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    Clinical Trial Results:
    A proof of concept study to evaluate the efficacy, safety and tolerability of secukinumab 300 mg over 32 weeks in adult patients with biopsy-proven forms of lichen planus not adequately controlled with topical therapies - PRELUDE

    Summary
    EudraCT number
    		 2019-003588-24
    Trial protocol
    		 DE   FR  
    Global end of trial date
    03 May 2022

    Results information
    Results version number
    		 v1(current)
    This version publication date
    04 May 2023
    First version publication date
    04 May 2023
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    CAIN457S12201
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT04300296
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Novartis Pharma AG
    Sponsor organisation address
    Novartis Campus, Basel, Switzerland,
    Public contact
    Clinical Disclosure Office, Novartis Pharma AG, 41 613241111, Novartis.email@Novartis.com
    Scientific contact
    Clinical Disclosure Office, Novartis Pharma AG, 41 613241111, Novartis.email@Novartis.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    03 May 2022
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    03 May 2022
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The primary objective was to demonstrate the clinical efficacy of secukinumab 300 mg every 4 weeks (Q4W) in subjects with cutaneous lichen planus (CLP), mucosal lichen planus (MLP), or lichen planopilaris (LPP) inadequately controlled by topical therapies, with respect to improvement in Investigator’s Global Assessment.
    Protection of trial subjects
    The study was in compliance with the ethical principles derived from the Declaration of Helsinki and the International Conference on Harmonization (ICH) Good Clinical Practice (GCP) guidelines. All the local regulatory requirements pertinent to safety of trial subjects were also followed during the conduct of the trial.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    27 Jul 2020
    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
    France: 28
    Country: Number of subjects enrolled
    Germany: 34
    Country: Number of subjects enrolled
    United States: 49
    Worldwide total number of subjects
    111
    EEA total number of subjects
    62
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    0
    Infants and toddlers (28 days-23 months)
    0
    Children (2-11 years)
    0
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    87
    From 65 to 84 years
    24
    85 years and over
    0

    Subject disposition

    		 Close Top of page
    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 163 subjects (3 cohorts) were screened and 111 were randomized. Subjects in the AIN457 300 mg Q4W group in TP1 continued on AIN457 300mg Q4W in TP2. Subjects in the Placebo group in TP1 received AIN457 300mg Q2W in TP2. Patients in the Placebo group with spontaneous remission at Week 16 entered the Follow-up period.

    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, Assessor

    Arms
    Are arms mutually exclusive
    No

    Arm title
    		 AIN457 300 mg Q4W - TP 1 - CLP cohort
    Arm description
    		 AIN457 300 mg every 4 weeks up to 16 weeks administered via a pre-filled syringe
    Arm type
    		 Experimental

    Investigational medicinal product name
    secukinumab
    Investigational medicinal product code
    AIN457
    Other name
    Pharmaceutical forms
    Solution for injection/infusion in pre-filled syringe
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    300 mg every 4 weeks (Q4W)

    Arm title
    		 Placebo - TP 1 - CLP cohort
    Arm description
    		 Matching placebo administered every 4 weeks up to 16 weeks via a pre-filled syringe
    Arm type
    		 Placebo

    Investigational medicinal product name
    Matching placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection/infusion in pre-filled syringe
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Matching placebo every 4 weeks (Q4W)

    Arm title
    		 AIN457 300 mg Q4W - TP 1 and TP 2 - CLP cohort
    Arm description
    		 AIN457 300 mg every 4 weeks administered via a pre-filled syringe. Participants on AIN457 in TP 1 for 16 weeks continued AIN457 in TP 2 for 16 weeks.
    Arm type
    		 Experimental

    Investigational medicinal product name
    secukinumab
    Investigational medicinal product code
    AIN457
    Other name
    Pharmaceutical forms
    Solution for injection/infusion in pre-filled syringe
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    300 mg every 4 weeks (Q4W)

    Arm title
    		 Placebo to AIN457 300 mg Q2W - TP 2 - CLP cohort
    Arm description
    		 Placebo non-responders during TP 1 received AIN457 300 mg every 2 weeks from Week 16 to Week 32 in TP 2 via a pre-filled syringe.
    Arm type
    		 Experimental

    Investigational medicinal product name
    secukinumab
    Investigational medicinal product code
    AIN457
    Other name
    Pharmaceutical forms
    Solution for injection/infusion in pre-filled syringe
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    300 mg every 2 weeks (Q2W)

    Arm title
    		 AIN457 300 mg Q4W - TP 1 - MLP cohort
    Arm description
    		 AIN457 300 mg every 4 weeks up to 16 weeks administered via a pre-filled syringe
    Arm type
    		 Experimental

    Investigational medicinal product name
    secukinumab
    Investigational medicinal product code
    AIN457
    Other name
    Pharmaceutical forms
    Solution for injection/infusion in pre-filled syringe
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    300 mg every 4 weeks (Q4W)

    Arm title
    		 Placebo - TP 1 - MLP cohort
    Arm description
    		 Matching placebo administered every 4 weeks up to 16 weeks via a pre-filled syringe
    Arm type
    		 Placebo

    Investigational medicinal product name
    Matching placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection/infusion in pre-filled syringe
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Matching placebo every 4 weeks (Q4W)

    Arm title
    		 AIN457 300 mg Q4W - TP 1 and TP 2 - MLP cohort
    Arm description
    		 AIN457 300 mg every 4 weeks administered via a pre-filled syringe. Participants on AIN457 in TP 1 for 16 weeks continued AIN457 in TP 2 for 16 weeks.
    Arm type
    		 Experimental

    Investigational medicinal product name
    secukinumab
    Investigational medicinal product code
    AIN457
    Other name
    Pharmaceutical forms
    Solution for injection/infusion in pre-filled syringe
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    300 mg every 4 weeks (Q4W)

    Arm title
    		 Placebo to AIN457 300 mg Q2W TP 2 - MLP cohort
    Arm description
    		 Placebo non-responders during TP 1 received AIN457 300 mg every 2 weeks from Week 16 to Week 32 in TP 2 via a pre-filled syringe.
    Arm type
    		 Experimental

    Investigational medicinal product name
    secukinumab
    Investigational medicinal product code
    AIN457
    Other name
    Pharmaceutical forms
    Solution for injection/infusion in pre-filled syringe
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    300 mg every 2 weeks (Q2W)

    Arm title
    		 AIN457 300 mg Q4W - TP 1 - LPP cohort
    Arm description
    		 AIN457457 300 mg every 4 weeks up to 16 weeks administered via a pre-filled syringe
    Arm type
    		 Experimental

    Investigational medicinal product name
    secukinumab
    Investigational medicinal product code
    AIN457
    Other name
    Pharmaceutical forms
    Solution for injection/infusion in pre-filled syringe
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    300 mg every 4 weeks (Q4W)

    Arm title
    		 Placebo - TP 1 - LPP cohort
    Arm description
    		 Matching placebo administered every 4 weeks up to 16 weeks via a pre-filled syringe
    Arm type
    		 Placebo

    Investigational medicinal product name
    Matching placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection/infusion in pre-filled syringe
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Matching placebo every 4 weeks (Q4W)

    Arm title
    		 AIN457 300 mg Q4W - TP 1 and TP 2 - LPP cohort
    Arm description
    		 AIN457 300 mg every 4 weeks administered via a pre-filled syringe. Participants on AIN457 in TP 1 for 16 weeks continued AIN457 in TP 2 for 16 weeks.
    Arm type
    		 Experimental

    Investigational medicinal product name
    secukinumab
    Investigational medicinal product code
    AIN457
    Other name
    Pharmaceutical forms
    Solution for injection/infusion in pre-filled syringe
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    300 mg every 4 weeks (Q4W)

    Arm title
    		 Placebo to AIN457 300 mg Q2W - TP 2 - LPP cohort
    Arm description
    		 Placebo non-responders during TP 1 received AIN457 300 mg every 2 weeks from Week 16 to Week 32 in TP 2 via a pre-filled syringe.
    Arm type
    		 Experimental

    Investigational medicinal product name
    secukinumab
    Investigational medicinal product code
    AIN457
    Other name
    Pharmaceutical forms
    Solution for injection/infusion in pre-filled syringe
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    300 mg every 2 weeks (Q2W)

    Number of subjects in period 1
    		AIN457 300 mg Q4W - TP 1 - CLP cohort Placebo - TP 1 - CLP cohort AIN457 300 mg Q4W - TP 1 and TP 2 - CLP cohort Placebo to AIN457 300 mg Q2W - TP 2 - CLP cohort AIN457 300 mg Q4W - TP 1 - MLP cohort Placebo - TP 1 - MLP cohort AIN457 300 mg Q4W - TP 1 and TP 2 - MLP cohort Placebo to AIN457 300 mg Q2W TP 2 - MLP cohort AIN457 300 mg Q4W - TP 1 - LPP cohort Placebo - TP 1 - LPP cohort AIN457 300 mg Q4W - TP 1 and TP 2 - LPP cohort Placebo to AIN457 300 mg Q2W - TP 2 - LPP cohort
    Started
    25
    12
    25
    12
    24
    13
    24
    13
    24
    13
    24
    13
    Completed
    22
    10
    16
    7
    23
    13
    16
    10
    23
    12
    18
    11
    Not completed
    3
    2
    9
    5
    1
    0
    8
    3
    1
    1
    6
    2
         Discontinued TP and went to Follow-up
    1
    -
    1
    -
    1
    -
    4
    2
    -
    -
    -
    1
         Subject/Guardian decision - TP 2
    -
    -
    2
    -
    -
    -
    1
    1
    -
    -
    3
    -
         Subject/Guardian decision - TP 1
    1
    2
    -
    -
    -
    -
    -
    -
    -
    1
    -
    1
         Adverse Event - TP 1
    -
    -
    -
    -
    -
    -
    -
    -
    1
    -
    -
    -
         Adverse Event - TP 2
    -
    -
    1
    -
    -
    -
    2
    -
    -
    -
    1
    -
         Discontinued study in TP 1
    -
    -
    3
    3
    -
    -
    -
    -
    -
    -
    -
    -
         Progressive Disease - TP 1
    1
    -
    -
    -
    -
    -
    -
    -
    -
    -
    -
    -
         Protocol Deviation-TP 2
    -
    -
    -
    1
    -
    -
    -
    -
    -
    -
    -
    -
         Placebo Responder in TP1
    -
    -
    -
    1
    -
    -
    -
    -
    -
    -
    -
    -
         Progressive Disease - TP 2
    -
    -
    2
    -
    -
    -
    1
    -
    -
    -
    2
    -

    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
    		 111 111
    Age Categorical
    Units: Participants
        18 to <65 years
    		 84 84
        > or = 65 years
    		 27 27
    Sex: Female, Male
    Units: Participants
        Female
    		 79 79
        Male
    		 32 32
    Race/Ethnicity, Customized
    Units: Subjects
        Asian (Indian)
    		 2 2
        Black or African American
    		 14 14
        White
    		 94 94
        White, American Indian or Alaska Native
    		 1 1
    Baseline of Investigator's Global Assessment (IGA)
    The IGA provides a harmonized, 5-point grading system to assess disease severity for subjects of all 3 subtypes entering the study. The predominant subtype alone defined the IGA score of the subject and was collected separately for concomitant subtypes, if present (0=clear, 1=minimal, 2=mild, 3=moderate, 4=severe).
    Units: Subjects
        0=Clear
    		 0 0
        1=Minimal
    		 1 1
        2=Mild
    		 0 0
        3=Moderate
    		 82 82
        4=Severe
    		 28 28
    Subject analysis sets

    Subject analysis set title
    AIN457 300 mg Q4W - TP 1 - CLP cohort BL
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Baseline (BL) for AIN457 300 mg every 4 weeks up to 16 weeks administered via a pre-filled syringe

    Subject analysis set title
    Placebo - TP 1 - CLP cohort BL
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Baseline (BL) for matching placebo administered every 4 weeks up to 16 weeks via a pre-filled syringe

    Subject analysis set title
    AIN457 300 mg Q4W - TP 1 - MLP cohort BL
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Baseline (BL) for AIN457 300 mg every 4 weeks up to 16 weeks administered via a pre-filled syringe

    Subject analysis set title
    Placebo - TP 1 - MLP cohort Matching placebo BL
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Baseline (BL) for matching placebo administered every 4 weeks up to 16 weeks via a pre-filled syringe

    Subject analysis set title
    AIN457 300 mg Q4W - TP 1 - LPP cohort BL
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Baseline (BL) for AIN457457 300 mg every 4 weeks up to 16 weeks administered via a pre-filled syringe

    Subject analysis set title
    Placebo - TP 1 - LPP cohort Matching placebo BL
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Baseline (BL) for matching placebo administered every 4 weeks up to 16 weeks via a pre-filled syringe

    Subject analysis sets values
    		 AIN457 300 mg Q4W - TP 1 - CLP cohort BL Placebo - TP 1 - CLP cohort BL AIN457 300 mg Q4W - TP 1 - MLP cohort BL Placebo - TP 1 - MLP cohort Matching placebo BL AIN457 300 mg Q4W - TP 1 - LPP cohort BL Placebo - TP 1 - LPP cohort Matching placebo BL
    Number of subjects
    25
    12
    24
    13
    24
    13
    Age Categorical
    Units: Participants
        18 to <65 years
    22
    9
    14
    8
    19
    12
        > or = 65 years
    3
    3
    10
    5
    5
    1
    Age continuous
    Units:
        
    ( )
    ( )
    ( )
    ( )
    ( )
    ( )
    Sex: Female, Male
    Units: Participants
        Female
    15
    8
    14
    12
    20
    10
        Male
    10
    4
    10
    1
    4
    3
    Race/Ethnicity, Customized
    Units: Subjects
        Asian (Indian)
    0
    0
    2
    0
    0
    0
        Black or African American
    6
    0
    2
    1
    1
    0
        White
    19
    8
    19
    12
    23
    13
        White, American Indian or Alaska Native
    0
    0
    1
    0
    0
    0
    Baseline of Investigator's Global Assessment (IGA)
    The IGA provides a harmonized, 5-point grading system to assess disease severity for subjects of all 3 subtypes entering the study. The predominant subtype alone defined the IGA score of the subject and was collected separately for concomitant subtypes, if present (0=clear, 1=minimal, 2=mild, 3=moderate, 4=severe).
    Units: Subjects
        0=Clear
    0
    0
    0
    0
    0
    0
        1=Minimal
    1
    0
    0
    0
    0
    0
        2=Mild
    0
    0
    0
    0
    0
    0
        3=Moderate
    16
    9
    22
    8
    17
    10
        4=Severe
    8
    3
    2
    5
    7
    3

    End points

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    End points reporting groups
    Reporting group title
    AIN457 300 mg Q4W - TP 1 - CLP cohort
    Reporting group description
    		 AIN457 300 mg every 4 weeks up to 16 weeks administered via a pre-filled syringe

    Reporting group title
    Placebo - TP 1 - CLP cohort
    Reporting group description
    		 Matching placebo administered every 4 weeks up to 16 weeks via a pre-filled syringe

    Reporting group title
    AIN457 300 mg Q4W - TP 1 and TP 2 - CLP cohort
    Reporting group description
    		 AIN457 300 mg every 4 weeks administered via a pre-filled syringe. Participants on AIN457 in TP 1 for 16 weeks continued AIN457 in TP 2 for 16 weeks.

    Reporting group title
    Placebo to AIN457 300 mg Q2W - TP 2 - CLP cohort
    Reporting group description
    		 Placebo non-responders during TP 1 received AIN457 300 mg every 2 weeks from Week 16 to Week 32 in TP 2 via a pre-filled syringe.

    Reporting group title
    AIN457 300 mg Q4W - TP 1 - MLP cohort
    Reporting group description
    		 AIN457 300 mg every 4 weeks up to 16 weeks administered via a pre-filled syringe

    Reporting group title
    Placebo - TP 1 - MLP cohort
    Reporting group description
    		 Matching placebo administered every 4 weeks up to 16 weeks via a pre-filled syringe

    Reporting group title
    AIN457 300 mg Q4W - TP 1 and TP 2 - MLP cohort
    Reporting group description
    		 AIN457 300 mg every 4 weeks administered via a pre-filled syringe. Participants on AIN457 in TP 1 for 16 weeks continued AIN457 in TP 2 for 16 weeks.

    Reporting group title
    Placebo to AIN457 300 mg Q2W TP 2 - MLP cohort
    Reporting group description
    		 Placebo non-responders during TP 1 received AIN457 300 mg every 2 weeks from Week 16 to Week 32 in TP 2 via a pre-filled syringe.

    Reporting group title
    AIN457 300 mg Q4W - TP 1 - LPP cohort
    Reporting group description
    		 AIN457457 300 mg every 4 weeks up to 16 weeks administered via a pre-filled syringe

    Reporting group title
    Placebo - TP 1 - LPP cohort
    Reporting group description
    		 Matching placebo administered every 4 weeks up to 16 weeks via a pre-filled syringe

    Reporting group title
    AIN457 300 mg Q4W - TP 1 and TP 2 - LPP cohort
    Reporting group description
    		 AIN457 300 mg every 4 weeks administered via a pre-filled syringe. Participants on AIN457 in TP 1 for 16 weeks continued AIN457 in TP 2 for 16 weeks.

    Reporting group title
    Placebo to AIN457 300 mg Q2W - TP 2 - LPP cohort
    Reporting group description
    		 Placebo non-responders during TP 1 received AIN457 300 mg every 2 weeks from Week 16 to Week 32 in TP 2 via a pre-filled syringe.

    Subject analysis set title
    AIN457 300 mg Q4W - TP 1 - CLP cohort BL
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Baseline (BL) for AIN457 300 mg every 4 weeks up to 16 weeks administered via a pre-filled syringe

    Subject analysis set title
    Placebo - TP 1 - CLP cohort BL
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Baseline (BL) for matching placebo administered every 4 weeks up to 16 weeks via a pre-filled syringe

    Subject analysis set title
    AIN457 300 mg Q4W - TP 1 - MLP cohort BL
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Baseline (BL) for AIN457 300 mg every 4 weeks up to 16 weeks administered via a pre-filled syringe

    Subject analysis set title
    Placebo - TP 1 - MLP cohort Matching placebo BL
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Baseline (BL) for matching placebo administered every 4 weeks up to 16 weeks via a pre-filled syringe

    Subject analysis set title
    AIN457 300 mg Q4W - TP 1 - LPP cohort BL
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Baseline (BL) for AIN457457 300 mg every 4 weeks up to 16 weeks administered via a pre-filled syringe

    Subject analysis set title
    Placebo - TP 1 - LPP cohort Matching placebo BL
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Baseline (BL) for matching placebo administered every 4 weeks up to 16 weeks via a pre-filled syringe

    Primary: Response rate of Investigator Global Assessment (IGA) score of 2 or lower at week 16 for CLP, MLP and LPP

    		 Close Top of page
    End point title
    		 Response rate of Investigator Global Assessment (IGA) score of 2 or lower at week 16 for CLP, MLP and LPP [1]
    End point description
    Number of treatment responders at week 16, where response is defined as an Investigator's Global Assessment (IGA) score of 2 or lower at Week 16. IGA is measured on a scale from 0 - 4 with 0 = Clear, 1 = Minimal; 2 = Mild; 3 = Moderate; and 4 = Severe with 0 being best score and 4 being worst score. CLP=Cutaneous lichen planus, MLP=Mucosal lichen planus, LPP=Lichen planopilaris. Posterior median and 95% credible interval (instead of 95% confidence interval) were derived using Bayesian method based on beta-binomial model.
    End point type
    Primary
    End point timeframe
    Baseline up to week 16
    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: Endpoints reported by cohort.
    End point values
    		 AIN457 300 mg Q4W - TP 1 - CLP cohort Placebo - TP 1 - CLP cohort AIN457 300 mg Q4W - TP 1 - MLP cohort Placebo - TP 1 - MLP cohort AIN457 300 mg Q4W - TP 1 - LPP cohort Placebo - TP 1 - LPP cohort
    Number of subjects analysed
    25
    12
    24
    13
    24
    13
    Units: scores on a scale
        median (confidence interval 95%)
    44.0 (25.8 to 63.32)
    58.2 (31.0 to 82.6)
    37.5 (20.3 to 57.2)
    23.1 (6.5 to 49.2)
    37.6 (20.2 to 57.3)
    30.9 (10.8 to 57.6)
    Statistical analysis title
    		 CLP cohort
    Comparison groups
    AIN457 300 mg Q4W - TP 1 - CLP cohort v Placebo - TP 1 - CLP cohort
    Number of subjects included in analysis
    37
    Analysis specification
    Pre-specified
    Analysis type
    Method
    Parameter type
    		 Posterior median difference
    Point estimate
    -13.9
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -44.8
         upper limit
    		 19.3
    Statistical analysis title
    		 MLP cohort
    Comparison groups
    AIN457 300 mg Q4W - TP 1 - MLP cohort v Placebo - TP 1 - MLP cohort
    Number of subjects included in analysis
    37
    Analysis specification
    Pre-specified
    Analysis type
    Method
    Parameter type
    		 Posterior median difference
    Point estimate
    14.1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -17
         upper limit
    		 40.7
    Statistical analysis title
    		 LPP cohort
    Comparison groups
    AIN457 300 mg Q4W - TP 1 - LPP cohort v Placebo - TP 1 - LPP cohort
    Number of subjects included in analysis
    37
    Analysis specification
    Pre-specified
    Analysis type
    Method
    Parameter type
    		 Posterior median difference
    Point estimate
    6.5
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -25.4
         upper limit
    		 35.4

    Secondary: Number (%) of subjects with IGA ≤ 2 response, IGA ≥2 points improvement response, and IGA 0 or 1 response by visit – CLP cohort (BOCF)- Entire Treatment Period (FAS)

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    End point title
    		 Number (%) of subjects with IGA ≤ 2 response, IGA ≥2 points improvement response, and IGA 0 or 1 response by visit – CLP cohort (BOCF)- Entire Treatment Period (FAS) [2]
    End point description
    Number of subjects with IGA of 2 or lower, improvement in the IGA score of at least 2 points, or IGA score of 0/1. IGA is measured on a scale from 0-4 with 0=Clear, 1=minimal, 2=mild, 3=moderate, and 4=severe with 0 being best score and 4 being worst score.
    End point type
    Secondary
    End point timeframe
    Baseline up to week 32
    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: Endpoints reported by cohort.
    End point values
    		 Placebo - TP 1 - CLP cohort AIN457 300 mg Q4W - TP 1 and TP 2 - CLP cohort Placebo to AIN457 300 mg Q2W - TP 2 - CLP cohort
    Number of subjects analysed
    12
    25
    10
    Units: participants
        Week 2 IGA <=2
    1
    5
    0
        Week 2 IGA improvement >=2 n=25,12,0
    0
    2
    0
        Week 2 IGA 0/1 n=25,12,0
    0
    2
    0
        Week 4 IGA <=2 n=24,11,0
    2
    9
    0
        Week 4 IGA improvement. >=2 n=24,11,0
    0
    3
    0
        Week 4 IGA 0/1 n=24,11,0
    0
    2
    0
        Week 8 IGA <=2 n=25,11,0
    3
    10
    0
        Week 8 IGA improvement. >=2 n=25,11,0
    1
    4
    0
        Week 8 IGA 0/1 n=25,11,0
    1
    3
    0
        Week 12 IGA <=2 n=25,12,0
    4
    10
    0
        Week 12 IGA improvement. >=2 n=25,12,0
    2
    3
    0
        Week 12 IGA 0/1 n=25,12,0
    1
    4
    0
        Week16 IGA <=2 n=25,12,10
    7
    11
    5
        Week 16 IGA improvement. >=2 n=25,12,10
    3
    4
    1
        Week 16 IGA 0/1 n=25,12,10
    2
    4
    0
        Week 20 IGA <=2 n=24,0,10
    0
    11
    1
        Week 20 IGA improvement. >=2 n=24,0,10
    0
    5
    1
        Week 20 IGA 0/1 n=24,0,10
    0
    5
    1
        Week 24 IGA <=2 n=25,0,10
    0
    14
    3
        Week 24 IGA improvement. >=2 n=25,0,10
    0
    10
    2
        Week 24 IGA 0/1 n=25,0,10
    0
    10
    1
        Week 28 IGA <=2 n=23,0,10
    0
    12
    4
        Week 28 IGA improvement. >=2 n=23,0,10
    0
    7
    1
        Week 28 IGA 0/1 n=23,0,10
    0
    6
    1
        Week 32 IGA <=2 n=24,0,9
    0
    9
    2
        Week 32 IGA improvement. >=2 n=24,0,9
    0
    7
    2
        Week 32 IGA 0/1 n=24,0,9
    0
    6
    1
    No statistical analyses for this end point

    Secondary: Number (%) of subjects with IGA ≤ 2 response, IGA ≥2 points improvement response, and IGA 0 or 1 response by visit – MLP cohort (BOCF)- Entire Treatment Period (FAS)

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    End point title
    		 Number (%) of subjects with IGA ≤ 2 response, IGA ≥2 points improvement response, and IGA 0 or 1 response by visit – MLP cohort (BOCF)- Entire Treatment Period (FAS) [3]
    End point description
    Number of subjects with IGA of 2 of lower, improvement in the IGA score of at least 2 points, or IGA score of 0/1. IGA is measured on a scale from 0-4 with 0=Clear, 1=minimal, 2=mild, 3=moderate, and 4=severe with 0 being best score and 4 being worst score.
    End point type
    Secondary
    End point timeframe
    Baseline up to week 32
    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: Endpoints reported by cohort.
    End point values
    		 Placebo - TP 1 - MLP cohort AIN457 300 mg Q4W - TP 1 and TP 2 - MLP cohort Placebo to AIN457 300 mg Q2W TP 2 - MLP cohort
    Number of subjects analysed
    13
    24
    11
    Units: participants
        Week 2 IGA <=2 n=24,12,0
    3
    5
    0
        Week 2 IGA improvement >=2 n=24,12,0
    1
    1
    0
        Week 2 IGA 0/1 n=24,12,0
    1
    1
    0
        Week 4 IGA <=2 n=24,13,0
    2
    4
    0
        Week 4 IGA improvement. >=2 n=24,13,0
    1
    1
    0
        Week 4 IGA 0/1 n=24,13,0
    1
    1
    0
        Week 8 IGA <=2 n=24,13,0
    3
    5
    0
        Week 8 IGA improvement. >=2 n=24,13,0
    2
    0
    0
        Week 8 IGA 0/1 n=24,13,0
    1
    0
    0
        Week 12 IGA <=2 n=24,13,0
    4
    5
    0
        Week 12 IGA improvement. >=2 n=24,13,0
    4
    5
    0
        Week 12 IGA 0/1 n=24,13,0
    2
    4
    0
        Week16 IGA <=2 n=24,13,11
    3
    9
    1
        Week 16 IGA improvement. >=2 n=24,13,11
    3
    5
    1
        Week 16 IGA 0/1 n=24,13,11
    2
    4
    0
        Week 20 IGA <=2 n=24,0,11
    0
    10
    3
        Week 20 IGA improvement. >=2 n=24,0,11
    0
    5
    2
        Week 20 IGA 0/1 n=24,0,11
    0
    5
    1
        Week 24 IGA <=2 n=24,0,10
    0
    10
    4
        Week 24 IGA improvement. >=2 n=24,0,10
    0
    3
    2
        Week 24 IGA 0/1 n=24,0,10
    0
    3
    0
        Week 28 IGA <=2 n=23,0,11
    0
    7
    4
        Week 28 IGA improvement. >=2 n=23,0,11
    0
    1
    3
        Week 28 IGA 0/1 n=23,0,11
    0
    1
    0
        Week 32 IGA <=2 n=23,0,10
    0
    9
    2
        Week 32 IGA improvement. >=2 n=23,0,10
    0
    2
    1
        Week 32 IGA 0/1 n=23,0,10
    0
    2
    0
    No statistical analyses for this end point

    Secondary: Number (%) of subjects with IGA ≤ 2 response, IGA ≥2 points improvement response, and IGA 0 or 1 response by visit – LPP cohort (BOCF)- Entire Treatment Period (FAS)

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    End point title
    		 Number (%) of subjects with IGA ≤ 2 response, IGA ≥2 points improvement response, and IGA 0 or 1 response by visit – LPP cohort (BOCF)- Entire Treatment Period (FAS) [4]
    End point description
    Number of subjects with IGA of 2 or lower, improvement in the IGA score of at least 2 points, or IGA score of 0/1. IGA is measured on a scale from 0-4 with 0=Clear, 1=minimal, 2=mild, 3=moderate, and 4=severe with 0 being best score and 4 being worst score.
    End point type
    Secondary
    End point timeframe
    Baseline up to week 32
    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: Endpoints are reported by cohort.
    End point values
    		 Placebo - TP 1 - LPP cohort AIN457 300 mg Q4W - TP 1 and TP 2 - LPP cohort Placebo to AIN457 300 mg Q2W - TP 2 - LPP cohort
    Number of subjects analysed
    13
    24
    13
    Units: participants
        Week 2 IGA <=2 n=24,13,0
    1
    4
    0
        Week 2 IGA improvement >=2 n=24,13,0
    0
    1
    0
        Week 2 IGA 0/1 n=24,13,0
    0
    1
    0
        Week 4 IGA <=2 n=24,13,0
    2
    9
    0
        Week 4 IGA improvement. >=2 n=24,13,0
    1
    2
    0
        Week 4 IGA 0/1 n=24,13,0
    1
    2
    0
        Week 8 IGA <=2 n=24,13,0
    3
    8
    0
        Week 8 IGA improvement. >=2 n=24,13,0
    1
    3
    0
        Week 8 IGA 0/1 n=24,13,0
    1
    3
    0
        Week 12 IGA <=2 n=24,13,0
    4
    8
    0
        Week 12 IGA improvement. >=2 n=24,13,0
    2
    3
    0
        Week 12 IGA 0/1 n=24,13,0
    2
    2
    0
        Week16 IGA <=2 n=24,13,13
    4
    9
    4
        Week 16 IGA improvement. >=2 n=24,13,13
    0
    3
    0
        Week 16 IGA 0/1 n=24,13,13
    0
    2
    0
        Week 20 IGA <=2 n=24,0,13
    0
    10
    6
        Week 20 IGA improvement. >=2 n=24,0,13
    0
    6
    1
        Week 20 IGA 0/1 n=24,0,13
    0
    4
    0
        Week 24 IGA <=2 n=23,0,13
    0
    10
    8
        Week 24 IGA improvement. >=2 n=23,0,13
    0
    7
    3
        Week 24 IGA 0/1 n=23,0,13
    0
    6
    2
        Week 28 IGA <=2 n=24,0,13
    0
    10
    9
        Week 28 IGA improvement. >=2 n=24,0,13
    0
    6
    4
        Week 28 IGA 0/1 n=24,0,13
    0
    5
    3
        Week 32 IGA <=2 n==24,0,11
    0
    11
    7
        Week 32 IGA improvement. >=2 n==24,0,11
    0
    5
    5
        Week 32 IGA 0/1 n==24,0,11
    0
    4
    4
    No statistical analyses for this end point

    Secondary: Number (%) of subjects in each category in Physician´s assessment of surface area of disease (PSAD) - CLP (BOCF) – Entire treatment period (FAS)

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    End point title
    		 Number (%) of subjects in each category in Physician´s assessment of surface area of disease (PSAD) - CLP (BOCF) – Entire treatment period (FAS) [5]
    End point description
    The Physician Assessment of Surface Area of Disease (PSAD) evaluates the extent of cutaneous lesions estimated by investigator or qualified designee. Assessment scores range from 0-5, with lower scores corresponding to lower percentages of surface area with disease: 0=clear, 1=<2%, 2=2-9%, 3=10-29%, 4=30-50%, 5=>50% of total body surface
    End point type
    Secondary
    End point timeframe
    Baseline up to week 32
    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: Endpoints reported by cohort.
    End point values
    		 Placebo - TP 1 - CLP cohort AIN457 300 mg Q4W - TP 1 and TP 2 - CLP cohort Placebo to AIN457 300 mg Q2W - TP 2 - CLP cohort
    Number of subjects analysed
    12
    25
    10
    Units: participants
        Baseline 0 Score
    0
    0
    0
        Baseline 1 score
    0
    3
    0
        Baseline 2 score
    0
    6
    0
        Baseline 3 score
    3
    6
    0
        Baseline 4 score
    6
    5
    0
        Baseline 5 score
    3
    5
    0
        Week 2 0 score
    0
    0
    0
        Week 2 1 score
    0
    6
    0
        Week 2 2 score
    1
    5
    0
        Week 2 3 score
    3
    9
    0
        Week 2 4 score
    5
    3
    0
        Week 2 5 score
    3
    2
    0
        Week 4 0 score
    0
    0
    0
        Week 4 1 score
    0
    3
    0
        Week 4 2 score
    0
    8
    0
        Week 4 3 score
    3
    8
    0
        Week 4 4 score
    5
    3
    0
        Week 4 5 score
    3
    2
    0
        Week 8 0 score
    0
    0
    0
        Week 8 1 score
    1
    7
    0
        Week 8 2 score
    1
    5
    0
        Week 8 3 score
    2
    7
    0
        Week 8 4 score
    4
    4
    0
        Week 8 5 score
    3
    2
    0
        Week 12 0 score
    0
    0
    0
        Week 12 1 score
    1
    6
    0
        Week 12 2 score
    2
    7
    0
        Week 12 3 score
    0
    7
    0
        Week 12 4 score
    7
    3
    0
        Week 12 5 score
    2
    2
    0
        Week 16 0 score
    0
    0
    0
        Week 16 1 score
    2
    4
    0
        Week 16 2 score
    3
    12
    3
        Week 16 3 score
    3
    5
    3
        Week 16 4 score
    4
    2
    4
        Week 16 5 score
    0
    2
    0
        Week 20 0 score
    0
    0
    0
        Week 20 1 score
    0
    6
    0
        Week 20 2 score
    0
    12
    3
        Week 20 3 score
    0
    3
    2
        Week 20 4 score
    0
    1
    3
        Week 20 5 score
    0
    2
    2
        Week 24 0 score
    0
    1
    0
        Week 24 1 score
    0
    8
    0
        Week 24 2 score
    0
    10
    2
        Week 24 3 score
    0
    1
    2
        Week 24 4 score
    0
    2
    4
        Week 24 5 score
    0
    3
    2
        Week 28 0 score
    0
    0
    0
        Week 28 1 score
    0
    6
    0
        Week 28 2 score
    0
    11
    2
        Week 28 3 score
    0
    1
    3
        Week 28 4 score
    0
    3
    3
        Week 28 5 score
    0
    2
    2
        Week 32 0 score
    0
    2
    0
        Week 32 1 score
    0
    5
    1
        Week 32 2 score
    0
    10
    0
        Week 32 3 score
    0
    3
    4
        Week 32 4 score
    0
    1
    2
        Week 32 5 score
    0
    3
    2
    No statistical analyses for this end point

    Secondary: Number (%) of subjects with Dermatology Life Quality Index response (DLQI 0/1) up to Week 32 - CLP cohort - Entire treatment period (FAS)

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    End point title
    		 Number (%) of subjects with Dermatology Life Quality Index response (DLQI 0/1) up to Week 32 - CLP cohort - Entire treatment period (FAS) [6]
    End point description
    The DLQI is a 10-item general dermatology disability index designed to assess health-related quality of life (HRQoL) in adult subjects with skin diseases such as eczema, psoriasis, acne, and viral warts (Finlay and Khan 1994). The measure is self-administered and includes domains of daily activities, leisure, personal relationships, symptoms and feelings, treatment, and work/school. The recall period is the last week, and the instrument requires 1 to 2 minutes for completion. Each item has four response categories ranging from 0 (not at all) to 3 (very much). “Not relevant” is also a valid response and is scored as 0. The DLQI total score is a sum of the 10 questions. Scores range from 0 to 30, with higher scores indicating greater HRQoL impairment.
    End point type
    Secondary
    End point timeframe
    Baseline up to week 32
    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: Endpoints reported by cohort.
    End point values
    		 Placebo - TP 1 - CLP cohort AIN457 300 mg Q4W - TP 1 and TP 2 - CLP cohort Placebo to AIN457 300 mg Q2W - TP 2 - CLP cohort
    Number of subjects analysed
    12
    25
    10
    Units: participants
        Baseline n=25,12,0
    0
    0
    0
        Week 4 n=24,11,0
    0
    2
    0
        Week 8 n=25,11,0
    0
    2
    0
        Week 12 n=25,12,0
    1
    3
    0
        Week 16 n=25,12,10
    2
    3
    2
        Week 20 n=24,0,10
    0
    3
    1
        Week 24 n=25,0,10
    0
    4
    1
        Week 28 n=23,0,10
    0
    3
    1
        Week 32 n=25,0,9
    0
    2
    1
    No statistical analyses for this end point

    Secondary: Number (%) of subjects with Dermatology Life Quality Index response (DLQI 0/1) up to Week 32 - MLP cohort - Entire treatment period (FAS)

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    End point title
    		 Number (%) of subjects with Dermatology Life Quality Index response (DLQI 0/1) up to Week 32 - MLP cohort - Entire treatment period (FAS) [7]
    End point description
    The DLQI is a 10-item general dermatology disability index designed to assess health-related quality of life (HRQoL) in adult subjects with skin diseases such as eczema, psoriasis, acne, and viral warts (Finlay and Khan 1994). The measure is self-administered and includes domains of daily activities, leisure, personal relationships, symptoms and feelings, treatment, and work/school. The recall period is the last week, and the instrument requires 1 to 2 minutes for completion. Each item has four response categories ranging from 0 (not at all) to 3 (very much). “Not relevant” is also a valid response and is scored as 0. The DLQI total score is a sum of the 10 questions. Scores range from 0 to 30, with higher scores indicating greater HRQoL impairment.
    End point type
    Secondary
    End point timeframe
    Baseline up to week 32
    Notes
    [7] - 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: Endpoints reported by cohort.
    End point values
    		 Placebo - TP 1 - MLP cohort AIN457 300 mg Q4W - TP 1 and TP 2 - MLP cohort Placebo to AIN457 300 mg Q2W TP 2 - MLP cohort
    Number of subjects analysed
    13
    24
    11
    Units: participants
        Baseline n=24,13,0
    0
    0
    0
        Week 4 n=24,13,0
    1
    2
    0
        Week 8 n=24,13,0
    1
    4
    0
        Week 12 n=24,13,0
    2
    4
    0
        Week 16 n=24,13,11
    3
    5
    2
        Week 20 n=24,0,11
    0
    7
    2
        Week 24 n=24,0,10
    0
    7
    3
        Week 28 n=23,0,11
    0
    3
    2
        Week 32 n=23,0,10
    0
    4
    2
    No statistical analyses for this end point

    Secondary: Number (%) of subjects with Dermatology Life Quality Index response (DLQI 0/1) up to Week 32 - LPP cohort - Entire treatment period (FAS)

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    End point title
    		 Number (%) of subjects with Dermatology Life Quality Index response (DLQI 0/1) up to Week 32 - LPP cohort - Entire treatment period (FAS) [8]
    End point description
    The DLQI is a 10-item general dermatology disability index designed to assess health-related quality of life (HRQoL) in adult subjects with skin diseases such as eczema, psoriasis, acne, and viral warts (Finlay and Khan 1994). The measure is self-administered and includes domains of daily activities, leisure, personal relationships, symptoms and feelings, treatment, and work/school. The recall period is the last week, and the instrument requires 1 to 2 minutes for completion. Each item has four response categories ranging from 0 (not at all) to 3 (very much). “Not relevant” is also a valid response and is scored as 0. The DLQI total score is a sum of the 10 questions. Scores range from 0 to 30, with higher scores indicating greater HRQoL impairment.
    End point type
    Secondary
    End point timeframe
    Baseline up to week 32
    Notes
    [8] - 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: Endpoints reported by cohort.
    End point values
    		 Placebo - TP 1 - LPP cohort AIN457 300 mg Q4W - TP 1 and TP 2 - LPP cohort Placebo to AIN457 300 mg Q2W - TP 2 - LPP cohort
    Number of subjects analysed
    13
    24
    13
    Units: participants
        Baseline n=24,13,0
    0
    0
    0
        Week 4 n=24,13,0
    1
    3
    0
        Week 8 n=24,13,0
    1
    3
    0
        Week 12 n=24,13,0
    2
    2
    0
        Week 16 n=24,13,13
    1
    2
    1
        Week 20 n=24,0,13
    0
    4
    3
        Week 24 n=23,0,13
    0
    2
    3
        Week 28 n=24,0,13
    0
    2
    2
        Week 32 n=24,0,11
    0
    1
    3
    No statistical analyses for this end point

    Secondary: Summary of baseline score and change from baseline for Patient Assessment of Itch using numeric rating scale (NRS) by question – CLP cohort (BOCF) (FAS)

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    End point title
    		 Summary of baseline score and change from baseline for Patient Assessment of Itch using numeric rating scale (NRS) by question – CLP cohort (BOCF) (FAS) [9]
    End point description
    Itch is assessed with the following questions: • "Overall, how severe was your lichen planus-related itching during the past 24 hours?" • "How severe was your lichen planus-related itching at the worst moment during the past 24 hours?" • "Overall, how bothered were you by your lichen planus-related itching during the past 24 hours?" Answers are given on a numeric rating scale (NRS) from 0 to 10, with 0 meaning "no itch" and 10 meaning "the worst itch imaginable".
    End point type
    Secondary
    End point timeframe
    Baseline, Week 16 and Week 32
    Notes
    [9] - 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: Endpoints reported by cohort.
    End point values
    		 Placebo - TP 1 - CLP cohort AIN457 300 mg Q4W - TP 1 and TP 2 - CLP cohort Placebo to AIN457 300 mg Q2W - TP 2 - CLP cohort
    Number of subjects analysed
    12
    25
    10
    Units: scores on a scale
    arithmetic mean (standard deviation)
        Baseline - Question 1
    5.7 ( 2.77 )
    5.1 ( 2.66 )
    5.8 ( 3.01 )
        Week 16 Severity of itch n=25,12,10
    -2.3 ( 3.25 )
    -0.8 ( 1.91 )
    -2.0 ( 3.53 )
        Week 32 Severity of itch n=25,0,9
    999 ( 999 )
    -1.5 ( 2.24 )
    -1.1 ( 2.42 )
        Baseline- Question 2
    6.3 ( 2.86 )
    5.6 ( 2.72 )
    5.9 ( 3.03 )
        Week 16 How severe at worst moment n=25,12,10
    -2.7 ( 3.73 )
    -0.9 ( 2.52 )
    -1.9 ( 3.54 )
        Week 32 How severe st worst moment n=25,0,9
    999 ( 999 )
    -1.3 ( 2.13 )
    -1.2 ( 2.49 )
        Baseline- Question 3
    6.1 ( 2.94 )
    4.8 ( 3.08 )
    6.1 ( 3.21 )
        Week 16 How bothered by Itch n=25,12,10
    -2.7 ( 3.55 )
    -1.0 ( 2.65 )
    -2.4 ( 3.84 )
        Week 32 How bothered by Itch n=25,0,9
    999 ( 999 )
    -1.1 ( 2.45 )
    -1.2 ( 2.28 )
    No statistical analyses for this end point

    Secondary: Summary of baseline score and change from baseline for Patient Assessment of Itch using numeric rating scale (NRS) by question – MLP cohort (BOCF) (FAS)

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    End point title
    		 Summary of baseline score and change from baseline for Patient Assessment of Itch using numeric rating scale (NRS) by question – MLP cohort (BOCF) (FAS) [10]
    End point description
    Itch is assessed with the following questions: • "Overall, how severe was your lichen planus-related itching during the past 24 hours?" • "How severe was your lichen planus-related itching at the worst moment during the past 24 hours?" • "Overall, how bothered were you by your lichen planus-related itching during the past 24 hours?" Answers are given on a numeric rating scale (NRS) from 0 to 10, with 0 meaning "no itch" and 10 meaning "the worst itch imaginable".
    End point type
    Secondary
    End point timeframe
    Baseline, Week 16 and Week 32
    Notes
    [10] - 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: Endpoints reported by cohort.
    End point values
    		 Placebo - TP 1 - MLP cohort AIN457 300 mg Q4W - TP 1 and TP 2 - MLP cohort Placebo to AIN457 300 mg Q2W TP 2 - MLP cohort
    Number of subjects analysed
    13
    24
    13
    Units: scores on a scale
    arithmetic mean (standard deviation)
        Baseline - Question 1 n=24,13,11
    3.8 ( 3.81 )
    2.5 ( 2.83 )
    4.3 ( 3.93 )
        Week 16 Severity of itch n=23,13,11
    -0.2 ( 3.41 )
    -0.3 ( 3.26 )
    -0.3 ( 3.72 )
        Week 32 Severity of itch n=22,0,10
    999 ( 999 )
    0.1 ( 2.97 )
    -0.4 ( 3.37 )
        Baseline - Question 2 n=24,13,11
    3.6 ( 3.99 )
    2.4 ( 2.90 )
    4.1 ( 4.16 )
        Week 16 How severe at worst moment n=23,13,11
    0.4 ( 3.25 )
    0.8 ( 3.04 )
    0.4 ( 3.56 )
        Week 32 How severe at worst moment n=22,0,10
    999 ( 999 )
    0.3 ( 2.43 )
    0.4 ( 3.81 )
        Baseline - Question 3 n=24,13,11
    4.0 ( 4.14 )
    3.4 ( 3.41 )
    4.5 ( 4.27 )
        Week 16 How bothered by Itch n=23,13,11
    0.1 ( 3.12 )
    -0.5 ( 2.95 )
    0.0 ( 3.41 )
        Week 32 How bothered by Itch n=22,0,10
    999 ( 999 )
    -0.4 ( 1.33 )
    -0.4 ( 4.25 )
    No statistical analyses for this end point

    Secondary: Summary of baseline score and change from baseline for Patient Assessment of Itch using numeric rating scale (NRS) by question – LPP cohort (BOCF) (FAS)

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    End point title
    		 Summary of baseline score and change from baseline for Patient Assessment of Itch using numeric rating scale (NRS) by question – LPP cohort (BOCF) (FAS) [11]
    End point description
    Itch is assessed with the following questions: • "Overall, how severe was your lichen planus-related itching during the past 24 hours?" • "How severe was your lichen planus-related itching at the worst moment during the past 24 hours?" • "Overall, how bothered were you by your lichen planus-related itching during the past 24 hours?" Answers are given on a numeric rating scale (NRS) from 0 to 10, with 0 meaning "no itch" and 10 meaning "the worst itch imaginable".
    End point type
    Secondary
    End point timeframe
    Baseline, Week 16 and Week 32
    Notes
    [11] - 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: Endpoints reported by cohort.
    End point values
    		 Placebo - TP 1 - LPP cohort AIN457 300 mg Q4W - TP 1 and TP 2 - LPP cohort Placebo to AIN457 300 mg Q2W - TP 2 - LPP cohort
    Number of subjects analysed
    13
    24
    12
    Units: scores on a scale
    arithmetic mean (standard deviation)
        Baseline - Question 1 n=24,13,12
    3.8 ( 3.81 )
    2.5 ( 2.83 )
    4.3 ( 3.93 )
        Week 16 Severity of itch n=24,13,11
    -1.1 ( 2.47 )
    -0.5 ( 2.25 )
    -1.1 ( 2.47 )
        Week 32 Severity of itch n=24,0,11
    999 ( 999 )
    -1.6 ( 2.06 )
    -2.4 ( 2.84 )
        Baseline - Question 2 n=24,13,11
    3.6 ( 3.99 )
    2.4 ( 2.90 )
    4.1 ( 4.16 )
        Week 16 How severe at worst moment n=24,13,11
    -1.3 ( 2.81 )
    -0.7 ( 2.35 )
    -1.3 ( 2.81 )
        Week 32 How severe at worst moment n=24,0,11
    999 ( 999 )
    -1.8 ( 2.23 )
    -2.6 ( 3.01 )
        Baseline - Question 3 n=24,13,11
    4.0 ( 4.14 )
    3.4 ( 3.41 )
    4.5 ( 4.27 )
        Week 16 How bothered by Itch n=24,13,11
    -1.2 ( 3.02 )
    -0.4 ( 2.43 )
    -1.2 ( 3.02 )
        Week 32 How bothered by Itch n=24,0,11
    999 ( 999 )
    -1.7 ( 2.08 )
    -2.2 ( 2.44 )
    No statistical analyses for this end point

    Secondary: Summary of baseline score and change from baseline for Patient Assessment of Pain using numeric rating scale (NRS) by question – CLP cohort (BOCF) (FAS)

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    End point title
    		 Summary of baseline score and change from baseline for Patient Assessment of Pain using numeric rating scale (NRS) by question – CLP cohort (BOCF) (FAS) [12]
    End point description
    Pain is assessed with the following questions: • "Overall, how severe was your lichen planus-related pain during the past 24 hours?" • "How severe was your lichen planus-related pain at the worst moment during the past 24 hours?" • "Overall, how bothered were you by your lichen planus-related pain during the past 24 hours?" Answers are given on a numeric rating scale (NRS) from 0 to 10, with 0 meaning "no pain" and 10 meaning "the worst pain imaginable".
    End point type
    Secondary
    End point timeframe
    Baseline, Week 16 and Week 32
    Notes
    [12] - 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: Endpoints reported by cohort.
    End point values
    		 Placebo - TP 1 - CLP cohort AIN457 300 mg Q4W - TP 1 and TP 2 - CLP cohort Placebo to AIN457 300 mg Q2W - TP 2 - CLP cohort
    Number of subjects analysed
    12
    25
    10
    Units: scores on a scale
    arithmetic mean (standard deviation)
        Baseline - Question 1 n=25,12,10
    3.4 ( 2.61 )
    1.09 ( 2.05 )
    3.5 ( 2.51 )
        Week 16 Severity of pain n=25,12,10
    -0.8 ( 1.40 )
    0.2 ( 1.48 )
    -0.8 ( 1.48 )
        Week 32 Severity of pain n=25,0,9
    999 ( 999 )
    -0.3 ( 1.65 )
    -0.3 ( 2.29 )
        Baseline - Question 2 n=25,12,10
    3.9 ( 3.23 )
    2.2 ( 2.48 )
    3.9 ( 3.03 )
        Week 16 How severe at worst moment n=25,12,10
    -1.2 ( 1.70 )
    0.1 ( 2.03 )
    -1.0 ( 1.56 )
        Week 32 How severe at worst moment n=25,0,9
    999 ( 999 )
    -0.4 ( 2.35 )
    -0.4 ( 2.70 )
        Baseline - Question 3 n=25,12,10
    3.7 ( 2.96 )
    2.1 ( 2.55 )
    3.8 ( 2.94 )
        Week 16 How bothered by pain n=25,12,10
    -0.6 ( 1.62 )
    0.1 ( 2.09 )
    0.5 ( 1.72 )
        Week 32 How bothered by pain n=25, 0,9
    999 ( 999 )
    -0.2 ( 1.71 )
    -0.3 ( 2.45 )
    No statistical analyses for this end point

    Secondary: Summary of baseline score and change from baseline for Patient Assessment of Pain using numeric rating scale (NRS) by question –MLP cohort (BOCF) (FAS)

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    End point title
    		 Summary of baseline score and change from baseline for Patient Assessment of Pain using numeric rating scale (NRS) by question –MLP cohort (BOCF) (FAS) [13]
    End point description
    Pain is assessed with the following questions: • "Overall, how severe was your lichen planus-related pain during the past 24 hours?" • "How severe was your lichen planus-related pain at the worst moment during the past 24 hours?" • "Overall, how bothered were you by your lichen planus-related pain during the past 24 hours?" Answers are given on a numeric rating scale (NRS) from 0 to 10, with 0 meaning "no pain" and 10 meaning "the worst pain imaginable".
    End point type
    Secondary
    End point timeframe
    Baseline, Week 16 and Week 32
    Notes
    [13] - 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: Endpoints reported by cohort.
    End point values
    		 Placebo - TP 1 - MLP cohort AIN457 300 mg Q4W - TP 1 and TP 2 - MLP cohort Placebo to AIN457 300 mg Q2W TP 2 - MLP cohort
    Number of subjects analysed
    13
    24
    11
    Units: scores on a scale
    arithmetic mean (standard deviation)
        Baseline - Question 1 n=24,13,11
    5.9 ( 3.09 )
    5.1 ( 2.86 )
    6.3 ( 3.23 )
        Week 16 Severity of pain n=24,13,11
    -0.1 ( 3.01 )
    -0.5 ( 3.08 )
    0.0 ( 3.29 )
        Week 32 Severity of pain n=23,0,10
    999 ( 999 )
    -0.3 ( 2.18 )
    -0.6 ( 2.59 )
        Baseline - Question 2 n=24,13,11
    6.4 ( 3.15 )
    5.4 ( 2.99 )
    6.7 ( 3.26 )
        Week 16 How severe at worst moment n=24,13,11
    -0.3 ( 2.75 )
    -0.5 ( 3.13 )
    -0.2 ( 2.99 )
        Week 32 How severe at worst moment n=23,0,10
    999 ( 999 )
    -0.3 ( 2.06 )
    -0.5 ( 2.46 )
        Baseline - Question 3 n=24,13,11
    6.5 ( 2.76 )
    5.5 ( 3.35 )
    6.8 ( 2.79 )
        Week 16 How bothered by pain n=24,13,11
    -0.3 ( 2.21 )
    -0.8 ( 3.54 )
    -0.1 ( 2.34 )
        Week 32 How bothered by pain n=23,0,10
    999 ( 999 )
    -0.5 ( 2.74 )
    -0.9 ( 2.69 )
    No statistical analyses for this end point

    Secondary: Summary of baseline score and change from baseline for Patient Assessment of Pain using numeric rating scale (NRS) by question – LPP cohort (BOCF) (FAS)

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    End point title
    		 Summary of baseline score and change from baseline for Patient Assessment of Pain using numeric rating scale (NRS) by question – LPP cohort (BOCF) (FAS) [14]
    End point description
    Pain is assessed with the following questions: • "Overall, how severe was your lichen planus-related pain during the past 24 hours?" • "How severe was your lichen planus-related pain at the worst moment during the past 24 hours?" • "Overall, how bothered were you by your lichen planus-related pain during the past 24 hours?" Answers are given on a numeric rating scale (NRS) from 0 to 10, with 0 meaning "no pain" and 10 meaning "the worst pain imaginable".
    End point type
    Secondary
    End point timeframe
    Baseline, Week 16 and Week 32
    Notes
    [14] - 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: Endpoints reported by cohort.
    End point values
    		 Placebo - TP 1 - LPP cohort AIN457 300 mg Q4W - TP 1 and TP 2 - LPP cohort Placebo to AIN457 300 mg Q2W - TP 2 - LPP cohort
    Number of subjects analysed
    13
    24
    12
    Units: scores on a scale
    arithmetic mean (standard deviation)
        Baseline - Question 1 n=24,13,12
    2.0 ( 2.38 )
    2.5 ( 2.43 )
    2.0 ( 2.38 )
        Week 16 Severity of pain past 24 hours n=24,13,12
    -0.5 ( 1.90 )
    0.3 ( 2.61 )
    -0.5 ( 1.90 )
        Week 32 Severity of pain p ast 24 hours n=24,0,11
    999 ( 999 )
    -0.6 ( 1.72 )
    -1.5 ( 2.02 )
        Baseline - Question 2 24,13,12
    2.5 ( 2.73 )
    2.8 ( 2.68 )
    2.5 ( 2.73 )
        Week 16 How severe at worst moment n=24,13,12
    -0.9 ( 2.25 )
    0.2 ( 3.16 )
    -0.9 ( 2.25 )
        Week 32 How severe at worst moment n=24,0,11
    999 ( 999 )
    -0.8 ( 2.06 )
    -2.0 ( 2.45 )
        Baseline - Question 3 n=24,13,12
    2.4 ( 2.75 )
    2.7 ( 2.56 )
    2.4 ( 2.75 )
        Week 16 How bothered by pain n=24,13,12
    -1.1 ( 2.25 )
    0.0 ( 2.87 )
    -1.1 ( 2.25 )
        Week 32 How bothered by pain n=24,0,11
    999 ( 999 )
    -0.8 ( 1.79 )
    -1.9 ( 2.51 )
    No statistical analyses for this end point

    Secondary: Summary of baseline score and change from baseline in Oral Lichen Planus Symptom Severity Measure (OLPSSM) - MLP Cohort - (BOCF) – Entire treatment period

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    End point title
    		 Summary of baseline score and change from baseline in Oral Lichen Planus Symptom Severity Measure (OLPSSM) - MLP Cohort - (BOCF) – Entire treatment period [15]
    End point description
    OLPSSM is a self-administered assessment of the symptom experience of subjects with oral LP in clinical studies. It includes 7 triggers contributing to soreness of oral lichen planus: Brushing teeth, eating food, drinking liquids, smiling, breathing through mouth, talking and touching. These 7 items contributed equally to a total OLP symptom severity score, ranging from 0 to 28, with higher scores indicating worse severity.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 16 and Week 32
    Notes
    [15] - 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: Endpoints reported by cohort.
    End point values
    		 Placebo - TP 1 - MLP cohort AIN457 300 mg Q4W - TP 1 and TP 2 - MLP cohort Placebo to AIN457 300 mg Q2W TP 2 - MLP cohort
    Number of subjects analysed
    12
    21
    10
    Units: scores on a scale
    arithmetic mean (standard deviation)
        Baseline n=21,12,10
    13.4 ( 5.50 )
    11.0 ( 5.98 )
    13.9 ( 5.78 )
        Week 16 n=21,12,10
    0.8 ( 6.47 )
    -1.0 ( 6.82 )
    -0.4 ( 7.09 )
        Week 32 n=20,0,9
    999 ( 999 )
    -1.8 ( 5.67 )
    -0.7 ( 7.00 )
    No statistical analyses for this end point

    Secondary: Summary of baseline score and change from baseline in Reticular Erythematous Ulcerative score (REU) - MLP Cohort - (BOCF) – Entire treatment period

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    End point title
    		 Summary of baseline score and change from baseline in Reticular Erythematous Ulcerative score (REU) - MLP Cohort - (BOCF) – Entire treatment period [16]
    End point description
    REU measured disease severity based on 3 dimensions: reticulation, erythema and ulceration for all subjects in the MLP cohort who had an oral presentation of the disease. The total score ranged from 0-115 with higher values corresponding to higher activity of the disease.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 16 and Week 32
    Notes
    [16] - 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: Endpoints are reported by cohort.
    End point values
    		 Placebo - TP 1 - MLP cohort AIN457 300 mg Q4W - TP 1 and TP 2 - MLP cohort Placebo to AIN457 300 mg Q2W TP 2 - MLP cohort
    Number of subjects analysed
    13
    21
    10
    Units: scores on a scale
    arithmetic mean (standard deviation)
        Baseline n=21,12,10
    25.29 ( 9.102 )
    21.31 ( 8.747 )
    26.95 ( 8.855 )
        Week 16 n=21,12,10
    -5.79 ( 14.476 )
    -4.83 ( 11.102 )
    -4.10 ( 15.196 )
        Week 32 n=20,0,9
    999 ( 999 )
    -6.08 ( 10.206 )
    -2.17 ( 15.802 )
    No statistical analyses for this end point

    Secondary: Summary of baseline score and change from baseline for Lichen Planopilaris Activity Index (LPPAI)– LPP cohort (BOCF) (FAS)

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    End point title
    		 Summary of baseline score and change from baseline for Lichen Planopilaris Activity Index (LPPAI)– LPP cohort (BOCF) (FAS) [17]
    End point description
    The LPPAI assesses symptoms (pruritus, pain, burning), signs (erythema, perifollicular erythema and scale), a measure of activity (pull test) and extension of disease. These subjective and objective measures are assigned numeric values to establish a disease activity score. The total score ranges from 0 to 10, with higher scores corresponding to higher disease activity
    End point type
    Secondary
    End point timeframe
    Baseline, Week 16 and Week 32
    Notes
    [17] - 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: Endpoints reported by cohort.
    End point values
    		 Placebo - TP 1 - LPP cohort AIN457 300 mg Q4W - TP 1 and TP 2 - LPP cohort Placebo to AIN457 300 mg Q2W - TP 2 - LPP cohort
    Number of subjects analysed
    13
    24
    13
    Units: scores on a scale
    arithmetic mean (standard deviation)
        Baseline n=24,13,13
    5.95 ( 1.767 )
    5.92 ( 2.071 )
    5.95 ( 1.767 )
        Week 16 n=24,13,13
    -2.24 ( 2.522 )
    -1.44 ( 2.517 )
    -2.24 ( 2.522 )
        Week 32 n=24,0,13
    999 ( 999 )
    -2.44 ( 2.428 )
    -3.20 ( 2.927 )
    No statistical analyses for this end point

    Secondary: Summary of baseline score and change from baseline for Scalpdex – LPP cohort (BOCF) (FAS)

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    End point title
    		 Summary of baseline score and change from baseline for Scalpdex – LPP cohort (BOCF) (FAS) [18]
    End point description
    Scalpdex is a self-administered, health-related quality of life instrument originally developed for scalp dermatitis. This survey includes 23 items, each item scored on a scale of 0-100, where 0=never, 25=rarely, 50=sometimes, 75=often and 100=all the time. The 23 items pertain to 3 domains: symptom, emotions and functioning. Subjects were asked to score themselves on how true each of the 23 statements has been for them over the past four weeks. the total score is the average of the scores of the 23 items. A higher total score indicated a higher impairment in quality of life.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 16 and Week 32
    Notes
    [18] - 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: Endpoints reported by cohort.
    End point values
    		 Placebo - TP 1 - LPP cohort AIN457 300 mg Q4W - TP 1 and TP 2 - LPP cohort Placebo to AIN457 300 mg Q2W - TP 2 - LPP cohort
    Number of subjects analysed
    13
    24
    12
    Units: scores on a scale
    arithmetic mean (standard deviation)
        Baseline n=24,13,12
    54.01 ( 23.252 )
    55.75 ( 16.476 )
    54.01 ( 23.252 )
        Week 16 n=24,13,12
    -6.94 ( 11.508 )
    1.86 ( 10.695 )
    -6.94 ( 11.508 )
        Week 32 n=24,0,11
    999 ( 999 )
    -4.26 ( 12.876 )
    -14.43 ( 16.464 )
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Adverse events were reported from first dose of study treatment up to a maximum of 300 days which included an approximate follow up period of 8 weeks for AIN457 treatment groups.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    25.0
    Reporting groups
    Reporting group title
    Placebo to AIN457 300mg Q2W – CLP cohort
    Reporting group description
    		 Placebo non-responders during TP1 received AIN457 300mg every 2 weeks from Week 16 to Week 32 in TP2 via a pre-filled syringe

    Reporting group title
    AIN457 300mg Q4W – CLP cohort
    Reporting group description
    		 AIN457 300mg every 4 weeks up to 32 Weeks administered via a pre-filled syringe

    Reporting group title
    Any AIN457 300mg – CLP cohort
    Reporting group description
    		 AIN457 300mg administered every 4 weeks or every 2 weeks via a pre-filled syringe

    Reporting group title
    Any AIN457 300mg – MLP cohort
    Reporting group description
    		 AIN457 300mg administered every 4 weeks or every 2 weeks via a pre-filled syringe

    Reporting group title
    Placebo – MLP cohort
    Reporting group description
    		 Matching placebo administered every 4 weeks up to 16 Weeks via a pre-filled syringe

    Reporting group title
    AIN457 300mg Q4W – LPP cohort
    Reporting group description
    		 AIN457 300mg every 4 weeks up to 32 Weeks administered via a pre-filled syringe

    Reporting group title
    Placebo to AIN457 300mg Q2W – LPP cohort
    Reporting group description
    		 Placebo non-responders during TP1 received AIN457 300mg every 2 weeks from Week 16 to Week 32 in TP2 via a pre-filled syringe

    Reporting group title
    Any AIN457 300mg – LPP cohort
    Reporting group description
    		 AIN457 300mg administered every 4 weeks or every 2 weeks via a pre-filled syringe

    Reporting group title
    Placebo – LPP cohort
    Reporting group description
    		 Matching placebo administered every 4 weeks up to 16 Weeks via a pre-filled syringe

    Reporting group title
    AIN457 300mg Q4W – MLP cohort
    Reporting group description
    		 AIN457 300mg every 4 weeks up to 32 Weeks administered via a pre-filled syringe

    Reporting group title
    Placebo – CLP cohort
    Reporting group description
    		 Matching placebo administered every 4 weeks up to 16 Weeks via a pre-filled syringe

    Reporting group title
    Placebo to AIN457 300mg Q2W – MLP cohort
    Reporting group description
    		 Placebo non-responders during TP1 received AIN457 300mg every 2 weeks from Week 16 to Week 32 in TP2 via a pre-filled syringe

    Serious adverse events
    		 Placebo to AIN457 300mg Q2W – CLP cohort AIN457 300mg Q4W – CLP cohort Any AIN457 300mg – CLP cohort Any AIN457 300mg – MLP cohort Placebo – MLP cohort AIN457 300mg Q4W – LPP cohort Placebo to AIN457 300mg Q2W – LPP cohort Any AIN457 300mg – LPP cohort Placebo – LPP cohort AIN457 300mg Q4W – MLP cohort Placebo – CLP cohort Placebo to AIN457 300mg Q2W – MLP cohort
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 8 (0.00%)
    0 / 25 (0.00%)
    0 / 33 (0.00%)
    2 / 35 (5.71%)
    0 / 13 (0.00%)
    0 / 24 (0.00%)
    1 / 12 (8.33%)
    1 / 36 (2.78%)
    1 / 13 (7.69%)
    1 / 24 (4.17%)
    1 / 12 (8.33%)
    1 / 11 (9.09%)
         number of deaths (all causes)
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Adenocarcinoma of colon
         subjects affected / exposed
    0 / 8 (0.00%)
    0 / 25 (0.00%)
    0 / 33 (0.00%)
    0 / 35 (0.00%)
    0 / 13 (0.00%)
    0 / 24 (0.00%)
    0 / 12 (0.00%)
    0 / 36 (0.00%)
    0 / 13 (0.00%)
    0 / 24 (0.00%)
    1 / 12 (8.33%)
    0 / 11 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cardiac disorders
    Angina pectoris
         subjects affected / exposed
    0 / 8 (0.00%)
    0 / 25 (0.00%)
    0 / 33 (0.00%)
    0 / 35 (0.00%)
    0 / 13 (0.00%)
    0 / 24 (0.00%)
    0 / 12 (0.00%)
    0 / 36 (0.00%)
    1 / 13 (7.69%)
    0 / 24 (0.00%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Nervous system disorders
    Neuralgia
         subjects affected / exposed
    0 / 8 (0.00%)
    0 / 25 (0.00%)
    0 / 33 (0.00%)
    0 / 35 (0.00%)
    0 / 13 (0.00%)
    0 / 24 (0.00%)
    1 / 12 (8.33%)
    1 / 36 (2.78%)
    0 / 13 (0.00%)
    0 / 24 (0.00%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Colitis ulcerative
         subjects affected / exposed
    0 / 8 (0.00%)
    0 / 25 (0.00%)
    0 / 33 (0.00%)
    1 / 35 (2.86%)
    0 / 13 (0.00%)
    0 / 24 (0.00%)
    0 / 12 (0.00%)
    0 / 36 (0.00%)
    0 / 13 (0.00%)
    1 / 24 (4.17%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    1 / 1
    0 / 0
    0 / 0
    0 / 0
    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
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Pleurisy
         subjects affected / exposed
    0 / 8 (0.00%)
    0 / 25 (0.00%)
    0 / 33 (0.00%)
    1 / 35 (2.86%)
    0 / 13 (0.00%)
    0 / 24 (0.00%)
    0 / 12 (0.00%)
    0 / 36 (0.00%)
    0 / 13 (0.00%)
    1 / 24 (4.17%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    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
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Osteoarthritis
         subjects affected / exposed
    0 / 8 (0.00%)
    0 / 25 (0.00%)
    0 / 33 (0.00%)
    1 / 35 (2.86%)
    0 / 13 (0.00%)
    0 / 24 (0.00%)
    0 / 12 (0.00%)
    0 / 36 (0.00%)
    0 / 13 (0.00%)
    0 / 24 (0.00%)
    0 / 12 (0.00%)
    1 / 11 (9.09%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    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
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Placebo to AIN457 300mg Q2W – CLP cohort AIN457 300mg Q4W – CLP cohort Any AIN457 300mg – CLP cohort Any AIN457 300mg – MLP cohort Placebo – MLP cohort AIN457 300mg Q4W – LPP cohort Placebo to AIN457 300mg Q2W – LPP cohort Any AIN457 300mg – LPP cohort Placebo – LPP cohort AIN457 300mg Q4W – MLP cohort Placebo – CLP cohort Placebo to AIN457 300mg Q2W – MLP cohort
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    6 / 8 (75.00%)
    15 / 25 (60.00%)
    21 / 33 (63.64%)
    26 / 35 (74.29%)
    8 / 13 (61.54%)
    16 / 24 (66.67%)
    6 / 12 (50.00%)
    22 / 36 (61.11%)
    7 / 13 (53.85%)
    18 / 24 (75.00%)
    7 / 12 (58.33%)
    8 / 11 (72.73%)
    Vascular disorders
    Hypertension
         subjects affected / exposed
    0 / 8 (0.00%)
    2 / 25 (8.00%)
    2 / 33 (6.06%)
    1 / 35 (2.86%)
    1 / 13 (7.69%)
    1 / 24 (4.17%)
    1 / 12 (8.33%)
    2 / 36 (5.56%)
    2 / 13 (15.38%)
    1 / 24 (4.17%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
         occurrences all number
    0
    2
    2
    1
    1
    1
    1
    2
    2
    1
    0
    0
    General disorders and administration site conditions
    Fatigue
         subjects affected / exposed
    0 / 8 (0.00%)
    1 / 25 (4.00%)
    1 / 33 (3.03%)
    0 / 35 (0.00%)
    0 / 13 (0.00%)
    2 / 24 (8.33%)
    0 / 12 (0.00%)
    2 / 36 (5.56%)
    0 / 13 (0.00%)
    0 / 24 (0.00%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
         occurrences all number
    0
    1
    1
    0
    0
    4
    0
    4
    0
    0
    0
    0
    Asthenia
         subjects affected / exposed
    1 / 8 (12.50%)
    0 / 25 (0.00%)
    1 / 33 (3.03%)
    0 / 35 (0.00%)
    0 / 13 (0.00%)
    1 / 24 (4.17%)
    0 / 12 (0.00%)
    1 / 36 (2.78%)
    0 / 13 (0.00%)
    0 / 24 (0.00%)
    1 / 12 (8.33%)
    0 / 11 (0.00%)
         occurrences all number
    1
    0
    1
    0
    0
    1
    0
    1
    0
    0
    1
    0
    Injection site haemorrhage
         subjects affected / exposed
    0 / 8 (0.00%)
    0 / 25 (0.00%)
    0 / 33 (0.00%)
    0 / 35 (0.00%)
    0 / 13 (0.00%)
    0 / 24 (0.00%)
    0 / 12 (0.00%)
    0 / 36 (0.00%)
    1 / 13 (7.69%)
    0 / 24 (0.00%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    Pyrexia
         subjects affected / exposed
    0 / 8 (0.00%)
    0 / 25 (0.00%)
    0 / 33 (0.00%)
    0 / 35 (0.00%)
    0 / 13 (0.00%)
    2 / 24 (8.33%)
    0 / 12 (0.00%)
    2 / 36 (5.56%)
    0 / 13 (0.00%)
    0 / 24 (0.00%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    3
    0
    3
    0
    0
    0
    0
    Peripheral swelling
         subjects affected / exposed
    0 / 8 (0.00%)
    2 / 25 (8.00%)
    2 / 33 (6.06%)
    0 / 35 (0.00%)
    0 / 13 (0.00%)
    0 / 24 (0.00%)
    0 / 12 (0.00%)
    0 / 36 (0.00%)
    0 / 13 (0.00%)
    0 / 24 (0.00%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
         occurrences all number
    0
    2
    2
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Oedema peripheral
         subjects affected / exposed
    0 / 8 (0.00%)
    0 / 25 (0.00%)
    0 / 33 (0.00%)
    1 / 35 (2.86%)
    1 / 13 (7.69%)
    0 / 24 (0.00%)
    0 / 12 (0.00%)
    0 / 36 (0.00%)
    0 / 13 (0.00%)
    1 / 24 (4.17%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
         occurrences all number
    0
    0
    0
    1
    1
    0
    0
    0
    0
    1
    0
    0
    Immune system disorders
    Immunisation reaction
         subjects affected / exposed
    0 / 8 (0.00%)
    3 / 25 (12.00%)
    3 / 33 (9.09%)
    0 / 35 (0.00%)
    0 / 13 (0.00%)
    0 / 24 (0.00%)
    0 / 12 (0.00%)
    0 / 36 (0.00%)
    1 / 13 (7.69%)
    0 / 24 (0.00%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
         occurrences all number
    0
    8
    8
    0
    0
    0
    0
    0
    1
    0
    0
    0
    Seasonal allergy
         subjects affected / exposed
    0 / 8 (0.00%)
    0 / 25 (0.00%)
    0 / 33 (0.00%)
    2 / 35 (5.71%)
    0 / 13 (0.00%)
    0 / 24 (0.00%)
    0 / 12 (0.00%)
    0 / 36 (0.00%)
    0 / 13 (0.00%)
    2 / 24 (8.33%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
         occurrences all number
    0
    0
    0
    2
    0
    0
    0
    0
    0
    2
    0
    0
    Reproductive system and breast disorders
    Breast cyst
         subjects affected / exposed
    0 / 8 (0.00%)
    0 / 25 (0.00%)
    0 / 33 (0.00%)
    0 / 35 (0.00%)
    0 / 13 (0.00%)
    0 / 24 (0.00%)
    1 / 12 (8.33%)
    1 / 36 (2.78%)
    0 / 13 (0.00%)
    0 / 24 (0.00%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    1
    1
    0
    0
    0
    0
    Respiratory, thoracic and mediastinal disorders
    Dyspnoea
         subjects affected / exposed
    0 / 8 (0.00%)
    0 / 25 (0.00%)
    0 / 33 (0.00%)
    0 / 35 (0.00%)
    0 / 13 (0.00%)
    0 / 24 (0.00%)
    0 / 12 (0.00%)
    0 / 36 (0.00%)
    1 / 13 (7.69%)
    0 / 24 (0.00%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    Psychiatric disorders
    Insomnia
         subjects affected / exposed
    1 / 8 (12.50%)
    0 / 25 (0.00%)
    1 / 33 (3.03%)
    0 / 35 (0.00%)
    1 / 13 (7.69%)
    0 / 24 (0.00%)
    0 / 12 (0.00%)
    0 / 36 (0.00%)
    0 / 13 (0.00%)
    0 / 24 (0.00%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
         occurrences all number
    1
    0
    1
    0
    1
    0
    0
    0
    0
    0
    0
    0
    Investigations
    SARS-CoV-2 test positive
         subjects affected / exposed
    0 / 8 (0.00%)
    0 / 25 (0.00%)
    0 / 33 (0.00%)
    0 / 35 (0.00%)
    0 / 13 (0.00%)
    0 / 24 (0.00%)
    0 / 12 (0.00%)
    0 / 36 (0.00%)
    1 / 13 (7.69%)
    0 / 24 (0.00%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    Gamma-glutamyltransferase increased
         subjects affected / exposed
    1 / 8 (12.50%)
    0 / 25 (0.00%)
    1 / 33 (3.03%)
    1 / 35 (2.86%)
    0 / 13 (0.00%)
    0 / 24 (0.00%)
    0 / 12 (0.00%)
    0 / 36 (0.00%)
    0 / 13 (0.00%)
    1 / 24 (4.17%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
         occurrences all number
    1
    0
    1
    1
    0
    0
    0
    0
    0
    1
    0
    0
    Injury, poisoning and procedural complications
    Fall
         subjects affected / exposed
    1 / 8 (12.50%)
    0 / 25 (0.00%)
    1 / 33 (3.03%)
    0 / 35 (0.00%)
    0 / 13 (0.00%)
    0 / 24 (0.00%)
    0 / 12 (0.00%)
    0 / 36 (0.00%)
    0 / 13 (0.00%)
    0 / 24 (0.00%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
         occurrences all number
    1
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Ligament sprain
         subjects affected / exposed
    0 / 8 (0.00%)
    0 / 25 (0.00%)
    0 / 33 (0.00%)
    0 / 35 (0.00%)
    0 / 13 (0.00%)
    0 / 24 (0.00%)
    1 / 12 (8.33%)
    1 / 36 (2.78%)
    0 / 13 (0.00%)
    0 / 24 (0.00%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    1
    1
    0
    0
    0
    0
    Meniscus injury
         subjects affected / exposed
    0 / 8 (0.00%)
    0 / 25 (0.00%)
    0 / 33 (0.00%)
    0 / 35 (0.00%)
    0 / 13 (0.00%)
    0 / 24 (0.00%)
    1 / 12 (8.33%)
    1 / 36 (2.78%)
    0 / 13 (0.00%)
    0 / 24 (0.00%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    1
    1
    0
    0
    0
    0
    Limb injury
         subjects affected / exposed
    0 / 8 (0.00%)
    0 / 25 (0.00%)
    0 / 33 (0.00%)
    0 / 35 (0.00%)
    0 / 13 (0.00%)
    0 / 24 (0.00%)
    0 / 12 (0.00%)
    0 / 36 (0.00%)
    1 / 13 (7.69%)
    0 / 24 (0.00%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    Traumatic fracture
         subjects affected / exposed
    1 / 8 (12.50%)
    0 / 25 (0.00%)
    1 / 33 (3.03%)
    0 / 35 (0.00%)
    0 / 13 (0.00%)
    0 / 24 (0.00%)
    0 / 12 (0.00%)
    0 / 36 (0.00%)
    0 / 13 (0.00%)
    0 / 24 (0.00%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
         occurrences all number
    1
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Tendon rupture
         subjects affected / exposed
    1 / 8 (12.50%)
    0 / 25 (0.00%)
    1 / 33 (3.03%)
    0 / 35 (0.00%)
    0 / 13 (0.00%)
    0 / 24 (0.00%)
    0 / 12 (0.00%)
    0 / 36 (0.00%)
    0 / 13 (0.00%)
    0 / 24 (0.00%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
         occurrences all number
    1
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Cardiac disorders
    Arteriosclerosis coronary artery
         subjects affected / exposed
    0 / 8 (0.00%)
    0 / 25 (0.00%)
    0 / 33 (0.00%)
    0 / 35 (0.00%)
    0 / 13 (0.00%)
    0 / 24 (0.00%)
    0 / 12 (0.00%)
    0 / 36 (0.00%)
    1 / 13 (7.69%)
    0 / 24 (0.00%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    Nervous system disorders
    Headache
         subjects affected / exposed
    0 / 8 (0.00%)
    3 / 25 (12.00%)
    3 / 33 (9.09%)
    2 / 35 (5.71%)
    1 / 13 (7.69%)
    5 / 24 (20.83%)
    0 / 12 (0.00%)
    5 / 36 (13.89%)
    2 / 13 (15.38%)
    0 / 24 (0.00%)
    0 / 12 (0.00%)
    2 / 11 (18.18%)
         occurrences all number
    0
    6
    6
    2
    1
    5
    0
    5
    2
    0
    0
    2
    Dizziness
         subjects affected / exposed
    0 / 8 (0.00%)
    1 / 25 (4.00%)
    1 / 33 (3.03%)
    0 / 35 (0.00%)
    0 / 13 (0.00%)
    1 / 24 (4.17%)
    0 / 12 (0.00%)
    1 / 36 (2.78%)
    1 / 13 (7.69%)
    0 / 24 (0.00%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
         occurrences all number
    0
    1
    1
    0
    0
    1
    0
    1
    1
    0
    0
    0
    Paraesthesia
         subjects affected / exposed
    0 / 8 (0.00%)
    0 / 25 (0.00%)
    0 / 33 (0.00%)
    0 / 35 (0.00%)
    0 / 13 (0.00%)
    0 / 24 (0.00%)
    0 / 12 (0.00%)
    0 / 36 (0.00%)
    0 / 13 (0.00%)
    0 / 24 (0.00%)
    1 / 12 (8.33%)
    0 / 11 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    Syncope
         subjects affected / exposed
    0 / 8 (0.00%)
    0 / 25 (0.00%)
    0 / 33 (0.00%)
    0 / 35 (0.00%)
    0 / 13 (0.00%)
    0 / 24 (0.00%)
    0 / 12 (0.00%)
    0 / 36 (0.00%)
    0 / 13 (0.00%)
    0 / 24 (0.00%)
    1 / 12 (8.33%)
    0 / 11 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    Presyncope
         subjects affected / exposed
    1 / 8 (12.50%)
    0 / 25 (0.00%)
    1 / 33 (3.03%)
    0 / 35 (0.00%)
    0 / 13 (0.00%)
    0 / 24 (0.00%)
    0 / 12 (0.00%)
    0 / 36 (0.00%)
    0 / 13 (0.00%)
    0 / 24 (0.00%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
         occurrences all number
    1
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Blood and lymphatic system disorders
    Lymph node pain
         subjects affected / exposed
    0 / 8 (0.00%)
    0 / 25 (0.00%)
    0 / 33 (0.00%)
    0 / 35 (0.00%)
    0 / 13 (0.00%)
    0 / 24 (0.00%)
    0 / 12 (0.00%)
    0 / 36 (0.00%)
    0 / 13 (0.00%)
    0 / 24 (0.00%)
    1 / 12 (8.33%)
    0 / 11 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    Ear and labyrinth disorders
    Auricular swelling
         subjects affected / exposed
    0 / 8 (0.00%)
    0 / 25 (0.00%)
    0 / 33 (0.00%)
    0 / 35 (0.00%)
    0 / 13 (0.00%)
    0 / 24 (0.00%)
    0 / 12 (0.00%)
    0 / 36 (0.00%)
    0 / 13 (0.00%)
    0 / 24 (0.00%)
    1 / 12 (8.33%)
    0 / 11 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    Eye disorders
    Dry eye
         subjects affected / exposed
    0 / 8 (0.00%)
    0 / 25 (0.00%)
    0 / 33 (0.00%)
    0 / 35 (0.00%)
    1 / 13 (7.69%)
    0 / 24 (0.00%)
    0 / 12 (0.00%)
    0 / 36 (0.00%)
    0 / 13 (0.00%)
    0 / 24 (0.00%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    Gastrointestinal disorders
    Abdominal discomfort
         subjects affected / exposed
    0 / 8 (0.00%)
    0 / 25 (0.00%)
    0 / 33 (0.00%)
    0 / 35 (0.00%)
    0 / 13 (0.00%)
    0 / 24 (0.00%)
    0 / 12 (0.00%)
    0 / 36 (0.00%)
    1 / 13 (7.69%)
    0 / 24 (0.00%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    Abdominal pain
         subjects affected / exposed
    0 / 8 (0.00%)
    0 / 25 (0.00%)
    0 / 33 (0.00%)
    2 / 35 (5.71%)
    1 / 13 (7.69%)
    0 / 24 (0.00%)
    0 / 12 (0.00%)
    0 / 36 (0.00%)
    0 / 13 (0.00%)
    0 / 24 (0.00%)
    0 / 12 (0.00%)
    2 / 11 (18.18%)
         occurrences all number
    0
    0
    0
    2
    1
    0
    0
    0
    0
    0
    0
    2
    Abdominal pain upper
         subjects affected / exposed
    0 / 8 (0.00%)
    0 / 25 (0.00%)
    0 / 33 (0.00%)
    1 / 35 (2.86%)
    0 / 13 (0.00%)
    2 / 24 (8.33%)
    0 / 12 (0.00%)
    2 / 36 (5.56%)
    0 / 13 (0.00%)
    0 / 24 (0.00%)
    0 / 12 (0.00%)
    1 / 11 (9.09%)
         occurrences all number
    0
    0
    0
    1
    0
    2
    0
    2
    0
    0
    0
    1
    Colitis
         subjects affected / exposed
    0 / 8 (0.00%)
    0 / 25 (0.00%)
    0 / 33 (0.00%)
    0 / 35 (0.00%)
    1 / 13 (7.69%)
    0 / 24 (0.00%)
    0 / 12 (0.00%)
    0 / 36 (0.00%)
    0 / 13 (0.00%)
    0 / 24 (0.00%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    Diarrhoea
         subjects affected / exposed
    1 / 8 (12.50%)
    2 / 25 (8.00%)
    3 / 33 (9.09%)
    3 / 35 (8.57%)
    0 / 13 (0.00%)
    0 / 24 (0.00%)
    0 / 12 (0.00%)
    0 / 36 (0.00%)
    0 / 13 (0.00%)
    1 / 24 (4.17%)
    0 / 12 (0.00%)
    2 / 11 (18.18%)
         occurrences all number
    1
    2
    3
    4
    0
    0
    0
    0
    0
    2
    0
    2
    Gastrooesophageal reflux disease
         subjects affected / exposed
    0 / 8 (0.00%)
    0 / 25 (0.00%)
    0 / 33 (0.00%)
    1 / 35 (2.86%)
    0 / 13 (0.00%)
    0 / 24 (0.00%)
    1 / 12 (8.33%)
    1 / 36 (2.78%)
    0 / 13 (0.00%)
    1 / 24 (4.17%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    1
    1
    0
    1
    0
    0
    Haemorrhoids
         subjects affected / exposed
    0 / 8 (0.00%)
    2 / 25 (8.00%)
    2 / 33 (6.06%)
    0 / 35 (0.00%)
    0 / 13 (0.00%)
    0 / 24 (0.00%)
    0 / 12 (0.00%)
    0 / 36 (0.00%)
    0 / 13 (0.00%)
    0 / 24 (0.00%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
         occurrences all number
    0
    2
    2
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Leukoplakia oral
         subjects affected / exposed
    0 / 8 (0.00%)
    0 / 25 (0.00%)
    0 / 33 (0.00%)
    1 / 35 (2.86%)
    0 / 13 (0.00%)
    0 / 24 (0.00%)
    0 / 12 (0.00%)
    0 / 36 (0.00%)
    0 / 13 (0.00%)
    0 / 24 (0.00%)
    0 / 12 (0.00%)
    1 / 11 (9.09%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    1
    Nausea
         subjects affected / exposed
    0 / 8 (0.00%)
    0 / 25 (0.00%)
    0 / 33 (0.00%)
    2 / 35 (5.71%)
    1 / 13 (7.69%)
    0 / 24 (0.00%)
    0 / 12 (0.00%)
    0 / 36 (0.00%)
    0 / 13 (0.00%)
    1 / 24 (4.17%)
    0 / 12 (0.00%)
    1 / 11 (9.09%)
         occurrences all number
    0
    0
    0
    2
    1
    0
    0
    0
    0
    1
    0
    1
    Oral pain
         subjects affected / exposed
    0 / 8 (0.00%)
    0 / 25 (0.00%)
    0 / 33 (0.00%)
    1 / 35 (2.86%)
    0 / 13 (0.00%)
    0 / 24 (0.00%)
    0 / 12 (0.00%)
    0 / 36 (0.00%)
    0 / 13 (0.00%)
    1 / 24 (4.17%)
    1 / 12 (8.33%)
    0 / 11 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    0
    0
    0
    1
    1
    0
    Toothache
         subjects affected / exposed
    0 / 8 (0.00%)
    0 / 25 (0.00%)
    0 / 33 (0.00%)
    0 / 35 (0.00%)
    1 / 13 (7.69%)
    0 / 24 (0.00%)
    0 / 12 (0.00%)
    0 / 36 (0.00%)
    1 / 13 (7.69%)
    0 / 24 (0.00%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    0
    0
    1
    0
    0
    0
    Skin and subcutaneous tissue disorders
    Acne
         subjects affected / exposed
    0 / 8 (0.00%)
    0 / 25 (0.00%)
    0 / 33 (0.00%)
    0 / 35 (0.00%)
    0 / 13 (0.00%)
    0 / 24 (0.00%)
    0 / 12 (0.00%)
    0 / 36 (0.00%)
    0 / 13 (0.00%)
    0 / 24 (0.00%)
    1 / 12 (8.33%)
    0 / 11 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    Actinic keratosis
         subjects affected / exposed
    1 / 8 (12.50%)
    0 / 25 (0.00%)
    1 / 33 (3.03%)
    0 / 35 (0.00%)
    0 / 13 (0.00%)
    1 / 24 (4.17%)
    0 / 12 (0.00%)
    1 / 36 (2.78%)
    0 / 13 (0.00%)
    0 / 24 (0.00%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
         occurrences all number
    1
    0
    1
    0
    0
    1
    0
    1
    0
    0
    0
    0
    Dermal cyst
         subjects affected / exposed
    1 / 8 (12.50%)
    0 / 25 (0.00%)
    1 / 33 (3.03%)
    0 / 35 (0.00%)
    0 / 13 (0.00%)
    1 / 24 (4.17%)
    1 / 12 (8.33%)
    2 / 36 (5.56%)
    0 / 13 (0.00%)
    0 / 24 (0.00%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
         occurrences all number
    2
    0
    2
    0
    0
    1
    1
    2
    0
    0
    0
    0
    Dermatitis
         subjects affected / exposed
    0 / 8 (0.00%)
    0 / 25 (0.00%)
    0 / 33 (0.00%)
    0 / 35 (0.00%)
    0 / 13 (0.00%)
    0 / 24 (0.00%)
    1 / 12 (8.33%)
    1 / 36 (2.78%)
    0 / 13 (0.00%)
    0 / 24 (0.00%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    1
    1
    0
    0
    0
    0
    Intertrigo
         subjects affected / exposed
    0 / 8 (0.00%)
    0 / 25 (0.00%)
    0 / 33 (0.00%)
    0 / 35 (0.00%)
    0 / 13 (0.00%)
    1 / 24 (4.17%)
    0 / 12 (0.00%)
    1 / 36 (2.78%)
    0 / 13 (0.00%)
    0 / 24 (0.00%)
    1 / 12 (8.33%)
    0 / 11 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    0
    1
    0
    0
    1
    0
    Skin burning sensation
         subjects affected / exposed
    0 / 8 (0.00%)
    0 / 25 (0.00%)
    0 / 33 (0.00%)
    1 / 35 (2.86%)
    0 / 13 (0.00%)
    0 / 24 (0.00%)
    0 / 12 (0.00%)
    0 / 36 (0.00%)
    0 / 13 (0.00%)
    0 / 24 (0.00%)
    0 / 12 (0.00%)
    1 / 11 (9.09%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    1
    Pruritus
         subjects affected / exposed
    0 / 8 (0.00%)
    0 / 25 (0.00%)
    0 / 33 (0.00%)
    3 / 35 (8.57%)
    0 / 13 (0.00%)
    3 / 24 (12.50%)
    0 / 12 (0.00%)
    3 / 36 (8.33%)
    1 / 13 (7.69%)
    3 / 24 (12.50%)
    1 / 12 (8.33%)
    0 / 11 (0.00%)
         occurrences all number
    0
    0
    0
    6
    0
    4
    0
    4
    1
    6
    1
    0
    Lichen planus
         subjects affected / exposed
    1 / 8 (12.50%)
    3 / 25 (12.00%)
    4 / 33 (12.12%)
    5 / 35 (14.29%)
    0 / 13 (0.00%)
    1 / 24 (4.17%)
    1 / 12 (8.33%)
    2 / 36 (5.56%)
    0 / 13 (0.00%)
    4 / 24 (16.67%)
    1 / 12 (8.33%)
    1 / 11 (9.09%)
         occurrences all number
    1
    3
    4
    5
    0
    2
    1
    3
    0
    4
    1
    1
    Urticaria
         subjects affected / exposed
    0 / 8 (0.00%)
    0 / 25 (0.00%)
    0 / 33 (0.00%)
    0 / 35 (0.00%)
    0 / 13 (0.00%)
    2 / 24 (8.33%)
    0 / 12 (0.00%)
    2 / 36 (5.56%)
    0 / 13 (0.00%)
    0 / 24 (0.00%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    2
    0
    2
    0
    0
    0
    0
    Renal and urinary disorders
    Micturition urgency
         subjects affected / exposed
    0 / 8 (0.00%)
    0 / 25 (0.00%)
    0 / 33 (0.00%)
    0 / 35 (0.00%)
    1 / 13 (7.69%)
    0 / 24 (0.00%)
    0 / 12 (0.00%)
    0 / 36 (0.00%)
    0 / 13 (0.00%)
    0 / 24 (0.00%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    Micturition disorder
         subjects affected / exposed
    0 / 8 (0.00%)
    0 / 25 (0.00%)
    0 / 33 (0.00%)
    0 / 35 (0.00%)
    1 / 13 (7.69%)
    0 / 24 (0.00%)
    0 / 12 (0.00%)
    0 / 36 (0.00%)
    0 / 13 (0.00%)
    0 / 24 (0.00%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    Musculoskeletal and connective tissue disorders
    Osteonecrosis of jaw
         subjects affected / exposed
    0 / 8 (0.00%)
    0 / 25 (0.00%)
    0 / 33 (0.00%)
    1 / 35 (2.86%)
    0 / 13 (0.00%)
    0 / 24 (0.00%)
    0 / 12 (0.00%)
    0 / 36 (0.00%)
    0 / 13 (0.00%)
    0 / 24 (0.00%)
    0 / 12 (0.00%)
    1 / 11 (9.09%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    1
    Muscle spasms
         subjects affected / exposed
    0 / 8 (0.00%)
    0 / 25 (0.00%)
    0 / 33 (0.00%)
    0 / 35 (0.00%)
    0 / 13 (0.00%)
    0 / 24 (0.00%)
    0 / 12 (0.00%)
    0 / 36 (0.00%)
    0 / 13 (0.00%)
    0 / 24 (0.00%)
    1 / 12 (8.33%)
    0 / 11 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    2
    0
    Limb discomfort
         subjects affected / exposed
    1 / 8 (12.50%)
    0 / 25 (0.00%)
    1 / 33 (3.03%)
    0 / 35 (0.00%)
    0 / 13 (0.00%)
    0 / 24 (0.00%)
    0 / 12 (0.00%)
    0 / 36 (0.00%)
    0 / 13 (0.00%)
    0 / 24 (0.00%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
         occurrences all number
    1
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Exostosis
         subjects affected / exposed
    0 / 8 (0.00%)
    0 / 25 (0.00%)
    0 / 33 (0.00%)
    0 / 35 (0.00%)
    0 / 13 (0.00%)
    0 / 24 (0.00%)
    1 / 12 (8.33%)
    1 / 36 (2.78%)
    0 / 13 (0.00%)
    0 / 24 (0.00%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    1
    1
    0
    0
    0
    0
    Bone pain
         subjects affected / exposed
    0 / 8 (0.00%)
    0 / 25 (0.00%)
    0 / 33 (0.00%)
    0 / 35 (0.00%)
    1 / 13 (7.69%)
    0 / 24 (0.00%)
    0 / 12 (0.00%)
    0 / 36 (0.00%)
    0 / 13 (0.00%)
    0 / 24 (0.00%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    Arthralgia
         subjects affected / exposed
    0 / 8 (0.00%)
    1 / 25 (4.00%)
    1 / 33 (3.03%)
    1 / 35 (2.86%)
    0 / 13 (0.00%)
    2 / 24 (8.33%)
    0 / 12 (0.00%)
    2 / 36 (5.56%)
    0 / 13 (0.00%)
    1 / 24 (4.17%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
         occurrences all number
    0
    1
    1
    1
    0
    2
    0
    2
    0
    1
    0
    0
    Plantar fasciitis
         subjects affected / exposed
    0 / 8 (0.00%)
    0 / 25 (0.00%)
    0 / 33 (0.00%)
    0 / 35 (0.00%)
    0 / 13 (0.00%)
    0 / 24 (0.00%)
    1 / 12 (8.33%)
    1 / 36 (2.78%)
    0 / 13 (0.00%)
    0 / 24 (0.00%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    1
    1
    0
    0
    0
    0
    Infections and infestations
    Gastroenteritis viral
         subjects affected / exposed
    0 / 8 (0.00%)
    0 / 25 (0.00%)
    0 / 33 (0.00%)
    1 / 35 (2.86%)
    0 / 13 (0.00%)
    0 / 24 (0.00%)
    0 / 12 (0.00%)
    0 / 36 (0.00%)
    0 / 13 (0.00%)
    0 / 24 (0.00%)
    0 / 12 (0.00%)
    1 / 11 (9.09%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    1
    Furuncle
         subjects affected / exposed
    0 / 8 (0.00%)
    0 / 25 (0.00%)
    0 / 33 (0.00%)
    0 / 35 (0.00%)
    0 / 13 (0.00%)
    0 / 24 (0.00%)
    0 / 12 (0.00%)
    0 / 36 (0.00%)
    1 / 13 (7.69%)
    0 / 24 (0.00%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    Fungal skin infection
         subjects affected / exposed
    1 / 8 (12.50%)
    0 / 25 (0.00%)
    1 / 33 (3.03%)
    0 / 35 (0.00%)
    0 / 13 (0.00%)
    0 / 24 (0.00%)
    0 / 12 (0.00%)
    0 / 36 (0.00%)
    0 / 13 (0.00%)
    0 / 24 (0.00%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
         occurrences all number
    1
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Ear infection
         subjects affected / exposed
    0 / 8 (0.00%)
    0 / 25 (0.00%)
    0 / 33 (0.00%)
    1 / 35 (2.86%)
    0 / 13 (0.00%)
    0 / 24 (0.00%)
    0 / 12 (0.00%)
    0 / 36 (0.00%)
    0 / 13 (0.00%)
    0 / 24 (0.00%)
    0 / 12 (0.00%)
    1 / 11 (9.09%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    1
    Cystitis
         subjects affected / exposed
    0 / 8 (0.00%)
    0 / 25 (0.00%)
    0 / 33 (0.00%)
    1 / 35 (2.86%)
    1 / 13 (7.69%)
    1 / 24 (4.17%)
    0 / 12 (0.00%)
    1 / 36 (2.78%)
    0 / 13 (0.00%)
    1 / 24 (4.17%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
         occurrences all number
    0
    0
    0
    1
    1
    1
    0
    1
    0
    1
    0
    0
    COVID-19
         subjects affected / exposed
    1 / 8 (12.50%)
    1 / 25 (4.00%)
    2 / 33 (6.06%)
    4 / 35 (11.43%)
    0 / 13 (0.00%)
    0 / 24 (0.00%)
    0 / 12 (0.00%)
    0 / 36 (0.00%)
    1 / 13 (7.69%)
    2 / 24 (8.33%)
    0 / 12 (0.00%)
    2 / 11 (18.18%)
         occurrences all number
    1
    1
    2
    4
    0
    0
    0
    0
    1
    2
    0
    2
    Oral candidiasis
         subjects affected / exposed
    0 / 8 (0.00%)
    1 / 25 (4.00%)
    1 / 33 (3.03%)
    1 / 35 (2.86%)
    0 / 13 (0.00%)
    2 / 24 (8.33%)
    1 / 12 (8.33%)
    3 / 36 (8.33%)
    0 / 13 (0.00%)
    1 / 24 (4.17%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
         occurrences all number
    0
    1
    1
    2
    0
    3
    1
    4
    0
    2
    0
    0
    Oral herpes
         subjects affected / exposed
    0 / 8 (0.00%)
    1 / 25 (4.00%)
    1 / 33 (3.03%)
    2 / 35 (5.71%)
    0 / 13 (0.00%)
    0 / 24 (0.00%)
    0 / 12 (0.00%)
    0 / 36 (0.00%)
    0 / 13 (0.00%)
    2 / 24 (8.33%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
         occurrences all number
    0
    2
    2
    8
    0
    0
    0
    0
    0
    8
    0
    0
    Pneumonia
         subjects affected / exposed
    0 / 8 (0.00%)
    0 / 25 (0.00%)
    0 / 33 (0.00%)
    0 / 35 (0.00%)
    0 / 13 (0.00%)
    0 / 24 (0.00%)
    0 / 12 (0.00%)
    0 / 36 (0.00%)
    1 / 13 (7.69%)
    0 / 24 (0.00%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    Nasopharyngitis
         subjects affected / exposed
    0 / 8 (0.00%)
    2 / 25 (8.00%)
    2 / 33 (6.06%)
    2 / 35 (5.71%)
    0 / 13 (0.00%)
    0 / 24 (0.00%)
    0 / 12 (0.00%)
    0 / 36 (0.00%)
    0 / 13 (0.00%)
    2 / 24 (8.33%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
         occurrences all number
    0
    2
    2
    2
    0
    0
    0
    0
    0
    2
    0
    0
    Herpes ophthalmic
         subjects affected / exposed
    0 / 8 (0.00%)
    0 / 25 (0.00%)
    0 / 33 (0.00%)
    0 / 35 (0.00%)
    0 / 13 (0.00%)
    0 / 24 (0.00%)
    0 / 12 (0.00%)
    0 / 36 (0.00%)
    0 / 13 (0.00%)
    0 / 24 (0.00%)
    1 / 12 (8.33%)
    0 / 11 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    Helicobacter infection
         subjects affected / exposed
    0 / 8 (0.00%)
    0 / 25 (0.00%)
    0 / 33 (0.00%)
    0 / 35 (0.00%)
    0 / 13 (0.00%)
    0 / 24 (0.00%)
    0 / 12 (0.00%)
    0 / 36 (0.00%)
    0 / 13 (0.00%)
    0 / 24 (0.00%)
    1 / 12 (8.33%)
    0 / 11 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    Post-acute COVID-19 syndrome
         subjects affected / exposed
    1 / 8 (12.50%)
    0 / 25 (0.00%)
    1 / 33 (3.03%)
    0 / 35 (0.00%)
    0 / 13 (0.00%)
    0 / 24 (0.00%)
    0 / 12 (0.00%)
    0 / 36 (0.00%)
    0 / 13 (0.00%)
    0 / 24 (0.00%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
         occurrences all number
    1
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Sinusitis
         subjects affected / exposed
    0 / 8 (0.00%)
    1 / 25 (4.00%)
    1 / 33 (3.03%)
    1 / 35 (2.86%)
    0 / 13 (0.00%)
    0 / 24 (0.00%)
    1 / 12 (8.33%)
    1 / 36 (2.78%)
    0 / 13 (0.00%)
    1 / 24 (4.17%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
         occurrences all number
    0
    1
    1
    1
    0
    0
    1
    1
    0
    1
    0
    0
    Superinfection
         subjects affected / exposed
    1 / 8 (12.50%)
    0 / 25 (0.00%)
    1 / 33 (3.03%)
    0 / 35 (0.00%)
    0 / 13 (0.00%)
    0 / 24 (0.00%)
    0 / 12 (0.00%)
    0 / 36 (0.00%)
    0 / 13 (0.00%)
    0 / 24 (0.00%)
    1 / 12 (8.33%)
    0 / 11 (0.00%)
         occurrences all number
    1
    0
    1
    0
    0
    0
    0
    0
    0
    0
    1
    0
    Tongue fungal infection
         subjects affected / exposed
    0 / 8 (0.00%)
    0 / 25 (0.00%)
    0 / 33 (0.00%)
    1 / 35 (2.86%)
    0 / 13 (0.00%)
    0 / 24 (0.00%)
    0 / 12 (0.00%)
    0 / 36 (0.00%)
    0 / 13 (0.00%)
    0 / 24 (0.00%)
    0 / 12 (0.00%)
    1 / 11 (9.09%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    1
    Upper respiratory tract infection
         subjects affected / exposed
    0 / 8 (0.00%)
    0 / 25 (0.00%)
    0 / 33 (0.00%)
    2 / 35 (5.71%)
    0 / 13 (0.00%)
    0 / 24 (0.00%)
    0 / 12 (0.00%)
    0 / 36 (0.00%)
    0 / 13 (0.00%)
    2 / 24 (8.33%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
         occurrences all number
    0
    0
    0
    2
    0
    0
    0
    0
    0
    2
    0
    0
    Urinary tract infection
         subjects affected / exposed
    0 / 8 (0.00%)
    1 / 25 (4.00%)
    1 / 33 (3.03%)
    2 / 35 (5.71%)
    1 / 13 (7.69%)
    0 / 24 (0.00%)
    1 / 12 (8.33%)
    1 / 36 (2.78%)
    0 / 13 (0.00%)
    1 / 24 (4.17%)
    1 / 12 (8.33%)
    1 / 11 (9.09%)
         occurrences all number
    0
    1
    1
    2
    1
    0
    1
    1
    0
    1
    1
    1
    Metabolism and nutrition disorders
    Vitamin D deficiency
         subjects affected / exposed
    0 / 8 (0.00%)
    0 / 25 (0.00%)
    0 / 33 (0.00%)
    0 / 35 (0.00%)
    0 / 13 (0.00%)
    3 / 24 (12.50%)
    0 / 12 (0.00%)
    3 / 36 (8.33%)
    0 / 13 (0.00%)
    0 / 24 (0.00%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    3
    0
    3
    0
    0
    0
    0
    Hypercholesterolaemia
         subjects affected / exposed
    0 / 8 (0.00%)
    0 / 25 (0.00%)
    0 / 33 (0.00%)
    0 / 35 (0.00%)
    1 / 13 (7.69%)
    0 / 24 (0.00%)
    0 / 12 (0.00%)
    0 / 36 (0.00%)
    0 / 13 (0.00%)
    0 / 24 (0.00%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    08 Apr 2020
    IGA score specifications were updated to make them more specific regarding certain aspects of the disease, for easier clinical application and to cover additional cases. The use of historical biopsies (if available) was allowed at screening for subjects with all 3 subtypes of LP instead of allowing it for the LPP cohort only. This made the study more subject friendly and reduced the need for biopsies. The protocol was adapted to pandemic/epidemic related challenges and the long term impact on clinical studies and to reduce the risk of infectious disease transmission. The protocol was amended to allow for home shipment of study drug and urine pregnancy tests as well as safety assessment by telephone.
    26 Oct 2020
    The use of biopsies assessed by local pathologists was allowed.

    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.
    EudraCT system limitation does not accept blank data fields: 999 entered for blank mean data. 0 entered for blank countable data for Wk 20-32 (Placebo arm) and Wk 2-12 (Placebo to AIN457 arm) indicating no participants evaluated for that timepoint
    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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