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    Summary
    EudraCT Number:2005-006074-10
    Sponsor's Protocol Code Number:MEE103219
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2006-02-07
    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 ConcernedUK - MHRA
    A.2EudraCT number2005-006074-10
    A.3Full title of the trial
    A randomized, double-blind, parallel group clinical trial to assess safety, tolerability, pharmacokinetics, and pharmacodynamics of intravenous mepolizumab (SB240563) (0.55mg/kg, 2.5mg/kg or 10mg/kg) in pediatric subjects with eosinophilic esophagitis, aged 2 to 17 years
    A.3.2Name or abbreviated title of the trial where available
    Mepolizumab in paediatric eosinophilic oesophagitis
    A.4.1Sponsor's protocol code numberMEE103219
    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 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 support
    B.4.2Country
    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 Information not present in EudraCT
    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 Powder for solution for injection
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNMepolizumab
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number250
    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.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 Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee 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 Information not present in EudraCT
    D.3.11.8Extractive medicinal product Information not present in EudraCT
    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.3.11.13.1Other medicinal product typeRecombinant humanised monoclonal antibody specific for human IL-5
    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
    Eosinophilic oesophagitis
    MedDRA Classification
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To investigate in paediatric subjects with eosinophilic oesophagitis
    1. safety and tolerability of iv mepolizumab (0.55mg/kg, 2.5mg/kg or 10mg/kg),
    2. pharmacokinetics of iv mepolizumab (0.55mg/kg, 2.5mg/kg or 10mg/kg),
    3. the capacity of iv mepolizumab (0.55mg/kg, 2.5mg/kg or 10mg/kg) to reduce oesophageal eosinophil counts to within normal limits (highest count of eosinophils per HPF of all oesophageal sites biopsied to lower than 5 cells per HPF at X400 magnification)
    E.2.2Secondary objectives of the trial
    1. To obtain dose-response information for design of subsequent studies.
    2. To explore the relationship between dose and clinical response:
    • Frequency and severity of the cardinal symptoms at Week 12 and Week 24:
    a. oeosinophilic esophagitis-related pain,
    b. regurgitation,
    c. vomiting
    d. swallowing disorders,
    e. feeding difficulties,
    • Time to relapse in subjects who responded at Week 12 as defined by histopathology confirmation with peak eosinophil count (highest count of eosinophils per HPF of all esophageal sites biopsied) of 20 or more eosinophils per HPF at 400 X magnification in esophageal biopsy specimens.
    3. To investigate the relationship between pharmacodynamic parameters (e.g. counts of circulating eosinophils, histopathology parameters) and pharmacokinetics.

    E.2.3Trial contains a sub-study Information not present in EudraCT
    E.3Principal inclusion criteria
    1. The subject signs a written assent form and the parent/guardian signs a written informed consent form prior to the initiation of any study-related activities.
    2. Male or female subjects aged 2 to 17 years who speak, read and write English as age appropriate and/or parent guardian
    3. To be eligible for entry in the treatment group of the study, a female must be
    a. Not pregnant or nursing
    b. Of non-childbearing potential ie a pre-menarcheal female who has not yet entered puberty as evidenced by lack of breast development or who has had a hysterectomy and/or bilateral oophorectomy.
    c. If of childbearing potential, subjects must have a negative urine pregnancy test at the screening visit, and agree to use of an acceptable method of contraception from at least the commencement of their last period prior to the first dose of study medication and to continue until the first period after treatment or after the Week 24 Follow-up visit, whichever is longest
    4. The subject has isolated eosinophilic oesophagitis defined as:
    • Peak esophageal eosinophil counts (highest count of eosinophils per HPF in at least one of all esophageal sites biopsied) of 20 or more eosinophils in a minimum of one HPF at 400X magnification on histology of oesophageal biopsies from distal and mid-oesophagus within 2 weeks of commencing study medication.
    and
    • Inadequate response to or intolerant of therapy for eosinophilic oesophagitis
    E.4Principal exclusion criteria
    1. Current evidence of eosinophilic gastrointestinal enteropathy (EGID), other than eosinophilic oesophagitis
    2. Current, or suspected evidence of gastroesophageal reflux disease, or other causes of oesophagitis.
    3. Current evidence, or history of (anytime in the past):
    a. hypereosinophilic syndromes,
    b. allergic gastroenteritis,
    c. bacterial infections*,
    d. parasitic infestations*,
    e. collagen vascular disease,
    f. vasculitis,
    g. allergic drug reaction,
    h. graft-versus host disease.
    i. chronic idiopathic inflammatory bowel disorders (ulcerative colitis, Crohn's disease, chronic granulomatous disease)
    *If the subject has a past history of bacterial or parasite infection/infestation, the investigator must ensure that the bacterial or parasite infaction/infestation was adequately treated and/or that there is no current bacterial or parasite infection/infestation.
    4. Current evidence, or history of celiac disease
    5. Current evidence of active H. pylori infection.
    6. Abnormal 12-lead ECG at Screening which is clinically significant. Note that this exclusion criteria does not apply for subject who are considered for enrolment in the observational cohort
    7. Use or administration of any of the prohibited medications listed in Section 9.2 of the protocol from Screening and throughout completion of Week 34 follow-up assessments or immunisation from 6 weeks prior to Screening through the Week 24 visit. Note that this exclusion criteria does not apply for subject who are considered for enrolment in the observational cohort
    8. Failure to remain on a stable dose of one (or more) permitted medication(s) for at least 1 month prior to the Screening visit and throughout completion of Week 34 follow-up assessments. Note that this exclusion criteria does not apply for subject who are considered for enrolment in the observational cohort
    9. Failure to remain on stable elemental diet or dietary manipulations for at least 3 months prior to the Screening Visit and throughout completion of Week 34 follow-up assessments. Note that this exclusion criteria does not apply for subject who are considered for enrolment in the observational cohort
    10. Known history of allergic reaction to previous antibody therapy.
    11. Any previous treatment with anti-hIL-5, anti-IgE monoclonal antibody or other biological agents.
    12. Use of an investigational drug within 30 days of entering the study. Note that this exclusion criteria does not apply for subject who are considered for enrolment in the observational cohort
    13. Evidence of renal disease or serum creatinine > 1.5 times upper limit of normal range (ULN). Note that this exclusion criteria does not apply for subject who are considered for enrolment in the observational cohort
    14. Evidence of hepatic disease, impairment or abnormal liver function test i.e. AST, ALT >1.5 times ULN , bilirubin >1.5 times ULN. Note that this exclusion criteria does not apply for subject who are considered for enrolment in the observational cohort
    15. Current evidence of HIV, Hepatitis B or C infection.
    16. History or suspicion of current drug abuse and alcohol abuse within the last 6 months.
    E.5 End points
    E.5.1Primary end point(s)
    1. Safety and tolerability endpoints will be assessed separately for the treatment (up to Week 12) and the follow-up phase Week 13-24)
    • Adverse Events: frequency, severity and relationship to study medication
    • Changes in laboratory values (including biochemistry, hematology including eosinophil counts (absolute values and percentage of total white blood cells), and urinalysis
    • Changes in vital signs
    • Changes in 12-lead ECG.
    • Levels of anti-mepolizumab antibodies
    2. Pharmacokinetics endpoints
    • Pharmacokinetic parameters such as V and CL of mepolizumab will be obtained.
    3. Histopathology primary endpoint
    • Proportion of subjects who achieve a reduction in peak eosinophil counts (highest count of eosinophils per HPF in all esophageal sites biopsied) to lower than 5 eosinophils per HPF at 400X magnification, in esophageal biopsy specimens taken at Week 12.
    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 Yes
    E.6.10Pharmacogenetic Information not present in EudraCT
    E.6.11Pharmacogenomic Yes
    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 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 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.8.5The trial involves multiple Member States No
    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 Information not present in EudraCT
    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 months8
    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 months8
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 Yes
    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.1.1.6Adolescents (12-17 years) Yes
    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 Information not present in EudraCT
    F.3.3.1Women of childbearing potential not using contraception For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2006-02-07. Yes
    F.3.3.2Women of child-bearing potential using contraception Information not present in EudraCT
    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
    Minors
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state10
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 10
    F.4.2.2In the whole clinical trial 72
    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)
    Not different from the expected normal treatment of that condition.
    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 Decision2006-03-07
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2006-06-15
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2008-11-25
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