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    Clinical Trial Results:
    A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase 2 Study to Evaluate the Efficacy and Safety of LY3375880 in Adult Subjects with Moderate-to-Severe Atopic Dermatitis

    Summary
    EudraCT number
    2018-002401-56
    Trial protocol
    HU   AT   FR   ES   DE   IT  
    Global end of trial date
    27 Feb 2020

    Results information
    Results version number
    v1(current)
    This version publication date
    28 Feb 2021
    First version publication date
    28 Feb 2021
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    I9N-MC-FCAB
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    NCT03831191
    WHO universal trial number (UTN)
    -
    Other trial identifiers
    Trial Number: 17104
    Sponsors
    Sponsor organisation name
    Eli Lilly and Company
    Sponsor organisation address
    Lilly Corporate Center, Indianapolis, IN, United States, 46285
    Public contact
    Available Mon ‐ Fri 9 AM ‐ 5 PM EST, Eli Lilly and Company, 1 877‐CTLilly,
    Scientific contact
    Available Mon ‐ Fri 9 AM ‐ 5 PM EST, Eli Lilly and Company, 1 877‐285‐4559,
    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 Feb 2020
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    27 Feb 2020
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The reason for this study is to see if the study drug LY3375880 is safe and effective in adults with moderate-to-severe atopic dermatitis (AD).
    Protection of trial subjects
    This study was conducted in accordance with International Conference on Harmonization (ICH) Good Clinical Practice, and the principles of the Declaration of Helsinki, in addition to following the laws and regulations of the country or countries in which a study is conducted.
    Background therapy
    -
    Evidence for comparator
    -
    Actual start date of recruitment
    12 Feb 2019
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Spain: 4
    Country: Number of subjects enrolled
    United States: 48
    Country: Number of subjects enrolled
    Argentina: 17
    Country: Number of subjects enrolled
    Austria: 7
    Country: Number of subjects enrolled
    Canada: 4
    Country: Number of subjects enrolled
    France: 4
    Country: Number of subjects enrolled
    Hungary: 5
    Country: Number of subjects enrolled
    Italy: 6
    Country: Number of subjects enrolled
    Japan: 41
    Worldwide total number of subjects
    136
    EEA total number of subjects
    26
    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)
    128
    From 65 to 84 years
    8
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    No Text Available

    Pre-assignment
    Screening details
    Responders are participants who achieved a 50% reduction in the Eczema Area and Severity Index score [EASI-50] response, regardless of whether rescue therapy had been initiated during induction period. Participants did not receive 300 mg because the trial was stopped early.

    Period 1
    Period 1 title
    Induction Period (16 Weeks)
    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
    Placebo
    Arm description
    Induction Period: Participants received placebo administered subcutaneously (SC) every 4 weeks (Q4W).
    Arm type
    Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Administered SC

    Arm title
    50 mg LY3375880
    Arm description
    Induction Period: Participants received 50 milligrams (mg) LY3375880 administered SC Q4W.
    Arm type
    Experimental

    Investigational medicinal product name
    LY3375880
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Administered SC

    Arm title
    150 mg LY3375880
    Arm description
    Induction Period: Participants received 150 mg LY3375880 administered SC Q4W.
    Arm type
    Experimental

    Investigational medicinal product name
    LY3375880
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Administered SC

    Arm title
    600 mg LY3375880
    Arm description
    Induction Period: Participants received 600 mg LY3375880 administered SC Q4W.
    Arm type
    Experimental

    Investigational medicinal product name
    LY3375880
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Administered SC

    Number of subjects in period 1
    Placebo 50 mg LY3375880 150 mg LY3375880 600 mg LY3375880
    Started
    33
    35
    34
    34
    Received at least one dose of study drug
    33
    35
    34
    33
    Completed
    10
    14
    13
    11
    Not completed
    23
    21
    21
    23
         Study Terminated by Sponsor
    12
    15
    16
    13
         Protocol deviation
    -
    -
    -
    2
         Lack of efficacy
    2
    3
    -
    -
         Pregnancy
    -
    -
    1
    -
         Adverse event, non-fatal
    2
    1
    3
    4
         Consent withdrawn by subject
    7
    2
    1
    3
         Sponsor Decision
    -
    -
    -
    1
    Period 2
    Period 2 title
    Maintenance Period (36 Weeks)
    Is this the baseline period?
    No
    Allocation method
    Randomised - controlled
    Blinding used
    Double blind
    Roles blinded
    Subject, Investigator

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    Placebo Responder to Placebo/300 mg LY3375880
    Arm description
    Maintenance Period: Participants received placebo administered SC Q4W until loss of response then 300 mg LY3375880 SC Q4W . Participants had received placebo SC Q4W during the induction period.
    Arm type
    Experimental

    Investigational medicinal product name
    LY3375880
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Administered SC

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Administered SC .

    Arm title
    Placebo Non-Responder to 300 mg LY3375880
    Arm description
    Maintenance Period: Participants received 300 mg LY3375880 administered SC Q4W. Participants had received placebo SC Q4W during the induction period.
    Arm type
    Experimental

    Investigational medicinal product name
    LY3375880
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Administered SC.

    Arm title
    50 mg Responder to Placebo/50 mg LY3375880
    Arm description
    Maintenance Period: Participants received placebo administered SC Q4W until loss of response then 50 mg LY3375880 SC Q4W. Participants had received 50 mg LY3375880 SC Q4W during the induction period.
    Arm type
    Experimental

    Investigational medicinal product name
    LY3375880
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Administered SC.

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Administered SC.

    Arm title
    50 mg LY3375880 Responder to 50 mg LY3375880
    Arm description
    Maintenance Period: Participants received 50 mg LY3375880 administered SC Q4W. Participants had received 50 mg LY3375880 SC Q4W during the induction period.
    Arm type
    Experimental

    Investigational medicinal product name
    LY3375880
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Administered SC.

    Arm title
    50 mg LY3375880 Non-Responder to 150 mg LY3375880
    Arm description
    Maintenance Period: Participants received 150 mg LY3375880 administered SC Q4W. Participants had received 50 mg LY3375880 SC Q4W during the induction period.
    Arm type
    Experimental

    Investigational medicinal product name
    LY3375880
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Administered SC.

    Arm title
    150 mg Responder to Placebo/150 mg LY3375880
    Arm description
    Maintenance Period: Participants received placebo administered SC Q4W until loss of response then 150 mg LY3375880 SC Q4W. Participants had received 150 mg LY3375880 SC Q4W during the induction period.
    Arm type
    Experimental

    Investigational medicinal product name
    LY3375880
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Administered SC.

    Arm title
    150 mg LY3375880 Responder to 150 mg LY3375880
    Arm description
    Maintenance Period: Participants received 150 mg LY3375880 administered SC Q4W. Participants had received 150 mg LY3375880 SC Q4W during the induction period.
    Arm type
    Experimental

    Investigational medicinal product name
    LY3375880
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Administered SC.

    Arm title
    150 mg LY3375880 Non-Responder to 300 mg LY3375880
    Arm description
    Maintenance Period: Participants received 300 mg LY3375880 administered SC Q4W. Participants had received 150 mg LY3375880 SC Q4W during the induction period.
    Arm type
    Experimental

    Investigational medicinal product name
    LY3375880
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Administered SC.

    Arm title
    600 mg Responder to Placebo/600 mg LY3375880
    Arm description
    Maintenance Period: Participants received placebo administered SC Q4W until loss of response then 600 mg LY3375880 SC Q4W. Participants had received 600 mg LY3375880 SC Q4W during the induction period.
    Arm type
    Experimental

    Investigational medicinal product name
    LY3375880
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Administered SC.

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Administered SC.

    Arm title
    600 mg LY3375880 Responder to 600 mg LY3375880
    Arm description
    Maintenance Period: Participants received 600 mg LY3375880 administered SC Q4W. Participants had received 600 mg LY3375880 SC Q4W during the induction period.
    Arm type
    Experimental

    Investigational medicinal product name
    LY3375880
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Administered SC.

    Arm title
    600 mg LY3375880 Non-Responder to 600 mg LY3375880
    Arm description
    Maintenance Period: Participants received 600 mg LY3375880 administered SC Q4W. Participants had received 600 mg LY3375880 SC Q4W during the induction period.
    Arm type
    Experimental

    Investigational medicinal product name
    LY3375880
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Administered SC.

    Number of subjects in period 2 [1]
    Placebo Responder to Placebo/300 mg LY3375880 Placebo Non-Responder to 300 mg LY3375880 50 mg Responder to Placebo/50 mg LY3375880 50 mg LY3375880 Responder to 50 mg LY3375880 50 mg LY3375880 Non-Responder to 150 mg LY3375880 150 mg Responder to Placebo/150 mg LY3375880 150 mg LY3375880 Responder to 150 mg LY3375880 150 mg LY3375880 Non-Responder to 300 mg LY3375880 600 mg Responder to Placebo/600 mg LY3375880 600 mg LY3375880 Responder to 600 mg LY3375880 600 mg LY3375880 Non-Responder to 600 mg LY3375880
    Started
    4
    5
    2
    4
    8
    1
    4
    8
    1
    1
    9
    Completed
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    Not completed
    4
    5
    2
    4
    8
    1
    4
    7
    1
    1
    9
         Study Terminated by Sponsor
    4
    5
    2
    4
    8
    1
    4
    7
    1
    1
    6
         Consent withdrawn by subject
    -
    -
    -
    -
    -
    -
    -
    -
    -
    -
    2
         Lost to follow-up
    -
    -
    -
    -
    -
    -
    -
    -
    -
    -
    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: Participants were assigned to these arms during maintenance period.

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Placebo
    Reporting group description
    Induction Period: Participants received placebo administered subcutaneously (SC) every 4 weeks (Q4W).

    Reporting group title
    50 mg LY3375880
    Reporting group description
    Induction Period: Participants received 50 milligrams (mg) LY3375880 administered SC Q4W.

    Reporting group title
    150 mg LY3375880
    Reporting group description
    Induction Period: Participants received 150 mg LY3375880 administered SC Q4W.

    Reporting group title
    600 mg LY3375880
    Reporting group description
    Induction Period: Participants received 600 mg LY3375880 administered SC Q4W.

    Reporting group values
    Placebo 50 mg LY3375880 150 mg LY3375880 600 mg LY3375880 Total
    Number of subjects
    33 35 34 34 136
    Age categorical
    Units: Subjects
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    37.00 ± 14.98 37.70 ± 16.00 39.50 ± 13.94 36.80 ± 13.84 -
    Gender categorical
    Units: Subjects
        Female
    11 16 17 14 58
        Male
    22 19 17 20 78
    Ethnicity (NIH/OMB)
    Units: Subjects
        Hispanic or Latino
    9 11 9 8 37
        Not Hispanic or Latino
    12 14 14 16 56
        Unknown or Not Reported
    12 10 11 10 43
    Race (NIH/OMB)
    Units: Subjects
        American Indian or Alaska Native
    1 0 0 0 1
        Asian
    11 14 10 12 47
        Native Hawaiian or Other Pacific Islander
    0 0 0 0 0
        Black or African American
    0 1 2 3 6
        White
    19 19 20 19 77
        More than one race
    0 0 1 0 1
        Unknown or Not Reported
    2 1 1 0 4
    Region of Enrollment
    Units: Subjects
        Argentina
    5 3 5 4 17
        Austria
    0 4 1 2 7
        Canada
    0 0 3 1 4
        France
    2 1 1 0 4
        Hungary
    1 0 3 1 5
        Italy
    1 1 1 3 6
        Spain
    0 0 3 1 4
        United States
    14 15 7 12 48
        Japan
    10 11 10 10 41

    End points

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    End points reporting groups
    Reporting group title
    Placebo
    Reporting group description
    Induction Period: Participants received placebo administered subcutaneously (SC) every 4 weeks (Q4W).

    Reporting group title
    50 mg LY3375880
    Reporting group description
    Induction Period: Participants received 50 milligrams (mg) LY3375880 administered SC Q4W.

    Reporting group title
    150 mg LY3375880
    Reporting group description
    Induction Period: Participants received 150 mg LY3375880 administered SC Q4W.

    Reporting group title
    600 mg LY3375880
    Reporting group description
    Induction Period: Participants received 600 mg LY3375880 administered SC Q4W.
    Reporting group title
    Placebo Responder to Placebo/300 mg LY3375880
    Reporting group description
    Maintenance Period: Participants received placebo administered SC Q4W until loss of response then 300 mg LY3375880 SC Q4W . Participants had received placebo SC Q4W during the induction period.

    Reporting group title
    Placebo Non-Responder to 300 mg LY3375880
    Reporting group description
    Maintenance Period: Participants received 300 mg LY3375880 administered SC Q4W. Participants had received placebo SC Q4W during the induction period.

    Reporting group title
    50 mg Responder to Placebo/50 mg LY3375880
    Reporting group description
    Maintenance Period: Participants received placebo administered SC Q4W until loss of response then 50 mg LY3375880 SC Q4W. Participants had received 50 mg LY3375880 SC Q4W during the induction period.

    Reporting group title
    50 mg LY3375880 Responder to 50 mg LY3375880
    Reporting group description
    Maintenance Period: Participants received 50 mg LY3375880 administered SC Q4W. Participants had received 50 mg LY3375880 SC Q4W during the induction period.

    Reporting group title
    50 mg LY3375880 Non-Responder to 150 mg LY3375880
    Reporting group description
    Maintenance Period: Participants received 150 mg LY3375880 administered SC Q4W. Participants had received 50 mg LY3375880 SC Q4W during the induction period.

    Reporting group title
    150 mg Responder to Placebo/150 mg LY3375880
    Reporting group description
    Maintenance Period: Participants received placebo administered SC Q4W until loss of response then 150 mg LY3375880 SC Q4W. Participants had received 150 mg LY3375880 SC Q4W during the induction period.

    Reporting group title
    150 mg LY3375880 Responder to 150 mg LY3375880
    Reporting group description
    Maintenance Period: Participants received 150 mg LY3375880 administered SC Q4W. Participants had received 150 mg LY3375880 SC Q4W during the induction period.

    Reporting group title
    150 mg LY3375880 Non-Responder to 300 mg LY3375880
    Reporting group description
    Maintenance Period: Participants received 300 mg LY3375880 administered SC Q4W. Participants had received 150 mg LY3375880 SC Q4W during the induction period.

    Reporting group title
    600 mg Responder to Placebo/600 mg LY3375880
    Reporting group description
    Maintenance Period: Participants received placebo administered SC Q4W until loss of response then 600 mg LY3375880 SC Q4W. Participants had received 600 mg LY3375880 SC Q4W during the induction period.

    Reporting group title
    600 mg LY3375880 Responder to 600 mg LY3375880
    Reporting group description
    Maintenance Period: Participants received 600 mg LY3375880 administered SC Q4W. Participants had received 600 mg LY3375880 SC Q4W during the induction period.

    Reporting group title
    600 mg LY3375880 Non-Responder to 600 mg LY3375880
    Reporting group description
    Maintenance Period: Participants received 600 mg LY3375880 administered SC Q4W. Participants had received 600 mg LY3375880 SC Q4W during the induction period.

    Subject analysis set title
    300 mg LY3375880
    Subject analysis set type
    Per protocol
    Subject analysis set description
    Participants received 300 mg LY3375880 administered SC Q4W.

    Primary: Percentage of Participants Achieving Validated Investigator’s Global Assessment for AD (vIGA-AD) of 0 or 1 with a ≥2 Point Improvement

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    End point title
    Percentage of Participants Achieving Validated Investigator’s Global Assessment for AD (vIGA-AD) of 0 or 1 with a ≥2 Point Improvement
    End point description
    vIGA-AD measures participants' overall severity of their atopic dermatitis (AD), based on a static, numeric 5 point scale from 0 (clear) to 4 (severe). Higher scores indicate greater severity.The score is based on an overall assessment of the degree of erythema, papulation/induration, oozing/crusting, and lichenification. Non-responder imputation (NRI) method was used to impute missing data. Analysis Population Description (APD): Induction Period; All randomized participants who completed or discontinued the study prior to study termination by the sponsor.
    End point type
    Primary
    End point timeframe
    Week 16
    End point values
    Placebo 50 mg LY3375880 150 mg LY3375880 600 mg LY3375880
    Number of subjects analysed
    21
    20
    17
    21
    Units: Percentage of participants
        number (confidence interval 95%)
    9.5 (2.7 to 28.9)
    5.0 (0.9 to 23.6)
    5.9 (1.0 to 27.0)
    4.8 (0.8 to 22.7)
    Statistical analysis title
    % of Participants Achieving vIGA-AD) of 0 or 1
    Statistical analysis description
    % of Participants Achieving vIGA-AD) of 0 or 1 With a ≥2 Point Improvement.
    Comparison groups
    Placebo v 50 mg LY3375880
    Number of subjects included in analysis
    41
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.638
    Method
    Regression, Logistic
    Parameter type
    Odds ratio (OR)
    Point estimate
    0.55
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    0.04
         upper limit
    6.81
    Statistical analysis title
    % of Participants Achieving vIGA-AD) of 0 or 1
    Statistical analysis description
    % of Participants Achieving vIGA-AD) of 0 or 1 With a ≥2 Point Improvement.
    Comparison groups
    Placebo v 150 mg LY3375880
    Number of subjects included in analysis
    38
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.773
    Method
    Regression, Logistic
    Parameter type
    Odds ratio (OR)
    Point estimate
    0.69
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    0.05
         upper limit
    8.76
    Statistical analysis title
    % of Participants Achieving vIGA-AD) of 0 or 1
    Statistical analysis description
    % of Participants Achieving vIGA-AD) of 0 or 1 With a ≥2 Point Improvement.
    Comparison groups
    Placebo v 600 mg LY3375880
    Number of subjects included in analysis
    42
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.671
    Method
    Regression, Logistic
    Parameter type
    Odds ratio (OR)
    Point estimate
    0.58
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    0.05
         upper limit
    7.26

    Secondary: Percentage of Participants Achieving Eczema Area and Severity Index 75 (EASI-75)

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    End point title
    Percentage of Participants Achieving Eczema Area and Severity Index 75 (EASI-75)
    End point description
    EASI assesses objective physician estimates of 2 dimensions of atopic dermatitis - disease extent and clinical signs - by scoring the extent of disease (percentage of skin affected: 0 = 0%; 1 = 1-9%; 2 = 10-29%; 3 = 30-49%; 4 = 50-69%; 5 = 70-89%; 6 = 90-100%) and the severity of 4 clinical signs (erythema, edema/papulation, excoriation, and lichenification) each on a scale of 0 to 3 (0 = none, absent; 1 = mild; 2 = moderate; 3 = severe) at 4 body sites (head and neck, trunk, upper limbs, and lower limbs). Half scores are allowed. Each body site will have a score that ranges from 0 to 72, and the final EASI score will be obtained by weight-averaging these 4 scores. Hence, the final EASI score will range from 0 to 72 (severe) for each time point. A higher score represented greater disease severity.The EASI75 is defined as a ≥ 75% improvement from baseline in the EASI score. Non-responder imputation (NRI) method was used to impute missing data.
    End point type
    Secondary
    End point timeframe
    Week 16 APD: Induction Period; All randomized participants who completed or discontinued the study prior to study termination by the sponsor.
    End point values
    Placebo 50 mg LY3375880 150 mg LY3375880 600 mg LY3375880
    Number of subjects analysed
    21
    20
    17
    21
    Units: Percentage of Participants
        number (confidence interval 95%)
    19.0 (7.7 to 40.0)
    15.0 (5.2 to 36.0)
    23.5 (9.6 to 47.3)
    0.0 (0.0 to 15.5)
    Statistical analysis title
    Percentage of Participants Achieving EASI-75
    Comparison groups
    Placebo v 50 mg LY3375880
    Number of subjects included in analysis
    41
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    > 0.999
    Method
    Fisher exact
    Parameter type
    Risk difference (RD)
    Point estimate
    -4
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -27.2
         upper limit
    19.9
    Statistical analysis title
    Percentage of Participants Achieving EASI-75
    Comparison groups
    Placebo v 150 mg LY3375880
    Number of subjects included in analysis
    38
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    > 0.999
    Method
    Fisher exact
    Parameter type
    Risk difference (RD)
    Point estimate
    4.5
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -20.7
         upper limit
    30.8
    Statistical analysis title
    Percentage of Participants Achieving EASI-75
    Comparison groups
    Placebo v 600 mg LY3375880
    Number of subjects included in analysis
    42
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.107
    Method
    Fisher exact
    Parameter type
    Risk difference (RD)
    Point estimate
    -19
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -40
         upper limit
    0.2

    Secondary: Percentage of Participants Achieving SCORing Atopic Dermatitis 75 (SCORAD-75)

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    End point title
    Percentage of Participants Achieving SCORing Atopic Dermatitis 75 (SCORAD-75)
    End point description
    The SCORAD index uses the rule of nines to assess disease extent (head and neck 9%; upper limbs 9% each; lower limbs 18% each; anterior trunk 18%; back 18%; and genitals 1%). It evaluates 6 clinical characteristics to determine disease severity: (1) erythema, (2) edema/papulation, (3) oozing/crusts, (4) excoriation, (5) lichenification, and (6) dryness on a scale of 0 to 3 (0=absence, 1=mild, 2=moderate, 3=severe). The SCORAD index also assesses subjective symptoms of pruritus and sleep loss in the last 72 hours on visual analogue scales (VAS) of 0 to 10 where 0 is no itch or sleep loss and 10 is worst imaginable itch or sleep loss. These 3 aspects: extent of disease, disease severity, and subjective symptoms combine to give a score between 0(no disease) and 103 (severe disease). Higher scores indicate greater severity.Non-responder imputation (NRI) method was used to impute missing data.
    End point type
    Secondary
    End point timeframe
    Week 16 APD: Induction Period; All randomized participants who completed or discontinued the study prior to study termination by the sponsor.
    End point values
    Placebo 50 mg LY3375880 150 mg LY3375880 600 mg LY3375880
    Number of subjects analysed
    21
    20
    17
    21
    Units: Percentage of participants
        number (confidence interval 95%)
    4.8 (0.8 to 22.7)
    5.0 (0.9 to 23.6)
    0.0 (0.0 to 18.4)
    0.0 (0.0 to 15.5)
    Statistical analysis title
    Percentage of Participants Achieving SCORAD-75
    Comparison groups
    Placebo v 50 mg LY3375880
    Number of subjects included in analysis
    41
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    > 0.999
    Method
    Fisher exact
    Parameter type
    Risk difference (RD)
    Point estimate
    0.2
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -18.1
         upper limit
    19.3
    Statistical analysis title
    Percentage of Participants Achieving SCORAD-75
    Comparison groups
    Placebo v 150 mg LY3375880
    Number of subjects included in analysis
    38
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    > 0.999
    Method
    Fisher exact
    Parameter type
    Risk difference (RD)
    Point estimate
    -4.8
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -22.7
         upper limit
    14.1
    Statistical analysis title
    Percentage of Participants Achieving SCORAD-75
    Comparison groups
    Placebo v 600 mg LY3375880
    Number of subjects included in analysis
    42
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    > 0.999
    Method
    Fisher exact
    Parameter type
    Risk difference (RD)
    Point estimate
    -4.8
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -22.7
         upper limit
    11.2

    Secondary: Percentage of Participants Achieving vIGA-AD of 0

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    End point title
    Percentage of Participants Achieving vIGA-AD of 0
    End point description
    vIGA-AD measures participants overall severity of their atopic dermatitis (AD), based on a static, numeric 5 point scale from 0 (clear) to 4 (severe). Higher scores indicate greater severity. The score is based on an overall assessment of the degree of erythema, papulation/induration, oozing/crusting, and lichenification. Non-responder imputation (NRI) method was used to impute missing data. APD: Induction Period; All randomized participants who completed or discontinued the study prior to study termination by the sponsor.
    End point type
    Secondary
    End point timeframe
    Week 16
    End point values
    Placebo 50 mg LY3375880 150 mg LY3375880 600 mg LY3375880
    Number of subjects analysed
    21
    20
    17
    21
    Units: Percentage of participants
        number (confidence interval 95%)
    0.0 (0.0 to 0.0)
    0.0 (0.0 to 0.0)
    0.0 (0.0 to 0.0)
    0.0 (0.0 to 0.0)
    Statistical analysis title
    Percentage of Participants Achieving vIGA-AD of 0
    Comparison groups
    Placebo v 50 mg LY3375880
    Number of subjects included in analysis
    41
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    Method
    Parameter type
    Risk difference (RD)
    Point estimate
    0
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    0
         upper limit
    0
    Statistical analysis title
    Percentage of Participants Achieving vIGA-AD of 0
    Comparison groups
    Placebo v 150 mg LY3375880
    Number of subjects included in analysis
    38
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    Method
    Parameter type
    Risk difference (RD)
    Point estimate
    0
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    0
         upper limit
    0
    Statistical analysis title
    Percentage of Participants Achieving vIGA-AD of 0
    Comparison groups
    Placebo v 600 mg LY3375880
    Number of subjects included in analysis
    42
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    Method
    Parameter type
    Risk difference (RD)
    Point estimate
    0
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    0
         upper limit
    0

    Secondary: Mean Change from Baseline in Eczema Area and Severity Index (EASI) Score

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    End point title
    Mean Change from Baseline in Eczema Area and Severity Index (EASI) Score
    End point description
    EASI assesses objective physician estimates of 2 dimensions of atopic dermatitis-disease extent and clinical signs-by scoring the extent of disease(percentage of skin affected: 0= 0%;1 =1-9%; 2 =10-29%;3 = 30-49%;4 = 50-69%;5 = 70-89%;6 = 90-100%) and the severity of 4 clinical signs (erythema,edema/papulation,excoriation,and lichenification) each on a scale of 0 to 3(0= none,absent;1 =mild;2 = moderate;3=severe) at 4 body sites(head and neck,trunk,upper limbs,and lower limbs).Half scores are allowed.Each body site will have a score that ranges from 0 to 72,and the final EASI score will be obtained by weight-averaging these 4 scores.Hence,the final EASI score will range from 0 to 72(severe) for each time point.Higher scores indicate greater severity.Least Squares Mean(LS Means) were calculated using mixed model repeated measures(MMRM) model with treatment,region, baseline disease severity,visit,treatment-by-visit-interaction,baseline and baseline-by-visit-interaction as fixed effects.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 16 APD: Induction Period; All randomized participants who had a baseline and at least one post-baseline EASI value.
    End point values
    Placebo 50 mg LY3375880 150 mg LY3375880 600 mg LY3375880
    Number of subjects analysed
    6
    8
    8
    9
    Units: score on a scale
        least squares mean (standard error)
    -11.45 ± 4.68
    -4.90 ± 4.30
    -5.89 ± 4.55
    -7.87 ± 4.02
    Statistical analysis title
    Mean Change From Baseline in EASI Score
    Comparison groups
    Placebo v 50 mg LY3375880
    Number of subjects included in analysis
    14
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.31
    Method
    Mixed models analysis
    Parameter type
    Median difference (net)
    Point estimate
    6.55
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -6.36
         upper limit
    19.45
    Statistical analysis title
    Mean Change From Baseline in EASI Score
    Comparison groups
    Placebo v 150 mg LY3375880
    Number of subjects included in analysis
    14
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.393
    Method
    Mixed models analysis
    Parameter type
    Mean difference (net)
    Point estimate
    5.56
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -7.5
         upper limit
    18.63
    Statistical analysis title
    Mean Change From Baseline in EASI Score
    Comparison groups
    Placebo v 600 mg LY3375880
    Number of subjects included in analysis
    15
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.564
    Method
    Mixed models analysis
    Parameter type
    Mean difference (net)
    Point estimate
    3.59
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -8.91
         upper limit
    16.08

    Secondary: Mean Change from Baseline in SCORAD

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    End point title
    Mean Change from Baseline in SCORAD
    End point description
    The SCORAD index uses the rule of nines to assess disease extent (head and neck 9%;upper limbs 9% each;lower limbs 18% each;anterior trunk 18%;back 18%;and genitals 1%).It evaluates 6 clinical characteristics to determine disease severity: (1)erythema,(2)edema/papulation, (3)oozing/crusts,(4) excoriation,(5) lichenification, and (6) dryness on a scale of 0 to 3(0=absence,1=mild,2=moderate,3=severe).The SCORAD index also assesses subjective symptoms of pruritus and sleep loss in the last 72 hours on visual analogue scales(VAS) of 0 to 10 where 0 is no itch or sleep loss and 10 is worst imaginable itch or sleep loss.These 3 aspects: extent of disease,disease severity,and subjective symptoms combine to give a score between 0(no disease) and 103(severe disease).Higher scores indicate greater severity. LS Means were calculated using a MMRM model with treatment,region,baseline disease severity,visit, treatment-by-visit-interaction,baseline and baseline-by-visit-interaction as fixed effects.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 16 APD: Induction Period; All randomized participants who had a baseline and at least one post-baseline SCORAD value.
    End point values
    Placebo 50 mg LY3375880 150 mg LY3375880 600 mg LY3375880
    Number of subjects analysed
    7
    8
    8
    9
    Units: score on a scale
        least squares mean (standard error)
    -19.27 ± 5.92
    -11.66 ± 5.72
    -16.94 ± 6.03
    -12.75 ± 5.3
    Statistical analysis title
    Mean Change from Baseline in SCORAD
    Comparison groups
    Placebo v 50 mg LY3375880
    Number of subjects included in analysis
    15
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.356
    Method
    Mixed models analysis
    Parameter type
    Mean difference (net)
    Point estimate
    7.61
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -8.82
         upper limit
    24.05
    Statistical analysis title
    Mean Change from Baseline in SCORAD
    Comparison groups
    Placebo v 150 mg LY3375880
    Number of subjects included in analysis
    15
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.783
    Method
    Mixed models analysis
    Parameter type
    Mean difference (net)
    Point estimate
    2.33
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -14.64
         upper limit
    19.3
    Statistical analysis title
    Mean Change from Baseline in SCORAD
    Comparison groups
    Placebo v 600 mg LY3375880
    Number of subjects included in analysis
    16
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.414
    Method
    Mixed models analysis
    Parameter type
    Mean difference (net)
    Point estimate
    6.52
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -9.4
         upper limit
    22.43

    Secondary: Percentage of Participants Achieving vIGA-AD of 0 or 1 with a >=2-point improvement at Week 52

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    End point title
    Percentage of Participants Achieving vIGA-AD of 0 or 1 with a >=2-point improvement at Week 52
    End point description
    vIGA-AD measures participants overall severity of their atopic dermatitis (AD), based on a static, numeric 5 point scale from 0 (clear) to 4 (severe). Higher scores indicate greater severity. The score is based on an overall assessment of the degree of erythema, papulation/induration, oozing/crusting, and lichenification. Non-responder imputation (NRI) method was used to impute missing data. APD: Maintenance Period; All randomized participants who had a >=2-point improvement at Week 52.
    End point type
    Secondary
    End point timeframe
    Week 52
    End point values
    Placebo 50 mg LY3375880 150 mg LY3375880 600 mg LY3375880 300 mg LY3375880
    Number of subjects analysed
    8
    4
    12
    10
    13
    Units: Percentage of participants
        number (confidence interval 95%)
    0.0 (0.0 to 32.4)
    0.0 (0.0 to 49.0)
    0.0 (0.0 to 24.2)
    0.0 (0.0 to 27.8)
    0.0 (0.0 to 22.8)
    No statistical analyses for this end point

    Secondary: Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve at a steady state (AUCτ,ss) of LY3375880

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    End point title
    Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve at a steady state (AUCτ,ss) of LY3375880 [1]
    End point description
    Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve at a steady state (AUCτ,ss) of LY3375880 APD: All randomized participants who received LY3375880 and had evaluable PK data. Participants did not receive 300 mg because the trial was stopped early.
    End point type
    Secondary
    End point timeframe
    Induction Period: Pre-dose, Day 0, Day 7, Day 14, Day 28, Day 56, Day 112 Post-dose; Maintenance Period:Predose, Day 168; Day 252, Day 364 Post-dose
    Notes
    [1] - 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: PK analysis exclude placebo arm.
    End point values
    50 mg LY3375880 150 mg LY3375880 600 mg LY3375880
    Number of subjects analysed
    35
    34
    33
    Units: Nanograms*hour per millilitre (ng*h/mL)
        geometric mean (geometric coefficient of variation)
    4450 ± 80.2
    11200 ± 41.9
    49000 ± 40.5
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Baseline Up To 45 Weeks
    Adverse event reporting additional description
    All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
    Assessment type
    Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    21.1
    Reporting groups
    Reporting group title
    50 mg LY3375880
    Reporting group description
    Induction Period: Participants received 50 mg LY3375880 administered SC Q4W.

    Reporting group title
    150 mg LY3375880
    Reporting group description
    Induction Period: Participants received 150 mg LY3375880 administered SC Q4W.

    Reporting group title
    600 mg LY3375880
    Reporting group description
    Induction Period: Participants received 600 mg LY3375880 administered SC Q4W.

    Reporting group title
    Placebo
    Reporting group description
    Induction Period: Participants received placebo administered subcutaneously (SC) every 4 weeks (Q4W).

    Reporting group title
    50 mg LY3375880 Non-Responder to 150 mg LY3375880
    Reporting group description
    Maintenance Period: Participants received 150 mg LY3375880 administered SC Q4W. Participants had received 50 mg LY3375880 SC Q4W during the induction period.

    Reporting group title
    50 mg LY3375880 Responder to 50 mg LY3375880
    Reporting group description
    Maintenance Period: Participants received 50 mg LY3375880 administered SC Q4W. Participants had received 50 mg LY3375880 SC Q4W during the induction period.

    Reporting group title
    50 mg Responder to Placebo/50 mg LY3375880
    Reporting group description
    Maintenance Period: Participants received placebo administered SC Q4W until loss of response then 50 mg LY3375880 SC Q4W. Participants had received 50 mg LY3375880 SC Q4W during the induction period.

    Reporting group title
    150 mg LY3375880 Non-Responder to 300 mg LY3375880
    Reporting group description
    Maintenance Period: Participants received 300 mg LY3375880 administered SC Q4W. Participants had received 150 mg LY3375880 SC Q4W during the induction period.

    Reporting group title
    150 mg LY3375880 Responder to 150 mg LY3375880
    Reporting group description
    Maintenance Period: Participants received 150 mg LY3375880 administered SC Q4W. Participants had received 150 mg LY3375880 SC Q4W during the induction period.

    Reporting group title
    150 mg Responder to Placebo/150 mg LY3375880
    Reporting group description
    Maintenance Period: Participants received placebo administered SC Q4W until loss of response then 150 mg LY3375880 SC Q4W. Participants had received 150 mg LY3375880 SC Q4W during the induction period.

    Reporting group title
    600 mg LY3375880 Non-Responder to 600 mg LY3375880
    Reporting group description
    Maintenance Period: Participants received 600 mg LY3375880 administered SC Q4W. Participants had received 600 mg LY3375880 SC Q4W during the induction period.

    Reporting group title
    600 mg LY3375880 Responder to 600 mg LY3375880
    Reporting group description
    Maintenance Period: Participants received 600 mg LY3375880 administered SC Q4W. Participants had received 600 mg LY3375880 SC Q4W during the induction period.

    Reporting group title
    600 mg Responder to Placebo/600 mg LY3375880
    Reporting group description
    Maintenance Period: Participants received placebo administered SC Q4W until loss of response then 600 mg LY3375880 SC Q4W. Participants had received 600 mg LY3375880 SC Q4W during the induction period.

    Reporting group title
    Placebo Non-Responder to 300 mg LY3375880
    Reporting group description
    Maintenance Period: Participants received 300 mg LY3375880 administered SC Q4W. Participants had received placebo SC Q4W during the induction period.

    Reporting group title
    Placebo Responder to Placebo/300 mg LY3375880
    Reporting group description
    Maintenance Period: Participants received placebo administered SC Q4W until loss of response then 300 mg LY3375880 SC Q4W . Participants had received placebo SC Q4W during the induction period.

    Reporting group title
    50 mg LY3375880 Q4W Post-Treatment Follow-Up Period
    Reporting group description
    Follow-up: participants did not receive drug during the follow-up period.

    Reporting group title
    150 mg LY3375880 Q4W Post-Treatment Follow-Up Period
    Reporting group description
    Follow-up: participants did not receive drug during the follow-up period.

    Reporting group title
    600 mg LY3375880 Q4W Post-Treatment Follow-Up Period
    Reporting group description
    Follow-up: participants did not receive drug during the follow-up period.

    Reporting group title
    Placebo Post-Treatment Follow-Up Period
    Reporting group description
    Follow-up: participants did not receive drug during the follow-up period.

    Serious adverse events
    50 mg LY3375880 150 mg LY3375880 600 mg LY3375880 Placebo 50 mg LY3375880 Non-Responder to 150 mg LY3375880 50 mg LY3375880 Responder to 50 mg LY3375880 50 mg Responder to Placebo/50 mg LY3375880 150 mg LY3375880 Non-Responder to 300 mg LY3375880 150 mg LY3375880 Responder to 150 mg LY3375880 150 mg Responder to Placebo/150 mg LY3375880 600 mg LY3375880 Non-Responder to 600 mg LY3375880 600 mg LY3375880 Responder to 600 mg LY3375880 600 mg Responder to Placebo/600 mg LY3375880 Placebo Non-Responder to 300 mg LY3375880 Placebo Responder to Placebo/300 mg LY3375880 50 mg LY3375880 Q4W Post-Treatment Follow-Up Period 150 mg LY3375880 Q4W Post-Treatment Follow-Up Period 600 mg LY3375880 Q4W Post-Treatment Follow-Up Period Placebo Post-Treatment Follow-Up Period
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 35 (0.00%)
    0 / 34 (0.00%)
    2 / 33 (6.06%)
    0 / 33 (0.00%)
    0 / 8 (0.00%)
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    0 / 8 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    1 / 5 (20.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 8 (0.00%)
         number of deaths (all causes)
    0
    0
    0
    0
    0
    0
    0
    0
    0
    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
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    lung adenocarcinoma
    alternative dictionary used: MedDRA 21.1
         subjects affected / exposed
    0 / 35 (0.00%)
    0 / 34 (0.00%)
    1 / 33 (3.03%)
    0 / 33 (0.00%)
    0 / 8 (0.00%)
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    0 / 8 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 8 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cardiac disorders
    cardiac arrest
    alternative dictionary used: MedDRA 21.1
         subjects affected / exposed
    0 / 35 (0.00%)
    0 / 34 (0.00%)
    0 / 33 (0.00%)
    0 / 33 (0.00%)
    0 / 8 (0.00%)
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    0 / 8 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    1 / 5 (20.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 8 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Skin and subcutaneous tissue disorders
    dermatitis atopic
    alternative dictionary used: MedDRA 21.1
         subjects affected / exposed
    0 / 35 (0.00%)
    0 / 34 (0.00%)
    1 / 33 (3.03%)
    0 / 33 (0.00%)
    0 / 8 (0.00%)
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    0 / 8 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 8 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    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: 5%
    Non-serious adverse events
    50 mg LY3375880 150 mg LY3375880 600 mg LY3375880 Placebo 50 mg LY3375880 Non-Responder to 150 mg LY3375880 50 mg LY3375880 Responder to 50 mg LY3375880 50 mg Responder to Placebo/50 mg LY3375880 150 mg LY3375880 Non-Responder to 300 mg LY3375880 150 mg LY3375880 Responder to 150 mg LY3375880 150 mg Responder to Placebo/150 mg LY3375880 600 mg LY3375880 Non-Responder to 600 mg LY3375880 600 mg LY3375880 Responder to 600 mg LY3375880 600 mg Responder to Placebo/600 mg LY3375880 Placebo Non-Responder to 300 mg LY3375880 Placebo Responder to Placebo/300 mg LY3375880 50 mg LY3375880 Q4W Post-Treatment Follow-Up Period 150 mg LY3375880 Q4W Post-Treatment Follow-Up Period 600 mg LY3375880 Q4W Post-Treatment Follow-Up Period Placebo Post-Treatment Follow-Up Period
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    9 / 35 (25.71%)
    12 / 34 (35.29%)
    12 / 33 (36.36%)
    7 / 33 (21.21%)
    2 / 8 (25.00%)
    1 / 4 (25.00%)
    1 / 2 (50.00%)
    3 / 8 (37.50%)
    1 / 4 (25.00%)
    1 / 1 (100.00%)
    2 / 9 (22.22%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    4 / 5 (80.00%)
    1 / 4 (25.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 8 (0.00%)
    General disorders and administration site conditions
    injection site pain
    alternative dictionary used: MedDRA 21.1
         subjects affected / exposed
    0 / 35 (0.00%)
    0 / 34 (0.00%)
    2 / 33 (6.06%)
    1 / 33 (3.03%)
    0 / 8 (0.00%)
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    0 / 8 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 8 (0.00%)
         occurrences all number
    0
    0
    4
    6
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    injection site reaction
    alternative dictionary used: MedDRA 21.1
         subjects affected / exposed
    0 / 35 (0.00%)
    1 / 34 (2.94%)
    0 / 33 (0.00%)
    0 / 33 (0.00%)
    0 / 8 (0.00%)
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    0 / 8 (0.00%)
    1 / 4 (25.00%)
    0 / 1 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 8 (0.00%)
         occurrences all number
    0
    2
    0
    0
    0
    0
    0
    0
    4
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Psychiatric disorders
    depression
    alternative dictionary used: MedDRA 21.1
         subjects affected / exposed
    1 / 35 (2.86%)
    0 / 34 (0.00%)
    0 / 33 (0.00%)
    0 / 33 (0.00%)
    0 / 8 (0.00%)
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    1 / 8 (12.50%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 8 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    insomnia
    alternative dictionary used: MedDRA 21.1
         subjects affected / exposed
    1 / 35 (2.86%)
    4 / 34 (11.76%)
    1 / 33 (3.03%)
    2 / 33 (6.06%)
    0 / 8 (0.00%)
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    0 / 8 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 8 (0.00%)
         occurrences all number
    1
    4
    1
    2
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Reproductive system and breast disorders
    menstruation irregular
    alternative dictionary used: MedDRA 21.1
         subjects affected / exposed [1]
    1 / 16 (6.25%)
    0 / 17 (0.00%)
    0 / 13 (0.00%)
    0 / 11 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
    0 / 1 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Injury, poisoning and procedural complications
    ligament rupture
    alternative dictionary used: MedDRA 21.1
         subjects affected / exposed
    0 / 35 (0.00%)
    0 / 34 (0.00%)
    0 / 33 (0.00%)
    0 / 33 (0.00%)
    1 / 8 (12.50%)
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    0 / 8 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 8 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    ligament sprain
    alternative dictionary used: MedDRA 21.1
         subjects affected / exposed
    0 / 35 (0.00%)
    0 / 34 (0.00%)
    0 / 33 (0.00%)
    0 / 33 (0.00%)
    0 / 8 (0.00%)
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    0 / 8 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
    1 / 9 (11.11%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 8 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    meniscus injury
    alternative dictionary used: MedDRA 21.1
         subjects affected / exposed
    0 / 35 (0.00%)
    0 / 34 (0.00%)
    0 / 33 (0.00%)
    0 / 33 (0.00%)
    0 / 8 (0.00%)
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    0 / 8 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
    1 / 9 (11.11%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 8 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    Investigations
    alanine aminotransferase increased
    alternative dictionary used: MedDRA 21.1
         subjects affected / exposed
    0 / 35 (0.00%)
    0 / 34 (0.00%)
    1 / 33 (3.03%)
    0 / 33 (0.00%)
    0 / 8 (0.00%)
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    0 / 8 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    1 / 5 (20.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 8 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    aspartate aminotransferase increased
    alternative dictionary used: MedDRA 21.1
         subjects affected / exposed
    0 / 35 (0.00%)
    0 / 34 (0.00%)
    2 / 33 (6.06%)
    0 / 33 (0.00%)
    0 / 8 (0.00%)
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    0 / 8 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 8 (0.00%)
         occurrences all number
    0
    0
    2
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    electrocardiogram qt prolonged
    alternative dictionary used: MedDRA 21.1
         subjects affected / exposed
    0 / 35 (0.00%)
    0 / 34 (0.00%)
    0 / 33 (0.00%)
    0 / 33 (0.00%)
    0 / 8 (0.00%)
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    0 / 8 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    1 / 5 (20.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 8 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    Cardiac disorders
    cardiac failure congestive
    alternative dictionary used: MedDRA 21.1
         subjects affected / exposed
    0 / 35 (0.00%)
    0 / 34 (0.00%)
    0 / 33 (0.00%)
    0 / 33 (0.00%)
    0 / 8 (0.00%)
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    0 / 8 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    1 / 5 (20.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 8 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    cardiomyopathy
    alternative dictionary used: MedDRA 21.1
         subjects affected / exposed
    0 / 35 (0.00%)
    0 / 34 (0.00%)
    0 / 33 (0.00%)
    0 / 33 (0.00%)
    0 / 8 (0.00%)
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    0 / 8 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    1 / 5 (20.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 8 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    Respiratory, thoracic and mediastinal disorders
    cough
    alternative dictionary used: MedDRA 21.1
         subjects affected / exposed
    0 / 35 (0.00%)
    0 / 34 (0.00%)
    0 / 33 (0.00%)
    0 / 33 (0.00%)
    0 / 8 (0.00%)
    1 / 4 (25.00%)
    0 / 2 (0.00%)
    0 / 8 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 8 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    pneumonitis
    alternative dictionary used: MedDRA 21.1
         subjects affected / exposed
    0 / 35 (0.00%)
    0 / 34 (0.00%)
    0 / 33 (0.00%)
    0 / 33 (0.00%)
    0 / 8 (0.00%)
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    1 / 8 (12.50%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 8 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Nervous system disorders
    headache
    alternative dictionary used: MedDRA 21.1
         subjects affected / exposed
    2 / 35 (5.71%)
    0 / 34 (0.00%)
    2 / 33 (6.06%)
    1 / 33 (3.03%)
    0 / 8 (0.00%)
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    1 / 8 (12.50%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 8 (0.00%)
         occurrences all number
    2
    0
    2
    1
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    hypoaesthesia
    alternative dictionary used: MedDRA 21.1
         subjects affected / exposed
    0 / 35 (0.00%)
    0 / 34 (0.00%)
    2 / 33 (6.06%)
    0 / 33 (0.00%)
    0 / 8 (0.00%)
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    0 / 8 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 8 (0.00%)
         occurrences all number
    0
    0
    2
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Eye disorders
    cataract
    alternative dictionary used: MedDRA 21.1
         subjects affected / exposed
    0 / 35 (0.00%)
    0 / 34 (0.00%)
    1 / 33 (3.03%)
    0 / 33 (0.00%)
    0 / 8 (0.00%)
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    0 / 8 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
    1 / 9 (11.11%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 8 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    Gastrointestinal disorders
    gastrooesophageal reflux disease
    alternative dictionary used: MedDRA 21.1
         subjects affected / exposed
    0 / 35 (0.00%)
    0 / 34 (0.00%)
    0 / 33 (0.00%)
    0 / 33 (0.00%)
    0 / 8 (0.00%)
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    0 / 8 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    1 / 5 (20.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 8 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    Skin and subcutaneous tissue disorders
    androgenetic alopecia
    alternative dictionary used: MedDRA 21.1
         subjects affected / exposed
    0 / 35 (0.00%)
    0 / 34 (0.00%)
    0 / 33 (0.00%)
    0 / 33 (0.00%)
    0 / 8 (0.00%)
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    0 / 8 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    1 / 5 (20.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 8 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    dermatitis atopic
    alternative dictionary used: MedDRA 21.1
         subjects affected / exposed
    1 / 35 (2.86%)
    3 / 34 (8.82%)
    3 / 33 (9.09%)
    3 / 33 (9.09%)
    0 / 8 (0.00%)
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    0 / 8 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 5 (0.00%)
    1 / 4 (25.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 8 (0.00%)
         occurrences all number
    1
    4
    3
    3
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    pain of skin
    alternative dictionary used: MedDRA 21.1
         subjects affected / exposed
    0 / 35 (0.00%)
    0 / 34 (0.00%)
    2 / 33 (6.06%)
    0 / 33 (0.00%)
    0 / 8 (0.00%)
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    0 / 8 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 8 (0.00%)
         occurrences all number
    0
    0
    2
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    pruritus
    alternative dictionary used: MedDRA 21.1
         subjects affected / exposed
    1 / 35 (2.86%)
    2 / 34 (5.88%)
    3 / 33 (9.09%)
    0 / 33 (0.00%)
    0 / 8 (0.00%)
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    0 / 8 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 8 (0.00%)
         occurrences all number
    1
    2
    3
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Musculoskeletal and connective tissue disorders
    synovial cyst
    alternative dictionary used: MedDRA 21.1
         subjects affected / exposed
    0 / 35 (0.00%)
    0 / 34 (0.00%)
    0 / 33 (0.00%)
    0 / 33 (0.00%)
    0 / 8 (0.00%)
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    0 / 8 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
    1 / 9 (11.11%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 8 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    Metabolism and nutrition disorders
    hypokalaemia
    alternative dictionary used: MedDRA 21.1
         subjects affected / exposed
    0 / 35 (0.00%)
    0 / 34 (0.00%)
    0 / 33 (0.00%)
    0 / 33 (0.00%)
    0 / 8 (0.00%)
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    0 / 8 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    1 / 5 (20.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 8 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    Infections and infestations
    cellulitis
    alternative dictionary used: MedDRA 21.1
         subjects affected / exposed
    0 / 35 (0.00%)
    0 / 34 (0.00%)
    0 / 33 (0.00%)
    0 / 33 (0.00%)
    0 / 8 (0.00%)
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    0 / 8 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    1 / 5 (20.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 8 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    1
    0
    1
    folliculitis
    alternative dictionary used: MedDRA 21.1
         subjects affected / exposed
    1 / 35 (2.86%)
    0 / 34 (0.00%)
    0 / 33 (0.00%)
    1 / 33 (3.03%)
    1 / 8 (12.50%)
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    0 / 8 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 8 (0.00%)
         occurrences all number
    1
    0
    0
    1
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    nasopharyngitis
    alternative dictionary used: MedDRA 21.1
         subjects affected / exposed
    3 / 35 (8.57%)
    1 / 34 (2.94%)
    0 / 33 (0.00%)
    0 / 33 (0.00%)
    1 / 8 (12.50%)
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    0 / 8 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    1 / 5 (20.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 8 (0.00%)
         occurrences all number
    3
    1
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    1
    0
    paronychia
    alternative dictionary used: MedDRA 21.1
         subjects affected / exposed
    0 / 35 (0.00%)
    2 / 34 (5.88%)
    0 / 33 (0.00%)
    0 / 33 (0.00%)
    0 / 8 (0.00%)
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    0 / 8 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 8 (0.00%)
         occurrences all number
    0
    2
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    postoperative wound infection
    alternative dictionary used: MedDRA 21.1
         subjects affected / exposed
    1 / 35 (2.86%)
    3 / 34 (8.82%)
    1 / 33 (3.03%)
    1 / 33 (3.03%)
    0 / 8 (0.00%)
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    0 / 8 (0.00%)
    0 / 4 (0.00%)
    1 / 1 (100.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 8 (0.00%)
         occurrences all number
    1
    4
    1
    1
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    upper respiratory tract infection
    alternative dictionary used: MedDRA 21.1
         subjects affected / exposed
    0 / 35 (0.00%)
    1 / 34 (2.94%)
    1 / 33 (3.03%)
    0 / 33 (0.00%)
    0 / 8 (0.00%)
    0 / 4 (0.00%)
    1 / 2 (50.00%)
    0 / 8 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 8 (0.00%)
         occurrences all number
    0
    1
    1
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Notes
    [1] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: This event is gender specific, only occurring in male or female subjects. The number of subjects exposed has been adjusted accordingly.

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    Substantial protocol amendments (globally)

    Were there any global substantial amendments to the protocol? No

    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.
    The study was terminated for lack of efficacy after an interim analysis was performed.
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