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    Clinical Trial Results:
    STRAUSS: responSe To ustekinumab foR Anti-tnf IndUced pSoriasiform Skin lesions

    Summary
    EudraCT number
    		 2018-003189-15
    Trial protocol
    		 BE  
    Global end of trial date
    10 Oct 2024

    Results information
    Results version number
    		 v1(current)
    This version publication date
    26 Oct 2024
    First version publication date
    26 Oct 2024
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    S61472
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT03629379
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    University Hospitals Leuven
    Sponsor organisation address
    Herestraat 49, Leuven, Belgium, 3000
    Public contact
    Clinical Trial Center UZ Leuven, University Hospitals Leuven, +32 1634 19 98, ctc@uzleuven.be
    Scientific contact
    Clinical Trial Center UZ Leuven, University Hospitals Leuven, +32 1634 19 98, ctc@uzleuven.be
    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
    10 Oct 2024
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    10 Oct 2024
    Global end of trial reached?
    Yes
    Global end of trial date
    10 Oct 2024
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The primary objective of this prospective, observational study is to indentify transcriptomic and proteomic signatures, which can predict good response to ustekinumab in anti-TNF treated patients with psoriasiform skin lesions
    Protection of trial subjects
    No specific requirements are necesarry
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    01 Oct 2018
    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
    Worldwide total number of subjects
    10
    EEA total number of subjects
    10
    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)
    8
    From 65 to 84 years
    2
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 We will prospectively include patients with crohn's disease or ulcerative colitis, who develop psoriasiform skin lesions (including psoriasiform eczema, psoriasis guttata, psoriasis inversa and pustulosis) under therapy with anti-TNF and refractory to at least 12 weeks of topical therapy.

    Pre-assignment
    Screening details
    		 IBD patients not treated with anti-TNF therapy or IBD patients with paradoxical skin lesions due to anti-TNF who are not refractory to topical therapy were excluded. Patients who previously received anti-IL12/23 or anti-IL23 therapy or vedolizumab were excluded. Pregnant IBD patients were excluded.

    Period 1
    Period 1 title
    overall trial (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Non-randomised - controlled
    Blinding used
    		 Not blinded
    Blinding implementation details
    Study was not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 vedolizumab therapy
    Arm description
    		 -
    Arm type
    		 Active comparator

    Investigational medicinal product name
    vedolizumab
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Concentrate for concentrate for solution for infusion
    Routes of administration
    Infusion
    Dosage and administration details
    intravenous vedolizumab 300mg at weeks 0, 2, 6, 14

    Arm title
    		 ustekinumab therapy
    Arm description
    		 -
    Arm type
    		 Active comparator

    Investigational medicinal product name
    ustekinumab
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Concentrate and solvent for solution for infusion, Suspension for injection in pre-filled syringe
    Routes of administration
    Infusion , Injection
    Dosage and administration details
    standard induction with intravenous ustekinumab of 6mg/kg, followed by subcutaneous injection of 90mg every 8 weeks

    Number of subjects in period 1
    		vedolizumab therapy ustekinumab therapy
    Started
    5
    5
    Completed
    5
    5

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    overall trial
    Reporting group description
    		 -

    Reporting group values
    		 overall trial Total
    Number of subjects
    		 10 10
    Age categorical
    Units: Subjects
        In utero
    		 0
        Preterm newborn infants (gestational age < 37 wks)
    		 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)
    		 0
        From 65-84 years
    		 0
        85 years and over
    		 0
    Age continuous
    All patients patients with inflammatory bowel disease aged 18 to 80-years-old
    Units: years
        median (inter-quartile range (Q1-Q3))
    		 49.5 (36.0 to 64.3) -
    Gender categorical
    Both female and male patients were included
    Units: Subjects
        Female
    		 5 5
        Male
    		 5 5

    End points

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    End points reporting groups
    Reporting group title
    vedolizumab therapy
    Reporting group description
    		 -

    Reporting group title
    ustekinumab therapy
    Reporting group description
    		 -

    Primary: chnages in transcriptomic and proteomic signatures

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    End point title
    		 chnages in transcriptomic and proteomic signatures [1]
    End point description
    The primary objective of this prospective, interventional study is to identify transcriptomic and proteomic signatures, which can predict good response to UST in anti-TNF treated patients with inflammatory skin lesions.
    End point type
    Primary
    End point timeframe
    14 weeks if patients receive vedolizumab or 16 weeks if patients receive ustekinumab
    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: Proof of concept trial. No statistical analyses was feasible due to limited patient recruitment.
    End point values
    		 vedolizumab therapy ustekinumab therapy
    Number of subjects analysed
    5
    5
    Units: whole
        reduction lesion
    0
    0
    No statistical analyses for this end point

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    16 weeks
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 SNOMED CT
    Dictionary version
    20240901
    Reporting groups
    Reporting group title
    Ustekinumab
    Reporting group description
    		 -

    Reporting group title
    vedolizumab
    Reporting group description
    		 -

    Serious adverse events
    		 Ustekinumab vedolizumab
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 5 (0.00%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Frequency threshold for reporting non-serious adverse events: 1%
    Non-serious adverse events
    		 Ustekinumab vedolizumab
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    Notes
    [1] - There are no non-serious adverse events recorded for these results. It is expected that there will be at least one non-serious adverse event reported.
    Justification: No adverse events

    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.
    Power of study limted due to difficulty in patient recruitment
    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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