Flag of the European Union EU Clinical Trials Register Help

Clinical trials

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

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

    The EU Clinical Trials Register currently displays   44336   clinical trials with a EudraCT protocol, of which   7366   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

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

    < Back to search results

    Download PDF

    Clinical Trial Results:
    A Randomised, Double-Blind, Placebo-Controlled Phase 3 Clinical Trial to Assess the Efficacy and Safety of Lebrikizumab in Combination With Topical Corticosteroids in Adult and Adolescent Patients With Moderate-To-Severe Atopic Dermatitis That Are Not Adequately Controlled With Cyclosporine or For Whom Cyclosporine is Not Medically Advisable

    Summary
    EudraCT number
    		 2021-002967-23
    Trial protocol
    		 DE   FR   ES   PL   BE   IT   NL   AT  
    Global end of trial date
    07 May 2024

    Results information
    Results version number
    		 v1(current)
    This version publication date
    16 May 2025
    First version publication date
    16 May 2025
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    M-17923-30
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT05149313
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Almirall S.A
    Sponsor organisation address
    Ronda General Mitre, 151, Barcelona, Spain, 08022
    Public contact
    Clinical Trials Information, Almirall, S.A., +34 932913545, gco@almirall.com
    Scientific contact
    Clinical Trials Information, Almirall, S.A., +34 932913545, gco@almirall.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    07 May 2024
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    07 May 2024
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To evaluate the efficacy of lebrikizumab compared with placebo in patients not adequately controlled with cyclosporine or for whom cyclosporine is not medically advisable up to Week 16.
    Protection of trial subjects
    This study is conducted in accordance with the recommendations guiding physicians in biomedical research involving human patients adopted by the 18th World Medical Assembly of Helsinki (1964), as amended in Fortaleza, Brazil (2013), as well as in compliance with ICH GCP guidelines, and according to the appropriate regulatory requirements in the countries where the study is conducted.
    Background therapy
    		 All subjects will receive background topical corticosteroids (TCS) therapy at a dosage that can be adapted based on the patient’s needs, for up to Week 16.
    Evidence for comparator
    		 All eligible subjects must use concomitant TCS (mid-potency TCS and low-potency TCS) At baseline (Week 0, Visit 2) and until Week 16.
    Actual start date of recruitment
    30 Sep 2021
    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
    United Kingdom: 10
    Country: Number of subjects enrolled
    Netherlands: 7
    Country: Number of subjects enrolled
    Poland: 159
    Country: Number of subjects enrolled
    Spain: 32
    Country: Number of subjects enrolled
    Austria: 2
    Country: Number of subjects enrolled
    Belgium: 4
    Country: Number of subjects enrolled
    France: 43
    Country: Number of subjects enrolled
    Germany: 69
    Country: Number of subjects enrolled
    Italy: 5
    Worldwide total number of subjects
    331
    EEA total number of subjects
    321
    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)
    39
    Adults (18-64 years)
    280
    From 65 to 84 years
    12
    85 years and over
    0

    Subject disposition

    		 Close Top of page
    Recruitment
    Recruitment details
    		 Study was conducted at 54 sites in Austria, Belgium, France, Germany, Italy, Netherlands, Poland, Spain, and United Kingdom. Randomization was stratified by previous use of dupilumab, age (adolescent subjects aged >=12 to < 18 years comprises 11.8% of the population compared to adults aged >=18 years) and baseline disease severity (IGA 3 vs 4).

    Pre-assignment
    Screening details
    		 A total of 368 subjects were screened, of which 331 subjects were randomized into 2 treatment arms (Lebrikizumab and Placebo). The study has 2 treatment periods: a 16-week double-blind Induction Period and 36 week open-label Maintenance Period.

    Period 1
    Period 1 title
    Double-blind Induction Period (16-weeks)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Monitor, Data analyst

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Double-blind Induction Period: Lebrikizumab +TCS
    Arm description
    		 Subjects received loading dose of lebrikizumab 500 milligrams (mg) subcutaneous (SC) injection at Day 1 (Baseline) and Week 2 followed by lebrikizumab 250 mg SC injection once every two weeks (Q2W) for up to 16 weeks concomitantly with topical corticosteroids (TCS) in the double-blind induction period.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Lebrikizumab
    Investigational medicinal product code
    LY3650150
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Subjects received lebrikizumab SC injections Q2W for up to 16 weeks concomitantly with TCS.

    Arm title
    		 Double-blind Induction Period: Placebo +TCS
    Arm description
    		 Subjects received lebrikizumab-matched placebo SC injection, Q2W for up to 16 weeks concomitantly with TCS in the double-blind induction period.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Subjects received lebrikizumab-matched placebo SC injection, Q2W for up to 16 weeks concomitantly with TCS.

    Number of subjects in period 1
    		Double-blind Induction Period: Lebrikizumab +TCS Double-blind Induction Period: Placebo +TCS
    Started
    220
    111
    Completed
    212
    100
    Not completed
    8
    11
         Consent withdrawn by subject
    2
    5
         Physician decision
    1
    -
         Adverse Event
    2
    2
         Pregnancy
    1
    -
         Unspecified
    -
    1
         Lost to follow-up
    2
    3
    Period 2
    Period 2 title
    Open-label Maintenance Period (36 Weeks)
    Is this the baseline period?
    		 No
    Allocation method
    Non-randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Open-label Maintenance Period: Lebrikizumab to Lebrikizumab
    Arm description
    		 Subjects who received lebrikizumab 250 mg Q2W during the Double-blind Induction Period continued to receive lebrikizumab 250 mg, Q2W during the 36-week Maintenance Period.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Lebrikizumab
    Investigational medicinal product code
    LY3650150
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Subjects received lebrikizumab 250 mg, Q2W up to Week 52.

    Arm title
    		 Open-label Maintenance Period: Placebo to Lebrikizumab
    Arm description
    		 During Maintenance Period, subjects who received placebo Q2W during the Induction Period received loading doses of lebrikizumab (500 mg) at Weeks 16 and 18. From Week 20 onward, the subjects received 1 injection of lebrikizumab 250mg Q2W.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Lebrikizumab
    Investigational medicinal product code
    LY3650150
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Subjects received lebrikizumab 500 mg at Week 16 and 18. From Week 20 onward, Subjects received 250 mg, Q2W.

    Number of subjects in period 2
    		Open-label Maintenance Period: Lebrikizumab to Lebrikizumab Open-label Maintenance Period: Placebo to Lebrikizumab
    Started
    212
    100
    Completed
    180
    87
    Not completed
    32
    13
         Consent withdrawn by subject
    14
    7
         Adverse Event
    7
    1
         Lost to follow-up
    4
    -
         Lack of efficacy
    6
    5
         Protocol deviation
    1
    -

    Baseline characteristics

    		 Close Top of page
    Baseline characteristics reporting groups
    Reporting group title
    Double-blind Induction Period: Lebrikizumab +TCS
    Reporting group description
    		 Subjects received loading dose of lebrikizumab 500 milligrams (mg) subcutaneous (SC) injection at Day 1 (Baseline) and Week 2 followed by lebrikizumab 250 mg SC injection once every two weeks (Q2W) for up to 16 weeks concomitantly with topical corticosteroids (TCS) in the double-blind induction period.

    Reporting group title
    Double-blind Induction Period: Placebo +TCS
    Reporting group description
    		 Subjects received lebrikizumab-matched placebo SC injection, Q2W for up to 16 weeks concomitantly with TCS in the double-blind induction period.

    Reporting group values
    		 Double-blind Induction Period: Lebrikizumab +TCS Double-blind Induction Period: Placebo +TCS Total
    Number of subjects
    		 220 111 331
    Age categorical
    Units: Subjects
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 33.7 ( 14.85 ) 34.1 ( 15.24 ) -
    Gender categorical
    Units: Subjects
        Female
    		 100 56 156
        Male
    		 120 55 175
    Ethnicity
    Units: Subjects
        Hispanic or Latino
    		 14 14 28
        Not Hispanic or Latino
    		 197 93 290
        Unknown or Not Reported
    		 9 4 13
    Race
    Units: Subjects
        American Indian or Alaska Native
    		 1 0 1
        Asian
    		 1 3 4
        Native Hawaiian or Other Pacific Islander
    		 0 0 0
        Black or African American
    		 5 0 5
        White
    		 206 104 310
        More than one race
    		 0 2 2
        Unknown or Not Reported
    		 7 2 9

    End points

    		 Close Top of page
    End points reporting groups
    Reporting group title
    Double-blind Induction Period: Lebrikizumab +TCS
    Reporting group description
    		 Subjects received loading dose of lebrikizumab 500 milligrams (mg) subcutaneous (SC) injection at Day 1 (Baseline) and Week 2 followed by lebrikizumab 250 mg SC injection once every two weeks (Q2W) for up to 16 weeks concomitantly with topical corticosteroids (TCS) in the double-blind induction period.

    Reporting group title
    Double-blind Induction Period: Placebo +TCS
    Reporting group description
    		 Subjects received lebrikizumab-matched placebo SC injection, Q2W for up to 16 weeks concomitantly with TCS in the double-blind induction period.
    Reporting group title
    Open-label Maintenance Period: Lebrikizumab to Lebrikizumab
    Reporting group description
    		 Subjects who received lebrikizumab 250 mg Q2W during the Double-blind Induction Period continued to receive lebrikizumab 250 mg, Q2W during the 36-week Maintenance Period.

    Reporting group title
    Open-label Maintenance Period: Placebo to Lebrikizumab
    Reporting group description
    		 During Maintenance Period, subjects who received placebo Q2W during the Induction Period received loading doses of lebrikizumab (500 mg) at Weeks 16 and 18. From Week 20 onward, the subjects received 1 injection of lebrikizumab 250mg Q2W.

    Primary: Double-blind Induction Period: Percentage of Subjects Who Achieved Eczema Area and Severity Index (EASI) 75 (>=75% Reduction From Baseline in EASI Score) at Week 16

    		 Close Top of page
    End point title
    		 Double-blind Induction Period: Percentage of Subjects Who Achieved Eczema Area and Severity Index (EASI) 75 (>=75% Reduction From Baseline in EASI Score) at Week 16
    End point description
    The EASI score is used to measure the severity and extent of atopic dermatitis (AD) and measures erythema, infiltration, excoriation and lichenification on 4 anatomic regions of the body: head, trunk, upper limbs, and lower limbs. The severity of the clinical signs of AD for each of 4 body regions was scored on a 4-point scale: 0=absent, 1=mild, 2=moderate and 3=severe. The area of AD involvement on each of the 4 anatomic regions was assessed as a percentage by body area: 0=no eruption, 1=1% to 9%, 2=10% to 29%, 3=30% to 49%, 4=50% to 60%, 5=70% to 80% and 6=90% to 100%. The composite index with total score ranged from 0 to 72, where higher scores indicates more severe and or extensive disease. FAS included all randomized subjects and were analyzed under the treatment group as randomized.
    End point type
    Primary
    End point timeframe
    At Week 16
    End point values
    		 Double-blind Induction Period: Lebrikizumab +TCS Double-blind Induction Period: Placebo +TCS
    Number of subjects analysed
    220
    111
    Units: Percentage of subjects
        number (not applicable)
    68.4
    40.8
    Statistical analysis title
    		 Lebrikizumab +TCS vs Placebo +TCS
    Comparison groups
    Double-blind Induction Period: Lebrikizumab +TCS v Double-blind Induction Period: Placebo +TCS
    Number of subjects included in analysis
    331
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Difference in percentages
    Point estimate
    27.88
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 15.63
         upper limit
    		 40.14

    Secondary: Double-blind Induction Period: Percentage of Subjects Who Achieved Investigator Global Assessment (IGA) Score of 0 or 1 and 2-point Improvement at Week 16

    		 Close Top of page
    End point title
    		 Double-blind Induction Period: Percentage of Subjects Who Achieved Investigator Global Assessment (IGA) Score of 0 or 1 and 2-point Improvement at Week 16
    End point description
    The IGA is an instrument used to globally rate the severity of the subjects AD. It is based on a 5-point scale ranging from 0 (clear), 1 (almost clear), 2 (mild), 3 (moderate) and 4 (severe), and a score is selected using descriptors that best describe the overall appearance of the lesions at a given time point. The score is based on an overall assessment of the degree of erythema, papulation/induration, oozing/crusting (minimal, palpable induration and significant induration). Therapeutic response is an IGA score of 0 (clear) or 1 (almost clear). FAS included all randomized subjects and were analyzed under the treatment group as randomized.
    End point type
    Secondary
    End point timeframe
    At Week 16
    End point values
    		 Double-blind Induction Period: Lebrikizumab +TCS Double-blind Induction Period: Placebo +TCS
    Number of subjects analysed
    220
    111
    Units: Percentage of subjects
        number (not applicable)
    42.0
    24.5
    Statistical analysis title
    		 Lebrikizumab +TCS vs Placebo +TCS
    Comparison groups
    Double-blind Induction Period: Lebrikizumab +TCS v Double-blind Induction Period: Placebo +TCS
    Number of subjects included in analysis
    331
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0052
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Difference in percentages
    Point estimate
    17.8
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 7.03
         upper limit
    		 28.57

    Secondary: Double-blind Induction Period: Percentage of Subjects Who Achieved a 4-point Improvement in Pruritus Numeric Rating Score (NRS) at Week 16

    		 Close Top of page
    End point title
    		 Double-blind Induction Period: Percentage of Subjects Who Achieved a 4-point Improvement in Pruritus Numeric Rating Score (NRS) at Week 16
    End point description
    The Pruritus NRS is an 11-point scale used by subjects to rate their worst pruritus (itch) severity over the past 24 hours, with 0 indicating "No itch," and 10 indicating "Worst itch imaginable. Higher score indicates more severity. FAS included all randomized subjects with the Baseline score >=4. Here, "subjects analysed" signifies subjects who were evaluable for this endpoint.
    End point type
    Secondary
    End point timeframe
    At Week 16
    End point values
    		 Double-blind Induction Period: Lebrikizumab +TCS Double-blind Induction Period: Placebo +TCS
    Number of subjects analysed
    199
    102
    Units: Percentage of subjects
        number (not applicable)
    49.9
    29.7
    Statistical analysis title
    		 Lebrikizumab +TCS vs Placebo +TCS
    Comparison groups
    Double-blind Induction Period: Lebrikizumab +TCS v Double-blind Induction Period: Placebo +TCS
    Number of subjects included in analysis
    301
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0114
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Difference in percentages
    Point estimate
    18.15
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 5.47
         upper limit
    		 30.83

    Secondary: Double-blind Induction Period: Percentage of Subjects Who Achieved EASI 75 (>=75% Reduction From Baseline in EASI Score) at Weeks 2, 4, 8, and 12

    		 Close Top of page
    End point title
    		 Double-blind Induction Period: Percentage of Subjects Who Achieved EASI 75 (>=75% Reduction From Baseline in EASI Score) at Weeks 2, 4, 8, and 12
    End point description
    The EASI score is used to measure the severity and extent of atopic dermatitis (AD) and measures erythema, infiltration, excoriation and lichenification on 4 anatomic regions of the body: head, trunk, upper limbs, and lower limbs. The severity of the clinical signs of AD for each of 4 body regions was scored on a 4-point scale: 0=absent, 1=mild, 2=moderate and 3=severe. The area of AD involvement on each of the 4 anatomic regions was assessed as a percentage by body area: 0=no eruption, 1=1% to 9%, 2=10% to 29%, 3=30% to 49%, 4=50% to 60%, 5=70% to 80% and 6=90% to 100%. The composite index with total score ranged from 0 to 72, where higher scores indicates more severe and or extensive disease. Percentage of subjects who achieved EASI 75 (>=75% reduction from baseline in EASI score) at Weeks 2, 4, 8, and 12 were reported. FAS included all randomized subjects and were analyzed under the treatment group as randomized.
    End point type
    Secondary
    End point timeframe
    At Weeks 2, 4, 8, and12
    End point values
    		 Double-blind Induction Period: Lebrikizumab +TCS Double-blind Induction Period: Placebo +TCS
    Number of subjects analysed
    220
    111
    Units: Percentage of subjects
    number (not applicable)
        At Week 2
    9.7
    6.3
        At Week 4
    28.3
    19.2
        At Week 8
    54.9
    31.5
        At Week 12
    64.9
    41.1
    No statistical analyses for this end point

    Secondary: Double-blind Induction Period: Percentage of Subjects Who Achieved EASI 90 (>=90% Reduction From Baseline in EASI Score) at Weeks 2, 4, 8, 12 and 16

    		 Close Top of page
    End point title
    		 Double-blind Induction Period: Percentage of Subjects Who Achieved EASI 90 (>=90% Reduction From Baseline in EASI Score) at Weeks 2, 4, 8, 12 and 16
    End point description
    The EASI score is used to measure the severity and extent of AD and measures erythema, infiltration, excoriation and lichenification on 4 anatomic regions of the body: head, trunk, upper limbs, and lower limbs. The severity of the clinical signs of AD for each of 4 body regions was scored on a 4-point scale: 0=absent, 1=mild, 2=moderate and 3=severe. The area of AD involvement on each of the 4 anatomic regions was assessed as a percentage by body area: 0=no eruption, 1=1% to 9%, 2=10% to 29%, 3=30% to 49%, 4=50% to 60%, 5=70% to 80% and 6=90% to 100%. The composite index with total score ranged from 0 to 72, where higher scores indicates more severe and or extensive disease. FAS included all randomized subjects and were analyzed under the treatment group as randomized.
    End point type
    Secondary
    End point timeframe
    At Weeks 2, 4, 8, 12 and 16
    End point values
    		 Double-blind Induction Period: Lebrikizumab +TCS Double-blind Induction Period: Placebo +TCS
    Number of subjects analysed
    220
    111
    Units: Percentage of subjects
    number (not applicable)
        At Week 2
    1.5
    0.9
        At Week 4
    15.8
    6.4
        At Week 8
    28.9
    10.6
        At Week 12
    42.1
    21.0
        At Week 16
    42.9
    20.8
    No statistical analyses for this end point

    Secondary: Double-blind Induction Period: Percentage of Subjects Who Achieved EASI 50 (>=50% Reduction From Baseline in EASI Score) at Weeks 2, 4, 8, 12 and 16

    		 Close Top of page
    End point title
    		 Double-blind Induction Period: Percentage of Subjects Who Achieved EASI 50 (>=50% Reduction From Baseline in EASI Score) at Weeks 2, 4, 8, 12 and 16
    End point description
    The EASI score is used to measure the severity and extent of AD and measures erythema, infiltration, excoriation and lichenification on 4 anatomic regions of the body: head, trunk, upper limbs, and lower limbs. The severity of the clinical signs of AD for each of 4 body regions was scored on a 4-point scale: 0=absent, 1=mild, 2=moderate and 3=severe. The area of AD involvement on each of the 4 anatomic regions was assessed as a percentage by body area: 0=no eruption, 1=1% to 9%, 2=10% to 29%, 3=30% to 49%, 4=50% to 60%, 5=70% to 80% and 6=90% to 100%. The composite index with total score ranged from 0 to 72, where higher scores indicates more severe and or extensive disease. FAS included all randomized subjects and were analyzed under the treatment group as randomized.
    End point type
    Secondary
    End point timeframe
    At Weeks 2, 4, 8, 12 and 16
    End point values
    		 Double-blind Induction Period: Lebrikizumab +TCS Double-blind Induction Period: Placebo +TCS
    Number of subjects analysed
    220
    111
    Units: Percentage of subjects
    number (not applicable)
        At Week 2
    30.8
    23.4
        At Week 4
    58.9
    46.0
        At Week 8
    75.2
    59.3
        At Week 12
    80.3
    68.0
        At Week 16
    82.6
    65.3
    No statistical analyses for this end point

    Secondary: Double-blind Induction Period: Percentage of Subjects Who Achieved a 4-point Improvement in Dermatology Life Quality Index (DLQI) at Weeks 2, 4, 8, 12 and 16

    		 Close Top of page
    End point title
    		 Double-blind Induction Period: Percentage of Subjects Who Achieved a 4-point Improvement in Dermatology Life Quality Index (DLQI) at Weeks 2, 4, 8, 12 and 16
    End point description
    The DLQI is a 10-item validated questionnaire completed by the subject or caregiver used to assess the impact of skin disease on the participant's quality of life (QoL during the previous week. The 10 questions cover the following topics: symptoms, embarrassment, shopping and home care, clothes, social and leisure, sport, work or study, close relationships, sex, and treatment. Each question was scored on a 4-point scale (ranged from 0 to 3) where, 0 = not at all, 1= a little, 2= a lot, 3= very much, giving a total score ranging from 0 (not at all) to 30 (very much). A high score is indicative of a poor QoL. FAS included all randomized subjects with Baseline DLQI score of >=4. Here” number of subjects analysed" signified subjects who were evaluable for this endpoint.
    End point type
    Secondary
    End point timeframe
    At Weeks 2, 4, 8, 12 and 16
    End point values
    		 Double-blind Induction Period: Lebrikizumab +TCS Double-blind Induction Period: Placebo +TCS
    Number of subjects analysed
    180
    90
    Units: Percentage of subjects
    number (not applicable)
        At Week 2
    52.8
    57.1
        At Week 4
    66.1
    61.9
        At Week 8
    70.5
    56.1
        At Week 12
    73.1
    59.6
        At Week 16
    78.0
    69.6
    No statistical analyses for this end point

    Secondary: Double-blind Induction Period: Percentage of Subjects Who Achieved a 4-point Improvement in Children's Dermatology Life Quality Index (CDLQI) at Weeks 2, 4, 8, 12 and 16

    		 Close Top of page
    End point title
    		 Double-blind Induction Period: Percentage of Subjects Who Achieved a 4-point Improvement in Children's Dermatology Life Quality Index (CDLQI) at Weeks 2, 4, 8, 12 and 16
    End point description
    The CDLQI is validated from adolescents younger than age of 16 years, which is based on a set of 10 questions different from those of the DLQI to measure the impact of AD disease on QoL in children during the previous week. Each question is scored as follows: 0=not at all or unanswered, 1 = only a little, 2 = quite a lot and 3 = very much. Question 7 has an added possible response, which was scored as 3. CDLQI equals the sum of the score of each question, ranged from 0 (no impact of skin disease on QoL) to 30 (maximum impact on QoL). Higher scores indicate higher impact on QoL. FAS included all randomized subjects with Baseline Score >= 4. Here” number of subjects analysed" signified subjects who were evaluable for this endpoint.
    End point type
    Secondary
    End point timeframe
    At Weeks 2, 4, 8, 12 and 16
    End point values
    		 Double-blind Induction Period: Lebrikizumab +TCS Double-blind Induction Period: Placebo +TCS
    Number of subjects analysed
    22
    8
    Units: Percentage of subjects
    number (not applicable)
        At Week 2
    90.9
    100
        At Week 4
    68.2
    62.5
        At Week 8
    90.9
    100
        At Week 12
    95.5
    100
        At Week 16
    93.1
    100
    No statistical analyses for this end point

    Secondary: Double-blind Induction Period: Percentage of Subjects Who Achieved a 4- Point Improvement in Skin Pain NRS at Week 16

    		 Close Top of page
    End point title
    		 Double-blind Induction Period: Percentage of Subjects Who Achieved a 4- Point Improvement in Skin Pain NRS at Week 16
    End point description
    The Skin Pain NRS is an 11-point scale completed by subjects to rate their worst skin pain (example, discomfort or soreness) severity over the past 24 hours, with 0 (indicating "No pain") and 10 (indicating "Worst pain imaginable). Higher scores indicated worse pain. FAS included all randomized subjects with Baseline Score >= 4. Here” number of subjects analysed" signified subjects who were evaluable for this endpoint.
    End point type
    Secondary
    End point timeframe
    At Week 16
    End point values
    		 Double-blind Induction Period: Lebrikizumab +TCS Double-blind Induction Period: Placebo +TCS
    Number of subjects analysed
    173
    88
    Units: Percentage of Subjects
        number (not applicable)
    51.6
    27.5
    No statistical analyses for this end point

    Secondary: Double-blind Induction Period: Change From Baseline in Body Surface Area (BSA) at Weeks 2, 4, 8, 12 and 16

    		 Close Top of page
    End point title
    		 Double-blind Induction Period: Change From Baseline in Body Surface Area (BSA) at Weeks 2, 4, 8, 12 and 16
    End point description
    The BSA assessment estimates the extent of disease or skin involvement with respect to AD and is expressed as a percentage of total body surface. BSA was determined by the Investigator or designee using the subject palm = 1% BSA rule. The subject's palm is measured from the wrist to the proximal interphalangeal and thumb. This higher the BSA %, the more active atopic dermatitis is present. Percent of BSA for a body region = total number of palms in a body region * % surface area equivalent to 1 palm. Overall percent BSA for an individual is arithmetic mean of % BSA of all 4 body regions and ranges from 0% to 100% with higher values representing greater severity of AD and negative change from baseline indicate no severity. FAS included all randomized subjects and were analyzed under the treatment group as randomized. Here” number of subjects analysed" signified subjects who were evaluable for this endpoint and "n=number analysed" signifies who were evaluable at specified timepoints.
    End point type
    Secondary
    End point timeframe
    Baseline, Weeks 2, 4, 8, 12 and 16
    End point values
    		 Double-blind Induction Period: Lebrikizumab +TCS Double-blind Induction Period: Placebo +TCS
    Number of subjects analysed
    217
    111
    Units: Percentage of body surface area
    arithmetic mean (standard deviation)
        Change at Week 2 (n= 216, 111)
    -11.4 ( 15.33 )
    -10.6 ( 12.04 )
        Change at Week 4 (n= 217, 107)
    -19.5 ( 19.22 )
    -15.3 ( 13.77 )
        Change at Week 8 (n= 211, 102)
    -27.3 ( 20.60 )
    -19.2 ( 17.12 )
        Change at Week 12 (n= 205, 99)
    -30.6 ( 21.25 )
    -22.5 ( 17.06 )
        Change at Week 16 (n= 209, 99)
    -32.5 ( 21.44 )
    -22.1 ( 18.57 )
    No statistical analyses for this end point

    Secondary: Double-blind Induction Period: Change From Baseline in Scoring Atopic Dermatitis (SCORAD) at Weeks 8 and 16

    		 Close Top of page
    End point title
    		 Double-blind Induction Period: Change From Baseline in Scoring Atopic Dermatitis (SCORAD) at Weeks 8 and 16
    End point description
    SCORAD is a validated clinical tool for assessing the extent and intensity of AD. There are 3 components: A) Surface involvement is assessed as proportion of involved surface area segment by segment by applying the rule of 9s and reported as the sum of all areas, with a score ranging from 0-100. B) Intensity part of the SCORAD consists of 6 items: erythema, oedema, oozing/crusting, excoriation, lichenification, and dryness. Each item graded as: none (0), mild (1), moderate (2), or severe (3). C) Subjective assessment of itch and of sleeplessness is recorded for each symptom using a visual analogue scale (VAS), where 0=no itch (or no sleeplessness) and 10= worst imaginable itch (or sleeplessness), with max score of 20. Formula: A/5+7B/2+C, A: extent (0-100), B: intensity (0-18), C: subjective symptoms (0-20). SCORAD total score ranged from 0 (no disease)- 103 (severe disease). Higher values represent worse outcome and negative change from baseline indicate improvement. FAS population.
    End point type
    Secondary
    End point timeframe
    Baseline, Weeks 8 and 16
    End point values
    		 Double-blind Induction Period: Lebrikizumab +TCS Double-blind Induction Period: Placebo +TCS
    Number of subjects analysed
    199
    94
    Units: Score on a Scale
    arithmetic mean (standard deviation)
        Change at Week 8 (n= 198, 94)
    -32.1 ( 17.90 )
    -20.0 ( 18.04 )
        Change at Week 16 (n= 199, 89)
    -36.8 ( 20.40 )
    -23.7 ( 21.25 )
    No statistical analyses for this end point

    Secondary: Double-blind Induction Period: Change From Baseline in Pruritus NRS by Week up to Week 16

    		 Close Top of page
    End point title
    		 Double-blind Induction Period: Change From Baseline in Pruritus NRS by Week up to Week 16
    End point description
    The Pruritus NRS is an 11-point scale used by subjects to rate their worst pruritus (itch) severity over the past 24 hours, with 0 indicating "No itch," and 10 indicating "Worst itch imaginable." Higher scores indicated greater severity and negative change from baseline indicate no severity. FAS included all randomized subjects and were analyzed under the treatment group as randomized. Here” number of subjects analysed" signified subjects who were evaluable for this endpoint and "n=number analysed" signifies subjects who were evaluable at specified timepoints.
    End point type
    Secondary
    End point timeframe
    Baseline, Weeks 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15 and 16
    End point values
    		 Double-blind Induction Period: Lebrikizumab +TCS Double-blind Induction Period: Placebo +TCS
    Number of subjects analysed
    214
    108
    Units: Score on a Scale
    arithmetic mean (standard deviation)
        Change at Week 2 (n= 206, 105)
    -1.543 ( 1.6304 )
    -1.113 ( 1.7468 )
        Change at Week 3 (n= 213, 108)
    -2.199 ( 2.0960 )
    -1.420 ( 2.1401 )
        Change at Week 4 (n= 214, 107)
    -2.351 ( 2.2558 )
    -1.450 ( 2.3924 )
        Change at Week 5 (n=211, 101)
    -2.771 ( 2.4152 )
    -1.485 ( 2.4553 )
        Change at Week 6 (n=207, 101)
    -3.053 ( 2.3975 )
    -1.711 ( 2.5330 )
        Change at Week 7 (n=203, 101)
    -3.204 ( 2.4643 )
    -1.823 ( 2.5263 )
        Change at Week 8 (n=212, 99)
    -3.080 ( 2.4552 )
    -1.856 ( 2.5670 )
        Change at Week 9 (n= 205, 100)
    -3.283 ( 2.5105 )
    -1.861 ( 2.5872 )
        Change at Week 10 (n=205, 98)
    -3.245 ( 2.6101 )
    -1.529 ( 2.7489 )
        Change at Week 11 (n= 201, 96)
    -3.285 ( 2.5484 )
    -1.776 ( 2.7302 )
        Change at Week 12 (n=206, 97)
    -3.388 ( 2.6195 )
    -1.853 ( 2.3583 )
        Change at Week 13 (n=196, 97)
    -3.326 ( 2.6697 )
    -2.053 ( 2.5284 )
        Change at Week 14 (n= 203, 96)
    -3.313 ( 2.6843 )
    -1.948 ( 2.4181 )
        Change at Week 15 (n=202, 96)
    -3.366 ( 2.5291 )
    -1.938 ( 2.5245 )
        Change at Week 16 (n=203, 92)
    -3.476 ( 2.5453 )
    -2.183 ( 2.4246 )
    No statistical analyses for this end point

    Secondary: Double-blind Induction Period: Change From Baseline in the Sleep Loss at Week 16 Using Patient-related Outcome (PRO) by Week up to Week 16

    		 Close Top of page
    End point title
    		 Double-blind Induction Period: Change From Baseline in the Sleep Loss at Week 16 Using Patient-related Outcome (PRO) by Week up to Week 16
    End point description
    Sleep loss was assessed by all subjects using a PRO instrument. Subjects (and if applicable, with help of parents/caregiver if required) rate their sleep on a 5-point Likert scale (with scores ranging from 0 [not at all] to 4 [unable to sleep at all]). Higher scores indicated a greater impact and worse outcome; therefore, negative change from baseline indicate less impact. FAS included all randomized subjects and were analyzed under the treatment group as randomized. Here” number of subjects analysed" signified subjects who were evaluable for this endpoint and "n=number analysed" signifies subjects who were evaluable at specified timepoints.
    End point type
    Secondary
    End point timeframe
    Baseline, Weeks 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15 and 16
    End point values
    		 Double-blind Induction Period: Lebrikizumab +TCS Double-blind Induction Period: Placebo +TCS
    Number of subjects analysed
    214
    108
    Units: Score on a Scale
    arithmetic mean (standard deviation)
        Change at Week 2 (n=206, 105)
    -0.603 ( 0.6985 )
    -0.493 ( 0.8407 )
        Change at Week 3 (n=213, 108)
    -0.816 ( 0.8809 )
    -0.673 ( 1.0262 )
        Change at Week 4 (n=214, 107)
    -0.875 ( 0.9387 )
    -0.577 ( 1.0885 )
        Change at Week 5 (n=210, 101)
    -0.942 ( 0.9646 )
    -0.607 ( 1.1342 )
        Change at Week 6 (n=207,101)
    -0.998 ( 0.9088 )
    -0.613 ( 1.0641 )
        Change at Week 7 (n=203, 101)
    -1.038 ( 0.9388 )
    -0.661 ( 1.1119 )
        Change at Week 8 (n=212, 99)
    -0.974 ( 0.9941 )
    -0.708 ( 1.1500 )
        Change at Week 9 (n=205, 100)
    -1.052 ( 0.9352 )
    -0.668 ( 1.0604 )
        Change at Week 10 (n=205, 98)
    -1.091 ( 0.9624 )
    -0.560 ( 1.1349 )
        Change at Week 11 (n=201, 96)
    -1.040 ( 0.9966 )
    -0.676 ( 1.0938 )
        Change at Week 12 (n=206, 97)
    -1.123 ( 1.0281 )
    -0.721 ( 1.0768 )
        Change at Week 13 (n=196, 97)
    -1.069 ( 0.9776 )
    -0.797 ( 1.1037 )
        Change at Week 14 (n=203, 96)
    -1.072 ( 1.0446 )
    -0.809 ( 1.0751 )
        Change at Week 15 (n=202, 96)
    -1.096 ( 0.9819 )
    -0.756 ( 1.0891 )
        Change at Week 16 (n=203, 92)
    -1.201 ( 0.9775 )
    -0.857 ( 1.0615 )
    No statistical analyses for this end point

    Secondary: Double-blind Induction Period: Change From Baseline in Patient-Oriented Eczema Measure (POEM) Total Score at Weeks 4, 8, 12 and 16

    		 Close Top of page
    End point title
    		 Double-blind Induction Period: Change From Baseline in Patient-Oriented Eczema Measure (POEM) Total Score at Weeks 4, 8, 12 and 16
    End point description
    The POEM is a 7-item, validated questionnaire completed by the subject (and, if applicable, with help of parents/caregiver if required) to assess disease symptoms. Subjects are asked to respond to questions on skin dryness, itching, flaking, cracking, sleep loss, bleeding, and weeping. All answers carry equal weight, with a total possible score ranging from 0 to 28 (answers scored as: No days = 0; 1 to 2 days = 1; 3 to 4 days = 2; 5 to 6 days = 3; every day = 4. Higher scores indicated more severe disease and poor quality of life (QoL); therefore, negative change from baseline indicate improvement in QoL. Here” number of subjects analysed" signified subjects who were evaluable for this endpoint and "n=number analysed" signifies subjects who were evaluable at specified timepoints.
    End point type
    Secondary
    End point timeframe
    Baseline, Weeks 4, 8, 12 and 16
    End point values
    		 Double-blind Induction Period: Lebrikizumab +TCS Double-blind Induction Period: Placebo +TCS
    Number of subjects analysed
    201
    98
    Units: Score on a Scale
    arithmetic mean (standard deviation)
        Change at Week 4 (n=201, 98)
    -8.4 ( 6.82 )
    -4.7 ( 6.42 )
        Change at Week 8 (n=199, 91)
    -10.9 ( 7.45 )
    -5.2 ( 6.65 )
        Change at Week 12 (n=197, 87)
    -11.3 ( 8.08 )
    -5.1 ( 7.25 )
        Change at Week 16 (n=196, 87)
    -11.9 ( 8.01 )
    -5.8 ( 7.18 )
    No statistical analyses for this end point

    Secondary: Double-blind Induction Period: Change From Baseline in Dermatology Life Quality Index (DLQI) Total Score at Weeks 2. 4, 8, 12 and 16

    		 Close Top of page
    End point title
    		 Double-blind Induction Period: Change From Baseline in Dermatology Life Quality Index (DLQI) Total Score at Weeks 2. 4, 8, 12 and 16
    End point description
    The DLQI is a 10-item validated questionnaire completed by the subject or caregiver used to assess the impact of skin disease on the participant's QoL during the previous week. The 10 questions cover the following topics: symptoms, embarrassment, shopping and home care, clothes, social and leisure, sport, work or study, close relationships, sex, and treatment. Each question was scored on a 4-point scale (ranged from 0 to 3) where, 0 = not at all, 1= a little, 2= a lot, 3= very much, giving a total score ranging from 0 (not at all) to 30 (very much). A high score is indicative of a poor QoL and negative change from baseline indicate improvement in QoL. FAS included all randomized subjects and were analyzed under the treatment group as randomized. Here” number of subjects analysed" signified subjects who were evaluable for this endpoint and "n=number analysed" signifies subjects who were evaluable at specified timepoints.
    End point type
    Secondary
    End point timeframe
    Baseline, Weeks 2. 4, 8, 12 and 16
    End point values
    		 Double-blind Induction Period: Lebrikizumab +TCS Double-blind Induction Period: Placebo +TCS
    Number of subjects analysed
    185
    91
    Units: Score on a Scale
    arithmetic mean (standard deviation)
        Change at Week 2 (n=185, 91)
    -4.6 ( 5.54 )
    -4.5 ( 6.00 )
        Change at Week 4 (n=178, 90)
    -7.1 ( 6.54 )
    -5.4 ( 6.86 )
        Change at Week 8 (n=177, 83)
    -8.3 ( 7.03 )
    -5.7 ( 7.89 )
        Change at Week 12 (n=176, 79)
    -8.7 ( 7.38 )
    -5.9 ( 7.90 )
        Change at Week 16 (n=175, 79)
    -9.5 ( 7.40 )
    -8.1 ( 7.62 )
    No statistical analyses for this end point

    Secondary: Double-blind Induction Period: Change From Baseline in Children's Dermatology Life Quality Index (CDLQI) at Week 2. 4, 8, 12 and 16

    		 Close Top of page
    End point title
    		 Double-blind Induction Period: Change From Baseline in Children's Dermatology Life Quality Index (CDLQI) at Week 2. 4, 8, 12 and 16
    End point description
    The CDLQI is validated from adolescents younger than age of 16 years, which is based on a set of 10 questions different from those of the DLQI to measure the impact of AD disease on QoL in children during the previous week. Each question is scored as follows: 0=not at all or unanswered, 1 = only a little, 2 = quite a lot and 3 = very much. Question 7 has an added possible response, which was scored as 3. CDLQI equals the sum of the score of each question, ranged from 0 (no impact of skin disease on QoL) to 30 (maximum impact on QoL). Higher scores indicate higher impact on QoL and negative change from baseline indicate low impact on QoL. FAS included all randomized subjects and were analysed under the treatment group as randomized. Here” number of subjects analysed" signified subjects who were evaluable for this endpoint and "n=number analysed" signifies subjects who were evaluable at specified timepoints.
    End point type
    Secondary
    End point timeframe
    Baseline, Weeks 2, 4, 8, 12 and 16
    End point values
    		 Double-blind Induction Period: Lebrikizumab +TCS Double-blind Induction Period: Placebo +TCS
    Number of subjects analysed
    23
    8
    Units: Score on a Scale
    arithmetic mean (standard deviation)
        Change at Week 2 (n=23, 8)
    -2.9 ( 3.41 )
    -3.6 ( 3.25 )
        Change at Week 4 (n=23, 8)
    -5.1 ( 4.76 )
    -4.3 ( 4.65 )
        Change at Week 8 (n=23, 8)
    -6.6 ( 6.69 )
    -6.9 ( 4.82 )
        Change at Week 12 (n=21, 8)
    -7.7 ( 7.60 )
    -7.4 ( 6.30 )
        Change at Week 16 (n=21, 8)
    -7.7 ( 6.91 )
    -6.8 ( 5.73 )
    No statistical analyses for this end point

    Secondary: Double-blind Induction Period: Change From Baseline in Skin Pain NRS by Week up to Week 16

    		 Close Top of page
    End point title
    		 Double-blind Induction Period: Change From Baseline in Skin Pain NRS by Week up to Week 16
    End point description
    The Skin Pain NRS is an 11-point scale completed by subjects to rate their worst skin pain (example, discomfort or soreness) severity over the past 24 hours, with 0 (indicating "No pain") to 10 (indicating "Worst pain imaginable). Higher scores indicated worse pain and negative change from baseline indicate no pain. FAS included all randomized subjects and were analysed under the treatment group as randomized. Here” number of subjects analysed" signified subjects who were evaluable for this endpoint and "n=number analysed" signifies subjects who were evaluable at specified timepoints.
    End point type
    Secondary
    End point timeframe
    Baseline, Weeks 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15 and 16
    End point values
    		 Double-blind Induction Period: Lebrikizumab +TCS Double-blind Induction Period: Placebo +TCS
    Number of subjects analysed
    214
    108
    Units: Score on a Scale
    arithmetic mean (standard deviation)
        Change at Week 2 (n=206, 105)
    -1.546 ( 1.7978 )
    -0.905 ( 1.9170 )
        Change at Week 3 (n=213, 108)
    -2.152 ( 2.1719 )
    -1.316 ( 2.2680 )
        Change at Week 4 (n=214, 107)
    -2.308 ( 2.2457 )
    -1.271 ( 2.4880 )
        Change at Week 5 (n=211, 101)
    -2.589 ( 2.3577 )
    -1.333 ( 2.4462 )
        Change at Week 6 (n=207, 101)
    -2.862 ( 2.4428 )
    -1.309 ( 2.5079 )
        Change at Week 7 (n=203, 101)
    -2.886 ( 2.4473 )
    -1.656 ( 2.4816 )
        Change at Week 8 (n=212, 99)
    -2.872 ( 2.4975 )
    -1.711 ( 2.7208 )
        Change at Week 9 (n=205, 100)
    -3.017 ( 2.4897 )
    -1.598 ( 2.5693 )
        Change at Week 10 (n=205, 98)
    -3.017 ( 2.6017 )
    -1.382 ( 2.7463 )
        Change at Week 11 (n=201, 96)
    -3.116 ( 2.6230 )
    -1.572 ( 2.6465 )
        Change at Week 12 (n=206, 97)
    -3.115 ( 2.6181 )
    -1.520 ( 2.5976 )
        Change at Week 13 (n=196, 97)
    -3.140 ( 2.5568 )
    -1.788 ( 2.4726 )
        Change at Week 14 (n=203, 96)
    -3.035 ( 2.6733 )
    -1.683 ( 2.4462 )
        Change at Week 15 (n=203, 96)
    -3.138 ( 2.6062 )
    -1.781 ( 2.6443 )
        Change at Week 16 (n=203, 92)
    -3.302 ( 2.5844 )
    -1.831 ( 2.5766 )
    No statistical analyses for this end point

    Secondary: Double-blind Induction Period: Proportion of Topical Corticosteroids (TCS) Medication Free Days

    		 Close Top of page
    End point title
    		 Double-blind Induction Period: Proportion of Topical Corticosteroids (TCS) Medication Free Days
    End point description
    TCS free days proportion = Number of days subject did not take TCS medication / Number of days from Baseline to Week 16 Date or early discontinuation. FAS included all randomized subjects and were analysed under the treatment group as randomized.
    End point type
    Secondary
    End point timeframe
    Baseline up to Week 16
    End point values
    		 Double-blind Induction Period: Lebrikizumab +TCS Double-blind Induction Period: Placebo +TCS
    Number of subjects analysed
    220
    111
    Units: Proportion of Days
        arithmetic mean (standard deviation)
    0.224 ( 0.3491 )
    0.151 ( 0.3032 )
    No statistical analyses for this end point

    Secondary: Double-blind Induction Period: Median Time (Days) to TCS-Free Use

    		 Close Top of page
    End point title
    		 Double-blind Induction Period: Median Time (Days) to TCS-Free Use
    End point description
    Days from first study drug injection to the day subject stopped using all TCS. FAS included all randomized subjects and were analysed under the treatment group as randomized. Here, '99999' represents median and full range was not estimated due to insufficient number of events.
    End point type
    Secondary
    End point timeframe
    Baseline up to Week 16
    End point values
    		 Double-blind Induction Period: Lebrikizumab +TCS Double-blind Induction Period: Placebo +TCS
    Number of subjects analysed
    220
    111
    Units: Days
        median (full range (min-max))
    99999 (99999 to 99999)
    99999 (99999 to 99999)
    No statistical analyses for this end point

    Adverse events

    		 Close Top of page
    Adverse events information
    Timeframe for reporting adverse events
    Double-blind Induction Period: Day 1 to Week 16; Open-label Maintenance Period: Week 16 to Week 52
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    24.1
    Reporting groups
    Reporting group title
    Double-blind Induction Period: Lebrikizumab +TCS
    Reporting group description
    		 Subjects received loading dose of lebrikizumab 500 mg SC injection at Day 1 (Baseline) and Week 2 followed by lebrikizumab 250 mg SC injection once Q2W for up to 16 weeks concomitantly with TCS in the double-blind induction period.

    Reporting group title
    Double-blind Induction Period: Placebo +TCS
    Reporting group description
    		 Subjects received lebrikizumab-matched placebo SC injection, Q2W for up to 16 weeks concomitantly with TCS in the double-blind induction period.

    Reporting group title
    Open-label Maintenance Period: Lebrikizumab to Lebrikizumab
    Reporting group description
    		 Subjects who received lebrikizumab 250 mg Q2W during the Double-blind Induction Period continued to receive lebrikizumab 250 mg, Q2W during the 36-week Maintenance Period.

    Reporting group title
    Open-label Maintenance Period: Placebo to Lebrikizumab
    Reporting group description
    		 During Maintenance Period, subjects who received placebo Q2W during the Induction Period received loading doses of lebrikizumab (500 mg) at Weeks 16 and 18. From Week 20 onward, the subjects received 1 injection of lebrikizumab 250mg Q2W.

    Serious adverse events
    		 Double-blind Induction Period: Lebrikizumab +TCS Double-blind Induction Period: Placebo +TCS Open-label Maintenance Period: Lebrikizumab to Lebrikizumab Open-label Maintenance Period: Placebo to Lebrikizumab
    Total subjects affected by serious adverse events
         subjects affected / exposed
    3 / 220 (1.36%)
    1 / 111 (0.90%)
    12 / 212 (5.66%)
    4 / 100 (4.00%)
         number of deaths (all causes)
    0
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Cutaneous T-cell lymphoma
         subjects affected / exposed
    0 / 220 (0.00%)
    0 / 111 (0.00%)
    0 / 212 (0.00%)
    1 / 100 (1.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Fibroadenoma of breast
         subjects affected / exposed
    0 / 220 (0.00%)
    0 / 111 (0.00%)
    1 / 212 (0.47%)
    0 / 100 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Reproductive system and breast disorders
    Uterine polyp
         subjects affected / exposed
    0 / 220 (0.00%)
    0 / 111 (0.00%)
    0 / 212 (0.00%)
    1 / 100 (1.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Asthma
         subjects affected / exposed
    0 / 220 (0.00%)
    0 / 111 (0.00%)
    2 / 212 (0.94%)
    0 / 100 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cough
         subjects affected / exposed
    0 / 220 (0.00%)
    0 / 111 (0.00%)
    1 / 212 (0.47%)
    0 / 100 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Dyspnoea
         subjects affected / exposed
    0 / 220 (0.00%)
    0 / 111 (0.00%)
    1 / 212 (0.47%)
    0 / 100 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Psychiatric disorders
    Alcohol abuse
         subjects affected / exposed
    0 / 220 (0.00%)
    0 / 111 (0.00%)
    1 / 212 (0.47%)
    0 / 100 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Delirium
         subjects affected / exposed
    0 / 220 (0.00%)
    0 / 111 (0.00%)
    1 / 212 (0.47%)
    0 / 100 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Femoral neck fracture
         subjects affected / exposed
    0 / 220 (0.00%)
    0 / 111 (0.00%)
    1 / 212 (0.47%)
    0 / 100 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Femur fracture
         subjects affected / exposed
    0 / 220 (0.00%)
    0 / 111 (0.00%)
    1 / 212 (0.47%)
    0 / 100 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Radius fracture
         subjects affected / exposed
    0 / 220 (0.00%)
    0 / 111 (0.00%)
    1 / 212 (0.47%)
    0 / 100 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Nervous system disorders
    Multiple sclerosis
         subjects affected / exposed
    1 / 220 (0.45%)
    0 / 111 (0.00%)
    0 / 212 (0.00%)
    0 / 100 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Abdominal pain
         subjects affected / exposed
    0 / 220 (0.00%)
    0 / 111 (0.00%)
    0 / 212 (0.00%)
    1 / 100 (1.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Skin and subcutaneous tissue disorders
    Dermatitis atopic
         subjects affected / exposed
    0 / 220 (0.00%)
    1 / 111 (0.90%)
    1 / 212 (0.47%)
    0 / 100 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Renal and urinary disorders
    Urinary retention
         subjects affected / exposed
    0 / 220 (0.00%)
    0 / 111 (0.00%)
    1 / 212 (0.47%)
    0 / 100 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Endocrine disorders
    Autoimmune thyroiditis
         subjects affected / exposed
    0 / 220 (0.00%)
    0 / 111 (0.00%)
    0 / 212 (0.00%)
    1 / 100 (1.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Fracture pain
         subjects affected / exposed
    0 / 220 (0.00%)
    0 / 111 (0.00%)
    1 / 212 (0.47%)
    0 / 100 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Bronchitis
         subjects affected / exposed
    0 / 220 (0.00%)
    0 / 111 (0.00%)
    1 / 212 (0.47%)
    0 / 100 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Infection
         subjects affected / exposed
    1 / 220 (0.45%)
    0 / 111 (0.00%)
    0 / 212 (0.00%)
    0 / 100 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Influenza
         subjects affected / exposed
    1 / 220 (0.45%)
    0 / 111 (0.00%)
    0 / 212 (0.00%)
    0 / 100 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Lower respiratory tract infection
         subjects affected / exposed
    0 / 220 (0.00%)
    0 / 111 (0.00%)
    1 / 212 (0.47%)
    0 / 100 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Respiratory tract infection
         subjects affected / exposed
    0 / 220 (0.00%)
    0 / 111 (0.00%)
    1 / 212 (0.47%)
    0 / 100 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Diabetes mellitus
         subjects affected / exposed
    0 / 220 (0.00%)
    0 / 111 (0.00%)
    2 / 212 (0.94%)
    0 / 100 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Double-blind Induction Period: Lebrikizumab +TCS Double-blind Induction Period: Placebo +TCS Open-label Maintenance Period: Lebrikizumab to Lebrikizumab Open-label Maintenance Period: Placebo to Lebrikizumab
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    84 / 220 (38.18%)
    31 / 111 (27.93%)
    108 / 212 (50.94%)
    48 / 100 (48.00%)
    Nervous system disorders
    Headache
         subjects affected / exposed
    6 / 220 (2.73%)
    6 / 111 (5.41%)
    0 / 212 (0.00%)
    0 / 100 (0.00%)
         occurrences all number
    10
    10
    0
    0
    Eye disorders
    Conjunctivitis allergic
         subjects affected / exposed
    18 / 220 (8.18%)
    3 / 111 (2.70%)
    18 / 212 (8.49%)
    11 / 100 (11.00%)
         occurrences all number
    19
    4
    19
    14
    Skin and subcutaneous tissue disorders
    Dermatitis atopic
         subjects affected / exposed
    0 / 220 (0.00%)
    0 / 111 (0.00%)
    12 / 212 (5.66%)
    2 / 100 (2.00%)
         occurrences all number
    0
    0
    14
    4
    Infections and infestations
    COVID-19
         subjects affected / exposed
    8 / 220 (3.64%)
    7 / 111 (6.31%)
    13 / 212 (6.13%)
    4 / 100 (4.00%)
         occurrences all number
    8
    7
    13
    4
    Conjunctivitis
         subjects affected / exposed
    25 / 220 (11.36%)
    2 / 111 (1.80%)
    25 / 212 (11.79%)
    11 / 100 (11.00%)
         occurrences all number
    27
    2
    30
    11
    Nasopharyngitis
         subjects affected / exposed
    28 / 220 (12.73%)
    14 / 111 (12.61%)
    52 / 212 (24.53%)
    16 / 100 (16.00%)
         occurrences all number
    33
    18
    73
    21
    Oral herpes
         subjects affected / exposed
    11 / 220 (5.00%)
    3 / 111 (2.70%)
    0 / 212 (0.00%)
    0 / 100 (0.00%)
         occurrences all number
    15
    3
    0
    0
    Upper respiratory tract infection
         subjects affected / exposed
    8 / 220 (3.64%)
    7 / 111 (6.31%)
    17 / 212 (8.02%)
    6 / 100 (6.00%)
         occurrences all number
    8
    7
    21
    10

    More information

    		 Close Top of page

    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    13 Dec 2021
    Global Amendment 1: - This amendment provides an updated trial design of the 36-week open-label Maintenance Period with, lebrikizumab 250mg Q2W. Updated the statistical analysis plan accordingly. Removed every 4 weeks regimen and related details. - Added blood sample for the biomarkers assessment at Week 16. - Added genomic biomarker assessment at Baseline. - Added Treatment Satisfaction Questionnaire for Medication-9 items assessments at Baseline during the Induction Period. - Post-last dose follow-up period reviewed and increased from 12 to 18 weeks. Added urine pregnancy test follow-up every 4 weeks after last dose. - Updated number of trial centres and countries. - Added upadacitinib and tralokinumab to sentence about newly approved treatments in background section.
    10 Aug 2022
    Global Amendment 2: - Change of focus for primary analysis to Overall Population (instead of Dupilumab Naïve). - Estimand framework amended to match that of Phase III Lebrikizumab study. - Odds ratio added to CMH analyses.

    Interruptions (globally)
    Were there any global interruptions to the trial? No

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported
    For support, Contact us.
    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

    European Medicines Agency © 1995-Tue May 20 21:26:18 CEST 2025 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA