1Sponsor's protocol code number201312
    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 supportGlaxoSmithKline Research & Development Ltd
    B.4.2CountryUnited Kingdom
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationGlaxoSmithKline Research & Development Ltd
    B.5.2Functional name of contact pointClinical Trials Helpdesk
    B.5.3 Address:
    B.5.3.1Street AddressIron Bridge Road, Stockley Park West
    B.5.3.2Town/ cityUxbridge, Middlesex
    B.5.3.3Post codeUB11 1BU
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number+442089904466
    B.5.5Fax number+442089901234
    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
    D.3.2Product code SB-240563
    D.3.4Pharmaceutical form Lyophilisate for 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 INNMEPOLIZUMAB
    D.3.9.1CAS number 196078-29-2
    D.3.9.2Current sponsor codeSB240563
    D.3.9.3Other descriptive nameMEPOLIZUMAB
    D.3.9.4EV Substance CodeSUB21650
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    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 Yes
    D.3.11.13.1Other medicinal product typeMepolizumab (SB-240563) is a fully humanised IgG antibody (IgG1, kappa) with human heavy and light chain frameworks.
    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
    Subjects with Severe Asthma
    E.1.1.1Medical condition in easily understood language
    Severe 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 18.0
    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 provide extended treatment with mepolizumab to subjects with a history of lifethreatening or seriously debilitating asthma and a history of improved disease control while receiving mepolizumab as defined by this protocol
    E.2.2Secondary objectives of the trial
    ● To further describe the long-term clinical experience of mepolizumab in a subset of subjects who demonstrated significant clinical benefit since receiving mepolizumab
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Subjects eligible for enrolment in the study must additionally meet all of the following criteria:
    1. Informed Consent: Prior to commencing any study related activities, subjects must be able and willing to provide written informed consent.
    2. Male or Eligible Female Subjects:
    To be eligible for the study, females of child-bearing potential must commit to
    consistent and correct use of an acceptable method of birth control and for 4 months after the last study drug administration. Methods of acceptable birth control and the definitions for child-bearing and non-child bearing potential are provided in Appendix 1 of study protocol. A urine pregnancy test is required of all females of childbearing potential at the initial Baseline Visit (Visit 1).
    3. French Subjects Only: In France, a subject will be eligible for inclusion in this
    study only if either affiliated to or a beneficiary of a social security category.
    4. MEA115661 Participation: Subjects must have completed Visit 14 of MEA115661.
    5. Current Anti-Asthma Therapy: The subject’s asthma has been treated with an ICS controller medication for the last 8 months with fluticasone propionate (FP) ≥500 mcg/day (or equivalent).
    6. Disease Severity: Subjects must be assessed as having life-threatening /serious
    debilitating asthma in order to enroll, as defined by the following:
    Subjects enrolled in MEA115588 must meet one of the following criteria:
    a) Subject has a history of at least one intubation during their lifetime
    b) ≥3 asthma exacerbations in the 12 months prior to screening for MEA115588
    c) ≥1 or more hospitalization for asthma exacerbation in the 12 months prior to
    screening for MEA115588.
    Subjects enrolled in MEA115575 must meet one of the following criteria:
    d) Subject has a history of at least one intubation during their lifetime
    e) Their optimized dose at randomization in MEA115575 was ≥10mg of prednisone
    f) ≥1 or more hospitalization for asthma exacerbation in the 12 months prior to screening for MEA115575 Those subjects that do not meet the definition of potentially life threatening asthma must be assessed as having serious debilitating asthma. Subjects enrolled in MEA115588 or MEA115575 must meet the following criteria: At randomisation of MEA115588 or MEA115575 must have: g) A % predicted FEV1 of ≤50% and either h) ACQ5 score of ≥3 or i) SGRQ score of ≥60 7. Clinical Benefit: Subjects must have experienced documented clinical benefit to enroll. Subjects must meet the following criteria demonstrating clinical benefit: Subjects enrolled in MEA115588 who received mepolizumab must meet all of the following criteria: a)Subject must have had a reduction in their exacerbation frequency by ≥50% during MEA115588. The baseline for comparison is the total number of exacerbations reported in the 12 months prior to screening for MEA115588. b) The investigator confirms that the subject demonstrated improvement during MEA115588. Subjects enrolled in MEA115588 who received placebo must meet all of the following criteria: c) Subject must have had a reduction in their exacerbation frequency by ≥50% during the first 8 months of MEA115661. The baseline for comparison is the total number of exacerbations reported in the 12 months prior to screening for MEA115588. d) The investigator confirms that the subject demonstrated improvement during MEA115661 Subjects enrolled in MEA115575 who received mepolizumab must meet all of the following criteria: e) Subject must have reduced their oral corticosteroid dose by ≥ 50% during MEA115575. The baseline for comparison is the subject’s optimized OCS dose at randomization in MEA115575 f) The investigator confirms that the subject demonstrated improvement during MEA115575. Subjects enrolled in MEA115575 who received placebo must meet all of the following criteria: g) Subject must have reduced their oral corticosteroid dose at randomization by ≥50% in the first 6 months of MEA115661. The baseline for comparison is the subject’s optimized OCS dose at randomization in MEA115575. h) The investigator confirms that the subject demonstrated improvement during MEA115661 8. Subjects at Significant Safety Risk: If either criteria 6 or 7 are not met, subjects who are considered to be at risk of experiencing a life-threatening event, or whose functional health status will become significantly worse if returned to standard of care, as judged by the investigator and agreed by GSK
    E.4Principal exclusion criteria
    Subjects meeting any of the following criteria must not be enrolled in the study:
    1. Health Status: Clinically significant change in health status during MEA115661
    which in the opinion of the investigator would make the subject unsuitable for
    participation in this long-term study.
    2. Pregnancy: Subjects who are pregnant or breastfeeding. Subjects should not be
    enrolled if they plan to become pregnant during the time of study participation.
    3. Exacerbation History: Subjects who received placebo in MEA115588 and had NO
    exacerbations during the study.
    4. Oral Corticosteroid Use: Subjects who received placebo in MEA115575 and were
    able to discontinue oral corticosteroid therapy by the end of the study.
    5. Smoking Status: Current smokers
    6.Previous Significant Protocol Deviation: Subjects who were excluded from the per protocol analysis due to a significant protocol deviation in either study MEA115575 or MEA115588 which is deemed by the GSK Medical Monitor to put the subject at risk from further participation. 7. ECG Assessment: A clinically significant ECG abnormality as determined by the investigator.
    E.5 End points
    E.5.1Primary end point(s)
    ● Annualized rate of exacerbations
    ● Frequency of adverse events
    E.5.1.1Timepoint(s) of evaluation of this end point
    Interim analysis will be performed as needed in order to provide open-label safety data to inform the risk-benefit assessment of mepolizumab in severe asthma
    E.5.2Secondary end point(s)
    ● Asthma Control Questionnaire-5 score
    ● Forced expiratory volume in 1 second (FEV1)
    ● Number of withdrawals due to lack of efficacy
    ● Number of withdrawals due to adverse events
    ● Number of hospitalizations due to adverse events including asthma exacerbations
    ● Frequency of both systemic (i.e., allergic and non-allergic) and local site reactions
    ● 12-lead ECG parameters
    ● Vital signs
    ● Frequency of positive anti-mepolizumab binding antibodies/neutralizing antibodies
    ● Clinical Laboratory Parameters
    E.5.2.1Timepoint(s) of evaluation of this end point
    Interim analysis will be performed as needed in order to provide open-label safety data to inform the risk-benefit assessment of mepolizumab in severe asthma
    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 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) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    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 Yes
    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.8.2.4Number of treatment arms in the trial1
    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 EEA54
    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
    Australia
    Belgium
    Canada
    Chile
    Czech Republic
    France
    Germany
    Italy
    Japan
    Korea, Republic of
    Netherlands
    Poland
    Russian Federation
    Spain
    Ukraine
    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
    LVLS
    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 Yes
    F.1.1Number of subjects for this age range: 9
    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) Yes
    F.1.1.6.1Number of subjects for this age range: 9
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 302
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 64
    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 state13
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 183
    F.4.2.2In the whole clinical trial 375
    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)
    The investigator is responsible for ensuring that consideration has been given to the poststudy care of the patient’s medical condition whether or not GSK is providing specific post study treatment.
    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 Decision2014-07-08
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-07-24
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2017-10-05
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