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    Clinical Trial Results:
    A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study Evaluating the Efficacy and Safety of Bimekizumab in Study Participants With Moderate to Severe Hidradenitis Suppurativa

    Summary
    EudraCT number
    		 2019-002551-42
    Trial protocol
    		 DE   IE   FR   GB   HU   CZ   ES   BG  
    Global end of trial date
    28 Sep 2022

    Results information
    Results version number
    		 v2(current)
    This version publication date
    02 Nov 2023
    First version publication date
    13 Oct 2023
    Other versions
    		 v1
    Version creation reason
    • Correction of full data set
    Corrected the sequence of endpoints.

    Trial information

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    Trial identification
    Sponsor protocol code
    HS0004
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT04242498
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    UCB Biopharma SRL
    Sponsor organisation address
    Allée de la Recherche 60, Brussels, Belgium, 1070
    Public contact
    Clin Trial Reg & Results Disclosure, UCB BIOSCIENCES GmbH, clinicaltrials@ucb.com
    Scientific contact
    Clin Trial Reg & Results Disclosure, UCB BIOSCIENCES GmbH, clinicaltrials@ucb.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
    12 Oct 2022
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    09 Nov 2021
    Global end of trial reached?
    Yes
    Global end of trial date
    28 Sep 2022
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    Evaluate the efficacy of bimekizumab in study participants with moderate to severe Hidradenitis Suppurativa (HS)
    Protection of trial subjects
    During the conduct of the study all participants were closely monitored.
    Background therapy
    		 Background therapy as permitted in the protocol.
    Evidence for comparator
    		 Not applicable
    Actual start date of recruitment
    02 Mar 2020
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Australia: 5
    Country: Number of subjects enrolled
    Bulgaria: 61
    Country: Number of subjects enrolled
    Canada: 36
    Country: Number of subjects enrolled
    Czechia: 23
    Country: Number of subjects enrolled
    France: 52
    Country: Number of subjects enrolled
    Germany: 36
    Country: Number of subjects enrolled
    Hungary: 7
    Country: Number of subjects enrolled
    Ireland: 1
    Country: Number of subjects enrolled
    Israel: 2
    Country: Number of subjects enrolled
    Japan: 27
    Country: Number of subjects enrolled
    Poland: 124
    Country: Number of subjects enrolled
    Spain: 17
    Country: Number of subjects enrolled
    United Kingdom: 5
    Country: Number of subjects enrolled
    United States: 113
    Worldwide total number of subjects
    509
    EEA total number of subjects
    321
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    0
    Infants and toddlers (28 days-23 months)
    0
    Children (2-11 years)
    0
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    499
    From 65 to 84 years
    10
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 The study started to enroll participants in March 2020 and concluded in September 2022.

    Pre-assignment
    Screening details
    		 Participant Flow refers to the Randomized Set (RS) and Maintenance Set (MS).

    Period 1
    Period 1 title
    Initial Treatment Period: Week 0-16
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Carer, Assessor

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Placebo
    Arm description
    		 Participants received placebo during the 16-weeks Initial Treatment Period.
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Participants received placebo at prespecified time points.

    Arm title
    		 BKZ Dosing Regimen 1
    Arm description
    		 Participants received Bimekizumab (BKZ) dosing regimen 1 subcutaneously (SC) during the 16-weeks Initial Treatment Period.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Bimekizumab
    Investigational medicinal product code
    UCB4940
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Participants received BKZ dosing regimen 1 at prespecified time points.

    Arm title
    		 BKZ Dosing Regimen 2
    Arm description
    		 Participants received BKZ dosing regimen 2 SC during the 16-weeks Initial Treatment Period.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Bimekizumab
    Investigational medicinal product code
    UCB4940
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Participants received BKZ dosing regimen 2 at prespecified time points.

    Number of subjects in period 1
    		Placebo BKZ Dosing Regimen 1 BKZ Dosing Regimen 2
    Started
    74
    144
    291
    Completed
    69
    133
    262
    Not completed
    5
    11
    29
         Subject Moved Long Distance From Clinic (Abroad)
    -
    -
    1
         Adverse event, non-fatal
    1
    1
    9
         Consent withdrawn by subject, not due to AE
    2
    8
    12
         Lost to follow-up
    1
    -
    3
         Withdrawn by investigator’s decision
    -
    -
    1
         Randomized, not treated
    -
    2
    1
         Protocol deviation
    1
    -
    1
         Lack of efficacy
    -
    -
    1
    Period 2
    Period 2 title
    Maintenance Treatment Period: Week 16-48
    Is this the baseline period?
    		 No
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Carer, Assessor

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Placebo/BKZ Dosing Regimen 2
    Arm description
    		 After the 16-weeks Initial Treatment Period, participants initially randomized to placebo received BKZ dosing regimen 2 SC during the 32-weeks Maintenance Treatment Period (up to Week 48).
    Arm type
    		 Experimental

    Investigational medicinal product name
    Bimekizumab
    Investigational medicinal product code
    UCB4940
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Participants received BKZ dosing regimen 2 at prespecified time points.

    Arm title
    		 BKZ Dosing Regimen 1/BKZ Dosing Regimen 1
    Arm description
    		 After the 16-weeks Initial Treatment Period, participants initially randomized to BKZ dosing regimen 1 continued to receive BKZ dosing regimen 1 SC during the 32-weeks Maintenance Treatment Period (up to Week 48).
    Arm type
    		 Experimental

    Investigational medicinal product name
    Bimekizumab
    Investigational medicinal product code
    UCB4940
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Participants received BKZ dosing regimen 1 at prespecified time points.

    Arm title
    		 BKZ Dosing regimen 2/BKZ Dosing regimen 1
    Arm description
    		 After the 16-week Initial Treatment Period, participants initially randomized to BKZ dosing regimen 2 received BKZ dosing regimen 1 SC during the 32-weeks Maintenance Treatment Period (up to Week 48).
    Arm type
    		 Experimental

    Investigational medicinal product name
    Bimekizumab
    Investigational medicinal product code
    UCB4940
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Participants received BKZ dosing regimen 1 at prespecified time points.

    Arm title
    		 BKZ Dosing regimen 2/BKZ Dosing regimen 2
    Arm description
    		 After the 16-week Initial Treatment Period, participants initially randomized to BKZ dosing regimen 2 continued to receive BKZ dosing regimen 2 SC during the 32-weeks Maintenance Treatment Period (up to Week 48).
    Arm type
    		 Experimental

    Investigational medicinal product name
    Bimekizumab
    Investigational medicinal product code
    UCB4940
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Participants received BKZ dosing regimen 2 at prespecified time points.

    Number of subjects in period 2 [1]
    		Placebo/BKZ Dosing Regimen 2 BKZ Dosing Regimen 1/BKZ Dosing Regimen 1 BKZ Dosing regimen 2/BKZ Dosing regimen 1 BKZ Dosing regimen 2/BKZ Dosing regimen 2
    Started
    69
    133
    130
    131
    Completed
    61
    109
    107
    110
    Not completed
    8
    24
    23
    21
         Adverse event, non-fatal
    -
    7
    6
    4
         Change In Address-Patient Not Wanting To Continue
    -
    1
    -
    -
         Consent withdrawn by subject, not due to AE
    6
    9
    10
    11
         Subject Relocated
    -
    -
    1
    1
         Lost to follow-up
    2
    3
    1
    2
         Visits Too Time-Consuming, Only Sfu Will Be Done
    -
    -
    1
    -
         Lack of efficacy
    -
    4
    2
    2
         Protocol deviation
    -
    -
    2
    1
    Notes
    [1] - The number of subjects starting the period is not consistent with the number completing the preceding period. It is expected the number of subjects starting the subsequent period will be the same as the number completing the preceding period.
    Justification: 1 participant completed the 16-Week Initial Treatment Period but did not enter the Maintenance Treatment Period because of the below reason: consent withdrawn by subject (not due to adverse event).

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 Participants received placebo during the 16-weeks Initial Treatment Period.

    Reporting group title
    BKZ Dosing Regimen 1
    Reporting group description
    		 Participants received Bimekizumab (BKZ) dosing regimen 1 subcutaneously (SC) during the 16-weeks Initial Treatment Period.

    Reporting group title
    BKZ Dosing Regimen 2
    Reporting group description
    		 Participants received BKZ dosing regimen 2 SC during the 16-weeks Initial Treatment Period.

    Reporting group values
    		 Placebo BKZ Dosing Regimen 1 BKZ Dosing Regimen 2 Total
    Number of subjects
    		 74 144 291 509
    Age Categorical
    Units: Participants
        <=18 years
    		 0 7 10 17
        Between 18 and 65 years
    		 70 135 277 482
        >=65 years
    		 4 2 4 10
    Age Continuous
    Units: Years
        arithmetic mean (standard deviation)
    		 38.1 ( 13.2 ) 35.2 ( 11.9 ) 36.9 ( 12.3 ) -
    Sex: Female, Male
    Units: Participants
        Female
    		 31 77 150 258
        Male
    		 43 67 141 251

    End points

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    End points reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 Participants received placebo during the 16-weeks Initial Treatment Period.

    Reporting group title
    BKZ Dosing Regimen 1
    Reporting group description
    		 Participants received Bimekizumab (BKZ) dosing regimen 1 subcutaneously (SC) during the 16-weeks Initial Treatment Period.

    Reporting group title
    BKZ Dosing Regimen 2
    Reporting group description
    		 Participants received BKZ dosing regimen 2 SC during the 16-weeks Initial Treatment Period.
    Reporting group title
    Placebo/BKZ Dosing Regimen 2
    Reporting group description
    		 After the 16-weeks Initial Treatment Period, participants initially randomized to placebo received BKZ dosing regimen 2 SC during the 32-weeks Maintenance Treatment Period (up to Week 48).

    Reporting group title
    BKZ Dosing Regimen 1/BKZ Dosing Regimen 1
    Reporting group description
    		 After the 16-weeks Initial Treatment Period, participants initially randomized to BKZ dosing regimen 1 continued to receive BKZ dosing regimen 1 SC during the 32-weeks Maintenance Treatment Period (up to Week 48).

    Reporting group title
    BKZ Dosing regimen 2/BKZ Dosing regimen 1
    Reporting group description
    		 After the 16-week Initial Treatment Period, participants initially randomized to BKZ dosing regimen 2 received BKZ dosing regimen 1 SC during the 32-weeks Maintenance Treatment Period (up to Week 48).

    Reporting group title
    BKZ Dosing regimen 2/BKZ Dosing regimen 2
    Reporting group description
    		 After the 16-week Initial Treatment Period, participants initially randomized to BKZ dosing regimen 2 continued to receive BKZ dosing regimen 2 SC during the 32-weeks Maintenance Treatment Period (up to Week 48).

    Primary: Percentage of participants achieving clinical response as measured by Hidradenitis Suppurativa Clinical Response 50 (HiSCR50) at Week 16

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    End point title
    		 Percentage of participants achieving clinical response as measured by Hidradenitis Suppurativa Clinical Response 50 (HiSCR50) at Week 16
    End point description
    HiSCR50 was defined as at least a 50 percent (%) reduction from Baseline in the total abscess and inflammatory nodule (AN) count, with no increase from Baseline in abscess or draining tunnel count. Intermittent missing data are imputed using multiple imputation with Markov Chain Monte Carlo (MCMC) method followed by monotone regression for monotone missing data. Lesion counts are imputed and then dichotomized to obtain the response status. Participants who experienced an intercurrent event were treated as nonresponders following the intercurrent event. An intercurrent event was defined as receipt of systemic antibiotic rescue medication or discontinuation of study treatment due to an adverse event (AE) or lack of efficacy. Percentages of participants shown do not account for model effects using the logistic regression model. The RS consisted of all study participants randomized into the study.
    End point type
    Primary
    End point timeframe
    Week 16
    End point values
    		 Placebo BKZ Dosing Regimen 1 BKZ Dosing Regimen 2
    Number of subjects analysed
    74
    144
    291
    Units: percentage of participants
        number (confidence interval 95%)
    32.2 (21.4 to 42.9)
    53.8 (45.4 to 62.1)
    52.0 (46.1 to 57.8)
    Statistical analysis title
    		 Statistical Analysis 2
    Comparison groups
    Placebo v BKZ Dosing Regimen 2
    Number of subjects included in analysis
    365
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.003
    Method
    		 Regression, Logistic
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    2.287
    Confidence interval
         level
    		 97.5%
         sides
    2-sided
         lower limit
    		 1.22
         upper limit
    		 4.291
    Statistical analysis title
    		 Statistical Analysis 1
    Comparison groups
    Placebo v BKZ Dosing Regimen 1
    Number of subjects included in analysis
    218
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.004
    Method
    		 Regression, Logistic
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    2.422
    Confidence interval
         level
    		 97.5%
         sides
    2-sided
         lower limit
    		 1.221
         upper limit
    		 4.804

    Secondary: Percentage of participants achieving clinical response as measured by Hidradenitis Suppurativa Clinical Response 75 (HiSCR75) at Week 16

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    End point title
    		 Percentage of participants achieving clinical response as measured by Hidradenitis Suppurativa Clinical Response 75 (HiSCR75) at Week 16
    End point description
    HiSCR75 was defined as at least a 75% reduction from Baseline in the total AN count, with no increase from Baseline in abscess or draining tunnel count. Intermittent missing data were imputed using multiple imputation with MCMC method followed by monotone regression for monotone missing data. Lesion counts were imputed and then dichotomized to obtain the response status. Participants who experienced an intercurrent event were treated as nonresponders following the intercurrent event. An intercurrent event was defined as receipt of systemic antibiotic rescue medication or discontinuation of study treatment due to an AE or lack of efficacy. Percentages of participants shown do not account for model effects using the logistic regression model. The RS consisted of all study participants randomized into the study.
    End point type
    Secondary
    End point timeframe
    Week 16
    End point values
    		 Placebo BKZ Dosing Regimen 1 BKZ Dosing Regimen 2
    Number of subjects analysed
    74
    144
    291
    Units: percentage of participants
        number (confidence interval 95%)
    15.6 (7.2 to 24.0)
    33.7 (25.7 to 41.7)
    35.7 (30.1 to 41.3)
    Statistical analysis title
    		 Statistical Analysis 2
    Comparison groups
    Placebo v BKZ Dosing Regimen 2
    Number of subjects included in analysis
    365
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.002
    Method
    		 Regression, Logistic
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    3.007
    Confidence interval
         level
    		 97.5%
         sides
    2-sided
         lower limit
    		 1.374
         upper limit
    		 6.581
    Statistical analysis title
    		 Statistical Analysis 1
    Comparison groups
    Placebo v BKZ Dosing Regimen 1
    Number of subjects included in analysis
    218
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.007
    Method
    		 Regression, Logistic
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    2.722
    Confidence interval
         level
    		 97.5%
         sides
    2-sided
         lower limit
    		 1.182
         upper limit
    		 6.267

    Secondary: Percentage of participants with Flare by Week 16

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    End point title
    		 Percentage of participants with Flare by Week 16
    End point description
    Flare was defined as a greater than or equal to (>=) 25% increase in AN count with an absolute increase in AN count of >= 2 relative to Baseline. Intermittent missing data were imputed using multiple imputation with MCMC method followed by monotone regression for monotone missing data. Lesion counts were imputed and then dichotomized to obtain the response status. Participants who experienced an intercurrent event prior to experiencing a flare were treated as having experienced a flare at all flare assessments on and after the intercurrent event date. An intercurrent event was defined as receipt of systemic antibiotic rescue medication or discontinuation of study treatment due to an AE or lack of efficacy. Percentages of participants shown do not account for model effects using the logistic regression model. The RS consisted of all study participants randomized into the study.
    End point type
    Secondary
    End point timeframe
    From Baseline to Week 16
    End point values
    		 Placebo BKZ Dosing Regimen 1 BKZ Dosing Regimen 2
    Number of subjects analysed
    74
    144
    291
    Units: percentage of participants
        number (confidence interval 95%)
    28.0 (17.6 to 38.4)
    23.6 (16.5 to 30.7)
    28.8 (23.5 to 34.1)
    Statistical analysis title
    		 Statistical Analysis 1
    Comparison groups
    Placebo v BKZ Dosing Regimen 1
    Number of subjects included in analysis
    218
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.497
    Method
    		 Regression, Logistic
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    0.798
    Confidence interval
         level
    		 97.5%
         sides
    2-sided
         lower limit
    		 0.378
         upper limit
    		 1.683
    Statistical analysis title
    		 Statistical Analysis 2
    Comparison groups
    Placebo v BKZ Dosing Regimen 2
    Number of subjects included in analysis
    365
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.868
    Method
    		 Regression, Logistic
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    1.05
    Confidence interval
         level
    		 97.5%
         sides
    2-sided
         lower limit
    		 0.541
         upper limit
    		 2.041

    Secondary: Absolute change from Baseline in Dermatology Life Quality Index (DLQI) Total Score at Week 16

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    End point title
    		 Absolute change from Baseline in Dermatology Life Quality Index (DLQI) Total Score at Week 16
    End point description
    DLQI is patient-reported questionnaire designed for use in adult participants with skin diseases and HS. DLQI: skin disease-specific questionnaire aimed at evaluation of how symptoms and treatment affect patients' health related quality of life (HRQoL), with recall period of 7 days. This instrument asks participants 10 questions about symptoms and feelings, daily activities, leisure, work and school, personal relationships, and treatment. Scoring of each answer for DLQI is on scale range of 0 (not at all) to 3(very much). DLQI total score was calculated by adding score of each question. Max score is 30, and min score is 0. Higher score, more quality of life is impaired. Those who experienced intercurrent event were treated as missing following intercurrent event and imputed using multiple imputation method for missing data. RS consisted of all study participants randomized into study. Mean values shown do not account for model effects using the analysis of covariance (ANCOVA) model.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 16
    End point values
    		 Placebo BKZ Dosing Regimen 1 BKZ Dosing Regimen 2
    Number of subjects analysed
    74
    144
    291
    Units: score on a scale
        arithmetic mean (standard error)
    -3.2 ( 0.6 )
    -4.7 ( 0.5 )
    -4.6 ( 0.3 )
    Statistical analysis title
    		 Statistical Analysis 2
    Comparison groups
    Placebo v BKZ Dosing Regimen 2
    Number of subjects included in analysis
    365
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001 [1]
    Method
    		 ANCOVA
    Parameter type
    		 LS mean difference
    Point estimate
    -2.309
    Confidence interval
         level
    		 97.5%
         sides
    2-sided
         lower limit
    		 -3.705
         upper limit
    		 -0.914
    Notes
    [1] - Nominal p-value only due to the testing hierarchy failing on the flare endpoint.
    Statistical analysis title
    		 Statistical Analysis 1
    Comparison groups
    Placebo v BKZ Dosing Regimen 1
    Number of subjects included in analysis
    218
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001 [2]
    Method
    		 ANCOVA
    Parameter type
    		 LS mean difference
    Point estimate
    -2.393
    Confidence interval
         level
    		 97.5%
         sides
    2-sided
         lower limit
    		 -3.92
         upper limit
    		 -0.867
    Notes
    [2] - Nominal p-value only due to the testing hierarchy failing on the flare endpoint.

    Secondary: Absolute change from Baseline in Worst Skin Pain score at Week 16

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    End point title
    		 Absolute change from Baseline in Worst Skin Pain score at Week 16
    End point description
    Absolute change from Baseline in worst Skin Pain score at Week 16 was assessed using worst skin pain item in Hidradenitis Suppurativa Symptom Daily Diary (HSSDD). Worst skin pain during past 24 hours was assessed daily using 11-point numeric rating scale ranges from 0 (no skin pain) to 10 (skin pain as bad as you can imagine). Worst skin pain score was derived from weekly average of daily scores, defined as sum of scored item over course of study week divided by number of days in which item completed, relative to each respective visit date. Intermittent missing data imputed using multiple imputation with MCMC method followed by monotone regression for monotone missing data. Those who experienced intercurrent event were treated as missing following intercurrent event and imputed using multiple imputation method for missing data. RS consisted of all study participants randomized into study. Mean values shown do not account for model effects using the ANCOVA model.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 16
    End point values
    		 Placebo BKZ Dosing Regimen 1 BKZ Dosing Regimen 2
    Number of subjects analysed
    74
    144
    291
    Units: score on a scale
        arithmetic mean (standard error)
    -0.36 ( 0.30 )
    -1.44 ( 0.24 )
    -1.83 ( 0.17 )
    Statistical analysis title
    		 Statistical Analysis 2
    Comparison groups
    Placebo v BKZ Dosing Regimen 2
    Number of subjects included in analysis
    365
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001 [3]
    Method
    		 ANCOVA
    Parameter type
    		 LS mean difference
    Point estimate
    -1.265
    Confidence interval
         level
    		 97.5%
         sides
    2-sided
         lower limit
    		 -1.978
         upper limit
    		 -0.552
    Notes
    [3] - Nominal p-value only due to the testing hierarchy failing on the flare endpoint.
    Statistical analysis title
    		 Statistical Analysis 1
    Comparison groups
    Placebo v BKZ Dosing Regimen 1
    Number of subjects included in analysis
    218
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.01 [4]
    Method
    		 ANCOVA
    Parameter type
    		 LS mean difference
    Point estimate
    -0.898
    Confidence interval
         level
    		 97.5%
         sides
    2-sided
         lower limit
    		 -1.684
         upper limit
    		 -0.113
    Notes
    [4] - Nominal p-value only due to the testing hierarchy failing on the flare endpoint.

    Secondary: Percentage of participants achieving Skin Pain response at Week 16

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    End point title
    		 Percentage of participants achieving Skin Pain response at Week 16
    End point description
    Skin pain response at Week 16, as assessed by the “worst skin pain” item in the HSSDD, was defined as an improvement in the weekly worst skin pain score of at least 3 points versus Baseline. Intermittent missing data were imputed using multiple imputation with MCMC method followed by monotone regression for monotone missing data. Weekly pain scores were imputed and then dichotomized to obtain the response status. Participants who experienced an intercurrent event were treated as nonresponders following the intercurrent event. An intercurrent event was defined as receipt of systemic antibiotic rescue medication or discontinuation of study treatment due to an AE or lack of efficacy. The RS consisted of all study participants randomized into the study. Here, number of participants analyzed included RS with worst skin pain score >=3 at Baseline. Percentages of participants shown do not account for model effects using the logistic regression model.
    End point type
    Secondary
    End point timeframe
    Week 16
    End point values
    		 Placebo BKZ Dosing Regimen 1 BKZ Dosing Regimen 2
    Number of subjects analysed
    49
    108
    209
    Units: percentage of participants
        number (confidence interval 95%)
    10.9 (1.7 to 20.1)
    28.6 (19.5 to 37.8)
    31.8 (25.1 to 38.4)
    Statistical analysis title
    		 Statistical Analysis 2
    Comparison groups
    Placebo v BKZ Dosing Regimen 2
    Number of subjects included in analysis
    258
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.01 [5]
    Method
    		 Regression, Logistic
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    3.756
    Confidence interval
         level
    		 97.5%
         sides
    2-sided
         lower limit
    		 1.189
         upper limit
    		 11.867
    Notes
    [5] - Nominal p-value only due to the testing hierarchy failing on the flare endpoint.
    Statistical analysis title
    		 Statistical Analysis 1
    Comparison groups
    Placebo v BKZ Dosing Regimen 1
    Number of subjects included in analysis
    157
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.028 [6]
    Method
    		 Regression, Logistic
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    3.273
    Confidence interval
         level
    		 97.5%
         sides
    2-sided
         lower limit
    		 0.974
         upper limit
    		 10.997
    Notes
    [6] - Nominal p-value only due to the testing hierarchy failing on the flare endpoint.

    Secondary: Percentage of participants with treatment-emergent adverse events (TEAEs) during the study

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    End point title
    		 Percentage of participants with treatment-emergent adverse events (TEAEs) during the study
    End point description
    An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of investigational medicinal product (IMP), whether or not considered related to the IMP. An AE could therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of IMP. Treatment-emergent AEs are defined as those AEs that have a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week Safety Follow-Up [SFU] period). The Safety Set (SS) consisted of all study participants who received at least 1 dose (full or partial) of IMP. The MS consisted of all study participants who received at least 1 dose (full or partial) of BKZ in the Maintenance Treatment Period.
    End point type
    Secondary
    End point timeframe
    From Baseline (Day 1) until Safety Follow-Up (up to Week 71)
    End point values
    		 Placebo Placebo/BKZ Dosing Regimen 2 BKZ Dosing Regimen 1 BKZ Dosing Regimen 1/BKZ Dosing Regimen 1 BKZ Dosing Regimen 2 BKZ Dosing regimen 2/BKZ Dosing regimen 1 BKZ Dosing regimen 2/BKZ Dosing regimen 2
    Number of subjects analysed
    74
    69
    142
    133
    290
    130
    131
    Units: percentage of participants
        number (not applicable)
    56.8
    71.0
    51.4
    72.2
    64.5
    77.7
    77.1
    No statistical analyses for this end point

    Secondary: Percentage of participants with serious treatment-emergent adverse events during the study

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    End point title
    		 Percentage of participants with serious treatment-emergent adverse events during the study
    End point description
    A serious adverse event (SAE) is defined as any untoward medical occurrence that, at any dose: Results in death; Is life-threatening, Requires inpatient hospitalization or prolongation of existing hospitalization; Results in persistent disability/incapacity; Is a congenital anomaly/birth defect; Important medical events. Treatment-emergent AEs are defined as those AEs that have a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week SFU period). The SS consisted of all study participants who received at least 1 dose (full or partial) of IMP. The MS consisted of all study participants who received at least 1 dose (full or partial) of BKZ in the Maintenance Treatment Period.
    End point type
    Secondary
    End point timeframe
    From Baseline (Day 1) until Safety Follow-Up (up to Week 71)
    End point values
    		 Placebo Placebo/BKZ Dosing Regimen 2 BKZ Dosing Regimen 1 BKZ Dosing Regimen 1/BKZ Dosing Regimen 1 BKZ Dosing Regimen 2 BKZ Dosing regimen 2/BKZ Dosing regimen 1 BKZ Dosing regimen 2/BKZ Dosing regimen 2
    Number of subjects analysed
    74
    69
    142
    133
    290
    130
    131
    Units: percentage of participants
        number (not applicable)
    0
    2.9
    2.1
    3.0
    3.1
    2.3
    3.1
    No statistical analyses for this end point

    Secondary: Percentage of participants with treatment-emergent adverse events (TEAEs) leading to withdrawal from the study

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    End point title
    		 Percentage of participants with treatment-emergent adverse events (TEAEs) leading to withdrawal from the study
    End point description
    An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of IMP, whether or not considered related to the IMP. An AE could therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of IMP. Treatment-emergent AEs are defined as those AEs that have a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week SFU period). TEAEs leading to discontinuation of the study are reported. The SS consisted of all study participants who received at least 1 dose (full or partial) of IMP. The MS consisted of all study participants who received at least 1 dose (full or partial) of BKZ in the Maintenance Treatment Period.
    End point type
    Secondary
    End point timeframe
    From Baseline (Day 1) until Safety Follow-Up (up to Week 71)
    End point values
    		 Placebo Placebo/BKZ Dosing Regimen 2 BKZ Dosing Regimen 1 BKZ Dosing Regimen 1/BKZ Dosing Regimen 1 BKZ Dosing Regimen 2 BKZ Dosing regimen 2/BKZ Dosing regimen 1 BKZ Dosing regimen 2/BKZ Dosing regimen 2
    Number of subjects analysed
    74
    69
    142
    133
    290
    130
    131
    Units: percentage of participants
        number (not applicable)
    0
    0
    2.1
    4.5
    4.1
    3.1
    1.5
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    From Baseline (Day 1) until Safety Follow-Up (up to Week 71)
    Adverse event reporting additional description
    Treatment-emergent AEs are defined as those AEs that have a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week SFU period). TEAEs were analyzed and reported for Initial Treatment Period (SS) and Maintenance Treatment Period (MS) separately.
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    19.0
    Reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 Participants received placebo during the 16-weeks Initial Treatment Period.

    Reporting group title
    BKZ Dosing Regimen 1
    Reporting group description
    		 Participants received Bimekizumab (BKZ) dosing regimen 1 subcutaneously (SC) during the 16-weeks Initial Treatment Period.

    Reporting group title
    BKZ Dosing Regimen 2
    Reporting group description
    		 Participants received BKZ dosing regimen 2 SC during the 16-weeks Initial Treatment Period.

    Reporting group title
    Placebo/BKZ Dosing Regimen 2
    Reporting group description
    		 After the 16-weeks Initial Treatment Period, participants initially randomized to placebo received BKZ dosing regimen 2 SC during the 32-weeks Maintenance Treatment Period (up to Week 48).

    Reporting group title
    BKZ Dosing Regimen 1/BKZ Dosing Regimen 1
    Reporting group description
    		 After the 16-weeks Initial Treatment Period, participants initially randomized to BKZ dosing regimen 1 continued to receive BKZ dosing regimen 1 SC during the 32-weeks Maintenance Treatment Period (up to Week 48).

    Reporting group title
    BKZ Dosing regimen 2/BKZ Dosing regimen 1
    Reporting group description
    		 After the 16-week Initial Treatment Period, participants initially randomized to BKZ dosing regimen 2 received BKZ dosing regimen 1 SC during the 32-weeks Maintenance Treatment Period (up to Week 48).

    Reporting group title
    BKZ Dosing regimen 2/BKZ Dosing regimen 2
    Reporting group description
    		 After the 16-week Initial Treatment Period, participants initially randomized to BKZ dosing regimen 2 continued to receive BKZ dosing regimen 2 SC during the 32-weeks Maintenance Treatment Period (up to Week 48).

    Serious adverse events
    		 Placebo BKZ Dosing Regimen 1 BKZ Dosing Regimen 2 Placebo/BKZ Dosing Regimen 2 BKZ Dosing Regimen 1/BKZ Dosing Regimen 1 BKZ Dosing regimen 2/BKZ Dosing regimen 1 BKZ Dosing regimen 2/BKZ Dosing regimen 2
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 74 (0.00%)
    3 / 142 (2.11%)
    9 / 290 (3.10%)
    2 / 69 (2.90%)
    4 / 133 (3.01%)
    3 / 130 (2.31%)
    4 / 131 (3.05%)
         number of deaths (all causes)
    0
    0
    0
    0
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    0
    0
    0
    0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Breast cancer
         subjects affected / exposed
    0 / 74 (0.00%)
    0 / 142 (0.00%)
    1 / 290 (0.34%)
    0 / 69 (0.00%)
    0 / 133 (0.00%)
    0 / 130 (0.00%)
    0 / 131 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    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
    Injury, poisoning and procedural complications
    Fibula fracture
         subjects affected / exposed
    0 / 74 (0.00%)
    1 / 142 (0.70%)
    0 / 290 (0.00%)
    0 / 69 (0.00%)
    0 / 133 (0.00%)
    0 / 130 (0.00%)
    0 / 131 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Meniscus injury
         subjects affected / exposed
    0 / 74 (0.00%)
    0 / 142 (0.00%)
    1 / 290 (0.34%)
    0 / 69 (0.00%)
    0 / 133 (0.00%)
    0 / 130 (0.00%)
    0 / 131 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    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
    Tibia fracture
         subjects affected / exposed
    0 / 74 (0.00%)
    1 / 142 (0.70%)
    0 / 290 (0.00%)
    0 / 69 (0.00%)
    0 / 133 (0.00%)
    0 / 130 (0.00%)
    0 / 131 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Vascular disorders
    Lymphoedema
         subjects affected / exposed
    0 / 74 (0.00%)
    0 / 142 (0.00%)
    0 / 290 (0.00%)
    0 / 69 (0.00%)
    0 / 133 (0.00%)
    0 / 130 (0.00%)
    1 / 131 (0.76%)
         occurrences causally related to treatment / all
    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
    Pregnancy, puerperium and perinatal conditions
    Pregnancy on contraceptive
         subjects affected / exposed
    0 / 74 (0.00%)
    0 / 142 (0.00%)
    0 / 290 (0.00%)
    0 / 69 (0.00%)
    1 / 133 (0.75%)
    0 / 130 (0.00%)
    0 / 131 (0.00%)
         occurrences causally related to treatment / all
    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
    Blood and lymphatic system disorders
    Iron deficiency anaemia
         subjects affected / exposed
    0 / 74 (0.00%)
    1 / 142 (0.70%)
    0 / 290 (0.00%)
    0 / 69 (0.00%)
    0 / 133 (0.00%)
    0 / 130 (0.00%)
    0 / 131 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Colitis ulcerative
         subjects affected / exposed
    0 / 74 (0.00%)
    0 / 142 (0.00%)
    1 / 290 (0.34%)
    0 / 69 (0.00%)
    0 / 133 (0.00%)
    0 / 130 (0.00%)
    0 / 131 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Irritable bowel syndrome
         subjects affected / exposed
    0 / 74 (0.00%)
    0 / 142 (0.00%)
    1 / 290 (0.34%)
    0 / 69 (0.00%)
    0 / 133 (0.00%)
    0 / 130 (0.00%)
    0 / 131 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    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
    Anal fissure
         subjects affected / exposed
    0 / 74 (0.00%)
    0 / 142 (0.00%)
    0 / 290 (0.00%)
    0 / 69 (0.00%)
    0 / 133 (0.00%)
    0 / 130 (0.00%)
    1 / 131 (0.76%)
         occurrences causally related to treatment / all
    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
    Crohn's disease
         subjects affected / exposed
    0 / 74 (0.00%)
    0 / 142 (0.00%)
    0 / 290 (0.00%)
    0 / 69 (0.00%)
    1 / 133 (0.75%)
    0 / 130 (0.00%)
    0 / 131 (0.00%)
         occurrences causally related to treatment / all
    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
    Anal fistula
         subjects affected / exposed
    0 / 74 (0.00%)
    0 / 142 (0.00%)
    0 / 290 (0.00%)
    0 / 69 (0.00%)
    0 / 133 (0.00%)
    0 / 130 (0.00%)
    1 / 131 (0.76%)
         occurrences causally related to treatment / all
    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
    Abdominal pain
         subjects affected / exposed
    0 / 74 (0.00%)
    0 / 142 (0.00%)
    0 / 290 (0.00%)
    1 / 69 (1.45%)
    0 / 133 (0.00%)
    0 / 130 (0.00%)
    0 / 131 (0.00%)
         occurrences causally related to treatment / all
    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
    Reproductive system and breast disorders
    Menorrhagia
         subjects affected / exposed
    0 / 74 (0.00%)
    0 / 142 (0.00%)
    1 / 290 (0.34%)
    0 / 69 (0.00%)
    0 / 133 (0.00%)
    0 / 130 (0.00%)
    0 / 131 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    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
    Hepatobiliary disorders
    Cholelithiasis
         subjects affected / exposed
    0 / 74 (0.00%)
    1 / 142 (0.70%)
    0 / 290 (0.00%)
    0 / 69 (0.00%)
    0 / 133 (0.00%)
    0 / 130 (0.00%)
    0 / 131 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cholecystitis acute
         subjects affected / exposed
    0 / 74 (0.00%)
    1 / 142 (0.70%)
    0 / 290 (0.00%)
    0 / 69 (0.00%)
    0 / 133 (0.00%)
    0 / 130 (0.00%)
    0 / 131 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Skin and subcutaneous tissue disorders
    Pain of skin
         subjects affected / exposed
    0 / 74 (0.00%)
    0 / 142 (0.00%)
    1 / 290 (0.34%)
    0 / 69 (0.00%)
    1 / 133 (0.75%)
    0 / 130 (0.00%)
    0 / 131 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hidradenitis
         subjects affected / exposed
    0 / 74 (0.00%)
    0 / 142 (0.00%)
    2 / 290 (0.69%)
    0 / 69 (0.00%)
    1 / 133 (0.75%)
    1 / 130 (0.77%)
    0 / 131 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 2
    0 / 0
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Psychiatric disorders
    Depression
         subjects affected / exposed
    0 / 74 (0.00%)
    0 / 142 (0.00%)
    0 / 290 (0.00%)
    0 / 69 (0.00%)
    0 / 133 (0.00%)
    1 / 130 (0.77%)
    0 / 131 (0.00%)
         occurrences causally related to treatment / all
    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
    Musculoskeletal and connective tissue disorders
    Rhabdomyolysis
         subjects affected / exposed
    0 / 74 (0.00%)
    0 / 142 (0.00%)
    1 / 290 (0.34%)
    0 / 69 (0.00%)
    0 / 133 (0.00%)
    0 / 130 (0.00%)
    0 / 131 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    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
    Infections and infestations
    Appendicitis
         subjects affected / exposed
    0 / 74 (0.00%)
    0 / 142 (0.00%)
    0 / 290 (0.00%)
    1 / 69 (1.45%)
    0 / 133 (0.00%)
    0 / 130 (0.00%)
    0 / 131 (0.00%)
         occurrences causally related to treatment / all
    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
    Gastroenteritis
         subjects affected / exposed
    0 / 74 (0.00%)
    0 / 142 (0.00%)
    0 / 290 (0.00%)
    0 / 69 (0.00%)
    0 / 133 (0.00%)
    1 / 130 (0.77%)
    0 / 131 (0.00%)
         occurrences causally related to treatment / all
    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
    Bartholinitis
         subjects affected / exposed
    0 / 74 (0.00%)
    0 / 142 (0.00%)
    0 / 290 (0.00%)
    0 / 69 (0.00%)
    0 / 133 (0.00%)
    0 / 130 (0.00%)
    1 / 131 (0.76%)
         occurrences causally related to treatment / all
    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
    Rash pustular
         subjects affected / exposed
    0 / 74 (0.00%)
    0 / 142 (0.00%)
    0 / 290 (0.00%)
    0 / 69 (0.00%)
    0 / 133 (0.00%)
    0 / 130 (0.00%)
    1 / 131 (0.76%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Corona virus infection
         subjects affected / exposed
    0 / 74 (0.00%)
    0 / 142 (0.00%)
    0 / 290 (0.00%)
    0 / 69 (0.00%)
    1 / 133 (0.75%)
    0 / 130 (0.00%)
    0 / 131 (0.00%)
         occurrences causally related to treatment / all
    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
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Placebo BKZ Dosing Regimen 1 BKZ Dosing Regimen 2 Placebo/BKZ Dosing Regimen 2 BKZ Dosing Regimen 1/BKZ Dosing Regimen 1 BKZ Dosing regimen 2/BKZ Dosing regimen 1 BKZ Dosing regimen 2/BKZ Dosing regimen 2
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    18 / 74 (24.32%)
    40 / 142 (28.17%)
    101 / 290 (34.83%)
    26 / 69 (37.68%)
    49 / 133 (36.84%)
    57 / 130 (43.85%)
    64 / 131 (48.85%)
    Nervous system disorders
    Headache
         subjects affected / exposed
    7 / 74 (9.46%)
    7 / 142 (4.93%)
    18 / 290 (6.21%)
    3 / 69 (4.35%)
    7 / 133 (5.26%)
    4 / 130 (3.08%)
    7 / 131 (5.34%)
         occurrences all number
    9
    9
    21
    3
    10
    5
    7
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed
    6 / 74 (8.11%)
    5 / 142 (3.52%)
    18 / 290 (6.21%)
    2 / 69 (2.90%)
    6 / 133 (4.51%)
    4 / 130 (3.08%)
    3 / 131 (2.29%)
         occurrences all number
    7
    6
    21
    3
    8
    5
    3
    Skin and subcutaneous tissue disorders
    Hidradenitis
         subjects affected / exposed
    5 / 74 (6.76%)
    13 / 142 (9.15%)
    23 / 290 (7.93%)
    7 / 69 (10.14%)
    16 / 133 (12.03%)
    24 / 130 (18.46%)
    15 / 131 (11.45%)
         occurrences all number
    6
    15
    27
    11
    19
    33
    15
    Eczema
         subjects affected / exposed
    1 / 74 (1.35%)
    1 / 142 (0.70%)
    9 / 290 (3.10%)
    4 / 69 (5.80%)
    5 / 133 (3.76%)
    5 / 130 (3.85%)
    3 / 131 (2.29%)
         occurrences all number
    1
    1
    10
    4
    6
    5
    3
    Infections and infestations
    Oral candidiasis
         subjects affected / exposed
    0 / 74 (0.00%)
    5 / 142 (3.52%)
    24 / 290 (8.28%)
    3 / 69 (4.35%)
    11 / 133 (8.27%)
    16 / 130 (12.31%)
    14 / 131 (10.69%)
         occurrences all number
    0
    5
    26
    3
    13
    18
    17
    Vulvovaginal candidiasis
         subjects affected / exposed
    0 / 74 (0.00%)
    8 / 142 (5.63%)
    1 / 290 (0.34%)
    1 / 69 (1.45%)
    2 / 133 (1.50%)
    3 / 130 (2.31%)
    3 / 131 (2.29%)
         occurrences all number
    0
    8
    1
    1
    3
    4
    3
    Nasopharyngitis
         subjects affected / exposed
    0 / 74 (0.00%)
    3 / 142 (2.11%)
    11 / 290 (3.79%)
    2 / 69 (2.90%)
    6 / 133 (4.51%)
    8 / 130 (6.15%)
    11 / 131 (8.40%)
         occurrences all number
    0
    3
    11
    2
    6
    9
    15
    Folliculitis
         subjects affected / exposed
    0 / 74 (0.00%)
    5 / 142 (3.52%)
    8 / 290 (2.76%)
    2 / 69 (2.90%)
    5 / 133 (3.76%)
    6 / 130 (4.62%)
    9 / 131 (6.87%)
         occurrences all number
    0
    5
    9
    2
    8
    6
    11
    Corona virus infection
         subjects affected / exposed
    0 / 74 (0.00%)
    3 / 142 (2.11%)
    11 / 290 (3.79%)
    4 / 69 (5.80%)
    2 / 133 (1.50%)
    7 / 130 (5.38%)
    8 / 131 (6.11%)
         occurrences all number
    0
    3
    11
    4
    2
    7
    8
    Rhinitis
         subjects affected / exposed
    1 / 74 (1.35%)
    1 / 142 (0.70%)
    0 / 290 (0.00%)
    1 / 69 (1.45%)
    1 / 133 (0.75%)
    2 / 130 (1.54%)
    7 / 131 (5.34%)
         occurrences all number
    1
    1
    0
    1
    1
    2
    7
    Upper respiratory tract infection
         subjects affected / exposed
    1 / 74 (1.35%)
    0 / 142 (0.00%)
    5 / 290 (1.72%)
    4 / 69 (5.80%)
    7 / 133 (5.26%)
    5 / 130 (3.85%)
    3 / 131 (2.29%)
         occurrences all number
    1
    0
    6
    4
    7
    6
    3

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    09 Feb 2021
    Protocol Amendment 3 was dated 09 Feb 2021, and approximately 300 study participants were enrolled at the time of the amendment. The purpose of this substantial amendment was to update the protocol based on Regulatory Agency feedback and provide procedural clarifications. Key changes included the following: • Order of secondary efficacy endpoints was aligned for closed testing procedure • Removal of 30% cap on enrollment for the Baseline antibiotic therapy strata • Aligned the final Independent Data Monitoring Committee (DMC) Charter and the DMC Statistical Analysis Plan (SAP) for the planned unblinded futility analysis for the DMC • Update and clarifications to Schedule of Activities, inclusion criteria, exclusion criteria, and severe acute respiratory syndrome. Necessary protocol revisions due to the coronavirus disease 2019 (COVID-19) pandemic • Removal of depression as a safety topic of interest while maintaining collection of data to monitor for this potential effect • Added lesion care section and updated wound care section • Clarified and updated prohibited medications and associated washout periods • Addition of specific infection-related Investigational Medicinal Product (IMP) interruption criterion.
    06 May 2022
    Protocol Amendment 4 was dated 06 May 2022, and all study participants were enrolled at the time of the amendment. The purpose of this substantial amendment was to align with Food and Drug Administration (FDA) recommendations. It was recommended that a threshold for within patient clinically meaningful change to define treatment success be used in order to establish efficacy for skin pain in Phase 3 studies of patients with moderate to severe HS. The Sponsor conducted analyses to determine the threshold for within-patient clinically meaningful change that was applied in the final analysis for a responder definition based on the Hidradenitis Suppurativa Symptom Daily Diary (HSSDD) worst skin pain item score using established guidelines and analytical methods. Pain response status at Week 16 using this definition was added as a secondary endpoint to the study. This change also resulted in an addition to the sample size section, including assumptions on response rates.

    Interruptions (globally)
    Were there any global interruptions to the trial? Yes
    Date
    Interruption
    Restart date
    20 Mar 2020
    Pause in recruitment due to Covid-19 pandemic.
    02 Jun 2020

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported
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    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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