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    Clinical Trial Results:
    A Phase II, Randomized, Double-Blind, Placebo Controlled, Multicenter Trial to Assess the Oral Corticosteroid-Sparing Effect of Lebrikizumab in Patients With Severe Corticosteroid Dependent Asthma

    Summary
    EudraCT number
    		 2012-000190-24
    Trial protocol
    		 GB   ES   CZ   BE   SK   SI   NL   PL   BG   DK  
    Global end of trial date
    20 Dec 2016

    Results information
    Results version number
    		 v1(current)
    This version publication date
    01 Jul 2017
    First version publication date
    01 Jul 2017
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    WB28182
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01987492
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    F. Hoffmann-La Roche AG
    Sponsor organisation address
    Grenzacherstrasse 124, Basel, Switzerland, CH-4070
    Public contact
    Roche Trial Information Hotline, F. Hoffmann-La Roche AG, 41 61 6878333, global.trial_information@roche.com
    Scientific contact
    Roche Trial Information Hotline, F. Hoffmann-La Roche AG, 41 61 6878333, global.trial_information@roche.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    Yes
    EMA paediatric investigation plan number(s)
    		 EMEA-001053-PIP01-10
    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?
    Yes
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    17 Feb 2017
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    20 Dec 2016
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    The main objectives of this study were: 1) To evaluate the efficacy of lebrikizumab compared with placebo as measured by the ability of participants to achieve lower daily doses of oral corticosteroids (OCS; prednisone/prednisolone) while maintaining control of their asthma; 2) To evaluate periostin as a predictive biomarker to select participants most likely to receive benefit from lebrikizumab therapy; 3) To evaluate the safety and tolerability of lebrikizumab compared with placebo.
    Protection of trial subjects
    The study was conducted in full conformance with the International Conference on Harmonisation (ICH) E6 guidelines for Good Clinical Practice (GCP) and the principles of the “Declaration of Helsinki”, or the laws and regulations of the country in which the research was conducted, whichever afforded the greater protection to the individual. Approval from the Independent Ethics Committee (IEC)/Institutional Review Board (IRB) was obtained before study start and was documented in a letter to the Investigator specifying the date on which the committee met and granted the approval. The Sponsor also obtained approval from the relevant Competent Authority prior to starting the study.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    21 Feb 2014
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Czech Republic: 16
    Country: Number of subjects enrolled
    Poland: 34
    Country: Number of subjects enrolled
    Slovakia: 6
    Country: Number of subjects enrolled
    Slovenia: 5
    Country: Number of subjects enrolled
    United States: 6
    Country: Number of subjects enrolled
    Australia: 5
    Country: Number of subjects enrolled
    Mexico: 6
    Country: Number of subjects enrolled
    New Zealand: 7
    Country: Number of subjects enrolled
    United Kingdom: 97
    Country: Number of subjects enrolled
    Belgium: 5
    Country: Number of subjects enrolled
    Denmark: 3
    Country: Number of subjects enrolled
    Spain: 10
    Country: Number of subjects enrolled
    France: 26
    Country: Number of subjects enrolled
    Netherlands: 4
    Worldwide total number of subjects
    230
    EEA total number of subjects
    206
    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)
    12
    Adults (18-64 years)
    190
    From 65 to 84 years
    28
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 A total of 322 participants (including 21 adolescents) were screened and 230 participants (including 12 adolescent participants) were randomized.

    Period 1
    Period 1 title
    Overall Study (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Monitor, Data analyst, Carer, Assessor

    Arms
    Are arms mutually exclusive
    No

    Arm title
    		 Placebo
    Arm description
    		 Participants received subcutaneous (SC) injection of lebrikizumab matching placebo (2 placebo injections) every 4 weeks (Q4W) for 44 weeks during double-blind placebo controlled (DBPC) period. All participants were followed for safety for 24 weeks after last dose of study drug.
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection in pre-filled syringe
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Participants received SC injection of lebrikizumab matching placebo (2 placebo injections) Q4W for 44 weeks during DBPC period.

    Arm title
    		 Lebrikizumab 125 mg
    Arm description
    		 Participants received SC injection of lebrikizumab at dose level of 125 milligrams (mg) (1 injection of lebrikizumab 125 mg + 1 placebo injection) Q4W for 44 weeks during DBPC period and then for additional 32 weeks (up to Week 76) in active treatment extension (ATE) period. Following completion of the ATE period, participants who both tolerated and derived benefit from treatment, continued same treatment into optional long-term active-treatment extension (LTE) period (maximum up to 2 years and 10 months). All participants were followed for safety for 24 weeks after last dose of study drug.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Lebrikizumab
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection in pre-filled syringe
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Participants received SC injection of lebrikizumab (1 injection of lebrikizumab 125 mg + 1 placebo injection) Q4W for maximum up to 2 years and 10 months.

    Arm title
    		 Lebrikizumab 250 mg
    Arm description
    		 Participants received SC injection of lebrikizumab at dose level of 250 mg (2 injections of lebrikizumab 125 mg) Q4W for 44 weeks during DBPC period and then for additional 32 weeks (up to Week 76) in ATE period. Following completion of the ATE period, participants who both tolerated and derived benefit from treatment, continued same treatment into optional LTE period (maximum up to 2 years and 10 months). All participants were followed for safety for 24 weeks after last dose of study drug.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Lebrikizumab
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection in pre-filled syringe
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Participants received SC injection of lebrikizumab (2 injections of lebrikizumab 125 mg) Q4W for maximum up to 2 years and 10 months.

    Arm title
    		 Placebo/Lebrikizumab 125 mg
    Arm description
    		 Participants who received 'Placebo' during DBPC period and who were randomized to this group after completion of DBPC period, received SC injection of lebrikizumab at dose level of 125 mg (1 injection of lebrikizumab 125 mg + 1 placebo injection) Q4W for 32 weeks (up to Week 76) in ATE period. Following completion of the ATE period, participants who both tolerated and derived benefit from treatment, continued same treatment into optional LTE period (maximum up to 2 years and 10 months). All participants were followed for safety for 24 weeks after last dose of study drug.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Lebrikizumab
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection in pre-filled syringe
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Participants received SC injection of lebrikizumab (1 injection of lebrikizumab 125 mg + 1 placebo injection) Q4W from Week 44 up to maximum 2 years and 10 months.

    Arm title
    		 Placebo/Lebrikizumab 250 mg
    Arm description
    		 Participants who received 'Placebo' during DBPC period and who were randomized to this group after completion of DBPC period, received SC injection of lebrikizumab at dose level of 250 mg (2 injections of lebrikizumab 125 mg) Q4W for 32 weeks (up to Week 76) in ATE period. Following completion of the ATE period, participants who both tolerated and derived benefit from treatment, continued same treatment into optional LTE period (maximum up to 2 years and 10 months). All participants were followed for safety for 24 weeks after last dose of study drug.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Lebrikizumab
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection in pre-filled syringe
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Participants received SC injection of lebrikizumab (2 injections of lebrikizumab 125 mg) Q4W from Week 44 up to maximum 2 years and 10 months.

    Number of subjects in period 1
    		Placebo Lebrikizumab 125 mg Lebrikizumab 250 mg Placebo/Lebrikizumab 125 mg Placebo/Lebrikizumab 250 mg
    Started
    102
    56
    72
    24
    22
    Completed
    48
    39
    51
    18
    19
    Not completed
    54
    17
    21
    6
    3
         Consent withdrawn by subject
    5
    10
    16
    4
    2
         Physician decision
    1
    -
    1
    -
    -
         Non-Compliance
    -
    1
    1
    -
    -
         Adverse Event
    -
    1
    -
    -
    -
         Transferred to other arm
    46
    -
    -
    -
    -
         Unspecified
    -
    4
    -
    1
    1
         Study Terminated by Sponsor
    1
    1
    3
    1
    -
         Lost to follow-up
    1
    -
    -
    -
    -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Overall Study
    Reporting group description
    		 -

    Reporting group values
    		 Overall Study Total
    Number of subjects
    		 230
    Age Categorical
    Units: Subjects
    Age Continuous
    Units: years
        arithmetic mean (standard deviation)
    		 50.3 ± 14.2 -
    Gender Categorical
    Units: Subjects
        Female
    		 135 135
        Male
    		 95 95

    End points

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    End points reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 Participants received subcutaneous (SC) injection of lebrikizumab matching placebo (2 placebo injections) every 4 weeks (Q4W) for 44 weeks during double-blind placebo controlled (DBPC) period. All participants were followed for safety for 24 weeks after last dose of study drug.

    Reporting group title
    Lebrikizumab 125 mg
    Reporting group description
    		 Participants received SC injection of lebrikizumab at dose level of 125 milligrams (mg) (1 injection of lebrikizumab 125 mg + 1 placebo injection) Q4W for 44 weeks during DBPC period and then for additional 32 weeks (up to Week 76) in active treatment extension (ATE) period. Following completion of the ATE period, participants who both tolerated and derived benefit from treatment, continued same treatment into optional long-term active-treatment extension (LTE) period (maximum up to 2 years and 10 months). All participants were followed for safety for 24 weeks after last dose of study drug.

    Reporting group title
    Lebrikizumab 250 mg
    Reporting group description
    		 Participants received SC injection of lebrikizumab at dose level of 250 mg (2 injections of lebrikizumab 125 mg) Q4W for 44 weeks during DBPC period and then for additional 32 weeks (up to Week 76) in ATE period. Following completion of the ATE period, participants who both tolerated and derived benefit from treatment, continued same treatment into optional LTE period (maximum up to 2 years and 10 months). All participants were followed for safety for 24 weeks after last dose of study drug.

    Reporting group title
    Placebo/Lebrikizumab 125 mg
    Reporting group description
    		 Participants who received 'Placebo' during DBPC period and who were randomized to this group after completion of DBPC period, received SC injection of lebrikizumab at dose level of 125 mg (1 injection of lebrikizumab 125 mg + 1 placebo injection) Q4W for 32 weeks (up to Week 76) in ATE period. Following completion of the ATE period, participants who both tolerated and derived benefit from treatment, continued same treatment into optional LTE period (maximum up to 2 years and 10 months). All participants were followed for safety for 24 weeks after last dose of study drug.

    Reporting group title
    Placebo/Lebrikizumab 250 mg
    Reporting group description
    		 Participants who received 'Placebo' during DBPC period and who were randomized to this group after completion of DBPC period, received SC injection of lebrikizumab at dose level of 250 mg (2 injections of lebrikizumab 125 mg) Q4W for 32 weeks (up to Week 76) in ATE period. Following completion of the ATE period, participants who both tolerated and derived benefit from treatment, continued same treatment into optional LTE period (maximum up to 2 years and 10 months). All participants were followed for safety for 24 weeks after last dose of study drug.

    Primary: Percent Change From Baseline in Daily OCS Dose at Week 44

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    End point title
    		 Percent Change From Baseline in Daily OCS Dose at Week 44 [1]
    End point description
    OCS used in study: prednisone/prednisolone. Participants entered their total daily use of OCS into an electronic diary (eDiary) on a daily basis. The OCS intake since the previous study visit and the prescribed OCS dose for the next 28 days was captured by physician on a dedicated page in the electronic Case Report Form (eCRF). Baseline OCS dose was calculated using the eDiary as average daily dose over 28 days prior to randomization. Post-baseline OCS dose was obtained from the eCRF and calculated as average daily dose over the 28 days preceding the timepoint. Percent change = (post-baseline value - baseline value)/baseline value * 100. Modified intent-to-treat (mITT) adult participant population included all randomized adult participants who received at least one dose of study drug. Here, 'Number of Subjects Analysed'=participants with a valid baseline value and at least one non-missing value at Week 44.
    End point type
    Primary
    End point timeframe
    Baseline (including 28 days prior to Day 1), Week 44 (including 28 days prior to Week 44)
    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: Analysis was planned to be carried out in the indicated arms only
    End point values
    		 Placebo Lebrikizumab 125 mg Lebrikizumab 250 mg
    Number of subjects analysed
    61
    28
    44
    Units: percent change
        arithmetic mean (standard deviation)
    -43.17 ± 49.2
    -55.78 ± 33.33
    -39.63 ± 51.35
    Statistical analysis title
    		 Statistical Analysis 1
    Statistical analysis description
    Mixed model of repeated measures (MMRM) was utilized for analysis. The model used percent change from baseline in daily OCS dose as response and the following covariates: Treatment arm, Mean baseline OCS dose, Baseline 7-item Asthma Control Questionnaire (ACQ-7) score, British Thoracic Society (BTS) with 2 levels (yes/no), Study Week, and a 4-level categorical variable using Periostin and Eosinophil levels as (High/High, High/ Low, Low/High, and Low/Low).
    Comparison groups
    Placebo v Lebrikizumab 125 mg
    Number of subjects included in analysis
    89
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    Method
    Parameter type
    		 Difference in Adjusted Means
    Point estimate
    -6.5
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -27.2
         upper limit
    		 14.3
    Variability estimate
    Standard error of the mean
    Dispersion value
    10.5
    Statistical analysis title
    		 Statistical Analysis 2
    Statistical analysis description
    MMRM was utilized for analysis. The model used percent change from baseline in daily OCS dose as response and the following covariates: Treatment arm, Mean baseline OCS dose, Baseline ACQ-7 score, BTS with 2 levels (yes/no), Study Week, and a 4-level categorical variable using Periostin and Eosinophil levels as (High/High, High/ Low, Low/High, and Low/Low).
    Comparison groups
    Placebo v Lebrikizumab 250 mg
    Number of subjects included in analysis
    105
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    Method
    Parameter type
    		 Difference in Adjusted Means
    Point estimate
    -2.2
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -20.7
         upper limit
    		 16.3
    Variability estimate
    Standard error of the mean
    Dispersion value
    9.34

    Secondary: Change From Baseline in Daily OCS Dose at Week 44

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    End point title
    		 Change From Baseline in Daily OCS Dose at Week 44 [2]
    End point description
    OCS used in study: prednisone/prednisolone. Participants entered their total daily use of OCS into an eDiary on a daily basis. The OCS intake since the previous study visit and the prescribed OCS dose for the next 28 days was captured by physician on a dedicated page in the eCRF. Baseline OCS dose was calculated using the eDiary as average daily dose over 28 days prior to randomization. Post baseline OCS dose was obtained from the eCRF and calculated as average daily dose over the 28 days preceding the timepoint. Analysis was performed on mITT adult participant population. Here, 'Number of Subjects Analysed' signifies participants with a valid baseline value and 'n' signifies participants with a valid non-missing value at indicated time point, per arm, respectively.
    End point type
    Secondary
    End point timeframe
    Baseline (including 28 days prior to Day 1), Week 44 (including 28 days prior to Week 44)
    Notes
    [2] - 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: Analysis was planned to be carried out in the indicated arms only
    End point values
    		 Placebo Lebrikizumab 125 mg Lebrikizumab 250 mg
    Number of subjects analysed
    96
    56
    66
    Units: mg
    arithmetic mean (standard deviation)
        Baseline (n=96,56,66)
    16.13 ± 7.89
    14.75 ± 6.4
    15.01 ± 7.04
        Change at Week 44 (n=61,28,44)
    -5.89 ± 7.36
    -7.2 ± 5.37
    -5.27 ± 5.95
    Statistical analysis title
    		 Statistical Analysis 1
    Statistical analysis description
    MMRM was utilized for analysis. The model used absolute change from baseline in daily OCS dose as response and the following covariates: Treatment arm, Mean baseline OCS dose, Baseline ACQ-7 score, BTS with 2 levels (yes/no), Study Week, and a 4-level categorical variable using Periostin and Eosinophil levels as (High/High, High/ Low, Low/High, and Low/Low). Actual subjects included in analysis (at Week 44) = 89.
    Comparison groups
    Placebo v Lebrikizumab 125 mg
    Number of subjects included in analysis
    152
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    Method
    Parameter type
    		 Difference in Adjusted Means
    Point estimate
    -1.5
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -4.3
         upper limit
    		 1.4
    Variability estimate
    Standard error of the mean
    Dispersion value
    1.43
    Statistical analysis title
    		 Statistical Analysis 2
    Statistical analysis description
    MMRM was utilized for analysis. The model used absolute change from baseline in daily OCS dose as response and the following covariates: Treatment arm, Mean baseline OCS dose, Baseline ACQ-7 score, BTS with 2 levels (yes/no), Study Week, and a 4-level categorical variable using Periostin and Eosinophil levels as (High/High, High/ Low, Low/High, and Low/Low). Actual subjects included in analysis (at Week 44) = 105.
    Comparison groups
    Placebo v Lebrikizumab 250 mg
    Number of subjects included in analysis
    162
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    Method
    Parameter type
    		 Difference in Adjusted Means
    Point estimate
    -0.6
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -3.1
         upper limit
    		 1.9
    Variability estimate
    Standard error of the mean
    Dispersion value
    1.28

    Secondary: Percent Change From Week 12 in Daily OCS Dose at Week 44

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    End point title
    		 Percent Change From Week 12 in Daily OCS Dose at Week 44 [3]
    End point description
    OCS used in study: prednisone/prednisolone. Participants entered their total daily use of OCS into an eDiary on a daily basis. The OCS intake since the previous study visit and the prescribed OCS dose for the next 28 days was captured by physician on a dedicated page in the eCRF. OCS dose at a timepoint was obtained from the eCRF and calculated as average daily dose over the 28 days preceding the timepoint. Percent change = (value at Week 44 - value at Week 12)/value at Week 12 * 100. Reported values are adjusted mean values obtained from MMRM analysis. The analysis was performed on mITT adult participant population. Here, 'Number of Subjects Analysed' signifies participants with a valid non-missing value at Week 12 and at Week 44.
    End point type
    Secondary
    End point timeframe
    Week 12 (including 28 days prior to Week 12), Week 44 (including 28 days prior to Week 44)
    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: Analysis was planned to be carried out in the indicated arms only
    End point values
    		 Placebo Lebrikizumab 125 mg Lebrikizumab 250 mg
    Number of subjects analysed
    61
    28
    43
    Units: percent change
        least squares mean (standard error)
    -36.3 ± 5.69
    -44 ± 8.47
    -37.8 ± 6.97
    Statistical analysis title
    		 Statistical Analysis 2
    Statistical analysis description
    MMRM was utilized for analysis. The model used percent change from baseline in daily OCS dose as response and the following covariates: Treatment arm, Mean baseline OCS dose, Baseline ACQ-7 score, BTS with 2 levels (yes/no), Study Week, and a 4-level categorical variable using Periostin and Eosinophil levels as (High/High, High/ Low, Low/High, and Low/Low).
    Comparison groups
    Placebo v Lebrikizumab 250 mg
    Number of subjects included in analysis
    104
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    Method
    Parameter type
    		 Difference in Adjusted Means
    Point estimate
    -1.5
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -18.6
         upper limit
    		 15.7
    Variability estimate
    Standard error of the mean
    Dispersion value
    8.68
    Statistical analysis title
    		 Statistical Analysis 1
    Statistical analysis description
    MMRM was utilized for analysis. The model used percent change from baseline in daily OCS dose as response and the following covariates: Treatment arm, Mean baseline OCS dose, Baseline ACQ-7 score, BTS with 2 levels (yes/no), Study Week, and a 4-level categorical variable using Periostin and Eosinophil levels as (High/High, High/ Low, Low/High, and Low/Low).
    Comparison groups
    Placebo v Lebrikizumab 125 mg
    Number of subjects included in analysis
    89
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    Method
    Parameter type
    		 Difference in Adjusted Means
    Point estimate
    -7.7
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -27.3
         upper limit
    		 11.9
    Variability estimate
    Standard error of the mean
    Dispersion value
    9.95

    Secondary: Percentage of Participants Who Achieved at Least a 50 Percent (%) Reduction in Their Daily OCS Dose at Week 44 Relative to Baseline

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    End point title
    		 Percentage of Participants Who Achieved at Least a 50 Percent (%) Reduction in Their Daily OCS Dose at Week 44 Relative to Baseline [4]
    End point description
    OCS used in study: prednisone/prednisolone. Participants entered their total daily use of OCS into an eDiary on a daily basis. The OCS intake since the previous study visit and the prescribed OCS dose for the next 28 days was captured by physician on a dedicated page in the eCRF. Baseline OCS dose was calculated using the eDiary as average daily dose over 28 days prior to randomization. Post baseline OCS dose was obtained from the eCRF and calculated as average daily dose over the 28 days preceding the timepoint. The 95% confidence interval (CI) for the percentage was based on normal approximation for binomial proportion. Analysis was performed on mITT adult participant population. Here, 'Number of Subjects Analysed' signifies participants with a valid non-missing baseline value.
    End point type
    Secondary
    End point timeframe
    Baseline (including 28 days prior to Day 1), Week 44 (including 28 days prior to Week 44)
    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: Analysis was planned to be carried out in the indicated arms only
    End point values
    		 Placebo Lebrikizumab 125 mg Lebrikizumab 250 mg
    Number of subjects analysed
    96
    56
    66
    Units: percentage of participants
        number (confidence interval 95%)
    39.6 (29.8 to 49.4)
    30.4 (18.3 to 42.4)
    40.9 (29 to 52.8)
    Statistical analysis title
    		 Statistical Analysis 1
    Statistical analysis description
    The 95% CI for the difference in percentage was based on normal approximation for binomial proportion.
    Comparison groups
    Placebo v Lebrikizumab 125 mg
    Number of subjects included in analysis
    152
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    Method
    Parameter type
    		 Difference in Percentage
    Point estimate
    -9.2
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -24.7
         upper limit
    		 6.3
    Statistical analysis title
    		 Statistical Analysis 2
    Statistical analysis description
    The 95% CI for the difference in percentage was based on normal approximation for binomial proportion.
    Comparison groups
    Placebo v Lebrikizumab 250 mg
    Number of subjects included in analysis
    162
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    Method
    Parameter type
    		 Difference in Percentage
    Point estimate
    1.3
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -14
         upper limit
    		 16.7

    Secondary: Percentage of Participants Who Either Discontinued OCS Therapy or Achieved an Adrenal Maintenance Dose at Week 44

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    End point title
    		 Percentage of Participants Who Either Discontinued OCS Therapy or Achieved an Adrenal Maintenance Dose at Week 44 [5]
    End point description
    Percentage of participants who either discontinued OCS therapy or have achieved an adrenal maintenance dose is reported. Identification of participants achieving adrenal maintenance dose was based on physician assessment recorded in eCRF in the presence of cortisol = 100 nanomoles per liter (nmol/L). The 95% CI for the percentage was based on normal approximation for binomial proportion. Analysis was performed on mITT adult participant population. Here, 'Number of Subjects Analysed' signifies participants with a valid baseline value.
    End point type
    Secondary
    End point timeframe
    Week 44
    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: Analysis was planned to be carried out in the indicated arms only
    End point values
    		 Placebo Lebrikizumab 125 mg Lebrikizumab 250 mg
    Number of subjects analysed
    96
    56
    66
    Units: percentage of participants
        number (confidence interval 95%)
    11.5 (5.1 to 17.8)
    10.7 (2.6 to 18.8)
    9.1 (2.2 to 16)
    Statistical analysis title
    		 Statistical Analysis 1
    Statistical analysis description
    The 95% CI for the difference in percentage was based on normal approximation for binomial proportion.
    Comparison groups
    Placebo v Lebrikizumab 125 mg
    Number of subjects included in analysis
    152
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    Method
    Parameter type
    		 Difference in Percentage
    Point estimate
    -0.7
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -11.1
         upper limit
    		 9.6
    Statistical analysis title
    		 Statistical Analysis 2
    Statistical analysis description
    The 95% CI for the difference in percentage was based on normal approximation for binomial proportion.
    Comparison groups
    Placebo v Lebrikizumab 250 mg
    Number of subjects included in analysis
    162
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    Method
    Parameter type
    		 Difference in Percentage
    Point estimate
    -2.4
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -11.8
         upper limit
    		 7.1

    Secondary: Rate of Asthma Exacerbations During the 44-Week Double-Blind Placebo Controlled (DBPC) Period

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    End point title
    		 Rate of Asthma Exacerbations During the 44-Week Double-Blind Placebo Controlled (DBPC) Period [6]
    End point description
    An asthma exacerbation is defined as new or increased asthma symptoms (including wheeze, cough, dyspnea, chest tightness, and/or night-time awakening due to these symptoms) that lead to treatment with systemic corticosteroids or to hospitalization. Treatment with systemic corticosteroids is defined as treatment with oral, intravenous (IV), or intramuscular (IM) corticosteroids for at least 3 days or an emergency department visit with at least 1 dose of IV or IM corticosteroids. Rate of asthma exacerbation = total number of exacerbation events divided by total follow-up time in patient years. Analysis was performed on mITT adult participant population. Here, 'Number of Subjects Analysed' signifies participants with a valid baseline value.
    End point type
    Secondary
    End point timeframe
    Baseline up to Week 44
    Notes
    [6] - 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: Analysis was planned to be carried out in the indicated arms only
    End point values
    		 Placebo Lebrikizumab 125 mg Lebrikizumab 250 mg
    Number of subjects analysed
    96
    56
    66
    Units: events per patient year
        number (not applicable)
    1.93
    1.26
    1.58
    Statistical analysis title
    		 Statistical Analysis 1
    Statistical analysis description
    Adjusted exacerbation rates and rate ratios were estimated from a Poisson regression model with over-dispersion adjusted for the following covariates in addition to log(patient years) as an offset: Treatment arm, Mean baseline OCS dose, Baseline ACQ-7 score, BTS with 2 levels (yes/no), and a 4-level categorical variable using Periostin and Eosinophil levels as (High/High, High/ Low, Low/High, and Low/Low).
    Comparison groups
    Placebo v Lebrikizumab 125 mg
    Number of subjects included in analysis
    152
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    Method
    Parameter type
    		 Adjusted Rate Ratio
    Point estimate
    0.86
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.55
         upper limit
    		 1.36
    Statistical analysis title
    		 Statistical Analysis 2
    Statistical analysis description
    Adjusted exacerbation rates and rate ratios were estimated from a Poisson regression model with over-dispersion adjusted for the following covariates in addition to log(patient years) as an offset: Treatment arm, Mean baseline OCS dose, Baseline ACQ-7 score, BTS with 2 levels (yes/no), and a 4-level categorical variable using Periostin and Eosinophil levels as (High/High, High/ Low, Low/High, and Low/Low).
    Comparison groups
    Placebo v Lebrikizumab 250 mg
    Number of subjects included in analysis
    162
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    Method
    Parameter type
    		 Adjusted Rate Ratio
    Point estimate
    0.83
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.57
         upper limit
    		 1.21

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    From Baseline up to 24 weeks after last dose (up to approximately 2 years and 10 months)
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    19.1
    Reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 Participants received SC injection of lebrikizumab matching placebo (2 placebo injections) Q4W for 44 weeks during DBPC period. All participants were followed for safety for 24 weeks after last dose of study drug.

    Reporting group title
    Lebrikizumab 125 mg
    Reporting group description
    		 Participants received SC injection of lebrikizumab at dose level of 125 mg (1 injection of lebrikizumab 125 mg + 1 placebo injection) Q4W for 44 weeks during DBPC period and then for additional 32 weeks (up to Week 76) in ATE period. Following completion of the ATE period, participants who both tolerated and derived benefit from treatment, continued same treatment into optional LTE period (maximum up to 2 years and 10 months). All participants were followed for safety for 24 weeks after last dose of study drug.

    Reporting group title
    Lebrikizumab 250 mg
    Reporting group description
    		 Participants received SC injection of lebrikizumab at dose level of 250 mg (2 injections of lebrikizumab 125 mg) Q4W for 44 weeks during DBPC period and then for additional 32 weeks (up to Week 76) in ATE period. Following completion of the ATE period, participants who both tolerated and derived benefit from treatment, continued same treatment into optional LTE period (maximum up to 2 years and 10 months). All participants were followed for safety for 24 weeks after last dose of study drug.

    Reporting group title
    Placebo/Lebrikizumab 125 mg
    Reporting group description
    		 Participants who received 'Placebo' during DBPC period and who were randomized to this group after completion of DBPC period, received SC injection of lebrikizumab at dose level of 125 mg (1 injection of lebrikizumab 125 mg + 1 placebo injection) Q4W for 32 weeks (up to Week 76) in ATE period. Following completion of the ATE period, participants who both tolerated and derived benefit from treatment, continued same treatment into optional LTE period (maximum up to 2 years and 10 months). All participants were followed for safety for 24 weeks after last dose of study drug.

    Reporting group title
    Placebo/Lebrikizumab 250 mg
    Reporting group description
    		 Participants who received 'Placebo' during DBPC period and who were randomized to this group after completion of DBPC period, received SC injection of lebrikizumab at dose level of 250 mg (2 injections of lebrikizumab 125 mg) Q4W for 32 weeks (up to Week 76) in ATE period. Following completion of the ATE period, participants who both tolerated and derived benefit from treatment, continued same treatment into optional LTE period (maximum up to 2 years and 10 months). All participants were followed for safety for 24 weeks after last dose of study drug.

    Serious adverse events
    		 Placebo Lebrikizumab 125 mg Lebrikizumab 250 mg Placebo/Lebrikizumab 125 mg Placebo/Lebrikizumab 250 mg
    Total subjects affected by serious adverse events
         subjects affected / exposed
    14 / 56 (25.00%)
    6 / 56 (10.71%)
    27 / 72 (37.50%)
    8 / 24 (33.33%)
    3 / 22 (13.64%)
         number of deaths (all causes)
    0
    1
    0
    0
    0
         number of deaths resulting from adverse events
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Breast cancer
         subjects affected / exposed
    1 / 56 (1.79%)
    0 / 56 (0.00%)
    0 / 72 (0.00%)
    0 / 24 (0.00%)
    0 / 22 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Colon adenoma
         subjects affected / exposed
    0 / 56 (0.00%)
    0 / 56 (0.00%)
    1 / 72 (1.39%)
    0 / 24 (0.00%)
    0 / 22 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Haemangioma
         subjects affected / exposed
    0 / 56 (0.00%)
    0 / 56 (0.00%)
    0 / 72 (0.00%)
    1 / 24 (4.17%)
    0 / 22 (0.00%)
         occurrences causally related to treatment / all
    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
    Invasive ductal breast carcinoma
         subjects affected / exposed
    1 / 56 (1.79%)
    0 / 56 (0.00%)
    0 / 72 (0.00%)
    0 / 24 (0.00%)
    0 / 22 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Invasive lobular breast carcinoma
         subjects affected / exposed
    1 / 56 (1.79%)
    0 / 56 (0.00%)
    0 / 72 (0.00%)
    0 / 24 (0.00%)
    0 / 22 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Prostate cancer
         subjects affected / exposed
    0 / 56 (0.00%)
    0 / 56 (0.00%)
    1 / 72 (1.39%)
    0 / 24 (0.00%)
    0 / 22 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Vascular disorders
    Deep vein thrombosis
         subjects affected / exposed
    1 / 56 (1.79%)
    0 / 56 (0.00%)
    0 / 72 (0.00%)
    0 / 24 (0.00%)
    0 / 22 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Temporal arteritis
         subjects affected / exposed
    0 / 56 (0.00%)
    0 / 56 (0.00%)
    1 / 72 (1.39%)
    0 / 24 (0.00%)
    0 / 22 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Non-cardiac chest pain
         subjects affected / exposed
    1 / 56 (1.79%)
    0 / 56 (0.00%)
    0 / 72 (0.00%)
    0 / 24 (0.00%)
    0 / 22 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Immune system disorders
    Anaphylactic reaction
         subjects affected / exposed
    0 / 56 (0.00%)
    1 / 56 (1.79%)
    0 / 72 (0.00%)
    0 / 24 (0.00%)
    1 / 22 (4.55%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Anaphylactic shock
         subjects affected / exposed
    0 / 56 (0.00%)
    1 / 56 (1.79%)
    0 / 72 (0.00%)
    0 / 24 (0.00%)
    0 / 22 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Eosinophilic granulomatosis with polyangiitis
         subjects affected / exposed
    0 / 56 (0.00%)
    1 / 56 (1.79%)
    0 / 72 (0.00%)
    0 / 24 (0.00%)
    0 / 22 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hypersensitivity
         subjects affected / exposed
    0 / 56 (0.00%)
    0 / 56 (0.00%)
    1 / 72 (1.39%)
    0 / 24 (0.00%)
    0 / 22 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Asthma
         subjects affected / exposed
    7 / 56 (12.50%)
    0 / 56 (0.00%)
    10 / 72 (13.89%)
    4 / 24 (16.67%)
    0 / 22 (0.00%)
         occurrences causally related to treatment / all
    2 / 17
    0 / 0
    0 / 18
    0 / 5
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Vocal cord disorder
         subjects affected / exposed
    1 / 56 (1.79%)
    0 / 56 (0.00%)
    1 / 72 (1.39%)
    0 / 24 (0.00%)
    0 / 22 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Dyspnoea
         subjects affected / exposed
    1 / 56 (1.79%)
    0 / 56 (0.00%)
    0 / 72 (0.00%)
    0 / 24 (0.00%)
    0 / 22 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Eosinophilic pneumonia
         subjects affected / exposed
    0 / 56 (0.00%)
    0 / 56 (0.00%)
    1 / 72 (1.39%)
    0 / 24 (0.00%)
    0 / 22 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pulmonary embolism
         subjects affected / exposed
    0 / 56 (0.00%)
    1 / 56 (1.79%)
    0 / 72 (0.00%)
    0 / 24 (0.00%)
    0 / 22 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    Stridor
         subjects affected / exposed
    1 / 56 (1.79%)
    0 / 56 (0.00%)
    0 / 72 (0.00%)
    0 / 24 (0.00%)
    0 / 22 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Psychiatric disorders
    Mania
         subjects affected / exposed
    0 / 56 (0.00%)
    0 / 56 (0.00%)
    1 / 72 (1.39%)
    0 / 24 (0.00%)
    0 / 22 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Panic attack
         subjects affected / exposed
    1 / 56 (1.79%)
    0 / 56 (0.00%)
    0 / 72 (0.00%)
    0 / 24 (0.00%)
    0 / 22 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Hip fracture
         subjects affected / exposed
    0 / 56 (0.00%)
    0 / 56 (0.00%)
    1 / 72 (1.39%)
    0 / 24 (0.00%)
    0 / 22 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Humerus fracture
         subjects affected / exposed
    0 / 56 (0.00%)
    1 / 56 (1.79%)
    0 / 72 (0.00%)
    0 / 24 (0.00%)
    0 / 22 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Meniscus injury
         subjects affected / exposed
    0 / 56 (0.00%)
    0 / 56 (0.00%)
    1 / 72 (1.39%)
    0 / 24 (0.00%)
    0 / 22 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Postoperative renal failure
         subjects affected / exposed
    0 / 56 (0.00%)
    0 / 56 (0.00%)
    0 / 72 (0.00%)
    1 / 24 (4.17%)
    0 / 22 (0.00%)
         occurrences causally related to treatment / all
    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
    Radius fracture
         subjects affected / exposed
    0 / 56 (0.00%)
    1 / 56 (1.79%)
    0 / 72 (0.00%)
    0 / 24 (0.00%)
    0 / 22 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Skeletal injury
         subjects affected / exposed
    0 / 56 (0.00%)
    0 / 56 (0.00%)
    0 / 72 (0.00%)
    1 / 24 (4.17%)
    0 / 22 (0.00%)
         occurrences causally related to treatment / all
    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
    Femur fracture
         subjects affected / exposed
    0 / 56 (0.00%)
    0 / 56 (0.00%)
    1 / 72 (1.39%)
    0 / 24 (0.00%)
    0 / 22 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Nervous system disorders
    Dizziness
         subjects affected / exposed
    0 / 56 (0.00%)
    0 / 56 (0.00%)
    0 / 72 (0.00%)
    1 / 24 (4.17%)
    0 / 22 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Dysarthria
         subjects affected / exposed
    0 / 56 (0.00%)
    0 / 56 (0.00%)
    0 / 72 (0.00%)
    1 / 24 (4.17%)
    0 / 22 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Headache
         subjects affected / exposed
    0 / 56 (0.00%)
    0 / 56 (0.00%)
    0 / 72 (0.00%)
    1 / 24 (4.17%)
    0 / 22 (0.00%)
         occurrences causally related to treatment / all
    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
    Migraine
         subjects affected / exposed
    1 / 56 (1.79%)
    0 / 56 (0.00%)
    0 / 72 (0.00%)
    0 / 24 (0.00%)
    0 / 22 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Migraine with aura
         subjects affected / exposed
    0 / 56 (0.00%)
    0 / 56 (0.00%)
    0 / 72 (0.00%)
    0 / 24 (0.00%)
    1 / 22 (4.55%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Paraesthesia
         subjects affected / exposed
    0 / 56 (0.00%)
    0 / 56 (0.00%)
    0 / 72 (0.00%)
    1 / 24 (4.17%)
    0 / 22 (0.00%)
         occurrences causally related to treatment / all
    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
    Gastrointestinal disorders
    Colitis
         subjects affected / exposed
    0 / 56 (0.00%)
    0 / 56 (0.00%)
    2 / 72 (2.78%)
    0 / 24 (0.00%)
    0 / 22 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastritis
         subjects affected / exposed
    0 / 56 (0.00%)
    0 / 56 (0.00%)
    0 / 72 (0.00%)
    1 / 24 (4.17%)
    0 / 22 (0.00%)
         occurrences causally related to treatment / all
    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
    Intestinal perforation
         subjects affected / exposed
    0 / 56 (0.00%)
    0 / 56 (0.00%)
    1 / 72 (1.39%)
    0 / 24 (0.00%)
    0 / 22 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Strangulated umbilical hernia
         subjects affected / exposed
    0 / 56 (0.00%)
    0 / 56 (0.00%)
    0 / 72 (0.00%)
    1 / 24 (4.17%)
    0 / 22 (0.00%)
         occurrences causally related to treatment / all
    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
    Umbilical hernia
         subjects affected / exposed
    0 / 56 (0.00%)
    0 / 56 (0.00%)
    1 / 72 (1.39%)
    0 / 24 (0.00%)
    0 / 22 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Vomiting
         subjects affected / exposed
    0 / 56 (0.00%)
    0 / 56 (0.00%)
    0 / 72 (0.00%)
    1 / 24 (4.17%)
    0 / 22 (0.00%)
         occurrences causally related to treatment / all
    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
    Skin and subcutaneous tissue disorders
    Erythema nodosum
         subjects affected / exposed
    0 / 56 (0.00%)
    0 / 56 (0.00%)
    1 / 72 (1.39%)
    0 / 24 (0.00%)
    0 / 22 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Skin necrosis
         subjects affected / exposed
    0 / 56 (0.00%)
    1 / 56 (1.79%)
    0 / 72 (0.00%)
    0 / 24 (0.00%)
    0 / 22 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Musculoskeletal chest pain
         subjects affected / exposed
    0 / 56 (0.00%)
    0 / 56 (0.00%)
    1 / 72 (1.39%)
    0 / 24 (0.00%)
    0 / 22 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Spondylolisthesis
         subjects affected / exposed
    0 / 56 (0.00%)
    0 / 56 (0.00%)
    0 / 72 (0.00%)
    1 / 24 (4.17%)
    0 / 22 (0.00%)
         occurrences causally related to treatment / all
    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
    Infections and infestations
    Lower respiratory tract infection
         subjects affected / exposed
    0 / 56 (0.00%)
    0 / 56 (0.00%)
    1 / 72 (1.39%)
    1 / 24 (4.17%)
    1 / 22 (4.55%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cellulitis
         subjects affected / exposed
    0 / 56 (0.00%)
    0 / 56 (0.00%)
    1 / 72 (1.39%)
    0 / 24 (0.00%)
    1 / 22 (4.55%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pneumonia
         subjects affected / exposed
    1 / 56 (1.79%)
    0 / 56 (0.00%)
    0 / 72 (0.00%)
    1 / 24 (4.17%)
    0 / 22 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastroenteritis
         subjects affected / exposed
    0 / 56 (0.00%)
    0 / 56 (0.00%)
    1 / 72 (1.39%)
    0 / 24 (0.00%)
    0 / 22 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Herpes zoster
         subjects affected / exposed
    1 / 56 (1.79%)
    0 / 56 (0.00%)
    0 / 72 (0.00%)
    0 / 24 (0.00%)
    0 / 22 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Meningitis bacterial
         subjects affected / exposed
    1 / 56 (1.79%)
    0 / 56 (0.00%)
    0 / 72 (0.00%)
    0 / 24 (0.00%)
    0 / 22 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Wound infection
         subjects affected / exposed
    0 / 56 (0.00%)
    0 / 56 (0.00%)
    1 / 72 (1.39%)
    0 / 24 (0.00%)
    0 / 22 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Hyperglycaemia
         subjects affected / exposed
    0 / 56 (0.00%)
    1 / 56 (1.79%)
    0 / 72 (0.00%)
    0 / 24 (0.00%)
    0 / 22 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Placebo Lebrikizumab 125 mg Lebrikizumab 250 mg Placebo/Lebrikizumab 125 mg Placebo/Lebrikizumab 250 mg
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    43 / 56 (76.79%)
    48 / 56 (85.71%)
    62 / 72 (86.11%)
    24 / 24 (100.00%)
    21 / 22 (95.45%)
    Vascular disorders
    Hypertension
         subjects affected / exposed
    0 / 56 (0.00%)
    1 / 56 (1.79%)
    1 / 72 (1.39%)
    1 / 24 (4.17%)
    3 / 22 (13.64%)
         occurrences all number
    0
    1
    1
    1
    3
    General disorders and administration site conditions
    Injection site pain
         subjects affected / exposed
    1 / 56 (1.79%)
    2 / 56 (3.57%)
    4 / 72 (5.56%)
    1 / 24 (4.17%)
    4 / 22 (18.18%)
         occurrences all number
    2
    7
    7
    2
    10
    Fatigue
         subjects affected / exposed
    2 / 56 (3.57%)
    2 / 56 (3.57%)
    4 / 72 (5.56%)
    1 / 24 (4.17%)
    2 / 22 (9.09%)
         occurrences all number
    3
    2
    5
    2
    2
    Injection site erythema
         subjects affected / exposed
    0 / 56 (0.00%)
    2 / 56 (3.57%)
    3 / 72 (4.17%)
    1 / 24 (4.17%)
    3 / 22 (13.64%)
         occurrences all number
    0
    6
    6
    2
    4
    Peripheral swelling
         subjects affected / exposed
    1 / 56 (1.79%)
    0 / 56 (0.00%)
    3 / 72 (4.17%)
    1 / 24 (4.17%)
    3 / 22 (13.64%)
         occurrences all number
    2
    0
    3
    1
    3
    Oedema peripheral
         subjects affected / exposed
    1 / 56 (1.79%)
    0 / 56 (0.00%)
    2 / 72 (2.78%)
    1 / 24 (4.17%)
    3 / 22 (13.64%)
         occurrences all number
    1
    0
    2
    1
    5
    Injection site pruritus
         subjects affected / exposed
    0 / 56 (0.00%)
    3 / 56 (5.36%)
    0 / 72 (0.00%)
    1 / 24 (4.17%)
    0 / 22 (0.00%)
         occurrences all number
    0
    12
    0
    2
    0
    Administration site pain
         subjects affected / exposed
    0 / 56 (0.00%)
    0 / 56 (0.00%)
    0 / 72 (0.00%)
    0 / 24 (0.00%)
    2 / 22 (9.09%)
         occurrences all number
    0
    0
    0
    0
    4
    Respiratory, thoracic and mediastinal disorders
    Asthma
         subjects affected / exposed
    31 / 56 (55.36%)
    38 / 56 (67.86%)
    47 / 72 (65.28%)
    22 / 24 (91.67%)
    20 / 22 (90.91%)
         occurrences all number
    68
    104
    226
    92
    141
    Cough
         subjects affected / exposed
    2 / 56 (3.57%)
    2 / 56 (3.57%)
    6 / 72 (8.33%)
    6 / 24 (25.00%)
    3 / 22 (13.64%)
         occurrences all number
    2
    2
    6
    8
    4
    Dyspnoea
         subjects affected / exposed
    2 / 56 (3.57%)
    2 / 56 (3.57%)
    1 / 72 (1.39%)
    2 / 24 (8.33%)
    2 / 22 (9.09%)
         occurrences all number
    2
    2
    1
    4
    2
    Oropharyngeal pain
         subjects affected / exposed
    2 / 56 (3.57%)
    0 / 56 (0.00%)
    2 / 72 (2.78%)
    2 / 24 (8.33%)
    2 / 22 (9.09%)
         occurrences all number
    2
    0
    2
    2
    2
    Sputum increased
         subjects affected / exposed
    2 / 56 (3.57%)
    1 / 56 (1.79%)
    0 / 72 (0.00%)
    3 / 24 (12.50%)
    0 / 22 (0.00%)
         occurrences all number
    2
    1
    0
    3
    0
    Dyspnoea exertional
         subjects affected / exposed
    0 / 56 (0.00%)
    0 / 56 (0.00%)
    1 / 72 (1.39%)
    1 / 24 (4.17%)
    2 / 22 (9.09%)
         occurrences all number
    0
    0
    1
    1
    2
    Psychiatric disorders
    Depression
         subjects affected / exposed
    1 / 56 (1.79%)
    1 / 56 (1.79%)
    1 / 72 (1.39%)
    2 / 24 (8.33%)
    0 / 22 (0.00%)
         occurrences all number
    1
    1
    1
    2
    0
    Injury, poisoning and procedural complications
    Fall
         subjects affected / exposed
    0 / 56 (0.00%)
    0 / 56 (0.00%)
    5 / 72 (6.94%)
    0 / 24 (0.00%)
    5 / 22 (22.73%)
         occurrences all number
    0
    0
    7
    0
    7
    Contusion
         subjects affected / exposed
    1 / 56 (1.79%)
    1 / 56 (1.79%)
    3 / 72 (4.17%)
    0 / 24 (0.00%)
    3 / 22 (13.64%)
         occurrences all number
    1
    1
    3
    0
    4
    Limb injury
         subjects affected / exposed
    0 / 56 (0.00%)
    1 / 56 (1.79%)
    2 / 72 (2.78%)
    1 / 24 (4.17%)
    2 / 22 (9.09%)
         occurrences all number
    0
    1
    2
    1
    2
    Muscle strain
         subjects affected / exposed
    0 / 56 (0.00%)
    0 / 56 (0.00%)
    4 / 72 (5.56%)
    0 / 24 (0.00%)
    1 / 22 (4.55%)
         occurrences all number
    0
    0
    4
    0
    1
    Skin abrasion
         subjects affected / exposed
    0 / 56 (0.00%)
    0 / 56 (0.00%)
    1 / 72 (1.39%)
    0 / 24 (0.00%)
    2 / 22 (9.09%)
         occurrences all number
    0
    0
    1
    0
    2
    Cardiac disorders
    Palpitations
         subjects affected / exposed
    1 / 56 (1.79%)
    3 / 56 (5.36%)
    1 / 72 (1.39%)
    0 / 24 (0.00%)
    1 / 22 (4.55%)
         occurrences all number
    1
    3
    1
    0
    1
    Nervous system disorders
    Headache
         subjects affected / exposed
    7 / 56 (12.50%)
    6 / 56 (10.71%)
    13 / 72 (18.06%)
    2 / 24 (8.33%)
    4 / 22 (18.18%)
         occurrences all number
    8
    9
    19
    4
    6
    Paraesthesia
         subjects affected / exposed
    2 / 56 (3.57%)
    3 / 56 (5.36%)
    2 / 72 (2.78%)
    0 / 24 (0.00%)
    2 / 22 (9.09%)
         occurrences all number
    3
    3
    2
    0
    4
    Dizziness
         subjects affected / exposed
    1 / 56 (1.79%)
    0 / 56 (0.00%)
    3 / 72 (4.17%)
    1 / 24 (4.17%)
    2 / 22 (9.09%)
         occurrences all number
    1
    0
    7
    2
    3
    Lethargy
         subjects affected / exposed
    1 / 56 (1.79%)
    1 / 56 (1.79%)
    1 / 72 (1.39%)
    2 / 24 (8.33%)
    1 / 22 (4.55%)
         occurrences all number
    1
    1
    1
    2
    1
    Neuralgia
         subjects affected / exposed
    1 / 56 (1.79%)
    0 / 56 (0.00%)
    0 / 72 (0.00%)
    0 / 24 (0.00%)
    3 / 22 (13.64%)
         occurrences all number
    1
    0
    0
    0
    4
    Sciatica
         subjects affected / exposed
    0 / 56 (0.00%)
    1 / 56 (1.79%)
    0 / 72 (0.00%)
    2 / 24 (8.33%)
    1 / 22 (4.55%)
         occurrences all number
    0
    1
    0
    2
    1
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    1 / 56 (1.79%)
    1 / 56 (1.79%)
    1 / 72 (1.39%)
    3 / 24 (12.50%)
    1 / 22 (4.55%)
         occurrences all number
    1
    1
    1
    3
    1
    Eye disorders
    Cataract
         subjects affected / exposed
    0 / 56 (0.00%)
    0 / 56 (0.00%)
    4 / 72 (5.56%)
    1 / 24 (4.17%)
    1 / 22 (4.55%)
         occurrences all number
    0
    0
    6
    1
    1
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed
    1 / 56 (1.79%)
    1 / 56 (1.79%)
    5 / 72 (6.94%)
    2 / 24 (8.33%)
    3 / 22 (13.64%)
         occurrences all number
    1
    1
    6
    3
    3
    Vomiting
         subjects affected / exposed
    2 / 56 (3.57%)
    1 / 56 (1.79%)
    5 / 72 (6.94%)
    3 / 24 (12.50%)
    1 / 22 (4.55%)
         occurrences all number
    2
    1
    6
    4
    1
    Nausea
         subjects affected / exposed
    1 / 56 (1.79%)
    2 / 56 (3.57%)
    2 / 72 (2.78%)
    2 / 24 (8.33%)
    2 / 22 (9.09%)
         occurrences all number
    1
    2
    2
    2
    2
    Gastrooesophageal reflux disease
         subjects affected / exposed
    0 / 56 (0.00%)
    2 / 56 (3.57%)
    3 / 72 (4.17%)
    0 / 24 (0.00%)
    2 / 22 (9.09%)
         occurrences all number
    0
    2
    3
    0
    2
    Skin and subcutaneous tissue disorders
    Rash
         subjects affected / exposed
    2 / 56 (3.57%)
    2 / 56 (3.57%)
    3 / 72 (4.17%)
    1 / 24 (4.17%)
    2 / 22 (9.09%)
         occurrences all number
    2
    2
    8
    2
    5
    Erythema
         subjects affected / exposed
    0 / 56 (0.00%)
    2 / 56 (3.57%)
    2 / 72 (2.78%)
    0 / 24 (0.00%)
    2 / 22 (9.09%)
         occurrences all number
    0
    4
    2
    0
    2
    Pruritus
         subjects affected / exposed
    1 / 56 (1.79%)
    1 / 56 (1.79%)
    1 / 72 (1.39%)
    0 / 24 (0.00%)
    3 / 22 (13.64%)
         occurrences all number
    7
    1
    2
    0
    3
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    4 / 56 (7.14%)
    3 / 56 (5.36%)
    10 / 72 (13.89%)
    5 / 24 (20.83%)
    9 / 22 (40.91%)
         occurrences all number
    5
    3
    12
    5
    12
    Back pain
         subjects affected / exposed
    2 / 56 (3.57%)
    5 / 56 (8.93%)
    6 / 72 (8.33%)
    1 / 24 (4.17%)
    4 / 22 (18.18%)
         occurrences all number
    2
    5
    7
    1
    5
    Pain in extremity
         subjects affected / exposed
    2 / 56 (3.57%)
    3 / 56 (5.36%)
    3 / 72 (4.17%)
    1 / 24 (4.17%)
    4 / 22 (18.18%)
         occurrences all number
    3
    3
    3
    2
    4
    Myalgia
         subjects affected / exposed
    0 / 56 (0.00%)
    1 / 56 (1.79%)
    5 / 72 (6.94%)
    0 / 24 (0.00%)
    3 / 22 (13.64%)
         occurrences all number
    0
    1
    6
    0
    4
    Muscle spasms
         subjects affected / exposed
    1 / 56 (1.79%)
    1 / 56 (1.79%)
    4 / 72 (5.56%)
    1 / 24 (4.17%)
    1 / 22 (4.55%)
         occurrences all number
    1
    1
    4
    1
    1
    Musculoskeletal chest pain
         subjects affected / exposed
    1 / 56 (1.79%)
    0 / 56 (0.00%)
    3 / 72 (4.17%)
    1 / 24 (4.17%)
    3 / 22 (13.64%)
         occurrences all number
    1
    0
    3
    1
    3
    Musculoskeletal pain
         subjects affected / exposed
    1 / 56 (1.79%)
    0 / 56 (0.00%)
    2 / 72 (2.78%)
    2 / 24 (8.33%)
    2 / 22 (9.09%)
         occurrences all number
    1
    0
    2
    2
    2
    Infections and infestations
    Lower respiratory tract infection
         subjects affected / exposed
    6 / 56 (10.71%)
    7 / 56 (12.50%)
    27 / 72 (37.50%)
    11 / 24 (45.83%)
    15 / 22 (68.18%)
         occurrences all number
    17
    18
    65
    26
    40
    Nasopharyngitis
         subjects affected / exposed
    3 / 56 (5.36%)
    8 / 56 (14.29%)
    8 / 72 (11.11%)
    6 / 24 (25.00%)
    2 / 22 (9.09%)
         occurrences all number
    3
    8
    10
    10
    4
    Upper respiratory tract infection
         subjects affected / exposed
    4 / 56 (7.14%)
    1 / 56 (1.79%)
    9 / 72 (12.50%)
    2 / 24 (8.33%)
    5 / 22 (22.73%)
         occurrences all number
    4
    1
    15
    2
    9
    Sinusitis
         subjects affected / exposed
    6 / 56 (10.71%)
    5 / 56 (8.93%)
    5 / 72 (6.94%)
    1 / 24 (4.17%)
    3 / 22 (13.64%)
         occurrences all number
    6
    5
    7
    1
    3
    Pharyngitis
         subjects affected / exposed
    4 / 56 (7.14%)
    4 / 56 (7.14%)
    6 / 72 (8.33%)
    3 / 24 (12.50%)
    1 / 22 (4.55%)
         occurrences all number
    5
    4
    6
    3
    1
    Urinary tract infection
         subjects affected / exposed
    1 / 56 (1.79%)
    4 / 56 (7.14%)
    7 / 72 (9.72%)
    3 / 24 (12.50%)
    2 / 22 (9.09%)
         occurrences all number
    1
    4
    8
    6
    3
    Bronchitis
         subjects affected / exposed
    4 / 56 (7.14%)
    9 / 56 (16.07%)
    1 / 72 (1.39%)
    1 / 24 (4.17%)
    1 / 22 (4.55%)
         occurrences all number
    9
    17
    1
    1
    2
    Oral candidiasis
         subjects affected / exposed
    4 / 56 (7.14%)
    1 / 56 (1.79%)
    5 / 72 (6.94%)
    1 / 24 (4.17%)
    3 / 22 (13.64%)
         occurrences all number
    4
    1
    5
    1
    4
    Viral upper respiratory tract infection
         subjects affected / exposed
    2 / 56 (3.57%)
    1 / 56 (1.79%)
    6 / 72 (8.33%)
    2 / 24 (8.33%)
    2 / 22 (9.09%)
         occurrences all number
    2
    1
    8
    3
    3
    Gastroenteritis
         subjects affected / exposed
    1 / 56 (1.79%)
    1 / 56 (1.79%)
    1 / 72 (1.39%)
    0 / 24 (0.00%)
    2 / 22 (9.09%)
         occurrences all number
    1
    1
    1
    0
    2
    Cellulitis
         subjects affected / exposed
    0 / 56 (0.00%)
    1 / 56 (1.79%)
    1 / 72 (1.39%)
    0 / 24 (0.00%)
    2 / 22 (9.09%)
         occurrences all number
    0
    1
    1
    0
    2
    Tooth abscess
         subjects affected / exposed
    0 / 56 (0.00%)
    0 / 56 (0.00%)
    1 / 72 (1.39%)
    1 / 24 (4.17%)
    2 / 22 (9.09%)
         occurrences all number
    0
    0
    1
    2
    3
    Vulvovaginal candidiasis
         subjects affected / exposed
    1 / 56 (1.79%)
    3 / 56 (5.36%)
    0 / 72 (0.00%)
    0 / 24 (0.00%)
    0 / 22 (0.00%)
         occurrences all number
    1
    4
    0
    0
    0
    Conjunctivitis
         subjects affected / exposed
    0 / 56 (0.00%)
    1 / 56 (1.79%)
    0 / 72 (0.00%)
    0 / 24 (0.00%)
    2 / 22 (9.09%)
         occurrences all number
    0
    1
    0
    0
    2
    Lower respiratory tract infection viral
         subjects affected / exposed
    0 / 56 (0.00%)
    0 / 56 (0.00%)
    0 / 72 (0.00%)
    2 / 24 (8.33%)
    1 / 22 (4.55%)
         occurrences all number
    0
    0
    0
    2
    1
    Tooth infection
         subjects affected / exposed
    0 / 56 (0.00%)
    0 / 56 (0.00%)
    0 / 72 (0.00%)
    2 / 24 (8.33%)
    1 / 22 (4.55%)
         occurrences all number
    0
    0
    0
    3
    2
    Metabolism and nutrition disorders
    Diabetes mellitus
         subjects affected / exposed
    3 / 56 (5.36%)
    0 / 56 (0.00%)
    2 / 72 (2.78%)
    0 / 24 (0.00%)
    1 / 22 (4.55%)
         occurrences all number
    3
    0
    2
    0
    1
    Hypokalaemia
         subjects affected / exposed
    3 / 56 (5.36%)
    0 / 56 (0.00%)
    1 / 72 (1.39%)
    1 / 24 (4.17%)
    1 / 22 (4.55%)
         occurrences all number
    4
    0
    1
    2
    1

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    14 Dec 2013
    Made study objectives and endpoints consistent; reinforced the need for eDiary compliance during the screening period; provided clarity around the application of a number of inclusion criteria; clarified that optional remnant sampling extended to both serum and plasma; updated relevant sections to reflect that the protocol would be reviewed by a single IRB; updated medical monitor contact information; added clarity to the method by which the primary endpoint would be calculated; and aligned discrepancies within the schedule of assessments and the main body of the protocol.
    04 Aug 2014
    Allowed exploration of lebrikizumab 125mg SC Q4W; expanded the study from a United Kingdom-only to a global study; enrolled an additional 90 participants (60 participants into the newly added lebrikizumab 125 mg arm and an additional 30 participants into the placebo arm); replaced the Internal Monitoring Committee and Scientific Oversight Committee with an IDMC; included statistical mechanism to control Type 1 error; provided calculations of statistical power; and allowed flexibility within the screening period for technical issues should it be required (eDairy malfunction or unavailable laboratory data to confirm eligibility).
    12 Jun 2015
    Added a long-term ATE period that would have lasted until 31 March 2018; Amended the requirements for contraceptive measures in participants included into the study; clarified events to be monitored and the reporting of adverse events of special interest (AESIs) during the study periods; and removed the requirement for reporting of pregnancies in partners of male participants.
    18 Jun 2015
    Removed “non-serious” from AESIs and included minor editorial corrections that were not addressed in last protocol version.
    23 Sep 2015
    Addressed inconsistencies identified in the last protocol version; added urine pregnancy tests to the schedule of assessments of the dosing termination visit and safety follow-up (SFU) period of the LTE period; clarified the schedule of the SFU visits in relation to the last dose of study drug throughout the document; and incorporated the collection of bone mineral density data during the DBPC, ATE and corresponding SFU periods if obtained as part of the routine clinical care of the participant.

    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 enrollment was closed, and dosing was terminated in this study following the sponsor’s decision to discontinue development of lebrikizumab. Thus, this study was treated as exploratory (rather than confirmatory).
    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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