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    Clinical Trial Results:
    Ilaris (Canakinumab) in the Schnitzler syndrome : A Case series

    Summary
    EudraCT number
    		 2010-023603-10
    Trial protocol
    		 BE  
    Global end of trial date
    30 Jun 2019

    Results information
    Results version number
    		 v1(current)
    This version publication date
    12 Mar 2023
    First version publication date
    12 Mar 2023
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    S52762
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    UZ Leuven
    Sponsor organisation address
    Herestraat 49, Leuven, Belgium, 3000
    Public contact
    Prof Steven Vanderschueren, UZ Leuven,, steven.vanderschueren@uzleuven.be
    Scientific contact
    Prof Steven Vanderschueren, UZ Leuven,, steven.vanderschueren@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
    Final
    Date of interim/final analysis
    30 Jun 2019
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    30 Jun 2019
    Global end of trial reached?
    Yes
    Global end of trial date
    30 Jun 2019
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To evaluate if canakinumab 150mg every 8 weeks can induce and maintain clinical remission in patients with the Schnitzler syndrome.
    Protection of trial subjects
    subcutaneous injections and peripheral blood sampling are done by trained study nurses to minimise pain and distress
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    05 May 2011
    Long term follow-up planned
    Yes
    Long term follow-up rationale
    		 Efficacy
    Long term follow-up duration
    		 8 Years
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Belgium: 1
    Worldwide total number of subjects
    1
    EEA total number of subjects
    1
    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)
    1
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 One patient was recruited on 5 May 2011. Pat was followed up in the trial until 30 June 2019 , when the trial ended.

    Pre-assignment
    Screening details
    		 only one patient fullfilled all inclusion criteria: diagnosed with Schnitzler syndrome

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

    Arms
    Arm title
    		 canakinumab arm
    Arm description
    		 treatment with canakinumab ,open label
    Arm type
    		 Experimental

    Investigational medicinal product name
    canakinumab
    Investigational medicinal product code
    ATC L04AC08
    Other name
    Pharmaceutical forms
    Powder and solvent for suspension for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    150 -300 mg every 4 to 8 weeks, subcutaneous injections

    Number of subjects in period 1
    		canakinumab arm
    Started
    1
    Completed
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    one patient trial
    Reporting group description
    		 patient diagnosed with Schnitzler Syndrome

    Reporting group values
    		 one patient trial Total
    Number of subjects
    		 1 1
    Age categorical
    one adult patient
    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)
    		 0 0
        Adults (18-64 years)
    		 1 1
        From 65-84 years
    		 0 0
        85 years and over
    		 0 0
        adult
    		 0 0
    Gender categorical
    male patient, adult
    Units: Subjects
        Female
    		 0 0
        Male
    		 1 1

    End points

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    End points reporting groups
    Reporting group title
    canakinumab arm
    Reporting group description
    		 treatment with canakinumab ,open label

    Primary: clinical remission

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    End point title
    		 clinical remission [1]
    End point description
    This therapy is expected to induce a response as long as administration continues. Symptoms (including high-grade relapsing fevers, chronic urticaria, bone and joint pains) and signs (chronic lab inflammatory syndrome) are likely to recur after the cessation of therapy has ended.
    End point type
    Primary
    End point timeframe
    28 weeks,( prolongation of therapy 18 months)
    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: no statistical analyses as only 1 patient is included in the trial
    End point values
    		 canakinumab arm
    Number of subjects analysed
    1
    Units: clinical evaluation
    number (not applicable)
        resolution of signs and symptoms
    1
    No statistical analyses for this end point

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    during the entire trial
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 CTCAE
    Dictionary version
    1
    Reporting groups
    Reporting group title
    canakinumab arm
    Reporting group description
    		 treatment with canakinumab ,open label

    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: Indeed, No non serious adverse events ware recorded,
    Serious adverse events
    		 canakinumab arm
    Total subjects affected by serious adverse events
         subjects affected / exposed
    1 / 1 (100.00%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    0
    Infections and infestations
    epidydimitis
         subjects affected / exposed
    1 / 1 (100.00%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 canakinumab arm
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    0 / 1 (0.00%)

    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

    Online references
    http://www.ncbi.nlm.nih.gov/pubmed/22901459
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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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