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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
    2019-002550-23
    Trial protocol
    DE   GR   BE   NL   DK   ES   IT  
    Global end of trial date
    19 Feb 2023

    Results information
    Results version number
    v1(current)
    This version publication date
    06 Mar 2024
    First version publication date
    06 Mar 2024
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    HS0003
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    NCT04242446
    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
    10 Mar 2023
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    07 Apr 2022
    Global end of trial reached?
    Yes
    Global end of trial date
    19 Feb 2023
    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
    19 Feb 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: 22
    Country: Number of subjects enrolled
    Belgium: 8
    Country: Number of subjects enrolled
    Canada: 30
    Country: Number of subjects enrolled
    Denmark: 6
    Country: Number of subjects enrolled
    France: 38
    Country: Number of subjects enrolled
    Germany: 52
    Country: Number of subjects enrolled
    Greece: 45
    Country: Number of subjects enrolled
    Israel: 3
    Country: Number of subjects enrolled
    Italy: 24
    Country: Number of subjects enrolled
    Netherlands: 18
    Country: Number of subjects enrolled
    Norway: 2
    Country: Number of subjects enrolled
    Spain: 30
    Country: Number of subjects enrolled
    Switzerland: 4
    Country: Number of subjects enrolled
    Türkiye: 17
    Country: Number of subjects enrolled
    United States: 206
    Worldwide total number of subjects
    505
    EEA total number of subjects
    223
    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)
    497
    From 65 to 84 years
    8
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    The study started to enroll participants in February 2020 and concluded in February 2023.

    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
    72
    144
    289
    Completed
    65
    127
    259
    Not completed
    7
    17
    30
         Adverse event, non-fatal
    1
    5
    7
         Consent withdrawn by subject, not due to AE
    4
    6
    14
         Withdrawn based to Exclusion Criterion
    -
    -
    1
         Lost to follow-up
    1
    3
    2
         Per Sponsors Request Due To Covid 19 Pandemic
    -
    -
    1
         Randomized, not treated
    -
    1
    3
         Country Relocation
    1
    -
    -
         Protocol deviation
    -
    2
    2
    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
    65
    125
    129
    129
    Completed
    44
    87
    104
    98
    Not completed
    21
    38
    25
    31
         Relocation
    -
    1
    -
    -
         Sponsor's Decision
    -
    -
    -
    1
         Subject Withdrew Due To Custody Issue & Relocation
    -
    1
    -
    -
         Study Schedule Too Demanding, Clashing With Work
    -
    1
    -
    -
         Consent withdrawn by subject, not due to AE
    7
    12
    11
    14
         Patient Relocated And Withdrew Consent
    -
    1
    -
    -
         Patient Relocated Last Minute Decision
    -
    -
    1
    -
         Subject Moved A Long Distance From Clinic
    -
    1
    -
    -
         Subject Is Moving A Long Distance From Clinic
    1
    -
    -
    -
         Patient Move Away
    -
    -
    1
    -
         Adverse event, non-fatal
    9
    7
    5
    6
         Needs Systemic Therapy Incompatible With Protocol
    -
    -
    -
    1
         Lost to follow-up
    2
    5
    3
    3
         Develop Illness Would Interfere With Participation
    -
    -
    -
    1
         Lack of efficacy
    1
    7
    3
    3
         Protocol deviation
    1
    2
    1
    2
    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: 2 participants completed the 16-Week Initial Treatment Period but did not enter the Maintenance Treatment Period because of the reason: Adverse event and Consent withdrawn by subject (not due to adverse event) of BKZ Dosing Regimen 1/BKZ Dosing Regimen 1 arm. 1 participant completed the 16-Week Initial Treatment Period but did not enter the Maintenance Treatment Period because of the reason: Protocol violation of BKZ Dosing regimen 2/BKZ Dosing regimen 1 arm.

    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
    72 144 289 505
    Age Categorical
    Units: Participants
        18 years - <65 years
    71 143 283 497
        65 years - <85 years
    1 1 6 8
    Age Continuous
    Units: Years
        arithmetic mean (standard deviation)
    36.4 ± 12.4 36.3 ± 11.2 36.9 ± 12.4 -
    Sex: Female, Male
    Units: Participants
        Female
    44 98 176 318
        Male
    28 46 113 187

    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 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 adverse event (AE) or lack of efficacy. Percentage of participants shown do not account for model effects using the logistic regression model. The RS consisted of all 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
    72
    144
    289
    Units: percentage of participants
        number (confidence interval 95%)
    28.7 (18.1 to 39.3)
    45.3 (36.8 to 53.8)
    47.8 (41.8 to 53.7)
    Statistical analysis title
    Statistical Analysis 1
    Comparison groups
    Placebo v BKZ Dosing Regimen 1
    Number of subjects included in analysis
    216
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.03
    Method
    Regression, Logistic
    Parameter type
    Odds ratio (OR)
    Point estimate
    2
    Confidence interval
         level
    97.5%
         sides
    2-sided
         lower limit
    0.979
         upper limit
    4.089
    Statistical analysis title
    Statistical Analysis 2
    Comparison groups
    Placebo v BKZ Dosing Regimen 2
    Number of subjects included in analysis
    361
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.006
    Method
    Regression, Logistic
    Parameter type
    Odds ratio (OR)
    Point estimate
    2.234
    Confidence interval
         level
    97.5%
         sides
    2-sided
         lower limit
    1.159
         upper limit
    4.307

    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. Percentage of participants shown do not account for model effects using the logistic regression model. The RS consisted of all 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
    72
    144
    289
    Units: percentage of participants
        number (confidence interval 95%)
    18.4 (9.3 to 27.5)
    24.7 (17.3 to 32.1)
    33.4 (27.8 to 39.1)
    Statistical analysis title
    Statistical Analysis 2
    Comparison groups
    Placebo v BKZ Dosing Regimen 2
    Number of subjects included in analysis
    361
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.021
    Method
    Regression, Logistic
    Parameter type
    Odds ratio (OR)
    Point estimate
    2.175
    Confidence interval
         level
    97.5%
         sides
    2-sided
         lower limit
    1.021
         upper limit
    4.635
    Statistical analysis title
    Statistical Analysis 1
    Comparison groups
    Placebo v BKZ Dosing Regimen 1
    Number of subjects included in analysis
    216
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.35 [1]
    Method
    Regression, Logistic
    Parameter type
    Odds ratio (OR)
    Point estimate
    1.416
    Confidence interval
         level
    97.5%
         sides
    2-sided
         lower limit
    0.615
         upper limit
    3.26
    Notes
    [1] - Nominal p-value only due to the testing hierarchy failing on the HISCR50 outcome.

    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
    72
    144
    289
    Units: score on a scale
        arithmetic mean (standard error)
    -2.7 ± 0.9
    -5.5 ± 0.6
    -5.0 ± 0.4
    Statistical analysis title
    Statistical Analysis 2
    Comparison groups
    Placebo v BKZ Dosing Regimen 2
    Number of subjects included in analysis
    361
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.001
    Method
    ANCOVA
    Parameter type
    LS mean difference
    Point estimate
    -2.682
    Confidence interval
         level
    97.5%
         sides
    2-sided
         lower limit
    -4.394
         upper limit
    -0.97
    Statistical analysis title
    Statistical Analysis 1
    Comparison groups
    Placebo v BKZ Dosing Regimen 1
    Number of subjects included in analysis
    216
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.002 [2]
    Method
    ANCOVA
    Parameter type
    LS mean difference
    Point estimate
    -2.574
    Confidence interval
         level
    97.5%
         sides
    2-sided
         lower limit
    -4.472
         upper limit
    -0.675
    Notes
    [2] - Nominal p-value only due to the testing hierarchy failing on the HISCR50 outcome.

    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
    72
    144
    289
    Units: score on a scale
        arithmetic mean (standard error)
    -0.99 ± 0.38
    -1.56 ± 0.26
    -2.00 ± 0.17
    Statistical analysis title
    Statistical Analysis 1
    Comparison groups
    Placebo v BKZ Dosing Regimen 1
    Number of subjects included in analysis
    216
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.201 [3]
    Method
    ANCOVA
    Parameter type
    LS mean difference
    Point estimate
    -0.551
    Confidence interval
         level
    97.5%
         sides
    2-sided
         lower limit
    -1.521
         upper limit
    0.418
    Notes
    [3] - Nominal p-value only due to the testing hierarchy failing on the HISCR50 outcome.
    Statistical analysis title
    Statistical Analysis 2
    Comparison groups
    Placebo v BKZ Dosing Regimen 2
    Number of subjects included in analysis
    361
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.002
    Method
    ANCOVA
    Parameter type
    LS mean difference
    Point estimate
    -1.186
    Confidence interval
         level
    97.5%
         sides
    2-sided
         lower limit
    -2.05
         upper limit
    -0.322

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

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    End point title
    Percentage of participants achieving Worst 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. Percentage 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
    46
    103
    190
    Units: percentage of participants
        number (confidence interval 95%)
    15.0 (3.6 to 26.5)
    22.1 (12.7 to 31.4)
    32.3 (25.1 to 39.5)
    Statistical analysis title
    Statistical Analysis 1
    Comparison groups
    Placebo v BKZ Dosing Regimen 1
    Number of subjects included in analysis
    149
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.367 [4]
    Method
    Regression, Logistic
    Parameter type
    Odds ratio (OR)
    Point estimate
    1.618
    Confidence interval
         level
    97.5%
         sides
    2-sided
         lower limit
    0.489
         upper limit
    5.352
    Notes
    [4] - Nominal p-value only due to the testing hierarchy failing on the HISCR50 outcome.
    Statistical analysis title
    Statistical Analysis 2
    Comparison groups
    Placebo v BKZ Dosing Regimen 2
    Number of subjects included in analysis
    236
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.041
    Method
    Regression, Logistic
    Parameter type
    Odds ratio (OR)
    Point estimate
    2.757
    Confidence interval
         level
    97.5%
         sides
    2-sided
         lower limit
    0.909
         upper limit
    8.364

    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. TEAEs are defined as 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
    72
    65
    143
    125
    286
    129
    129
    Units: percentage of participants
        number (not applicable)
    66.7
    81.5
    65.7
    76.0
    67.1
    79.1
    81.4
    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. TEAEs are defined as 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
    72
    65
    143
    125
    286
    129
    129
    Units: percentage of participants
        number (not applicable)
    0
    9.2
    2.8
    8.0
    2.1
    5.4
    7.8
    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. TEAEs are defined as 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. TEAEs leading to discontinuation of the study are reported.
    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
    72
    65
    143
    125
    286
    129
    129
    Units: percentage of participants
        number (not applicable)
    1.4
    13.8
    4.2
    4.8
    3.5
    1.6
    4.7
    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
    TEAEs are defined as 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
    BKZ Dosing Regimen 2
    Reporting group description
    Participants received BKZ dosing regimen 2 SC 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
    Placebo
    Reporting group description
    Participants received placebo during the 16-weeks Initial Treatment Period.

    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 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 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).

    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).

    Serious adverse events
    BKZ Dosing Regimen 2 BKZ Dosing Regimen 1 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 Placebo/BKZ Dosing Regimen 2
    Total subjects affected by serious adverse events
         subjects affected / exposed
    6 / 286 (2.10%)
    4 / 143 (2.80%)
    0 / 72 (0.00%)
    7 / 129 (5.43%)
    10 / 125 (8.00%)
    10 / 129 (7.75%)
    6 / 65 (9.23%)
         number of deaths (all causes)
    0
    0
    0
    0
    0
    1
    0
         number of deaths resulting from adverse events
    0
    0
    0
    0
    0
    1
    0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Intraductal proliferative breast lesion
         subjects affected / exposed
    0 / 286 (0.00%)
    0 / 143 (0.00%)
    0 / 72 (0.00%)
    0 / 129 (0.00%)
    0 / 125 (0.00%)
    0 / 129 (0.00%)
    1 / 65 (1.54%)
         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
    Vascular disorders
    Deep vein thrombosis
         subjects affected / exposed
    0 / 286 (0.00%)
    0 / 143 (0.00%)
    0 / 72 (0.00%)
    0 / 129 (0.00%)
    0 / 125 (0.00%)
    1 / 129 (0.78%)
    0 / 65 (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
    Thrombophlebitis superficial
         subjects affected / exposed
    0 / 286 (0.00%)
    0 / 143 (0.00%)
    0 / 72 (0.00%)
    0 / 129 (0.00%)
    1 / 125 (0.80%)
    0 / 129 (0.00%)
    0 / 65 (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
    Surgical and medical procedures
    Abortion induced
         subjects affected / exposed
    0 / 286 (0.00%)
    1 / 143 (0.70%)
    0 / 72 (0.00%)
    0 / 129 (0.00%)
    0 / 125 (0.00%)
    0 / 129 (0.00%)
    0 / 65 (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
    Pregnancy, puerperium and perinatal conditions
    Pregnancy on contraceptive
         subjects affected / exposed
    1 / 286 (0.35%)
    0 / 143 (0.00%)
    0 / 72 (0.00%)
    0 / 129 (0.00%)
    0 / 125 (0.00%)
    0 / 129 (0.00%)
    0 / 65 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Abortion spontaneous
         subjects affected / exposed
    0 / 286 (0.00%)
    0 / 143 (0.00%)
    0 / 72 (0.00%)
    1 / 129 (0.78%)
    0 / 125 (0.00%)
    0 / 129 (0.00%)
    0 / 65 (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
    Genital erythema
         subjects affected / exposed
    0 / 286 (0.00%)
    0 / 143 (0.00%)
    0 / 72 (0.00%)
    0 / 129 (0.00%)
    0 / 125 (0.00%)
    0 / 129 (0.00%)
    1 / 65 (1.54%)
         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
    Psychiatric disorders
    Suicidal ideation
         subjects affected / exposed
    0 / 286 (0.00%)
    1 / 143 (0.70%)
    0 / 72 (0.00%)
    0 / 129 (0.00%)
    1 / 125 (0.80%)
    1 / 129 (0.78%)
    1 / 65 (1.54%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
    0 / 0
    0 / 1
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Ankle fracture
         subjects affected / exposed
    0 / 286 (0.00%)
    0 / 143 (0.00%)
    0 / 72 (0.00%)
    0 / 129 (0.00%)
    1 / 125 (0.80%)
    0 / 129 (0.00%)
    0 / 65 (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
    Road traffic accident
         subjects affected / exposed
    0 / 286 (0.00%)
    0 / 143 (0.00%)
    0 / 72 (0.00%)
    1 / 129 (0.78%)
    0 / 125 (0.00%)
    0 / 129 (0.00%)
    0 / 65 (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
    Laceration
         subjects affected / exposed
    0 / 286 (0.00%)
    0 / 143 (0.00%)
    0 / 72 (0.00%)
    0 / 129 (0.00%)
    0 / 125 (0.00%)
    0 / 129 (0.00%)
    1 / 65 (1.54%)
         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
    Cardiac disorders
    Cardiac failure acute
         subjects affected / exposed
    1 / 286 (0.35%)
    0 / 143 (0.00%)
    0 / 72 (0.00%)
    0 / 129 (0.00%)
    0 / 125 (0.00%)
    0 / 129 (0.00%)
    0 / 65 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cardiac failure congestive
         subjects affected / exposed
    0 / 286 (0.00%)
    0 / 143 (0.00%)
    0 / 72 (0.00%)
    0 / 129 (0.00%)
    0 / 125 (0.00%)
    1 / 129 (0.78%)
    0 / 65 (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 / 1
    0 / 0
    Acute coronary syndrome
         subjects affected / exposed
    0 / 286 (0.00%)
    0 / 143 (0.00%)
    0 / 72 (0.00%)
    1 / 129 (0.78%)
    0 / 125 (0.00%)
    0 / 129 (0.00%)
    0 / 65 (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
    Atrial fibrillation
         subjects affected / exposed
    0 / 286 (0.00%)
    0 / 143 (0.00%)
    0 / 72 (0.00%)
    0 / 129 (0.00%)
    0 / 125 (0.00%)
    0 / 129 (0.00%)
    1 / 65 (1.54%)
         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
    Nervous system disorders
    Cerebral infarction
         subjects affected / exposed
    0 / 286 (0.00%)
    0 / 143 (0.00%)
    0 / 72 (0.00%)
    0 / 129 (0.00%)
    0 / 125 (0.00%)
    1 / 129 (0.78%)
    0 / 65 (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
    Ear and labyrinth disorders
    Vertigo
         subjects affected / exposed
    0 / 286 (0.00%)
    0 / 143 (0.00%)
    0 / 72 (0.00%)
    0 / 129 (0.00%)
    1 / 125 (0.80%)
    0 / 129 (0.00%)
    0 / 65 (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
    Eye disorders
    Keratitis
         subjects affected / exposed
    0 / 286 (0.00%)
    1 / 143 (0.70%)
    0 / 72 (0.00%)
    0 / 129 (0.00%)
    0 / 125 (0.00%)
    0 / 129 (0.00%)
    0 / 65 (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
    Gastrointestinal disorders
    Small intestinal obstruction
         subjects affected / exposed
    0 / 286 (0.00%)
    1 / 143 (0.70%)
    0 / 72 (0.00%)
    0 / 129 (0.00%)
    0 / 125 (0.00%)
    0 / 129 (0.00%)
    0 / 65 (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
    Colitis ulcerative
         subjects affected / exposed
    0 / 286 (0.00%)
    0 / 143 (0.00%)
    0 / 72 (0.00%)
    1 / 129 (0.78%)
    0 / 125 (0.00%)
    0 / 129 (0.00%)
    0 / 65 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    1 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Aphthous ulcer
         subjects affected / exposed
    0 / 286 (0.00%)
    0 / 143 (0.00%)
    0 / 72 (0.00%)
    0 / 129 (0.00%)
    0 / 125 (0.00%)
    0 / 129 (0.00%)
    1 / 65 (1.54%)
         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
    Hepatobiliary disorders
    Cholelithiasis
         subjects affected / exposed
    1 / 286 (0.35%)
    0 / 143 (0.00%)
    0 / 72 (0.00%)
    0 / 129 (0.00%)
    0 / 125 (0.00%)
    0 / 129 (0.00%)
    0 / 65 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Drug-induced liver injury
         subjects affected / exposed
    1 / 286 (0.35%)
    0 / 143 (0.00%)
    0 / 72 (0.00%)
    0 / 129 (0.00%)
    0 / 125 (0.00%)
    0 / 129 (0.00%)
    0 / 65 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Skin and subcutaneous tissue disorders
    Hidradenitis
         subjects affected / exposed
    1 / 286 (0.35%)
    0 / 143 (0.00%)
    0 / 72 (0.00%)
    0 / 129 (0.00%)
    3 / 125 (2.40%)
    2 / 129 (1.55%)
    1 / 65 (1.54%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 3
    1 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Intertrigo
         subjects affected / exposed
    0 / 286 (0.00%)
    0 / 143 (0.00%)
    0 / 72 (0.00%)
    0 / 129 (0.00%)
    1 / 125 (0.80%)
    0 / 129 (0.00%)
    0 / 65 (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
    Diabetic foot
         subjects affected / exposed
    0 / 286 (0.00%)
    0 / 143 (0.00%)
    0 / 72 (0.00%)
    0 / 129 (0.00%)
    0 / 125 (0.00%)
    1 / 129 (0.78%)
    0 / 65 (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
    Diabetic ulcer
         subjects affected / exposed
    0 / 286 (0.00%)
    0 / 143 (0.00%)
    0 / 72 (0.00%)
    0 / 129 (0.00%)
    0 / 125 (0.00%)
    1 / 129 (0.78%)
    0 / 65 (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
    Renal and urinary disorders
    Nephrolithiasis
         subjects affected / exposed
    0 / 286 (0.00%)
    0 / 143 (0.00%)
    0 / 72 (0.00%)
    1 / 129 (0.78%)
    1 / 125 (0.80%)
    0 / 129 (0.00%)
    0 / 65 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    1 / 1
    0 / 3
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Ureterolithiasis
         subjects affected / exposed
    0 / 286 (0.00%)
    0 / 143 (0.00%)
    0 / 72 (0.00%)
    0 / 129 (0.00%)
    1 / 125 (0.80%)
    0 / 129 (0.00%)
    0 / 65 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 2
    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
    Cellulitis
         subjects affected / exposed
    1 / 286 (0.35%)
    0 / 143 (0.00%)
    0 / 72 (0.00%)
    0 / 129 (0.00%)
    0 / 125 (0.00%)
    1 / 129 (0.78%)
    0 / 65 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    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
    Peritonitis
         subjects affected / exposed
    0 / 286 (0.00%)
    0 / 143 (0.00%)
    0 / 72 (0.00%)
    0 / 129 (0.00%)
    0 / 125 (0.00%)
    1 / 129 (0.78%)
    0 / 65 (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
    Periorbital cellulitis
         subjects affected / exposed
    0 / 286 (0.00%)
    0 / 143 (0.00%)
    0 / 72 (0.00%)
    0 / 129 (0.00%)
    0 / 125 (0.00%)
    0 / 129 (0.00%)
    1 / 65 (1.54%)
         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
    Genital candidiasis
         subjects affected / exposed
    0 / 286 (0.00%)
    0 / 143 (0.00%)
    0 / 72 (0.00%)
    0 / 129 (0.00%)
    1 / 125 (0.80%)
    0 / 129 (0.00%)
    0 / 65 (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
    Oropharyngeal candidiasis
         subjects affected / exposed
    0 / 286 (0.00%)
    0 / 143 (0.00%)
    0 / 72 (0.00%)
    0 / 129 (0.00%)
    1 / 125 (0.80%)
    0 / 129 (0.00%)
    0 / 65 (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
    Tooth abscess
         subjects affected / exposed
    0 / 286 (0.00%)
    0 / 143 (0.00%)
    0 / 72 (0.00%)
    1 / 129 (0.78%)
    0 / 125 (0.00%)
    0 / 129 (0.00%)
    0 / 65 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 2
    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
    Groin infection
         subjects affected / exposed
    0 / 286 (0.00%)
    0 / 143 (0.00%)
    0 / 72 (0.00%)
    0 / 129 (0.00%)
    0 / 125 (0.00%)
    1 / 129 (0.78%)
    0 / 65 (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
    Bronchitis
         subjects affected / exposed
    0 / 286 (0.00%)
    0 / 143 (0.00%)
    0 / 72 (0.00%)
    1 / 129 (0.78%)
    0 / 125 (0.00%)
    0 / 129 (0.00%)
    0 / 65 (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
    Sepsis
         subjects affected / exposed
    0 / 286 (0.00%)
    0 / 143 (0.00%)
    0 / 72 (0.00%)
    0 / 129 (0.00%)
    0 / 125 (0.00%)
    1 / 129 (0.78%)
    0 / 65 (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
    Wound infection staphylococcal
         subjects affected / exposed
    0 / 286 (0.00%)
    0 / 143 (0.00%)
    0 / 72 (0.00%)
    1 / 129 (0.78%)
    0 / 125 (0.00%)
    0 / 129 (0.00%)
    0 / 65 (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
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    BKZ Dosing Regimen 2 BKZ Dosing Regimen 1 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 Placebo/BKZ Dosing Regimen 2
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    94 / 286 (32.87%)
    52 / 143 (36.36%)
    23 / 72 (31.94%)
    69 / 129 (53.49%)
    63 / 125 (50.40%)
    63 / 129 (48.84%)
    38 / 65 (58.46%)
    Investigations
    Psychiatric evaluation abnormal
         subjects affected / exposed
    2 / 286 (0.70%)
    7 / 143 (4.90%)
    2 / 72 (2.78%)
    2 / 129 (1.55%)
    4 / 125 (3.20%)
    1 / 129 (0.78%)
    4 / 65 (6.15%)
         occurrences all number
    2
    7
    2
    2
    4
    1
    4
    Nervous system disorders
    Headache
         subjects affected / exposed
    22 / 286 (7.69%)
    8 / 143 (5.59%)
    3 / 72 (4.17%)
    8 / 129 (6.20%)
    4 / 125 (3.20%)
    5 / 129 (3.88%)
    5 / 65 (7.69%)
         occurrences all number
    27
    14
    3
    8
    9
    5
    5
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed
    18 / 286 (6.29%)
    12 / 143 (8.39%)
    1 / 72 (1.39%)
    5 / 129 (3.88%)
    6 / 125 (4.80%)
    6 / 129 (4.65%)
    6 / 65 (9.23%)
         occurrences all number
    21
    14
    1
    6
    7
    9
    7
    Skin and subcutaneous tissue disorders
    Hidradenitis
         subjects affected / exposed
    18 / 286 (6.29%)
    12 / 143 (8.39%)
    10 / 72 (13.89%)
    19 / 129 (14.73%)
    27 / 125 (21.60%)
    17 / 129 (13.18%)
    11 / 65 (16.92%)
         occurrences all number
    21
    15
    11
    25
    38
    32
    13
    Eczema
         subjects affected / exposed
    5 / 286 (1.75%)
    3 / 143 (2.10%)
    1 / 72 (1.39%)
    5 / 129 (3.88%)
    7 / 125 (5.60%)
    7 / 129 (5.43%)
    2 / 65 (3.08%)
         occurrences all number
    5
    3
    1
    5
    7
    7
    2
    Seborrhoeic dermatitis
         subjects affected / exposed
    6 / 286 (2.10%)
    4 / 143 (2.80%)
    0 / 72 (0.00%)
    7 / 129 (5.43%)
    3 / 125 (2.40%)
    1 / 129 (0.78%)
    3 / 65 (4.62%)
         occurrences all number
    6
    4
    0
    7
    3
    1
    4
    Musculoskeletal and connective tissue disorders
    Back pain
         subjects affected / exposed
    7 / 286 (2.45%)
    0 / 143 (0.00%)
    6 / 72 (8.33%)
    1 / 129 (0.78%)
    4 / 125 (3.20%)
    2 / 129 (1.55%)
    0 / 65 (0.00%)
         occurrences all number
    7
    0
    6
    1
    4
    2
    0
    Infections and infestations
    Oral candidiasis
         subjects affected / exposed
    17 / 286 (5.94%)
    2 / 143 (1.40%)
    0 / 72 (0.00%)
    10 / 129 (7.75%)
    11 / 125 (8.80%)
    11 / 129 (8.53%)
    3 / 65 (4.62%)
         occurrences all number
    18
    2
    0
    13
    12
    17
    4
    Corona virus infection
         subjects affected / exposed
    9 / 286 (3.15%)
    2 / 143 (1.40%)
    2 / 72 (2.78%)
    19 / 129 (14.73%)
    14 / 125 (11.20%)
    18 / 129 (13.95%)
    9 / 65 (13.85%)
         occurrences all number
    9
    2
    2
    20
    14
    18
    9
    Fungal skin infection
         subjects affected / exposed
    2 / 286 (0.70%)
    3 / 143 (2.10%)
    1 / 72 (1.39%)
    7 / 129 (5.43%)
    3 / 125 (2.40%)
    4 / 129 (3.10%)
    2 / 65 (3.08%)
         occurrences all number
    2
    3
    1
    7
    3
    5
    2
    Influenza
         subjects affected / exposed
    3 / 286 (1.05%)
    0 / 143 (0.00%)
    2 / 72 (2.78%)
    2 / 129 (1.55%)
    2 / 125 (1.60%)
    2 / 129 (1.55%)
    4 / 65 (6.15%)
         occurrences all number
    3
    0
    2
    3
    2
    2
    4
    Nasopharyngitis
         subjects affected / exposed
    12 / 286 (4.20%)
    7 / 143 (4.90%)
    3 / 72 (4.17%)
    10 / 129 (7.75%)
    6 / 125 (4.80%)
    4 / 129 (3.10%)
    4 / 65 (6.15%)
         occurrences all number
    14
    10
    5
    12
    6
    4
    7
    Upper respiratory tract infection
         subjects affected / exposed
    4 / 286 (1.40%)
    0 / 143 (0.00%)
    0 / 72 (0.00%)
    7 / 129 (5.43%)
    7 / 125 (5.60%)
    7 / 129 (5.43%)
    2 / 65 (3.08%)
         occurrences all number
    4
    0
    0
    8
    8
    10
    2
    Urinary tract infection
         subjects affected / exposed
    4 / 286 (1.40%)
    4 / 143 (2.80%)
    1 / 72 (1.39%)
    9 / 129 (6.98%)
    3 / 125 (2.40%)
    8 / 129 (6.20%)
    4 / 65 (6.15%)
         occurrences all number
    4
    4
    1
    9
    3
    8
    5

    More information

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    Substantial protocol amendments (globally)

    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    03 Feb 2021
    Protocol Amendment 3 was dated 03 Feb 2021, and approximately 162 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 IMP interruption criterion.
    09 May 2022
    Protocol Amendment 4 was dated 09 May 2022, and all 505 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.
    27 Sep 2022
    Protocol Amendment 5 was dated 27 Sep 2022, and all 505 study participants were enrolled at the time of the amendment. The purpose of this substantial amendment was to remove the flare (secondary) endpoint from the statistical testing procedure. The rationale for the amendment was the lack of unanimous consensus on the definition of HS flare, including the flare definition used in previous and ongoing clinical studies (outside of and independent of HS0003), the continued lack of published validation studies of a flare endpoint, and inconsistent data on the flare endpoint observed both within the bimekizumab program and in recently published data from another experimental HS treatment. (Kimball et al, 2022). Flare was included as an “Other” endpoint in the study.

    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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    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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