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    Clinical Trial Results:
    A Phase II Open-Label Extension Study to Evaluate the Long-Term Safety of Etrolizumab in Patients with Moderate to Severe Ulcerative Colitis

    Summary
    EudraCT number
    2011-003409-36
    Trial protocol
    BE   DE   CZ   ES   GB  
    Global end of trial date
    08 Aug 2016

    Results information
    Results version number
    v1(current)
    This version publication date
    10 Aug 2017
    First version publication date
    10 Aug 2017
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    GA27927
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    NCT01461317
    WHO universal trial number (UTN)
    -
    Sponsors
    Sponsor organisation name
    Genentech, Inc.
    Sponsor organisation address
    Grenzacherstrasse 124, Basel, Switzerland, CH-4070
    Public contact
    Roche Trial Information Hotline, Genentech, Inc., +41 616878333, global.trial_information@roche.com
    Scientific contact
    Roche Trial Information Hotline, Genentech, Inc., +41 616878333, global.trial_information@roche.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
    08 Aug 2016
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    08 Aug 2016
    Global end of trial reached?
    Yes
    Global end of trial date
    08 Aug 2016
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The main objective of this study was to assess the long-term safety and tolerability of etrolizumab over an extended treatment period of up to 240 weeks.
    Protection of trial subjects
    All subjects were required to sign an informed consent form prior to study participation.
    Background therapy
    -
    Evidence for comparator
    -
    Actual start date of recruitment
    17 Nov 2011
    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
    Spain: 1
    Country: Number of subjects enrolled
    United Kingdom: 8
    Country: Number of subjects enrolled
    United States: 11
    Country: Number of subjects enrolled
    Australia: 5
    Country: Number of subjects enrolled
    Belgium: 30
    Country: Number of subjects enrolled
    Canada: 11
    Country: Number of subjects enrolled
    Czech Republic: 11
    Country: Number of subjects enrolled
    Germany: 8
    Country: Number of subjects enrolled
    Hungary: 6
    Country: Number of subjects enrolled
    Israel: 11
    Country: Number of subjects enrolled
    New Zealand: 6
    Worldwide total number of subjects
    108
    EEA total number of subjects
    64
    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)
    103
    From 65 to 84 years
    5
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    -

    Pre-assignment
    Screening details
    A total of 124 subjects at 40 sites were enrolled in the parent Study ABS4986g, and 118 were potentially eligible for inclusion in this extension study. Of these, 115 subjects were enrolled, and 108 received study drug.

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

    Arms
    Arm title
    Etrolizumab
    Arm description
    Etrolizumab 300 milligrams (mg), subcutaneous (SC) administration (dose lowered to 100 mg at 15 - 16 weeks after first dose) every 4 weeks during the treatment period, up to 240 weeks.
    Arm type
    Experimental

    Investigational medicinal product name
    Etrolizumab
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Etrolizumab 300 milligrams (mg), subcutaneous (SC) administration (dose lowered to 100 mg at 15 - 16 weeks after first dose) every 4 weeks during the treatment period, up to 240 weeks.

    Number of subjects in period 1
    Etrolizumab
    Started
    108
    Completed
    24
    Not completed
    84
         Physician decision
    1
         Ulcerative colitis
    15
         Lack of efficacy
    48
         Pregnancy
    1
         Withdrawal by subject
    12
         Other adverse event
    4
         Lost to follow-up
    1
         Reason not specified
    2

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Etrolizumab
    Reporting group description
    Etrolizumab 300 milligrams (mg), subcutaneous (SC) administration (dose lowered to 100 mg at 15 - 16 weeks after first dose) every 4 weeks during the treatment period, up to 240 weeks.

    Reporting group values
    Etrolizumab Total
    Number of subjects
    108 108
    Age Categorical
    Units: Subjects
        Adults (18-64 years)
    103 103
        From 65-84 years
    5 5
        85 years and over
    0 0
    Age Continuous
    Units: years
        arithmetic mean (standard deviation)
    40.3 ± 13.7 -
    Gender Categorical
    Units: Subjects
        Female
    47 47
        Male
    61 61

    End points

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    End points reporting groups
    Reporting group title
    Etrolizumab
    Reporting group description
    Etrolizumab 300 milligrams (mg), subcutaneous (SC) administration (dose lowered to 100 mg at 15 - 16 weeks after first dose) every 4 weeks during the treatment period, up to 240 weeks.

    Primary: Percentage of Subjects With Adverse Events (AEs)

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    End point title
    Percentage of Subjects With Adverse Events (AEs) [1]
    End point description
    An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medical treatment or procedure that may or may not be considered related to the medical treatment or procedure. The treated subjects population included any subject who received at least one dose of open-label study drug.
    End point type
    Primary
    End point timeframe
    From first dose of study drug to 12 weeks following last dose of study drug
    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 statistics only
    End point values
    Etrolizumab
    Number of subjects analysed
    108
    Units: percentage of subjects
        number (not applicable)
    83.3
    No statistical analyses for this end point

    Primary: Number of Subjects With Anti-Therapeutic Antibodies (ATAs) to Etrolizumab

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    End point title
    Number of Subjects With Anti-Therapeutic Antibodies (ATAs) to Etrolizumab [2]
    End point description
    A positive ATA antibody sample was defined as one in which the presence of detectable ATAs could be confirmed by competitive binding with etrolizumab. Treatment-induced ATAs = a subject with a negative baseline result followed by a positive post-dose result. Treatment-enhanced ATAs = a subject with a positive baseline result followed by positive post dose result(s) of at least 0.6 titer units greater than the baseline titer. The treated subjects population included any subject who received at least one dose of open-label study drug.
    End point type
    Primary
    End point timeframe
    From first dose of study drug to 12 weeks following last dose of study drug (assessed at baseline, Week 4, Week 8, Week 12, every 12 weeks thereafter up to last dose and safety follow-up)
    Notes
    [2] - 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 statistics only
    End point values
    Etrolizumab
    Number of subjects analysed
    108
    Units: subjects
    number (not applicable)
        Subjects positive for ATAs
    6
        Treatment-induced ATAs
    5
        Treatment-enhanced ATAs
    1
        Subjects negative for ATAs
    102
        Treatment unaffected
    1
    No statistical analyses for this end point

    Secondary: Serum Concentrations of Etrolizumab

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    End point title
    Serum Concentrations of Etrolizumab
    End point description
    Minimum serum concentration among available samples collected with 35 days of at least 3 consecutive doses of either 300 mg or 100 mg of study drug. The treated subjects population included any subject who received at least one dose of open-label study drug.
    End point type
    Secondary
    End point timeframe
    From first dose of study drug to 12 weeks following last dose of study drug (assessed at baseline, Week 4, Week 8, Week 12, every 12 weeks thereafter up to last dose and safety follow-up)
    End point values
    Etrolizumab
    Number of subjects analysed
    108
    Units: micrograms per milliliter
    median (full range (min-max))
        After 3 doses of 300 mg (n=92)
    14.8 (2.46 to 53.2)
        After 3 doses of 100 mg (n=41)
    3.86 (0.236 to 11.5)
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    From first dose of study drug to 12 weeks following last dose of study drug.
    Assessment type
    Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    19.0
    Reporting groups
    Reporting group title
    Etrolizumab
    Reporting group description
    Etrolizumab 300 milligrams (mg), subcutaneous (SC) administration (dose lowered to 100 mg at 15 - 16 weeks after first dose) every 4 weeks during the treatment period, up to 240 weeks.

    Serious adverse events
    Etrolizumab
    Total subjects affected by serious adverse events
         subjects affected / exposed
    26 / 108 (24.07%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    Vascular disorders
    Hypertension
         subjects affected / exposed
    1 / 108 (0.93%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Nervous system disorders
    Cerebral haematoma
         subjects affected / exposed
    1 / 108 (0.93%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Intracranial venous sinus thrombosis
         subjects affected / exposed
    1 / 108 (0.93%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Gastrointestinal disorders
    Abdominal pain
         subjects affected / exposed
    1 / 108 (0.93%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Colitis ulcerative
         subjects affected / exposed
    13 / 108 (12.04%)
         occurrences causally related to treatment / all
    0 / 13
         deaths causally related to treatment / all
    0 / 0
    Diarrhoea
         subjects affected / exposed
    1 / 108 (0.93%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Renal and urinary disorders
    Ureterolithiasis
         subjects affected / exposed
    1 / 108 (0.93%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    1 / 108 (0.93%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Extraskeletal ossification
         subjects affected / exposed
    1 / 108 (0.93%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Osteoarthritis
         subjects affected / exposed
    1 / 108 (0.93%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Vertebral foraminal stenosis
         subjects affected / exposed
    1 / 108 (0.93%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Metabolism and nutrition disorders
    Dehydration
         subjects affected / exposed
    2 / 108 (1.85%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Infections and infestations
    Anal abscess
         subjects affected / exposed
    2 / 108 (1.85%)
         occurrences causally related to treatment / all
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    Bronchitis
         subjects affected / exposed
    1 / 108 (0.93%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Campylobacter infection
         subjects affected / exposed
    1 / 108 (0.93%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Cytomegalovirus infection
         subjects affected / exposed
    1 / 108 (0.93%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Gastroenteritis
         subjects affected / exposed
    3 / 108 (2.78%)
         occurrences causally related to treatment / all
    1 / 3
         deaths causally related to treatment / all
    0 / 0
    Infected dermal cyst
         subjects affected / exposed
    1 / 108 (0.93%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Liver abscess
         subjects affected / exposed
    1 / 108 (0.93%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Pilonidal cyst
         subjects affected / exposed
    1 / 108 (0.93%)
         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
    Etrolizumab
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    80 / 108 (74.07%)
    Respiratory, thoracic and mediastinal disorders
    Nasal congestion
         subjects affected / exposed
    7 / 108 (6.48%)
         occurrences all number
    7
    Cough
         subjects affected / exposed
    10 / 108 (9.26%)
         occurrences all number
    13
    Blood and lymphatic system disorders
    Iron deficiency anaemia
         subjects affected / exposed
    6 / 108 (5.56%)
         occurrences all number
    6
    Nervous system disorders
    Headache
         subjects affected / exposed
    14 / 108 (12.96%)
         occurrences all number
    25
    General disorders and administration site conditions
    Influenza like illness
         subjects affected / exposed
    9 / 108 (8.33%)
         occurrences all number
    14
    Pyrexia
         subjects affected / exposed
    7 / 108 (6.48%)
         occurrences all number
    7
    Gastrointestinal disorders
    Abdominal pain
         subjects affected / exposed
    9 / 108 (8.33%)
         occurrences all number
    15
    Colitis ulcerative
         subjects affected / exposed
    27 / 108 (25.00%)
         occurrences all number
    34
    Abdominal pain upper
         subjects affected / exposed
    7 / 108 (6.48%)
         occurrences all number
    8
    Nausea
         subjects affected / exposed
    10 / 108 (9.26%)
         occurrences all number
    11
    Diarrhoea
         subjects affected / exposed
    9 / 108 (8.33%)
         occurrences all number
    15
    Skin and subcutaneous tissue disorders
    Rash
         subjects affected / exposed
    6 / 108 (5.56%)
         occurrences all number
    7
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    14 / 108 (12.96%)
         occurrences all number
    17
    Back pain
         subjects affected / exposed
    8 / 108 (7.41%)
         occurrences all number
    10
    Infections and infestations
    Bronchitis
         subjects affected / exposed
    11 / 108 (10.19%)
         occurrences all number
    15
    Gastroenteritis
         subjects affected / exposed
    11 / 108 (10.19%)
         occurrences all number
    15
    Nasopharyngitis
         subjects affected / exposed
    28 / 108 (25.93%)
         occurrences all number
    47
    Influenza
         subjects affected / exposed
    6 / 108 (5.56%)
         occurrences all number
    7
    Pharyngitis
         subjects affected / exposed
    8 / 108 (7.41%)
         occurrences all number
    10
    Upper respiratory tract infection
         subjects affected / exposed
    16 / 108 (14.81%)
         occurrences all number
    26

    More information

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    Substantial protocol amendments (globally)

    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    28 Feb 2013
    The dose of etrolizumab was lowered from 300 mg to 100 mg (subcutaneously) every 4 weeks.
    04 Oct 2013
    The dosing period was extended from 104 weeks to 180 weeks.
    27 Jun 2015
    The dosing period was extended from up to 180 weeks to up to Week 240. Added the option of transferring subjects within Study GA27927 to Study GA28951 for continued access to open-label etrolizumab.

    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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