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    Summary
    EudraCT Number:2018-003924-35
    Sponsor's Protocol Code Number:0690
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:GB - no longer in EU/EEA
    Date on which this record was first entered in the EudraCT database:2019-09-06
    Trial 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 number2018-003924-35
    A.3Full title of the trial
    A Randomised Controlled Trial of Mepolizumab Initiated During Admission to Hospital for a Severe Exacerbation of Eosinophilic COPD
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Mepolizumab for COPD Hospital Eosinophilic admissions Pragmatic trial (COPD-HELP)
    A.3.2Name or abbreviated title of the trial where available
    Mepolizumab for COPD Hospital Eosinophilic admissions Pragmatic trial1
    A.4.1Sponsor's protocol code number0690
    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 SponsorUniversity of Leicester
    B.1.3.4CountryUnited Kingdom
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    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 organisationUniversity of Leicester
    B.5.2Functional name of contact pointEleanor Taylor
    B.5.3 Address:
    B.5.3.1Street AddressLeicester Clinical Trials Unit, University of Leicester
    B.5.3.2Town/ cityLeicester
    B.5.3.3Post codeLE1 7RH
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number01162297247
    B.5.6E-mailmepo@leicester.ac.uk
    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 Mepolizumab
    D.2.1.1.2Name of the Marketing Authorisation holderGlaxoSmithKline Trading Services Limited
    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 N/A
    D.3.4Pharmaceutical form Powder 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 code0690
    D.3.9.3Other descriptive namen/a
    D.3.9.4EV Substance CodeAS1
    D.3.10 Strength
    D.3.10.1Concentration unit mg/g milligram(s)/gram
    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 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 (IgG1, kappa)
    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
    Eosinophilic Chronic Obstructive Pulmonary Disease (COPD)
    E.1.1.1Medical condition in easily understood language
    COPD is a disease that causes breathlessness and flare-ups due to damage to the lungs from toxic substances. It includes emphysema and chronic bronchitis.
    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 21.1
    E.1.2Level LLT
    E.1.2Classification code 10010952
    E.1.2Term COPD
    E.1.2System Organ Class 100000004855
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level LLT
    E.1.2Classification code 10010953
    E.1.2Term COPD exacerbation
    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
    The primary objective is to evaluate the efficacy of mepolizumab initiated during hospitalisation on future hospital readmission or death (all cause) compared with placebo in severe exacerbations of eosinophilic COPD.
    E.2.2Secondary objectives of the trial
    To assess the effects of mepolizumab on health status, well-being, exercise capacity, frailty, moderate exacerbations, healthcare usage and death compared with placebo in patients admitted to hospital with an eosinophilic exacerbation of COPD.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Symptoms typical of COPD when stable (baseline eMRC dyspnoea grade 2 or more).
    2. A clinician defined exacerbation of COPD requiring admission to hospital.
    3. Serum eosinophil count of ≥ 300 cells/microlitre either at time of admission or at any one time in the preceding 12 months.
    4. Smoking pack years > 10 years.
    5. Age ≥ 40 years.
    6. Established on inhaled corticosteroids (ICS) prior to this admission.
    7. Willing and able to consent to participate in trial.
    8. Able to understand written and spoken English.
    E.4Principal exclusion criteria
    1. COPD patients without eosinophilia (defined as persistently < 300 cells/microlitre within the last 12 months).
    2. Other conditions that may be the cause of eosinophilia (such as hypereosinophilic syndrome, eosinophilic granulomatosis, eosinophilic oesophagitis or parasitic infection).
    3. Patients whose treatment is considered palliative (life expectancy < 6 months).
    4. Other respiratory conditions including active lung cancer, interstitial lung disease, primary pulmonary hypertension or any other conditions that in the view of the investigator will affect the trial.
    5. Known history of anaphylaxis or hypersensitivity to mepolizumab or any of the excipients (sucrose, sodium phosphate dibasic heptahydrate, polysorbate 80).
    6. Unstable or life-threatening cardiac disease including myocardial infarction or unstable angina in the last 6 months, unstable or life-threatening cardiac arrhythmia requiring intervention in the last 3 months and New York Heart Association (NYHA) Class IV heart failure.
    7. Decompensated liver disease or cirrhosis.
    8. Pregnant, breastfeeding, or lactating women. Women of child-bearing potential must agree to use appropriate methods of birth control and have a negative blood serum pregnancy test performed after randomisation but prior to dosing with randomised treatment.*
    9. Participation in an interventional clinical trial within 3 months of visit 1 or receipt of any investigational medicinal product within 3 months or 5 half-lives.
    10. Known blood born infection (e.g. HIV, hepatitis B or C).

    * Women of child bearing potential (WOCBP) – A woman is defined as being of childbearing potential (WOCBP), i.e. fertile, following menarche and until becoming post-menopausal, unless permanently sterile. Permanent sterilisation methods include hysterectomy, bilateral salpingectomy and bilateral oophorectomy. A postmenopausal state is defined as no menses for 12 months without an alternative medical cause.
    E.5 End points
    E.5.1Primary end point(s)
    The primary outcome is the time from randomisation to next hospital readmission or death (all cause).
    E.5.1.1Timepoint(s) of evaluation of this end point
    Time to event between first dose and first event, up to 48 weeks.
    E.5.2Secondary end point(s)
    Exacerbations and Healthcare Utilisation
    • Time from starting trial treatment to next hospital readmission or death due to a respiratory cause
    • Total number of hospital readmissions all cause over 48 weeks
    • Total number of moderate exacerbations over 48 weeks
    • Time from starting trial treatment to treatment failure (defined as the composite of three endpoints: 1. treatment intensification with systemic corticosteroids and/or antibiotics for respiratory reasons; 2. step-up in hospital care for respiratory reasons including transfer to the intensive care unit or readmission; or 3. all-cause mortality)
    • Time from starting trial treatment to next hospital readmission (all cause)
    • Time from starting trial treatment to next hospital readmission (respiratory cause)

    Quality of Life/Symptoms
    • Breathlessness:
    Extended MRC dyspnoea score (eMRC)
    • Health Status
    St George’s Respiratory Questionnaire (SGRQ)
    COPD Assessment Tool (CAT)
    • Mental wellbeing
    Warwick-Edinburgh Mental wellbeing score (WEMWBS)
    • Functional
    London Chest Activities of Daily Living Questionnaire (LCADL)

    Physiological Measures
    • Lung Function (post-bronchodilator)
    Forced Expiratory Volume in 1 second (FEV1)
    Forced Vital Capacity (FVC)
    Oscillometry
    • Frailty
    Short physical performance battery (SPPB)
    Physical activity (accelerometry)
    Handgrip Strength

    Inflammatory Markers
    • Serum eosinophil count (total count)
    • Sputum eosinophil count (percentage)

    Safety and Tolerability
    • Adverse Events (AEs)
    • Serious Adverse Events (SAEs)
    • Clinical assessments and investigations (heart rate, blood pressure, temperature)
    E.5.2.1Timepoint(s) of evaluation of this end point
    Exacerbations and Healthcare Utilisation will be measured as Time to Event between first dose and first event, up to 48 weeks.

    Quality of Life/Symptoms will be collected at Weeks 0,4,8,12,24,36,48

    Physiological Measures will be collected at Weeks 0,4,8,12,24,36,48

    Inflammatory Markers will be collected at Weeks 0,4,8,12,24,36,48

    Safety and Tolerability will be collected between first dose and first event, up to 48 weeks
    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 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) 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.8.2.4Number of treatment arms in the trial2
    E.8.3 The trial involves single site in the Member State concerned Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    E.8.4.1Number of sites anticipated in Member State concerned1
    E.8.5The trial involves multiple Member States No
    E.8.5.1Number of sites anticipated in the EEA1
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.7Trial has a data monitoring committee Yes
    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
    Database lock following last patient last visit.

    Data reported in the final report to REC and MHRA within 12 months of the End of Trial will include the primary and secondary outcomes.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months4
    E.8.9.1In the Member State concerned days28
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months4
    E.8.9.2In all countries concerned by the trial days28
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1Number of subjects for this age range: 0
    F.1.1.1In Utero No
    F.1.1.1.1Number of subjects for this age range: 0
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.2.1Number of subjects for this age range: 0
    F.1.1.3Newborns (0-27 days) No
    F.1.1.3.1Number of subjects for this age range: 0
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.4.1Number of subjects for this age range: 0
    F.1.1.5Children (2-11years) No
    F.1.1.5.1Number of subjects for this age range: 0
    F.1.1.6Adolescents (12-17 years) No
    F.1.1.6.1Number of subjects for this age range: 0
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 24
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 214
    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 No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    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 state238
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 238
    F.4.2.2In the whole clinical trial 238
    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)
    There is no provision for continued treatment with this trial drug once the trial has finished as it is not licensed for use in this patient population within the UK.
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2019-10-25
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-11-18
    P. End of Trial
    P.End of Trial StatusGB - no longer in EU/EEA
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