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    Summary
    EudraCT Number:2016-004255-70
    Sponsor's Protocol Code Number:205687
    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:2017-03-31
    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 number2016-004255-70
    A.3Full title of the trial
    A randomised, double-blind, parallel group PhIII study to assess the clinical efficacy and safety of 100 mg SC Mepolizumab as an add on to maintenance treatment in adults with severe bilateral nasal polyps
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Effect of Mepolizumab in severe bilateral nasal polyps
    A.4.1Sponsor's protocol code number205687
    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 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+4408007839733
    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 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 Solution for injection in pre-filled syringe
    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/ml milligram(s)/millilitre
    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 No
    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 in pre-filled syringe
    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
    Treatment of nasal polyposis
    E.1.1.1Medical condition in easily understood language
    severe bilateral nasal polyps
    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 PT
    E.1.2Classification code 10028756
    E.1.2Term Nasal polyps
    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 evaluate the efficacy of 100 mg mepolizumab compared to placebo
    E.2.2Secondary objectives of the trial
    - To evaluate the impact on actual nasal surgery of 100mg mepolizumab compared to placebo

    - To further evaluate the efficacy of 100mg mepolizumab compared to placebo

    - To evaluate the impact on quality of life of 100mg mepolizumab
    compared to placebo



    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Participants are eligible to be included in the study only if all of the following criteria apply:

    AGE
    1. 18 years of age and older inclusive, at the time of signing the informed consent.

    WEIGHT
    2. Body weight greater or equal to 40kg.

    Gender
    3. Male or female participants (with appropriate contraceptive methods) to be eligible for entry into the study;
    To be eligible for entry into the study Woman of Childbearing Potential (WOCBP; see Appendix 5 for definition) must commit to consistent and correct use of an acceptable method of birth control from the time of consent, for the duration of the trial, and for 105
    Days after last study drug administration. See Appendix 5 for a listing of acceptable methods of birth control.

    Previous polyps surgery
    4. Participants who have had at least one previous surgery in the previous 10 years for the removal of NP. NP Surgery is defined as any procedure involving instruments with resulting incision (cutting open) and removal of polyp tissue from the nasal cavity (polypectomy). For the purpose of inclusion into this study any procedure involving instrumentation in the nasal cavity resulting in dilatation of the nasal
    passage such as balloon sinuplasty, insertion of coated stents or direct injection of steroids or other medication without any removal of NP tissue is not accepted.

    Current polyps diagnosis medication and need for surgery
    5. Participants with bilateral NP as diagnosed by endoscopy or CT scan
    6. Presence of at least two of the following symptoms one of which should be either nasal blockage/obstruction/congestion or nasal discharge (anterior/posterior nasal drip) and either nasal discharge (anterior/posterior nasal drip); facial pain/pressure; reduction or loss of smell for at least 12 weeks prior to screening
    7. Participants with severe NP symptoms defined as an obstruction VAS symptom score of >5
    8. Severity consistent with a need for surgery as described by:
    a) Participants with an overall VAS symptom score >7
    b) Participants with an endoscopic bilateral NP score of at least 5 out of a maximum score of 8 (with a minimum score of 2 in each nasal cavity)
    9. Treatment with INCS for at least 8 weeks prior to screening

    INFORMED CONSENT
    10. Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.
    E.4Principal exclusion criteria
    Participants are excluded from the study if any of the following criteria apply:

    CONCURRENT CONDITIONS/MEDICAL HISTORY
    1. As a result of medical interview, physical examination, or screening investigation the physician responsible considers the participant unfit for the study.
    2. Cystic fibrosis
    3. Eosinophilic granulomatosis with polyangiitis (also known as Churg Strauss syndrome), Young’s, Kartagener’s or dyskinetic ciliary syndromes
    4. Antrochoanal polyps
    5. Nasal septal deviation occluding one nostril
    6. Acute sinusitis or upper respiratory track infection (URTI) at screening or in 2 weeks prior to screening
    7. Ongoing rhinitis medicamentosa (rebound or chemical induced rhinitis)
    8. Participants who have had an asthma exacerbation requiring admission to hospital within 4 weeks of Screening.
    9. Participants who have undergone any intranasal and/or sinus surgery (for example polypectomy, balloon dilatation or nasal stent insertion) within 6 months prior V1
    10. Participants where NP surgery is contraindicated in the opinion of the Investigator
    11. Participants with a known medical history of HIV infection.
    12. Participants with a known, pre-existing parasitic infestation within 6 months prior to Visit 1.
    13. Participants who are currently receiving, or have received within 3 months (or 5 half lives – whatever is the longest) prior to first mepolizumab dose, chemotherapy, radiotherapy or investigational medications/therapies.
    14. Participants with a 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 GSK Medical Monitor, contraindicates their participation. Aspirinsensitive
    participants are acceptable.
    15. Participants with a history of allergic reaction to anti-IL-5 or other monoclonal antibody therapy.
    16. Participants on a waiting list for NP surgery while at screening
    17. Participants that have taken part in previous mepolizumab, reslizumab, dupilumab or benralizumab studies

    CONCOMITANT MEDICATIONS
    18. Use of systemic corticosteroids (including oral corticosteroids) or corticosteroid nasal solution (intranasal corticosteroid is excepted) within 4 weeks prior to screening or planned use of such medications during the double-blind period
    19. INCS dose changes within 1 month prior to screening.
    20. Treatments with biological or immunosuppressive treatment (other than Xolair) treatment within 5 terminal phase half lives of Visit 1
    21. Omalizumab (Xolair) treatment in the 130 days prior to Visit 1
    22. Commencement of leukotriene antagonist treatment less than 30 days prior to Visit 1
    23. Allergen immunotherapy within the previous 3 months.

    Pregnancy:
    24. Women who are pregnant or lactating or are planning on becoming pregnant during the study.

    Smoking History:
    25. Participants who currently smoke or have smoked in the last 6 months

    Other Diseases/Abnormalities:
    26. Any subject who is considered unlikely to survive the duration of the study period or has any rapidly progressing disease or immediate life-threatening illness (e.g. cancer). In addition, any subject who has any other condition (e.g. neurological condition) that is likely to affect respiratory function should not be included in the study.
    27. Other Concurrent Medical Conditions: Participants who have known, pre-existing, clinically significant endocrine, autoimmune, cardiovascular, metabolic, neurological, renal, gastrointestinal, hepatic, haematological or any other system abnormalities that are uncontrolled with standard treatment.
    28. Participants with a known, pre-existing or suspected parasitic infection within 6 months before the Screening visit.
    29. Immunocompromised, other than that explained by the use of corticosteroids taken as therapy
    30. A current malignancy or previous history of cancer in remission for less than 12 months prior to screening.
    Note: Participants with successfully treated basal cell carcinoma, squamous cell carcinoma of the skin, or cervical carcinoma in situ, with no evidence of recurrence may participate in the study.

    For Exclusion criteria (point 31 to 35) please refer to the protocol P 36-37.
    E.5 End points
    E.5.1Primary end point(s)
    - Change from baseline in total endoscopic NP score at Week 52
    - Change from baseline in mean nasal obstruction VAS score during the 4 weeks prior to Week 52
    E.5.1.1Timepoint(s) of evaluation of this end point
    52 Weeks
    E.5.2Secondary end point(s)
    - Time to first nasal surgery up to Week 52.

    - Change from baseline in mean overall VAS symptom score during the 4 weeks prior to Week 52

    - Change from baseline in SNOT-22 total score at Week 52

    - Number of mgs per year of prednisolone-equivalent OCS dose up to Week 52
    E.5.2.1Timepoint(s) of evaluation of this end point
    52 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 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 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 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 concerned7
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA26
    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
    Canada
    Germany
    Japan
    Korea, Republic of
    Netherlands
    Romania
    Russian Federation
    Sweden
    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 years2
    E.8.9.1In the Member State concerned months2
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months2
    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: 350
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 50
    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 state20
    F.4.2 For a multinational trial
    F.4.2.2In the whole clinical trial 400
    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 subject’s medical condition, whether or not GSK is providing specific post-study treatment.

    There are no plans to provide mepolizumab following study completion.
    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 Decision2017-04-25
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-06-28
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2019-12-11
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
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