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    Summary
    EudraCT Number:2014-002666-76
    Sponsor's Protocol Code Number:200363PARTA
    Clinical Trial Type:Outside EU/EEA
    Date on which this record was first entered in the EudraCT database:2018-08-16
    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
    H.4 THIRD COUNTRY IN WHICH THE TRIAL WAS FIRST AUTHORISED
    Expand All   Collapse All
    A. Protocol Information
    A.2EudraCT number2014-002666-76
    A.3Full title of the trial
    An open-label study to characterize the pharmacokinetics and pharmacodynamics of mepolizumab administered subcutaneously in children from 6 to 11 years of age with severe eosinophilic asthma (PART A)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study of mepolizumab in children from 6 to 11 years of age with severe asthma (PART A)
    A.3.2Name or abbreviated title of the trial where available
    Mepolizumab Pediatric Safety Study
    A.4.1Sponsor's protocol code number200363PARTA
    A.7Trial is part of a Paediatric Investigation Plan Yes
    A.8EMA Decision number of Paediatric Investigation PlanP/234/2014
    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
    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 pointGSK Clinical Support Help Desk
    B.5.3 Address:
    B.5.3.1Street Address1-3 Iron Bridge Road, Stockley Park West
    B.5.3.2Town/ cityUxbridge, Middlesex
    B.5.3.3Post codeUB11 1BT
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number+44 0800 783 9733
    B.5.5Fax numberNot Applicable
    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 Yes
    D.2.1.1.1Trade name Nucala
    D.2.1.1.2Name of the Marketing Authorisation holderGSK Trading Services Ltd
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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 PRD907320
    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 codeSB-240563
    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
    Severe Eosinophilic Asthma
    E.1.1.1Medical condition in easily understood language
    Severe Eosinophilic 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 20.0
    E.1.2Level LLT
    E.1.2Classification code 10068462
    E.1.2Term Eosinophilic asthma
    E.1.2System Organ Class 100000004855
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Pharmacokinetic/Pharmacodynamic Phase (Part A)

    - To characterize the pharmacokinetics of mepolizumab administered subcutaneously to subjects aged 6 to 11 years old with severe eosinophilic asthma.

    - To characterize the pharmacodynamics of mepolizumab administered subcutaneously to subjects aged 6 to 11 years old with severe eosinophilic asthma.
    E.2.2Secondary objectives of the trial
    Pharmacokinetic/Pharmacodynamic Phase (Part A)

    - To compare the bodyweight-adjusted clearance between adults and subjects aged 6 to 11 years old with severe eosinophilic asthma when mepolizumab is administered subcutaneously

    - To characterize asthma control following subcutaneous administration of mepolizumab to subjects aged 6 to 11 years old with severe eosinophilic asthma

    - To assess the safety and tolerability of mepolizumab when administered subcutaneously to subjects aged 6 to 11 years old with severe eosinophilic asthma.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Inclusion Criteria for Part A
    [1] AGE
    1. Between 6 and 11 years of age inclusive, at the time of screening.

    [2] TYPE OF SUBJECT AND DIAGNOSIS INCLUDING DISEASE SEVERITY
    2. Diagnosis of severe asthma, defined by the regional asthma guidelines (i.e., NIH, GINA, etc.), for at least 12 months prior to Visit 1. If the subject is naïve to the study site, the subject/guardian must self-report a physician diagnosis of asthma and the investigator must confirm by review of medical history with the subject/guardian.

    3. Eosinophilic airway inflammation that is related to asthma characterized as eosinophilic in nature as indicated by:

    - elevated peripheral blood eosinophil count of ≥300 cells/μL demonstrated in the past 12 months OR

    - elevated peripheral blood eosinophil count of ≥150 cells/μL at visit 1.

    4. A well-documented requirement for regular treatment with inhaled corticosteroid (>200 μg/day fluticasone propionate (DPI) or equivalent daily) with or without maintenance oral corticosteroids (OCS). The ICS dose should represent medium or high dose in children aged 6-11 years of age [GINA, 2015].

    5. Current treatment with an additional controller medication for at least 3 months or a documented failure in the past 12 months of an additional controller medication for at least 3 successive months. [e.g., long-acting beta-2-agonist (LABA), leukotriene receptor antagonist (LTRA), or theophylline.]

    6. FEV1: Persistent airflow obstruction at either visit 1 or Visit 2 (FEV1 performed prior to first dose of study medication) as indicated by:

    - A pre-bronchodilator FEV1 <110% predicted (Quanjer, 2012) OR

    - FEV1:FVC ratio < 0.8 recorded at visit 1

    7. Previously confirmed history of two or more exacerbations requiring treatment with systemic CS (intramuscular (IM), intravenous, or oral), in the 12 months prior to visit 1, despite the use of inhaled corticosteroids (ICS). For subjects receiving maintenance OCS, treatment for the exacerbations must have been a two-fold increase or greater in the CS dose.

    8. No changes in the dose or regimen of baseline ICS and/or additional controller medication during the run-in period.

    9. Male or female: Females of childbearing potential must commit to consistent and correct use of an acceptable method of contraception (refer Appendix 7 in the protocol) for the duration of the trial and for 4 months after the last dose of investigational product. A urine pregnancy test is required of girls of childbearing potential. This test will be performed at the initial screening visit (Visit 1) and will be performed at each scheduled study visit prior to the administration of investigational product, and during the Exit Visit, Early Withdrawal and Follow-up Visits.

    10. Parent(s)/guardian able to give written informed consent prior to participation in the study, which will include the ability to comply with the requirements and restrictions listed in the consent form. If applicable, the subject must be able and willing to give assent to take part in the study according to the local requirement.
    E.4Principal exclusion criteria
    Exclusion Criteria for Part A
    1. Subjects with any history of life threatening asthma (e.g. requiring intubation), immunosuppressive medications intake or immunodeficiency disorder

    2. Subjects with any medical condition or circumstance making the volunteer unsuitable for participation in the study.

    3. Significant abnormality of rate, interval, conduction or rhythm in the 12-lead ECG, determined by the investigator in conjunction with the age and gender of the child at Visit 1.

    4. ALT, and bilirubin > 2xULN (isolated bilirubin >1.5xULN is acceptable if bilirubin is fractionated and direct bilirubin <35%) at Visit 1.

    5. Positive Hepatitis B Surface Antigen or positive Hepatitis C antibody at Visit 1

    6. Parent/guardian has a history of psychiatric disease, intellectual deficiency, substance abuse, or other condition (e.g. inability to read, comprehend and write) which will limit the validity of consent to participate in this study.

    7. Unwillingness or inability of the subject or parent/guardian to follow the procedures outlined in the protocol.

    8. Subject who is mentally or legally incapacitated.

    9. Children who are wards of the state or government.

    10. A subject will not be eligible for this study if he/she is an immediate family member of the participating investigator, sub-investigator, study coordinator, or employee of the participating investigator.

    11. Xolair: Subjects who have received omalizumab [Xolair] within 130 days of Visit 1.

    12. Other Biologics: Subjects who have received any biological (other than Xolair) to treat inflammatory disease within 5 half-lives of visit 1.

    13. History of sensitivity to any of the study medications, or components thereof or a history of drug or other allergy that, in the opinion of the investigator or Medical Monitor, contraindicates their participation.

    14. Hypersensitivity: Subjects with allergy/intolerance to a monoclonal antibody or biologic.

    15. The subject has participated in a clinical trial and has received an investigational product within the following time period prior to the first dosing day in the current study: 30 days, 5 half-lives or twice the duration of the biological effect of the investigational product (whichever is longer).

    E.5 End points
    E.5.1Primary end point(s)
    Pharmacokinetic/Pharmacodynamic Phase (Part A)

    1. Population-PK model derived estimates of clearance, area under the plasma-concentration time curve (AUC(0-inf), maximum plasma concentration (Cmax), and terminal phase elimination half-life (t1/2) of mepolizumab

    2. Change from baseline in blood eosinophil count at week 12
    E.5.1.1Timepoint(s) of evaluation of this end point
    1. At week 4, 8, 9, 12, 16, 20 and if applicable at the Early Withdrawal visit

    2. At week 12
    E.5.2Secondary end point(s)
    Pharmacokinetic/Pharmacodynamic Phase (Part A)

    1. Bodyweight-adjusted clearance estimates obtained by population PK methods.

    2. Change from Baseline in ACQ-7 measured at week 12

    3. Change from Baseline in ACQ-7 measured at week 4,8,16 and 20

    4. Incidence of Adverse Events

    5. Incidence of clinically significant changes in clinical laboratory parameters

    6. Frequency of positive antimepolizumab binding antibodies and neutralizing antibodies

    7. Incidence of clinically significant changes in vital sign measurements

    8. Change from Baseline in C-ACT measured at week 12

    9. Change from Baseline in C-ACT measured at week 4,8, 16 and 20
    E.5.2.1Timepoint(s) of evaluation of this end point
    1. At week 4, 8, 9, 12, 16, 20 and if applicable at the Early Withdrawal visit

    2. At week 12

    3. At week 4,8,16 and 20

    4. Throughout the study
    5.
    - Clinical chemistry will be at weeks 4, 8, 12 and 20 and if applicable at the Early Withdrawal visit
    - Haematology will be at weeks 0, 4, 8, 9, 12, 16 and 20 and if applicable at the Early Withdrawal visit

    6. Prior to dosing at week 0, and at weeks 16, 20 and EW

    7. Weeks 0, 4, 8, 9, 12, 16, 20 and early withdrawal (if applicable)

    8. Week 12

    9. Week 4,8, 16 and 20

    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 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 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 trial2
    E.8.3 Will this trial be conducted at a single site globally? No
    E.8.4 Will this trial be conducted at multiple sites globally? Yes
    E.8.6 Trial involving sites outside the EEA
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3Specify the countries outside of the EEA in which trial sites are planned
    Japan
    Poland
    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
    Last subject last visit
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months3
    E.8.9.2In all countries concerned by the trial days14
    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: 36
    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) Yes
    F.1.1.5.1Number of subjects for this age range: 36
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) No
    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 Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    Subjects under age incapable of giving consent personally.
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.2 For a multinational trial
    F.4.2.2In the whole clinical trial 36
    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)
    At the end of Part A, a benefit/risk assessment will be performed by the Investigator and if this assessment supports continued therapy with mepolizumab , the subject will be offered the opportunity to enrol in Part B following the Part A Follow-up visit (Visit 8).
    G. Investigator Networks to be involved in the Trial
    H.4 Third Country in which the Trial was first authorised
    H.4.1Third Country in which the trial was first authorised: United States
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