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    Clinical Trial Results:
    A Phase 3, Multicenter, Randomized, Double-Blind, Placebo- and Active Comparator-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of Bimekizumab in Adult Subjects With Moderate to Severe Chronic Plaque Psoriasis

    Summary
    EudraCT number
    2016-003425-42
    Trial protocol
    DE   GB   HU   BE   FR   IT  
    Global end of trial date
    13 Dec 2019

    Results information
    Results version number
    v1(current)
    This version publication date
    26 Dec 2020
    First version publication date
    26 Dec 2020
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    PS0009
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    NCT03370133
    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
    07 Feb 2020
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    13 Dec 2019
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    Compare the efficacy of bimekizumab administered subcutaneously (sc) for 16 weeks versus placebo in the treatment of subjects with moderate to severe plaque psoriasis (PSO)
    Protection of trial subjects
    During the conduct of the study all participants were closely monitored.
    Background therapy
    Not Applicable
    Evidence for comparator
    Ustekinumab has been approved in the US and the EU for the treatment of patients with moderate to severe plaque PSO who are candidates for phototherapy or systemic therapy. Ustekinumab is a human immunoglobulin (Ig) G1κ monoclonal antibody that binds with specificity to the p40 protein subunit used by both the IL-12 and IL-23 cytokines, naturally occurring cytokines that are involved in inflammatory and immune responses, such as natural killer cell activation and CD4+ T-cell differentiation and activation.
    Actual start date of recruitment
    06 Dec 2017
    Long term follow-up planned
    Yes
    Long term follow-up rationale
    Safety
    Long term follow-up duration
    3 Years
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Australia: 14
    Country: Number of subjects enrolled
    Belgium: 6
    Country: Number of subjects enrolled
    Canada: 61
    Country: Number of subjects enrolled
    Germany: 62
    Country: Number of subjects enrolled
    Hungary: 27
    Country: Number of subjects enrolled
    Italy: 4
    Country: Number of subjects enrolled
    Japan: 108
    Country: Number of subjects enrolled
    Poland: 143
    Country: Number of subjects enrolled
    Russian Federation: 19
    Country: Number of subjects enrolled
    United Kingdom: 7
    Country: Number of subjects enrolled
    United States: 116
    Worldwide total number of subjects
    567
    EEA total number of subjects
    249
    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)
    505
    From 65 to 84 years
    62
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    This study started to enroll participants in December 2017 and concluded in December 2019.

    Pre-assignment
    Screening details
    The study included a 2-5 week Screening Period, a 16-week Initial Period and a 36-week Maintenance Period. After the Maintenance Period participants either enrolled in an open-label study or had a SFU Visit 20 weeks after their final dose (including those withdrawn from IMP). Participant Flow refers to the Randomized Set and Maintenance Set.

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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    Placebo
    Arm description
    Participants received placebo up to Week 16 and bimekizumab starting at Week 16 through Week 52.
    Arm type
    Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    PBO
    Other name
    Pharmaceutical forms
    Solution for injection in pre-filled syringe
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Participants received placebo at pre-specified time intervals.

    Arm title
    Bimekizumab
    Arm description
    Participants received bimekizumab for 52 weeks.
    Arm type
    Experimental

    Investigational medicinal product name
    Bimekizumab
    Investigational medicinal product code
    BKZ
    Other name
    UCB4940
    Pharmaceutical forms
    Solution for injection in pre-filled syringe
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Bimekizumab was provided at pre-specified time intervals.

    Arm title
    Ustekinumab
    Arm description
    Participants received ustekinumab (dose 1 or dose 2 depending on participants weight) for 52 weeks. Placebo was administered at pre-specified time points to maintain the blinding.
    Arm type
    Active comparator

    Investigational medicinal product name
    Ustekinumab
    Investigational medicinal product code
    Uste
    Other name
    Stelara®
    Pharmaceutical forms
    Solution for injection in pre-filled syringe
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Ustekinumab was provided as dose 1 for participants weighing <=100 kg and as dose 2 for participants weighing >100 kg at pre-specified time intervals.

    Number of subjects in period 1
    Placebo Bimekizumab Ustekinumab
    Started
    83
    321
    163
    Completed
    74
    306
    157
    Not completed
    9
    15
    6
         Protocol deviation
    -
    -
    2
         Site closed
    -
    2
    -
         Non-compliance
    -
    1
    -
         Lack of efficacy
    2
    1
    -
         Adverse event, serious fatal
    1
    1
    1
         Adverse event, non-fatal
    5
    5
    2
         Consent withdrawn by subject
    1
    2
    1
         Lost to follow-up
    -
    3
    -
    Period 2
    Period 2 title
    Maintenance Treatment Period (WK 52)
    Is this the baseline period?
    No
    Allocation method
    Randomised - controlled
    Blinding used
    Double blind
    Roles blinded
    Carer, Assessor, Subject, Investigator

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    Placebo/Bimekizumab
    Arm description
    After the 16-week Initial Treatment Period (Initial Period) participants initially randomized to placebo received bimekizumab during the 36-week Maintenance Treatment Period (Maintenance Period).
    Arm type
    Experimental

    Investigational medicinal product name
    Bimekizumab
    Investigational medicinal product code
    BKZ
    Other name
    UCB4940
    Pharmaceutical forms
    Solution for injection in pre-filled syringe
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Bimekizumab was provided at pre-specified time intervals.

    Arm title
    Bimekizumab/Bimekizumab
    Arm description
    After the 16-week Initial Treatment Period participants initially randomized to bimekizumab continued to receive bimekizumab during the 36-week Maintenance Treatment Period.
    Arm type
    Experimental

    Investigational medicinal product name
    Bimekizumab
    Investigational medicinal product code
    BKZ
    Other name
    UCB4940
    Pharmaceutical forms
    Solution for injection in pre-filled syringe
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Bimekizumab was provided at pre-specified time intervals.

    Arm title
    Ustekinumab/Ustekinumab
    Arm description
    After the 16-week Initial Treatment Period participants initially randomized to ustekinumab continued to receive ustekinumab during the 36-week Maintenance Treatment Period.
    Arm type
    Active comparator

    Investigational medicinal product name
    Ustekinumab
    Investigational medicinal product code
    Uste
    Other name
    Stelara®
    Pharmaceutical forms
    Solution for injection in pre-filled syringe
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Ustekinumab was provided as dose 1 for participants weighing <=100 kg and as dose 2 for participants weighing >100 kg at pre-specified time intervals.

    Number of subjects in period 2
    Placebo/Bimekizumab Bimekizumab/Bimekizumab Ustekinumab/Ustekinumab
    Started
    74
    306
    157
    Completed
    69
    283
    141
    Not completed
    5
    23
    16
         Protocol deviation
    1
    1
    -
         Non-compliance
    -
    1
    -
         Lack of efficacy
    -
    1
    4
         Adverse event, non-fatal
    3
    12
    4
         Consent Withdrawn for IMP Not Procedures
    -
    -
    1
         Consent withdrawn by subject
    1
    4
    4
         Lost to follow-up
    -
    4
    3

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Placebo
    Reporting group description
    Participants received placebo up to Week 16 and bimekizumab starting at Week 16 through Week 52.

    Reporting group title
    Bimekizumab
    Reporting group description
    Participants received bimekizumab for 52 weeks.

    Reporting group title
    Ustekinumab
    Reporting group description
    Participants received ustekinumab (dose 1 or dose 2 depending on participants weight) for 52 weeks. Placebo was administered at pre-specified time points to maintain the blinding.

    Reporting group values
    Placebo Bimekizumab Ustekinumab Total
    Number of subjects
    83 321 163 567
    Age categorical
    Units: Subjects
        <=18 years
    0 2 1 3
        Between 18 and 65 years
    73 285 144 502
        >=65 years
    10 34 18 62
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    49.7 ± 13.6 45.2 ± 14.0 46.0 ± 13.6 -
    Gender categorical
    Units: Subjects
        Female
    23 92 46 161
        Male
    60 229 117 406

    End points

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    End points reporting groups
    Reporting group title
    Placebo
    Reporting group description
    Participants received placebo up to Week 16 and bimekizumab starting at Week 16 through Week 52.

    Reporting group title
    Bimekizumab
    Reporting group description
    Participants received bimekizumab for 52 weeks.

    Reporting group title
    Ustekinumab
    Reporting group description
    Participants received ustekinumab (dose 1 or dose 2 depending on participants weight) for 52 weeks. Placebo was administered at pre-specified time points to maintain the blinding.
    Reporting group title
    Placebo/Bimekizumab
    Reporting group description
    After the 16-week Initial Treatment Period (Initial Period) participants initially randomized to placebo received bimekizumab during the 36-week Maintenance Treatment Period (Maintenance Period).

    Reporting group title
    Bimekizumab/Bimekizumab
    Reporting group description
    After the 16-week Initial Treatment Period participants initially randomized to bimekizumab continued to receive bimekizumab during the 36-week Maintenance Treatment Period.

    Reporting group title
    Ustekinumab/Ustekinumab
    Reporting group description
    After the 16-week Initial Treatment Period participants initially randomized to ustekinumab continued to receive ustekinumab during the 36-week Maintenance Treatment Period.

    Subject analysis set title
    Placebo (RS)
    Subject analysis set type
    Full analysis
    Subject analysis set description
    Participants received placebo up to Week 16 and bimekizumab starting at Week 16 through Week 52. Participants formed the Randomized Set (RS).

    Subject analysis set title
    Bimekizumab (RS)
    Subject analysis set type
    Full analysis
    Subject analysis set description
    Participants received bimekizumab for 52 weeks. Participants formed the RS.

    Subject analysis set title
    Ustekinumab (RS)
    Subject analysis set type
    Full analysis
    Subject analysis set description
    Participants received ustekinumab(dose 1 or dose 2 depending on participants weight) for 52 weeks. Placebo was administered at pre-specified time points to maintain the blinding. Participants formed the RS.

    Subject analysis set title
    Placebo Initial Period (SS)
    Subject analysis set type
    Safety analysis
    Subject analysis set description
    During the 16-week Initial Treatment Period participants received placebo. Participants formed the Safety Set (SS).

    Subject analysis set title
    Bimekizumab Initial Period (SS)
    Subject analysis set type
    Safety analysis
    Subject analysis set description
    During the 16-week Initial Treatment Period participants received bimekizumab. Participants formed the SS.

    Subject analysis set title
    Ustekinumab Initial Period (SS)
    Subject analysis set type
    Safety analysis
    Subject analysis set description
    During the 16-week Initial Treatment Period participants received ustekinumab. Participants formed the SS.

    Subject analysis set title
    Any Bimekizumab (AMS)
    Subject analysis set type
    Safety analysis
    Subject analysis set description
    This arm consisted of all participants who received bimekizumab at any time in the study (up to Week 52). It also includes the participants that switched from placebo to bimekizumab after the 16-week Initial Treatment Period. Participants formed the SS.

    Subject analysis set title
    Any Ustekinumab (AMS)
    Subject analysis set type
    Safety analysis
    Subject analysis set description
    This arm consisted of all participants who received ustekinumab at any time in the study (up to Week 52). Participants formed the SS.

    Subject analysis set title
    Placebo (SS)
    Subject analysis set type
    Safety analysis
    Subject analysis set description
    Participants received placebo up to Week 16 and bimekizumab starting at Week 16 through Week 52. Participants formed the Safety Set (SS).

    Subject analysis set title
    Bimekizumab (SS)
    Subject analysis set type
    Safety analysis
    Subject analysis set description
    Participants received bimekizumab for 52 weeks. Participants formed the SS.

    Subject analysis set title
    Ustekinumab (SS)
    Subject analysis set type
    Safety analysis
    Subject analysis set description
    Participants received ustekinumab (dose 1 or dose 2 depending on participants weight) for 52 weeks. Placebo was administered at pre-specified time points to maintain the blinding. Participants formed the SS.

    Subject analysis set title
    Placebo/Bimekizumab (MS)
    Subject analysis set type
    Safety analysis
    Subject analysis set description
    After the 16-week Initial Treatment Period participants initially randomized to placebo received bimekizumab during the 36-week Maintenance Treatment Period. Participants formed the Maintenance Set (MS).

    Subject analysis set title
    Bimekizumab/Bimekizumab (MS)
    Subject analysis set type
    Safety analysis
    Subject analysis set description
    After the 16-week Initial Treatment Period participants initially randomized to bimekizumab continued to receive bimekizumab during the 36-week Maintenance Treatment Period. Participants formed the MS.

    Subject analysis set title
    Ustekinumab/Ustekinumab (MS)
    Subject analysis set type
    Safety analysis
    Subject analysis set description
    After the 16-week Initial Treatment Period participants initially randomized to ustekinumab continued to receive ustekinumab during the 36-week Maintenance Treatment Period. Participants formed the MS.

    Primary: Percentage of participants with a Psoriasis Area and Severity Index 90 (PASI90) response at Week 16

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    End point title
    Percentage of participants with a Psoriasis Area and Severity Index 90 (PASI90) response at Week 16
    End point description
    The PASI90 response assessments are based on at least 90% improvement in the PASI score from Baseline. This is a scoring system that averages the redness, thickness and scaliness of the psoriatic lesions (on 0-4 scale), and weights the resulting score by the area of skin involved. Body divided into 4 areas: head/arms/trunk to groin/legs to top of buttocks. Assignment of an average score for the redness, thickness, and scaling for each of the 4 body areas with a score of 0 (clear)-4 (very marked). Determining the percentage of skin covered with PSO for each of the body areas and converting to a 0-6 scale. Final PASI= average redness, thickness, and scaliness of the psoriatic skin lesions, multiplied by the involved psoriasis area score of the respective section, and weighted by the percentage of the person’s affected skin for the respective section. The min possible PASI score is 0=no disease, the max score is 72=maximal disease. The RS consisted of all randomized study participants.
    End point type
    Primary
    End point timeframe
    Week 16
    End point values
    Placebo (RS) Bimekizumab (RS) Ustekinumab (RS)
    Number of subjects analysed
    83
    321
    163
    Units: percentage of participants
        number (not applicable)
    4.8
    85.0
    49.7
    Statistical analysis title
    Statistical analysis 1
    Statistical analysis description
    Odds ratio was calculated using stratified CMH (Cochran-Mantel-Haenszel) test with region and prior biologic exposure as stratification variables.
    Comparison groups
    Bimekizumab (RS) v Placebo (RS)
    Number of subjects included in analysis
    404
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.001 [1]
    Method
    Cochran-Mantel-Haenszel
    Parameter type
    Odds ratio (OR)
    Point estimate
    99.869
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    34.02
         upper limit
    293.175
    Notes
    [1] - P-values for the comparison of treatment groups (BKZ vs PBO) were based on the CMH test from the general association.
    Statistical analysis title
    Statistical analysis 2
    Statistical analysis description
    Odds ratio was calculated using stratified CMH (Cochran-Mantel-Haenszel) test with region and prior biologic exposure as stratification variables.
    Comparison groups
    Bimekizumab (RS) v Ustekinumab (RS)
    Number of subjects included in analysis
    484
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.001 [2]
    Method
    Cochran-Mantel-Haenszel
    Parameter type
    Odds ratio (OR)
    Point estimate
    6.056
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    3.874
         upper limit
    9.466
    Notes
    [2] - P-values for the comparison of treatment groups (BKZ vs Ustekinumab) were based on the CMH test from the general association.

    Primary: Percentage of participants with an Investigator's Global Assessment (IGA) (Clear or Almost Clear with at least a 2-category improvement from Baseline) response at Week 16

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    End point title
    Percentage of participants with an Investigator's Global Assessment (IGA) (Clear or Almost Clear with at least a 2-category improvement from Baseline) response at Week 16
    End point description
    The Investigator's Global Assessment (IGA) measures the overall psoriasis severity following a 5-point scale (0-4), where scale 0= clear, no signs of psoriasis; presence of post-inflammatory hyperpigmentation, scale 1= almost clear, no thickening; normal to pink coloration; no to minimal focal scaling, scale 2= mild thickening, pink to light red coloration and predominately fine scaling, 3= moderate, clearly distinguishable to moderate thickening; dull to bright red, clearly distinguishable to moderate thickening; moderate scaling and 4= severe thickening with hard edges; bright to deep dark red coloration; severe/coarse scaling covering almost all or all lesions. IGA response was defined as clear [0] or almost clear [1] with at least a two-category improvement from Baseline at Week 16. The Randomized Set (RS) consisted of all randomized study participants.
    End point type
    Primary
    End point timeframe
    Week 16
    End point values
    Placebo (RS) Bimekizumab (RS) Ustekinumab (RS)
    Number of subjects analysed
    83
    321
    163
    Units: percentage of participants
        number (not applicable)
    4.8
    84.1
    53.4
    Statistical analysis title
    Statistical analysis 1
    Statistical analysis description
    Odds ratio was calculated using stratified CMH (Cochran-Mantel-Haenszel) test with region and prior biologic exposure as stratification variables.
    Comparison groups
    Bimekizumab (RS) v Placebo (RS)
    Number of subjects included in analysis
    404
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.001 [3]
    Method
    Cochran-Mantel-Haenszel
    Parameter type
    Odds ratio (OR)
    Point estimate
    118.762
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    36.701
         upper limit
    384.307
    Notes
    [3] - P-values for the comparison of treatment groups (BKZ vs PBO) were based on the CMH test from the general association.
    Statistical analysis title
    Statistical analysis 2
    Statistical analysis description
    Odds ratio was calculated using stratified CMH (Cochran-Mantel-Haenszel) test with region and prior biologic exposure as stratification variables.
    Comparison groups
    Bimekizumab (RS) v Ustekinumab (RS)
    Number of subjects included in analysis
    484
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.001 [4]
    Method
    Cochran-Mantel-Haenszel
    Parameter type
    Odds ratio (OR)
    Point estimate
    4.809
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    3.096
         upper limit
    7.47
    Notes
    [4] - P-values for the comparison of treatment groups (BKZ vs Ustekinumab) were based on the CMH test from the general association.

    Secondary: Percentage of participants with a PASI100 response at Week 16

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    End point title
    Percentage of participants with a PASI100 response at Week 16
    End point description
    The PASI100 response assessments are based on a 100% improvement in the PASI score from Baseline. This is a scoring system that averages the redness, thickness and scaliness of the psoriatic lesions (on a 0-4 scale), and weights the resulting score by the area of skin involved. Body divided into 4 areas: head/arms/trunk to groin/legs to top of buttocks. Assignment of an average score for the redness, thickness, and scaling for each of the 4 body areas with a score of 0 (clear)-4 (very marked). Determining the percentage of skin covered with PSO for each of the body areas and converting to a 0-6 scale. Final PASI= average redness, thickness, and scaliness of the psoriatic skin lesions, multiplied by the involved psoriasis area score of the respective section, and weighted by the percentage of the person’s affected skin for the respective section. The min possible PASI score is 0=no disease, the max score is 72=maximal disease. The RS consisted of all randomized study participants.
    End point type
    Secondary
    End point timeframe
    Week 16
    End point values
    Placebo (RS) Bimekizumab (RS) Ustekinumab (RS)
    Number of subjects analysed
    83
    321
    163
    Units: percentage of participants
        number (not applicable)
    0
    58.6
    20.9
    Statistical analysis title
    Statistical analysis 1
    Statistical analysis description
    Odds ratio was calculated using stratified CMH test with region and prior biologic exposure as stratification variables. Logit method was used where CMH test not possible due to very low response.
    Comparison groups
    Bimekizumab (RS) v Placebo (RS)
    Number of subjects included in analysis
    404
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.001 [5]
    Method
    Cochran-Mantel-Haenszel
    Parameter type
    Odds ratio (OR)
    Point estimate
    25.59
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    9.063
         upper limit
    72.253
    Notes
    [5] - P-values for the comparison of treatment groups (BKZ vs PBO) were based on the CMH test from the general association.

    Secondary: Percentage of participants with an IGA 0 response at Week 16

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    End point title
    Percentage of participants with an IGA 0 response at Week 16
    End point description
    The Investigator's Global Assessment (IGA) measures the overall psoriasis severity following a 5-point scale (0-4), where scale 0= clear, no signs of psoriasis; presence of post-inflammatory hyperpigmentation, scale 1= almost clear, no thickening; normal to pink coloration; no to minimal focal scaling, scale 2= mild thickening, pink to light red coloration and predominately fine scaling, 3= moderate, clearly distinguishable to moderate thickening; dull to bright red, clearly distinguishable to moderate thickening; moderate scaling and 4= severe thickening with hard edges; bright to deep dark red coloration; severe/coarse scaling covering almost all or all lesions. IGA response was defined as clear [0] with at least a two-category improvement from Baseline at Week 16. The Randomized Set (RS) consisted of all randomized study participants.
    End point type
    Secondary
    End point timeframe
    Week 16
    End point values
    Placebo (RS) Bimekizumab (RS) Ustekinumab (RS)
    Number of subjects analysed
    83
    321
    163
    Units: percentage of participants
        number (not applicable)
    0
    58.6
    22.1
    Statistical analysis title
    Statistical analysis 1
    Statistical analysis description
    Odds ratio was calculated using stratified CMH test with region and prior biologic exposure as stratification variables. Logit method was used where CMH test not possible due to very low response.
    Comparison groups
    Bimekizumab (RS) v Placebo (RS)
    Number of subjects included in analysis
    404
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.001 [6]
    Method
    Cochran-Mantel-Haenszel
    Parameter type
    Odds ratio (OR)
    Point estimate
    25.471
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    9.02
         upper limit
    71.925
    Notes
    [6] - P-values for the comparison of treatment groups (BKZ vs PBO) were based on the CMH test from the general association.

    Secondary: Percentage of participants with a PASI75 response at Week 4

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    End point title
    Percentage of participants with a PASI75 response at Week 4
    End point description
    The PASI75 response assessments are based on at least 75% improvement in the PASI score from Baseline. This is a scoring system that averages the redness, thickness and scaliness of the psoriatic lesions (on a 0-4 scale), and weights the resulting score by the area of skin involved. Body divided into 4 areas: head/arms/trunk to groin/legs to top of buttocks. Assignment of an average score for the redness, thickness, and scaling for each of the 4 body areas with a score of 0 (clear)-4 (very marked). Determining the percentage of skin covered with PSO for each of the body areas and converting to a 0-6 scale. Final PASI= average redness, thickness, and scaliness of the psoriatic skin lesions, multiplied by the involved psoriasis area score of the respective section, and weighted by the percentage of the person’s affected skin for the respective section. The min possible PASI score is 0=no disease, the max score is 72=maximal disease. The RS consisted of all randomized study participants.
    End point type
    Secondary
    End point timeframe
    Week 4
    End point values
    Placebo (RS) Bimekizumab (RS) Ustekinumab (RS)
    Number of subjects analysed
    83
    321
    163
    Units: percentage of participants
        number (not applicable)
    2.4
    76.9
    15.3
    Statistical analysis title
    Statistical analysis 1
    Statistical analysis description
    Odds ratio was calculated using stratified CMH test with region and prior biologic exposure as stratification variables. Logit method was used where CMH test not possible due to very low response.
    Comparison groups
    Bimekizumab (RS) v Placebo (RS)
    Number of subjects included in analysis
    404
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.001 [7]
    Method
    Cochran-Mantel-Haenszel
    Parameter type
    Odds ratio (OR)
    Point estimate
    123.02
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    29.394
         upper limit
    514.862
    Notes
    [7] - P-values for the comparison of treatment groups (BKZ vs PBO) were based on the CMH test from the general association.
    Statistical analysis title
    Statistical analysis 2
    Statistical analysis description
    Odds ratio was calculated using stratified CMH test with region and prior biologic exposure as stratification variables.
    Comparison groups
    Bimekizumab (RS) v Ustekinumab (RS)
    Number of subjects included in analysis
    484
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.001 [8]
    Method
    Cochran-Mantel-Haenszel
    Parameter type
    Odds ratio (OR)
    Point estimate
    18.202
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    10.998
         upper limit
    30.123
    Notes
    [8] - P-values for the comparison of treatment groups (BKZ vs Ustekinumab) were based on the CMH test from the general association.

    Secondary: Percentage of participants with a Patient Symptom Diary response for pain at Week 16

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    End point title
    Percentage of participants with a Patient Symptom Diary response for pain at Week 16
    End point description
    A PRO measured the PSD (further published as P-SIM) and was used to assess key symptoms relevant to patients with moderate to severe plaque psoriasis. Site staff trained the participants on the use of the electronic device used to collect ePRO diary data at the Screening Visit, following which the device was dispensed to the participant for home use until the Week 16 Visit. The ePRO diary was completed on a daily basis from Screening to the Week 16 Visit. PSD score for pain was an average of the daily values over the week prior to the visit. The response variable was characterized in terms of cumulative percent of participants demonstrating a prespecified point improvement (above the 1.98 response threshold) at Week 16. Analysis was limited to participants with a Baseline score at or above the 1.98 response threshold. The RS consisted of all randomized participants. Number of participants analyzed reflect those with a Baseline score at or above the 1.98 response threshold.
    End point type
    Secondary
    End point timeframe
    Week 16
    End point values
    Placebo (RS) Bimekizumab (RS) Ustekinumab (RS)
    Number of subjects analysed
    54
    229
    107
    Units: percentage of participants
        number (not applicable)
    16.7
    77.3
    68.2
    Statistical analysis title
    Statistical analysis 1
    Statistical analysis description
    Odds ratio was calculated using stratified CMH test with region and prior biologic exposure as stratification variables. Logit method was used where CMH test not possible due to very low response.
    Comparison groups
    Bimekizumab (RS) v Placebo (RS)
    Number of subjects included in analysis
    283
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.001 [9]
    Method
    Cochran-Mantel-Haenszel
    Parameter type
    Odds ratio (OR)
    Point estimate
    16.258
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    7.356
         upper limit
    35.931
    Notes
    [9] - P-values for the comparison of treatment groups (BKZ vs PBO) were based on the CMH test from the general association.

    Secondary: Percentage of participants with a Patient Symptom Diary response for itch at Week 16

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    End point title
    Percentage of participants with a Patient Symptom Diary response for itch at Week 16
    End point description
    A PRO measured the PSD (further published as P-SIM) and was used to assess key symptoms relevant to patients with moderate to severe plaque psoriasis. Site staff trained the participants on the use of the electronic device used to collect ePRO diary data at the Screening Visit, following which the device was dispensed to the participant for home use until the Week 16 Visit. The ePRO diary was completed on a daily basis from Screening to the Week 16 Visit. PSD score for itch was an average of the daily values over the week prior to the visit. The response variable was characterized in terms of cumulative percent of participants demonstrating a prespecified point improvement (above the 2.39 response threshold) at Week 16. Analysis was limited to participants with a Baseline score at or above the 2.39 response threshold. The RS consisted of all randomized participants. Number of participants analyzed reflect those with a Baseline score at or above the 2.39 response threshold.
    End point type
    Secondary
    End point timeframe
    Week 16
    End point values
    Placebo (RS) Bimekizumab (RS) Ustekinumab (RS)
    Number of subjects analysed
    61
    244
    117
    Units: percentage of participants
        number (not applicable)
    13.1
    76.6
    65.8
    Statistical analysis title
    Statistical analysis 1
    Statistical analysis description
    Odds ratio was calculated using stratified CMH test with region and prior biologic exposure as stratification variables. Logit method was used where CMH test not possible due to very low response.
    Comparison groups
    Bimekizumab (RS) v Placebo (RS)
    Number of subjects included in analysis
    305
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.001 [10]
    Method
    Cochran-Mantel-Haenszel
    Parameter type
    Odds ratio (OR)
    Point estimate
    22.279
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    9.795
         upper limit
    50.674
    Notes
    [10] - P-values for the comparison of treatment groups (BKZ vs PBO) were based on the CMH test from the general association.

    Secondary: Percentage of participants with a Patient Symptom Diary response for scaling at Week 16

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    End point title
    Percentage of participants with a Patient Symptom Diary response for scaling at Week 16
    End point description
    A PRO measured the PSD (further published as P-SIM) and was used to assess key symptoms relevant to patients with moderate to severe plaque psoriasis. Site staff trained the participants on the use of the electronic device used to collect ePRO diary data at the Screening Visit, following which the device was dispensed to the participant for home use until the Week 16 Visit. The ePRO diary was completed on a daily basis from Screening to the Week 16 Visit. PSD score for scaling was an average of the daily values over the week prior to the visit. The response variable was characterized in terms of cumulative percent of participants demonstrating a prespecified point improvement (above the 2.86 response threshold) at Week 16. Analysis was limited to participants with a Baseline score at or above the 2.86 response threshold. The RS consisted of all randomized participants. Number of participants analyzed reflect those with a Baseline score at or above the 2.86 response threshold.
    End point type
    Secondary
    End point timeframe
    Week 16
    End point values
    Placebo (RS) Bimekizumab (RS) Ustekinumab (RS)
    Number of subjects analysed
    63
    246
    116
    Units: percentage of participants
        number (not applicable)
    12.7
    78.5
    59.5
    Statistical analysis title
    Statistical analysis 1
    Statistical analysis description
    Odds ratio was calculated using stratified CMH test with region and prior biologic exposure as stratification variables. Logit method was used where CMH test not possible due to very low response.
    Comparison groups
    Bimekizumab (RS) v Placebo (RS)
    Number of subjects included in analysis
    309
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.001 [11]
    Method
    Cochran-Mantel-Haenszel
    Parameter type
    Odds ratio (OR)
    Point estimate
    23.049
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    10.201
         upper limit
    52.077
    Notes
    [11] - P-values for the comparison of treatment groups (BKZ vs PBO) were based on the CMH test from the general association.

    Secondary: Percentage of participants with a Scalp IGA response (Clear or Almost Clear) at Week 16 for participants with scalp psoriasis (PSO) >=2 at Baseline

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    End point title
    Percentage of participants with a Scalp IGA response (Clear or Almost Clear) at Week 16 for participants with scalp psoriasis (PSO) >=2 at Baseline
    End point description
    Only participants with scalp involvement at Baseline completed the scalp IGA. Participants with scalp involvement at Baseline were defined as those with a scalp IGA score >0 at Baseline. Scalp lesions were assessed in terms of clinical signs of redness, thickness, and scaliness using a 5-point scale (0=Clear, 1=Almost Clear, 2=Mild, 3=Moderate, 4= Severe). Scalp IGA 0/1 response at Week 16 was defined as clear (0) or almost clear (1) with at least a 2-category improvement from Baseline to Week 16. The Randomized Set (RS) consisted of all randomized study participants. Number of participants analyzed reflect those with a Baseline score of at least 2.
    End point type
    Secondary
    End point timeframe
    Week 16
    End point values
    Placebo (RS) Bimekizumab (RS) Ustekinumab (RS)
    Number of subjects analysed
    72
    285
    146
    Units: percentage of participants
        number (not applicable)
    15.3
    84.2
    70.5
    Statistical analysis title
    Statistical analysis 1
    Statistical analysis description
    Odds ratio was calculated using stratified CMH test with region and prior biologic exposure as stratification variables. Logit method was used where CMH test not possible due to very low response.
    Comparison groups
    Bimekizumab (RS) v Placebo (RS)
    Number of subjects included in analysis
    357
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.001 [12]
    Method
    Cochran-Mantel-Haenszel
    Parameter type
    Odds ratio (OR)
    Point estimate
    37.696
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    16.92
         upper limit
    83.987
    Notes
    [12] - P-values for the comparison of treatment groups (BKZ vs PBO) were based on the CMH test from the general association.

    Secondary: Percentage of participants with a PASI90 response at Week 12

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    End point title
    Percentage of participants with a PASI90 response at Week 12
    End point description
    The PASI90 response assessments are based on at least 90% improvement in the PASI score from Baseline. This is a scoring system that averages the redness, thickness and scaliness of the psoriatic lesions (on a 0-4 scale), and weights the resulting score by the area of skin involved. Body divided into 4 areas: head/arms/trunk to groin/legs to top of buttocks. Assignment of an average score for the redness, thickness, and scaling for each of the 4 body areas with a score of 0 (clear)-4 (very marked). Determining the percentage of skin covered with PSO for each of the body areas and converting to a 0-6 scale. Final PASI= average redness, thickness, and scaliness of the psoriatic skin lesions, multiplied by the involved psoriasis area score of the respective section, and weighted by the percentage of the person’s affected skin for the respective section. The min possible PASI score is 0=no disease, the max score is 72=maximal disease. The RS consisted of all randomized study participants.
    End point type
    Secondary
    End point timeframe
    Week 12
    End point values
    Placebo (RS) Bimekizumab (RS) Ustekinumab (RS)
    Number of subjects analysed
    83
    321
    163
    Units: percentage of participants
        number (not applicable)
    2.4
    85.0
    43.6
    Statistical analysis title
    Statistical analysis 1
    Statistical analysis description
    Odds ratio was calculated using stratified CMH test with region and prior biologic exposure as stratification variables.
    Comparison groups
    Bimekizumab (RS) v Ustekinumab (RS)
    Number of subjects included in analysis
    484
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.001 [13]
    Method
    Cochran-Mantel-Haenszel
    Parameter type
    Odds ratio (OR)
    Point estimate
    8.047
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    5.107
         upper limit
    12.679
    Notes
    [13] - P-values for the comparison of treatment groups (BKZ vs Ustekinumab) were based on the CMH test from the general association.

    Secondary: Percentage of participants with a PASI90 response at Week 52

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    End point title
    Percentage of participants with a PASI90 response at Week 52
    End point description
    PASI90 response assessments are based on at least 90% improvement in the PASI score from Baseline. This is a scoring system that averages the redness/thickness/scaliness of the psoriatic lesions (0-4 scale) and weights the resulting score by the area of skin involved. Body divided into 4 areas: head/arms/trunk to groin/legs to top of buttocks. Assignment of an average score for the redness/thickness/scaling for each of the 4 body areas with a score of 0 (clear)-4 (very marked). Determining the percentage of skin covered with PSO for each of the body areas and converting to a 0-6 scale. Final PASI=average redness/thickness/scaliness of the psoriatic skin lesions, multiplied by the involved psoriasis area score of the respective section, and weighted by the percentage of the person’s affected skin. Min possible PASI score is 0=no disease, the max score is 72=maximal disease. The RS consisted of all randomized participants. PBO was provided up to Week 16 and not included in the analysis.
    End point type
    Secondary
    End point timeframe
    Week 52
    End point values
    Bimekizumab (RS) Ustekinumab (RS)
    Number of subjects analysed
    321
    163
    Units: percentage of participants
        number (not applicable)
    81.9
    55.8
    Statistical analysis title
    Statistical analysis 1
    Statistical analysis description
    Odds ratio was calculated using stratified CMH test with region and prior biologic exposure as stratification variables.
    Comparison groups
    Bimekizumab (RS) v Ustekinumab (RS)
    Number of subjects included in analysis
    484
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.001 [14]
    Method
    Cochran-Mantel-Haenszel
    Parameter type
    Odds ratio (OR)
    Point estimate
    3.795
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    2.442
         upper limit
    5.899
    Notes
    [14] - P-values for the comparison of treatment groups (BKZ vs Ustekinumab) were based on the CMH test from the general association.

    Secondary: Percentage of participants with an IGA (Clear or Almost Clear with at least a 2-category improvement from Baseline) response at Week 12

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    End point title
    Percentage of participants with an IGA (Clear or Almost Clear with at least a 2-category improvement from Baseline) response at Week 12
    End point description
    The Investigator's Global Assessment (IGA) measures the overall psoriasis severity following a 5-point scale (0-4), where scale 0= clear, no signs of psoriasis; presence of post-inflammatory hyperpigmentation, scale 1= almost clear, no thickening; normal to pink coloration; no to minimal focal scaling, scale 2= mild thickening, pink to light red coloration and predominately fine scaling, 3= moderate, clearly distinguishable to moderate thickening; dull to bright red, clearly distinguishable to moderate thickening; moderate scaling and 4= severe thickening with hard edges; bright to deep dark red coloration; severe/coarse scaling covering almost all or all lesions. IGA response was defined as clear [0] or almost clear [1] with at least a two-category improvement from Baseline at Week 12. The Randomized Set (RS) consisted of all randomized study participants.
    End point type
    Secondary
    End point timeframe
    Week 12
    End point values
    Placebo (RS) Bimekizumab (RS) Ustekinumab (RS)
    Number of subjects analysed
    83
    321
    163
    Units: percentage of participants
        number (not applicable)
    4.8
    81.9
    52.1
    Statistical analysis title
    Statistical analysis 1
    Statistical analysis description
    Odds ratio was calculated using stratified CMH test with region and prior biologic exposure as stratification variables.
    Comparison groups
    Bimekizumab (RS) v Ustekinumab (RS)
    Number of subjects included in analysis
    484
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.001 [15]
    Method
    Cochran-Mantel-Haenszel
    Parameter type
    Odds ratio (OR)
    Point estimate
    4.379
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    2.85
         upper limit
    6.73
    Notes
    [15] - P-values for the comparison of treatment groups (BKZ vs Ustekinumab) were based on the CMH test from the general association.

    Secondary: Percentage of participants with an IGA (Clear or Almost Clear with at least a 2-category improvement from Baseline) response at Week 52

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    End point title
    Percentage of participants with an IGA (Clear or Almost Clear with at least a 2-category improvement from Baseline) response at Week 52
    End point description
    The Investigator's Global Assessment (IGA) measures the overall psoriasis severity following a 5-point scale (0-4), where scale 0= clear, no signs of psoriasis; presence of post-inflammatory hyperpigmentation, scale 1= almost clear, no thickening; normal to pink coloration; no to minimal focal scaling, scale 2= mild thickening, pink to light red coloration and predominately fine scaling, 3= moderate, clearly distinguishable to moderate thickening; dull to bright red, clearly distinguishable to moderate thickening; moderate scaling and 4= severe thickening with hard edges; bright to deep dark red coloration; severe/coarse scaling covering almost all or all lesions. IGA response was defined as clear [0] or almost clear [1] with at least a two-category improvement from Baseline at Week 52. The Randomized Set (RS) consisted of all randomized study participants. Placebo was only provided up to Week 16 and was not included in this analysis.
    End point type
    Secondary
    End point timeframe
    Week 52
    End point values
    Bimekizumab (RS) Ustekinumab (RS)
    Number of subjects analysed
    321
    163
    Units: percentage of participants
        number (not applicable)
    78.2
    60.7
    Statistical analysis title
    Statistical analysis 1
    Statistical analysis description
    Odds ratio was calculated using stratified CMH test with region and prior biologic exposure as stratification variables.
    Comparison groups
    Bimekizumab (RS) v Ustekinumab (RS)
    Number of subjects included in analysis
    484
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.001 [16]
    Method
    Cochran-Mantel-Haenszel
    Parameter type
    Odds ratio (OR)
    Point estimate
    2.412
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    1.573
         upper limit
    3.699
    Notes
    [16] - P-values for the comparison of treatment groups (BKZ vs Ustekinumab) were based on the CMH test from the general association.

    Secondary: Number of Treatment Emergent Adverse Events (TEAEs) adjusted by duration of subject exposure to study treatment during the Initial Treatment Period

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    End point title
    Number of Treatment Emergent Adverse Events (TEAEs) adjusted by duration of subject exposure to study treatment during the Initial Treatment Period
    End point description
    The number of TEAEs adjusted by duration of exposure to study treatment was scaled such that provided an incidence rate per 100 patient-years. If a participant had multiple events, the time of exposure was calculated to the first occurrence of the Adverse Event (AE) being considered. If a participant had no events, the total time at risk was used. The Safety Set (SS) consisted of all study participants that received at least 1 dose of IMP.
    End point type
    Secondary
    End point timeframe
    From Baseline to end of Initial Treatment Period, including the Safety Follow-Up visit for those withdrawn from IMP (up to 36 weeks)
    End point values
    Placebo (SS) Bimekizumab (SS) Ustekinumab (SS)
    Number of subjects analysed
    83
    321
    163
    Units: no. of new events per 100 subject-years
        number (confidence interval 95%)
    238.41 (169.53 to 325.91)
    287.26 (246.93 to 332.29)
    247.62 (197.23 to 306.96)
    No statistical analyses for this end point

    Secondary: Number of Serious Adverse Events (SAEs) adjusted by duration of subject exposure to study treatment during the Initial Treatment Period

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    End point title
    Number of Serious Adverse Events (SAEs) adjusted by duration of subject exposure to study treatment during the Initial Treatment Period
    End point description
    The number of SAEs adjusted by duration of exposure to study treatment was scaled such that it provided an incidence rate per 100 patient-years. If a participant had multiple events, the time of exposure was calculated to the first occurrence of the AE being considered. If a participant had no events, the total time at risk was used. The Safety Set (SS) consisted of all study participants that received at least 1 dose of IMP.
    End point type
    Secondary
    End point timeframe
    From Baseline to end of Initial Treatment Period, including the Safety Follow-Up visit for those withdrawn from IMP (up to 36 weeks)
    End point values
    Placebo (SS) Bimekizumab (SS) Ustekinumab (SS)
    Number of subjects analysed
    83
    321
    163
    Units: no. of new events per 100 subject-years
        number (confidence interval 95%)
    7.97 (0.97 to 28.80)
    5.06 (1.64 to 11.80)
    10.14 (3.29 to 23.66)
    No statistical analyses for this end point

    Secondary: Number of TEAEs leading to withdrawal adjusted by duration of subject exposure to study treatment during the Initial Treatment Period

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    End point title
    Number of TEAEs leading to withdrawal adjusted by duration of subject exposure to study treatment during the Initial Treatment Period
    End point description
    The number of TEAEs leading to discontinuation adjusted by duration of exposure to study treatment was scaled such that it provided an incidence rate per 100 patient-years. If a participant had multiple events, the time of exposure was calculated to the first occurrence of the AE being considered. If a participant had no events, the total time at risk was used. The Safety Set (SS) consisted of all study participants that received at least 1 dose of IMP.
    End point type
    Secondary
    End point timeframe
    From Baseline to end of Initial Treatment Period, including the Safety Follow-Up visit for those withdrawn from IMP (up to 36 weeks)
    End point values
    Placebo (SS) Bimekizumab (SS) Ustekinumab (SS)
    Number of subjects analysed
    83
    321
    163
    Units: no. of new events per 100 subject-years
        number (confidence interval 95%)
    24.39 (8.95 to 53.09)
    6.08 (2.23 to 13.24)
    5.99 (1.24 to 17.52)
    No statistical analyses for this end point

    Secondary: Number of Treatment Emergent Adverse Events (TEAEs) adjusted by duration of subject exposure to study treatment during the Maintenance Treatment Period

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    End point title
    Number of Treatment Emergent Adverse Events (TEAEs) adjusted by duration of subject exposure to study treatment during the Maintenance Treatment Period
    End point description
    The number of TEAEs adjusted by duration of exposure to study treatment was scaled such that it provided an incidence rate per 100 patient-years. If a participant had multiple events, the time of exposure was calculated to the first occurrence of the Adverse Event (AE) being considered. If a participant had no events, the total time at risk was used. The Maintenance Set (MS) consisted of all study participants who had received at least 1 dose of active IMP (bimekizumab or ustekinumab) in the Maintenance Treatment Period.
    End point type
    Secondary
    End point timeframe
    From Week 16 to Safety Follow-Up (up to 52 weeks duration)
    End point values
    Placebo/Bimekizumab (MS) Bimekizumab/Bimekizumab (MS) Ustekinumab/Ustekinumab (MS)
    Number of subjects analysed
    74
    306
    157
    Units: no. of new events per 100 subject-years
        number (confidence interval 95%)
    149.35 (114.24 to 191.85)
    127.84 (111.58 to 145.81)
    111.24 (90.80 to 134.91)
    No statistical analyses for this end point

    Secondary: Number of Serious Adverse Events (SAEs) adjusted by duration of subject exposure to study treatment during the Maintenance Treatment Period

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    End point title
    Number of Serious Adverse Events (SAEs) adjusted by duration of subject exposure to study treatment during the Maintenance Treatment Period
    End point description
    The number of SAEs adjusted by duration of exposure to study treatment was scaled such that it provided an incidence rate per 100 patient-years. If a participant had multiple events, the time of exposure was calculated to the first occurrence of the AE being considered. If a participant had no events, the total time at risk was used. The Maintenance Set (MS) consisted of all study participants who had received at least 1 dose of active IMP (bimekizumab or ustekinumab) in the Maintenance Treatment Period.
    End point type
    Secondary
    End point timeframe
    From Week 16 to Safety Follow-Up (up to 52 weeks duration)
    End point values
    Placebo/Bimekizumab (MS) Bimekizumab/Bimekizumab (MS) Ustekinumab/Ustekinumab (MS)
    Number of subjects analysed
    74
    306
    157
    Units: no. of new events per 100 subject-years
        number (confidence interval 95%)
    9.88 (3.21 to 23.05)
    6.19 (3.30 to 10.58)
    7.46 (3.22 to 14.70)
    No statistical analyses for this end point

    Secondary: Number of TEAEs leading to withdrawal adjusted by duration of subject exposure to study treatment during the Maintenance Treatment Period

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    End point title
    Number of TEAEs leading to withdrawal adjusted by duration of subject exposure to study treatment during the Maintenance Treatment Period
    End point description
    The number of TEAEs leading to discontinuation adjusted by duration of exposure to study treatment was scaled such that it provided an incidence rate per 100 patient-years. If a participant had multiple events, the time of exposure was calculated to the first occurrence of the AE being considered. If a participant had no events, the total time at risk was used. The Maintenance Set (MS) consisted of all study participants who had received at least 1 dose of active IMP (bimekizumab or ustekinumab) in the Maintenance Treatment Period.
    End point type
    Secondary
    End point timeframe
    From Week 16 to Safety Follow-Up (up to 52 weeks duration)
    End point values
    Placebo/Bimekizumab (MS) Bimekizumab/Bimekizumab (MS) Ustekinumab/Ustekinumab (MS)
    Number of subjects analysed
    74
    306
    157
    Units: no. of new events per 100 subject-years
        number (confidence interval 95%)
    5.91 (1.22 to 17.27)
    5.72 (2.95 to 9.99)
    3.71 (1.01 to 9.51)
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Treatment-emergent AEs were collected from Baseline to Safety Follow Up (up to Week 68)
    Adverse event reporting additional description
    Treatment-emergent AEs were defined as those AEs that had 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). Deaths in Any bimekizumab arm occurred in the initial period (1 in Placebo/ 1 in bimekizumab).
    Assessment type
    Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    19.0
    Reporting groups
    Reporting group title
    Placebo Initial Period (SS)
    Reporting group description
    During the 16-week Initial Treatment Period participants received placebo. Participants formed the Safety Set (SS).

    Reporting group title
    Bimekizumab Initial Period (SS)
    Reporting group description
    During the 16-week Initial Treatment Period participants received bimekizumab. Participants formed the SS.

    Reporting group title
    Ustekinumab Initial Period (SS)
    Reporting group description
    During the 16-week Initial Treatment Period participants received ustekinumab. Participants formed the SS.

    Reporting group title
    Any Bimekizumab (AMS)
    Reporting group description
    This arm consisted of all participants who received bimekizumab at any time in the study (up to Week 52). It also includes the participants that switched from placebo to bimekizumab after the 16-week Initial Treatment Period. Participants formed the SS.

    Reporting group title
    Any Ustekinumab (AMS)
    Reporting group description
    This arm consisted of all participants who received ustekinumab at any time in the study (up to Week 52). Participants formed the SS.

    Serious adverse events
    Placebo Initial Period (SS) Bimekizumab Initial Period (SS) Ustekinumab Initial Period (SS) Any Bimekizumab (AMS) Any Ustekinumab (AMS)
    Total subjects affected by serious adverse events
         subjects affected / exposed
    2 / 83 (2.41%)
    5 / 321 (1.56%)
    5 / 163 (3.07%)
    24 / 395 (6.08%)
    13 / 163 (7.98%)
         number of deaths (all causes)
    1
    1
    1
    2
    1
         number of deaths resulting from adverse events
    0
    0
    0
    0
    0
    Surgical and medical procedures
    Metabolic surgery
         subjects affected / exposed
    0 / 83 (0.00%)
    0 / 321 (0.00%)
    0 / 163 (0.00%)
    1 / 395 (0.25%)
    0 / 163 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Oesophageal adenocarcinoma
         subjects affected / exposed
    1 / 83 (1.20%)
    0 / 321 (0.00%)
    0 / 163 (0.00%)
    0 / 395 (0.00%)
    0 / 163 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastric cancer
         subjects affected / exposed
    0 / 83 (0.00%)
    0 / 321 (0.00%)
    0 / 163 (0.00%)
    1 / 395 (0.25%)
    0 / 163 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Thyroid adenoma
         subjects affected / exposed
    0 / 83 (0.00%)
    0 / 321 (0.00%)
    0 / 163 (0.00%)
    0 / 395 (0.00%)
    1 / 163 (0.61%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pregnancy, puerperium and perinatal conditions
    Haemorrhage in pregnancy
         subjects affected / exposed
    0 / 83 (0.00%)
    0 / 321 (0.00%)
    0 / 163 (0.00%)
    1 / 395 (0.25%)
    0 / 163 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Death
         subjects affected / exposed
    0 / 83 (0.00%)
    0 / 321 (0.00%)
    0 / 163 (0.00%)
    1 / 395 (0.25%)
    0 / 163 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    Psychiatric disorders
    Alcoholism
         subjects affected / exposed
    0 / 83 (0.00%)
    0 / 321 (0.00%)
    0 / 163 (0.00%)
    1 / 395 (0.25%)
    0 / 163 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Suicide attempt
         subjects affected / exposed
    0 / 83 (0.00%)
    0 / 321 (0.00%)
    0 / 163 (0.00%)
    0 / 395 (0.00%)
    1 / 163 (0.61%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Heart injury
         subjects affected / exposed
    0 / 83 (0.00%)
    0 / 321 (0.00%)
    1 / 163 (0.61%)
    0 / 395 (0.00%)
    1 / 163 (0.61%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 1
    Tendon injury
         subjects affected / exposed
    1 / 83 (1.20%)
    0 / 321 (0.00%)
    0 / 163 (0.00%)
    0 / 395 (0.00%)
    0 / 163 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Toxicity to various agents
         subjects affected / exposed
    1 / 83 (1.20%)
    0 / 321 (0.00%)
    0 / 163 (0.00%)
    0 / 395 (0.00%)
    0 / 163 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Humerus fracture
         subjects affected / exposed
    0 / 83 (0.00%)
    0 / 321 (0.00%)
    0 / 163 (0.00%)
    1 / 395 (0.25%)
    0 / 163 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Tibia fracture
         subjects affected / exposed
    0 / 83 (0.00%)
    0 / 321 (0.00%)
    0 / 163 (0.00%)
    0 / 395 (0.00%)
    1 / 163 (0.61%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Upper limb fracture
         subjects affected / exposed
    0 / 83 (0.00%)
    0 / 321 (0.00%)
    0 / 163 (0.00%)
    1 / 395 (0.25%)
    0 / 163 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Investigations
    Liver function test increased
         subjects affected / exposed
    0 / 83 (0.00%)
    0 / 321 (0.00%)
    0 / 163 (0.00%)
    1 / 395 (0.25%)
    0 / 163 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    False positive tuberculosis test
         subjects affected / exposed
    0 / 83 (0.00%)
    0 / 321 (0.00%)
    0 / 163 (0.00%)
    1 / 395 (0.25%)
    0 / 163 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cardiac disorders
    Acute myocardial infarction
         subjects affected / exposed
    0 / 83 (0.00%)
    1 / 321 (0.31%)
    0 / 163 (0.00%)
    2 / 395 (0.51%)
    0 / 163 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cardiac arrest
         subjects affected / exposed
    0 / 83 (0.00%)
    1 / 321 (0.31%)
    1 / 163 (0.61%)
    1 / 395 (0.25%)
    1 / 163 (0.61%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
    0 / 1
    0 / 1
    Myocardial infarction
         subjects affected / exposed
    0 / 83 (0.00%)
    0 / 321 (0.00%)
    0 / 163 (0.00%)
    2 / 395 (0.51%)
    0 / 163 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Epistaxis
         subjects affected / exposed
    0 / 83 (0.00%)
    0 / 321 (0.00%)
    0 / 163 (0.00%)
    1 / 395 (0.25%)
    0 / 163 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Nervous system disorders
    Intracranial aneurysm
         subjects affected / exposed
    0 / 83 (0.00%)
    1 / 321 (0.31%)
    0 / 163 (0.00%)
    1 / 395 (0.25%)
    0 / 163 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Brain injury
         subjects affected / exposed
    0 / 83 (0.00%)
    0 / 321 (0.00%)
    1 / 163 (0.61%)
    0 / 395 (0.00%)
    1 / 163 (0.61%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 1
    Cerebral infarction
         subjects affected / exposed
    0 / 83 (0.00%)
    0 / 321 (0.00%)
    0 / 163 (0.00%)
    1 / 395 (0.25%)
    0 / 163 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hydrocephalus
         subjects affected / exposed
    0 / 83 (0.00%)
    0 / 321 (0.00%)
    0 / 163 (0.00%)
    0 / 395 (0.00%)
    1 / 163 (0.61%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Vocal cord paresis
         subjects affected / exposed
    0 / 83 (0.00%)
    0 / 321 (0.00%)
    0 / 163 (0.00%)
    1 / 395 (0.25%)
    0 / 163 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Eye disorders
    Macular hole
         subjects affected / exposed
    0 / 83 (0.00%)
    0 / 321 (0.00%)
    1 / 163 (0.61%)
    0 / 395 (0.00%)
    1 / 163 (0.61%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Haemorrhoids
         subjects affected / exposed
    0 / 83 (0.00%)
    0 / 321 (0.00%)
    0 / 163 (0.00%)
    0 / 395 (0.00%)
    1 / 163 (0.61%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Colitis ulcerative
         subjects affected / exposed
    0 / 83 (0.00%)
    1 / 321 (0.31%)
    0 / 163 (0.00%)
    1 / 395 (0.25%)
    0 / 163 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Skin and subcutaneous tissue disorders
    Psoriasis
         subjects affected / exposed
    0 / 83 (0.00%)
    0 / 321 (0.00%)
    0 / 163 (0.00%)
    1 / 395 (0.25%)
    0 / 163 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Osteochondrosis
         subjects affected / exposed
    0 / 83 (0.00%)
    1 / 321 (0.31%)
    0 / 163 (0.00%)
    1 / 395 (0.25%)
    0 / 163 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Intervertebral disc protrusion
         subjects affected / exposed
    0 / 83 (0.00%)
    0 / 321 (0.00%)
    1 / 163 (0.61%)
    0 / 395 (0.00%)
    1 / 163 (0.61%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Facet joint syndrome
         subjects affected / exposed
    0 / 83 (0.00%)
    1 / 321 (0.31%)
    0 / 163 (0.00%)
    1 / 395 (0.25%)
    0 / 163 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Arthritis
         subjects affected / exposed
    0 / 83 (0.00%)
    0 / 321 (0.00%)
    0 / 163 (0.00%)
    0 / 395 (0.00%)
    1 / 163 (0.61%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Spinal column stenosis
         subjects affected / exposed
    0 / 83 (0.00%)
    0 / 321 (0.00%)
    0 / 163 (0.00%)
    1 / 395 (0.25%)
    0 / 163 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Diabetes mellitus
         subjects affected / exposed
    0 / 83 (0.00%)
    0 / 321 (0.00%)
    0 / 163 (0.00%)
    0 / 395 (0.00%)
    1 / 163 (0.61%)
         occurrences causally related to treatment / all
    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
    Infections and infestations
    Wound infection
         subjects affected / exposed
    0 / 83 (0.00%)
    0 / 321 (0.00%)
    1 / 163 (0.61%)
    0 / 395 (0.00%)
    1 / 163 (0.61%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Urinary tract infection
         subjects affected / exposed
    0 / 83 (0.00%)
    0 / 321 (0.00%)
    1 / 163 (0.61%)
    0 / 395 (0.00%)
    1 / 163 (0.61%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastroenteritis
         subjects affected / exposed
    0 / 83 (0.00%)
    0 / 321 (0.00%)
    0 / 163 (0.00%)
    1 / 395 (0.25%)
    0 / 163 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Oesophageal candidiasis
         subjects affected / exposed
    0 / 83 (0.00%)
    0 / 321 (0.00%)
    0 / 163 (0.00%)
    1 / 395 (0.25%)
    0 / 163 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Mastoiditis
         subjects affected / exposed
    0 / 83 (0.00%)
    0 / 321 (0.00%)
    0 / 163 (0.00%)
    0 / 395 (0.00%)
    1 / 163 (0.61%)
         occurrences causally related to treatment / all
    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
    Otitis externa
         subjects affected / exposed
    0 / 83 (0.00%)
    0 / 321 (0.00%)
    0 / 163 (0.00%)
    0 / 395 (0.00%)
    1 / 163 (0.61%)
         occurrences causally related to treatment / all
    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
    Otitis media acute
         subjects affected / exposed
    0 / 83 (0.00%)
    0 / 321 (0.00%)
    0 / 163 (0.00%)
    0 / 395 (0.00%)
    1 / 163 (0.61%)
         occurrences causally related to treatment / all
    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
    Pneumonia
         subjects affected / exposed
    0 / 83 (0.00%)
    0 / 321 (0.00%)
    0 / 163 (0.00%)
    0 / 395 (0.00%)
    1 / 163 (0.61%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Infective tenosynovitis
         subjects affected / exposed
    0 / 83 (0.00%)
    0 / 321 (0.00%)
    0 / 163 (0.00%)
    1 / 395 (0.25%)
    0 / 163 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Necrotising fasciitis
         subjects affected / exposed
    0 / 83 (0.00%)
    0 / 321 (0.00%)
    0 / 163 (0.00%)
    1 / 395 (0.25%)
    0 / 163 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Subglottic laryngitis
         subjects affected / exposed
    0 / 83 (0.00%)
    0 / 321 (0.00%)
    0 / 163 (0.00%)
    1 / 395 (0.25%)
    0 / 163 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    Placebo Initial Period (SS) Bimekizumab Initial Period (SS) Ustekinumab Initial Period (SS) Any Bimekizumab (AMS) Any Ustekinumab (AMS)
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    17 / 83 (20.48%)
    87 / 321 (27.10%)
    37 / 163 (22.70%)
    192 / 395 (48.61%)
    73 / 163 (44.79%)
    Vascular disorders
    Hypertension
         subjects affected / exposed
    1 / 83 (1.20%)
    7 / 321 (2.18%)
    5 / 163 (3.07%)
    14 / 395 (3.54%)
    10 / 163 (6.13%)
         occurrences all number
    1
    7
    5
    14
    11
    Nervous system disorders
    Headache
         subjects affected / exposed
    0 / 83 (0.00%)
    11 / 321 (3.43%)
    7 / 163 (4.29%)
    16 / 395 (4.05%)
    10 / 163 (6.13%)
         occurrences all number
    0
    11
    10
    17
    14
    Skin and subcutaneous tissue disorders
    Psoriasis
         subjects affected / exposed
    5 / 83 (6.02%)
    3 / 321 (0.93%)
    2 / 163 (1.23%)
    9 / 395 (2.28%)
    2 / 163 (1.23%)
         occurrences all number
    5
    4
    2
    11
    2
    Musculoskeletal and connective tissue disorders
    Back pain
         subjects affected / exposed
    2 / 83 (2.41%)
    3 / 321 (0.93%)
    4 / 163 (2.45%)
    10 / 395 (2.53%)
    9 / 163 (5.52%)
         occurrences all number
    2
    3
    4
    10
    10
    Infections and infestations
    Nasopharyngitis
         subjects affected / exposed
    7 / 83 (8.43%)
    30 / 321 (9.35%)
    14 / 163 (8.59%)
    86 / 395 (21.77%)
    36 / 163 (22.09%)
         occurrences all number
    8
    35
    15
    121
    53
    Oral candidiasis
         subjects affected / exposed
    0 / 83 (0.00%)
    28 / 321 (8.72%)
    0 / 163 (0.00%)
    60 / 395 (15.19%)
    1 / 163 (0.61%)
         occurrences all number
    0
    30
    0
    98
    1
    Upper respiratory tract infection
         subjects affected / exposed
    2 / 83 (2.41%)
    9 / 321 (2.80%)
    5 / 163 (3.07%)
    36 / 395 (9.11%)
    18 / 163 (11.04%)
         occurrences all number
    2
    9
    6
    48
    22
    Urinary tract infection
         subjects affected / exposed
    5 / 83 (6.02%)
    6 / 321 (1.87%)
    1 / 163 (0.61%)
    12 / 395 (3.04%)
    6 / 163 (3.68%)
         occurrences all number
    5
    6
    1
    14
    7

    More information

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    Substantial protocol amendments (globally)

    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    06 Apr 2018
    Protocol Amendment 3 (06 Apr 2018) included the following modifications: -Update name and contact information for Sponsor study physician -Extend the duration of the Screening Period, and therefore the overall study duration, by 1 week -Update list of current treatment for psoriasis to reflect changes in labeling and approved countries -Update list of completed and ongoing bimekizumab studies to reflect completion of study UP0042 -Clarify calculation of Psoriasis Area Severity Index responder rates -Remove references to pharmacodynamics assessments as they will not be conducted in this study -Update Schedule of study assessments to include a hematology and biochemistry sample at Week 20, to modify the visits at which the tuberculosis questionnaire, body weight, physical examination, and electrocardiogram are assessed, and to modify the visits at which photographs are taken -Clarify that all visits from first dose to Week 24 would have a ±3 day visit window, while all visits from Week 28 to end of study would have a ±7 day window -Clarify the dosing window -Modify exclusion criterion to clarify exclusion of subjects who have participated in other studies of bimekizumab, other medications (systemic or topical), or devices -Modify exclusion criteria pertaining to history of malignancy, systemic disease, and major depression -Add new withdrawal criteria for nonresponders and for subjects with newly diagnosed inflammatory bowel disease -Clarify withdrawal criteria for subjects with depression or suicidal ideation or behavior
    06 Apr 2018
    Continuation of Protocol Amendment 3 -Clarify that for subjects receiving ustekinumab, dosing is based on weight at Baseline -Update prohibited concomitant medications to include tildrakizumab and risankizumab -Corrected discrepancies between Section 8 Study procedures by visit and Schedule of study assessments -Revise Psoriatic Arthritis Screening and Evaluation questionnaire scoring -Remove immunophenotyping assessments -Clarify photography requirements -Clarify definition of abortion -Updated laboratory measurements to be performed -Provide additional details for requirements for investigational medicinal product rechallenge in the event of potential drug-induced liver injury -Defined a Maintenance Set as an analysis population -Update the definition of the Full Analysis Set -Clarify regions for analyses -Update the sequence testing In addition, minor spelling, editorial, and formatting changes were made, and the List of abbreviations was updated.

    Interruptions (globally)

    Were there any global interruptions to the trial? No

    Limitations and caveats

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