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    Clinical Trial Results:
    DUAL HOMING MECHANISMS OF EOSINOPHILS TO THE SPUTUM; ONLY ONE OF WHICH IS SENSITIVE FOR MEPOLIZUMAB

    Summary
    EudraCT number
    		 2016-002014-52
    Trial protocol
    		 NL  
    Global end of trial date
    10 Jan 2020

    Results information
    Results version number
    		 v1(current)
    This version publication date
    28 Jun 2021
    First version publication date
    28 Jun 2021
    Other versions
    Summary report(s)
    		 abstract study FOOTSTEP

    Trial information

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    Trial identification
    Sponsor protocol code
    FOOTSTEP
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    University Medical Center Utrecht
    Sponsor organisation address
    Heidelberglaan 100, Utrecht, Netherlands, 3584CX
    Public contact
    Clinical Trials information, University Medical Center Utrecht, l.koenderman@umcutrecht.nl
    Scientific contact
    Clinical Trials information, University Medical Center Utrecht, +31 887557255, l.koenderman@umcutrecht.nl
    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
    Interim
    Date of interim/final analysis
    23 Apr 2021
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    10 Jan 2020
    Global end of trial reached?
    Yes
    Global end of trial date
    10 Jan 2020
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    Understanding of the mechanisms underlying eosinophilic inflammation in the lung
    Protection of trial subjects
    There were no specific reasons for protection of trial subjects. It was a low-risk trial.
    Background therapy
    		 The medication score (IQR) was 4 on the 5-point ordinal scale based on guidelines of the Britisch Thoracic Society.
    Evidence for comparator
    		 Randomized placebo controlled trial with the placebo as a comparitor
    Actual start date of recruitment
    01 Jan 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
    Netherlands: 20
    Worldwide total number of subjects
    20
    EEA total number of subjects
    20
    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)
    0
    Adults (18-64 years)
    19
    From 65 to 84 years
    1
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 The patients were recruited in the out-clinic of the University Medical Center Utrecht and the HAGA hospital in The Hague

    Pre-assignment
    Screening details
    		 Potential patients were screened for the inclusion criteria by treating physicians at the out clinic. No specific details were requested.

    Pre-assignment period milestones
    Number of subjects started
    		 20
    Number of subjects completed
    		 20

    Period 1
    Period 1 title
    overall trial (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator
    Blinding implementation details
    Blinding was done by hospital pharmacist.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Mepolizumab
    Arm description
    		 treatment with Mepolizumab (100 mg) once every 4 weeks
    Arm type
    		 Experimental

    Investigational medicinal product name
    Mepolizumab
    Investigational medicinal product code
    Other name
    NUCALA
    Pharmaceutical forms
    Solution for injection in pre-filled injector
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    100 mg every 4 weeks by subcutaneous injection

    Arm title
    		 Placebo
    Arm description
    		 Treatment with placebo
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for infusion in pre-filled syringe
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Placebo

    Number of subjects in period 1
    		Mepolizumab Placebo
    Started
    10
    10
    Completed
    10
    10

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Mepolizumab
    Reporting group description
    		 treatment with Mepolizumab (100 mg) once every 4 weeks

    Reporting group title
    Placebo
    Reporting group description
    		 Treatment with placebo

    Reporting group values
    		 Mepolizumab Placebo Total
    Number of subjects
    		 10 10 20
    Age categorical
    Population: 18-85 years
    Units: Subjects
        Adults (18-85years)
    		 10 10 20
    Age continuous
    Units: years
        median (inter-quartile range (Q1-Q3))
    		 57 (46 to 62) 51 (33 to 65) -
    Gender categorical
    Units: Subjects
        Female
    		 5 6 11
        Male
    		 5 4 9
    Subject analysis sets

    Subject analysis set title
    Eosinophilic asthmatics
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Patients suffering from T2-eosinophilic asthma

    Subject analysis sets values
    		 Eosinophilic asthmatics
    Number of subjects
    20
    Age categorical
    Population: 18-85 years
    Units: Subjects
        Adults (18-85years)
    20
    Age continuous
    Units: years
        median (inter-quartile range (Q1-Q3))
    53 (44 to 63)
    Gender categorical
    Units: Subjects
        Female
    11
        Male
    9

    End points

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    End points reporting groups
    Reporting group title
    Mepolizumab
    Reporting group description
    		 treatment with Mepolizumab (100 mg) once every 4 weeks

    Reporting group title
    Placebo
    Reporting group description
    		 Treatment with placebo

    Subject analysis set title
    Eosinophilic asthmatics
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Patients suffering from T2-eosinophilic asthma

    Primary: change in eosinophil kinetics in blood and sputum

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    End point title
    		 change in eosinophil kinetics in blood and sputum
    End point description
    The effect of mepolizumab on deuterium enrichment of DNA of eosinophils in blood and sputum was measured
    End point type
    Primary
    End point timeframe
    84 days
    End point values
    		 Mepolizumab Placebo
    Number of subjects analysed
    10
    10
    Units: enrichment of deuterium in DNA
        number (not applicable)
    10
    10
    Statistical analysis title
    		 Delay in blood and sputum retention time
    Statistical analysis description
    Linear regression
    Comparison groups
    Mepolizumab v Placebo
    Number of subjects included in analysis
    20
    Analysis specification
    Post-hoc
    Analysis type
    		 equivalence
    P-value
    		 < 0.01
    Method
    		 Regression, Linear
    Confidence interval

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    84 days between start and end of investigation
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 UMCU.RvB.SF051_AE
    Dictionary version
    1
    Reporting groups
    Reporting group title
    patients in FOOTSTEP study
    Reporting group description
    		 -

    Serious adverse events
    		 patients in FOOTSTEP study
    Total subjects affected by serious adverse events
         subjects affected / exposed
    1 / 20 (5.00%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    0
    Skin and subcutaneous tissue disorders
    Cellulitis
    Additional description: Treated with antibiotics. After study it turns out that patient was in the placebo group
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 20 (5.00%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 1%
    Non-serious adverse events
    		 patients in FOOTSTEP study
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    1 / 20 (5.00%)
    General disorders and administration site conditions
    aspecific complaints
    Additional description: Aspecific complaints after Mepolizumab/placebo administration
         subjects affected / exposed
    1 / 20 (5.00%)
         occurrences all number
    2
    Eye disorders
    slight decrease in visual acuity
    Additional description: A slight decrease of visual acuity 1 hour after administation of the drug
         subjects affected / exposed
    1 / 20 (5.00%)
         occurrences all number
    1

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? No

    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
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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
    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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