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    Clinical Trial Results:
    A randomized, subject and investigator blinded, placebo-controlled, multi-center study in parallel groups to assess the efficacy and safety of CJM112 in patients with moderate to severe inflammatory acne

    Summary
    EudraCT number
    		 2016-002492-95
    Trial protocol
    		 DE   NL  
    Global end of trial date
    01 Aug 2018

    Results information
    Results version number
    		 v2(current)
    This version publication date
    03 Jul 2022
    First version publication date
    22 Aug 2019
    Other versions
    		 v1
    Version creation reason
    • New data added to full data set
    Actual doses added to treatment arms

    Trial information

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    Trial identification
    Sponsor protocol code
    CCJM112X2203
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT02998671
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Novartis Pharma AG
    Sponsor organisation address
    CH-4002, Basel, Switzerland,
    Public contact
    Clinical Disclosure Office, Novartis Pharma AG, 41 613241111, novartis.email@novartis.com
    Scientific contact
    Clinical Disclosure Office, Novartis Pharma AG, 41 613241111, novartis.email@novartis.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
    01 Aug 2018
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    01 Aug 2018
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    To assess the efficacy of CJM112 versus placebo on facial inflammatory lesion counts in patients with moderate to severe inflammatory acne.
    Protection of trial subjects
    The study was in compliance with the ethical principles derived from the Declaration of Helsinki and the International Conference on Harmonization (ICH) Good Clinical Practice (GCP) guidelines. All the local regulatory requirements pertinent to safety of trial subjects were also followed during the conduct of the trial.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    22 Dec 2016
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Germany: 18
    Country: Number of subjects enrolled
    Netherlands: 13
    Country: Number of subjects enrolled
    United States: 21
    Worldwide total number of subjects
    52
    EEA total number of subjects
    31
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    0
    Infants and toddlers (28 days-23 months)
    0
    Children (2-11 years)
    0
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    52
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 A total of approximately 75 subjects were planned to be enrolled in the study. The study was terminated early due to futility after a total of 52 subjects were enrolled and randomized.

    Pre-assignment
    Screening details
    		 For period 1 (12 weeks) subjects were randomized to one of the 3 treatment groups CJM112 high dose, CJM112 low dose or placebo. For Period 2 (12 weeks) subjects treated with Placebo in Period 1 were rerandomized to CJM112 high dose or CJM112 low dose. All other subjects remained on the same dose.

    Period 1
    Period 1 title
    Period 1
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 P1: CJM112 high dose (300mg) / P2: CJM112 high dose (300mg)
    Arm description
    		 CJM112 high dose (300mg) in treatment period 1 (Day 1 - 85) ; CJM112 high dose (300mg) in extension period 2 (Day 86 - 169)
    Arm type
    		 Experimental

    Investigational medicinal product name
    CJM112
    Investigational medicinal product code
    CJM112
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Injection once a month in period 1

    Arm title
    		 P1: CJM112 low dose (75mg) / P2: CJM112 low dose (75mg)
    Arm description
    		 CJM112 low dose (75mg) in treatment period 1 (Day 1 - 85) ; CJM112 low dose (75mg) in extension period 2 (Day 86 - 169)
    Arm type
    		 Experimental

    Investigational medicinal product name
    CJM112
    Investigational medicinal product code
    CJM112
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Injection once a month in period 1

    Arm title
    		 P1: Placebo / P2 CJM112 low dose or high dose
    Arm description
    		 Placebo in treatment period 1 (Day 1 - 85) ; CJM112 low dose (75mg) or CJM112 high dose (300mg) in extension period 2 (Day 86 - 169)
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Placebo
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Injection once a month in period 1

    Number of subjects in period 1
    		P1: CJM112 high dose (300mg) / P2: CJM112 high dose (300mg) P1: CJM112 low dose (75mg) / P2: CJM112 low dose (75mg) P1: Placebo / P2 CJM112 low dose or high dose
    Started
    21
    13
    18
    Completed
    17
    10
    14
    Not completed
    4
    3
    4
         Consent withdrawn by subject
    1
    2
    2
         Study Terminated By Sponsor
    2
    1
    1
         Adverse event, non-fatal
    -
    -
    1
         Pregnancy
    1
    -
    -
    Period 2
    Period 2 title
    Period 2
    Is this the baseline period?
    		 No
    Allocation method
    Non-randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 P1: CJM112 high dose (300mg)/ P2: CJM112 high dose (300mg)
    Arm description
    		 CJM112 high dose (300mg) in treatment period 1 (Day 1 - 85) ; CJM112 high dose (300mg) in extension period 2 (Day 86 - 169)
    Arm type
    		 Experimental

    Investigational medicinal product name
    CJM112
    Investigational medicinal product code
    CJM112
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Injection once a month in period 2

    Arm title
    		 P1: CJM112 low dose (75mg) / P2: CJM112 low dose (75mg)
    Arm description
    		 CJM112 low dose (75mg) in treatment period 1 (Day 1 - 85) ; CJM112 low dose (75mg) in extension period 2 (Day 86 - 169)
    Arm type
    		 Experimental

    Investigational medicinal product name
    CJM112
    Investigational medicinal product code
    CJM112
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Injection once a month in period 2

    Arm title
    		 P1: Placebo / P2 CJM112 low dose or high dose
    Arm description
    		 Placebo in treatment period 1 (Day 1 - 85) ; CJM112 low dose (75mg) or CJM112 high dose (300mg) in extension period 2 (Day 86 - 169)
    Arm type
    		 Experimental

    Investigational medicinal product name
    CJM112
    Investigational medicinal product code
    CJM112
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Injection once a month in period 2

    Number of subjects in period 2
    		P1: CJM112 high dose (300mg)/ P2: CJM112 high dose (300mg) P1: CJM112 low dose (75mg) / P2: CJM112 low dose (75mg) P1: Placebo / P2 CJM112 low dose or high dose
    Started
    17
    10
    14
    Completed
    14
    3
    9
    Not completed
    3
    7
    5
         Consent withdrawn by subject
    -
    1
    -
         Study Terminated By Sponsor
    3
    5
    4
         Adverse event, non-fatal
    -
    1
    -
         Lost to follow-up
    -
    -
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    P1: CJM112 high dose (300mg) / P2: CJM112 high dose (300mg)
    Reporting group description
    		 CJM112 high dose (300mg) in treatment period 1 (Day 1 - 85) ; CJM112 high dose (300mg) in extension period 2 (Day 86 - 169)

    Reporting group title
    P1: CJM112 low dose (75mg) / P2: CJM112 low dose (75mg)
    Reporting group description
    		 CJM112 low dose (75mg) in treatment period 1 (Day 1 - 85) ; CJM112 low dose (75mg) in extension period 2 (Day 86 - 169)

    Reporting group title
    P1: Placebo / P2 CJM112 low dose or high dose
    Reporting group description
    		 Placebo in treatment period 1 (Day 1 - 85) ; CJM112 low dose (75mg) or CJM112 high dose (300mg) in extension period 2 (Day 86 - 169)

    Reporting group values
    		 P1: CJM112 high dose (300mg) / P2: CJM112 high dose (300mg) P1: CJM112 low dose (75mg) / P2: CJM112 low dose (75mg) P1: Placebo / P2 CJM112 low dose or high dose Total
    Number of subjects
    		 21 13 18 52
    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)
    		 21 13 18 52
        From 65-84 years
    		 0 0 0 0
        85 years and over
    		 0 0 0 0
    Age Continuous
    Units: years
        arithmetic mean (standard deviation)
    		 23.8 ( 4.19 ) 25.5 ( 5.99 ) 23.9 ( 4.07 ) -
    Sex: Female, Male
    Units: Subjects
        Female
    		 13 8 13 34
        Male
    		 8 5 5 18
    Race/Ethnicity, Customized
    Units: Subjects
        White
    		 18 10 17 45
        Other
    		 3 3 1 7

    End points

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    End points reporting groups
    Reporting group title
    P1: CJM112 high dose (300mg) / P2: CJM112 high dose (300mg)
    Reporting group description
    		 CJM112 high dose (300mg) in treatment period 1 (Day 1 - 85) ; CJM112 high dose (300mg) in extension period 2 (Day 86 - 169)

    Reporting group title
    P1: CJM112 low dose (75mg) / P2: CJM112 low dose (75mg)
    Reporting group description
    		 CJM112 low dose (75mg) in treatment period 1 (Day 1 - 85) ; CJM112 low dose (75mg) in extension period 2 (Day 86 - 169)

    Reporting group title
    P1: Placebo / P2 CJM112 low dose or high dose
    Reporting group description
    		 Placebo in treatment period 1 (Day 1 - 85) ; CJM112 low dose (75mg) or CJM112 high dose (300mg) in extension period 2 (Day 86 - 169)
    Reporting group title
    P1: CJM112 high dose (300mg)/ P2: CJM112 high dose (300mg)
    Reporting group description
    		 CJM112 high dose (300mg) in treatment period 1 (Day 1 - 85) ; CJM112 high dose (300mg) in extension period 2 (Day 86 - 169)

    Reporting group title
    P1: CJM112 low dose (75mg) / P2: CJM112 low dose (75mg)
    Reporting group description
    		 CJM112 low dose (75mg) in treatment period 1 (Day 1 - 85) ; CJM112 low dose (75mg) in extension period 2 (Day 86 - 169)

    Reporting group title
    P1: Placebo / P2 CJM112 low dose or high dose
    Reporting group description
    		 Placebo in treatment period 1 (Day 1 - 85) ; CJM112 low dose (75mg) or CJM112 high dose (300mg) in extension period 2 (Day 86 - 169)

    Subject analysis set title
    P1: Placebo / P2: CJM112 high dose
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Placebo in treatment period 1; CJM112 high dose in extension period 2

    Subject analysis set title
    P1: Placebo / P2: CJM112 low dose
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Placebo in treatment period 1; CJM112 low dose in extension period 2

    Primary: Total inflammatory facial lesion count at day 85

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    End point title
    		 Total inflammatory facial lesion count at day 85
    End point description
    Total inflammatory facial lesion count was the total count of papules, pustules and nodules assessed at day 85
    End point type
    Primary
    End point timeframe
    Day 85
    End point values
    		 P1: CJM112 high dose (300mg) / P2: CJM112 high dose (300mg) P1: CJM112 low dose (75mg) / P2: CJM112 low dose (75mg) P1: Placebo / P2 CJM112 low dose or high dose
    Number of subjects analysed
    17
    10
    15
    Units: Lesions
        geometric mean (confidence interval 90%)
    21.9 (16.58 to 29.14)
    20.3 (13.76 to 29.66)
    18.5 (13.51 to 25.13)
    Statistical analysis title
    		 Total inflammatory facial lesion count
    Comparison groups
    P1: CJM112 high dose (300mg) / P2: CJM112 high dose (300mg) v P1: Placebo / P2 CJM112 low dose or high dose
    Number of subjects included in analysis
    32
    Analysis specification
    Pre-specified
    Analysis type
    		 [1]
    Method
    		 Bayesian model for repeated measurements
    Parameter type
    		 Ratio of geometric means
    Point estimate
    1.18
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 0.79
         upper limit
    		 1.81
    Notes
    [1] - Comparison at end of Period 1 (P1): CJM112 versus Placebo.
    Statistical analysis title
    		 Total inflammatory facial lesion count
    Comparison groups
    P1: CJM112 low dose (75mg) / P2: CJM112 low dose (75mg) v P1: Placebo / P2 CJM112 low dose or high dose
    Number of subjects included in analysis
    25
    Analysis specification
    Pre-specified
    Analysis type
    		 [2]
    Method
    		 Bayesian model for repeated measurements
    Parameter type
    		 Ratio of geometric means
    Point estimate
    1.1
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 0.66
         upper limit
    		 1.8
    Notes
    [2] - Comparison at end of Period 1 (P1): CJM112 versus Placebo.

    Secondary: Number and severity of adverse events in Period 1

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    End point title
    		 Number and severity of adverse events in Period 1
    End point description
    Frequency and severity of adverse events in Period 1
    End point type
    Secondary
    End point timeframe
    Day 1 to Day 85
    End point values
    		 P1: CJM112 high dose (300mg) / P2: CJM112 high dose (300mg) P1: CJM112 low dose (75mg) / P2: CJM112 low dose (75mg) P1: Placebo / P2 CJM112 low dose or high dose
    Number of subjects analysed
    21
    13
    18
    Units: Adverse Events
        Number of AEs of mild intensity
    27
    25
    20
        Number of AEs of moderate intensity
    5
    7
    9
        Number of AEs of severe intensity
    0
    1
    0
    No statistical analyses for this end point

    Secondary: Number and severity of adverse events in Period 2

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    End point title
    		 Number and severity of adverse events in Period 2 [3]
    End point description
    Frequency and severity of adverse events in Period 2
    End point type
    Secondary
    End point timeframe
    Day 86 to Day 260
    Notes
    [3] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: no statistical analysis performed
    End point values
    		 P1: CJM112 high dose (300mg) / P2: CJM112 high dose (300mg) P1: CJM112 low dose (75mg) / P2: CJM112 low dose (75mg) P1: Placebo / P2: CJM112 high dose P1: Placebo / P2: CJM112 low dose
    Number of subjects analysed
    17
    10
    6
    8
    Units: Adverse Events
        Number of AEs of mild intensity
    21
    20
    6
    13
        Number of AEs of moderate intensity
    6
    1
    3
    1
        Number of AEs of severe intensity
    1
    1
    0
    0
    No statistical analyses for this end point

    Secondary: Pharmacokinetics (PK): Serum trough concentrations of CJM112 in Period 1

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    End point title
    		 Pharmacokinetics (PK): Serum trough concentrations of CJM112 in Period 1 [4]
    End point description
    Pharmacokinetics (PK): Serum trough concentrations of CJM112
    End point type
    Secondary
    End point timeframe
    Day 1, Day 29, Day 57 and Day 85
    Notes
    [4] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: no statistical analysis performed
    End point values
    		 P1: CJM112 high dose (300mg) / P2: CJM112 high dose (300mg) P1: CJM112 low dose (75mg) / P2: CJM112 low dose (75mg)
    Number of subjects analysed
    21
    12
    Units: ng/mL
    arithmetic mean (standard deviation)
        Period 1 Day 1 (Pre Dose)
    152 ( 663 )
    0 ( 0 )
        Period 1 Day 29 (Pre Dose)
    8670 ( 3370 )
    802 ( 961 )
        Period 1 Day 57 (Pre Dose)
    11500 ( 5020 )
    1550 ( 1130 )
        Period 1 Day 85 (Pre Dose)
    17000 ( 8080 )
    2040 ( 1570 )
    No statistical analyses for this end point

    Secondary: Pharmacokinetics (PK): Serum trough concentrations of CJM112 in Period 2

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    End point title
    		 Pharmacokinetics (PK): Serum trough concentrations of CJM112 in Period 2 [5]
    End point description
    Pharmacokinetics (PK): Serum trough concentrations of CJM112
    End point type
    Secondary
    End point timeframe
    Day 85, Day 113, Day 141 and Day 169
    Notes
    [5] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: no statistical analysis performed
    End point values
    		 P1: CJM112 high dose (300mg) / P2: CJM112 high dose (300mg) P1: CJM112 low dose (75mg) / P2: CJM112 low dose (75mg) P1: Placebo / P2: CJM112 high dose P1: Placebo / P2: CJM112 low dose
    Number of subjects analysed
    21
    12
    6
    8
    Units: ng/mL
    arithmetic mean (standard deviation)
        Period 2 Day 85 (Pre Dose)
    17000 ( 8080 )
    2040 ( 1570 )
    713 ( 1750 )
    0 ( 0 )
        Period 2 Day 113 (Pre Dose)
    15900 ( 8140 )
    1890 ( 634 )
    8260 ( 5120 )
    1430 ( 1190 )
        Period 2 Day 141 (Pre Dose)
    18700 ( 9450 )
    3140 ( 2180 )
    15700 ( 10700 )
    3700 ( 1250 )
        Period 2 Day 169 (Pre Dose)
    19400 ( 9650 )
    3890 ( 1890 )
    16600 ( 6610 )
    2890 ( 672 )
    No statistical analyses for this end point

    Secondary: Number of patients with clinically significant abnormal hematology laboratory parameters

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    End point title
    		 Number of patients with clinically significant abnormal hematology laboratory parameters
    End point description
    Abnormalities were considered clinically significant by the Investigator if they could impact the study conduct or safety of the subjects.
    End point type
    Secondary
    End point timeframe
    38 Weeks
    End point values
    		 P1: CJM112 high dose (300mg) / P2: CJM112 high dose (300mg) P1: CJM112 low dose (75mg) / P2: CJM112 low dose (75mg) P1: Placebo / P2 CJM112 low dose or high dose
    Number of subjects analysed
    21
    13
    18
    Units: Participants
    0
    0
    0
    No statistical analyses for this end point

    Secondary: Number of patients with clinically significant abnormal clinical chemistry laboratory parameters parameters

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    End point title
    		 Number of patients with clinically significant abnormal clinical chemistry laboratory parameters parameters
    End point description
    Abnormalities were considered clinically significant by the Investigator if they could impact the study conduct or safety of the subjects. Clinically significant abnormalities are also reported as Adverse Events.
    End point type
    Secondary
    End point timeframe
    38 Weeks
    End point values
    		 P1: CJM112 high dose (300mg) / P2: CJM112 high dose (300mg) P1: CJM112 low dose (75mg) / P2: CJM112 low dose (75mg) P1: Placebo / P2 CJM112 low dose or high dose
    Number of subjects analysed
    21
    13
    18
    Units: Participants
        Period 1
    3
    0
    0
        Period 2
    0
    3
    2
    No statistical analyses for this end point

    Secondary: Number of patients with clinically significant abnormal urinalysis laboratory parameters

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    End point title
    		 Number of patients with clinically significant abnormal urinalysis laboratory parameters
    End point description
    Abnormalities were considered clinically significant by the Investigator if they could impact the study conduct or safety of the subjects.
    End point type
    Secondary
    End point timeframe
    38 Weeks
    End point values
    		 P1: CJM112 high dose (300mg) / P2: CJM112 high dose (300mg) P1: CJM112 low dose (75mg) / P2: CJM112 low dose (75mg) P1: Placebo / P2 CJM112 low dose or high dose
    Number of subjects analysed
    21
    13
    18
    Units: Participants
    0
    0
    0
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    38 weeks
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    21.0
    Reporting groups
    Reporting group title
    Period 1 CJM112 low dose
    Reporting group description
    		 Period 1 CJM112 low dose

    Reporting group title
    Period 1 CJM112 high dose
    Reporting group description
    		 Period 1 CJM112 high dose

    Reporting group title
    Period 1 Pooled CJM112
    Reporting group description
    		 Period 1 Pooled CJM112

    Reporting group title
    Period 1 Placebo
    Reporting group description
    		 Period 1 Placebo

    Reporting group title
    Period 2 CJM112 high dose/CJM112 high dose
    Reporting group description
    		 Period 2 CJM112 high dose/CJM112 high dose

    Reporting group title
    Period 2 Placebo/ CJM112 high dose
    Reporting group description
    		 Period 2 Placebo/ CJM112 high dose

    Reporting group title
    Period 2 CJM112 low dose/CJM112 low dose
    Reporting group description
    		 Period 2 CJM112 low dose/CJM112 low dose

    Reporting group title
    Period 2 Placebo/ CJM112 low dose
    Reporting group description
    		 Period 2 Placebo/ CJM112 low dose

    Reporting group title
    Period 2 Pooled CJM112 high dose
    Reporting group description
    		 Period 2 Pooled CJM112 high dose

    Reporting group title
    Period 2 Pooled CJM112 low dose
    Reporting group description
    		 Period 2 Pooled CJM112 low dose

    Serious adverse events
    		 Period 1 CJM112 low dose Period 1 CJM112 high dose Period 1 Pooled CJM112 Period 1 Placebo Period 2 CJM112 high dose/CJM112 high dose Period 2 Placebo/ CJM112 high dose Period 2 CJM112 low dose/CJM112 low dose Period 2 Placebo/ CJM112 low dose Period 2 Pooled CJM112 high dose Period 2 Pooled CJM112 low dose
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 13 (0.00%)
    0 / 21 (0.00%)
    0 / 34 (0.00%)
    0 / 18 (0.00%)
    1 / 17 (5.88%)
    0 / 6 (0.00%)
    0 / 10 (0.00%)
    0 / 8 (0.00%)
    1 / 23 (4.35%)
    0 / 18 (0.00%)
         number of deaths (all causes)
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Hepatobiliary disorders
    Cholelithiasis
         subjects affected / exposed
    0 / 13 (0.00%)
    0 / 21 (0.00%)
    0 / 34 (0.00%)
    0 / 18 (0.00%)
    1 / 17 (5.88%)
    0 / 6 (0.00%)
    0 / 10 (0.00%)
    0 / 8 (0.00%)
    1 / 23 (4.35%)
    0 / 18 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 3%
    Non-serious adverse events
    		 Period 1 CJM112 low dose Period 1 CJM112 high dose Period 1 Pooled CJM112 Period 1 Placebo Period 2 CJM112 high dose/CJM112 high dose Period 2 Placebo/ CJM112 high dose Period 2 CJM112 low dose/CJM112 low dose Period 2 Placebo/ CJM112 low dose Period 2 Pooled CJM112 high dose Period 2 Pooled CJM112 low dose
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    11 / 13 (84.62%)
    16 / 21 (76.19%)
    27 / 34 (79.41%)
    10 / 18 (55.56%)
    10 / 17 (58.82%)
    5 / 6 (83.33%)
    9 / 10 (90.00%)
    5 / 8 (62.50%)
    15 / 23 (65.22%)
    14 / 18 (77.78%)
    General disorders and administration site conditions
    Asthenia
         subjects affected / exposed
    0 / 13 (0.00%)
    0 / 21 (0.00%)
    0 / 34 (0.00%)
    1 / 18 (5.56%)
    0 / 17 (0.00%)
    0 / 6 (0.00%)
    0 / 10 (0.00%)
    0 / 8 (0.00%)
    0 / 23 (0.00%)
    0 / 18 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    Fatigue
         subjects affected / exposed
    1 / 13 (7.69%)
    0 / 21 (0.00%)
    1 / 34 (2.94%)
    1 / 18 (5.56%)
    0 / 17 (0.00%)
    0 / 6 (0.00%)
    0 / 10 (0.00%)
    0 / 8 (0.00%)
    0 / 23 (0.00%)
    0 / 18 (0.00%)
         occurrences all number
    2
    0
    2
    1
    0
    0
    0
    0
    0
    0
    Influenza like illness
         subjects affected / exposed
    0 / 13 (0.00%)
    1 / 21 (4.76%)
    1 / 34 (2.94%)
    1 / 18 (5.56%)
    0 / 17 (0.00%)
    0 / 6 (0.00%)
    0 / 10 (0.00%)
    0 / 8 (0.00%)
    0 / 23 (0.00%)
    0 / 18 (0.00%)
         occurrences all number
    0
    1
    1
    1
    0
    0
    0
    0
    0
    0
    Injection site bruising
         subjects affected / exposed
    0 / 13 (0.00%)
    1 / 21 (4.76%)
    1 / 34 (2.94%)
    0 / 18 (0.00%)
    0 / 17 (0.00%)
    0 / 6 (0.00%)
    0 / 10 (0.00%)
    0 / 8 (0.00%)
    0 / 23 (0.00%)
    0 / 18 (0.00%)
         occurrences all number
    0
    2
    2
    0
    0
    0
    0
    0
    0
    0
    Injection site reaction
         subjects affected / exposed
    1 / 13 (7.69%)
    0 / 21 (0.00%)
    1 / 34 (2.94%)
    0 / 18 (0.00%)
    0 / 17 (0.00%)
    0 / 6 (0.00%)
    0 / 10 (0.00%)
    0 / 8 (0.00%)
    0 / 23 (0.00%)
    0 / 18 (0.00%)
         occurrences all number
    3
    0
    3
    0
    0
    0
    0
    0
    0
    0
    Non-cardiac chest pain
         subjects affected / exposed
    0 / 13 (0.00%)
    0 / 21 (0.00%)
    0 / 34 (0.00%)
    1 / 18 (5.56%)
    0 / 17 (0.00%)
    0 / 6 (0.00%)
    0 / 10 (0.00%)
    0 / 8 (0.00%)
    0 / 23 (0.00%)
    0 / 18 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    Sensation of foreign body
         subjects affected / exposed
    0 / 13 (0.00%)
    0 / 21 (0.00%)
    0 / 34 (0.00%)
    0 / 18 (0.00%)
    1 / 17 (5.88%)
    0 / 6 (0.00%)
    0 / 10 (0.00%)
    0 / 8 (0.00%)
    1 / 23 (4.35%)
    0 / 18 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    0
    0
    1
    0
    Immune system disorders
    Hypersensitivity
         subjects affected / exposed
    0 / 13 (0.00%)
    0 / 21 (0.00%)
    0 / 34 (0.00%)
    1 / 18 (5.56%)
    0 / 17 (0.00%)
    0 / 6 (0.00%)
    0 / 10 (0.00%)
    0 / 8 (0.00%)
    0 / 23 (0.00%)
    0 / 18 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    Seasonal allergy
         subjects affected / exposed
    0 / 13 (0.00%)
    0 / 21 (0.00%)
    0 / 34 (0.00%)
    0 / 18 (0.00%)
    0 / 17 (0.00%)
    0 / 6 (0.00%)
    1 / 10 (10.00%)
    0 / 8 (0.00%)
    0 / 23 (0.00%)
    1 / 18 (5.56%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    1
    0
    0
    1
    Reproductive system and breast disorders
    Dysmenorrhoea
         subjects affected / exposed
    1 / 13 (7.69%)
    0 / 21 (0.00%)
    1 / 34 (2.94%)
    0 / 18 (0.00%)
    0 / 17 (0.00%)
    0 / 6 (0.00%)
    0 / 10 (0.00%)
    0 / 8 (0.00%)
    0 / 23 (0.00%)
    0 / 18 (0.00%)
         occurrences all number
    1
    0
    1
    0
    0
    0
    0
    0
    0
    0
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    1 / 13 (7.69%)
    0 / 21 (0.00%)
    1 / 34 (2.94%)
    0 / 18 (0.00%)
    0 / 17 (0.00%)
    0 / 6 (0.00%)
    0 / 10 (0.00%)
    0 / 8 (0.00%)
    0 / 23 (0.00%)
    0 / 18 (0.00%)
         occurrences all number
    1
    0
    1
    0
    0
    0
    0
    0
    0
    0
    Dyspnoea
         subjects affected / exposed
    0 / 13 (0.00%)
    0 / 21 (0.00%)
    0 / 34 (0.00%)
    1 / 18 (5.56%)
    0 / 17 (0.00%)
    0 / 6 (0.00%)
    0 / 10 (0.00%)
    0 / 8 (0.00%)
    0 / 23 (0.00%)
    0 / 18 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    Nasal congestion
         subjects affected / exposed
    0 / 13 (0.00%)
    0 / 21 (0.00%)
    0 / 34 (0.00%)
    0 / 18 (0.00%)
    1 / 17 (5.88%)
    0 / 6 (0.00%)
    0 / 10 (0.00%)
    0 / 8 (0.00%)
    1 / 23 (4.35%)
    0 / 18 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    0
    0
    1
    0
    Oropharyngeal pain
         subjects affected / exposed
    1 / 13 (7.69%)
    1 / 21 (4.76%)
    2 / 34 (5.88%)
    0 / 18 (0.00%)
    0 / 17 (0.00%)
    0 / 6 (0.00%)
    1 / 10 (10.00%)
    1 / 8 (12.50%)
    0 / 23 (0.00%)
    2 / 18 (11.11%)
         occurrences all number
    1
    1
    2
    0
    0
    0
    1
    1
    0
    2
    Rhinorrhoea
         subjects affected / exposed
    0 / 13 (0.00%)
    1 / 21 (4.76%)
    1 / 34 (2.94%)
    0 / 18 (0.00%)
    0 / 17 (0.00%)
    0 / 6 (0.00%)
    0 / 10 (0.00%)
    0 / 8 (0.00%)
    0 / 23 (0.00%)
    0 / 18 (0.00%)
         occurrences all number
    0
    1
    1
    0
    0
    0
    0
    0
    0
    0
    Psychiatric disorders
    Depression
         subjects affected / exposed
    0 / 13 (0.00%)
    0 / 21 (0.00%)
    0 / 34 (0.00%)
    1 / 18 (5.56%)
    0 / 17 (0.00%)
    0 / 6 (0.00%)
    0 / 10 (0.00%)
    0 / 8 (0.00%)
    0 / 23 (0.00%)
    0 / 18 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    Investigations
    Alanine aminotransferase increased
         subjects affected / exposed
    0 / 13 (0.00%)
    1 / 21 (4.76%)
    1 / 34 (2.94%)
    0 / 18 (0.00%)
    0 / 17 (0.00%)
    0 / 6 (0.00%)
    0 / 10 (0.00%)
    0 / 8 (0.00%)
    0 / 23 (0.00%)
    0 / 18 (0.00%)
         occurrences all number
    0
    1
    1
    0
    0
    0
    0
    0
    0
    0
    Aspartate aminotransferase increased
         subjects affected / exposed
    0 / 13 (0.00%)
    0 / 21 (0.00%)
    0 / 34 (0.00%)
    0 / 18 (0.00%)
    0 / 17 (0.00%)
    0 / 6 (0.00%)
    0 / 10 (0.00%)
    1 / 8 (12.50%)
    0 / 23 (0.00%)
    1 / 18 (5.56%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    1
    0
    1
    Blood creatine phosphokinase increased
         subjects affected / exposed
    0 / 13 (0.00%)
    1 / 21 (4.76%)
    1 / 34 (2.94%)
    0 / 18 (0.00%)
    0 / 17 (0.00%)
    1 / 6 (16.67%)
    2 / 10 (20.00%)
    1 / 8 (12.50%)
    1 / 23 (4.35%)
    3 / 18 (16.67%)
         occurrences all number
    0
    1
    1
    0
    0
    1
    2
    1
    1
    3
    Blood creatinine increased
         subjects affected / exposed
    0 / 13 (0.00%)
    0 / 21 (0.00%)
    0 / 34 (0.00%)
    0 / 18 (0.00%)
    0 / 17 (0.00%)
    0 / 6 (0.00%)
    1 / 10 (10.00%)
    0 / 8 (0.00%)
    0 / 23 (0.00%)
    1 / 18 (5.56%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    1
    0
    0
    1
    Blood triglycerides increased
         subjects affected / exposed
    0 / 13 (0.00%)
    1 / 21 (4.76%)
    1 / 34 (2.94%)
    0 / 18 (0.00%)
    0 / 17 (0.00%)
    0 / 6 (0.00%)
    0 / 10 (0.00%)
    0 / 8 (0.00%)
    0 / 23 (0.00%)
    0 / 18 (0.00%)
         occurrences all number
    0
    2
    2
    0
    0
    0
    0
    0
    0
    0
    Glucose urine present
         subjects affected / exposed
    0 / 13 (0.00%)
    1 / 21 (4.76%)
    1 / 34 (2.94%)
    0 / 18 (0.00%)
    0 / 17 (0.00%)
    0 / 6 (0.00%)
    0 / 10 (0.00%)
    0 / 8 (0.00%)
    0 / 23 (0.00%)
    0 / 18 (0.00%)
         occurrences all number
    0
    1
    1
    0
    0
    0
    0
    0
    0
    0
    Injury, poisoning and procedural complications
    Concussion
         subjects affected / exposed
    1 / 13 (7.69%)
    0 / 21 (0.00%)
    1 / 34 (2.94%)
    0 / 18 (0.00%)
    0 / 17 (0.00%)
    0 / 6 (0.00%)
    0 / 10 (0.00%)
    0 / 8 (0.00%)
    0 / 23 (0.00%)
    0 / 18 (0.00%)
         occurrences all number
    1
    0
    1
    0
    0
    0
    0
    0
    0
    0
    Joint dislocation
         subjects affected / exposed
    0 / 13 (0.00%)
    0 / 21 (0.00%)
    0 / 34 (0.00%)
    0 / 18 (0.00%)
    0 / 17 (0.00%)
    1 / 6 (16.67%)
    0 / 10 (0.00%)
    0 / 8 (0.00%)
    1 / 23 (4.35%)
    0 / 18 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    0
    0
    1
    0
    Ligament sprain
         subjects affected / exposed
    0 / 13 (0.00%)
    0 / 21 (0.00%)
    0 / 34 (0.00%)
    0 / 18 (0.00%)
    1 / 17 (5.88%)
    0 / 6 (0.00%)
    0 / 10 (0.00%)
    0 / 8 (0.00%)
    1 / 23 (4.35%)
    0 / 18 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    0
    0
    1
    0
    Limb injury
         subjects affected / exposed
    1 / 13 (7.69%)
    0 / 21 (0.00%)
    1 / 34 (2.94%)
    0 / 18 (0.00%)
    0 / 17 (0.00%)
    0 / 6 (0.00%)
    0 / 10 (0.00%)
    0 / 8 (0.00%)
    0 / 23 (0.00%)
    0 / 18 (0.00%)
         occurrences all number
    1
    0
    1
    0
    0
    0
    0
    0
    0
    0
    Road traffic accident
         subjects affected / exposed
    1 / 13 (7.69%)
    0 / 21 (0.00%)
    1 / 34 (2.94%)
    0 / 18 (0.00%)
    0 / 17 (0.00%)
    0 / 6 (0.00%)
    0 / 10 (0.00%)
    0 / 8 (0.00%)
    0 / 23 (0.00%)
    0 / 18 (0.00%)
         occurrences all number
    1
    0
    1
    0
    0
    0
    0
    0
    0
    0
    Sports injury
         subjects affected / exposed
    0 / 13 (0.00%)
    0 / 21 (0.00%)
    0 / 34 (0.00%)
    1 / 18 (5.56%)
    0 / 17 (0.00%)
    0 / 6 (0.00%)
    0 / 10 (0.00%)
    0 / 8 (0.00%)
    0 / 23 (0.00%)
    0 / 18 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    Wound
         subjects affected / exposed
    0 / 13 (0.00%)
    1 / 21 (4.76%)
    1 / 34 (2.94%)
    0 / 18 (0.00%)
    0 / 17 (0.00%)
    0 / 6 (0.00%)
    0 / 10 (0.00%)
    0 / 8 (0.00%)
    0 / 23 (0.00%)
    0 / 18 (0.00%)
         occurrences all number
    0
    1
    1
    0
    0
    0
    0
    0
    0
    0
    Cardiac disorders
    Sinus arrest
         subjects affected / exposed
    0 / 13 (0.00%)
    0 / 21 (0.00%)
    0 / 34 (0.00%)
    0 / 18 (0.00%)
    1 / 17 (5.88%)
    0 / 6 (0.00%)
    0 / 10 (0.00%)
    0 / 8 (0.00%)
    1 / 23 (4.35%)
    0 / 18 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    0
    0
    1
    0
    Supraventricular extrasystoles
         subjects affected / exposed
    0 / 13 (0.00%)
    0 / 21 (0.00%)
    0 / 34 (0.00%)
    0 / 18 (0.00%)
    1 / 17 (5.88%)
    0 / 6 (0.00%)
    0 / 10 (0.00%)
    0 / 8 (0.00%)
    1 / 23 (4.35%)
    0 / 18 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    0
    0
    1
    0
    Nervous system disorders
    Headache
         subjects affected / exposed
    3 / 13 (23.08%)
    1 / 21 (4.76%)
    4 / 34 (11.76%)
    1 / 18 (5.56%)
    1 / 17 (5.88%)
    0 / 6 (0.00%)
    0 / 10 (0.00%)
    0 / 8 (0.00%)
    1 / 23 (4.35%)
    0 / 18 (0.00%)
         occurrences all number
    4
    1
    5
    1
    2
    0
    0
    0
    2
    0
    Blood and lymphatic system disorders
    Increased tendency to bruise
         subjects affected / exposed
    0 / 13 (0.00%)
    1 / 21 (4.76%)
    1 / 34 (2.94%)
    0 / 18 (0.00%)
    0 / 17 (0.00%)
    0 / 6 (0.00%)
    0 / 10 (0.00%)
    0 / 8 (0.00%)
    0 / 23 (0.00%)
    0 / 18 (0.00%)
         occurrences all number
    0
    1
    1
    0
    0
    0
    0
    0
    0
    0
    Eye disorders
    Blepharospasm
         subjects affected / exposed
    0 / 13 (0.00%)
    0 / 21 (0.00%)
    0 / 34 (0.00%)
    0 / 18 (0.00%)
    0 / 17 (0.00%)
    1 / 6 (16.67%)
    0 / 10 (0.00%)
    0 / 8 (0.00%)
    1 / 23 (4.35%)
    0 / 18 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    0
    0
    1
    0
    Dry eye
         subjects affected / exposed
    0 / 13 (0.00%)
    0 / 21 (0.00%)
    0 / 34 (0.00%)
    0 / 18 (0.00%)
    0 / 17 (0.00%)
    0 / 6 (0.00%)
    0 / 10 (0.00%)
    1 / 8 (12.50%)
    0 / 23 (0.00%)
    1 / 18 (5.56%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    1
    0
    1
    Eye irritation
         subjects affected / exposed
    0 / 13 (0.00%)
    0 / 21 (0.00%)
    0 / 34 (0.00%)
    0 / 18 (0.00%)
    1 / 17 (5.88%)
    0 / 6 (0.00%)
    0 / 10 (0.00%)
    0 / 8 (0.00%)
    1 / 23 (4.35%)
    0 / 18 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    0
    0
    1
    0
    Eye pruritus
         subjects affected / exposed
    0 / 13 (0.00%)
    0 / 21 (0.00%)
    0 / 34 (0.00%)
    0 / 18 (0.00%)
    0 / 17 (0.00%)
    0 / 6 (0.00%)
    0 / 10 (0.00%)
    1 / 8 (12.50%)
    0 / 23 (0.00%)
    1 / 18 (5.56%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    1
    0
    1
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed
    0 / 13 (0.00%)
    1 / 21 (4.76%)
    1 / 34 (2.94%)
    2 / 18 (11.11%)
    1 / 17 (5.88%)
    1 / 6 (16.67%)
    1 / 10 (10.00%)
    0 / 8 (0.00%)
    2 / 23 (8.70%)
    1 / 18 (5.56%)
         occurrences all number
    0
    1
    1
    2
    1
    1
    1
    0
    2
    1
    Flatulence
         subjects affected / exposed
    0 / 13 (0.00%)
    0 / 21 (0.00%)
    0 / 34 (0.00%)
    1 / 18 (5.56%)
    0 / 17 (0.00%)
    0 / 6 (0.00%)
    0 / 10 (0.00%)
    0 / 8 (0.00%)
    0 / 23 (0.00%)
    0 / 18 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    Frequent bowel movements
         subjects affected / exposed
    1 / 13 (7.69%)
    0 / 21 (0.00%)
    1 / 34 (2.94%)
    0 / 18 (0.00%)
    0 / 17 (0.00%)
    0 / 6 (0.00%)
    0 / 10 (0.00%)
    0 / 8 (0.00%)
    0 / 23 (0.00%)
    0 / 18 (0.00%)
         occurrences all number
    1
    0
    1
    0
    0
    0
    0
    0
    0
    0
    Inguinal hernia
         subjects affected / exposed
    0 / 13 (0.00%)
    0 / 21 (0.00%)
    0 / 34 (0.00%)
    0 / 18 (0.00%)
    1 / 17 (5.88%)
    0 / 6 (0.00%)
    0 / 10 (0.00%)
    0 / 8 (0.00%)
    1 / 23 (4.35%)
    0 / 18 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    0
    0
    1
    0
    Lip dry
         subjects affected / exposed
    0 / 13 (0.00%)
    0 / 21 (0.00%)
    0 / 34 (0.00%)
    0 / 18 (0.00%)
    0 / 17 (0.00%)
    0 / 6 (0.00%)
    1 / 10 (10.00%)
    0 / 8 (0.00%)
    0 / 23 (0.00%)
    1 / 18 (5.56%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    1
    0
    0
    1
    Nausea
         subjects affected / exposed
    0 / 13 (0.00%)
    0 / 21 (0.00%)
    0 / 34 (0.00%)
    0 / 18 (0.00%)
    1 / 17 (5.88%)
    0 / 6 (0.00%)
    0 / 10 (0.00%)
    0 / 8 (0.00%)
    1 / 23 (4.35%)
    0 / 18 (0.00%)
         occurrences all number
    0
    0
    0
    0
    2
    0
    0
    0
    2
    0
    Toothache
         subjects affected / exposed
    1 / 13 (7.69%)
    1 / 21 (4.76%)
    2 / 34 (5.88%)
    0 / 18 (0.00%)
    0 / 17 (0.00%)
    0 / 6 (0.00%)
    0 / 10 (0.00%)
    0 / 8 (0.00%)
    0 / 23 (0.00%)
    0 / 18 (0.00%)
         occurrences all number
    1
    1
    2
    0
    0
    0
    0
    0
    0
    0
    Skin and subcutaneous tissue disorders
    Acne
         subjects affected / exposed
    2 / 13 (15.38%)
    0 / 21 (0.00%)
    2 / 34 (5.88%)
    0 / 18 (0.00%)
    0 / 17 (0.00%)
    0 / 6 (0.00%)
    0 / 10 (0.00%)
    0 / 8 (0.00%)
    0 / 23 (0.00%)
    0 / 18 (0.00%)
         occurrences all number
    2
    0
    2
    0
    0
    0
    0
    0
    0
    0
    Dermal cyst
         subjects affected / exposed
    0 / 13 (0.00%)
    1 / 21 (4.76%)
    1 / 34 (2.94%)
    0 / 18 (0.00%)
    0 / 17 (0.00%)
    0 / 6 (0.00%)
    0 / 10 (0.00%)
    0 / 8 (0.00%)
    0 / 23 (0.00%)
    0 / 18 (0.00%)
         occurrences all number
    0
    1
    1
    0
    0
    0
    0
    0
    0
    0
    Dermatitis
         subjects affected / exposed
    0 / 13 (0.00%)
    0 / 21 (0.00%)
    0 / 34 (0.00%)
    1 / 18 (5.56%)
    0 / 17 (0.00%)
    0 / 6 (0.00%)
    0 / 10 (0.00%)
    0 / 8 (0.00%)
    0 / 23 (0.00%)
    0 / 18 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    Diffuse alopecia
         subjects affected / exposed
    0 / 13 (0.00%)
    0 / 21 (0.00%)
    0 / 34 (0.00%)
    1 / 18 (5.56%)
    0 / 17 (0.00%)
    0 / 6 (0.00%)
    0 / 10 (0.00%)
    0 / 8 (0.00%)
    0 / 23 (0.00%)
    0 / 18 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    Dry skin
         subjects affected / exposed
    0 / 13 (0.00%)
    2 / 21 (9.52%)
    2 / 34 (5.88%)
    2 / 18 (11.11%)
    0 / 17 (0.00%)
    0 / 6 (0.00%)
    1 / 10 (10.00%)
    0 / 8 (0.00%)
    0 / 23 (0.00%)
    1 / 18 (5.56%)
         occurrences all number
    0
    2
    2
    2
    0
    0
    1
    0
    0
    1
    Erythema
         subjects affected / exposed
    0 / 13 (0.00%)
    0 / 21 (0.00%)
    0 / 34 (0.00%)
    0 / 18 (0.00%)
    1 / 17 (5.88%)
    0 / 6 (0.00%)
    0 / 10 (0.00%)
    0 / 8 (0.00%)
    1 / 23 (4.35%)
    0 / 18 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    0
    0
    1
    0
    Papule
         subjects affected / exposed
    0 / 13 (0.00%)
    0 / 21 (0.00%)
    0 / 34 (0.00%)
    0 / 18 (0.00%)
    0 / 17 (0.00%)
    0 / 6 (0.00%)
    0 / 10 (0.00%)
    1 / 8 (12.50%)
    0 / 23 (0.00%)
    1 / 18 (5.56%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    1
    0
    1
    Pityriasis rosea
         subjects affected / exposed
    1 / 13 (7.69%)
    0 / 21 (0.00%)
    1 / 34 (2.94%)
    0 / 18 (0.00%)
    0 / 17 (0.00%)
    0 / 6 (0.00%)
    0 / 10 (0.00%)
    0 / 8 (0.00%)
    0 / 23 (0.00%)
    0 / 18 (0.00%)
         occurrences all number
    1
    0
    1
    0
    0
    0
    0
    0
    0
    0
    Pruritus
         subjects affected / exposed
    0 / 13 (0.00%)
    1 / 21 (4.76%)
    1 / 34 (2.94%)
    3 / 18 (16.67%)
    0 / 17 (0.00%)
    1 / 6 (16.67%)
    0 / 10 (0.00%)
    0 / 8 (0.00%)
    1 / 23 (4.35%)
    0 / 18 (0.00%)
         occurrences all number
    0
    1
    1
    3
    0
    1
    0
    0
    1
    0
    Psoriasis
         subjects affected / exposed
    0 / 13 (0.00%)
    0 / 21 (0.00%)
    0 / 34 (0.00%)
    1 / 18 (5.56%)
    0 / 17 (0.00%)
    0 / 6 (0.00%)
    0 / 10 (0.00%)
    0 / 8 (0.00%)
    0 / 23 (0.00%)
    0 / 18 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    Rash maculo-papular
         subjects affected / exposed
    0 / 13 (0.00%)
    0 / 21 (0.00%)
    0 / 34 (0.00%)
    1 / 18 (5.56%)
    0 / 17 (0.00%)
    0 / 6 (0.00%)
    0 / 10 (0.00%)
    0 / 8 (0.00%)
    0 / 23 (0.00%)
    0 / 18 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    Urticaria
         subjects affected / exposed
    0 / 13 (0.00%)
    0 / 21 (0.00%)
    0 / 34 (0.00%)
    1 / 18 (5.56%)
    0 / 17 (0.00%)
    0 / 6 (0.00%)
    0 / 10 (0.00%)
    0 / 8 (0.00%)
    0 / 23 (0.00%)
    0 / 18 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    Renal and urinary disorders
    Micturition urgency
         subjects affected / exposed
    0 / 13 (0.00%)
    1 / 21 (4.76%)
    1 / 34 (2.94%)
    0 / 18 (0.00%)
    0 / 17 (0.00%)
    0 / 6 (0.00%)
    1 / 10 (10.00%)
    0 / 8 (0.00%)
    0 / 23 (0.00%)
    1 / 18 (5.56%)
         occurrences all number
    0
    1
    1
    0
    0
    0
    1
    0
    0
    1
    Pollakiuria
         subjects affected / exposed
    0 / 13 (0.00%)
    1 / 21 (4.76%)
    1 / 34 (2.94%)
    0 / 18 (0.00%)
    0 / 17 (0.00%)
    0 / 6 (0.00%)
    1 / 10 (10.00%)
    0 / 8 (0.00%)
    0 / 23 (0.00%)
    1 / 18 (5.56%)
         occurrences all number
    0
    1
    1
    0
    0
    0
    1
    0
    0
    1
    Proteinuria
         subjects affected / exposed
    0 / 13 (0.00%)
    0 / 21 (0.00%)
    0 / 34 (0.00%)
    0 / 18 (0.00%)
    0 / 17 (0.00%)
    0 / 6 (0.00%)
    2 / 10 (20.00%)
    1 / 8 (12.50%)
    0 / 23 (0.00%)
    3 / 18 (16.67%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    3
    1
    0
    4
    Musculoskeletal and connective tissue disorders
    Arthritis
         subjects affected / exposed
    1 / 13 (7.69%)
    0 / 21 (0.00%)
    1 / 34 (2.94%)
    0 / 18 (0.00%)
    0 / 17 (0.00%)
    0 / 6 (0.00%)
    1 / 10 (10.00%)
    0 / 8 (0.00%)
    0 / 23 (0.00%)
    1 / 18 (5.56%)
         occurrences all number
    1
    0
    1
    0
    0
    0
    0
    0
    0
    0
    Back pain
         subjects affected / exposed
    1 / 13 (7.69%)
    0 / 21 (0.00%)
    1 / 34 (2.94%)
    1 / 18 (5.56%)
    1 / 17 (5.88%)
    0 / 6 (0.00%)
    0 / 10 (0.00%)
    0 / 8 (0.00%)
    1 / 23 (4.35%)
    0 / 18 (0.00%)
         occurrences all number
    1
    0
    1
    1
    1
    0
    0
    0
    1
    0
    Joint effusion
         subjects affected / exposed
    0 / 13 (0.00%)
    0 / 21 (0.00%)
    0 / 34 (0.00%)
    0 / 18 (0.00%)
    0 / 17 (0.00%)
    0 / 6 (0.00%)
    1 / 10 (10.00%)
    0 / 8 (0.00%)
    0 / 23 (0.00%)
    1 / 18 (5.56%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    1
    0
    0
    1
    Myalgia
         subjects affected / exposed
    0 / 13 (0.00%)
    0 / 21 (0.00%)
    0 / 34 (0.00%)
    0 / 18 (0.00%)
    0 / 17 (0.00%)
    0 / 6 (0.00%)
    1 / 10 (10.00%)
    1 / 8 (12.50%)
    0 / 23 (0.00%)
    2 / 18 (11.11%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    1
    1
    0
    2
    Neck pain
         subjects affected / exposed
    1 / 13 (7.69%)
    0 / 21 (0.00%)
    1 / 34 (2.94%)
    0 / 18 (0.00%)
    0 / 17 (0.00%)
    0 / 6 (0.00%)
    0 / 10 (0.00%)
    0 / 8 (0.00%)
    0 / 23 (0.00%)
    0 / 18 (0.00%)
         occurrences all number
    1
    0
    1
    0
    0
    0
    0
    0
    0
    0
    Pain in extremity
         subjects affected / exposed
    0 / 13 (0.00%)
    1 / 21 (4.76%)
    1 / 34 (2.94%)
    0 / 18 (0.00%)
    0 / 17 (0.00%)
    0 / 6 (0.00%)
    0 / 10 (0.00%)
    0 / 8 (0.00%)
    0 / 23 (0.00%)
    0 / 18 (0.00%)
         occurrences all number
    0
    1
    1
    0
    0
    0
    0
    0
    0
    0
    Infections and infestations
    Bacterial vaginosis
         subjects affected / exposed
    1 / 13 (7.69%)
    0 / 21 (0.00%)
    1 / 34 (2.94%)
    0 / 18 (0.00%)
    0 / 17 (0.00%)
    0 / 6 (0.00%)
    0 / 10 (0.00%)
    0 / 8 (0.00%)
    0 / 23 (0.00%)
    0 / 18 (0.00%)
         occurrences all number
    1
    0
    1
    0
    0
    0
    0
    0
    0
    0
    Bronchitis
         subjects affected / exposed
    1 / 13 (7.69%)
    0 / 21 (0.00%)
    1 / 34 (2.94%)
    0 / 18 (0.00%)
    0 / 17 (0.00%)
    0 / 6 (0.00%)
    0 / 10 (0.00%)
    0 / 8 (0.00%)
    0 / 23 (0.00%)
    0 / 18 (0.00%)
         occurrences all number
    1
    0
    1
    0
    0
    0
    0
    0
    0
    0
    Conjunctivitis
         subjects affected / exposed
    0 / 13 (0.00%)
    0 / 21 (0.00%)
    0 / 34 (0.00%)
    0 / 18 (0.00%)
    0 / 17 (0.00%)
    0 / 6 (0.00%)
    0 / 10 (0.00%)
    1 / 8 (12.50%)
    0 / 23 (0.00%)
    1 / 18 (5.56%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    1
    0
    1
    Cystitis
         subjects affected / exposed
    1 / 13 (7.69%)
    1 / 21 (4.76%)
    2 / 34 (5.88%)
    0 / 18 (0.00%)
    0 / 17 (0.00%)
    0 / 6 (0.00%)
    0 / 10 (0.00%)
    0 / 8 (0.00%)
    0 / 23 (0.00%)
    0 / 18 (0.00%)
         occurrences all number
    1
    1
    2
    0
    0
    0
    0
    0
    0
    0
    Fungal skin infection
         subjects affected / exposed
    0 / 13 (0.00%)
    0 / 21 (0.00%)
    0 / 34 (0.00%)
    0 / 18 (0.00%)
    1 / 17 (5.88%)
    0 / 6 (0.00%)
    0 / 10 (0.00%)
    0 / 8 (0.00%)
    1 / 23 (4.35%)
    0 / 18 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    0
    0
    1
    0
    Gastroenteritis
         subjects affected / exposed
    1 / 13 (7.69%)
    0 / 21 (0.00%)
    1 / 34 (2.94%)
    0 / 18 (0.00%)
    1 / 17 (5.88%)
    1 / 6 (16.67%)
    0 / 10 (0.00%)
    0 / 8 (0.00%)
    2 / 23 (8.70%)
    0 / 18 (0.00%)
         occurrences all number
    1
    0
    1
    0
    1
    1
    0
    0
    2
    0
    Gastroenteritis viral
         subjects affected / exposed
    1 / 13 (7.69%)
    0 / 21 (0.00%)
    1 / 34 (2.94%)
    0 / 18 (0.00%)
    0 / 17 (0.00%)
    0 / 6 (0.00%)
    0 / 10 (0.00%)
    0 / 8 (0.00%)
    0 / 23 (0.00%)
    0 / 18 (0.00%)
         occurrences all number
    1
    0
    1
    0
    0
    0
    0
    0
    0
    0
    Helicobacter gastritis
         subjects affected / exposed
    0 / 13 (0.00%)
    0 / 21 (0.00%)
    0 / 34 (0.00%)
    0 / 18 (0.00%)
    1 / 17 (5.88%)
    0 / 6 (0.00%)
    0 / 10 (0.00%)
    0 / 8 (0.00%)
    1 / 23 (4.35%)
    0 / 18 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    0
    0
    1
    0
    Laryngitis
         subjects affected / exposed
    0 / 13 (0.00%)
    1 / 21 (4.76%)
    1 / 34 (2.94%)
    0 / 18 (0.00%)
    0 / 17 (0.00%)
    0 / 6 (0.00%)
    0 / 10 (0.00%)
    0 / 8 (0.00%)
    0 / 23 (0.00%)
    0 / 18 (0.00%)
         occurrences all number
    0
    1
    1
    0
    0
    0
    0
    0
    0
    0
    Nasopharyngitis
         subjects affected / exposed
    1 / 13 (7.69%)
    3 / 21 (14.29%)
    4 / 34 (11.76%)
    1 / 18 (5.56%)
    2 / 17 (11.76%)
    0 / 6 (0.00%)
    1 / 10 (10.00%)
    2 / 8 (25.00%)
    2 / 23 (8.70%)
    3 / 18 (16.67%)
         occurrences all number
    1
    3
    4
    1
    2
    0
    1
    3
    2
    4
    Oral herpes
         subjects affected / exposed
    0 / 13 (0.00%)
    0 / 21 (0.00%)
    0 / 34 (0.00%)
    1 / 18 (5.56%)
    0 / 17 (0.00%)
    0 / 6 (0.00%)
    0 / 10 (0.00%)
    0 / 8 (0.00%)
    0 / 23 (0.00%)
    0 / 18 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    Pharyngitis
         subjects affected / exposed
    1 / 13 (7.69%)
    1 / 21 (4.76%)
    2 / 34 (5.88%)
    0 / 18 (0.00%)
    0 / 17 (0.00%)
    0 / 6 (0.00%)
    0 / 10 (0.00%)
    0 / 8 (0.00%)
    0 / 23 (0.00%)
    0 / 18 (0.00%)
         occurrences all number
    1
    1
    2
    0
    0
    0
    0
    0
    0
    0
    Sinusitis
         subjects affected / exposed
    0 / 13 (0.00%)
    0 / 21 (0.00%)
    0 / 34 (0.00%)
    0 / 18 (0.00%)
    0 / 17 (0.00%)
    0 / 6 (0.00%)
    0 / 10 (0.00%)
    1 / 8 (12.50%)
    0 / 23 (0.00%)
    1 / 18 (5.56%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    1
    0
    1
    Tonsillitis
         subjects affected / exposed
    0 / 13 (0.00%)
    0 / 21 (0.00%)
    0 / 34 (0.00%)
    0 / 18 (0.00%)
    1 / 17 (5.88%)
    0 / 6 (0.00%)
    0 / 10 (0.00%)
    0 / 8 (0.00%)
    1 / 23 (4.35%)
    0 / 18 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    0
    0
    1
    0
    Tooth infection
         subjects affected / exposed
    0 / 13 (0.00%)
    0 / 21 (0.00%)
    0 / 34 (0.00%)
    0 / 18 (0.00%)
    0 / 17 (0.00%)
    1 / 6 (16.67%)
    0 / 10 (0.00%)
    0 / 8 (0.00%)
    1 / 23 (4.35%)
    0 / 18 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    0
    0
    1
    0
    Upper respiratory tract infection
         subjects affected / exposed
    2 / 13 (15.38%)
    1 / 21 (4.76%)
    3 / 34 (8.82%)
    0 / 18 (0.00%)
    1 / 17 (5.88%)
    1 / 6 (16.67%)
    2 / 10 (20.00%)
    0 / 8 (0.00%)
    2 / 23 (8.70%)
    2 / 18 (11.11%)
         occurrences all number
    2
    1
    3
    0
    1
    1
    3
    0
    2
    3
    Urinary tract infection
         subjects affected / exposed
    1 / 13 (7.69%)
    1 / 21 (4.76%)
    2 / 34 (5.88%)
    1 / 18 (5.56%)
    2 / 17 (11.76%)
    0 / 6 (0.00%)
    0 / 10 (0.00%)
    1 / 8 (12.50%)
    2 / 23 (8.70%)
    1 / 18 (5.56%)
         occurrences all number
    1
    1
    2
    1
    5
    0
    0
    1
    5
    1
    Vulvovaginal mycotic infection
         subjects affected / exposed
    0 / 13 (0.00%)
    1 / 21 (4.76%)
    1 / 34 (2.94%)
    0 / 18 (0.00%)
    0 / 17 (0.00%)
    0 / 6 (0.00%)
    1 / 10 (10.00%)
    0 / 8 (0.00%)
    0 / 23 (0.00%)
    1 / 18 (5.56%)
         occurrences all number
    0
    1
    1
    0
    0
    0
    1
    0
    0
    1
    Metabolism and nutrition disorders
    Hypoglycaemia
         subjects affected / exposed
    0 / 13 (0.00%)
    0 / 21 (0.00%)
    0 / 34 (0.00%)
    0 / 18 (0.00%)
    0 / 17 (0.00%)
    1 / 6 (16.67%)
    0 / 10 (0.00%)
    0 / 8 (0.00%)
    1 / 23 (4.35%)
    0 / 18 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    0
    0
    1
    0
    Vitamin D deficiency
         subjects affected / exposed
    0 / 13 (0.00%)
    0 / 21 (0.00%)
    0 / 34 (0.00%)
    0 / 18 (0.00%)
    1 / 17 (5.88%)
    0 / 6 (0.00%)
    0 / 10 (0.00%)
    0 / 8 (0.00%)
    1 / 23 (4.35%)
    0 / 18 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    0
    0
    1
    0

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    14 Nov 2016
    The study population had been redefined such that adolescent subjects were excluded from the study, as per the guidance from the ethics committees. As a result, subjects aged 18-45 years were only eligible. The amendment was implemented prior to FPFV.
    14 Dec 2016
    Changes were made to the inclusion criteria to include only adults who have failed other systemic therapies for inflammatory acne. Changes were also made to sample size that was reduced from 90 to 75 subjects. A study design change was implemented that offers the subjects at week 12 an option to continue in an extension period. The amendment was implemented prior to FPFV.

    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.

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