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    Clinical Trial Results:
    An exploratory, open-label, single centre, phase II, proof of concept study of gevokizumab treatment in patients with Schnitzler syndrome.

    Summary
    EudraCT number
    		 2013-002562-39
    Trial protocol
    		 NL  
    Global end of trial date
    04 Jan 2016

    Results information
    Results version number
    		 v1(current)
    This version publication date
    27 Apr 2017
    First version publication date
    27 Apr 2017
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    CL2-78989-018
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Institut de Recherches Internationales Servier
    Sponsor organisation address
    50 rue Carnot, Suresnes, France,
    Public contact
    ITP (Innovative Therapeutic Pole), Institut de Recherches Internationales Servier, +33 15572 4366, clinicaltrials@servier.com
    Scientific contact
    ITP (Innovative Therapeutic Pole), Institut de Recherches Internationales Servier, +33 15572 4366, clinicaltrials@servier.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
    04 Jan 2016
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    04 Jan 2016
    Global end of trial reached?
    Yes
    Global end of trial date
    04 Jan 2016
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The objective of this study is to explore the efficacy and safety of gevokizumab in patients with Schnitzler syndrome.
    Protection of trial subjects
    This study was conducted in accordance with Good Clinical Practice standards, ethical principles stated in the Declaration of Helsinki and applicable regulatory requirements. After the subject has ended his/her participation in the trial, the investigator provided appropriate medication and/or arranged access to appropriate care for the patient.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    05 Dec 2013
    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: 3
    Worldwide total number of subjects
    3
    EEA total number of subjects
    3
    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)
    0
    From 65 to 84 years
    3
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 Males or females aged ≥ 18 years with diagnosis of Schnitzler syndrome at least one year prior, and with active Schnitzler syndrome disease as defined by the presence of at least 2 of 3 clinical criteria (from rash, fever (defined as ≥ 38°C) and bone or arthritis pain) and elevated CRP levels ≥ 30 mg/L, and without clinical signs of tuberculosis.

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

    Arms
    Arm title
    		 Gevokizumab
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    Gevokizumab
    Investigational medicinal product code
    S78989
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Gevokizumab was administered to 3 patients with starting dose of 60 mg and were to receive maximum dose of 180 mg per 2-week period over a 2-year treatment duration.

    Number of subjects in period 1
    		Gevokizumab
    Started
    3
    Completed
    3

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Treatment period
    Reporting group description
    		 -

    Reporting group values
    		 Treatment period Total
    Number of subjects
    		 3 3
    Age categorical
    Units: Subjects
        From 65-84 years
    		 3 3
    Gender categorical
    Units: Subjects
        Female
    		 2 2
        Male
    		 1 1

    End points

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    End points reporting groups
    Reporting group title
    Gevokizumab
    Reporting group description
    		 -

    Primary: no primary criterion

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    End point title
    		 no primary criterion [1]
    End point description
    End point type
    Primary
    End point timeframe
    As the study was exploratory, no primary endpoint was defined.
    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: As no primary endpoint was defined for this exploratory study, no statistical analysis was performed.
    End point values
    		 Gevokizumab
    Number of subjects analysed
    0 [2]
    Units: no unit
    Notes
    [2] - As the study was exploratory, no primary endpoint was defined.
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    All adverse events which occurred during the treatment period are presented here.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    18.0
    Reporting groups
    Reporting group title
    Gevokizumab
    Reporting group description
    		 -

    Serious adverse events
    		 Gevokizumab
    Total subjects affected by serious adverse events
         subjects affected / exposed
    1 / 3 (33.33%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    0
    Reproductive system and breast disorders
    Cervical dysplasia
         subjects affected / exposed
    1 / 3 (33.33%)
         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
    		 Gevokizumab
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    3 / 3 (100.00%)
    Injury, poisoning and procedural complications
    Animal bite
         subjects affected / exposed
    1 / 3 (33.33%)
         occurrences all number
    1
    Fall
         subjects affected / exposed
    1 / 3 (33.33%)
         occurrences all number
    1
    Head injury
         subjects affected / exposed
    1 / 3 (33.33%)
         occurrences all number
    1
    Vaccination complication
         subjects affected / exposed
    1 / 3 (33.33%)
         occurrences all number
    1
    Nervous system disorders
    Somnolence
         subjects affected / exposed
    1 / 3 (33.33%)
         occurrences all number
    1
    General disorders and administration site conditions
    Fatigue
         subjects affected / exposed
    1 / 3 (33.33%)
         occurrences all number
    2
    Feeling cold
         subjects affected / exposed
    1 / 3 (33.33%)
         occurrences all number
    1
    General physical health deterioration
         subjects affected / exposed
    1 / 3 (33.33%)
         occurrences all number
    1
    Malaise
         subjects affected / exposed
    1 / 3 (33.33%)
         occurrences all number
    1
    Gastrointestinal disorders
    Abdominal pain
         subjects affected / exposed
    1 / 3 (33.33%)
         occurrences all number
    1
    Abdominal pain upper
         subjects affected / exposed
    1 / 3 (33.33%)
         occurrences all number
    1
    Diarrhoea
         subjects affected / exposed
    2 / 3 (66.67%)
         occurrences all number
    3
    Dry mouth
         subjects affected / exposed
    1 / 3 (33.33%)
         occurrences all number
    1
    Dyspepsia
         subjects affected / exposed
    1 / 3 (33.33%)
         occurrences all number
    1
    Eructation
         subjects affected / exposed
    1 / 3 (33.33%)
         occurrences all number
    1
    Nausea
         subjects affected / exposed
    1 / 3 (33.33%)
         occurrences all number
    1
    Reproductive system and breast disorders
    Atrophic vulvovaginitis
         subjects affected / exposed
    1 / 3 (33.33%)
         occurrences all number
    1
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    1 / 3 (33.33%)
         occurrences all number
    2
    Epistaxis
         subjects affected / exposed
    1 / 3 (33.33%)
         occurrences all number
    1
    Nasal congestion
         subjects affected / exposed
    1 / 3 (33.33%)
         occurrences all number
    3
    Oropharyngeal pain
         subjects affected / exposed
    1 / 3 (33.33%)
         occurrences all number
    1
    Psychiatric disorders
    Insomnia
         subjects affected / exposed
    1 / 3 (33.33%)
         occurrences all number
    1
    Stress
         subjects affected / exposed
    1 / 3 (33.33%)
         occurrences all number
    1
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    1 / 3 (33.33%)
         occurrences all number
    2
    Back pain
         subjects affected / exposed
    1 / 3 (33.33%)
         occurrences all number
    1
    Metatarsalgia
         subjects affected / exposed
    1 / 3 (33.33%)
         occurrences all number
    1
    Musculoskeletal stiffness
         subjects affected / exposed
    1 / 3 (33.33%)
         occurrences all number
    1
    Myalgia
         subjects affected / exposed
    1 / 3 (33.33%)
         occurrences all number
    1
    Neck pain
         subjects affected / exposed
    1 / 3 (33.33%)
         occurrences all number
    1
    Osteoarthritis
         subjects affected / exposed
    1 / 3 (33.33%)
         occurrences all number
    1
    Infections and infestations
    Bronchitis viral
         subjects affected / exposed
    1 / 3 (33.33%)
         occurrences all number
    1
    Cystitis
         subjects affected / exposed
    1 / 3 (33.33%)
         occurrences all number
    1
    Gastrointestinal viral infection
         subjects affected / exposed
    2 / 3 (66.67%)
         occurrences all number
    2
    Oral herpes
         subjects affected / exposed
    1 / 3 (33.33%)
         occurrences all number
    4
    Respiratory tract infection bacterial
         subjects affected / exposed
    1 / 3 (33.33%)
         occurrences all number
    1
    Sinusitis
         subjects affected / exposed
    1 / 3 (33.33%)
         occurrences all number
    1
    Upper respiratory tract infection
         subjects affected / exposed
    1 / 3 (33.33%)
         occurrences all number
    1
    Viral upper respiratory tract infection
         subjects affected / exposed
    2 / 3 (66.67%)
         occurrences all number
    3

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    16 Jul 2014
    At inclusion, the starting dose of gevokizumab was increased to 180 mg; as no patient was recruited after the amendment, all included patients received a starting dose of 60 mg as per initial protocol. For on-going patients, the maximum authorised dose was increased up to 180 mg gevokizumab per 2-week period if deemed appropriate by the investigator according to the patient’s clinical response over the 2-year treatment period.
    21 Oct 2014
    The overall follow-up of patient was extended from 1 to 2 years.

    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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