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    Clinical Trial Results:
    A multi-centre, open-label extension, safety study to describe the long-term clinical experience of mepolizumab in participants with hypereosinophilic syndrome (HES) from Study 200622

    Summary
    EudraCT number
    		 2017-000184-32
    Trial protocol
    		 DE   GB   BE   ES   FR   PL   Outside EU/EEA   IT   RO  
    Global end of trial date
    30 Dec 2019

    Results information
    Results version number
    		 v1(current)
    This version publication date
    20 Jun 2020
    First version publication date
    20 Jun 2020
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    205203
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    GlaxoSmithKline
    Sponsor organisation address
    980 Great West Road, Brentford, Middlesex, United Kingdom, TW8 9GS
    Public contact
    GSK Response Center, GlaxoSmithKline, 1 8664357343, GSKClinicalSupportHD@gsk.com
    Scientific contact
    GSK Response Center, GlaxoSmithKline, 1 8664357343, GSKClinicalSupportHD@gsk.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    13 Mar 2020
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    30 Dec 2019
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To describe the long-term safety profile of mepolizumab in participants with HES who took part in Study 200622.
    Protection of trial subjects
    Not Applicable
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    13 Nov 2017
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Belgium: 10
    Country: Number of subjects enrolled
    Brazil: 3
    Country: Number of subjects enrolled
    France: 17
    Country: Number of subjects enrolled
    Germany: 13
    Country: Number of subjects enrolled
    Italy: 5
    Country: Number of subjects enrolled
    Argentina: 6
    Country: Number of subjects enrolled
    Mexico: 5
    Country: Number of subjects enrolled
    Poland: 10
    Country: Number of subjects enrolled
    Romania: 2
    Country: Number of subjects enrolled
    Russian Federation: 7
    Country: Number of subjects enrolled
    Spain: 3
    Country: Number of subjects enrolled
    United Kingdom: 6
    Country: Number of subjects enrolled
    United States: 15
    Worldwide total number of subjects
    102
    EEA total number of subjects
    66
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    0
    Infants and toddlers (28 days-23 months)
    0
    Children (2-11 years)
    0
    Adolescents (12-17 years)
    4
    Adults (18-64 years)
    85
    From 65 to 84 years
    13
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 This was a multi-center, open-label extension study to evaluate the long-term safety profile of mepolizumab in participants with Hypereosinophilic Syndrome (HES). In this study, participants received open-label mepolizumab 300 milligram (mg) subcutaneously (SC).

    Pre-assignment
    Screening details
    		 A total of 102 participants who completed the parent study (200622 [NCT02836496]) and met the eligibility criteria were enrolled in this open-label extension study.

    Period 1
    Period 1 title
    Overall Study (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded

    Arms
    Arm title
    		 Mepolizumab 300 mg SC
    Arm description
    		 Participants were administered 300 mg SC mepolizumab every 4 weeks (starting approximately 32 weeks after the first dose of study treatment in Study 200622). The final dose of mepolizumab was administered at Visit 5 (Week 16).
    Arm type
    		 Experimental

    Investigational medicinal product name
    Mepolizumab
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Mepolizumab was administered as three 100 mg SC injections every 4 weeks. It was provided in a 100 mg vial for injection.

    Number of subjects in period 1
    		Mepolizumab 300 mg SC
    Started
    102
    Completed
    98
    Not completed
    4
         Consent withdrawn by subject
    2
         Adverse event, non-fatal
    1
         Lost to follow-up
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Mepolizumab 300 mg SC
    Reporting group description
    		 Participants were administered 300 mg SC mepolizumab every 4 weeks (starting approximately 32 weeks after the first dose of study treatment in Study 200622). The final dose of mepolizumab was administered at Visit 5 (Week 16).

    Reporting group values
    		 Mepolizumab 300 mg SC Total
    Number of subjects
    		 102 102
    Age categorical
    Units: Subjects
        In utero
    		 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0
        Newborns (0-27 days)
    		 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0
        Children (2-11 years)
    		 0 0
        Adolescents (12-17 years)
    		 4 4
        Adults (18-64 years)
    		 85 85
        From 65-84 years
    		 13 13
        85 years and over
    		 0 0
    Age Continuous
    Units: Years
        arithmetic mean (standard deviation)
    		 46.0 ± 15.54 -
    Sex: Female, Male
    Units: Participants
        Female
    		 55 55
        Male
    		 47 47
    Race/Ethnicity, Customized
    Units: Subjects
        Asian-East Asian Heritage
    		 1 1
        Black or African American
    		 2 2
        White-White/Caucasian/European Heritage
    		 79 79
        American Indian or Alaskan Native
    		 3 3
        Unknown
    		 17 17

    End points

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    End points reporting groups
    Reporting group title
    Mepolizumab 300 mg SC
    Reporting group description
    		 Participants were administered 300 mg SC mepolizumab every 4 weeks (starting approximately 32 weeks after the first dose of study treatment in Study 200622). The final dose of mepolizumab was administered at Visit 5 (Week 16).

    Primary: Number of participants with common (>=3%) non-serious adverse events (AEs)

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    End point title
    		 Number of participants with common (>=3%) non-serious adverse events (AEs) [1]
    End point description
    An AE was any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. Serious AE was defined as any untoward medical occurrence that, at any dose results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in persistent disability/incapacity, congenital anomaly/birth defect or any other situation according to medical or scientific judgment. Non-serious AEs from start of study treatment until 28 days after last dose (up to Week 20) are reported. Number of participants with common (>=3% incidence) non-serious AEs are presented. Safety Population comprised of all participants who received at least one dose of open-label mepolizumab.
    End point type
    Primary
    End point timeframe
    Up to Week 20
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: There are no statistical data to report.
    End point values
    		 Mepolizumab 300 mg SC
    Number of subjects analysed
    102 [2]
    Units: Participants
    34
    Notes
    [2] - Safety Population
    No statistical analyses for this end point

    Primary: Number of participants with serious AEs

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    End point title
    		 Number of participants with serious AEs [3]
    End point description
    An AE was any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. Serious AE was defined as any untoward medical occurrence that, at any dose results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in persistent disability/incapacity, congenital anomaly/birth defect or any other situation according to medical or scientific judgment. Number of participants with serious AEs are presented.
    End point type
    Primary
    End point timeframe
    Up to Week 28
    Notes
    [3] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: There are no statistical data to report.
    End point values
    		 Mepolizumab 300 mg SC
    Number of subjects analysed
    102 [4]
    Units: Participants
    9
    Notes
    [4] - Safety Population
    No statistical analyses for this end point

    Primary: Number of participants with the presence of anti-drug antibody

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    End point title
    		 Number of participants with the presence of anti-drug antibody [5]
    End point description
    Blood samples were analyzed for the presence of anti-mepolizumab antibodies by binding anti-drug antibody (ADA) assay. The binding ADA assay results at each visit were summarized as negative or positive. The binding ADA assay was performed in three steps; screening, confirmation and titration. The screening assay produced a result of positive or negative relative to a screening cut point. Positive samples continued with the confirmation assay, which also produced a result of positive or negative relative to a confirmation cut point. For positive confirmation samples, a titre value was obtained to quantify the degree of binding in a titration assay. Participants were considered 'Positive' if they had a positive confirmation ADA assay result. Only those participants with data available at specified data points were analyzed (represented by n= X in the category titles).
    End point type
    Primary
    End point timeframe
    Baseline (Day 1), Week 20 and Week 28
    Notes
    [5] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: There are no statistical data to report.
    End point values
    		 Mepolizumab 300 mg SC
    Number of subjects analysed
    102 [6]
    Units: Participants
        Baseline, Negative, n=102
    101
        Baseline, Positive, n=102
    1
        Week 20, Negative, n=101
    101
        Week 20, Positive, n=101
    0
        Week 28, Negative, n=14
    14
        Week 28, Positive, n=14
    0
    Notes
    [6] - Safety Population
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Serious AEs were reported from start of study (Week 0) up to end of study (up to Week 28) and non-serious AEs were reported from start of study treatment until 28 days after last dose (up to Week 20)
    Adverse event reporting additional description
    Non-serious AEs and serious AEs were reported for Safety Population.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    22.1
    Reporting groups
    Reporting group title
    Mepolizumab 300 mg SC
    Reporting group description
    		 Participants were administered 300 mg SC mepolizumab every 4 weeks (starting approximately 32 weeks after the first dose of study treatment in Study 200622). The final dose of mepolizumab was administered at Visit 5 (Week 16).

    Serious adverse events
    		 Mepolizumab 300 mg SC
    Total subjects affected by serious adverse events
         subjects affected / exposed
    9 / 102 (8.82%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Peripheral T-cell lymphoma unspecified
         subjects affected / exposed
    1 / 102 (0.98%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Injury, poisoning and procedural complications
    Joint dislocation
         subjects affected / exposed
    1 / 102 (0.98%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Blood and lymphatic system disorders
    Hypereosinophilic syndrome
         subjects affected / exposed
    1 / 102 (0.98%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Gastrointestinal disorders
    Gastroenteritis eosinophilic
         subjects affected / exposed
    1 / 102 (0.98%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Infections and infestations
    Bacteraemia
         subjects affected / exposed
    1 / 102 (0.98%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Clostridium difficile colitis
         subjects affected / exposed
    1 / 102 (0.98%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Diverticulitis
         subjects affected / exposed
    1 / 102 (0.98%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Gastrointestinal infection
         subjects affected / exposed
    1 / 102 (0.98%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Infective exacerbation of bronchiectasis
         subjects affected / exposed
    1 / 102 (0.98%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Mycobacterium abscessus infection
         subjects affected / exposed
    1 / 102 (0.98%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Perihepatic abscess
         subjects affected / exposed
    1 / 102 (0.98%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Pneumonia
         subjects affected / exposed
    1 / 102 (0.98%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Sinusitis
         subjects affected / exposed
    1 / 102 (0.98%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 3%
    Non-serious adverse events
    		 Mepolizumab 300 mg SC
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    34 / 102 (33.33%)
    Nervous system disorders
    Headache
         subjects affected / exposed
    6 / 102 (5.88%)
         occurrences all number
    7
    General disorders and administration site conditions
    Fatigue
         subjects affected / exposed
    4 / 102 (3.92%)
         occurrences all number
    4
    Injection site reaction
         subjects affected / exposed
    4 / 102 (3.92%)
         occurrences all number
    11
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed
    12 / 102 (11.76%)
         occurrences all number
    13
    Vomiting
         subjects affected / exposed
    6 / 102 (5.88%)
         occurrences all number
    7
    Constipation
         subjects affected / exposed
    5 / 102 (4.90%)
         occurrences all number
    6
    Nausea
         subjects affected / exposed
    5 / 102 (4.90%)
         occurrences all number
    5
    Skin and subcutaneous tissue disorders
    Pruritus
         subjects affected / exposed
    7 / 102 (6.86%)
         occurrences all number
    7
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    5 / 102 (4.90%)
         occurrences all number
    6
    Infections and infestations
    Nasopharyngitis
         subjects affected / exposed
    5 / 102 (4.90%)
         occurrences all number
    5
    Bronchitis
         subjects affected / exposed
    4 / 102 (3.92%)
         occurrences all number
    4
    Sinusitis
         subjects affected / exposed
    4 / 102 (3.92%)
         occurrences all number
    4
    Upper respiratory tract infection
         subjects affected / exposed
    4 / 102 (3.92%)
         occurrences all number
    4

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    13 Jan 2017
    Amendment 01: Correct EudraCT number was provided in the protocol.
    16 Nov 2017
    Amendment 02: Added the optional biomarker sub-study and updated the text around the HES therapy adjustment after HES flare considering therapy reduction during the study.

    Interruptions (globally)
    Were there any global interruptions to the trial? No

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported
    For support, Contact us.
    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
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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