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    Clinical Trial Results:
    A Phase 2b Double-blind, Multi-dose, Placebo-controlled Study to Evaluate the Efficacy and Safety of MEDI2070 in Subjects with Moderate to Severe Crohn’s Disease Who Have Failed or Are Intolerant to Anti-tumor Necrosis Factor-alpha Therapy

    Summary
    EudraCT number
    2015-000609-38
    Trial protocol
    DE   CZ   NL   ES   BG   HU   BE   IT   GB  
    Global end of trial date
    29 Jan 2018

    Results information
    Results version number
    v1(current)
    This version publication date
    15 Feb 2019
    First version publication date
    15 Feb 2019
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    D5170C00002
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    NCT02574637
    WHO universal trial number (UTN)
    -
    Sponsors
    Sponsor organisation name
    Allergan plc
    Sponsor organisation address
    Clonshaugh Business & Technology Park, Coolock, Dublin, Ireland, D17 E400
    Public contact
    Clinical Trials Registry Team, Allergan plc, 001 877‐277‐8566, IR-CTRegistration@Allergan.com
    Scientific contact
    Therapeutic Area Head, Allergan plc, 001 862-261-7000, IR-CTRegistration@Allergan.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
    29 Jan 2018
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    29 Jan 2018
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    The primary objective of the study was to evaluate the efficacy of MEDI2070 versus placebo to induce clinical remission based on the Crohn’s Disease Activity Index (CDAI) score at Week 8 in participants with moderate to severe Crohn’s disease (CD) who have failed or are intolerant to anti-tumor necrosis factor-alpha (TNFα) therapy.
    Protection of trial subjects
    All study participants were required to read and sign an Informed Consent Form.
    Background therapy
    -
    Evidence for comparator
    -
    Actual start date of recruitment
    05 Jan 2016
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Belgium: 2
    Country: Number of subjects enrolled
    France: 3
    Country: Number of subjects enrolled
    Germany: 3
    Country: Number of subjects enrolled
    Hungary: 2
    Country: Number of subjects enrolled
    Italy: 1
    Country: Number of subjects enrolled
    Spain: 2
    Country: Number of subjects enrolled
    Australia: 1
    Country: Number of subjects enrolled
    Canada: 1
    Country: Number of subjects enrolled
    United States: 14
    Worldwide total number of subjects
    29
    EEA total number of subjects
    13
    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)
    28
    From 65 to 84 years
    1
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    -

    Pre-assignment
    Screening details
    The study enrolled 29 participants who were randomized to one of five treatment groups (Placebo/ Brazikumab High dose/ Brazikumab High-Medium dose/ Brazikumab Low dose/ Brazikumab Low-Medium dose). This study was early terminated.

    Period 1
    Period 1 title
    Double-blind Treatment Period, Week 0-24
    Is this the baseline period?
    Yes
    Allocation method
    Randomised - controlled
    Blinding used
    Double blind
    Roles blinded
    Subject, Investigator, Monitor, Carer, Data analyst, Assessor

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    Placebo
    Arm description
    Placebo-matching brazikumab intravenous (IV) infusion and subcutaneous (SC) injection at Weeks 0 and 4 followed by placebo-matching brazikumab SC injection at Weeks 8 and 12 in the induction phase and at Weeks 16, 20 and 24 in the maintenance phase.
    Arm type
    Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection/infusion
    Routes of administration
    Intravenous use, Subcutaneous use
    Dosage and administration details
    Placebo-matching brazikumab SC injection and IV infusion at Weeks 0 and 4 followed by placebo-matching brazikumab SC injection every 4 weeks starting at Week 8 up to Week 24 in the induction and maintenance phases.

    Arm title
    Brazikumab High Dose
    Arm description
    Brazikumab 700 mg, IV infusion and placebo-matching brazikumab, SC injection at Weeks 0 and 4 followed by brazikumab 210 mg, SC injection at Weeks 8 and 12 in the induction phase and at Weeks 16, 20 and 24 in the maintenance phase.
    Arm type
    Experimental

    Investigational medicinal product name
    Brazikumab
    Investigational medicinal product code
    Other name
    MEDI2070
    Pharmaceutical forms
    Solution for injection/infusion
    Routes of administration
    Intravenous use, Subcutaneous use
    Dosage and administration details
    Brazikumab 700 mg, IV infusion at Weeks 0 and 4 followed by brazikumab 210 mg, SC injection, every 4 weeks starting at Week 8 up to Week 24 in the induction and maintenance phases.

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection/infusion
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Placebo-matching brazikumab, SC injection at Weeks 0 and 4 in the induction phase.

    Arm title
    Brazikumab High- Medium Dose
    Arm description
    Brazikumab 280 mg, IV infusion and placebo-matching brazikumab, SC injection at Week 0 followed by brazikumab 210 mg, SC injection and placebo-matching brazikumab, IV infusion at Week 4, followed by brazikumab 210 mg, SC injection at Weeks 8 and 12 in the induction phase and at Weeks 16, 20 and 24 in the maintenance phase.
    Arm type
    Experimental

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection/infusion
    Routes of administration
    Intravenous use, Subcutaneous use
    Dosage and administration details
    Placebo-matching brazikumab, SC injection at Week 0 followed by placebo-matching brazikumab, IV infusion at Week 4 in the induction phase.

    Investigational medicinal product name
    Brazikumab
    Investigational medicinal product code
    Other name
    MEDI2070
    Pharmaceutical forms
    Solution for injection/infusion
    Routes of administration
    Intravenous use, Subcutaneous use
    Dosage and administration details
    Brazikumab 280 mg, IV infusion at Week 0 followed by brazikumab 210 mg, SC injection every 4 weeks starting at Week 4 up to Week 24 in the induction and the maintenance phases.

    Arm title
    Brazikumab Low- Medium Dose
    Arm description
    Brazikumab 210 mg, SC injection and placebo-matching brazikumab, IV infusion at Week 0 followed by brazikumab 105 mg, SC injection and placebo-matching brazikumab, IV infusion at Weeks 4, followed by brazikumab 105 mg, SC injection at Weeks 8 and 12 in the induction phase and at Weeks 16, 20 and 24 in the maintenance phase.
    Arm type
    Experimental

    Investigational medicinal product name
    Brazikumab
    Investigational medicinal product code
    Other name
    MEDI2070
    Pharmaceutical forms
    Solution for injection/infusion
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Brazikumab 210 mg, SC injection at Week 0 followed by brazikumab 105 mg, every 4 weeks, starting at Week 4 up to Week 24 in the induction and maintenance phases.

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection/infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Placebo-matching brazikumab, IV infusion at Weeks 0 and 4 in the induction phase.

    Arm title
    Brazikumab Low Dose
    Arm description
    Brazikumab 70 mg, SC injection and placebo-matching brazikumab, IV infusion at Week 0 followed by brazikumab 35 mg, SC injection and placebo-matching brazikumab, IV infusion at Week 4, followed by brazikumab 35 mg, SC injection at Weeks 8 and 12 in the induction phase and at Weeks 16, 20 and 24 in the maintenance phase.
    Arm type
    Experimental

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection/infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Placebo-matching brazikumab, IV infusion at Weeks 0 and 4 in the induction phase.

    Investigational medicinal product name
    Brazikumab
    Investigational medicinal product code
    Other name
    MEDI2070
    Pharmaceutical forms
    Solution for injection/infusion
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Brazikumab 70 mg, SC injection at Week 0 followed by brazikumab 35 mg, SC injection every 4 weeks starting at Week 4 up to Week 24 in the induction phase and the maintenance phases.

    Number of subjects in period 1
    Placebo Brazikumab High Dose Brazikumab High- Medium Dose Brazikumab Low- Medium Dose Brazikumab Low Dose
    Started
    5
    5
    9
    7
    3
    Completed
    2
    4
    2
    3
    1
    Not completed
    3
    1
    7
    4
    2
         Protocol Deviation
    1
    -
    -
    -
    -
         Lack of efficacy
    -
    -
    2
    -
    -
         Other Miscellaneous Reasons
    -
    -
    -
    1
    -
         Non-Compliance With Study Drug
    -
    -
    -
    1
    -
         Study Terminated By Sponsor
    1
    1
    5
    2
    2
         Adverse Event
    1
    -
    -
    -
    -
    Period 2
    Period 2 title
    Intermediate Period, Week 25-27
    Is this the baseline period?
    No
    Allocation method
    Not applicable
    Blinding used
    Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    Placebo
    Arm description
    -
    Arm type
    No intervention

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Arm title
    Brazikumab High Dose
    Arm description
    -
    Arm type
    No intervention

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Arm title
    Brazikumab High- Medium Dose
    Arm description
    -
    Arm type
    No intervention

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Arm title
    Brazikumab Low- Medium Dose
    Arm description
    -
    Arm type
    No intervention

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Arm title
    Brazikumab Low Dose
    Arm description
    -
    Arm type
    No intervention

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Number of subjects in period 2
    Placebo Brazikumab High Dose Brazikumab High- Medium Dose Brazikumab Low- Medium Dose Brazikumab Low Dose
    Started
    2
    4
    2
    3
    1
    Completed
    2
    3
    2
    3
    1
    Not completed
    0
    1
    0
    0
    0
         Other Miscellaneous Reasons
    -
    1
    -
    -
    -
    Period 3
    Period 3 title
    Open-label (OL) Period, Week 28-48
    Is this the baseline period?
    No
    Allocation method
    Not applicable
    Blinding used
    Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    Placebo/Brazikumab 210 mg in OL Period
    Arm description
    Brazikumab 210 mg, SC injection every 4 weeks in the open-label period starting at Week 28 up to Week 48. Participants received placebo-matching brazikumab in the double-blind treatment period.‌
    Arm type
    Experimental

    Investigational medicinal product name
    Brazikumab
    Investigational medicinal product code
    Other name
    MEDI2070
    Pharmaceutical forms
    Solution for injection/infusion
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Brazikumab 210 mg, SC injection, every 4 weeks starting at Week 28 up to Week 48 in the open-label period.

    Arm title
    Brazikumab High Dose/Brazikumab 210 mg in OL Period
    Arm description
    Brazikumab 210 mg, SC injection every 4 weeks in the open-label period starting at Week 28 up to Week 48. Participants received high dose of brazikumab in the double-blind treatment period.
    Arm type
    Experimental

    Investigational medicinal product name
    Brazikumab
    Investigational medicinal product code
    Other name
    MEDI2070
    Pharmaceutical forms
    Solution for injection/infusion
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Brazikumab 210 mg, SC injection, every 4 weeks starting at Week 28 up to Week 48 in the open-label period.

    Arm title
    Brazikumab High- Medium Dose/Brazikumab 210 mg in OL Period
    Arm description
    Brazikumab 210 mg, SC injection every 4 weeks in the open-label period starting at Week 28 up to Week 48. Participants received high-medium dose of brazikumab in the double-blind treatment period.‌
    Arm type
    Experimental

    Investigational medicinal product name
    Brazikumab
    Investigational medicinal product code
    Other name
    MEDI2070
    Pharmaceutical forms
    Solution for injection/infusion
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Brazikumab 210 mg, SC injection, every 4 weeks starting at Week 28 up to Week 48 in the open-label period.

    Arm title
    Brazikumab Low-Medium Dose/Brazikumab 210 mg in OL Period
    Arm description
    Brazikumab 210 mg, SC injection every 4 weeks in the open-label period starting at Week 28 up to Week 48. Participants received low-medium dose of brazikumab in the double-blind treatment period.
    Arm type
    Experimental

    Investigational medicinal product name
    Brazikumab
    Investigational medicinal product code
    Other name
    MEDI2070
    Pharmaceutical forms
    Solution for injection/infusion
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Brazikumab 210 mg, SC injection, every 4 weeks starting at Week 28 up to Week 48 in the open-label period.

    Arm title
    Brazikumab Low Dose/Brazikumab 210 mg in OL Period
    Arm description
    Brazikumab 210 mg, SC injection every 4 weeks in the open-label period starting at Week 28 up to Week 48. Participants received low dose of brazikumab in the double-blind treatment period.
    Arm type
    Experimental

    Investigational medicinal product name
    Brazikumab
    Investigational medicinal product code
    Other name
    MEDI2070
    Pharmaceutical forms
    Solution for injection/infusion
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Brazikumab 210 mg, SC injection, every 4 weeks starting at Week 28 up to Week 48 in the open-label period.

    Number of subjects in period 3
    Placebo/Brazikumab 210 mg in OL Period Brazikumab High Dose/Brazikumab 210 mg in OL Period Brazikumab High- Medium Dose/Brazikumab 210 mg in OL Period Brazikumab Low-Medium Dose/Brazikumab 210 mg in OL Period Brazikumab Low Dose/Brazikumab 210 mg in OL Period
    Started
    2
    3
    2
    3
    1
    Completed
    0
    1
    1
    1
    0
    Not completed
    2
    2
    1
    2
    1
         Withdrawal by Subject
    1
    -
    -
    -
    1
         Study Terminated By Sponsor
    1
    2
    1
    1
    -
         Adverse Event
    -
    -
    -
    1
    -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Placebo
    Reporting group description
    Placebo-matching brazikumab intravenous (IV) infusion and subcutaneous (SC) injection at Weeks 0 and 4 followed by placebo-matching brazikumab SC injection at Weeks 8 and 12 in the induction phase and at Weeks 16, 20 and 24 in the maintenance phase.

    Reporting group title
    Brazikumab High Dose
    Reporting group description
    Brazikumab 700 mg, IV infusion and placebo-matching brazikumab, SC injection at Weeks 0 and 4 followed by brazikumab 210 mg, SC injection at Weeks 8 and 12 in the induction phase and at Weeks 16, 20 and 24 in the maintenance phase.

    Reporting group title
    Brazikumab High- Medium Dose
    Reporting group description
    Brazikumab 280 mg, IV infusion and placebo-matching brazikumab, SC injection at Week 0 followed by brazikumab 210 mg, SC injection and placebo-matching brazikumab, IV infusion at Week 4, followed by brazikumab 210 mg, SC injection at Weeks 8 and 12 in the induction phase and at Weeks 16, 20 and 24 in the maintenance phase.

    Reporting group title
    Brazikumab Low- Medium Dose
    Reporting group description
    Brazikumab 210 mg, SC injection and placebo-matching brazikumab, IV infusion at Week 0 followed by brazikumab 105 mg, SC injection and placebo-matching brazikumab, IV infusion at Weeks 4, followed by brazikumab 105 mg, SC injection at Weeks 8 and 12 in the induction phase and at Weeks 16, 20 and 24 in the maintenance phase.

    Reporting group title
    Brazikumab Low Dose
    Reporting group description
    Brazikumab 70 mg, SC injection and placebo-matching brazikumab, IV infusion at Week 0 followed by brazikumab 35 mg, SC injection and placebo-matching brazikumab, IV infusion at Week 4, followed by brazikumab 35 mg, SC injection at Weeks 8 and 12 in the induction phase and at Weeks 16, 20 and 24 in the maintenance phase.

    Reporting group values
    Placebo Brazikumab High Dose Brazikumab High- Medium Dose Brazikumab Low- Medium Dose Brazikumab Low Dose Total
    Number of subjects
    5 5 9 7 3 29
    Age Categorical
    Units: Subjects
        Adults (18-64 years)
    5 5 8 7 3 28
        From 65-84 years
    0 0 1 0 0 1
    Age Continuous
    Units: years
        arithmetic mean (standard deviation)
    34.6 ± 9.07 37.2 ± 13.29 38.3 ± 15.03 39.9 ± 13.89 40.7 ± 11.37 -
    Gender Categorical
    Units: Subjects
        Female
    3 3 6 4 1 17
        Male
    2 2 3 3 2 12

    End points

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    End points reporting groups
    Reporting group title
    Placebo
    Reporting group description
    Placebo-matching brazikumab intravenous (IV) infusion and subcutaneous (SC) injection at Weeks 0 and 4 followed by placebo-matching brazikumab SC injection at Weeks 8 and 12 in the induction phase and at Weeks 16, 20 and 24 in the maintenance phase.

    Reporting group title
    Brazikumab High Dose
    Reporting group description
    Brazikumab 700 mg, IV infusion and placebo-matching brazikumab, SC injection at Weeks 0 and 4 followed by brazikumab 210 mg, SC injection at Weeks 8 and 12 in the induction phase and at Weeks 16, 20 and 24 in the maintenance phase.

    Reporting group title
    Brazikumab High- Medium Dose
    Reporting group description
    Brazikumab 280 mg, IV infusion and placebo-matching brazikumab, SC injection at Week 0 followed by brazikumab 210 mg, SC injection and placebo-matching brazikumab, IV infusion at Week 4, followed by brazikumab 210 mg, SC injection at Weeks 8 and 12 in the induction phase and at Weeks 16, 20 and 24 in the maintenance phase.

    Reporting group title
    Brazikumab Low- Medium Dose
    Reporting group description
    Brazikumab 210 mg, SC injection and placebo-matching brazikumab, IV infusion at Week 0 followed by brazikumab 105 mg, SC injection and placebo-matching brazikumab, IV infusion at Weeks 4, followed by brazikumab 105 mg, SC injection at Weeks 8 and 12 in the induction phase and at Weeks 16, 20 and 24 in the maintenance phase.

    Reporting group title
    Brazikumab Low Dose
    Reporting group description
    Brazikumab 70 mg, SC injection and placebo-matching brazikumab, IV infusion at Week 0 followed by brazikumab 35 mg, SC injection and placebo-matching brazikumab, IV infusion at Week 4, followed by brazikumab 35 mg, SC injection at Weeks 8 and 12 in the induction phase and at Weeks 16, 20 and 24 in the maintenance phase.
    Reporting group title
    Placebo
    Reporting group description
    -

    Reporting group title
    Brazikumab High Dose
    Reporting group description
    -

    Reporting group title
    Brazikumab High- Medium Dose
    Reporting group description
    -

    Reporting group title
    Brazikumab Low- Medium Dose
    Reporting group description
    -

    Reporting group title
    Brazikumab Low Dose
    Reporting group description
    -
    Reporting group title
    Placebo/Brazikumab 210 mg in OL Period
    Reporting group description
    Brazikumab 210 mg, SC injection every 4 weeks in the open-label period starting at Week 28 up to Week 48. Participants received placebo-matching brazikumab in the double-blind treatment period.‌

    Reporting group title
    Brazikumab High Dose/Brazikumab 210 mg in OL Period
    Reporting group description
    Brazikumab 210 mg, SC injection every 4 weeks in the open-label period starting at Week 28 up to Week 48. Participants received high dose of brazikumab in the double-blind treatment period.

    Reporting group title
    Brazikumab High- Medium Dose/Brazikumab 210 mg in OL Period
    Reporting group description
    Brazikumab 210 mg, SC injection every 4 weeks in the open-label period starting at Week 28 up to Week 48. Participants received high-medium dose of brazikumab in the double-blind treatment period.‌

    Reporting group title
    Brazikumab Low-Medium Dose/Brazikumab 210 mg in OL Period
    Reporting group description
    Brazikumab 210 mg, SC injection every 4 weeks in the open-label period starting at Week 28 up to Week 48. Participants received low-medium dose of brazikumab in the double-blind treatment period.

    Reporting group title
    Brazikumab Low Dose/Brazikumab 210 mg in OL Period
    Reporting group description
    Brazikumab 210 mg, SC injection every 4 weeks in the open-label period starting at Week 28 up to Week 48. Participants received low dose of brazikumab in the double-blind treatment period.

    Primary: Percentage of Participants With Crohn’s Disease Activity Index (CDAI) Remission at Week 8

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    End point title
    Percentage of Participants With Crohn’s Disease Activity Index (CDAI) Remission at Week 8 [1]
    End point description
    CDAI remission was defined as a CDAI score of <150 at Week 8. CDAI score was calculated by summing weighted scores for subjective items [number of liquid or very soft stools, abdominal pain (on a scale of 0=none to 3=severe) and general well-being (on a scale of 1=generally well to 4=terrible)] recorded by a diary during a 1-week period, and objective items [associated symptoms, taking antidiarrheal agents such as loperamide/opiates, abdominal mass, hematocrit, daily morning temperature, and body weight]. CDAI scores range from 0 to approximately 600 points, higher score indicates higher disease activity.
    End point type
    Primary
    End point timeframe
    Week 8
    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 data was collected for this endpoint.
    End point values
    Placebo Brazikumab High Dose Brazikumab High- Medium Dose Brazikumab Low- Medium Dose Brazikumab Low Dose
    Number of subjects analysed
    0 [2]
    0 [3]
    0 [4]
    0 [5]
    0 [6]
    Units: percentage of participants
        number (not applicable)
    Notes
    [2] - This endpoint was not performed as the study was terminated.
    [3] - This endpoint was not performed as the study was terminated.
    [4] - This endpoint was not performed as the study was terminated.
    [5] - This endpoint was not performed as the study was terminated.
    [6] - This endpoint was not performed as the study was terminated.
    No statistical analyses for this end point

    Secondary: Percentage of Participants With Simple Endoscopic Score for Crohn’s Disease (SES-CD) Remission at Weeks 16 and 28

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    End point title
    Percentage of Participants With Simple Endoscopic Score for Crohn’s Disease (SES-CD) Remission at Weeks 16 and 28
    End point description
    SES-CD remission was defined as a Total SES-CD score of ≤4 and no subscore >2. The SES-CD evaluates 4 endoscopic variables [ulcer size, proportion of the surface area that is ulcerated, proportion of the surface area affected, and stenosis] each rated from 0 (best) to 3 (worst) in 5 segments evaluated during ileocolonoscopy [ileum, right colon, transverse colon, left colon, and rectum]. The score for each endoscopic variable is the sum of values obtained for each segment. The SES-CD total is the sum of the 4 endoscopic variable scores from 0 to 60, where higher scores indicate more severe disease.
    End point type
    Secondary
    End point timeframe
    Weeks 16 and 28
    End point values
    Placebo Brazikumab High Dose Brazikumab High- Medium Dose Brazikumab Low- Medium Dose Brazikumab Low Dose
    Number of subjects analysed
    0 [7]
    0 [8]
    0 [9]
    0 [10]
    0 [11]
    Units: percentage of participants
        number (not applicable)
    Notes
    [7] - This endpoint was not performed as the study was terminated.
    [8] - This endpoint was not performed as the study was terminated.
    [9] - This endpoint was not performed as the study was terminated.
    [10] - This endpoint was not performed as the study was terminated.
    [11] - This endpoint was not performed as the study was terminated.
    No statistical analyses for this end point

    Secondary: Percentage of Participants With SES-CD Response at Week 16

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    End point title
    Percentage of Participants With SES-CD Response at Week 16
    End point description
    SES-CD response was defined as a decrease from baseline in SES-CD score ≥ 50%. The SES-CD evaluates 4 endoscopic variables [ulcer size, proportion of the surface area that is ulcerated, proportion of the surface area affected, and stenosis] each rated from 0 (best) to 3 (worst) in 5 segments evaluated during ileocolonoscopy [ileum, right colon, transverse colon, left colon, and rectum]. The score for each endoscopic variable is the sum of values obtained for each segment. The SES-CD total is the sum of the 4 endoscopic variable scores from 0 to 60, where higher scores indicate more severe disease.
    End point type
    Secondary
    End point timeframe
    Baseline to Week 16
    End point values
    Placebo Brazikumab High Dose Brazikumab High- Medium Dose Brazikumab Low- Medium Dose Brazikumab Low Dose
    Number of subjects analysed
    0 [12]
    0 [13]
    0 [14]
    0 [15]
    0 [16]
    Units: percentage of participants
        number (not applicable)
    Notes
    [12] - This endpoint was not performed as the study was terminated.
    [13] - This endpoint was not performed as the study was terminated.
    [14] - This endpoint was not performed as the study was terminated.
    [15] - This endpoint was not performed as the study was terminated.
    [16] - This endpoint was not performed as the study was terminated.
    No statistical analyses for this end point

    Secondary: Percentage of Participants With Patient Response Outcome-2 (PRO2) Remission at Weeks 8, 16 and 28

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    End point title
    Percentage of Participants With Patient Response Outcome-2 (PRO2) Remission at Weeks 8, 16 and 28
    End point description
    PRO2 evaluated 2 patient-reported symptoms: the frequency of liquid or soft stools and abdominal pain. A weekly score was calculated for the liquid or soft stool frequency and a separate weekly score was calculated for abdominal pain, in each case based on daily symptom reporting. PRO2-remission was defined as PRO2 less than 8 points. PRO2 is a composite index consisting of weighted scoring of both variables. PRO2 scores ranges from 0 to approximately 45, higher score indicates higher disease activity.
    End point type
    Secondary
    End point timeframe
    Weeks 8, 16 and 28
    End point values
    Placebo Brazikumab High Dose Brazikumab High- Medium Dose Brazikumab Low- Medium Dose Brazikumab Low Dose
    Number of subjects analysed
    0 [17]
    0 [18]
    0 [19]
    0 [20]
    0 [21]
    Units: percentage of participants
        number (not applicable)
    Notes
    [17] - This endpoint was not performed as the study was terminated.
    [18] - This endpoint was not performed as the study was terminated.
    [19] - This endpoint was not performed as the study was terminated.
    [20] - This endpoint was not performed as the study was terminated.
    [21] - This endpoint was not performed as the study was terminated.
    No statistical analyses for this end point

    Secondary: Percentage of Participants With PRO2 Response at Weeks 8 and 16

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    End point title
    Percentage of Participants With PRO2 Response at Weeks 8 and 16
    End point description
    PRO2 evaluated 2 patient-reported symptoms: the frequency of liquid or soft stools and abdominal pain. PRO2 response was defined as remission or response in one symptom (either abdominal pain or stool frequency) plus response in the other: a) abdominal pain remission: On an 11-point (0 to 10) pain scale: During 1 week, no daily score > 2, b) abdominal pain response: On an 11-point (0 to 10) pain scale: ≥ 30% reduction in weekly pain score from baseline, c) loose/liquid stool frequency remission: Counting stools identified as Type 6 or 7 on Bristol Stool Form Scale (BSFS), (The BSFS is a scale between 1-7, where 1 correlates with the firmest stool and 7 correlates with entirely liquid stool), during 1 week, each daily loose/liquid stool count ≤ 3, d) loose/liquid stool frequency response: Counting stools identified as Type 6 or 7 on BSFS, ≥ 30% reduction in weekly loose/liquid stool count compared to baseline.
    End point type
    Secondary
    End point timeframe
    Baseline to Weeks 8 and 16
    End point values
    Placebo Brazikumab High Dose Brazikumab High- Medium Dose Brazikumab Low- Medium Dose Brazikumab Low Dose
    Number of subjects analysed
    0 [22]
    0 [23]
    0 [24]
    0 [25]
    0 [26]
    Units: percentage of participants
        number (not applicable)
    Notes
    [22] - This endpoint was not performed as the study was terminated.
    [23] - This endpoint was not performed as the study was terminated.
    [24] - This endpoint was not performed as the study was terminated.
    [25] - This endpoint was not performed as the study was terminated.
    [26] - This endpoint was not performed as the study was terminated.
    No statistical analyses for this end point

    Secondary: Percentage of Participants With CDAI Clinical Remission at Week 28

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    End point title
    Percentage of Participants With CDAI Clinical Remission at Week 28
    End point description
    CDAI remission was defined as a CDAI score of <150 at Week 28. CDAI score was calculated by summing weighted scores for subjective items [number of liquid or very soft stools, abdominal pain (on a scale of 0=none to 3=severe) and general well-being (on a scale of 1=generally well to 4=terrible)] recorded by a diary during a 1-week period, and objective items [associated symptoms, taking antidiarrheal agents such as loperamide/opiates, abdominal mass, hematocrit, daily morning temperature, and body weight]. CDAI scores range from 0 to approximately 600 points, higher score indicates higher disease activity.
    End point type
    Secondary
    End point timeframe
    Week 28
    End point values
    Placebo Brazikumab High Dose Brazikumab High- Medium Dose Brazikumab Low- Medium Dose Brazikumab Low Dose
    Number of subjects analysed
    0 [27]
    0 [28]
    0 [29]
    0 [30]
    0 [31]
    Units: percentage of participants
        number (not applicable)
    Notes
    [27] - This endpoint was not performed as the study was terminated.
    [28] - This endpoint was not performed as the study was terminated.
    [29] - This endpoint was not performed as the study was terminated.
    [30] - This endpoint was not performed as the study was terminated.
    [31] - This endpoint was not performed as the study was terminated.
    No statistical analyses for this end point

    Secondary: Percentage of Participants With CDAI Modified Sustained Clinical Remission at Both Weeks 8 and 28

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    End point title
    Percentage of Participants With CDAI Modified Sustained Clinical Remission at Both Weeks 8 and 28
    End point description
    CDAI modified sustained clinical remission was defined as a CDAI score of <150 at both Week 8 and Week 28. CDAI score was calculated by summing weighted scores for subjective items [number of liquid or very soft stools, abdominal pain (on a scale of 0=mild to 3=severe) and general well-being (on a scale of 1=generally well to 4=terrible)] recorded by a diary during a 1-week period, and objective items [associated symptoms, taking antidiarrheal agents such as loperamide/opiates, abdominal mass, hematocrit, daily morning temperature and body weight]. CDAI scores range from 0 to approximately 600 points, higher score indicates higher disease activity.
    End point type
    Secondary
    End point timeframe
    Weeks 8 and 28
    End point values
    Placebo Brazikumab High Dose Brazikumab High- Medium Dose Brazikumab Low- Medium Dose Brazikumab Low Dose
    Number of subjects analysed
    0 [32]
    0 [33]
    0 [34]
    0 [35]
    0 [36]
    Units: percentage of participants
        number (not applicable)
    Notes
    [32] - This endpoint was not performed as the study was terminated.
    [33] - This endpoint was not performed as the study was terminated.
    [34] - This endpoint was not performed as the study was terminated.
    [35] - This endpoint was not performed as the study was terminated.
    [36] - This endpoint was not performed as the study was terminated.
    No statistical analyses for this end point

    Secondary: Percentage of Participants With SES-CD Modified Sustained Remission at Both Weeks 16 and 28

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    End point title
    Percentage of Participants With SES-CD Modified Sustained Remission at Both Weeks 16 and 28
    End point description
    SES-CD modified sustained remission was defined as remission at both Week 16 and Week 28. Endoscopic remission was defined as a SES-CD score of ≤4. The SES-CD evaluates 4 endoscopic variables [ulcer size, proportion of the surface area that is ulcerated, proportion of the surface area affected, and stenosis] each rated from 0 (best) to 3 (worst) in 5 segments evaluated during ileocolonoscopy [ileum, right colon, transverse colon, left colon, and rectum]. The score for each endoscopic variable is the sum of values obtained for each segment. The SES-CD total is the sum of the 4 endoscopic variable scores from 0 to 60, where higher scores indicate more severe disease.
    End point type
    Secondary
    End point timeframe
    Weeks 16 and 28
    End point values
    Placebo Brazikumab High Dose Brazikumab High- Medium Dose Brazikumab Low- Medium Dose Brazikumab Low Dose
    Number of subjects analysed
    0 [37]
    0 [38]
    0 [39]
    0 [40]
    0 [41]
    Units: percentage of participants
        number (not applicable)
    Notes
    [37] - This endpoint was not performed as the study was terminated.
    [38] - This endpoint was not performed as the study was terminated.
    [39] - This endpoint was not performed as the study was terminated.
    [40] - This endpoint was not performed as the study was terminated.
    [41] - This endpoint was not performed as the study was terminated.
    No statistical analyses for this end point

    Secondary: Percentage of Participants With PRO2 Modified Sustained Remission at Both Weeks 8 and 28

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    End point title
    Percentage of Participants With PRO2 Modified Sustained Remission at Both Weeks 8 and 28
    End point description
    PRO2 modified sustained remission was defined as PRO2 less than 8 points at both Week 8 and Week 28. PRO2 evaluated 2 patient-reported symptoms: the frequency of liquid or soft stools and abdominal pain. A weekly score was calculated for the liquid or soft stool frequency and a separate weekly score was calculated for abdominal pain, in each case based on daily symptom reporting. PRO2-remission was defined as PRO2 less than 8 points. PRO2 is a composite index consisting of weighted scoring of both variables. PRO2 scores ranges from 0 to approximately 45, higher score indicates higher disease activity.
    End point type
    Secondary
    End point timeframe
    Weeks 8 and 28
    End point values
    Placebo Brazikumab High Dose Brazikumab High- Medium Dose Brazikumab Low- Medium Dose Brazikumab Low Dose
    Number of subjects analysed
    0 [42]
    0 [43]
    0 [44]
    0 [45]
    0 [46]
    Units: percentage of participants
        number (not applicable)
    Notes
    [42] - This endpoint was not performed as the study was terminated.
    [43] - This endpoint was not performed as the study was terminated.
    [44] - This endpoint was not performed as the study was terminated.
    [45] - This endpoint was not performed as the study was terminated.
    [46] - This endpoint was not performed as the study was terminated.
    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 up to 28 weeks post last dose (approximately up to Week 80)
    Assessment type
    Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    20.1
    Reporting groups
    Reporting group title
    Placebo in Double-blind Treatment Period
    Reporting group description
    Placebo-matching brazikumab IV infusion and SC injection at Weeks 0 and 4 followed by placebo-matching brazikumab SC injection at Weeks 8 and 12 in the induction phase and at Weeks 16, 20 and 24 in the maintenance phase.

    Reporting group title
    Brazikumab High Dose in Double-blind Treatment Period
    Reporting group description
    Brazikumab 700 mg, IV infusion and placebo-matching brazikumab, SC injection at Weeks 0 and 4 followed by brazikumab 210 mg, SC injection at Weeks 8, 12, 20 and 24 in the induction and the maintenance phase.

    Reporting group title
    Brazikumab High- Medium dose in Double-blind Treatment Period
    Reporting group description
    Brazikumab 280 mg, IV infusion and placebo-matching brazikumab, SC injection at Week 0 followed by brazikumab 210 mg, SC injection and placebo-matching brazikumab, IV infusion at Weeks 4, followed by brazikumab 210 mg, SC injection at Weeks 8, 12, 20 and 24 in the induction and the maintenance phase.‌

    Reporting group title
    Brazikumab Low- Medium Dose in Double-blind Treatment Period
    Reporting group description
    Brazikumab 210 mg, SC injection and placebo-matching brazikumab, IV infusion at Week 0 followed by brazikumab 105 mg, SC injection and placebo-matching brazikumab, IV infusion at Weeks 4, followed by brazikumab 105 mg, SC injection at Weeks 8, 12, 20 and 24 in the induction and the maintenance phase.‌

    Reporting group title
    Brazikumab Low Dose in Double-blind Treatment Period
    Reporting group description
    Brazikumab 70 mg, SC injection and placebo-matching brazikumab, IV infusion at Week 0 followed by brazikumab 35 mg, SC injection and placebo-matching brazikumab, IV infusion at Week 4, followed by brazikumab 35 mg, SC injection at Weeks 8, 12, 20 and 24 in the induction and the maintenance phase.‌

    Reporting group title
    Placebo/Brazikumab 210 mg in OL Period
    Reporting group description
    Brazikumab 210 mg, SC injection every 4 weeks in the open-label period starting at Week 28 up to Week 48. Participants received placebo-matching brazikumab in the double-blind treatment period.

    Reporting group title
    Brazikumab High Dose/Brazikumab 210 mg in OL Period
    Reporting group description
    Brazikumab 210 mg, SC injection every 4 weeks in the open-label period starting at Week 28 up to Week 48. Participants received high dose of brazikumab in the double-blind treatment period.

    Reporting group title
    Brazikumab High- Medium Dose/Brazikumab 210 mg in OL Period
    Reporting group description
    Brazikumab 210 mg, SC injection every 4 weeks in the open-label period starting at Week 28 up to Week 48. Participants received high-medium dose of brazikumab in the double-blind treatment period.

    Reporting group title
    Brazikumab Low-Medium Dose/Brazikumab 210 mg in OL Period
    Reporting group description
    Brazikumab 210 mg, SC injection every 4 weeks in the open-label period starting at Week 28 up to Week 48. Participants received low-medium dose of brazikumab in the double-blind treatment period.

    Reporting group title
    Brazikumab Low Dose/Brazikumab 210 mg in OL Period
    Reporting group description
    Brazikumab 210 mg, SC injection every 4 weeks in the open-label period starting at Week 28 up to Week 48. Participants received low dose of brazikumab in the double-blind treatment period.

    Serious adverse events
    Placebo in Double-blind Treatment Period Brazikumab High Dose in Double-blind Treatment Period Brazikumab High- Medium dose in Double-blind Treatment Period Brazikumab Low- Medium Dose in Double-blind Treatment Period Brazikumab Low Dose in Double-blind Treatment Period Placebo/Brazikumab 210 mg in OL Period Brazikumab High Dose/Brazikumab 210 mg in OL Period Brazikumab High- Medium Dose/Brazikumab 210 mg in OL Period Brazikumab Low-Medium Dose/Brazikumab 210 mg in OL Period Brazikumab Low Dose/Brazikumab 210 mg in OL Period
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 5 (0.00%)
    1 / 5 (20.00%)
    0 / 9 (0.00%)
    1 / 7 (14.29%)
    1 / 3 (33.33%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
    1 / 3 (33.33%)
    0 / 1 (0.00%)
         number of deaths (all causes)
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Respiratory, thoracic and mediastinal disorders
    Asthma
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 9 (0.00%)
    1 / 7 (14.29%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Nervous system disorders
    Ischaemic stroke
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 9 (0.00%)
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
    1 / 3 (33.33%)
    0 / 1 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Crohn's disease
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 9 (0.00%)
    1 / 7 (14.29%)
    1 / 3 (33.33%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Pneumonia
         subjects affected / exposed
    0 / 5 (0.00%)
    1 / 5 (20.00%)
    0 / 9 (0.00%)
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    Placebo in Double-blind Treatment Period Brazikumab High Dose in Double-blind Treatment Period Brazikumab High- Medium dose in Double-blind Treatment Period Brazikumab Low- Medium Dose in Double-blind Treatment Period Brazikumab Low Dose in Double-blind Treatment Period Placebo/Brazikumab 210 mg in OL Period Brazikumab High Dose/Brazikumab 210 mg in OL Period Brazikumab High- Medium Dose/Brazikumab 210 mg in OL Period Brazikumab Low-Medium Dose/Brazikumab 210 mg in OL Period Brazikumab Low Dose/Brazikumab 210 mg in OL Period
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    5 / 5 (100.00%)
    4 / 5 (80.00%)
    8 / 9 (88.89%)
    7 / 7 (100.00%)
    1 / 3 (33.33%)
    2 / 2 (100.00%)
    1 / 3 (33.33%)
    1 / 2 (50.00%)
    1 / 3 (33.33%)
    0 / 1 (0.00%)
    Vascular disorders
    Phlebitis superficial
         subjects affected / exposed
    1 / 5 (20.00%)
    0 / 5 (0.00%)
    0 / 9 (0.00%)
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Eye naevus
         subjects affected / exposed
    0 / 5 (0.00%)
    1 / 5 (20.00%)
    0 / 9 (0.00%)
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    Melanocytic naevus
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 9 (0.00%)
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    1 / 2 (50.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    General disorders and administration site conditions
    Asthenia
         subjects affected / exposed
    1 / 5 (20.00%)
    0 / 5 (0.00%)
    1 / 9 (11.11%)
    1 / 7 (14.29%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    1
    0
    1
    1
    0
    0
    0
    0
    0
    0
    Fatigue
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 9 (0.00%)
    1 / 7 (14.29%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    Feeling hot
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    1 / 9 (11.11%)
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    Non-cardiac chest pain
         subjects affected / exposed
    0 / 5 (0.00%)
    1 / 5 (20.00%)
    0 / 9 (0.00%)
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    Peripheral swelling
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 9 (0.00%)
    1 / 7 (14.29%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    Drug intolerance
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 9 (0.00%)
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
    1 / 3 (33.33%)
    0 / 1 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    Psychiatric disorders
    Depression
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 9 (0.00%)
    1 / 7 (14.29%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    Stress
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 9 (0.00%)
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    1 / 2 (50.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    Injury, poisoning and procedural complications
    Contusion
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    1 / 9 (11.11%)
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    0
    0
    3
    0
    0
    0
    0
    0
    0
    0
    Spinal compression fracture
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    1 / 9 (11.11%)
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    Procedural nausea
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 9 (0.00%)
    1 / 7 (14.29%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    Investigations
    Blood alkaline phosphatase increased
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    1 / 9 (11.11%)
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    Vitamin D decreased
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    1 / 9 (11.11%)
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    White blood cell count increased
         subjects affected / exposed
    1 / 5 (20.00%)
    0 / 5 (0.00%)
    0 / 9 (0.00%)
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Cardiac disorders
    Palpitations
         subjects affected / exposed
    1 / 5 (20.00%)
    0 / 5 (0.00%)
    0 / 9 (0.00%)
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    0 / 5 (0.00%)
    1 / 5 (20.00%)
    1 / 9 (11.11%)
    1 / 7 (14.29%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    0
    1
    1
    1
    0
    0
    0
    0
    0
    0
    Respiratory symptom
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 9 (0.00%)
    1 / 7 (14.29%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    Oropharyngeal pain
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 9 (0.00%)
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
    1 / 3 (33.33%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    Upper respiratory tract congestion
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 9 (0.00%)
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
    1 / 3 (33.33%)
    0 / 1 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    1 / 9 (11.11%)
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    Nervous system disorders
    Headache
         subjects affected / exposed
    1 / 5 (20.00%)
    1 / 5 (20.00%)
    1 / 9 (11.11%)
    1 / 7 (14.29%)
    1 / 3 (33.33%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    1
    1
    1
    1
    1
    0
    0
    0
    0
    0
    Paraesthesia
         subjects affected / exposed
    0 / 5 (0.00%)
    1 / 5 (20.00%)
    0 / 9 (0.00%)
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    Hypoaesthesia
         subjects affected / exposed
    1 / 5 (20.00%)
    0 / 5 (0.00%)
    0 / 9 (0.00%)
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Eye disorders
    Cataract
         subjects affected / exposed
    0 / 5 (0.00%)
    1 / 5 (20.00%)
    0 / 9 (0.00%)
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    Conjunctivitis allergic
         subjects affected / exposed
    0 / 5 (0.00%)
    1 / 5 (20.00%)
    0 / 9 (0.00%)
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    Vision blurred
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 9 (0.00%)
    0 / 7 (0.00%)
    1 / 3 (33.33%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    Iritis
         subjects affected / exposed
    1 / 5 (20.00%)
    0 / 5 (0.00%)
    0 / 9 (0.00%)
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Ear and labyrinth disorders
    Tinnitus
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    1 / 9 (11.11%)
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    Gastrointestinal disorders
    Abdominal pain lower
         subjects affected / exposed
    0 / 5 (0.00%)
    1 / 5 (20.00%)
    0 / 9 (0.00%)
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    Crohn's disease
         subjects affected / exposed
    1 / 5 (20.00%)
    0 / 5 (0.00%)
    1 / 9 (11.11%)
    2 / 7 (28.57%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    1
    0
    1
    2
    0
    0
    0
    0
    0
    0
    Gastritis
         subjects affected / exposed
    1 / 5 (20.00%)
    0 / 5 (0.00%)
    0 / 9 (0.00%)
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Defaecation urgency
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    1 / 9 (11.11%)
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    Haemorrhoids
         subjects affected / exposed
    0 / 5 (0.00%)
    1 / 5 (20.00%)
    0 / 9 (0.00%)
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    Nausea
         subjects affected / exposed
    1 / 5 (20.00%)
    0 / 5 (0.00%)
    1 / 9 (11.11%)
    1 / 7 (14.29%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    1
    0
    1
    1
    0
    0
    0
    0
    0
    0
    Abdominal discomfort
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 9 (0.00%)
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    1 / 2 (50.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    Anal fissure
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 9 (0.00%)
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    1 / 2 (50.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    Constipation
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 9 (0.00%)
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    1 / 2 (50.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    Renal and urinary disorders
    Pollakiuria
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    1 / 9 (11.11%)
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    Skin and subcutaneous tissue disorders
    Alopecia
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    1 / 9 (11.11%)
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    Eczema
         subjects affected / exposed
    0 / 5 (0.00%)
    1 / 5 (20.00%)
    0 / 9 (0.00%)
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    Erythema
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    1 / 9 (11.11%)
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    Pruritus
         subjects affected / exposed
    1 / 5 (20.00%)
    0 / 5 (0.00%)
    0 / 9 (0.00%)
    1 / 7 (14.29%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    1
    0
    0
    1
    0
    0
    0
    0
    0
    0
    Rash
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 9 (0.00%)
    1 / 7 (14.29%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    1 / 2 (50.00%)
    1 / 3 (33.33%)
    0 / 1 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    0
    1
    1
    0
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 9 (0.00%)
    1 / 7 (14.29%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    Back pain
         subjects affected / exposed
    1 / 5 (20.00%)
    1 / 5 (20.00%)
    1 / 9 (11.11%)
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    1
    1
    1
    0
    0
    0
    0
    0
    0
    0
    Arthritis
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    1 / 9 (11.11%)
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    Joint swelling
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 9 (0.00%)
    1 / 7 (14.29%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    Metabolism and nutrition disorders
    Hypokalaemia
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 9 (0.00%)
    1 / 7 (14.29%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    Iron deficiency
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 9 (0.00%)
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    1 / 2 (50.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    Infections and infestations
    Folliculitis
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    1 / 9 (11.11%)
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    Herpes simplex
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    1 / 9 (11.11%)
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    Herpes zoster
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    1 / 9 (11.11%)
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    Lower respiratory tract infection
         subjects affected / exposed
    0 / 5 (0.00%)
    1 / 5 (20.00%)
    0 / 9 (0.00%)
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    Nasopharyngitis
         subjects affected / exposed
    0 / 5 (0.00%)
    2 / 5 (40.00%)
    0 / 9 (0.00%)
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    1 / 2 (50.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    0
    4
    0
    0
    0
    1
    0
    0
    0
    0
    Oral candidiasis
         subjects affected / exposed
    1 / 5 (20.00%)
    0 / 5 (0.00%)
    0 / 9 (0.00%)
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    2
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Oral fungal infection
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    1 / 9 (11.11%)
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    Viral infection
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 9 (0.00%)
    1 / 7 (14.29%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    Skin candida
         subjects affected / exposed
    1 / 5 (20.00%)
    0 / 5 (0.00%)
    0 / 9 (0.00%)
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Subcutaneous abscess
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    1 / 9 (11.11%)
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    Vulvovaginal mycotic infection
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    1 / 9 (11.11%)
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    Urinary tract infection
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    1 / 9 (11.11%)
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    Upper respiratory tract infection
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 9 (0.00%)
    0 / 7 (0.00%)
    1 / 3 (33.33%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    Postoperative abscess
         subjects affected / exposed
    1 / 5 (20.00%)
    0 / 5 (0.00%)
    0 / 9 (0.00%)
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Enterobiasis
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 9 (0.00%)
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    1 / 2 (50.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    Gastroenteritis
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 9 (0.00%)
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    1 / 2 (50.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0

    More information

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    Substantial protocol amendments (globally)

    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    18 Nov 2015
    The following changes were made by Amendment 1: 1) Inclusion criterion 9 was modified to state that the male condom plus spermicide method must be used in conjunction with another method specified. 2) Modified criteria for discontinuation of investigational product 3) Text was modified to clarify that screening assessments may be carried out over more than one visit to the site. 4) Text was modified to clarify that the investigators may use their own assessment of the SES-CD score to decide whether or not to begin oral glucocorticosteroid tapering after Week 16.

    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.
    Study was terminated for business reasons.
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