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    Clinical Trial Results:
    A Phase 3, Multicenter, Randomized, Double-Blind Study With an Active-Controlled Initial Treatment Period Followed by a Dose-Blind Maintenance Treatment Period to Evaluate the Efficacy and Safety of Bimekizumab in Adult Subjects With Moderate to Severe Chronic Plaque Psoriasis

    Summary
    EudraCT number
    2016-003392-22
    Trial protocol
    DE   HU  
    Global end of trial date
    26 Feb 2020

    Results information
    Results version number
    v1(current)
    This version publication date
    06 Mar 2021
    First version publication date
    06 Mar 2021
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    PS0008
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    NCT03412747
    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
    09 Apr 2020
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    26 Feb 2020
    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 adalimumab 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
    Background therapy as permitted in the protocol
    Evidence for comparator
    Adalimumab is a widely used treatment option for patients with moderate to severe plaque PSO who are candidates for systemic therapy or phototherapy. Adalimumab is a human immunoglobulin (Ig) G1 monoclonal antibody that binds specifically to tumor-necrosis factor (TNF). The efficacy of TNFα inhibitors in treating psoriasis is attributed to their inhibition of Th17-Tcells.
    Actual start date of recruitment
    26 Jan 2018
    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: 21
    Country: Number of subjects enrolled
    Canada: 77
    Country: Number of subjects enrolled
    Germany: 50
    Country: Number of subjects enrolled
    Hungary: 38
    Country: Number of subjects enrolled
    Poland: 126
    Country: Number of subjects enrolled
    Russian Federation: 14
    Country: Number of subjects enrolled
    Korea, Republic of: 5
    Country: Number of subjects enrolled
    Taiwan: 6
    Country: Number of subjects enrolled
    United States: 141
    Worldwide total number of subjects
    478
    EEA total number of subjects
    214
    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)
    434
    From 65 to 84 years
    44
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    The study started to enroll patients in January 2018 and concluded in February 2020.

    Pre-assignment
    Screening details
    This study included 4 periods: a Screening Period (2 to 5 weeks), an Initial Treatment Period (16 weeks), a Maintenance Treatment Period (40 weeks), and a Safety Follow-Up (SFU) Visit (20 weeks after the final dose of study drug). Participant Flow refers to the Randomized Set.

    Period 1
    Period 1 title
    Initial Treatment Period: Wk0-Wk16
    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
    Bimekizumab Arm 2
    Arm description
    Study participants received bimekizumab dose regimen 1 for 16 weeks and proceeded with bimekizumab dose regimen 2 until Week 56. Study participants received placebo at pre-specified time-points to maintain the blinding.
    Arm type
    Experimental

    Investigational medicinal product name
    Bimekizumab
    Investigational medicinal product code
    UCB4940
    Other name
    BKZ
    Pharmaceutical forms
    Solution for injection in pre-filled syringe
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Study participants received bimekizumab at pre-defined timepoints in dose regimen 1 and/or dose regimen 2.

    Arm title
    Bimekizumab Arm 1
    Arm description
    Study participants received bimekizumab dose regimen 1 for 56 weeks. Study participants received placebo at pre-specified time-points to maintain the blinding.
    Arm type
    Experimental

    Investigational medicinal product name
    Bimekizumab
    Investigational medicinal product code
    UCB4940
    Other name
    BKZ
    Pharmaceutical forms
    Solution for injection in pre-filled syringe
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Study participants received bimekizumab at pre-defined timepoints in dose regimen 1 and/or dose regimen 2.

    Arm title
    Adalimumab Arm
    Arm description
    Study participants received adalimumab for 24 weeks and then received bimekizumab dose regimen 1 until Week 56. Study participants received placebo at pre-specified time-points to maintain the blinding.
    Arm type
    Active comparator

    Investigational medicinal product name
    Adalimumab
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection in pre-filled syringe
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Adalimumab (ADA) was administered according to the labeling recommendations.

    Number of subjects in period 1
    Bimekizumab Arm 2 Bimekizumab Arm 1 Adalimumab Arm
    Started
    161
    158
    159
    Completed
    154
    153
    150
    Not completed
    7
    5
    9
         Protocol deviation
    -
    -
    2
         Lack of efficacy
    -
    -
    1
         Adverse event, serious fatal
    -
    -
    1
         Adverse event, non-fatal
    2
    2
    3
         Consent withdrawn by subject
    4
    1
    1
         Lost to follow-up
    -
    2
    1
         Participant moved out of state
    1
    -
    -
    Period 2
    Period 2 title
    Maintenance Treatment Period: Wk16-Wk24
    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
    Bimekizumab Arm 2
    Arm description
    Study participants received bimekizumab dose regimen 1 for 16 weeks and proceeded with bimekizumab dose regimen 2 until Week 56. Study participants received placebo at pre-specified time-points to maintain the blinding.
    Arm type
    Experimental

    Investigational medicinal product name
    Bimekizumab
    Investigational medicinal product code
    UCB4940
    Other name
    BKZ
    Pharmaceutical forms
    Solution for injection in pre-filled syringe
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Study participants received bimekizumab at pre-defined timepoints in dose regimen 1 and/or dose regimen 2.

    Arm title
    Bimekizumab Arm 1
    Arm description
    Study participants received bimekizumab dose regimen 1 for 56 weeks. Study participants received placebo at pre-specified time-points to maintain the blinding.
    Arm type
    Experimental

    Investigational medicinal product name
    Bimekizumab
    Investigational medicinal product code
    UCB4940
    Other name
    BKZ
    Pharmaceutical forms
    Solution for injection in pre-filled syringe
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Study participants received bimekizumab at pre-defined timepoints in dose regimen 1 and/or dose regimen 2.

    Arm title
    Adalimumab Arm
    Arm description
    Study participants received adalimumab for 24 weeks and then received bimekizumab dose regimen 1 until Week 56. Study participants received placebo at pre-specified time-points to maintain the blinding.
    Arm type
    Active comparator

    Investigational medicinal product name
    Adalimumab
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection in pre-filled syringe
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Adalimumab (ADA) was administered according to the labeling recommendations.

    Number of subjects in period 2
    Bimekizumab Arm 2 Bimekizumab Arm 1 Adalimumab Arm
    Started
    154
    153
    150
    Completed
    149
    152
    149
    Not completed
    5
    1
    1
         Lack of efficacy
    1
    -
    -
         Adverse event, non-fatal
    3
    1
    -
         Consent withdrawn by subject
    1
    -
    -
         Lost to follow-up
    -
    -
    1
    Period 3
    Period 3 title
    Maintenance Treatment Period: Wk24-Wk56
    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
    Bimekizumab Arm 2
    Arm description
    Study participants received bimekizumab dose regimen 1 for 16 weeks and proceeded with bimekizumab dose regimen 2 until Week 56. Study participants received placebo at pre-specified time-points to maintain the blinding.
    Arm type
    Experimental

    Investigational medicinal product name
    Bimekizumab
    Investigational medicinal product code
    UCB4940
    Other name
    BKZ
    Pharmaceutical forms
    Solution for injection in pre-filled syringe
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Study participants received bimekizumab at pre-defined timepoints in dose regimen 1 and/or dose regimen 2.

    Arm title
    Bimekizumab Arm 1
    Arm description
    Study participants received bimekizumab dose regimen 1 for 56 weeks. Study participants received placebo at pre-specified time-points to maintain the blinding.
    Arm type
    Experimental

    Investigational medicinal product name
    Bimekizumab
    Investigational medicinal product code
    UCB4940
    Other name
    BKZ
    Pharmaceutical forms
    Solution for injection in pre-filled syringe
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Study participants received bimekizumab at pre-defined timepoints in dose regimen 1 and/or dose regimen 2.

    Arm title
    Adalimumab Arm
    Arm description
    Study participants received adalimumab for 24 weeks and then received bimekizumab dose regimen 1 until Week 56. Study participants received placebo at pre-specified time-points to maintain the blinding.
    Arm type
    Active comparator

    Investigational medicinal product name
    Adalimumab
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection in pre-filled syringe
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Adalimumab (ADA) was administered according to the labeling recommendations.

    Number of subjects in period 3
    Bimekizumab Arm 2 Bimekizumab Arm 1 Adalimumab Arm
    Started
    149
    152
    149
    Completed
    143
    143
    133
    Not completed
    6
    9
    16
         Moving out of town
    -
    1
    -
         Lack of efficacy
    -
    1
    1
         Adverse event, non-fatal
    3
    4
    6
         Consent withdrawn by subject
    3
    1
    4
         Lost to follow-up
    -
    2
    5

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Bimekizumab Arm 2
    Reporting group description
    Study participants received bimekizumab dose regimen 1 for 16 weeks and proceeded with bimekizumab dose regimen 2 until Week 56. Study participants received placebo at pre-specified time-points to maintain the blinding.

    Reporting group title
    Bimekizumab Arm 1
    Reporting group description
    Study participants received bimekizumab dose regimen 1 for 56 weeks. Study participants received placebo at pre-specified time-points to maintain the blinding.

    Reporting group title
    Adalimumab Arm
    Reporting group description
    Study participants received adalimumab for 24 weeks and then received bimekizumab dose regimen 1 until Week 56. Study participants received placebo at pre-specified time-points to maintain the blinding.

    Reporting group values
    Bimekizumab Arm 2 Bimekizumab Arm 1 Adalimumab Arm Total
    Number of subjects
    161 158 159 478
    Age categorical
    Units: Subjects
        <=18 years
    3 0 2 5
        Between 18 and 65 years
    145 147 137 429
        >=65 years
    13 11 20 44
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    44.0 ± 13.5 45.3 ± 13.2 45.5 ± 14.3 -
    Gender categorical
    Units: Subjects
        Female
    49 56 45 150
        Male
    112 102 114 328

    End points

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    End points reporting groups
    Reporting group title
    Bimekizumab Arm 2
    Reporting group description
    Study participants received bimekizumab dose regimen 1 for 16 weeks and proceeded with bimekizumab dose regimen 2 until Week 56. Study participants received placebo at pre-specified time-points to maintain the blinding.

    Reporting group title
    Bimekizumab Arm 1
    Reporting group description
    Study participants received bimekizumab dose regimen 1 for 56 weeks. Study participants received placebo at pre-specified time-points to maintain the blinding.

    Reporting group title
    Adalimumab Arm
    Reporting group description
    Study participants received adalimumab for 24 weeks and then received bimekizumab dose regimen 1 until Week 56. Study participants received placebo at pre-specified time-points to maintain the blinding.
    Reporting group title
    Bimekizumab Arm 2
    Reporting group description
    Study participants received bimekizumab dose regimen 1 for 16 weeks and proceeded with bimekizumab dose regimen 2 until Week 56. Study participants received placebo at pre-specified time-points to maintain the blinding.

    Reporting group title
    Bimekizumab Arm 1
    Reporting group description
    Study participants received bimekizumab dose regimen 1 for 56 weeks. Study participants received placebo at pre-specified time-points to maintain the blinding.

    Reporting group title
    Adalimumab Arm
    Reporting group description
    Study participants received adalimumab for 24 weeks and then received bimekizumab dose regimen 1 until Week 56. Study participants received placebo at pre-specified time-points to maintain the blinding.
    Reporting group title
    Bimekizumab Arm 2
    Reporting group description
    Study participants received bimekizumab dose regimen 1 for 16 weeks and proceeded with bimekizumab dose regimen 2 until Week 56. Study participants received placebo at pre-specified time-points to maintain the blinding.

    Reporting group title
    Bimekizumab Arm 1
    Reporting group description
    Study participants received bimekizumab dose regimen 1 for 56 weeks. Study participants received placebo at pre-specified time-points to maintain the blinding.

    Reporting group title
    Adalimumab Arm
    Reporting group description
    Study participants received adalimumab for 24 weeks and then received bimekizumab dose regimen 1 until Week 56. Study participants received placebo at pre-specified time-points to maintain the blinding.

    Subject analysis set title
    Bimekizumab Arm 1 + Arm 2 (RS)
    Subject analysis set type
    Full analysis
    Subject analysis set description
    This group consisted of participants from both Arm 1 and Arm 2 who received bimekizumab dose regimen 1 for 16 weeks. Participants formed the Randomized Set (RS).

    Subject analysis set title
    Adalimumab Arm (RS)
    Subject analysis set type
    Full analysis
    Subject analysis set description
    Study participants received adalimumab for 24 weeks and then received bimekizumab dose regimen 1 until Week 56. Study participants received placebo at pre-specified time-points to maintain the blinding. Participants formed the Randomized Set (RS).

    Subject analysis set title
    Bimekizumab Arm 2 (RS)
    Subject analysis set type
    Full analysis
    Subject analysis set description
    Study participants received bimekizumab dose regimen 1 for 16 weeks and proceeded with bimekizumab dose regimen 2 until Week 56. Study participants received placebo at pre-specified time-points to maintain the blinding. Participants formed the Randomized Set (RS).

    Subject analysis set title
    Bimekizumab Arm 1 (RS)
    Subject analysis set type
    Full analysis
    Subject analysis set description
    Study participants received bimekizumab dose regimen 1 for 56 weeks. Study participants received placebo at pre-specified time-points to maintain the blinding. Participants formed the Randomized Set (RS).

    Subject analysis set title
    Bimekizumab Arm 2 through Week 24 (SS)
    Subject analysis set type
    Safety analysis
    Subject analysis set description
    Participants received bimekizumab dose regimen 1 for 16 weeks and proceeded with bimekizumab dose regimen 2 until Week 24. Participants received placebo at pre-specified time-points to maintain the blinding. Participants formed the Safety Set (SS).

    Subject analysis set title
    Bimekizumab Arm 1 through Week 24 (SS)
    Subject analysis set type
    Safety analysis
    Subject analysis set description
    Participants received bimekizumab dose regimen 1 for 24 weeks. Participants received placebo at pre-specified time-points to maintain the blinding. Participants formed the SS.

    Subject analysis set title
    Adalimumab Arm through Week 24 (SS)
    Subject analysis set type
    Safety analysis
    Subject analysis set description
    Participants received adalimumab for 24 weeks. Participants received placebo at pre-specified time-points to maintain the blinding. Participants formed the SS.

    Subject analysis set title
    Any bimekizumab dose regimen 2 (BKZ Set)
    Subject analysis set type
    Safety analysis
    Subject analysis set description
    This arm consisted of all participants who received bimekizumab dose regimen 2 at any time in the study (up to 56 weeks). Participants formed the Bimekizumab Set (BKZ Set).

    Subject analysis set title
    Any bimekizumab dose regimen 1 (BKZ Set)
    Subject analysis set type
    Safety analysis
    Subject analysis set description
    This arm consisted of all participants who received bimekizumab dose regimen 1 at any time in the study (up to 56 weeks). Participants formed the BKZ Set (BKZ Set).

    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. Body divided into 4 areas: head, arms, trunk to groin, and 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) to 4 (very marked). Determining the percentage of skin covered with PSO for each of the body areas and converting to a 0 to 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 minimum possible PASI score is 0= no disease, the maximum score is 72= maximal disease. The Randomized Set (RS) consisted of all randomized study participants. Both BKZ Arm 1 and BKZ Arm 2 are identical in terms of treatment received until Week 16 and therefore they are combined for analyses.
    End point type
    Primary
    End point timeframe
    Week 16
    End point values
    Bimekizumab Arm 1 + Arm 2 (RS) Adalimumab Arm (RS)
    Number of subjects analysed
    319
    159
    Units: percentage of participants
        number (not applicable)
    86.2
    47.2
    Statistical analysis title
    Statistical analysis 1
    Statistical analysis description
    Risk Difference: BKZ-ADA calculated using stratified CMH.
    Comparison groups
    Bimekizumab Arm 1 + Arm 2 (RS) v Adalimumab Arm (RS)
    Number of subjects included in analysis
    478
    Analysis specification
    Pre-specified
    Analysis type
    non-inferiority [1]
    Method
    Cochran-Mantel-Haenszel
    Parameter type
    Risk difference (RD)
    Point estimate
    39.3
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    30.9
         upper limit
    47.7
    Notes
    [1] - The evaluation of non-inferiority is tested at a 1-sided alpha level of 0.025 and based on a 1-sided 97.5% CI and a non-inferiority margin of 10%.
    Statistical analysis title
    Statistical Analysis 2
    Statistical analysis description
    Odds ratio: BKZ/ADA calculated using stratified Cochran-Mantel-Haenszel (CMH) test with region and prior biologic exposure as stratification variables.
    Comparison groups
    Bimekizumab Arm 1 + Arm 2 (RS) v Adalimumab Arm (RS)
    Number of subjects included in analysis
    478
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.001 [2]
    Method
    Cochran-Mantel-Haenszel
    Parameter type
    Odds ratio (OR)
    Point estimate
    7.459
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    4.709
         upper limit
    11.816
    Notes
    [2] - P-values for the comparison of treatment groups were based on the CMH test from the general association.

    Primary: Percentage of Participants With an Investigator's Global Assessment (IGA) Response (Clear or Almost Clear With at Least 2-Category Improvement Relative to Baseline) at Week 16

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    End point title
    Percentage of Participants With an Investigator's Global Assessment (IGA) Response (Clear or Almost Clear With at Least 2-Category Improvement Relative to Baseline) at Week 16
    End point description
    The 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. Both BKZ Arm 1 and BKZ Arm 2 are identical in terms of treatment received until Week 16 and therefore they are combined for analyses.
    End point type
    Primary
    End point timeframe
    Week 16
    End point values
    Bimekizumab Arm 1 + Arm 2 (RS) Adalimumab Arm (RS)
    Number of subjects analysed
    319
    159
    Units: percentage of participants
        number (not applicable)
    85.3
    57.2
    Statistical analysis title
    Statistical analysis 1
    Statistical analysis description
    Risk Difference: BKZ-ADA calculated using stratified CMH.
    Comparison groups
    Bimekizumab Arm 1 + Arm 2 (RS) v Adalimumab Arm (RS)
    Number of subjects included in analysis
    478
    Analysis specification
    Pre-specified
    Analysis type
    non-inferiority [3]
    Method
    Cochran-Mantel-Haenszel
    Parameter type
    Risk difference (RD)
    Point estimate
    28.2
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    19.7
         upper limit
    36.7
    Notes
    [3] - The evaluation of non-inferiority is tested at a 1-sided alpha level of 0.025 and based on a 1-sided 97.5% CI and a non-inferiority margin of 10%.
    Statistical analysis title
    Statistical analysis 2
    Statistical analysis description
    Odds ratio: BKZ/ADA calculated using stratified Cochran-Mantel-Haenszel (CMH) test with region and prior biologic exposure as stratification variables.
    Comparison groups
    Bimekizumab Arm 1 + Arm 2 (RS) v Adalimumab Arm (RS)
    Number of subjects included in analysis
    478
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.001 [4]
    Method
    Cochran-Mantel-Haenszel
    Parameter type
    Odds ratio (OR)
    Point estimate
    4.341
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    2.785
         upper limit
    6.765
    Notes
    [4] - P-values for the comparison of treatment groups were based on the CMH test from the general association.

    Secondary: Percentage of Participants With a PASI90 Response at Week 24

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    End point title
    Percentage of Participants With a PASI90 Response at Week 24
    End point description
    The PASI90 response assessments are based on at least 90% improvement in the PASI score from Baseline. Body divided into 4 areas: head, arms, trunk to groin, and 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) to 4 (very marked). Determining the percentage of skin covered with PSO for each of the body areas and converting to a 0 to 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 minimum possible PASI score is 0= no disease, the maximum score is 72= maximal disease. The Randomized Set (RS) consisted of all randomized study participants. BKZ Arm 1 and BKZ Arm 2 were also combined for analyses purposes at Week 24 since they differ only one dose (Week 20).
    End point type
    Secondary
    End point timeframe
    Week 24
    End point values
    Bimekizumab Arm 1 + Arm 2 (RS) Adalimumab Arm (RS) Bimekizumab Arm 2 (RS) Bimekizumab Arm 1 (RS)
    Number of subjects analysed
    319
    159
    161
    158
    Units: percentage of participants
        number (not applicable)
    85.6
    51.6
    85.1
    86.1
    Statistical analysis title
    Statistical analysis 1
    Statistical analysis description
    Odds ratio: BKZ/ADA calculated using stratified Cochran-Mantel-Haenszel (CMH) test with region and prior biologic exposure as stratification variables.
    Comparison groups
    Bimekizumab Arm 1 (RS) v Adalimumab Arm (RS)
    Number of subjects included in analysis
    317
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.001 [5]
    Method
    Cochran-Mantel-Haenszel
    Parameter type
    Odds ratio (OR)
    Point estimate
    6.231
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    3.515
         upper limit
    11.046
    Notes
    [5] - P-values for the comparison of treatment groups were based on the CMH test from the general association.
    Statistical analysis title
    Statistical Analysis 2
    Statistical analysis description
    Odds ratio: BKZ/ADA calculated using stratified CMH test with region and prior biologic exposure as stratification variables.
    Comparison groups
    Bimekizumab Arm 1 + Arm 2 (RS) v Adalimumab Arm (RS)
    Number of subjects included in analysis
    478
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.001 [6]
    Method
    Cochran-Mantel-Haenszel
    Parameter type
    Odds ratio (OR)
    Point estimate
    5.75
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    3.657
         upper limit
    9.041
    Notes
    [6] - P-values for the comparison of treatment groups were based on the CMH test from the general association.

    Secondary: Percentage of Participants With an IGA Response (Clear or Almost Clear with at least 2-category improvement relative to Baseline) at Week 24

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    End point title
    Percentage of Participants With an IGA Response (Clear or Almost Clear with at least 2-category improvement relative to Baseline) at Week 24
    End point description
    The 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 24. The Randomized Set (RS) consisted of all randomized study participants. BKZ Arm 1 and BKZ Arm 2 were also combined for analyses purposes at Week 24 since they differ only one dose (Week 20).
    End point type
    Secondary
    End point timeframe
    Week 24
    End point values
    Bimekizumab Arm 1 + Arm 2 (RS) Adalimumab Arm (RS) Bimekizumab Arm 2 (RS) Bimekizumab Arm 1 (RS)
    Number of subjects analysed
    319
    159
    161
    158
    Units: percentage of participants
        number (not applicable)
    86.5
    57.9
    87.0
    86.1
    Statistical analysis title
    Statistical analysis 1
    Statistical analysis description
    Odds ratio: BKZ/ADA calculated using stratified Cochran-Mantel-Haenszel (CMH) test with region and prior biologic exposure as stratification variables.
    Comparison groups
    Bimekizumab Arm 1 (RS) v Adalimumab Arm (RS)
    Number of subjects included in analysis
    317
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.001 [7]
    Method
    Cochran-Mantel-Haenszel
    Parameter type
    Odds ratio (OR)
    Point estimate
    4.724
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    2.683
         upper limit
    8.318
    Notes
    [7] - P-values for the comparison of treatment groups were based on the CMH test from the general association.
    Statistical analysis title
    Statistical analysis 2
    Statistical analysis description
    Odds ratio: BKZ/ADA calculated using stratified CMH test with region and prior biologic exposure as stratification variables.
    Comparison groups
    Bimekizumab Arm 1 + Arm 2 (RS) v Adalimumab Arm (RS)
    Number of subjects included in analysis
    478
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.001 [8]
    Method
    Cochran-Mantel-Haenszel
    Parameter type
    Odds ratio (OR)
    Point estimate
    4.762
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    3.014
         upper limit
    7.523
    Notes
    [8] - P-values for the comparison of treatment groups 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. Body divided into 4 areas: head, arms, trunk to groin, and 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) to 4 (very marked). Determining the percentage of skin covered with PSO for each of the body areas and converting to a 0 to 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 minimum possible PASI score is 0= no disease, the maximum score is 72= maximal disease. The Randomized Set (RS) consisted of all randomized study participants. Both BKZ Arm 1 and BKZ Arm 2 are identical in terms of treatment received until Week 16 and therefore they are combined for analyses.
    End point type
    Secondary
    End point timeframe
    Week 4
    End point values
    Bimekizumab Arm 1 + Arm 2 (RS) Adalimumab Arm (RS)
    Number of subjects analysed
    319
    159
    Units: percentage of participants
        number (not applicable)
    76.5
    31.4
    Statistical analysis title
    Statistical analysis 1
    Statistical analysis description
    Odds ratio: BKZ/ADA calculated using stratified Cochran-Mantel-Haenszel (CMH) test with region and prior biologic exposure as stratification variables.
    Comparison groups
    Bimekizumab Arm 1 + Arm 2 (RS) v Adalimumab Arm (RS)
    Number of subjects included in analysis
    478
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.001 [9]
    Method
    Cochran-Mantel-Haenszel
    Parameter type
    Odds ratio (OR)
    Point estimate
    7.103
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    4.637
         upper limit
    10.88
    Notes
    [9] - P-values for the comparison of treatment groups 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. Body divided into 4 areas: head, arms, trunk to groin, and 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) to 4 (very marked). Determining the percentage of skin covered with PSO for each of the body areas and converting to a 0 to 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 minimum possible PASI score is 0= no disease, the maximum score is 72= maximal disease. The Randomized Set (RS) consisted of all randomized study participants. Both BKZ Arm 1 and BKZ Arm 2 are identical in terms of treatment received until Week 16 and therefore they are combined for analyses.
    End point type
    Secondary
    End point timeframe
    Week 16
    End point values
    Bimekizumab Arm 1 + Arm 2 (RS) Adalimumab Arm (RS)
    Number of subjects analysed
    319
    159
    Units: percentage of participants
        number (not applicable)
    60.8
    23.9
    Statistical analysis title
    Statistical analysis 1
    Statistical analysis description
    Odds ratio: BKZ/ADA calculated using stratified Cochran-Mantel-Haenszel (CMH) test with region and prior biologic exposure as stratification variables.
    Comparison groups
    Bimekizumab Arm 1 + Arm 2 (RS) v Adalimumab Arm (RS)
    Number of subjects included in analysis
    478
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.001 [10]
    Method
    Cochran-Mantel-Haenszel
    Parameter type
    Odds ratio (OR)
    Point estimate
    4.974
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    3.23
         upper limit
    7.661
    Notes
    [10] - P-values for the comparison of treatment groups were based on the CMH test from the general association.

    Secondary: Percentage of Participants With a PASI100 Response at Week 24

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    End point title
    Percentage of Participants With a PASI100 Response at Week 24
    End point description
    The PASI100 response assessments are based on a 100% improvement in the PASI score from Baseline. Body divided into 4 areas: head, arms, trunk to groin, and 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) to 4 (very marked). Determining the percentage of skin covered with PSO for each of the body areas and converting to a 0 to 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 minimum possible PASI score is 0= no disease, the maximum score is 72= maximal disease. The Randomized Set (RS) consisted of all randomized study participants. BKZ Arm 1 and BKZ Arm 2 were also combined for analyses purposes at Week 24 since they differ only one dose (Week 20)
    End point type
    Secondary
    End point timeframe
    Week 24
    End point values
    Bimekizumab Arm 1 + Arm 2 (RS) Adalimumab Arm (RS) Bimekizumab Arm 2 (RS) Bimekizumab Arm 1 (RS)
    Number of subjects analysed
    319
    159
    161
    158
    Units: percentage of participants
        number (not applicable)
    66.8
    29.6
    65.8
    67.7
    Statistical analysis title
    Statistical analysis 1
    Statistical analysis description
    Odds ratio: BKZ/ADA calculated using stratified Cochran-Mantel-Haenszel (CMH) test with region and prior biologic exposure as stratification variables.
    Comparison groups
    Bimekizumab Arm 1 (RS) v Adalimumab Arm (RS)
    Number of subjects included in analysis
    317
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.001 [11]
    Method
    Cochran-Mantel-Haenszel
    Parameter type
    Odds ratio (OR)
    Point estimate
    5.249
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    3.207
         upper limit
    8.593
    Notes
    [11] - P-values for the comparison of treatment groups were based on the CMH test from the general association.
    Statistical analysis title
    Statistical analysis 2
    Statistical analysis description
    Odds ratio: BKZ/ADA calculated using stratified CMH test with region and prior biologic exposure as stratification variables.
    Comparison groups
    Bimekizumab Arm 1 + Arm 2 (RS) v Adalimumab Arm (RS)
    Number of subjects included in analysis
    478
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.001 [12]
    Method
    Cochran-Mantel-Haenszel
    Parameter type
    Odds ratio (OR)
    Point estimate
    4.974
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    3.257
         upper limit
    7.594
    Notes
    [12] - P-values for the comparison of treatment groups were based on the CMH test from the general association.

    Secondary: Percentage of Participants With a PASI90 Response at Week 56

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    End point title
    Percentage of Participants With a PASI90 Response at Week 56
    End point description
    PASI90 response assessments are based on at least 90% improvement in the PASI score from Baseline. Body divided into 4 areas: head/arms/trunk to groin/and 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 for the respective section. The min possible PASI score is 0=no disease, max score is 72=maximal disease. The RS consisted of all randomized study participants. ADA participants were not included as they did not start BKZ treatment at Baseline, thus did not have a year of BKZ treatment. The purpose of this table is to look at response after one year of BKZ.
    End point type
    Secondary
    End point timeframe
    Week 56
    End point values
    Bimekizumab Arm 2 (RS) Bimekizumab Arm 1 (RS)
    Number of subjects analysed
    161
    158
    Units: percentage of participants
        number (not applicable)
    82.6
    84.8
    No statistical analyses for this end point

    Secondary: Percentage of Participants With an IGA Response (Clear or Almost Clear with at least 2-category improvement relative to Baseline) at Week 56

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    End point title
    Percentage of Participants With an IGA Response (Clear or Almost Clear with at least 2-category improvement relative to Baseline) at Week 56
    End point description
    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]/almost clear [1] with at least a 2-category improvement from Baseline at Wk56. The RS consisted of all randomized study participants. ADA participants were not included as they did not start BKZ treatment at Baseline, thus did not have a year of BKZ treatment. The purpose of this table is to look at response after one year of BKZ.
    End point type
    Secondary
    End point timeframe
    Week 56
    End point values
    Bimekizumab Arm 2 (RS) Bimekizumab Arm 1 (RS)
    Number of subjects analysed
    161
    158
    Units: percentage of participants
        number (not applicable)
    83.2
    82.3
    No statistical analyses for this end point

    Secondary: Number of Treatment-emergent Adverse Events (TEAEs) Adjusted by Duration of Participant Exposure to Study Treatment from Baseline to Week 24

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    End point title
    Number of Treatment-emergent Adverse Events (TEAEs) Adjusted by Duration of Participant Exposure to Study Treatment from Baseline to Week 24
    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 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 who received at least 1 dose of IMP.
    End point type
    Secondary
    End point timeframe
    From Baseline to Week 24
    End point values
    Bimekizumab Arm 2 through Week 24 (SS) Bimekizumab Arm 1 through Week 24 (SS) Adalimumab Arm through Week 24 (SS)
    Number of subjects analysed
    161
    158
    159
    Units: no. of new events per 100 subject-years
        number (confidence interval 95%)
    310.44 (256.52 to 372.34)
    300.71 (247.60 to 361.83)
    297.54 (244.77 to 358.31)
    No statistical analyses for this end point

    Secondary: Number of Serious Adverse Events (SAEs) Adjusted by Duration of Participant Exposure to Study Treatment from Baseline to Week 24

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    End point title
    Number of Serious Adverse Events (SAEs) Adjusted by Duration of Participant Exposure to Study Treatment from Baseline to Week 24
    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 Week 24
    End point values
    Bimekizumab Arm 2 through Week 24 (SS) Bimekizumab Arm 1 through Week 24 (SS) Adalimumab Arm through Week 24 (SS)
    Number of subjects analysed
    161
    158
    159
    Units: no. of new events per 100 subject-years
        number (confidence interval 95%)
    1.37 (0.03 to 7.66)
    5.61 (1.53 to 14.38)
    6.98 (2.27 to 16.30)
    No statistical analyses for this end point

    Secondary: Number of Treatment-emergent Adverse Events (TEAEs) Leading to Withdrawal Adjusted by Duration of Participant Exposure to Study Treatment from Baseline to Week 24

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    End point title
    Number of Treatment-emergent Adverse Events (TEAEs) Leading to Withdrawal Adjusted by Duration of Participant Exposure to Study Treatment from Baseline to Week 24
    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 Week 24
    End point values
    Bimekizumab Arm 2 through Week 24 (SS) Bimekizumab Arm 1 through Week 24 (SS) Adalimumab Arm through Week 24 (SS)
    Number of subjects analysed
    161
    158
    159
    Units: no. of new events per 100 subject-years
        number (confidence interval 95%)
    8.30 (3.05 to 18.07)
    4.16 (0.86 to 12.17)
    6.98 (2.27 to 16.29)
    No statistical analyses for this end point

    Secondary: Number of Treatment-emergent Adverse Events (TEAEs) Adjusted by Duration of Participant Exposure to Study Treatment from Baseline to Safety Follow-Up Visit (up to Week 72)

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    End point title
    Number of Treatment-emergent Adverse Events (TEAEs) Adjusted by Duration of Participant Exposure to Study Treatment from Baseline to Safety Follow-Up Visit (up to Week 72)
    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 AE being considered. If a participant had no events, the total time at risk was used. The Bimekizumab Set (BKZ Set) consisted of all study participants who received at least 1 dose of bimekizumab in this study.
    End point type
    Secondary
    End point timeframe
    From Baseline to Safety Follow-Up Visit (up to Week 72)
    End point values
    Any bimekizumab dose regimen 2 (BKZ Set) Any bimekizumab dose regimen 1 (BKZ Set)
    Number of subjects analysed
    154
    468
    Units: no. of new events per 100 subject-years
        number (confidence interval 95%)
    231.38 (191.68 to 276.88)
    262.41 (235.37 to 291.71)
    No statistical analyses for this end point

    Secondary: Number of Serious Adverse Events (SAEs) Adjusted by Duration of Participant Exposure to Study Treatment from Baseline to Safety Follow-Up Visit (up to Week 72)

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    End point title
    Number of Serious Adverse Events (SAEs) Adjusted by Duration of Participant Exposure to Study Treatment from Baseline to Safety Follow-Up Visit (up to Week 72)
    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 Bimekizumab Set (BKZ Set) consisted of all study participants who received at least 1 dose of bimekizumab in this study.
    End point type
    Secondary
    End point timeframe
    From Baseline to Safety Follow-Up Visit (up to Week 72)
    End point values
    Any bimekizumab dose regimen 2 (BKZ Set) Any bimekizumab dose regimen 1 (BKZ Set)
    Number of subjects analysed
    154
    468
    Units: no. of new events per 100 subject-years
        number (confidence interval 95%)
    7.03 (3.04 to 13.86)
    5.34 (3.05 to 8.67)
    No statistical analyses for this end point

    Secondary: Number of Treatment-emergent Adverse Events (TEAEs) Leading to Withdrawal Adjusted by Duration of Participant Exposure to Study Treatment from Baseline to Safety Follow-Up Visit (up to Week 72)

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    End point title
    Number of Treatment-emergent Adverse Events (TEAEs) Leading to Withdrawal Adjusted by Duration of Participant Exposure to Study Treatment from Baseline to Safety Follow-Up Visit (up to Week 72)
    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 Bimekizumab Set (BKZ Set) consisted of all study participants who received at least 1 dose of bimekizumab in this study.
    End point type
    Secondary
    End point timeframe
    From Baseline to Safety Follow-Up Visit (up to Week 72)
    End point values
    Any bimekizumab dose regimen 2 (BKZ Set) Any bimekizumab dose regimen 1 (BKZ Set)
    Number of subjects analysed
    154
    468
    Units: no. of new events per 100 subject-years
        number (confidence interval 95%)
    4.37 (1.42 to 10.19)
    4.62 (2.53 to 7.75)
    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 Visit (up to Week 72)
    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 up to Safety Follow-Up Visit for study participants not enrolling in Open-label Extension (OLE) study).
    Assessment type
    Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    19.0
    Reporting groups
    Reporting group title
    Bimekizumab Arm 2 through Week 24 (SS)
    Reporting group description
    Participants received bimekizumab dose regimen 1 for 16 weeks and proceeded with bimekizumab dose regimen 2 until Week 24. Participants received placebo at pre-specified time-points to maintain the blinding. Participants formed the Safety Set (SS).

    Reporting group title
    Bimekizumab Arm 1 through Week 24 (SS)
    Reporting group description
    Participants received bimekizumab dose regimen 1 for 24 weeks. Participants received placebo at pre-specified time-points to maintain the blinding. Participants formed the SS.

    Reporting group title
    Adalimumab Arm through Week 24 (SS)
    Reporting group description
    Participants received adalimumab for 24 weeks. Participants received placebo at pre-specified time-points to maintain the blinding. Participants formed the SS.

    Reporting group title
    Any bimekizumab dose regimen 2 (BKZ Set)
    Reporting group description
    This arm consisted of all participants who received bimekizumab dose regimen 2 at any time in the study (up to 56 weeks). Participants formed the Bimekizumab Set (BKZ Set).

    Reporting group title
    Any bimekizumab dose regimen 1 (BKZ Set)
    Reporting group description
    This arm consisted of all participants who received bimekizumab dose regimen 1 at any time in the study (up to 56 weeks). Participants formed the BKZ Set (BKZ Set).

    Serious adverse events
    Bimekizumab Arm 2 through Week 24 (SS) Bimekizumab Arm 1 through Week 24 (SS) Adalimumab Arm through Week 24 (SS) Any bimekizumab dose regimen 2 (BKZ Set) Any bimekizumab dose regimen 1 (BKZ Set)
    Total subjects affected by serious adverse events
         subjects affected / exposed
    1 / 161 (0.62%)
    4 / 158 (2.53%)
    5 / 159 (3.14%)
    8 / 154 (5.19%)
    16 / 468 (3.42%)
         number of deaths (all causes)
    0
    0
    1
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    0
    0
    Vascular disorders
    Hypertension
         subjects affected / exposed
    0 / 161 (0.00%)
    0 / 158 (0.00%)
    0 / 159 (0.00%)
    1 / 154 (0.65%)
    0 / 468 (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)
    Squamous cell carcinoma of the tongue
         subjects affected / exposed
    0 / 161 (0.00%)
    0 / 158 (0.00%)
    1 / 159 (0.63%)
    0 / 154 (0.00%)
    0 / 468 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    Colon cancer
         subjects affected / exposed
    0 / 161 (0.00%)
    0 / 158 (0.00%)
    0 / 159 (0.00%)
    1 / 154 (0.65%)
    0 / 468 (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
    Immune system disorders
    Sarcoidosis
         subjects affected / exposed
    0 / 161 (0.00%)
    0 / 158 (0.00%)
    0 / 159 (0.00%)
    0 / 154 (0.00%)
    1 / 468 (0.21%)
         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
    Abortion spontaneous
         subjects affected / exposed
    0 / 161 (0.00%)
    1 / 158 (0.63%)
    0 / 159 (0.00%)
    0 / 154 (0.00%)
    1 / 468 (0.21%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Non-cardiac chest pain
         subjects affected / exposed
    0 / 161 (0.00%)
    0 / 158 (0.00%)
    0 / 159 (0.00%)
    1 / 154 (0.65%)
    0 / 468 (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
    Reproductive system and breast disorders
    Ovarian cyst ruptured
         subjects affected / exposed
    0 / 161 (0.00%)
    1 / 158 (0.63%)
    0 / 159 (0.00%)
    0 / 154 (0.00%)
    1 / 468 (0.21%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    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
    Subdural haematoma
         subjects affected / exposed
    0 / 161 (0.00%)
    0 / 158 (0.00%)
    0 / 159 (0.00%)
    0 / 154 (0.00%)
    1 / 468 (0.21%)
         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
    Investigations
    Hepatic enzyme increased
         subjects affected / exposed
    0 / 161 (0.00%)
    0 / 158 (0.00%)
    0 / 159 (0.00%)
    1 / 154 (0.65%)
    0 / 468 (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
    Coronary artery stenosis
         subjects affected / exposed
    0 / 161 (0.00%)
    0 / 158 (0.00%)
    0 / 159 (0.00%)
    0 / 154 (0.00%)
    1 / 468 (0.21%)
         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
    Blood and lymphatic system disorders
    Haemorrhagic anaemia
         subjects affected / exposed
    0 / 161 (0.00%)
    0 / 158 (0.00%)
    0 / 159 (0.00%)
    1 / 154 (0.65%)
    0 / 468 (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
    Carotid artery stenosis
         subjects affected / exposed
    0 / 161 (0.00%)
    0 / 158 (0.00%)
    1 / 159 (0.63%)
    0 / 154 (0.00%)
    0 / 468 (0.00%)
         occurrences causally related to treatment / all
    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
    Eye disorders
    Retinal detachment
         subjects affected / exposed
    0 / 161 (0.00%)
    1 / 158 (0.63%)
    0 / 159 (0.00%)
    0 / 154 (0.00%)
    1 / 468 (0.21%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Irritable bowel syndrome
         subjects affected / exposed
    0 / 161 (0.00%)
    1 / 158 (0.63%)
    0 / 159 (0.00%)
    0 / 154 (0.00%)
    1 / 468 (0.21%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Haemorrhoidal haemorrhage
         subjects affected / exposed
    0 / 161 (0.00%)
    0 / 158 (0.00%)
    1 / 159 (0.63%)
    0 / 154 (0.00%)
    0 / 468 (0.00%)
         occurrences causally related to treatment / all
    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
    Pancreatitis
         subjects affected / exposed
    0 / 161 (0.00%)
    0 / 158 (0.00%)
    0 / 159 (0.00%)
    0 / 154 (0.00%)
    1 / 468 (0.21%)
         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
    Gastric polyps
         subjects affected / exposed
    0 / 161 (0.00%)
    0 / 158 (0.00%)
    0 / 159 (0.00%)
    0 / 154 (0.00%)
    1 / 468 (0.21%)
         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
    Duodenal ulcer haemorrhage
         subjects affected / exposed
    0 / 161 (0.00%)
    0 / 158 (0.00%)
    0 / 159 (0.00%)
    1 / 154 (0.65%)
    0 / 468 (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
    Umbilical hernia
         subjects affected / exposed
    0 / 161 (0.00%)
    0 / 158 (0.00%)
    0 / 159 (0.00%)
    1 / 154 (0.65%)
    0 / 468 (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
    Renal and urinary disorders
    Calculus urinary
         subjects affected / exposed
    0 / 161 (0.00%)
    0 / 158 (0.00%)
    1 / 159 (0.63%)
    0 / 154 (0.00%)
    0 / 468 (0.00%)
         occurrences causally related to treatment / all
    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
    Hepatobiliary disorders
    Cholecystitis
         subjects affected / exposed
    0 / 161 (0.00%)
    0 / 158 (0.00%)
    0 / 159 (0.00%)
    0 / 154 (0.00%)
    1 / 468 (0.21%)
         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
    Skin and subcutaneous tissue disorders
    Subcutaneous abscess
         subjects affected / exposed
    0 / 161 (0.00%)
    0 / 158 (0.00%)
    0 / 159 (0.00%)
    0 / 154 (0.00%)
    1 / 468 (0.21%)
         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
    Erysipelas
         subjects affected / exposed
    0 / 161 (0.00%)
    0 / 158 (0.00%)
    0 / 159 (0.00%)
    1 / 154 (0.65%)
    0 / 468 (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
    Intervertebral disc protrusion
         subjects affected / exposed
    0 / 161 (0.00%)
    0 / 158 (0.00%)
    1 / 159 (0.63%)
    0 / 154 (0.00%)
    1 / 468 (0.21%)
         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
    Metabolism and nutrition disorders
    Diabetes mellitus inadequate control
         subjects affected / exposed
    0 / 161 (0.00%)
    0 / 158 (0.00%)
    0 / 159 (0.00%)
    0 / 154 (0.00%)
    1 / 468 (0.21%)
         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
    Type 2 diabetes mellitus
         subjects affected / exposed
    0 / 161 (0.00%)
    0 / 158 (0.00%)
    0 / 159 (0.00%)
    0 / 154 (0.00%)
    1 / 468 (0.21%)
         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
    Infections and infestations
    Cellulitis
         subjects affected / exposed
    1 / 161 (0.62%)
    0 / 158 (0.00%)
    0 / 159 (0.00%)
    0 / 154 (0.00%)
    3 / 468 (0.64%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
    0 / 0
    1 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Infected dermal cyst
         subjects affected / exposed
    0 / 161 (0.00%)
    0 / 158 (0.00%)
    1 / 159 (0.63%)
    0 / 154 (0.00%)
    0 / 468 (0.00%)
         occurrences causally related to treatment / all
    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
    Anal abscess
         subjects affected / exposed
    0 / 161 (0.00%)
    0 / 158 (0.00%)
    0 / 159 (0.00%)
    0 / 154 (0.00%)
    1 / 468 (0.21%)
         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
    Appendicitis
         subjects affected / exposed
    0 / 161 (0.00%)
    0 / 158 (0.00%)
    0 / 159 (0.00%)
    1 / 154 (0.65%)
    0 / 468 (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
    Helicobacter infection
         subjects affected / exposed
    0 / 161 (0.00%)
    0 / 158 (0.00%)
    0 / 159 (0.00%)
    0 / 154 (0.00%)
    1 / 468 (0.21%)
         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
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    Bimekizumab Arm 2 through Week 24 (SS) Bimekizumab Arm 1 through Week 24 (SS) Adalimumab Arm through Week 24 (SS) Any bimekizumab dose regimen 2 (BKZ Set) Any bimekizumab dose regimen 1 (BKZ Set)
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    65 / 161 (40.37%)
    61 / 158 (38.61%)
    62 / 159 (38.99%)
    60 / 154 (38.96%)
    182 / 468 (38.89%)
    Vascular disorders
    Hypertension
         subjects affected / exposed
    9 / 161 (5.59%)
    6 / 158 (3.80%)
    13 / 159 (8.18%)
    4 / 154 (2.60%)
    19 / 468 (4.06%)
         occurrences all number
    10
    6
    13
    4
    20
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed
    5 / 161 (3.11%)
    8 / 158 (5.06%)
    4 / 159 (2.52%)
    5 / 154 (3.25%)
    14 / 468 (2.99%)
         occurrences all number
    5
    9
    6
    5
    16
    Infections and infestations
    Nasopharyngitis
         subjects affected / exposed
    27 / 161 (16.77%)
    32 / 158 (20.25%)
    38 / 159 (23.90%)
    28 / 154 (18.18%)
    79 / 468 (16.88%)
         occurrences all number
    40
    46
    50
    35
    113
    Oral candidiasis
         subjects affected / exposed
    19 / 161 (11.80%)
    15 / 158 (9.49%)
    0 / 159 (0.00%)
    17 / 154 (11.04%)
    66 / 468 (14.10%)
         occurrences all number
    26
    20
    0
    26
    104
    Upper respiratory tract infection
         subjects affected / exposed
    12 / 161 (7.45%)
    7 / 158 (4.43%)
    15 / 159 (9.43%)
    13 / 154 (8.44%)
    30 / 468 (6.41%)
         occurrences all number
    14
    8
    21
    16
    40
    Pharyngitis
         subjects affected / exposed
    5 / 161 (3.11%)
    4 / 158 (2.53%)
    1 / 159 (0.63%)
    11 / 154 (7.14%)
    13 / 468 (2.78%)
         occurrences all number
    7
    4
    1
    11
    14

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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 2 (06 Apr 2018) included the following modifications: • Extended the duration of the Screening Period, and therefore the overall study duration, by 1 week • Updated list of current treatment for Psoriasis (PSO) to reflect changes in labeling and approved countries • Updated list of completed and ongoing bimekizumab studies to reflect completion of study UP0042 • Clarified calculation of PASI response rates • Removed references to pharmacodynamic (PD) assessments as they were not conducted in this study • Updated the schedule of study assessments to include a hematology and biochemistry sample at Week 28, and to modify the visits at which the Tuberculosis (TB) questionnaire, body weight, physical examination, and Electrocardiogram (ECG) were assessed • Clarified 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 • Clarified the dosing window • Modified exclusion criterion to clarify exclusion of study participants who participated in other studies of bimekizumab, other medications (systemic or topical), or devices • Modified exclusion criteria to exclude use of prohibited PSO medications • Modified exclusion criteria pertaining to history of malignancy, systemic disease, and major depression • Added new withdrawal criteria for nonresponders and for study participants with newly diagnosed inflammatory bowel disease (IBD) • Clarified withdrawal criteria for study participants with depression or suicidal ideation or behavior • Corrected information pertaining to how adalimumab was supplied • Updated prohibited concomitant medications to include tildrakizumab and risankizumab • Corrected discrepancies between Study procedures by visit and Schedule of study assessments • Revised Psoriatic Arthritis Screening and Evaluation (PASE) questionnaire scoring • Clarified definition of abortion • Updated laboratory measurements to be performed
    06 Apr 2018
    Continuation of Protocol Amendment 2: • Provided additional details for requirements for investigational medicinal product (IMP) rechallenge in the event of potential drug-induced liver injury (PDILI) • Defined a bimekizumab Set as an analysis population • Clarified regions for analyses • Updated the sequence testing and analysis of secondary efficacy variables 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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