Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   43865   clinical trials with a EudraCT protocol, of which   7286   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Download PDF

    Clinical Trial Results:
    A Randomized, Placebo-Controlled, Double-blind, Multicenter Study to Assess the Efficacy and Safety of Multiple Doses of BMS-986165 in Subjects with Active Psoriatic Arthritis (PsA)

    Summary
    EudraCT number
    		 2018-004293-10
    Trial protocol
    		 CZ   DE   HU   BE   ES   IT  
    Global end of trial date
    27 Jan 2021

    Results information
    Results version number
    		 v1(current)
    This version publication date
    10 Feb 2022
    First version publication date
    10 Feb 2022
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    IM011-084
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Bristol-Myers Squibb
    Sponsor organisation address
    Chaussée de la Hulpe 185, Brussels, Belgium, 1170
    Public contact
    EU Study Start-Up Unit, Bristol-Myers Squibb International Corporation, Clinical.Trials@bms.com
    Scientific contact
    Bristol-Myers Squibb Study Director, Bristol-Myers Squibb, Clinical.Trials@bms.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
    27 May 2021
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    27 Jan 2021
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To assess the dose-response relationship of BMS-986165 (6 or 12 mg once daily [QD]) at Week 16 in the treatment of subjects with active PsA
    Protection of trial subjects
    The study was in compliance with the ethical principles derived from the Declaration of Helsinki and in compliance with all International Conference on Harmonization Good Clinical Practice Guidelines. All the local regulatory requirements pertinent to safety of trial participants were followed.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    01 Apr 2019
    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
    Czechia: 21
    Country: Number of subjects enrolled
    Germany: 12
    Country: Number of subjects enrolled
    Hungary: 19
    Country: Number of subjects enrolled
    Poland: 58
    Country: Number of subjects enrolled
    Russian Federation: 48
    Country: Number of subjects enrolled
    Spain: 6
    Country: Number of subjects enrolled
    United States: 39
    Worldwide total number of subjects
    203
    EEA total number of subjects
    116
    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)
    170
    From 65 to 84 years
    33
    85 years and over
    0

    Subject disposition

    		 Close Top of page
    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 203 participants were randomized and treated.

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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Placebo
    Arm description
    		 In Part A, Placebo matching BMS-986165. In Part B, Ustekinumab SQ.
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo matching BMS-986165 12 mg
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    1 tablet daily

    Investigational medicinal product name
    Placebo matching BMS-986165 6 mg
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    1 tablet daily

    Arm title
    		 BMS-986165 6 mg
    Arm description
    		 In Part A, BMS-986165 6 mg administered QD for 16 weeks. In Part B, participants received either BMS-986165 at 6 mg (if they achieved minimal disease activity (MDA) in Part A) or Ustekinumab SQ (if they did not achieve MDA in Part A)
    Arm type
    		 Experimental

    Investigational medicinal product name
    Placebo matching BMS-986165 12 mg
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    1 tablet daily

    Investigational medicinal product name
    BMS-986165
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    6 mg - 1 tablet daily

    Arm title
    		 BMS-986165 12 mg
    Arm description
    		 In Part A, BMS-986165 12 mg administered QD for 16 weeks. In Part B, participants received either BMS-986165 at 12 mg (if they achieved minimal disease activity (MDA) in Part A) or Ustekinumab SQ (if they did not achieve MDA in Part A)
    Arm type
    		 Experimental

    Investigational medicinal product name
    BMS-986165
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    12 mg - 1 tablet daily

    Investigational medicinal product name
    Placebo matching BMS-986165 6 mg
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    1 tablet daily

    Number of subjects in period 1
    		Placebo BMS-986165 6 mg BMS-986165 12 mg
    Started
    66
    70
    67
    Completed
    58
    63
    59
    Not completed
    8
    7
    8
         Consent withdrawn by subject
    5
    2
    3
         Adverse event, non-fatal
    1
    3
    4
         Other
    2
    1
    -
         Randomized by mistake with study treatment
    -
    1
    1
    Period 2
    Period 2 title
    Treatment Period - Part B
    Is this the baseline period?
    		 No
    Allocation method
    Non-randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Monitor, Data analyst, Carer, Assessor

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Placebo in Part A, Ustekinumab in Part B
    Arm description
    		 In Part A, Placebo matching BMS-986165. In Part B, Ustekinumab SQ.
    Arm type
    		 Placebo

    Investigational medicinal product name
    Ustekinumab
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    45-90 mg Q4W

    Investigational medicinal product name
    Placebo matching BMS-986165 12 mg
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    1 tablet daily

    Investigational medicinal product name
    Placebo matching BMS-986165 6 mg
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    1 tablet daily

    Arm title
    		 BMS-986165 6 mg in Part A and Part B‌
    Arm description
    		 In Part A, BMS-986165 6 mg administered QD for 16 weeks. In Part B, BMS-986165 at 6 mg
    Arm type
    		 Experimental

    Investigational medicinal product name
    BMS-986165
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    6 mg - 1 tablet daily

    Investigational medicinal product name
    Normal Saline
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Q4W

    Investigational medicinal product name
    Placebo matching BMS-986165 12 mg
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    1 tablet daily

    Arm title
    		 BMS-986165 6 mg in Part A, Ustekinumab in Part B‌
    Arm description
    		 In Part A, BMS-986165 6 mg administered QD for 16 weeks. In Part B, Ustekinumab SQ
    Arm type
    		 Experimental

    Investigational medicinal product name
    Ustekinumab
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    45-90 mg Q4W

    Investigational medicinal product name
    Placebo matching BMS-986165 6 mg
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    1 tablet daily

    Investigational medicinal product name
    Placebo matching BMS-986165 12 mg
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    1 tablet daily

    Arm title
    		 BMS-986165 12 mg in Part A and Part B‌
    Arm description
    		 In Part A, BMS-986165 12 mg administered QD for 16 weeks. In Part B, BMS-986165 at 12 mg
    Arm type
    		 Experimental

    Investigational medicinal product name
    BMS-986165
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    12 mg - 1 tablet daily

    Investigational medicinal product name
    Normal Saline
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Q4W

    Investigational medicinal product name
    Placebo matching BMS-986165 6 mg
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    1 tablet daily

    Arm title
    		 BMS-986165 12 mg in Part A, Ustekinumab in Part B‌
    Arm description
    		 In Part A, BMS-986165 12 mg administered QD for 16 weeks. In Part B, Ustekinumab SQ
    Arm type
    		 Experimental

    Investigational medicinal product name
    Ustekinumab
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    45-90 mg Q4W

    Investigational medicinal product name
    Placebo matching BMS-986165 6 mg
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    1 tablet daily

    Investigational medicinal product name
    Placebo matching BMS-986165 12 mg
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    1 tablet daily

    Number of subjects in period 2 [1]
    		Placebo in Part A, Ustekinumab in Part B BMS-986165 6 mg in Part A and Part B‌ BMS-986165 6 mg in Part A, Ustekinumab in Part B‌ BMS-986165 12 mg in Part A and Part B‌ BMS-986165 12 mg in Part A, Ustekinumab in Part B‌
    Started
    55
    13
    47
    16
    42
    Completed
    47
    12
    42
    13
    34
    Not completed
    8
    1
    5
    3
    8
         Adverse event, serious fatal
    -
    -
    1
    -
    1
         Consent withdrawn by subject
    1
    -
    -
    -
    1
         Adverse event, non-fatal
    -
    -
    -
    1
    2
         Site terminated by sponsor
    1
    -
    -
    1
    2
         Other reasons
    4
    1
    2
    1
    2
         Lost to follow-up
    1
    -
    1
    -
    -
         Lack of efficacy
    1
    -
    1
    -
    -
    Notes
    [1] - The number of subjects starting the period is not consistent with the number completing the preceding period. It is expected the number of subjects starting the subsequent period will be the same as the number completing the preceding period.
    Justification: Participation in Part B was voluntary. Some of the participants who completed Part A decided not to start Part B.

    Baseline characteristics

    		 Close Top of page
    Baseline characteristics reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 In Part A, Placebo matching BMS-986165. In Part B, Ustekinumab SQ.

    Reporting group title
    BMS-986165 6 mg
    Reporting group description
    		 In Part A, BMS-986165 6 mg administered QD for 16 weeks. In Part B, participants received either BMS-986165 at 6 mg (if they achieved minimal disease activity (MDA) in Part A) or Ustekinumab SQ (if they did not achieve MDA in Part A)

    Reporting group title
    BMS-986165 12 mg
    Reporting group description
    		 In Part A, BMS-986165 12 mg administered QD for 16 weeks. In Part B, participants received either BMS-986165 at 12 mg (if they achieved minimal disease activity (MDA) in Part A) or Ustekinumab SQ (if they did not achieve MDA in Part A)

    Reporting group values
    		 Placebo BMS-986165 6 mg BMS-986165 12 mg Total
    Number of subjects
    		 66 70 67 203
    Age categorical
    Units: Subjects
        In utero
    		 0 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0 0 0
        Newborns (0-27 days)
    		 0 0 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0 0 0
        Children (2-11 years)
    		 0 0 0 0
        Adolescents (12-17 years)
    		 0 0 0 0
        Adults (18-64 years)
    		 59 57 54 170
        From 65-84 years
    		 7 13 13 33
        85 years and over
    		 0 0 0 0
    Age Continuous
    Units: Years
        arithmetic mean (standard deviation)
    		 48.5 ( 13.17 ) 50.5 ( 13.69 ) 50.5 ( 13.75 ) -
    Sex: Female, Male
    Units: Participants
        Female
    		 40 30 34 104
        Male
    		 26 40 33 99
    Race (NIH/OMB)
    Units: Subjects
        American Indian or Alaska Native
    		 0 0 0 0
        Asian
    		 0 0 0 0
        Native Hawaiian or Other Pacific Islander
    		 0 0 0 0
        Black or African American
    		 1 3 0 4
        White
    		 65 67 67 199
        More than one race
    		 0 0 0 0
        Unknown or Not Reported
    		 0 0 0 0
    Ethnicity (NIH/OMB)
    Units: Subjects
        Hispanic or Latino
    		 7 4 5 16
        Not Hispanic or Latino
    		 59 65 62 186
        Unknown or Not Reported
    		 0 1 0 1

    End points

    		 Close Top of page
    End points reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 In Part A, Placebo matching BMS-986165. In Part B, Ustekinumab SQ.

    Reporting group title
    BMS-986165 6 mg
    Reporting group description
    		 In Part A, BMS-986165 6 mg administered QD for 16 weeks. In Part B, participants received either BMS-986165 at 6 mg (if they achieved minimal disease activity (MDA) in Part A) or Ustekinumab SQ (if they did not achieve MDA in Part A)

    Reporting group title
    BMS-986165 12 mg
    Reporting group description
    		 In Part A, BMS-986165 12 mg administered QD for 16 weeks. In Part B, participants received either BMS-986165 at 12 mg (if they achieved minimal disease activity (MDA) in Part A) or Ustekinumab SQ (if they did not achieve MDA in Part A)
    Reporting group title
    Placebo in Part A, Ustekinumab in Part B
    Reporting group description
    		 In Part A, Placebo matching BMS-986165. In Part B, Ustekinumab SQ.

    Reporting group title
    BMS-986165 6 mg in Part A and Part B‌
    Reporting group description
    		 In Part A, BMS-986165 6 mg administered QD for 16 weeks. In Part B, BMS-986165 at 6 mg

    Reporting group title
    BMS-986165 6 mg in Part A, Ustekinumab in Part B‌
    Reporting group description
    		 In Part A, BMS-986165 6 mg administered QD for 16 weeks. In Part B, Ustekinumab SQ

    Reporting group title
    BMS-986165 12 mg in Part A and Part B‌
    Reporting group description
    		 In Part A, BMS-986165 12 mg administered QD for 16 weeks. In Part B, BMS-986165 at 12 mg

    Reporting group title
    BMS-986165 12 mg in Part A, Ustekinumab in Part B‌
    Reporting group description
    		 In Part A, BMS-986165 12 mg administered QD for 16 weeks. In Part B, Ustekinumab SQ

    Primary: Percentage of Participants Achieving the American College of Rheumatology (ACR) 20 Response at Week 16

    		 Close Top of page
    End point title
    		 Percentage of Participants Achieving the American College of Rheumatology (ACR) 20 Response at Week 16
    End point description
    A participant is considered an ACR 20 responder if the following three conditions are met: 1) ≥ 20% improvement from baseline in the number of tender joints (68 joint count). 2) ≥ 20% improvement from baseline in the number of swollen joints (66 joint count). 3) ≥ 20% improvement from baseline in at least 3 of the following 5 domains: o Subject Global Assessment of disease activity o Physician Global Assessment of psoriatic arthritis o Subject Global Assessment of pain o Health Assessment Questionnaire-Disability Index (HAQ-DI) o High-sensitivity C-reactive protein (hsCRP)
    End point type
    Primary
    End point timeframe
    16 weeks after first dose
    End point values
    		 Placebo BMS-986165 6 mg BMS-986165 12 mg
    Number of subjects analysed
    66
    70
    67
    Units: Percent of Participants
        number (confidence interval 95%)
    31.8 (20.6 to 43.1)
    52.9 (41.2 to 64.6)
    62.7 (51.1 to 74.3)
    Statistical analysis title
    		 ACR20-Week 16
    Comparison groups
    BMS-986165 6 mg v Placebo v BMS-986165 12 mg
    Number of subjects included in analysis
    203
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 < 0.001
    Method
    		 Regression, Logistic
    Parameter type
    		 Slope Coefficient of Dose
    Point estimate
    0.11
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.05
         upper limit
    		 0.17

    Secondary: Adjusted Change From Baseline in the Health Assessment Questionnaire-Disability Index (HAQ-DI)

    		 Close Top of page
    End point title
    		 Adjusted Change From Baseline in the Health Assessment Questionnaire-Disability Index (HAQ-DI)
    End point description
    The HAQ-DI is measured by the use of a patient-reported outcome measure questionnaire, assessing the degree of difficulty a person has experienced during the past week in 8 domains of daily living activities. Each activity category consists of 2 to 3 questions (total of 20 questions). For reach question the level of activity is scored from 0 to 3, with 0 representing “no difficulty” and 3 as “unable to do”. Any activity that requires assistance from another individual or an assistive device adjusts to a minimum score of 2. For each activity category, the highest score reported in the 2 or 3 questions pertinent to that category represents the category score. Scores from the 8 categories are then summed and divided by 8 to generate the final score. The final score can range from 0 (most desirable outcome) to 3 (least desirable outcome). Adjusted change represents a change from baseline based on statistical model.
    End point type
    Secondary
    End point timeframe
    From baseline (day of the first dose) to 16 weeks after first dose
    End point values
    		 Placebo BMS-986165 6 mg BMS-986165 12 mg
    Number of subjects analysed
    66
    70
    67
    Units: Score on a scale
        arithmetic mean (standard error)
    -0.11 ( 0.066 )
    -0.37 ( 0.065 )
    -0.39 ( 0.067 )
    No statistical analyses for this end point

    Secondary: Percentage of Participants Achieving the Psoriasis Area and Severity Index (PASI) 75 Response

    		 Close Top of page
    End point title
    		 Percentage of Participants Achieving the Psoriasis Area and Severity Index (PASI) 75 Response
    End point description
    The PASI is a measure of the average erythema, induration thickness and scaling of psoriatic skin lesions (each graded on a 0 to 4 scale), weighted by the area of involvement (head, arms, trunk to groin, and legs to top of buttocks). The PASI produces a numeric score that can range from 0 to 72, with higher PASI scores denoting more severe disease activity. The PASI 75 response rate represents the percentage of participants who experienced at least a 75% improvement in PASI score as compared with the baseline value. PASI assessment was performed by trained professionals.
    End point type
    Secondary
    End point timeframe
    16 weeks after first dose
    End point values
    		 Placebo BMS-986165 6 mg BMS-986165 12 mg
    Number of subjects analysed
    54
    59
    52
    Units: Percent of Participants
        number (confidence interval 95%)
    20.4 (9.6 to 31.1)
    42.4 (29.8 to 55.0)
    59.6 (46.3 to 73.0)
    No statistical analyses for this end point

    Secondary: Adjusted Change From Baseline in the Physical Component Summary (PCS) Score of the Short Form Health Survey-36 (SF-36) Questionnaire

    		 Close Top of page
    End point title
    		 Adjusted Change From Baseline in the Physical Component Summary (PCS) Score of the Short Form Health Survey-36 (SF-36) Questionnaire
    End point description
    The SF-36 is a patient-reported outcome measure, which includes 36 items in a Likert-type format to measure the following 8 health dimensions over the past week: 1) limitations in physical activities, such as bathing or dressing 2) limitations in social activities because of physical or emotional problems 3) limitations in usual role activities because of physical health problems 4) bodily pain 5) general mental health (psychological distress and well-being) 6) limitations in usual role activities because of emotional problems 7) vitality (energy and fatigue) and 8) general health perceptions. The 8 health dimensions assessed are grouped into 2 main components, physical and mental. Each of the 8 dimensions contribute to both the Physical Component Summary (PCS) score and the Mental Component Summary (MCS) score. PCS and MCS scores range from 0 to 100, with high scores indicating a better health status. Adjusted change represents a change from baseline based on statistical model.
    End point type
    Secondary
    End point timeframe
    From baseline (day of the first dose) to 16 weeks after first dose
    End point values
    		 Placebo BMS-986165 6 mg BMS-986165 12 mg
    Number of subjects analysed
    66
    70
    67
    Units: Score on a scale
        arithmetic mean (standard error)
    2.3 ( 0.97 )
    5.6 ( 0.94 )
    5.8 ( 0.97 )
    No statistical analyses for this end point

    Secondary: Percentage of Participants Achieving the American College of Rheumatology (ACR) 50 Response at Week 16

    		 Close Top of page
    End point title
    		 Percentage of Participants Achieving the American College of Rheumatology (ACR) 50 Response at Week 16
    End point description
    A participant is considered an ACR 50 responder if the following three conditions are met: 1) ≥ 50% improvement from baseline in the number of tender joints (68 joint count). 2) ≥ 50% improvement from baseline in the number of swollen joints (66 joint count). 3) ≥ 50% improvement from baseline in at least 3 of the following 5 domains: o Subject Global Assessment of disease activity o Physician Global Assessment of psoriatic arthritis o Subject Global Assessment of pain o Health Assessment Questionnaire-Disability Index (HAQ-DI) o High-sensitivity C-reactive protein (hsCRP)
    End point type
    Secondary
    End point timeframe
    16 weeks after first dose
    End point values
    		 Placebo BMS-986165 6 mg BMS-986165 12 mg
    Number of subjects analysed
    66
    70
    67
    Units: Percent of Participants
        number (confidence interval 95%)
    10.6 (3.2 to 18.0)
    24.3 (14.2 to 34.3)
    32.8 (21.6 to 44.1)
    No statistical analyses for this end point

    Secondary: Percentage of Participants Achieving the American College of Rheumatology (ACR) 70 Response at Week 16

    		 Close Top of page
    End point title
    		 Percentage of Participants Achieving the American College of Rheumatology (ACR) 70 Response at Week 16
    End point description
    A participant is considered an ACR 70 responder if the following three conditions are met: 1) ≥ 70% improvement from baseline in the number of tender joints (68 joint count). 2) ≥ 70% improvement from baseline in the number of swollen joints (66 joint count). 3) ≥ 70% improvement from baseline in at least 3 of the following 5 domains: o Subject Global Assessment of disease activity o Physician Global Assessment of psoriatic arthritis o Subject Global Assessment of pain o Health Assessment Questionnaire-Disability Index (HAQ-DI) o High-sensitivity C-reactive protein (hsCRP)
    End point type
    Secondary
    End point timeframe
    16 weeks after first dose
    End point values
    		 Placebo BMS-986165 6 mg BMS-986165 12 mg
    Number of subjects analysed
    66
    70
    67
    Units: Percent of Participants
        number (confidence interval 95%)
    1.5 (0.0 to 4.5)
    14.3 (6.1 to 22.5)
    19.4 (9.9 to 28.9)
    No statistical analyses for this end point

    Secondary: Percentage of Participants Achieving Low Disease Activity According to the Disease Activity Score-28 Using C Reactive Protein (DAS 28 CRP)

    		 Close Top of page
    End point title
    		 Percentage of Participants Achieving Low Disease Activity According to the Disease Activity Score-28 Using C Reactive Protein (DAS 28 CRP)
    End point description
    A Disease Activity Score (DAS) is a scoring system used to assess disease activity. DAS 28 CRP is a composite outcome measure that assesses: • How many joints in the hands (including metacarpophalangeal and proximal interphalangeal joints, but excluding distal interphalangeal joints), wrists, elbows, shoulders, and knees are swollen and/or tender over a total of 28. • C Reactive Protein (CRP) levels in the blood (as a measure of the degree of inflammation) • Subject Global Assessment of disease activity The results are combined to produce the DAS 28 CRP score, which correlates with the extent of disease activity as follows: • < 2.6: Disease remission • 2.6 – 3.2: Low disease activity • 3.2 – 5.1: Moderate disease activity • > 5.1: High disease activity. Only participants with a score < 3.2 are considered to have achieved low disease activity.
    End point type
    Secondary
    End point timeframe
    16 weeks after first dose
    End point values
    		 Placebo BMS-986165 6 mg BMS-986165 12 mg
    Number of subjects analysed
    66
    70
    67
    Units: Percent of Participants
        number (confidence interval 95%)
    22.7 (12.6 to 32.8)
    37.1 (25.8 to 48.5)
    43.3 (31.4 to 55.1)
    No statistical analyses for this end point

    Secondary: Percentage of Participants Achieving Remission According to the Disease Activity Score-28 Using C Reactive Protein (DAS 28 CRP)

    		 Close Top of page
    End point title
    		 Percentage of Participants Achieving Remission According to the Disease Activity Score-28 Using C Reactive Protein (DAS 28 CRP)
    End point description
    A Disease Activity Score (DAS) is a scoring system used to assess disease activity. DAS 28 CRP is a composite outcome measure that assesses: • How many joints in the hands (including metacarpophalangeal and proximal interphalangeal joints, but excluding distal interphalangeal joints), wrists, elbows, shoulders, and knees are swollen and/or tender over a total of 28. • C Reactive Protein (CRP) levels in the blood (as a measure of the degree of inflammation) • Subject Global Assessment of disease activity The results are combined to produce the DAS 28 CRP score, which correlates with the extent of disease activity as follows: • < 2.6: Disease remission • 2.6 – 3.2: Low disease activity • 3.2 – 5.1: Moderate disease activity • > 5.1: High disease activity. Only participants with a score < 2.6 are considered to have achieved remission.
    End point type
    Secondary
    End point timeframe
    16 weeks after first dose
    End point values
    		 Placebo BMS-986165 6 mg BMS-986165 12 mg
    Number of subjects analysed
    66
    70
    67
    Units: Percent of Participants
        number (confidence interval 95%)
    6.1 (0.3 to 11.8)
    24.3 (14.2 to 34.3)
    25.4 (15.0 to 35.8)
    No statistical analyses for this end point

    Secondary: Adjusted Change from Baseline in the Disease Activity Score-28 Using C Reactive Protein (DAS 28 CRP) Score

    		 Close Top of page
    End point title
    		 Adjusted Change from Baseline in the Disease Activity Score-28 Using C Reactive Protein (DAS 28 CRP) Score
    End point description
    A Disease Activity Score (DAS) is a scoring system used to assess disease activity. DAS 28 CRP is a composite outcome measure that assesses: • How many joints in the hands (including metacarpophalangeal and proximal interphalangeal joints, but excluding distal interphalangeal joints), wrists, elbows, shoulders, and knees are swollen and/or tender over a total of 28. • C Reactive Protein (CRP) levels in the blood (as a measure of the degree of inflammation) • Subject Global Assessment of disease activity The results are combined to produce the DAS 28 CRP score, which correlates with the extent of disease activity as follows: • < 2.6: Disease remission • 2.6 – 3.2: Low disease activity • 3.2 – 5.1: Moderate disease activity • > 5.1: High disease activity. Adjusted change represents a change from baseline based on statistical model.
    End point type
    Secondary
    End point timeframe
    From baseline (day of first dose) to 16 weeks after first dose
    End point values
    		 Placebo BMS-986165 6 mg BMS-986165 12 mg
    Number of subjects analysed
    66
    70
    67
    Units: Score on a scale
        arithmetic mean (standard error)
    -0.9 ( 0.15 )
    -1.7 ( 0.15 )
    -1.7 ( 0.15 )
    No statistical analyses for this end point

    Secondary: Adjusted Change from Baseline in Dactylitis Count

    		 Close Top of page
    End point title
    		 Adjusted Change from Baseline in Dactylitis Count
    End point description
    The number of digits in hands and feet with dactylitis (Tender + Non-Tender) was counted and change from baseline at week 16 was assessed. Adjusted change represents a change from baseline based on statistical model.
    End point type
    Secondary
    End point timeframe
    From baseline (day of first dose) to 16 weeks after first dose
    End point values
    		 Placebo BMS-986165 6 mg BMS-986165 12 mg
    Number of subjects analysed
    25
    33
    27
    Units: Digits with dactylitis
        arithmetic mean (standard error)
    -1.8 ( 0.40 )
    -2.0 ( 0.38 )
    -2.5 ( 0.38 )
    No statistical analyses for this end point

    Secondary: Adjusted Change from Baseline in the Leeds Dactylitis Index (LDI) Basic Score

    		 Close Top of page
    End point title
    		 Adjusted Change from Baseline in the Leeds Dactylitis Index (LDI) Basic Score
    End point description
    The Leeds Dactylitis Index (LDI) Basic is a quantitative measurement of dactylitis in the 20 digits using a dactylometer. The circumference of the affected and contralateral digits, and tenderness of the affected digits are measured to generate a total score. For each dactylitic digit, the final score is defined as: [{(A/B) – 1}*100]*C, where A is circumference of involved digit, B is circumference of the opposite, unaffected, digit or reference, and C is tenderness (0 or 1). The total score is determined by summing the relative score of all digits. A higher score indicates worse dactylitis. Adjusted change represents a change from baseline based on statistical model.
    End point type
    Secondary
    End point timeframe
    From baseline (day of first dose) to 16 weeks after first dose
    End point values
    		 Placebo BMS-986165 6 mg BMS-986165 12 mg
    Number of subjects analysed
    24
    30
    23
    Units: Score on a scale
        arithmetic mean (standard error)
    -28.3 ( 8.87 )
    -41.8 ( 8.35 )
    -44.5 ( 8.90 )
    No statistical analyses for this end point

    Secondary: Percentage of Participants Achieving Dactylitis Resolution

    		 Close Top of page
    End point title
    		 Percentage of Participants Achieving Dactylitis Resolution
    End point description
    Dactylitis resolution (tender digits only) is defined as a dactylitis count of 0 in participants with dactylitis count ≥ 1 at baseline
    End point type
    Secondary
    End point timeframe
    16 weeks after first dose
    End point values
    		 Placebo BMS-986165 6 mg BMS-986165 12 mg
    Number of subjects analysed
    25
    30
    24
    Units: Percent of Participants
        number (confidence interval 95%)
    60.0 (40.8 to 79.2)
    76.7 (61.5 to 91.8)
    79.2 (62.9 to 95.4)
    No statistical analyses for this end point

    Secondary: Adjusted Change from Baseline in Enthesitis by the Leeds Enthesitis Index (LEI)

    		 Close Top of page
    End point title
    		 Adjusted Change from Baseline in Enthesitis by the Leeds Enthesitis Index (LEI)
    End point description
    The LEI was developed specifically for psoriatic arthritis. An overall score of 0 to 6 is derived from the presence or absence of tenderness at 6 entheseal sites (right and left: lateral epicondyle, medial femoral condyle, and Achilles tendon insertion) at the time of evaluation. A higher count indicates a greater enthesitis burden. Adjusted change represents a change from baseline based on statistical model.
    End point type
    Secondary
    End point timeframe
    From baseline (day of first dose) to 16 weeks after first dose
    End point values
    		 Placebo BMS-986165 6 mg BMS-986165 12 mg
    Number of subjects analysed
    31
    39
    26
    Units: Score on a scale
        arithmetic mean (standard error)
    -1.2 ( 0.27 )
    -1.5 ( 0.25 )
    -1.7 ( 0.28 )
    No statistical analyses for this end point

    Secondary: Adjusted Change from Baseline in Enthesitis by the Spondyloarthritis Research Consortium of Canada (SPARCC) Enthesitis Index

    		 Close Top of page
    End point title
    		 Adjusted Change from Baseline in Enthesitis by the Spondyloarthritis Research Consortium of Canada (SPARCC) Enthesitis Index
    End point description
    The SPARCC Enthesitis Index has a 0 to 16 score that is derived from the evaluation of 8 locations: the greater trochanter (R/L), quadriceps tendon insertion into the patella (R/L), patellar ligament insertion into the patella and tibial tuberosity (R/L), Achilles tendon insertion (R/L), plantar fascia insertion (R/L), medial and lateral epicondyles (R/L), and the supraspinatus insertion (R/L). A higher count indicates a higher enthesitis burden based on the current evaluation. Adjusted change represents a change from baseline based on statistical model.
    End point type
    Secondary
    End point timeframe
    From baseline (day of first dose) to 16 weeks after first dose
    End point values
    		 Placebo BMS-986165 6 mg BMS-986165 12 mg
    Number of subjects analysed
    34
    43
    34
    Units: Score on a scale
        arithmetic mean (standard error)
    -1.2 ( 0.54 )
    -2.9 ( 0.48 )
    -3.1 ( 0.51 )
    No statistical analyses for this end point

    Secondary: Percentage of Participants Achieving Enthesitis Resolution by the Leeds Enthesitis Index (LEI)

    		 Close Top of page
    End point title
    		 Percentage of Participants Achieving Enthesitis Resolution by the Leeds Enthesitis Index (LEI)
    End point description
    The LEI was developed specifically for psoriatic arthritis. An overall score of 0 to 6 is derived from the presence or absence of tenderness at 6 entheseal sites (right and left: lateral epicondyle, medial femoral condyle, and Achilles tendon insertion) at the time of evaluation. A higher count indicates a greater enthesitis burden. Enthesitis resolution is defined as s LEI score of 0, in subjects with LEI ≥ 1 at baseline
    End point type
    Secondary
    End point timeframe
    16 weeks after first dose
    End point values
    		 Placebo BMS-986165 6 mg BMS-986165 12 mg
    Number of subjects analysed
    31
    39
    26
    Units: Percent of Participants
        number (confidence interval 95%)
    22.6 (7.9 to 37.3)
    51.3 (35.6 to 67.0)
    50.0 (30.8 to 69.2)
    No statistical analyses for this end point

    Secondary: Percentage of Participants Achieving Enthesitis Resolution by the Spondyloarthritis Research Consortium of Canada (SPARCC) Enthesitis Index

    		 Close Top of page
    End point title
    		 Percentage of Participants Achieving Enthesitis Resolution by the Spondyloarthritis Research Consortium of Canada (SPARCC) Enthesitis Index
    End point description
    The SPARCC Enthesitis Index has a 0 to 16 score that is derived from the evaluation of 8 locations: the greater trochanter (R/L), quadriceps tendon insertion into the patella (R/L), patellar ligament insertion into the patella and tibial tuberosity (R/L), Achilles tendon insertion (R/L), plantar fascia insertion (R/L), medial and lateral epicondyles (R/L), and the supraspinatus insertion (R/L). A higher count indicates a higher enthesitis burden based on the current evaluation. Enthesitis resolution defined as a SPARCC enthesitis index score of 0, in subjects with SPARCC ≥ 1 at baseline.
    End point type
    Secondary
    End point timeframe
    16 weeks after first dose
    End point values
    		 Placebo BMS-986165 6 mg BMS-986165 12 mg
    Number of subjects analysed
    34
    43
    34
    Units: Percent of Participants
        number (confidence interval 95%)
    17.6 (4.8 to 30.5)
    51.2 (36.2 to 66.1)
    41.2 (24.6 to 57.7)
    No statistical analyses for this end point

    Secondary: Percentage of Participants Achieving a Physicians Global Assessment-Fingernails (PGA-F) Score of 0 or 1

    		 Close Top of page
    End point title
    		 Percentage of Participants Achieving a Physicians Global Assessment-Fingernails (PGA-F) Score of 0 or 1
    End point description
    In participants with psoriasis fingernail involvement, the PGA-F score is used to evaluate the overall condition of the fingernails in terms of disease severity. The assessment is performed by the investigator, who rates the fingernail condition on a 5-point scale based on the higher of the nail bed/nail matrix score. Scores are 0 (clear), 1 (minimal), 2 (mild), 3 (moderate), 4 (severe).
    End point type
    Secondary
    End point timeframe
    16 weeks after first dose
    End point values
    		 Placebo BMS-986165 6 mg BMS-986165 12 mg
    Number of subjects analysed
    12
    14
    20
    Units: Percent of Participants
        number (confidence interval 95%)
    0 (0.0 to 0.0)
    21.4 (0.0 to 42.9)
    50.0 (28.1 to 71.9)
    No statistical analyses for this end point

    Secondary: Percentage of Participants Achieving Minimal Disease Activity (MDA) Response

    		 Close Top of page
    End point title
    		 Percentage of Participants Achieving Minimal Disease Activity (MDA) Response
    End point description
    A Minimal Disease Activity (MDA) responder is defined as a participant fulfilling 5 of the following 7 outcomes: • Tender joint count ≤ 1 • Swollen joint count ≤ 1 • Psoriasis Area and Severity Index (PASI) ≤ 1 or body surface area (BSA) ≤ 3% • Subject Global Assessment of pain ≤ 15 • Subject Global Assessment of disease activity ≤ 20 • Health Assessment Questionnaire-Disability Index (HAQ-DI) ≤ 0.5 • Tender entheseal points ≤ 1
    End point type
    Secondary
    End point timeframe
    16 weeks after first dose
    End point values
    		 Placebo BMS-986165 6 mg BMS-986165 12 mg
    Number of subjects analysed
    66
    70
    67
    Units: Percent of Participants
        number (confidence interval 95%)
    7.6 (1.2 to 14.0)
    22.9 (13.0 to 32.7)
    23.9 (13.7 to 34.1)
    No statistical analyses for this end point

    Secondary: Adjusted Change from Baseline in the Psoriatic Arthritis Disease Activity Score (PASDAS)

    		 Close Top of page
    End point title
    		 Adjusted Change from Baseline in the Psoriatic Arthritis Disease Activity Score (PASDAS)
    End point description
    PASDAS is a composite measure calculated from the Physician Global Assessment of psoriatic arthritis, the Subject Global Assessment of disease activity, the Short Form Health Survey-36 Item (SF-36) Physical Component Summary (PCS), the swollen joint count, the tender joint count, the Leeds Enthesitis Index (LEI), the Leeds Dactylitis Index (LDI) (Basic), and the the levels of high-sensitivity C-reactive Protein (hsCRP). Each item contributes differently to the final score, which ranges from 0 to 10 (higher scores represent a higher level of disease activity). Adjusted change represents a change from baseline based on statistical model.
    End point type
    Secondary
    End point timeframe
    From baseline (day of first dose) to 16 weeks after first dose
    End point values
    		 Placebo BMS-986165 6 mg BMS-986165 12 mg
    Number of subjects analysed
    63
    70
    66
    Units: Score on a scale
        arithmetic mean (standard error)
    -1.1 ( 0.21 )
    -2.0 ( 0.20 )
    -2.1 ( 0.20 )
    No statistical analyses for this end point

    Secondary: Adjusted Change from Baseline in the Disease Activity Index for Psoriatic Arthritis Score (DAPSA)

    		 Close Top of page
    End point title
    		 Adjusted Change from Baseline in the Disease Activity Index for Psoriatic Arthritis Score (DAPSA)
    End point description
    DAPSA is a composite measure to assess peripheral joint involvement that is based upon numerical summation of 5 variables of disease activity: tender/painful joint count 68, swollen joint count 66, Subject Global Assessment of disease activity, Subject Global Assessment of pain, and the levels of C-reactive Protein (CRP). Final scores are interpreted as follows: - ≤4 = Remission (REM) - > 4 and ≤ 28 = moderate disease activity (MDA) - >28 = high disease activity (HDA). Adjusted change represents a change from baseline based on statistical model.
    End point type
    Secondary
    End point timeframe
    From baseline (day of first dose) to 16 weeks after first dose
    End point values
    		 Placebo BMS-986165 6 mg BMS-986165 12 mg
    Number of subjects analysed
    66
    70
    67
    Units: Score on a scale
        arithmetic mean (standard error)
    -13.3 ( 2.20 )
    -23.2 ( 2.16 )
    -25.6 ( 2.23 )
    No statistical analyses for this end point

    Secondary: Percentage of Participants Achieving Psoriatic Arthritis Response Criteria (PsARC)

    		 Close Top of page
    End point title
    		 Percentage of Participants Achieving Psoriatic Arthritis Response Criteria (PsARC)
    End point description
    PsARC consists of 4 measurements: tender/painful joint count, swollen joint count, Physician Global Assessment of psoriatic arthritis, and Subject Global Assessment of pain ≤ 15. In order to be classified as a PsARC responder, participants must achieve improvement in 2 of 4 measures, one of which must be joint pain or swelling, without worsening in any measure.
    End point type
    Secondary
    End point timeframe
    16 weeks after first dose
    End point values
    		 Placebo BMS-986165 6 mg BMS-986165 12 mg
    Number of subjects analysed
    66
    70
    67
    Units: Percent of Participants
        number (confidence interval 95%)
    54.5 (42.5 to 66.6)
    75.7 (65.7 to 85.8)
    74.6 (64.2 to 85.0)
    No statistical analyses for this end point

    Secondary: Adjusted Change from Baseline in the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)

    		 Close Top of page
    End point title
    		 Adjusted Change from Baseline in the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)
    End point description
    In participants with baseline evidence of Psoriatic Arthritis Spondylitis, symptoms are evaluated using the BASDAI, which consists of a 0 to 100 scale measuring discomfort, pain, and fatigue in response to 6 questions pertaining to the 5 major symptoms of ankylosing spondylitis: • Fatigue (medical) • Spinal pain • Joint pain and swelling • Areas of localized tenderness • Morning stiffness duration • Morning stiffness severity A higher count indicates worse disease. Adjusted change represents a change from baseline based on statistical model.
    End point type
    Secondary
    End point timeframe
    From baseline (day of first dose) to 16 weeks after first dose
    End point values
    		 Placebo BMS-986165 6 mg BMS-986165 12 mg
    Number of subjects analysed
    15
    19
    16
    Units: Score on a scale
        arithmetic mean (standard error)
    -1.7 ( 0.55 )
    -2.0 ( 0.48 )
    -2.2 ( 0.57 )
    No statistical analyses for this end point

    Secondary: Adjusted Change From Baseline in the Mental Component Summary (MCS) Score of the Short Form Health Survey-36 (SF-36) Questionnaire

    		 Close Top of page
    End point title
    		 Adjusted Change From Baseline in the Mental Component Summary (MCS) Score of the Short Form Health Survey-36 (SF-36) Questionnaire
    End point description
    The SF-36 is a patient-reported outcome measure, which includes 36 items in a Likert-type format to measure the following 8 health dimensions over the past week: 1) limitations in physical activities, such as bathing or dressing 2) limitations in social activities because of physical or emotional problems 3) limitations in usual role activities because of physical health problems 4) bodily pain 5) general mental health (psychological distress and well-being) 6) limitations in usual role activities because of emotional problems 7) vitality (energy and fatigue) and 8) general health perceptions. The 8 health dimensions assessed are grouped into 2 main components, physical and mental. Each of the 8 dimensions contribute to both the Physical Component Summary (PCS) score and the Mental Component Summary (MCS) score. PCS and MCS scores range from 0 to 100, with high scores indicating a better health status. Adjusted change represents a change from baseline based on statistical model.
    End point type
    Secondary
    End point timeframe
    From baseline (day of the first dose) to 16 weeks after first dose
    End point values
    		 Placebo BMS-986165 6 mg BMS-986165 12 mg
    Number of subjects analysed
    66
    70
    67
    Units: Score on a scale
        arithmetic mean (standard error)
    0.7 ( 1.00 )
    3.6 ( 0.97 )
    3.5 ( 1.01 )
    No statistical analyses for this end point

    Secondary: Adjusted Change From Baseline in the Psoriatic Arthritis Impact of Disease (PsAID) 12 Score

    		 Close Top of page
    End point title
    		 Adjusted Change From Baseline in the Psoriatic Arthritis Impact of Disease (PsAID) 12 Score
    End point description
    PsAID is a 12-item self-report that measures psoriatic arthritis symptoms and impact of disease. Each item is scored on a 0 to 10 numeric rating scale, and each item contributes differently to the final score. Weighted scores for each item are summed and divided by 20 to generate the final score, ranging from 0 to 10 (higher values indicate worse health). Adjusted change represents a change from baseline based on statistical model.
    End point type
    Secondary
    End point timeframe
    From baseline (day of the first dose) to 16 weeks after first dose
    End point values
    		 Placebo BMS-986165 6 mg BMS-986165 12 mg
    Number of subjects analysed
    66
    70
    67
    Units: Score on a scale
        arithmetic mean (standard error)
    -1.0 ( 0.26 )
    -2.1 ( 0.26 )
    -2.3 ( 0.26 )
    No statistical analyses for this end point

    Secondary: Adjusted Change From Baseline in the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) Score

    		 Close Top of page
    End point title
    		 Adjusted Change From Baseline in the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) Score
    End point description
    The FACIT-Fatigue instrument is a questionnaire used to evaluate a range of self-reported symptoms over the past week, from mild subjective feelings of tiredness to an overwhelming, debilitating, and sustained sense of exhaustion that likely decreases one’s ability to execute daily activities and function normally in family or social roles. Fatigue is divided into the experience of fatigue (frequency, duration, and intensity) and the impact of fatigue on physical, mental, and social activities. The questionnaire is composed of 13 questions (Short Form 13a) and each question is scored from 1 to 5. The final score results from the sum of the scores of the 13 questions, and ranges from 13 (most desirable outcome) to 65 (least desirable outcome). Adjusted change represents a change from baseline based on statistical model.
    End point type
    Secondary
    End point timeframe
    From baseline (day of the first dose) to 16 weeks after first dose
    End point values
    		 Placebo BMS-986165 6 mg BMS-986165 12 mg
    Number of subjects analysed
    65
    67
    65
    Units: Score on a scale
        arithmetic mean (standard error)
    2.8 ( 1.17 )
    5.6 ( 1.16 )
    7.2 ( 1.18 )
    No statistical analyses for this end point

    Secondary: Adjusted Change From Baseline in the Work Limitation Questionnaire (WLQ) Score

    		 Close Top of page
    End point title
    		 Adjusted Change From Baseline in the Work Limitation Questionnaire (WLQ) Score
    End point description
    The Work Limitation Questionnaire (WLQ) is a 25-item self-report that measures the on-the-job impact of chronic health conditions and treatment over the past 2 weeks. It focuses on assessing limitations while performing specific job demands from the following 4 domains: 1) Time management: difficulty with handling time and scheduling demands (5 items) 2) Physical demands: ability to perform job tasks that involve bodily strength, movement, endurance, coordination, and flexibility (6 items) 3) Mental-interpersonal demands: cognitively demanding tasks and on-the-job social interactions (9 items) 4) Output demands: concerns reduced work productivity (5 items). Final score ranges from 0 (limited none of the time) to 100 (limited all of the time). The score can be used to calculate a percent of lost work productivity due to a particular disease state. Adjusted change represents a change from baseline based on statistical model.
    End point type
    Secondary
    End point timeframe
    From baseline (day of the first dose) to 16 weeks after first dose
    End point values
    		 Placebo BMS-986165 6 mg BMS-986165 12 mg
    Number of subjects analysed
    66
    70
    67
    Units: Score on a scale
        arithmetic mean (standard error)
    -1.2 ( 0.69 )
    -1.9 ( 0.67 )
    -2.7 ( 0.70 )
    No statistical analyses for this end point

    Secondary: Percentage of Participants Achieving Health Assessment Questionnaire-Disability Index (HAQ-DI) 0.35 Response

    		 Close Top of page
    End point title
    		 Percentage of Participants Achieving Health Assessment Questionnaire-Disability Index (HAQ-DI) 0.35 Response
    End point description
    The HAQ-DI is measured by the use of a patient-reported outcome measure questionnaire, assessing the degree of difficulty a person has experienced during the past week in 8 domains of daily living activities: dressing and grooming, arising, eating, walking, hygiene, reach, grip, and other activities. Each activity category consists of 2 to 3 questions (total of 20 questions). For reach question the level of activity is scored from 0 ("no difficulty") to 3 ("unable to do"). For each activity category, the highest score reported in the 2 or 3 questions pertinent to that category represents the category score. Scores from the 8 categories are then summed and divided by 8 to generate the final score. The final score can range from 0 (most desirable outcome) to 3 (least desirable outcome). A HAQ-DI 0.35 responder is defined as a participant with an improvement from baseline in HAQ-DI score of at least 0.35.
    End point type
    Secondary
    End point timeframe
    16 weeks after first dose
    End point values
    		 Placebo BMS-986165 6 mg BMS-986165 12 mg
    Number of subjects analysed
    66
    70
    67
    Units: Percent of Participants
        number (confidence interval 95%)
    15.2 (6.5 to 23.8)
    38.6 (27.2 to 50.0)
    40.3 (28.6 to 52.0)
    No statistical analyses for this end point

    Secondary: Percentage of Participants Achieving the Psoriasis Area and Severity Index (PASI) 90 Response

    		 Close Top of page
    End point title
    		 Percentage of Participants Achieving the Psoriasis Area and Severity Index (PASI) 90 Response
    End point description
    The PASI is a measure of the average erythema, induration thickness and scaling of psoriatic skin lesions (each graded on a 0 to 4 scale), weighted by the area of involvement (head, arms, trunk to groin, and legs to top of buttocks). The PASI produces a numeric score that can range from 0 to 72, with higher PASI scores denoting more severe disease activity. The PASI 90 response rate represents the percentage of participants who experienced at least a 90% improvement in PASI score as compared with the baseline value. PASI assessment was performed by trained professionals.
    End point type
    Secondary
    End point timeframe
    16 weeks after first dose
    End point values
    		 Placebo BMS-986165 6 mg BMS-986165 12 mg
    Number of subjects analysed
    54
    59
    52
    Units: Percent of Participants
        number (confidence interval 95%)
    9.3 (1.5 to 17.0)
    20.3 (10.1 to 30.6)
    34.6 (21.7 to 47.5)
    No statistical analyses for this end point

    Secondary: Change from Baseline in Electrocardiogram (ECG) Results

    		 Close Top of page
    End point title
    		 Change from Baseline in Electrocardiogram (ECG) Results
    End point description
    End point type
    Secondary
    End point timeframe
    From baseline (day of first dose) to 16 weeks after first dose
    End point values
    		 Placebo BMS-986165 6 mg BMS-986165 12 mg
    Number of subjects analysed
    66
    70
    67
    Units: msec
    arithmetic mean (standard deviation)
        PR Interval, Aggregate
    3.9 ( 16.40 )
    3.2 ( 17.83 )
    -2.9 ( 37.09 )
        QRS Duration, Aggregate
    -0.5 ( 9.07 )
    3.9 ( 11.58 )
    -1.1 ( 13.55 )
        QT Interval, Aggregate
    1.4 ( 27.47 )
    2.7 ( 28.56 )
    1.5 ( 26.81 )
        QTcB Interval, Aggregate
    2.8 ( 41.79 )
    -6.7 ( 24.46 )
    0.4 ( 20.34 )
        QTcF Interval, Aggregate
    -0.6 ( 29.83 )
    2.4 ( 29.62 )
    4.4 ( 22.96 )
    No statistical analyses for this end point

    Secondary: Change from Baseline in Electrocardiogram (ECG) Heart Rate

    		 Close Top of page
    End point title
    		 Change from Baseline in Electrocardiogram (ECG) Heart Rate
    End point description
    End point type
    Secondary
    End point timeframe
    From baseline (day of first dose) to 16 weeks after first dose
    End point values
    		 Placebo BMS-986165 6 mg BMS-986165 12 mg
    Number of subjects analysed
    57
    63
    59
    Units: beats/min
        arithmetic mean (standard deviation)
    -0.7 ( 8.28 )
    -1.0 ( 9.84 )
    0.0 ( 8.82 )
    No statistical analyses for this end point

    Secondary: Change from Baseline in Vital Signs - Diastolic Blood Pressure

    		 Close Top of page
    End point title
    		 Change from Baseline in Vital Signs - Diastolic Blood Pressure
    End point description
    End point type
    Secondary
    End point timeframe
    From baseline (day of first dose) to 16 weeks after first dose
    End point values
    		 Placebo BMS-986165 6 mg BMS-986165 12 mg
    Number of subjects analysed
    59
    64
    60
    Units: mmHg
        arithmetic mean (standard deviation)
    1.1 ( 8.67 )
    -0.9 ( 6.10 )
    -1.7 ( 7.06 )
    No statistical analyses for this end point

    Secondary: Change from Baseline in Vital Signs - Heart Rate

    		 Close Top of page
    End point title
    		 Change from Baseline in Vital Signs - Heart Rate
    End point description
    End point type
    Secondary
    End point timeframe
    From baseline (day of first dose) to 16 weeks after first dose
    End point values
    		 Placebo BMS-986165 6 mg BMS-986165 12 mg
    Number of subjects analysed
    59
    64
    60
    Units: beats/min
        arithmetic mean (standard deviation)
    0.7 ( 9.40 )
    -2.5 ( 9.02 )
    0.8 ( 8.56 )
    No statistical analyses for this end point

    Secondary: Change from Baseline in Vital Signs - Respiratory Rate

    		 Close Top of page
    End point title
    		 Change from Baseline in Vital Signs - Respiratory Rate
    End point description
    End point type
    Secondary
    End point timeframe
    From baseline (day of first dose) to 16 weeks after first dose
    End point values
    		 Placebo BMS-986165 6 mg BMS-986165 12 mg
    Number of subjects analysed
    59
    64
    60
    Units: breaths/min
        arithmetic mean (standard deviation)
    0.0 ( 1.88 )
    -0.2 ( 1.46 )
    0.2 ( 1.16 )
    No statistical analyses for this end point

    Secondary: Change from Baseline in Vital Signs - Systolic Blood Pressure

    		 Close Top of page
    End point title
    		 Change from Baseline in Vital Signs - Systolic Blood Pressure
    End point description
    End point type
    Secondary
    End point timeframe
    From baseline (day of first dose) to 16 weeks after first dose
    End point values
    		 Placebo BMS-986165 6 mg BMS-986165 12 mg
    Number of subjects analysed
    59
    64
    60
    Units: mmHg
        arithmetic mean (standard deviation)
    1.6 ( 11.05 )
    -0.6 ( 10.95 )
    -1.5 ( 11.44 )
    No statistical analyses for this end point

    Secondary: Change from Baseline in Vital Signs - Temperature

    		 Close Top of page
    End point title
    		 Change from Baseline in Vital Signs - Temperature
    End point description
    End point type
    Secondary
    End point timeframe
    From baseline (day of first dose) to 16 weeks after first dose
    End point values
    		 Placebo BMS-986165 6 mg BMS-986165 12 mg
    Number of subjects analysed
    59
    64
    60
    Units: Celsius degree (C)
        arithmetic mean (standard deviation)
    -0.05 ( 0.307 )
    -0.07 ( 0.364 )
    -0.06 ( 0.323 )
    No statistical analyses for this end point

    Secondary: Change from Baseline in Vital Signs - Weight

    		 Close Top of page
    End point title
    		 Change from Baseline in Vital Signs - Weight
    End point description
    End point type
    Secondary
    End point timeframe
    From baseline (day of first dose) to 16 weeks after first dose
    End point values
    		 Placebo BMS-986165 6 mg BMS-986165 12 mg
    Number of subjects analysed
    58
    63
    60
    Units: Kg
        arithmetic mean (standard deviation)
    -0.24 ( 3.690 )
    0.18 ( 2.646 )
    0.43 ( 2.823 )
    No statistical analyses for this end point

    Adverse events

    		 Close Top of page
    Adverse events information
    Timeframe for reporting adverse events
    All-cause mortality was assessed from date of first dose to study completion. Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
    Adverse event reporting additional description
    All participants receiving treatment either only in Part A or in Part A + Part B
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    23.0
    Reporting groups
    Reporting group title
    Only Part A:Placebo
    Reporting group description
    		 In Part A, Placebo matching BMS-986165.

    Reporting group title
    Only Part A:BMS-986165 12 mg QD
    Reporting group description
    		 In Part A, BMS-986165 12 mg administered QD for 16 weeks.

    Reporting group title
    Only Part A:BMS-986165 6 mg QD
    Reporting group description
    		 In Part A, BMS-986165 6 mg administered QD for 16 weeks.

    Reporting group title
    BMS-986165 6 mg in Part A and Part B‌
    Reporting group description
    		 In Part A, BMS-986165 6 mg administered QD for 16 weeks. In Part B, BMS-986165 at 6 mg

    Reporting group title
    Part A: BMS-986165 6 mg QD - Part B: Ustekinumab SQ
    Reporting group description
    		 In Part A, BMS-986165 6 mg administered QD for 16 weeks. In Part B, Ustekinumab SQ.

    Reporting group title
    BMS-986165 12 mg in Part A and Part B‌
    Reporting group description
    		 In Part A, BMS-986165 12 mg administered QD for 16 weeks. In Part B, BMS-986165 at 12 mg

    Reporting group title
    Part A: BMS-986165 12 mg QD - Part B: Ustekinumab SQ
    Reporting group description
    		 In Part A, BMS-986165 12 mg administered QD for 16 weeks. In Part B, Ustekinumab SQ

    Reporting group title
    Part A: Placebo + Part B: Ustekinumab SQ
    Reporting group description
    		 In Part A, Placebo matching BMS-986165. In Part B, Ustekinumab SQ.

    Serious adverse events
    		 Only Part A:Placebo Only Part A:BMS-986165 12 mg QD Only Part A:BMS-986165 6 mg QD BMS-986165 6 mg in Part A and Part B‌ Part A: BMS-986165 6 mg QD - Part B: Ustekinumab SQ BMS-986165 12 mg in Part A and Part B‌ Part A: BMS-986165 12 mg QD - Part B: Ustekinumab SQ Part A: Placebo + Part B: Ustekinumab SQ
    Total subjects affected by serious adverse events
         subjects affected / exposed
    2 / 11 (18.18%)
    0 / 9 (0.00%)
    0 / 10 (0.00%)
    1 / 13 (7.69%)
    3 / 47 (6.38%)
    0 / 16 (0.00%)
    4 / 42 (9.52%)
    0 / 55 (0.00%)
         number of deaths (all causes)
    0
    0
    0
    0
    1
    0
    1
    0
         number of deaths resulting from adverse events
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Metastatic carcinoid tumour
         subjects affected / exposed
    1 / 11 (9.09%)
    0 / 9 (0.00%)
    0 / 10 (0.00%)
    0 / 13 (0.00%)
    0 / 47 (0.00%)
    0 / 16 (0.00%)
    0 / 42 (0.00%)
    0 / 55 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    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
    Injury, poisoning and procedural complications
    Chest injury
         subjects affected / exposed
    0 / 11 (0.00%)
    0 / 9 (0.00%)
    0 / 10 (0.00%)
    0 / 13 (0.00%)
    0 / 47 (0.00%)
    0 / 16 (0.00%)
    1 / 42 (2.38%)
    0 / 55 (0.00%)
         occurrences causally related to treatment / all
    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
    Road traffic accident
         subjects affected / exposed
    0 / 11 (0.00%)
    0 / 9 (0.00%)
    0 / 10 (0.00%)
    0 / 13 (0.00%)
    0 / 47 (0.00%)
    0 / 16 (0.00%)
    1 / 42 (2.38%)
    0 / 55 (0.00%)
         occurrences causally related to treatment / all
    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 / 1
    0 / 0
    Vascular disorders
    Deep vein thrombosis
         subjects affected / exposed
    1 / 11 (9.09%)
    0 / 9 (0.00%)
    0 / 10 (0.00%)
    0 / 13 (0.00%)
    0 / 47 (0.00%)
    0 / 16 (0.00%)
    0 / 42 (0.00%)
    0 / 55 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    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
    Cardiac disorders
    Atrial fibrillation
         subjects affected / exposed
    0 / 11 (0.00%)
    0 / 9 (0.00%)
    0 / 10 (0.00%)
    0 / 13 (0.00%)
    0 / 47 (0.00%)
    0 / 16 (0.00%)
    1 / 42 (2.38%)
    0 / 55 (0.00%)
         occurrences causally related to treatment / all
    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
    Nervous system disorders
    Neuropathy peripheral
         subjects affected / exposed
    0 / 11 (0.00%)
    0 / 9 (0.00%)
    0 / 10 (0.00%)
    1 / 13 (7.69%)
    0 / 47 (0.00%)
    0 / 16 (0.00%)
    0 / 42 (0.00%)
    0 / 55 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    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
    General disorders and administration site conditions
    Death
         subjects affected / exposed
    0 / 11 (0.00%)
    0 / 9 (0.00%)
    0 / 10 (0.00%)
    0 / 13 (0.00%)
    1 / 47 (2.13%)
    0 / 16 (0.00%)
    0 / 42 (0.00%)
    0 / 55 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Nausea
         subjects affected / exposed
    0 / 11 (0.00%)
    0 / 9 (0.00%)
    0 / 10 (0.00%)
    0 / 13 (0.00%)
    1 / 47 (2.13%)
    0 / 16 (0.00%)
    0 / 42 (0.00%)
    0 / 55 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    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
    Musculoskeletal and connective tissue disorders
    Osteoarthritis
         subjects affected / exposed
    0 / 11 (0.00%)
    0 / 9 (0.00%)
    0 / 10 (0.00%)
    0 / 13 (0.00%)
    1 / 47 (2.13%)
    0 / 16 (0.00%)
    0 / 42 (0.00%)
    0 / 55 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    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
    Psoriatic arthropathy
         subjects affected / exposed
    0 / 11 (0.00%)
    0 / 9 (0.00%)
    0 / 10 (0.00%)
    1 / 13 (7.69%)
    0 / 47 (0.00%)
    0 / 16 (0.00%)
    0 / 42 (0.00%)
    0 / 55 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    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
    Infections and infestations
    Pneumonia
         subjects affected / exposed
    0 / 11 (0.00%)
    0 / 9 (0.00%)
    0 / 10 (0.00%)
    0 / 13 (0.00%)
    0 / 47 (0.00%)
    0 / 16 (0.00%)
    1 / 42 (2.38%)
    0 / 55 (0.00%)
         occurrences causally related to treatment / all
    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
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Only Part A:Placebo Only Part A:BMS-986165 12 mg QD Only Part A:BMS-986165 6 mg QD BMS-986165 6 mg in Part A and Part B‌ Part A: BMS-986165 6 mg QD - Part B: Ustekinumab SQ BMS-986165 12 mg in Part A and Part B‌ Part A: BMS-986165 12 mg QD - Part B: Ustekinumab SQ Part A: Placebo + Part B: Ustekinumab SQ
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    6 / 11 (54.55%)
    7 / 9 (77.78%)
    7 / 10 (70.00%)
    13 / 13 (100.00%)
    30 / 47 (63.83%)
    11 / 16 (68.75%)
    31 / 42 (73.81%)
    34 / 55 (61.82%)
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Adenoma benign
         subjects affected / exposed
    1 / 11 (9.09%)
    0 / 9 (0.00%)
    0 / 10 (0.00%)
    0 / 13 (0.00%)
    0 / 47 (0.00%)
    0 / 16 (0.00%)
    0 / 42 (0.00%)
    0 / 55 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    0
    Gastrointestinal neoplasm
         subjects affected / exposed
    1 / 11 (9.09%)
    0 / 9 (0.00%)
    0 / 10 (0.00%)
    0 / 13 (0.00%)
    0 / 47 (0.00%)
    0 / 16 (0.00%)
    0 / 42 (0.00%)
    0 / 55 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    0
    Mesenteric neoplasm
         subjects affected / exposed
    1 / 11 (9.09%)
    0 / 9 (0.00%)
    0 / 10 (0.00%)
    0 / 13 (0.00%)
    0 / 47 (0.00%)
    0 / 16 (0.00%)
    0 / 42 (0.00%)
    0 / 55 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    0
    Vascular disorders
    Hypertension
         subjects affected / exposed
    0 / 11 (0.00%)
    0 / 9 (0.00%)
    0 / 10 (0.00%)
    2 / 13 (15.38%)
    3 / 47 (6.38%)
    0 / 16 (0.00%)
    0 / 42 (0.00%)
    1 / 55 (1.82%)
         occurrences all number
    0
    0
    0
    2
    3
    0
    0
    1
    Post thrombotic syndrome
         subjects affected / exposed
    1 / 11 (9.09%)
    0 / 9 (0.00%)
    0 / 10 (0.00%)
    0 / 13 (0.00%)
    0 / 47 (0.00%)
    0 / 16 (0.00%)
    0 / 42 (0.00%)
    0 / 55 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    0
    General disorders and administration site conditions
    Asthenia
         subjects affected / exposed
    0 / 11 (0.00%)
    0 / 9 (0.00%)
    0 / 10 (0.00%)
    0 / 13 (0.00%)
    0 / 47 (0.00%)
    1 / 16 (6.25%)
    2 / 42 (4.76%)
    0 / 55 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    2
    0
    Pyrexia
         subjects affected / exposed
    0 / 11 (0.00%)
    0 / 9 (0.00%)
    1 / 10 (10.00%)
    1 / 13 (7.69%)
    0 / 47 (0.00%)
    3 / 16 (18.75%)
    1 / 42 (2.38%)
    0 / 55 (0.00%)
         occurrences all number
    0
    0
    1
    1
    0
    6
    1
    0
    Injection site discomfort
         subjects affected / exposed
    0 / 11 (0.00%)
    0 / 9 (0.00%)
    0 / 10 (0.00%)
    1 / 13 (7.69%)
    0 / 47 (0.00%)
    0 / 16 (0.00%)
    0 / 42 (0.00%)
    0 / 55 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    0
    0
    Peripheral swelling
         subjects affected / exposed
    1 / 11 (9.09%)
    0 / 9 (0.00%)
    0 / 10 (0.00%)
    0 / 13 (0.00%)
    0 / 47 (0.00%)
    1 / 16 (6.25%)
    0 / 42 (0.00%)
    0 / 55 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    1
    0
    0
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    0 / 11 (0.00%)
    0 / 9 (0.00%)
    0 / 10 (0.00%)
    1 / 13 (7.69%)
    2 / 47 (4.26%)
    0 / 16 (0.00%)
    1 / 42 (2.38%)
    0 / 55 (0.00%)
         occurrences all number
    0
    0
    0
    1
    2
    0
    1
    0
    Oropharyngeal pain
         subjects affected / exposed
    0 / 11 (0.00%)
    0 / 9 (0.00%)
    0 / 10 (0.00%)
    1 / 13 (7.69%)
    2 / 47 (4.26%)
    1 / 16 (6.25%)
    1 / 42 (2.38%)
    0 / 55 (0.00%)
         occurrences all number
    0
    0
    0
    1
    2
    1
    1
    0
    Pulmonary mass
         subjects affected / exposed
    0 / 11 (0.00%)
    0 / 9 (0.00%)
    0 / 10 (0.00%)
    1 / 13 (7.69%)
    0 / 47 (0.00%)
    0 / 16 (0.00%)
    0 / 42 (0.00%)
    0 / 55 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    0
    0
    Respiratory disorder
         subjects affected / exposed
    1 / 11 (9.09%)
    0 / 9 (0.00%)
    0 / 10 (0.00%)
    0 / 13 (0.00%)
    0 / 47 (0.00%)
    0 / 16 (0.00%)
    0 / 42 (0.00%)
    0 / 55 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    0
    Rhinorrhoea
         subjects affected / exposed
    0 / 11 (0.00%)
    0 / 9 (0.00%)
    0 / 10 (0.00%)
    0 / 13 (0.00%)
    1 / 47 (2.13%)
    0 / 16 (0.00%)
    3 / 42 (7.14%)
    0 / 55 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    3
    0
    Investigations
    Alanine aminotransferase increased
         subjects affected / exposed
    0 / 11 (0.00%)
    0 / 9 (0.00%)
    0 / 10 (0.00%)
    1 / 13 (7.69%)
    0 / 47 (0.00%)
    2 / 16 (12.50%)
    2 / 42 (4.76%)
    2 / 55 (3.64%)
         occurrences all number
    0
    0
    0
    8
    0
    2
    3
    2
    Aspartate aminotransferase increased
         subjects affected / exposed
    0 / 11 (0.00%)
    0 / 9 (0.00%)
    0 / 10 (0.00%)
    2 / 13 (15.38%)
    0 / 47 (0.00%)
    1 / 16 (6.25%)
    2 / 42 (4.76%)
    1 / 55 (1.82%)
         occurrences all number
    0
    0
    0
    6
    0
    1
    3
    1
    Blood creatine phosphokinase increased
         subjects affected / exposed
    0 / 11 (0.00%)
    0 / 9 (0.00%)
    0 / 10 (0.00%)
    0 / 13 (0.00%)
    0 / 47 (0.00%)
    1 / 16 (6.25%)
    2 / 42 (4.76%)
    1 / 55 (1.82%)
         occurrences all number
    0
    0
    0
    0
    0
    3
    2
    1
    Body temperature increased
         subjects affected / exposed
    0 / 11 (0.00%)
    0 / 9 (0.00%)
    0 / 10 (0.00%)
    0 / 13 (0.00%)
    0 / 47 (0.00%)
    1 / 16 (6.25%)
    0 / 42 (0.00%)
    0 / 55 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    0
    0
    Weight increased
         subjects affected / exposed
    0 / 11 (0.00%)
    0 / 9 (0.00%)
    0 / 10 (0.00%)
    1 / 13 (7.69%)
    1 / 47 (2.13%)
    0 / 16 (0.00%)
    1 / 42 (2.38%)
    0 / 55 (0.00%)
         occurrences all number
    0
    0
    0
    1
    1
    0
    1
    0
    Blood pressure increased
         subjects affected / exposed
    0 / 11 (0.00%)
    1 / 9 (11.11%)
    0 / 10 (0.00%)
    0 / 13 (0.00%)
    1 / 47 (2.13%)
    0 / 16 (0.00%)
    1 / 42 (2.38%)
    0 / 55 (0.00%)
         occurrences all number
    0
    2
    0
    0
    1
    0
    1
    0
    Haemoglobin decreased
         subjects affected / exposed
    0 / 11 (0.00%)
    0 / 9 (0.00%)
    0 / 10 (0.00%)
    0 / 13 (0.00%)
    1 / 47 (2.13%)
    0 / 16 (0.00%)
    3 / 42 (7.14%)
    0 / 55 (0.00%)
         occurrences all number
    0
    0
    0
    0
    3
    0
    5
    0
    Hepatic enzyme increased
         subjects affected / exposed
    1 / 11 (9.09%)
    0 / 9 (0.00%)
    0 / 10 (0.00%)
    0 / 13 (0.00%)
    0 / 47 (0.00%)
    0 / 16 (0.00%)
    0 / 42 (0.00%)
    0 / 55 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    0
    Platelet count increased
         subjects affected / exposed
    1 / 11 (9.09%)
    0 / 9 (0.00%)
    0 / 10 (0.00%)
    0 / 13 (0.00%)
    0 / 47 (0.00%)
    0 / 16 (0.00%)
    0 / 42 (0.00%)
    0 / 55 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    0
    Transaminases increased
         subjects affected / exposed
    0 / 11 (0.00%)
    0 / 9 (0.00%)
    0 / 10 (0.00%)
    0 / 13 (0.00%)
    1 / 47 (2.13%)
    1 / 16 (6.25%)
    0 / 42 (0.00%)
    0 / 55 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    1
    0
    0
    Injury, poisoning and procedural complications
    Eye injury
         subjects affected / exposed
    0 / 11 (0.00%)
    0 / 9 (0.00%)
    0 / 10 (0.00%)
    1 / 13 (7.69%)
    0 / 47 (0.00%)
    0 / 16 (0.00%)
    0 / 42 (0.00%)
    0 / 55 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    0
    0
    Tooth fracture
         subjects affected / exposed
    0 / 11 (0.00%)
    0 / 9 (0.00%)
    0 / 10 (0.00%)
    0 / 13 (0.00%)
    0 / 47 (0.00%)
    1 / 16 (6.25%)
    0 / 42 (0.00%)
    1 / 55 (1.82%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    0
    1
    Cardiac disorders
    Arteriosclerosis coronary artery
         subjects affected / exposed
    0 / 11 (0.00%)
    0 / 9 (0.00%)
    0 / 10 (0.00%)
    1 / 13 (7.69%)
    0 / 47 (0.00%)
    0 / 16 (0.00%)
    0 / 42 (0.00%)
    0 / 55 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    0
    0
    Palpitations
         subjects affected / exposed
    0 / 11 (0.00%)
    0 / 9 (0.00%)
    0 / 10 (0.00%)
    1 / 13 (7.69%)
    0 / 47 (0.00%)
    0 / 16 (0.00%)
    0 / 42 (0.00%)
    0 / 55 (0.00%)
         occurrences all number
    0
    0
    0
    2
    0
    0
    0
    0
    Nervous system disorders
    Headache
         subjects affected / exposed
    1 / 11 (9.09%)
    1 / 9 (11.11%)
    1 / 10 (10.00%)
    2 / 13 (15.38%)
    6 / 47 (12.77%)
    0 / 16 (0.00%)
    1 / 42 (2.38%)
    6 / 55 (10.91%)
         occurrences all number
    1
    2
    1
    3
    9
    0
    1
    7
    Dizziness
         subjects affected / exposed
    0 / 11 (0.00%)
    1 / 9 (11.11%)
    1 / 10 (10.00%)
    0 / 13 (0.00%)
    2 / 47 (4.26%)
    0 / 16 (0.00%)
    1 / 42 (2.38%)
    1 / 55 (1.82%)
         occurrences all number
    0
    2
    1
    0
    2
    0
    1
    1
    Paraesthesia
         subjects affected / exposed
    0 / 11 (0.00%)
    0 / 9 (0.00%)
    1 / 10 (10.00%)
    0 / 13 (0.00%)
    1 / 47 (2.13%)
    0 / 16 (0.00%)
    0 / 42 (0.00%)
    1 / 55 (1.82%)
         occurrences all number
    0
    0
    1
    0
    1
    0
    0
    1
    Blood and lymphatic system disorders
    Lymphopenia
         subjects affected / exposed
    0 / 11 (0.00%)
    0 / 9 (0.00%)
    0 / 10 (0.00%)
    0 / 13 (0.00%)
    2 / 47 (4.26%)
    0 / 16 (0.00%)
    3 / 42 (7.14%)
    0 / 55 (0.00%)
         occurrences all number
    0
    0
    0
    0
    2
    0
    3
    0
    Anaemia
         subjects affected / exposed
    1 / 11 (9.09%)
    0 / 9 (0.00%)
    0 / 10 (0.00%)
    0 / 13 (0.00%)
    2 / 47 (4.26%)
    0 / 16 (0.00%)
    2 / 42 (4.76%)
    2 / 55 (3.64%)
         occurrences all number
    1
    0
    0
    0
    2
    0
    2
    2
    Eosinophilia
         subjects affected / exposed
    0 / 11 (0.00%)
    0 / 9 (0.00%)
    0 / 10 (0.00%)
    1 / 13 (7.69%)
    0 / 47 (0.00%)
    0 / 16 (0.00%)
    0 / 42 (0.00%)
    0 / 55 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    0
    0
    Eye disorders
    Cataract
         subjects affected / exposed
    0 / 11 (0.00%)
    0 / 9 (0.00%)
    0 / 10 (0.00%)
    1 / 13 (7.69%)
    1 / 47 (2.13%)
    1 / 16 (6.25%)
    0 / 42 (0.00%)
    1 / 55 (1.82%)
         occurrences all number
    0
    0
    0
    2
    1
    2
    0
    2
    Conjunctival haemorrhage
         subjects affected / exposed
    0 / 11 (0.00%)
    0 / 9 (0.00%)
    0 / 10 (0.00%)
    1 / 13 (7.69%)
    0 / 47 (0.00%)
    0 / 16 (0.00%)
    0 / 42 (0.00%)
    0 / 55 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    0
    0
    Macular fibrosis
         subjects affected / exposed
    0 / 11 (0.00%)
    0 / 9 (0.00%)
    0 / 10 (0.00%)
    0 / 13 (0.00%)
    0 / 47 (0.00%)
    1 / 16 (6.25%)
    0 / 42 (0.00%)
    0 / 55 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    0
    0
    Eye haemorrhage
         subjects affected / exposed
    0 / 11 (0.00%)
    0 / 9 (0.00%)
    0 / 10 (0.00%)
    1 / 13 (7.69%)
    0 / 47 (0.00%)
    0 / 16 (0.00%)
    0 / 42 (0.00%)
    0 / 55 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    0
    0
    Gastrointestinal disorders
    Aphthous ulcer
         subjects affected / exposed
    0 / 11 (0.00%)
    0 / 9 (0.00%)
    0 / 10 (0.00%)
    0 / 13 (0.00%)
    1 / 47 (2.13%)
    2 / 16 (12.50%)
    1 / 42 (2.38%)
    0 / 55 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    2
    1
    0
    Mouth ulceration
         subjects affected / exposed
    0 / 11 (0.00%)
    1 / 9 (11.11%)
    0 / 10 (0.00%)
    1 / 13 (7.69%)
    0 / 47 (0.00%)
    1 / 16 (6.25%)
    1 / 42 (2.38%)
    0 / 55 (0.00%)
         occurrences all number
    0
    1
    0
    3
    0
    1
    1
    0
    Nausea
         subjects affected / exposed
    0 / 11 (0.00%)
    1 / 9 (11.11%)
    0 / 10 (0.00%)
    1 / 13 (7.69%)
    1 / 47 (2.13%)
    1 / 16 (6.25%)
    0 / 42 (0.00%)
    3 / 55 (5.45%)
         occurrences all number
    0
    2
    0
    1
    1
    1
    0
    5
    Noninfective sialoadenitis
         subjects affected / exposed
    0 / 11 (0.00%)
    0 / 9 (0.00%)
    0 / 10 (0.00%)
    1 / 13 (7.69%)
    0 / 47 (0.00%)
    0 / 16 (0.00%)
    0 / 42 (0.00%)
    0 / 55 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    0
    0
    Vomiting
         subjects affected / exposed
    0 / 11 (0.00%)
    0 / 9 (0.00%)
    0 / 10 (0.00%)
    0 / 13 (0.00%)
    1 / 47 (2.13%)
    1 / 16 (6.25%)
    0 / 42 (0.00%)
    1 / 55 (1.82%)
         occurrences all number
    0
    0
    0
    0
    1
    1
    0
    3
    Abdominal pain
         subjects affected / exposed
    1 / 11 (9.09%)
    0 / 9 (0.00%)
    0 / 10 (0.00%)
    0 / 13 (0.00%)
    1 / 47 (2.13%)
    0 / 16 (0.00%)
    0 / 42 (0.00%)
    1 / 55 (1.82%)
         occurrences all number
    2
    0
    0
    0
    1
    0
    0
    1
    Constipation
         subjects affected / exposed
    1 / 11 (9.09%)
    0 / 9 (0.00%)
    0 / 10 (0.00%)
    0 / 13 (0.00%)
    1 / 47 (2.13%)
    0 / 16 (0.00%)
    0 / 42 (0.00%)
    1 / 55 (1.82%)
         occurrences all number
    1
    0
    0
    0
    1
    0
    0
    1
    Diarrhoea
         subjects affected / exposed
    0 / 11 (0.00%)
    0 / 9 (0.00%)
    1 / 10 (10.00%)
    0 / 13 (0.00%)
    3 / 47 (6.38%)
    0 / 16 (0.00%)
    2 / 42 (4.76%)
    1 / 55 (1.82%)
         occurrences all number
    0
    0
    1
    0
    3
    0
    2
    1
    Diverticulum intestinal
         subjects affected / exposed
    1 / 11 (9.09%)
    0 / 9 (0.00%)
    0 / 10 (0.00%)
    0 / 13 (0.00%)
    0 / 47 (0.00%)
    0 / 16 (0.00%)
    0 / 42 (0.00%)
    1 / 55 (1.82%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    1
    Dry mouth
         subjects affected / exposed
    0 / 11 (0.00%)
    0 / 9 (0.00%)
    1 / 10 (10.00%)
    0 / 13 (0.00%)
    0 / 47 (0.00%)
    0 / 16 (0.00%)
    0 / 42 (0.00%)
    0 / 55 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    0
    Dyspepsia
         subjects affected / exposed
    1 / 11 (9.09%)
    0 / 9 (0.00%)
    1 / 10 (10.00%)
    0 / 13 (0.00%)
    0 / 47 (0.00%)
    0 / 16 (0.00%)
    1 / 42 (2.38%)
    0 / 55 (0.00%)
         occurrences all number
    1
    0
    1
    0
    0
    0
    1
    0
    Flatulence
         subjects affected / exposed
    0 / 11 (0.00%)
    0 / 9 (0.00%)
    1 / 10 (10.00%)
    0 / 13 (0.00%)
    0 / 47 (0.00%)
    0 / 16 (0.00%)
    0 / 42 (0.00%)
    0 / 55 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    0
    Gastritis
         subjects affected / exposed
    0 / 11 (0.00%)
    1 / 9 (11.11%)
    0 / 10 (0.00%)
    0 / 13 (0.00%)
    0 / 47 (0.00%)
    1 / 16 (6.25%)
    0 / 42 (0.00%)
    1 / 55 (1.82%)
         occurrences all number
    0
    1
    0
    0
    0
    1
    0
    1
    Gastrointestinal inflammation
         subjects affected / exposed
    1 / 11 (9.09%)
    0 / 9 (0.00%)
    0 / 10 (0.00%)
    0 / 13 (0.00%)
    0 / 47 (0.00%)
    0 / 16 (0.00%)
    0 / 42 (0.00%)
    0 / 55 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    0
    Gastrooesophageal reflux disease
         subjects affected / exposed
    0 / 11 (0.00%)
    1 / 9 (11.11%)
    0 / 10 (0.00%)
    0 / 13 (0.00%)
    0 / 47 (0.00%)
    0 / 16 (0.00%)
    0 / 42 (0.00%)
    0 / 55 (0.00%)
         occurrences all number
    0
    2
    0
    0
    0
    0
    0
    0
    Haemorrhoids
         subjects affected / exposed
    1 / 11 (9.09%)
    0 / 9 (0.00%)
    0 / 10 (0.00%)
    0 / 13 (0.00%)
    0 / 47 (0.00%)
    0 / 16 (0.00%)
    0 / 42 (0.00%)
    0 / 55 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    0
    Ileal ulcer
         subjects affected / exposed
    1 / 11 (9.09%)
    0 / 9 (0.00%)
    0 / 10 (0.00%)
    0 / 13 (0.00%)
    0 / 47 (0.00%)
    0 / 16 (0.00%)
    0 / 42 (0.00%)
    0 / 55 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    0
    Large intestine polyp
         subjects affected / exposed
    1 / 11 (9.09%)
    0 / 9 (0.00%)
    0 / 10 (0.00%)
    1 / 13 (7.69%)
    0 / 47 (0.00%)
    0 / 16 (0.00%)
    0 / 42 (0.00%)
    0 / 55 (0.00%)
         occurrences all number
    1
    0
    0
    1
    0
    0
    0
    0
    Retching
         subjects affected / exposed
    1 / 11 (9.09%)
    0 / 9 (0.00%)
    0 / 10 (0.00%)
    0 / 13 (0.00%)
    0 / 47 (0.00%)
    0 / 16 (0.00%)
    0 / 42 (0.00%)
    0 / 55 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    0
    Stomatitis
         subjects affected / exposed
    0 / 11 (0.00%)
    0 / 9 (0.00%)
    0 / 10 (0.00%)
    0 / 13 (0.00%)
    0 / 47 (0.00%)
    1 / 16 (6.25%)
    0 / 42 (0.00%)
    0 / 55 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    0
    0
    Subileus
         subjects affected / exposed
    1 / 11 (9.09%)
    0 / 9 (0.00%)
    0 / 10 (0.00%)
    0 / 13 (0.00%)
    0 / 47 (0.00%)
    0 / 16 (0.00%)
    0 / 42 (0.00%)
    0 / 55 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    0
    Hepatobiliary disorders
    Cholelithiasis
         subjects affected / exposed
    1 / 11 (9.09%)
    0 / 9 (0.00%)
    0 / 10 (0.00%)
    1 / 13 (7.69%)
    0 / 47 (0.00%)
    1 / 16 (6.25%)
    0 / 42 (0.00%)
    0 / 55 (0.00%)
         occurrences all number
    1
    0
    0
    1
    0
    1
    0
    0
    Hepatomegaly
         subjects affected / exposed
    0 / 11 (0.00%)
    0 / 9 (0.00%)
    0 / 10 (0.00%)
    1 / 13 (7.69%)
    0 / 47 (0.00%)
    0 / 16 (0.00%)
    0 / 42 (0.00%)
    0 / 55 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    0
    0
    Skin and subcutaneous tissue disorders
    Rash
         subjects affected / exposed
    0 / 11 (0.00%)
    0 / 9 (0.00%)
    1 / 10 (10.00%)
    1 / 13 (7.69%)
    2 / 47 (4.26%)
    1 / 16 (6.25%)
    4 / 42 (9.52%)
    0 / 55 (0.00%)
         occurrences all number
    0
    0
    1
    2
    2
    2
    4
    0
    Erythema
         subjects affected / exposed
    0 / 11 (0.00%)
    0 / 9 (0.00%)
    0 / 10 (0.00%)
    1 / 13 (7.69%)
    1 / 47 (2.13%)
    0 / 16 (0.00%)
    0 / 42 (0.00%)
    0 / 55 (0.00%)
         occurrences all number
    0
    0
    0
    1
    1
    0
    0
    0
    Nail bed inflammation
         subjects affected / exposed
    0 / 11 (0.00%)
    0 / 9 (0.00%)
    0 / 10 (0.00%)
    0 / 13 (0.00%)
    0 / 47 (0.00%)
    1 / 16 (6.25%)
    0 / 42 (0.00%)
    0 / 55 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    0
    0
    Skin exfoliation
         subjects affected / exposed
    0 / 11 (0.00%)
    0 / 9 (0.00%)
    0 / 10 (0.00%)
    1 / 13 (7.69%)
    0 / 47 (0.00%)
    0 / 16 (0.00%)
    0 / 42 (0.00%)
    0 / 55 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    0
    0
    Skin ulcer
         subjects affected / exposed
    0 / 11 (0.00%)
    0 / 9 (0.00%)
    0 / 10 (0.00%)
    1 / 13 (7.69%)
    0 / 47 (0.00%)
    0 / 16 (0.00%)
    0 / 42 (0.00%)
    0 / 55 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    0
    0
    Dermatitis acneiform
         subjects affected / exposed
    0 / 11 (0.00%)
    0 / 9 (0.00%)
    0 / 10 (0.00%)
    1 / 13 (7.69%)
    2 / 47 (4.26%)
    0 / 16 (0.00%)
    2 / 42 (4.76%)
    0 / 55 (0.00%)
         occurrences all number
    0
    0
    0
    1
    2
    0
    2
    0
    Intertrigo
         subjects affected / exposed
    0 / 11 (0.00%)
    0 / 9 (0.00%)
    0 / 10 (0.00%)
    1 / 13 (7.69%)
    0 / 47 (0.00%)
    0 / 16 (0.00%)
    0 / 42 (0.00%)
    0 / 55 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    0
    0
    Psoriasis
         subjects affected / exposed
    2 / 11 (18.18%)
    0 / 9 (0.00%)
    1 / 10 (10.00%)
    1 / 13 (7.69%)
    1 / 47 (2.13%)
    0 / 16 (0.00%)
    0 / 42 (0.00%)
    2 / 55 (3.64%)
         occurrences all number
    2
    0
    1
    1
    1
    0
    0
    2
    Rash macular
         subjects affected / exposed
    0 / 11 (0.00%)
    0 / 9 (0.00%)
    0 / 10 (0.00%)
    1 / 13 (7.69%)
    0 / 47 (0.00%)
    0 / 16 (0.00%)
    0 / 42 (0.00%)
    0 / 55 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    0
    0
    Rash papular
         subjects affected / exposed
    0 / 11 (0.00%)
    1 / 9 (11.11%)
    0 / 10 (0.00%)
    0 / 13 (0.00%)
    0 / 47 (0.00%)
    0 / 16 (0.00%)
    0 / 42 (0.00%)
    0 / 55 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    0
    Rash vesicular
         subjects affected / exposed
    0 / 11 (0.00%)
    0 / 9 (0.00%)
    0 / 10 (0.00%)
    1 / 13 (7.69%)
    0 / 47 (0.00%)
    0 / 16 (0.00%)
    0 / 42 (0.00%)
    0 / 55 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    0
    0
    Rosacea
         subjects affected / exposed
    0 / 11 (0.00%)
    0 / 9 (0.00%)
    1 / 10 (10.00%)
    0 / 13 (0.00%)
    1 / 47 (2.13%)
    1 / 16 (6.25%)
    0 / 42 (0.00%)
    0 / 55 (0.00%)
         occurrences all number
    0
    0
    1
    0
    1
    1
    0
    0
    Urticaria
         subjects affected / exposed
    0 / 11 (0.00%)
    1 / 9 (11.11%)
    0 / 10 (0.00%)
    0 / 13 (0.00%)
    1 / 47 (2.13%)
    1 / 16 (6.25%)
    0 / 42 (0.00%)
    0 / 55 (0.00%)
         occurrences all number
    0
    1
    0
    0
    1
    1
    0
    0
    Renal and urinary disorders
    Renal failure
         subjects affected / exposed
    0 / 11 (0.00%)
    0 / 9 (0.00%)
    0 / 10 (0.00%)
    1 / 13 (7.69%)
    0 / 47 (0.00%)
    0 / 16 (0.00%)
    0 / 42 (0.00%)
    0 / 55 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    0
    0
    Musculoskeletal and connective tissue disorders
    Muscle discomfort
         subjects affected / exposed
    0 / 11 (0.00%)
    0 / 9 (0.00%)
    0 / 10 (0.00%)
    1 / 13 (7.69%)
    0 / 47 (0.00%)
    0 / 16 (0.00%)
    0 / 42 (0.00%)
    0 / 55 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    0
    0
    Osteoarthritis
         subjects affected / exposed
    0 / 11 (0.00%)
    0 / 9 (0.00%)
    0 / 10 (0.00%)
    0 / 13 (0.00%)
    3 / 47 (6.38%)
    0 / 16 (0.00%)
    0 / 42 (0.00%)
    0 / 55 (0.00%)
         occurrences all number
    0
    0
    0
    0
    4
    0
    0
    0
    Pain in extremity
         subjects affected / exposed
    0 / 11 (0.00%)
    0 / 9 (0.00%)
    1 / 10 (10.00%)
    0 / 13 (0.00%)
    0 / 47 (0.00%)
    0 / 16 (0.00%)
    0 / 42 (0.00%)
    0 / 55 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    0
    Psoriatic arthropathy
         subjects affected / exposed
    0 / 11 (0.00%)
    0 / 9 (0.00%)
    1 / 10 (10.00%)
    0 / 13 (0.00%)
    0 / 47 (0.00%)
    0 / 16 (0.00%)
    1 / 42 (2.38%)
    0 / 55 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    1
    0
    Rotator cuff syndrome
         subjects affected / exposed
    0 / 11 (0.00%)
    0 / 9 (0.00%)
    1 / 10 (10.00%)
    0 / 13 (0.00%)
    0 / 47 (0.00%)
    0 / 16 (0.00%)
    0 / 42 (0.00%)
    0 / 55 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    0
    Infections and infestations
    Nasopharyngitis
         subjects affected / exposed
    0 / 11 (0.00%)
    1 / 9 (11.11%)
    0 / 10 (0.00%)
    1 / 13 (7.69%)
    6 / 47 (12.77%)
    2 / 16 (12.50%)
    11 / 42 (26.19%)
    7 / 55 (12.73%)
         occurrences all number
    0
    1
    0
    2
    8
    2
    14
    7
    Upper respiratory tract infection
         subjects affected / exposed
    0 / 11 (0.00%)
    0 / 9 (0.00%)
    0 / 10 (0.00%)
    2 / 13 (15.38%)
    3 / 47 (6.38%)
    1 / 16 (6.25%)
    0 / 42 (0.00%)
    4 / 55 (7.27%)
         occurrences all number
    0
    0
    0
    2
    3
    2
    0
    4
    COVID-19
         subjects affected / exposed
    0 / 11 (0.00%)
    0 / 9 (0.00%)
    0 / 10 (0.00%)
    0 / 13 (0.00%)
    1 / 47 (2.13%)
    1 / 16 (6.25%)
    5 / 42 (11.90%)
    0 / 55 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    1
    5
    0
    Ear infection
         subjects affected / exposed
    0 / 11 (0.00%)
    0 / 9 (0.00%)
    0 / 10 (0.00%)
    1 / 13 (7.69%)
    0 / 47 (0.00%)
    0 / 16 (0.00%)
    0 / 42 (0.00%)
    0 / 55 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    0
    0
    Gastroenteritis
         subjects affected / exposed
    0 / 11 (0.00%)
    0 / 9 (0.00%)
    0 / 10 (0.00%)
    0 / 13 (0.00%)
    0 / 47 (0.00%)
    1 / 16 (6.25%)
    0 / 42 (0.00%)
    0 / 55 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    0
    0
    Gingivitis
         subjects affected / exposed
    0 / 11 (0.00%)
    0 / 9 (0.00%)
    0 / 10 (0.00%)
    1 / 13 (7.69%)
    0 / 47 (0.00%)
    0 / 16 (0.00%)
    1 / 42 (2.38%)
    0 / 55 (0.00%)
         occurrences all number
    0
    0
    0
    2
    0
    0
    1
    0
    Herpes simplex
         subjects affected / exposed
    0 / 11 (0.00%)
    0 / 9 (0.00%)
    0 / 10 (0.00%)
    0 / 13 (0.00%)
    0 / 47 (0.00%)
    1 / 16 (6.25%)
    1 / 42 (2.38%)
    0 / 55 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    2
    2
    0
    Bronchitis
         subjects affected / exposed
    0 / 11 (0.00%)
    0 / 9 (0.00%)
    1 / 10 (10.00%)
    0 / 13 (0.00%)
    3 / 47 (6.38%)
    0 / 16 (0.00%)
    1 / 42 (2.38%)
    2 / 55 (3.64%)
         occurrences all number
    0
    0
    1
    0
    3
    0
    1
    2
    Furuncle
         subjects affected / exposed
    0 / 11 (0.00%)
    1 / 9 (11.11%)
    0 / 10 (0.00%)
    1 / 13 (7.69%)
    1 / 47 (2.13%)
    0 / 16 (0.00%)
    0 / 42 (0.00%)
    0 / 55 (0.00%)
         occurrences all number
    0
    1
    0
    1
    1
    0
    0
    0
    Oral herpes
         subjects affected / exposed
    0 / 11 (0.00%)
    0 / 9 (0.00%)
    0 / 10 (0.00%)
    1 / 13 (7.69%)
    1 / 47 (2.13%)
    1 / 16 (6.25%)
    1 / 42 (2.38%)
    0 / 55 (0.00%)
         occurrences all number
    0
    0
    0
    1
    2
    2
    1
    0
    Oral infection
         subjects affected / exposed
    0 / 11 (0.00%)
    1 / 9 (11.11%)
    0 / 10 (0.00%)
    0 / 13 (0.00%)
    0 / 47 (0.00%)
    0 / 16 (0.00%)
    0 / 42 (0.00%)
    0 / 55 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    0
    Pharyngitis
         subjects affected / exposed
    0 / 11 (0.00%)
    0 / 9 (0.00%)
    0 / 10 (0.00%)
    2 / 13 (15.38%)
    1 / 47 (2.13%)
    0 / 16 (0.00%)
    2 / 42 (4.76%)
    1 / 55 (1.82%)
         occurrences all number
    0
    0
    0
    2
    2
    0
    3
    1
    Respiratory tract infection
         subjects affected / exposed
    0 / 11 (0.00%)
    0 / 9 (0.00%)
    1 / 10 (10.00%)
    0 / 13 (0.00%)
    0 / 47 (0.00%)
    0 / 16 (0.00%)
    1 / 42 (2.38%)
    1 / 55 (1.82%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    1
    2
    Respiratory tract infection viral
         subjects affected / exposed
    0 / 11 (0.00%)
    0 / 9 (0.00%)
    0 / 10 (0.00%)
    0 / 13 (0.00%)
    0 / 47 (0.00%)
    1 / 16 (6.25%)
    0 / 42 (0.00%)
    0 / 55 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    0
    0
    Sinusitis
         subjects affected / exposed
    0 / 11 (0.00%)
    0 / 9 (0.00%)
    0 / 10 (0.00%)
    0 / 13 (0.00%)
    0 / 47 (0.00%)
    2 / 16 (12.50%)
    3 / 42 (7.14%)
    0 / 55 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    2
    4
    0
    Tonsillitis
         subjects affected / exposed
    0 / 11 (0.00%)
    0 / 9 (0.00%)
    0 / 10 (0.00%)
    1 / 13 (7.69%)
    0 / 47 (0.00%)
    0 / 16 (0.00%)
    0 / 42 (0.00%)
    0 / 55 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    0
    0
    Urinary tract infection
         subjects affected / exposed
    0 / 11 (0.00%)
    0 / 9 (0.00%)
    0 / 10 (0.00%)
    0 / 13 (0.00%)
    2 / 47 (4.26%)
    0 / 16 (0.00%)
    2 / 42 (4.76%)
    3 / 55 (5.45%)
         occurrences all number
    0
    0
    0
    0
    2
    0
    5
    3
    Viral infection
         subjects affected / exposed
    1 / 11 (9.09%)
    0 / 9 (0.00%)
    0 / 10 (0.00%)
    0 / 13 (0.00%)
    1 / 47 (2.13%)
    0 / 16 (0.00%)
    0 / 42 (0.00%)
    3 / 55 (5.45%)
         occurrences all number
    1
    0
    0
    0
    1
    0
    0
    4
    Viral upper respiratory tract infection
         subjects affected / exposed
    0 / 11 (0.00%)
    0 / 9 (0.00%)
    0 / 10 (0.00%)
    1 / 13 (7.69%)
    0 / 47 (0.00%)
    0 / 16 (0.00%)
    0 / 42 (0.00%)
    0 / 55 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    0
    0
    Metabolism and nutrition disorders
    Dyslipidaemia
         subjects affected / exposed
    0 / 11 (0.00%)
    0 / 9 (0.00%)
    0 / 10 (0.00%)
    0 / 13 (0.00%)
    0 / 47 (0.00%)
    1 / 16 (6.25%)
    0 / 42 (0.00%)
    0 / 55 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    0
    0
    Hyperglycaemia
         subjects affected / exposed
    0 / 11 (0.00%)
    0 / 9 (0.00%)
    0 / 10 (0.00%)
    0 / 13 (0.00%)
    1 / 47 (2.13%)
    1 / 16 (6.25%)
    0 / 42 (0.00%)
    1 / 55 (1.82%)
         occurrences all number
    0
    0
    0
    0
    1
    1
    0
    1
    Hyperuricaemia
         subjects affected / exposed
    0 / 11 (0.00%)
    0 / 9 (0.00%)
    0 / 10 (0.00%)
    0 / 13 (0.00%)
    0 / 47 (0.00%)
    1 / 16 (6.25%)
    2 / 42 (4.76%)
    1 / 55 (1.82%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    2
    1
    Hyperlipidaemia
         subjects affected / exposed
    0 / 11 (0.00%)
    0 / 9 (0.00%)
    0 / 10 (0.00%)
    1 / 13 (7.69%)
    0 / 47 (0.00%)
    0 / 16 (0.00%)
    0 / 42 (0.00%)
    0 / 55 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    0
    0
    Hypertriglyceridaemia
         subjects affected / exposed
    0 / 11 (0.00%)
    1 / 9 (11.11%)
    0 / 10 (0.00%)
    0 / 13 (0.00%)
    1 / 47 (2.13%)
    0 / 16 (0.00%)
    0 / 42 (0.00%)
    1 / 55 (1.82%)
         occurrences all number
    0
    1
    0
    0
    1
    0
    0
    1

    More information

    		 Close Top of page

    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    23 Sep 2019
    - Inclusion/Exclusion criteria - PK sampling and dosing schedule

    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
    For support, Contact us.
    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

    European Medicines Agency © 1995-Sat Apr 27 15:30:03 CEST 2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA