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    Clinical Trial Results:
    A safety open-label study of Gevokizumab in the treatment of patients with chronic non-infectious Uveitis disease, an eXtension study. The EYEGUARD-X study.

    Summary
    EudraCT number
    		 2013-004973-29
    Trial protocol
    		 DE   GB   IT   PT   ES   AT   GR  
    Global end of trial date
    02 Nov 2015

    Results information
    Results version number
    		 v1(current)
    This version publication date
    18 Sep 2016
    First version publication date
    18 Sep 2016
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    CL3-78989-019
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT02375685
    WHO universal trial number (UTN)
    		 U1111-1151-7937
    Sponsors
    Sponsor organisation name
    Institut de Recherches Internationales Servier
    Sponsor organisation address
    50 rue Carnot, Suresnes, France,
    Public contact
    Clinical Studies Department, Institut de Recherches Internationales Servier, +33 155 72 43 66, clinicaltrials@servier.com
    Scientific contact
    Clinical Studies Department, Institut de Recherches Internationales Servier, +33 155 72 43 66, 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
    02 Nov 2015
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    02 Nov 2015
    Global end of trial reached?
    Yes
    Global end of trial date
    02 Nov 2015
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    The objective of this study is to evaluate long-term safety of gevokizumab in patient with chronic non-infectious uveitis who previously well tolerated the study drug and may benefit from longterm treatment with gevokizumab
    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
    14 Aug 2014
    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
    Portugal: 1
    Country: Number of subjects enrolled
    Spain: 10
    Country: Number of subjects enrolled
    Austria: 4
    Country: Number of subjects enrolled
    France: 3
    Country: Number of subjects enrolled
    Germany: 6
    Country: Number of subjects enrolled
    Greece: 3
    Country: Number of subjects enrolled
    Italy: 4
    Country: Number of subjects enrolled
    Australia: 3
    Country: Number of subjects enrolled
    Korea, Republic of: 18
    Country: Number of subjects enrolled
    Taiwan: 15
    Country: Number of subjects enrolled
    Tunisia: 2
    Country: Number of subjects enrolled
    Turkey: 8
    Worldwide total number of subjects
    77
    EEA total number of subjects
    31
    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)
    76
    From 65 to 84 years
    1
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 To be eligible, all subjects were to have chronic non-infectious uveitis disease, and to have completed the study CL3-78989-002 (EYEGUARD™-B), or X052130/CL3-78989-005 (EYEGUARD™-A) or X052131/CL3-78989-006 (EYEGUARD™-C), or were receiving a gevokizumab treatment as compassionate use.

    Pre-assignment period milestones
    Number of subjects started
    		 77
    Number of subjects completed

    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 60 mg
    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
    planned: one dose of gevokizumab 60 mg every 4 weeks from Week 0 up to Week 92

    Number of subjects in period 1
    		Gevokizumab 60 mg
    Started
    77
    Completed
    0
    Not completed
    77
         non-medical reason
    5
         Adverse event, non-fatal
    1
         study discontinuation
    71

    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
    		 77 77
    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)
    		 0 0
        Adults (18-64 years)
    		 76 76
        From 65-84 years
    		 1 1
        85 years and over
    		 0 0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 40.7 ( 12.9 ) -
    Gender categorical
    Units: Subjects
        Female
    		 38 38
        Male
    		 39 39

    End points

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    End points reporting groups
    Reporting group title
    Gevokizumab 60 mg
    Reporting group description
    		 -

    Subject analysis set title
    safety set
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    All patients having taken at least one dose of IMP.

    Primary: Number of patients with at least one adverse event

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    End point title
    		 Number of patients with at least one adverse event [1]
    End point description
    End point type
    Primary
    End point timeframe
    Throughout the study
    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: Descriptive analysis was planned for this endpoint
    End point values
    		 Gevokizumab 60 mg safety set
    Number of subjects analysed
    77
    77
    Units: number of patients
    42
    42
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    All adverse events reported during the study (from W0 to the last visit) were taken into account.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    18.0
    Reporting groups
    Reporting group title
    Gevokizumab 60 mg
    Reporting group description
    		 -

    Serious adverse events
    		 Gevokizumab 60 mg
    Total subjects affected by serious adverse events
         subjects affected / exposed
    11 / 77 (14.29%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    0
    Investigations
    Intraocular pressure increased
         subjects affected / exposed
    1 / 77 (1.30%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Mycobacterium tuberculosis complex test positive
         subjects affected / exposed
    1 / 77 (1.30%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Weight decreased
         subjects affected / exposed
    1 / 77 (1.30%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Vascular disorders
    Behcet's syndrome
         subjects affected / exposed
    2 / 77 (2.60%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Pregnancy, puerperium and perinatal conditions
    Pregnancy
         subjects affected / exposed
    1 / 77 (1.30%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    General disorders and administration site conditions
    Pyrexia
         subjects affected / exposed
    1 / 77 (1.30%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Eye disorders
    Cataract
         subjects affected / exposed
    1 / 77 (1.30%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Retinal haemorrhage
         subjects affected / exposed
    1 / 77 (1.30%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Retinal infiltrates
         subjects affected / exposed
    1 / 77 (1.30%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Retinal neovascularisation
         subjects affected / exposed
    1 / 77 (1.30%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Vitreous detachment
         subjects affected / exposed
    1 / 77 (1.30%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Vitreous haemorrhage
         subjects affected / exposed
    2 / 77 (2.60%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Gastrointestinal disorders
    Abdominal pain
         subjects affected / exposed
    1 / 77 (1.30%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Umbilical hernia
         subjects affected / exposed
    1 / 77 (1.30%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Psychiatric disorders
    Depression
         subjects affected / exposed
    1 / 77 (1.30%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Insomnia
         subjects affected / exposed
    1 / 77 (1.30%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Renal and urinary disorders
    Acute kidney injury
         subjects affected / exposed
    1 / 77 (1.30%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Infections and infestations
    Appendicitis
         subjects affected / exposed
    1 / 77 (1.30%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Orchitis
         subjects affected / exposed
    1 / 77 (1.30%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Tuberculosis
         subjects affected / exposed
    1 / 77 (1.30%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Metabolism and nutrition disorders
    Metabolic acidosis
         subjects affected / exposed
    1 / 77 (1.30%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 2.5%
    Non-serious adverse events
    		 Gevokizumab 60 mg
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    39 / 77 (50.65%)
    Investigations
    Intraocular pressure increased
         subjects affected / exposed
    3 / 77 (3.90%)
         occurrences all number
    4
    Mycobacterium tuberculosis complex test positive
         subjects affected / exposed
    3 / 77 (3.90%)
         occurrences all number
    3
    Vascular disorders
    Behcet's syndrome
         subjects affected / exposed
    3 / 77 (3.90%)
         occurrences all number
    4
    Nervous system disorders
    Headache
         subjects affected / exposed
    3 / 77 (3.90%)
         occurrences all number
    3
    General disorders and administration site conditions
    Influenza like illness
         subjects affected / exposed
    3 / 77 (3.90%)
         occurrences all number
    3
    Eye disorders
    Cataract
         subjects affected / exposed
    2 / 77 (2.60%)
         occurrences all number
    2
    Vitreal cells
         subjects affected / exposed
    2 / 77 (2.60%)
         occurrences all number
    2
    Uveitis
         subjects affected / exposed
    7 / 77 (9.09%)
         occurrences all number
    11
    Ocular hypertension
         subjects affected / exposed
    2 / 77 (2.60%)
         occurrences all number
    3
    Macular oedema
         subjects affected / exposed
    5 / 77 (6.49%)
         occurrences all number
    9
    Gastrointestinal disorders
    Aphthous stomatitis
         subjects affected / exposed
    2 / 77 (2.60%)
         occurrences all number
    2
    Musculoskeletal and connective tissue disorders
    Back pain
         subjects affected / exposed
    2 / 77 (2.60%)
         occurrences all number
    3
    Infections and infestations
    Gastroenteritis
         subjects affected / exposed
    2 / 77 (2.60%)
         occurrences all number
    2
    Nasopharyngitis
         subjects affected / exposed
    4 / 77 (5.19%)
         occurrences all number
    7
    Hordeolum
         subjects affected / exposed
    2 / 77 (2.60%)
         occurrences all number
    2

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    31 Jul 2014
    ­- Update one of the inclusion criteria regarding the timelines between last study drug administration and inclusion in this study. - ­Add instructions in case of indeterminate result of interferon-gamma release assay (IGRA). - ­Update the study completion date, which depended on the end of CL3-78989-002 core study (event-driven trial).
    27 Nov 2014
    The requirement of the last IGRA re-test result before the first study drug administration for patients coming from compassionate use or for patients having received their last study drug administration more than 6 weeks before the inclusion visit.

    Interruptions (globally)
    Were there any global interruptions to the trial? Yes
    Date
    Interruption
    Restart date
    21 Sep 2015
    Sponsor's decision unrelated to safety
    -

    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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