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    Clinical Trial Results:
    A Phase 2 Multicenter, Investigator-Blind, Subject-Blind, Placebo-Controlled Study of the Efficacy, Safety, and Pharmacokinetics of Bimekizumab in Subjects with Moderate to Severe Hidradenitis Suppurativa

    Summary
    EudraCT number
    2017-000892-10
    Trial protocol
    DE   BE   DK   GR  
    Global end of trial date
    21 Feb 2019

    Results information
    Results version number
    v1(current)
    This version publication date
    07 Mar 2020
    First version publication date
    07 Mar 2020
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    HS0001
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    NCT03248531
    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
    28 Mar 2019
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    21 Feb 2019
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The primary objective of this study is to evaluate the efficacy of bimekizumab in subjects with moderate to severe Hidradenitis Suppurativa (HS).
    Protection of trial subjects
    During the conduct of the study all participants were closely monitored.
    Background therapy
    Subject agreed to daily use (and throughout the entirety of the study) of 1 of the following over-the-counter topical antiseptics on their HS lesions: chlorhexidine gluconate, triclosan, benzoyl peroxide, or dilute bleach in bathwater. Concomitant use of oral antibiotic therapy for treatment of HS was allowed provided the dosing regimen (dose and frequency) had been stable for at least 4 consecutive weeks (28 days) prior to Baseline.
    Evidence for comparator
    Adalimumab is the only approved medicinal product for the treatment of moderate to severe HS with an inadequate response to conventional systemic HS therapy (approved in Sep 2015).
    Actual start date of recruitment
    22 Sep 2017
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    United States: 46
    Country: Number of subjects enrolled
    Australia: 19
    Country: Number of subjects enrolled
    Belgium: 1
    Country: Number of subjects enrolled
    Denmark: 3
    Country: Number of subjects enrolled
    Germany: 8
    Country: Number of subjects enrolled
    Norway: 2
    Country: Number of subjects enrolled
    Russian Federation: 11
    Worldwide total number of subjects
    90
    EEA total number of subjects
    14
    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)
    89
    From 65 to 84 years
    1
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    The study started to enroll patients in September 2017 and concluded in February 2019.

    Pre-assignment
    Screening details
    The study included a Screening Period (≥ 2 weeks up to a maximum of 4 weeks prior to randomization), a Treatment Period (12 weeks), and a Safety Follow-Up (SFU) Period (20 weeks after the last dose of investigational medicinal product (IMP)). Participant Flow refers to the Randomized Set.

    Period 1
    Period 1 title
    Overall Study (overall period)
    Is this the baseline period?
    Yes
    Allocation method
    Randomised - controlled
    Blinding used
    Double blind
    Roles blinded
    Carer, Assessor, Subject, Investigator
    Blinding implementation details
    For reporting of this study, due to limitations of the drop-down list for blinding, the wording Double Blind was utilized instead of Investigator- and Subject-Blind.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    Placebo
    Arm description
    Participants received several placebo applications to keep the blinding and as a control group.
    Arm type
    Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    PBO
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Placebo will be provided for blinding and as a control group.

    Arm title
    Adalimumab
    Arm description
    Participants received one Adalimumab loading dose 1, one Adalimumab dose 2 application and several Adalimumab dose 3 applications.
    Arm type
    Active comparator

    Investigational medicinal product name
    Adalimumab
    Investigational medicinal product code
    Other name
    Humira®
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Adalimumab in different dosages (dose 1, 2 and 3).

    Arm title
    Bimekizumab
    Arm description
    Participants received one Bimekizumab loading dose 1 and several Bimekizumab dose 2 applications.
    Arm type
    Experimental

    Investigational medicinal product name
    Bimekizumab
    Investigational medicinal product code
    UCB4940
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Bimekizumab in different dosages (dose 1 and 2).

    Number of subjects in period 1
    Placebo Adalimumab Bimekizumab
    Started
    22
    22
    46
    Completed Week 12
    19
    18
    42
    Completed
    18
    17
    38
    Not completed
    4
    5
    8
         Adverse event, non-fatal
    -
    -
    1
         Consent withdrawn by subject
    3
    3
    2
         Sponsor Request
    -
    2
    -
         Lost to follow-up
    1
    -
    5

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Placebo
    Reporting group description
    Participants received several placebo applications to keep the blinding and as a control group.

    Reporting group title
    Adalimumab
    Reporting group description
    Participants received one Adalimumab loading dose 1, one Adalimumab dose 2 application and several Adalimumab dose 3 applications.

    Reporting group title
    Bimekizumab
    Reporting group description
    Participants received one Bimekizumab loading dose 1 and several Bimekizumab dose 2 applications.

    Reporting group values
    Placebo Adalimumab Bimekizumab Total
    Number of subjects
    22 22 46 90
    Age categorical
    Units: Subjects
        <=18 years
    0 0 2 2
        Between 18 and 65 years
    21 22 44 87
        >=65 years
    1 0 0 1
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    40.7 ± 12.5 31.0 ± 9.2 37.4 ± 11.9 -
    Gender categorical
    Units: Subjects
        Male
    7 4 16 27
        Female
    15 18 30 63

    End points

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    End points reporting groups
    Reporting group title
    Placebo
    Reporting group description
    Participants received several placebo applications to keep the blinding and as a control group.

    Reporting group title
    Adalimumab
    Reporting group description
    Participants received one Adalimumab loading dose 1, one Adalimumab dose 2 application and several Adalimumab dose 3 applications.

    Reporting group title
    Bimekizumab
    Reporting group description
    Participants received one Bimekizumab loading dose 1 and several Bimekizumab dose 2 applications.

    Subject analysis set title
    Placebo (PPS)
    Subject analysis set type
    Per protocol
    Subject analysis set description
    Participants received several placebo applications to keep the blinding and as a control group, forming the Per-Protocol Set (PPS).

    Subject analysis set title
    Adalimumab (PPS)
    Subject analysis set type
    Per protocol
    Subject analysis set description
    Participants received one Adalimumab loading dose 1, one Adalimumab dose 2 application and several Adalimumab dose 3 applications, forming the PPS.

    Subject analysis set title
    Bimekizumab (PPS)
    Subject analysis set type
    Per protocol
    Subject analysis set description
    Participants received one Bimekizumab loading dose 1 and several Bimekizumab dose 2 applications, forming the PPS.

    Subject analysis set title
    Bimekizumab (PK-PPS)
    Subject analysis set type
    Per protocol
    Subject analysis set description
    Participants received one Bimekizumab loading dose 1 and several Bimekizumab dose 2 applications, forming the Pharmacokinetic Per-Protocol Set (PK-PPS).

    Subject analysis set title
    Placebo (SS)
    Subject analysis set type
    Safety analysis
    Subject analysis set description
    Participants received several placebo applications to keep the blinding and as a control group, forming the Safety Set (SS).

    Subject analysis set title
    Adalimumab (SS)
    Subject analysis set type
    Safety analysis
    Subject analysis set description
    Participants received one Adalimumab loading dose 1, one Adalimumab dose 2 application and several Adalimumab dose 3 applications, forming the SS.

    Subject analysis set title
    Bimekizumab (SS)
    Subject analysis set type
    Safety analysis
    Subject analysis set description
    Participants received one Bimekizumab loading dose 1 and several Bimekizumab dose 2 applications, forming the SS.

    Primary: Percentage of subjects achieving clinical response as measured by Hidradenitis Suppurativa Clinical Response (HiSCR) at Week 12

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    End point title
    Percentage of subjects achieving clinical response as measured by Hidradenitis Suppurativa Clinical Response (HiSCR) at Week 12
    End point description
    HiSCR was defined as at least a 50 % reduction from Baseline in the total abscess and inflammatory nodule (AN) count, with no increase from Baseline in abscess or draining fistula count. Missing data were handled using non-response imputation (NRI) methods.
    End point type
    Primary
    End point timeframe
    Week 12
    End point values
    Placebo (PPS) Adalimumab (PPS) Bimekizumab (PPS)
    Number of subjects analysed
    20
    20
    44
    Units: percentage of participants
        number (confidence interval 95%)
    23.7 (10.2 to 45.8)
    59.8 (37.0 to 79.0)
    56.9 (41.4 to 71.2)
    Statistical analysis title
    Statistical analysis 1
    Statistical analysis description
    Results were based on a Bayesian logistic regression model where the number of responders was assumed to follow a binomial distribution. Treatment and Baseline Hurley Stage were included as predictors in the model. 95% credible intervals were presented for the BKZ vs PBO comparison.
    Comparison groups
    Placebo (PPS) v Bimekizumab (PPS)
    Number of subjects included in analysis
    64
    Analysis specification
    Pre-specified
    Analysis type
    other
    Method
    Regression, Logistic
    Parameter type
    Mean posterior difference
    Point estimate
    31.2
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    11
         upper limit
    50.4
    Variability estimate
    Standard deviation
    Dispersion value
    10.1
    Statistical analysis title
    Statistical analysis 2
    Statistical analysis description
    Results were based on a Bayesian logistic regression model where the number of responders was assumed to follow a binomial distribution. Treatment and Baseline Hurley Stage were included as predictors in the model. 60% credible intervals were presented for the BKZ vs ADA comparison.
    Comparison groups
    Adalimumab (PPS) v Bimekizumab (PPS)
    Number of subjects included in analysis
    64
    Analysis specification
    Pre-specified
    Analysis type
    other
    Method
    Regression, Logistic
    Parameter type
    Mean posterior difference
    Point estimate
    -2.2
    Confidence interval
         level
    60%
         sides
    2-sided
         lower limit
    -11.2
         upper limit
    6.6
    Variability estimate
    Standard deviation
    Dispersion value
    10.6
    Statistical analysis title
    Statistical analysis 3
    Statistical analysis description
    Results were based on a Bayesian logistic regression model where the number of responders was assumed to follow a binomial distribution. Treatment and Baseline Hurley Stage were included as predictors in the model. Pr[Diff > 0%](%) refers to the probability that the BKZ response rate was greater than the PBO response rate. 0% Confidence Interval (CI) [0,999] was used a placeholder.
    Comparison groups
    Placebo (PPS) v Bimekizumab (PPS)
    Number of subjects included in analysis
    64
    Analysis specification
    Pre-specified
    Analysis type
    other
    Method
    Regression, Logistic
    Parameter type
    Pr [Diff>0%] (%)
    Point estimate
    99.8
    Confidence interval
         level
    0%
         sides
    2-sided
         lower limit
    0
         upper limit
    999
    Statistical analysis title
    Statistical analysis 4
    Statistical analysis description
    Results were based on a Bayesian logistic regression model where the number of responders was assumed to follow a binomial distribution. Treatment and Baseline Hurley Stage were included as predictors in the model. Pr[Diff > 0%](%) refers to the probability that the BKZ response rate was greater than the ADA response rate. 0% Confidence Interval (CI) [0,999] was used a placeholder.
    Comparison groups
    Adalimumab (PPS) v Bimekizumab (PPS)
    Number of subjects included in analysis
    64
    Analysis specification
    Pre-specified
    Analysis type
    other
    Method
    Regression, Logistic
    Parameter type
    Pr[Diff > 0%](%)
    Point estimate
    42.1
    Confidence interval
         level
    0%
         sides
    2-sided
         lower limit
    0
         upper limit
    999

    Secondary: Bimekizumab plasma concentration at Day 1

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    End point title
    Bimekizumab plasma concentration at Day 1
    End point description
    Plasma concentration of Bimekizumab was expressed in nanograms per milliliter (ng/mL). Values Below Limit of Quantification (BLQ) were replaced by value of Lower Limit of Quantification (LLOQ) divided by 2 (75 ng/mL) in calculations of Means and Coefficient of Variations (CVs). Means and CVs were only calculated if at least 2/3 of the concentrations were quantified at the respective visit. Note: 999 is being used as a placeholder for values not reportable as per BLQ rules.
    End point type
    Secondary
    End point timeframe
    Day 1
    End point values
    Bimekizumab (PK-PPS)
    Number of subjects analysed
    46
    Units: ng/mL
        geometric mean (geometric coefficient of variation)
    999 ± 999
    No statistical analyses for this end point

    Secondary: Bimekizumab plasma concentration at Week 2

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    End point title
    Bimekizumab plasma concentration at Week 2
    End point description
    Plasma concentration of Bimekizumab was expressed in ng/mL. Values BLQ were replaced by value of LLOQ/2 (75 ng/mL) in calculations of Means and CVs. Means and CVs were only calculated if at least 2/3 of the concentrations were quantified at the respective visit.
    End point type
    Secondary
    End point timeframe
    Week 2
    End point values
    Bimekizumab (PK-PPS)
    Number of subjects analysed
    45
    Units: ng/mL
        geometric mean (geometric coefficient of variation)
    24086.4 ± 56.4
    No statistical analyses for this end point

    Secondary: Bimekizumab plasma concentration at Week 4

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    End point title
    Bimekizumab plasma concentration at Week 4
    End point description
    Plasma concentration of Bimekizumab was expressed in ng/mL. Values BLQ were replaced by value of LLOQ/2 (75 ng/mL) in calculations of Means and CVs. Means and CVs were only calculated if at least 2/3 of the concentrations were quantified at the respective visit.
    End point type
    Secondary
    End point timeframe
    Week 4
    End point values
    Bimekizumab (PK-PPS)
    Number of subjects analysed
    46
    Units: ng/mL
        geometric mean (geometric coefficient of variation)
    26572.6 ± 57.6
    No statistical analyses for this end point

    Secondary: Bimekizumab plasma concentration at Week 8

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    End point title
    Bimekizumab plasma concentration at Week 8
    End point description
    Plasma concentration of Bimekizumab was expressed in ng/mL. Values BLQ were replaced by value of LLOQ/2 (75 ng/mL) in calculations of Means and CVs. Means and CVs were only calculated if at least 2/3 of the concentrations were quantified at the respective visit.
    End point type
    Secondary
    End point timeframe
    Week 8
    End point values
    Bimekizumab (PK-PPS)
    Number of subjects analysed
    43
    Units: ng/mL
        geometric mean (geometric coefficient of variation)
    30222.6 ± 54.5
    No statistical analyses for this end point

    Secondary: Bimekizumab plasma concentration at Week 12

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    End point title
    Bimekizumab plasma concentration at Week 12
    End point description
    Plasma concentration of Bimekizumab was expressed in ng/mL. Values BLQ were replaced by value of LLOQ/2 (75 ng/mL) in calculations of Means and CVs. Means and CVs were only calculated if at least 2/3 of the concentrations were quantified at the respective visit.
    End point type
    Secondary
    End point timeframe
    Week 12
    End point values
    Bimekizumab (PK-PPS)
    Number of subjects analysed
    42
    Units: ng/mL
        geometric mean (geometric coefficient of variation)
    25319.0 ± 116.8
    No statistical analyses for this end point

    Secondary: Bimekizumab plasma concentration at Week 30

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    End point title
    Bimekizumab plasma concentration at Week 30
    End point description
    Plasma concentration of Bimekizumab was expressed in ng/mL. Values BLQ were replaced by value of LLOQ/2 (75 ng/mL) in calculations of Means and CVs. Means and CVs were only calculated if at least 2/3 of the concentrations were quantified at the respective visit. Note: 999 is being used as a placeholder for values not reportable as per BLQ rules.
    End point type
    Secondary
    End point timeframe
    Week 30
    End point values
    Bimekizumab (PK-PPS)
    Number of subjects analysed
    35
    Units: ng/mL
        geometric mean (geometric coefficient of variation)
    999 ± 999
    No statistical analyses for this end point

    Secondary: Percentage of participants with at least one adverse event during the study

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    End point title
    Percentage of participants with at least one adverse event during the study
    End point description
    An adverse event (AE) was any untoward medical occurrence in a patient or clinical investigation study participant administered a pharmaceutical product that did not necessarily have a causal relationship with this treatment. An AE could therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.
    End point type
    Secondary
    End point timeframe
    From Screening to Safety Follow-Up (Week 30)
    End point values
    Placebo (SS) Adalimumab (SS) Bimekizumab (SS)
    Number of subjects analysed
    21
    21
    46
    Units: percentage of participants
        number (not applicable)
    61.9
    71.4
    71.7
    No statistical analyses for this end point

    Secondary: Percentage of participants with at least one adverse event categorized by maximum severity during the study

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    End point title
    Percentage of participants with at least one adverse event categorized by maximum severity during the study
    End point description
    An adverse event (AE) was any untoward medical occurrence in a patient or clinical investigation study participant administered a pharmaceutical product that did not necessarily have a causal relationship with this treatment. An AE could therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.
    End point type
    Secondary
    End point timeframe
    From Screening to Safety Follow-Up (Week 30)
    End point values
    Placebo (SS) Adalimumab (SS) Bimekizumab (SS)
    Number of subjects analysed
    21
    21
    46
    Units: percentage of participants
    number (not applicable)
        Mild
    47.6
    66.7
    63.0
        Moderate
    33.3
    42.9
    39.1
        Severe
    4.8
    9.5
    6.5
    No statistical analyses for this end point

    Secondary: Percentage of participants with at least one serious adverse event during the study

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    End point title
    Percentage of participants with at least one serious adverse event during the study
    End point description
    A serious adverse event (SAE) was any untoward medical occurrence that at any dose: - Resulted in death - Was life-threatening - Required in patient hospitalization or prolongation of existing hospitalisation - Was a congenital anomaly or birth defect - Was an infection that required treatment parenteral antibiotics - Other important medical events which based on medical or scientific judgement may have jeopardised the patients, or may have required medical or surgical intervention to prevent any of the above.
    End point type
    Secondary
    End point timeframe
    From Screening to Safety Follow-Up (Week 30)
    End point values
    Placebo (SS) Adalimumab (SS) Bimekizumab (SS)
    Number of subjects analysed
    21
    21
    46
    Units: percentage of participants
        number (not applicable)
    9.5
    4.8
    4.3
    No statistical analyses for this end point

    Secondary: Percentage of participants with at least one serious adverse event categorized by severity during the study

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    End point title
    Percentage of participants with at least one serious adverse event categorized by severity during the study
    End point description
    A serious adverse event (SAE) was any untoward medical occurrence that at any dose: - Resulted in death - Was life-threatening - Required in patient hospitalization or prolongation of existing hospitalisation - Was a congenital anomaly or birth defect - Was an infection that required treatment parenteral antibiotics - Other important medical events which based on medical or scientific judgement may have jeopardised the patients, or may have required medical or surgical intervention to prevent any of the above.
    End point type
    Secondary
    End point timeframe
    From Screening to Safety Follow-Up (Week 30)
    End point values
    Placebo (SS) Adalimumab (SS) Bimekizumab (SS)
    Number of subjects analysed
    21
    21
    46
    Units: percentage of participants
    number (not applicable)
        Mild
    0
    4.8
    0
        Moderate
    4.8
    0
    0
        Severe
    4.8
    4.8
    4.3
    No statistical analyses for this end point

    Secondary: Percentage of participants that withdrew due to adverse events during the study

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    End point title
    Percentage of participants that withdrew due to adverse events during the study
    End point description
    An adverse event (AE) was any untoward medical occurrence in a patient or clinical investigation study participant administered a pharmaceutical product that did not necessarily have a causal relationship with this treatment. An AE could therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.
    End point type
    Secondary
    End point timeframe
    From Screening to Safety Follow-Up (Week 30)
    End point values
    Placebo (SS) Adalimumab (SS) Bimekizumab (SS)
    Number of subjects analysed
    21
    21
    46
    Units: percentage of participants
        number (not applicable)
    0
    0
    2.2
    No statistical analyses for this end point

    Secondary: Change from Baseline until Safety Follow-up Visit in vital signs (blood pressure)

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    End point title
    Change from Baseline until Safety Follow-up Visit in vital signs (blood pressure)
    End point description
    Blood pressure was measured in millimeters of mercury (mmHg). Note: The number of participants analyzed in Week 30 (Safety Follow-Up) for each parameter is presented in parentheses following this model (n= n1, n2, n3) where: n1 = number of participants analyzed in the Placebo (SS) group; n2 = number of participants analyzed in the Adalimumab (SS) group; n3 = number of participants analyzed in the Bimekizumab (SS) group.
    End point type
    Secondary
    End point timeframe
    From Screening to Safety Follow-Up (Week 30)
    End point values
    Placebo (SS) Adalimumab (SS) Bimekizumab (SS)
    Number of subjects analysed
    21
    21
    46
    Units: mmHg
    arithmetic mean (standard deviation)
        Systolic Blood Pressure (n= 18, 19, 38)
    -2.9 ± 14.8
    4.5 ± 14.5
    -0.4 ± 13.8
        Diastolic Blood Pressure (n= 18, 19, 38)
    -1.8 ± 8.4
    -0.6 ± 9.1
    -2.2 ± 11.2
    No statistical analyses for this end point

    Secondary: Change from Baseline until Safety Follow-up Visit in vital signs (pulse rate)

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    End point title
    Change from Baseline until Safety Follow-up Visit in vital signs (pulse rate)
    End point description
    Pulse rate was measured in beats per minute (beats/min).
    End point type
    Secondary
    End point timeframe
    From Screening to Safety Follow-Up (Week 30)
    End point values
    Placebo (SS) Adalimumab (SS) Bimekizumab (SS)
    Number of subjects analysed
    18
    19
    38
    Units: beats/min
        arithmetic mean (standard deviation)
    -1.4 ± 10.2
    -1.8 ± 10.8
    -1.6 ± 10.8
    No statistical analyses for this end point

    Secondary: Change from Baseline until Safety Follow-up Visit in body weight

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    End point title
    Change from Baseline until Safety Follow-up Visit in body weight
    End point description
    Body weight was measured in kilograms (kg).
    End point type
    Secondary
    End point timeframe
    From Screening to Safety Follow-Up (Week 30)
    End point values
    Placebo (SS) Adalimumab (SS) Bimekizumab (SS)
    Number of subjects analysed
    18
    19
    38
    Units: kg
        arithmetic mean (standard deviation)
    0.90 ± 7.39
    1.82 ± 3.94
    0.42 ± 6.89
    No statistical analyses for this end point

    Secondary: Change from Baseline until Safety Follow-up Visit in ECG parameters (ECG Mean Heart Rate)

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    End point title
    Change from Baseline until Safety Follow-up Visit in ECG parameters (ECG Mean Heart Rate)
    End point description
    Electrocardiogram (ECG) Mean Heart Rate was measured in beats/min.
    End point type
    Secondary
    End point timeframe
    From Screening to Safety Follow-Up (Week 30)
    End point values
    Placebo (SS) Adalimumab (SS) Bimekizumab (SS)
    Number of subjects analysed
    18
    15
    37
    Units: beats/min
        arithmetic mean (standard deviation)
    -2.1 ± 12.4
    -2.1 ± 11.1
    1.5 ± 10.1
    No statistical analyses for this end point

    Secondary: Change from Baseline until Safety Follow-up Visit in ECG parameters (PR Interval, QRS duration, QT interval, QTcF Interval)

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    End point title
    Change from Baseline until Safety Follow-up Visit in ECG parameters (PR Interval, QRS duration, QT interval, QTcF Interval)
    End point description
    PR Interval, QRS duration, QT interval and QT corrected for heart rate using Fridericia’s correction (QTcF) Interval were measured in milliseconds (msec). Note: The number of participants analyzed in Week 30 (Safety Follow-Up) for each parameter is presented in parentheses following this model (n= n1, n2, n3) where: n1 = number of participants analyzed in the Placebo (SS) group; n2 = number of participants analyzed in the Adalimumab (SS) group; n3 = number of participants analyzed in the Bimekizumab (SS) group.
    End point type
    Secondary
    End point timeframe
    From Screening to Safety Follow-Up (Week 30)
    End point values
    Placebo (SS) Adalimumab (SS) Bimekizumab (SS)
    Number of subjects analysed
    21
    21
    46
    Units: msec
    arithmetic mean (standard deviation)
        PR Interval (n= 18, 15, 37)
    0.8 ± 18.8
    2.4 ± 10.5
    3.6 ± 18.7
        QRS duration (n= 18, 15, 37)
    -0.3 ± 7.1
    0.2 ± 5.2
    0.6 ± 7.4
        QT interval (n= 18, 15, 37)
    4.8 ± 20.2
    4.2 ± 26.7
    1.8 ± 27.7
        QTcF Interval (n= 18, 15, 37)
    -11.7 ± 49.9
    -0.3 ± 14.4
    2.4 ± 12.7
    No statistical analyses for this end point

    Secondary: Change from Baseline until Safety Follow-up Visit in hematology parameters (erythrocytes)

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    End point title
    Change from Baseline until Safety Follow-up Visit in hematology parameters (erythrocytes)
    End point description
    Erythrocytes was measured in number of red blood cells per liter (10^12/L).
    End point type
    Secondary
    End point timeframe
    From Screening to Safety Follow-Up (Week 30)
    End point values
    Placebo (SS) Adalimumab (SS) Bimekizumab (SS)
    Number of subjects analysed
    14
    18
    33
    Units: 10^12 red blood cells per liter
        arithmetic mean (standard deviation)
    0.144 ± 0.349
    -0.151 ± 0.416
    -0.013 ± 0.274
    No statistical analyses for this end point

    Secondary: Change from Baseline until Safety Follow-up Visit in hematology parameters (hematocrit)

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    End point title
    Change from Baseline until Safety Follow-up Visit in hematology parameters (hematocrit)
    End point description
    Hematocrit was measured in volume percentage (%) of red blood cells in blood.
    End point type
    Secondary
    End point timeframe
    From Screening to Safety Follow-Up (Week 30)
    End point values
    Placebo (SS) Adalimumab (SS) Bimekizumab (SS)
    Number of subjects analysed
    14
    18
    33
    Units: volume % of red blood cells
        arithmetic mean (standard deviation)
    2.01 ± 2.83
    -0.81 ± 4.30
    0.39 ± 2.69
    No statistical analyses for this end point

    Secondary: Change from Baseline until Safety Follow-up Visit in hematology parameters (hemoglobin, erythrocytes mean corpuscular hemoglobin (HGB) concentration)

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    End point title
    Change from Baseline until Safety Follow-up Visit in hematology parameters (hemoglobin, erythrocytes mean corpuscular hemoglobin (HGB) concentration)
    End point description
    Hemoglobin, erythrocytes mean corpuscular hemoglobin (HGB) concentration were measured in grams per liter (g/L). Note: The number of participants analyzed in Week 30 (Safety Follow-Up) for each parameter is presented in parentheses following this model (n= n1, n2, n3) where: n1 = number of participants analyzed in the Placebo (SS) group; n2 = number of participants analyzed in the Adalimumab (SS) group; n3 = number of participants analyzed in the Bimekizumab (SS) group.
    End point type
    Secondary
    End point timeframe
    From Screening to Safety Follow-Up (Week 30)
    End point values
    Placebo (SS) Adalimumab (SS) Bimekizumab (SS)
    Number of subjects analysed
    21
    21
    46
    Units: g/L
    arithmetic mean (standard deviation)
        Hemoglobin (n= 14, 18, 33)
    5.3 ± 11.6
    -3.7 ± 11.6
    1.1 ± 7.6
        Erythrocytes mean corpuscular HGB (n= 14, 18, 33)
    -1.4 ± 16.2
    -2.6 ± 13.4
    -0.2 ± 13.2
    No statistical analyses for this end point

    Secondary: Change from Baseline until Safety Follow-up Visit in hematology parameters (erythrocytes mean corpuscular hemoglobin (HGB))

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    End point title
    Change from Baseline until Safety Follow-up Visit in hematology parameters (erythrocytes mean corpuscular hemoglobin (HGB))
    End point description
    Erythrocytes mean corpuscular hemoglobin (HGB) was measured in picograms (pg).
    End point type
    Secondary
    End point timeframe
    From Screening to Safety Follow-Up (Week 30)
    End point values
    Placebo (SS) Adalimumab (SS) Bimekizumab (SS)
    Number of subjects analysed
    14
    18
    33
    Units: picograms (pg)
        arithmetic mean (standard deviation)
    0.29 ± 0.76
    0.21 ± 0.78
    0.30 ± 0.99
    No statistical analyses for this end point

    Secondary: Change from Baseline until Safety Follow-up Visit in hematology parameters (erythrocytes mean corpuscular volume)

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    End point title
    Change from Baseline until Safety Follow-up Visit in hematology parameters (erythrocytes mean corpuscular volume)
    End point description
    Erythrocytes mean corpuscular volume was measured in femtolitres (fL).
    End point type
    Secondary
    End point timeframe
    From Screening to Safety Follow-Up (Week 30)
    End point values
    Placebo (SS) Adalimumab (SS) Bimekizumab (SS)
    Number of subjects analysed
    14
    18
    33
    Units: femtolitres (fL)
        arithmetic mean (standard deviation)
    1.49 ± 2.95
    1.36 ± 3.21
    1.04 ± 4.03
    No statistical analyses for this end point

    Secondary: Change from Baseline until Safety Follow-up Visit in hematology parameters (platelets)

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    End point title
    Change from Baseline until Safety Follow-up Visit in hematology parameters (platelets)
    End point description
    Platelets was measured in number of platelets per liter (10^9/L).
    End point type
    Secondary
    End point timeframe
    From Screening to Safety Follow-Up (Week 30)
    End point values
    Placebo (SS) Adalimumab (SS) Bimekizumab (SS)
    Number of subjects analysed
    14
    18
    33
    Units: 10^9 platelets per liter
        arithmetic mean (standard deviation)
    -17.4 ± 38.7
    2.3 ± 61.6
    -19.2 ± 51.4
    No statistical analyses for this end point

    Secondary: Change from Baseline until Safety Follow-up Visit in hematology parameters (leukocytes, basophils, eosinophils, lymphocytes, monocytes, neutrophils)

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    End point title
    Change from Baseline until Safety Follow-up Visit in hematology parameters (leukocytes, basophils, eosinophils, lymphocytes, monocytes, neutrophils)
    End point description
    Leukocytes, basophils, eosinophils, lymphocytes, monocytes and neutrophils were measured in number of white blood cells per liter (10^9/L). Note: The number of participants analyzed in Week 30 (Safety Follow-Up) for each parameter is presented in parentheses following this model (n= n1, n2, n3) where: n1 = number of participants analyzed in the Placebo (SS) group; n2 = number of participants analyzed in the Adalimumab (SS) group; n3 = number of participants analyzed in the Bimekizumab (SS) group.
    End point type
    Secondary
    End point timeframe
    From Screening to Safety Follow-Up (Week 30)
    End point values
    Placebo (SS) Adalimumab (SS) Bimekizumab (SS)
    Number of subjects analysed
    21
    21
    46
    Units: 10^9 white blood cells per liter
    arithmetic mean (standard deviation)
        Leukocytes (n= 14, 18, 33)
    -0.281 ± 2.621
    -0.114 ± 2.997
    -0.122 ± 2.308
        Basophils (n= 14, 18, 33)
    0.009 ± 0.026
    0.033 ± 0.077
    0.015 ± 0.048
        Eosinophils (n= 14, 18, 33)
    0.007 ± 0.077
    -0.012 ± 0.100
    0.002 ± 0.056
        Lymphocytes (n= 14, 18, 33)
    0.029 ± 0.812
    0.241 ± 0.682
    0.038 ± 0.570
        Monocytes (n= 14, 18, 33)
    0.072 ± 0.420
    -0.032 ± 0.322
    0.060 ± 0.192
        Neutrophils (n= 14, 18, 33)
    -0.396 ± 2.076
    -0.341 ± 2.460
    -0.240 ± 2.234
    No statistical analyses for this end point

    Secondary: Change from Baseline until Safety Follow-up Visit in hematology parameters (basophils/leukocytes, eosinophils/leukocytes, lymphocytes/leukocytes, monocytes/leukocytes, neutrophils/leukocytes)

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    End point title
    Change from Baseline until Safety Follow-up Visit in hematology parameters (basophils/leukocytes, eosinophils/leukocytes, lymphocytes/leukocytes, monocytes/leukocytes, neutrophils/leukocytes)
    End point description
    Basophils/leukocytes, eosinophils/leukocytes, lymphocytes/leukocytes, monocytes/leukocytes and neutrophils/leukocytes were measured in percentages (%). Note: The number of participants analyzed in Week 30 (Safety Follow-Up) for each parameter is presented in parentheses following this model (n= n1, n2, n3) where: n1 = number of participants analyzed in the Placebo (SS) group; n2 = number of participants analyzed in the Adalimumab (SS) group; n3 = number of participants analyzed in the Bimekizumab (SS) group.
    End point type
    Secondary
    End point timeframe
    From Screening to Safety Follow-Up (Week 30)
    End point values
    Placebo (SS) Adalimumab (SS) Bimekizumab (SS)
    Number of subjects analysed
    21
    21
    46
    Units: % of white blood cells per leukocytes
    arithmetic mean (standard deviation)
        Basophils/leukocytes (n= 14, 18, 33)
    0.13 ± 0.23
    0.42 ± 0.93
    0.13 ± 0.65
        Eosinophils/leukocytes (n= 14, 18, 33)
    -0.12 ± 1.92
    -0.03 ± 1.09
    0.12 ± 1.12
        Lymphocytes/leukocytes (n= 14, 18, 33)
    1.43 ± 5.47
    2.04 ± 6.73
    2.04 ± 8.07
        Monocytes/leukocytes (n= 14, 18, 33)
    0.49 ± 4.35
    -0.20 ± 2.79
    1.00 ± 2.17
        Neutrophils/leukocytes (n= 14, 18, 33)
    -1.93 ± 6.84
    -2.24 ± 7.50
    -3.29 ± 9.55
    No statistical analyses for this end point

    Secondary: Change from Baseline until Safety Follow-up Visit in biochemistry parameters (bicarbonate, chloride, potassium, sodium, calcium, magnesium, urea nitrogen, cholesterol, glucose)

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    End point title
    Change from Baseline until Safety Follow-up Visit in biochemistry parameters (bicarbonate, chloride, potassium, sodium, calcium, magnesium, urea nitrogen, cholesterol, glucose)
    End point description
    Bicarbonate, chloride, potassium, sodium, calcium, magnesium, urea nitrogen, cholesterol and glucose were measured in millimoles per liter (mmol/L). Note: The number of participants analyzed in Week 30 (Safety Follow-Up) for each parameter is presented in parentheses following this model (n= n1, n2, n3) where: n1 = number of participants analyzed in the Placebo (SS) group; n2 = number of participants analyzed in the Adalimumab (SS) group; n3 = number of participants analyzed in the Bimekizumab (SS) group.
    End point type
    Secondary
    End point timeframe
    From Screening to Safety Follow-Up (Week 30)
    End point values
    Placebo (SS) Adalimumab (SS) Bimekizumab (SS)
    Number of subjects analysed
    21
    21
    46
    Units: mmol/L
    arithmetic mean (standard deviation)
        Bicarbonate (n= 15, 19, 36)
    -0.1 ± 2.1
    0.7 ± 2.8
    0.6 ± 2.3
        Chloride (n= 15, 19, 36)
    0.9 ± 1.5
    1.3 ± 2.4
    0.1 ± 2.2
        Potassium (n= 15, 19, 36)
    -0.13 ± 0.79
    -0.09 ± 0.37
    0.03 ± 0.41
        Sodium (n= 15, 19, 36)
    0.4 ± 1.5
    0.4 ± 1.6
    0.1 ± 2.2
        Calcium (n= 15, 19, 36)
    0.027 ± 0.065
    0.008 ± 0.144
    0.067 ± 0.095
        Magnesium (n= 15, 19, 36)
    -0.029 ± 0.087
    -0.027 ± 0.052
    -0.009 ± 0.081
        Urea nitrogen (n= 15, 19, 36)
    0.00 ± 1.46
    -0.43 ± 1.37
    0.29 ± 1.79
        Cholesterol (n= 15, 19, 36)
    -0.311 ± 0.667
    -0.177 ± 0.634
    0.157 ± 0.585
        Glucose (n= 15, 19, 36)
    1.049 ± 1.835
    0.436 ± 2.990
    0.439 ± 2.212
    No statistical analyses for this end point

    Secondary: Change from Baseline until Safety Follow-up Visit in biochemistry parameters (creatinine, bilirubin, direct bilirubin, urate)

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    End point title
    Change from Baseline until Safety Follow-up Visit in biochemistry parameters (creatinine, bilirubin, direct bilirubin, urate)
    End point description
    Creatinine, bilirubin, direct bilirubin, urate were measured in micromols per liter (μmol/L). Note 1: 999 was used as a placeholder for the values that were not calculated. Note 2: The number of participants analyzed in Week 30 (Safety Follow-Up) for each parameter is presented in parentheses following this model (n= n1, n2, n3) where: n1 = number of participants analyzed in the Placebo (SS) group; n2 = number of participants analyzed in the Adalimumab (SS) group; n3 = number of participants analyzed in the Bimekizumab (SS) group.
    End point type
    Secondary
    End point timeframe
    From Screening to Safety Follow-Up (Week 30)
    End point values
    Placebo (SS) Adalimumab (SS) Bimekizumab (SS)
    Number of subjects analysed
    21
    21
    46
    Units: μmol/L
    arithmetic mean (standard deviation)
        Creatinine (n= 15, 19, 36)
    -1.73 ± 9.92
    -1.72 ± 9.04
    3.84 ± 9.22
        Bilirubin (n= 15, 19, 34)
    0.17 ± 3.48
    -1.38 ± 3.04
    0.18 ± 4.35
        Direct bilirubin (n= 0, 0, 0)
    999 ± 999
    999 ± 999
    999 ± 999
        Urate (n= 15, 19, 34)
    8.7 ± 52.2
    -8.9 ± 50.5
    1.5 ± 43.1
    No statistical analyses for this end point

    Secondary: Change from Baseline until Safety Follow-up Visit in biochemistry parameters (C reactive protein high sensitivity)

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    End point title
    Change from Baseline until Safety Follow-up Visit in biochemistry parameters (C reactive protein high sensitivity)
    End point description
    C reactive protein high sensitivity was measure in milligrams per liters (mg/L).
    End point type
    Secondary
    End point timeframe
    From Screening to Safety Follow-Up (Week 30)
    End point values
    Placebo (SS) Adalimumab (SS) Bimekizumab (SS)
    Number of subjects analysed
    15
    19
    36
    Units: mg/L
        arithmetic mean (standard deviation)
    -2.801 ± 16.851
    -4.865 ± 21.863
    -2.810 ± 10.853
    No statistical analyses for this end point

    Secondary: Change from Baseline until Safety Follow-up Visit in biochemistry parameters (alanine aminotransferase, alkaline phosphatase, aspartate aminotransferase, gamma glutamyl transferase, lactate dehydrogenase)

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    End point title
    Change from Baseline until Safety Follow-up Visit in biochemistry parameters (alanine aminotransferase, alkaline phosphatase, aspartate aminotransferase, gamma glutamyl transferase, lactate dehydrogenase)
    End point description
    Alanine aminotransferase, alkaline phosphatase, aspartate aminotransferase, gamma glutamyl transferase, lactate dehydrogenase were measured in units per liter (U/L). Note: The number of participants analyzed in Week 30 (Safety Follow-Up) for each parameter is presented in parentheses following this model (n= n1, n2, n3) where: n1 = number of participants analyzed in the Placebo (SS) group; n2 = number of participants analyzed in the Adalimumab (SS) group; n3 = number of participants analyzed in the Bimekizumab (SS) group.
    End point type
    Secondary
    End point timeframe
    From Screening to Safety Follow-Up (Week 30)
    End point values
    Placebo (SS) Adalimumab (SS) Bimekizumab (SS)
    Number of subjects analysed
    21
    21
    46
    Units: U/L
    arithmetic mean (standard deviation)
        Alanine aminotransferase (n= 15, 19, 34))
    -3.3 ± 8.3
    -3.6 ± 9.8
    3.6 ± 23.8
        Alkaline phosphatase (n= 15, 19, 36)
    -2.0 ± 12.2
    -2.4 ± 13.5
    -3.4 ± 11.6
        Aspartate aminotransferase (n= 15, 19, 36)
    -0.6 ± 3.6
    -1.0 ± 5.8
    2.0 ± 13.3
        Gamma glutamyl transferase (n= 15, 19, 36)
    -2.0 ± 9.5
    1.8 ± 14.2
    2.3 ± 10.1
        Lactate dehydrogenase (n= 15, 19, 36)
    -17.0 ± 29.9
    -16.3 ± 35.6
    -12.8 ± 61.8
    No statistical analyses for this end point

    Secondary: Change from Baseline until Safety Follow-up Visit in urinalysis parameters (urine urobilinogen)

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    End point title
    Change from Baseline until Safety Follow-up Visit in urinalysis parameters (urine urobilinogen)
    End point description
    Urine urobilinogen was measured in Ehrlich units per deciliter (EU/dL).
    End point type
    Secondary
    End point timeframe
    From Screening to Safety Follow-Up (Week 30)
    End point values
    Placebo (SS) Adalimumab (SS) Bimekizumab (SS)
    Number of subjects analysed
    14
    16
    31
    Units: EU/dL
        arithmetic mean (standard deviation)
    0.00 ± 0.00
    -0.05 ± 0.20
    0.08 ± 0.24
    No statistical analyses for this end point

    Secondary: Change from Baseline until Safety Follow-up Visit in urinalysis parameters (urine pH)

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    End point title
    Change from Baseline until Safety Follow-up Visit in urinalysis parameters (urine pH)
    End point description
    Urine pH was measured on a pH scale.
    End point type
    Secondary
    End point timeframe
    From Screening to Safety Follow-Up (Week 30)
    End point values
    Placebo (SS) Adalimumab (SS) Bimekizumab (SS)
    Number of subjects analysed
    14
    16
    31
    Units: pH
        arithmetic mean (standard deviation)
    -0.43 ± 0.98
    -0.25 ± 0.55
    -0.03 ± 0.69
    No statistical analyses for this end point

    Secondary: Change from Baseline until Safety Follow-up Visit in urinalysis parameters (urine albumin)

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    End point title
    Change from Baseline until Safety Follow-up Visit in urinalysis parameters (urine albumin)
    End point description
    Urine albumin was measured in milligrams per liter (mg/L).
    End point type
    Secondary
    End point timeframe
    From Screening to Safety Follow-Up (Week 30)
    End point values
    Placebo (SS) Adalimumab (SS) Bimekizumab (SS)
    Number of subjects analysed
    15
    18
    34
    Units: mg/L
        arithmetic mean (standard deviation)
    50.80 ± 211.30
    -28.25 ± 121.29
    0.49 ± 19.92
    No statistical analyses for this end point

    Secondary: Change from Baseline until Safety Follow-up Visit in urinalysis parameters (urine albumin/creatinine)

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    End point title
    Change from Baseline until Safety Follow-up Visit in urinalysis parameters (urine albumin/creatinine)
    End point description
    Urine albumin/creatinine was measured in milligrams per millimol (mg/mmol).
    End point type
    Secondary
    End point timeframe
    From Screening to Safety Follow-Up (Week 30)
    End point values
    Placebo (SS) Adalimumab (SS) Bimekizumab (SS)
    Number of subjects analysed
    15
    17
    33
    Units: mg/mmol
        arithmetic mean (standard deviation)
    2.46 ± 9.83
    -1.34 ± 4.98
    -0.19 ± 1.82
    No statistical analyses for this end point

    Secondary: Change from Baseline until Safety Follow-up Visit in urinalysis parameters (urine creatinine)

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    End point title
    Change from Baseline until Safety Follow-up Visit in urinalysis parameters (urine creatinine)
    End point description
    Urine creatinine was measured in millimoles per liter (mmol/L).
    End point type
    Secondary
    End point timeframe
    From Screening to Safety Follow-Up (Week 30)
    End point values
    Placebo (SS) Adalimumab (SS) Bimekizumab (SS)
    Number of subjects analysed
    15
    18
    34
    Units: mmol/L
        arithmetic mean (standard deviation)
    -0.92 ± 7.33
    0.63 ± 7.82
    3.99 ± 10.27
    No statistical analyses for this end point

    Secondary: Percentage of participants who shifted from Baseline until Safety Follow-up Visit in urinalysis parameters (urine bilirubin)

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    End point title
    Percentage of participants who shifted from Baseline until Safety Follow-up Visit in urinalysis parameters (urine bilirubin)
    End point description
    Percentages were based on the number of participants with non-missing urinalysis results at Baseline and at Week 30. Note: The number of participants analyzed in Week 30 (Safety Follow-Up) for each parameter is presented in parentheses following this model (n= n1, n2, n3) where: n1 = number of participants analyzed in the Placebo (SS) group; n2 = number of participants analyzed in the Adalimumab (SS) group; n3 = number of participants analyzed in the Bimekizumab (SS) group.
    End point type
    Secondary
    End point timeframe
    From Screening to Safety Follow-Up (Week 30)
    End point values
    Placebo (SS) Adalimumab (SS) Bimekizumab (SS)
    Number of subjects analysed
    21
    21
    46
    Units: percentage of participants
    number (not applicable)
        Baseline Low – Week 30 Low (14, 16, 31)
    0
    0
    0
        Baseline Low – Week 30 Normal (14, 16, 31)
    0
    0
    0
        Baseline Low – Week 30 High (14, 16, 31)
    0
    0
    0
        Baseline Normal – Week 30 Low (14, 16, 31)
    0
    0
    0
        Baseline Normal – Week 30 Normal (14, 16, 31)
    92.9
    93.8
    90.3
        Baseline Normal – Week 30 High (14, 16, 31)
    0
    0
    9.7
        Baseline High – Week 30 Low (14, 16, 31)
    0
    0
    0
        Baseline High – Week 30 Normal (14, 16, 31)
    0
    6.3
    0
        Baseline High – Week 30 High (14, 16, 31)
    7.1
    0
    0
    No statistical analyses for this end point

    Secondary: Percentage of participants who shifted from Baseline until Safety Follow-up Visit in urinalysis parameters (urine glucose)

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    End point title
    Percentage of participants who shifted from Baseline until Safety Follow-up Visit in urinalysis parameters (urine glucose)
    End point description
    Percentages were based on the number of participants with non-missing urinalysis results at Baseline and at Week 30. Note: The number of participants analyzed in Week 30 (Safety Follow-Up) for each parameter is presented in parentheses following this model (n= n1, n2, n3) where: n1 = number of participants analyzed in the Placebo (SS) group; n2 = number of participants analyzed in the Adalimumab (SS) group; n3 = number of participants analyzed in the Bimekizumab (SS) group.
    End point type
    Secondary
    End point timeframe
    From Screening to Safety Follow-Up (Week 30)
    End point values
    Placebo (SS) Adalimumab (SS) Bimekizumab (SS)
    Number of subjects analysed
    21
    21
    46
    Units: percentage of participants
    number (not applicable)
        Baseline Low – Week 30 Low (14, 16, 31)
    0
    0
    0
        Baseline Low – Week 30 Normal (14, 16, 31)
    0
    0
    0
        Baseline Low – Week 30 High (14, 16, 31)
    0
    0
    0
        Baseline Normal – Week 30 Low (14, 16, 31)
    0
    0
    0
        Baseline Normal – Week 30 Normal (14, 16, 31)
    85.7
    87.5
    90.3
        Baseline Normal – Week 30 High (14, 16, 31)
    7.1
    6.3
    0
        Baseline High – Week 30 Low (14, 16, 31)
    0
    0
    0
        Baseline High – Week 30 Normal (14, 16, 31)
    0
    6.3
    3.2
        Baseline High – Week 30 High (14, 16, 31)
    7.1
    0
    6.5
    No statistical analyses for this end point

    Secondary: Percentage of participants who shifted from Baseline until Safety Follow-up Visit in urinalysis parameters (urine hemoglobin)

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    End point title
    Percentage of participants who shifted from Baseline until Safety Follow-up Visit in urinalysis parameters (urine hemoglobin)
    End point description
    Percentages were based on the number of participants with non-missing urinalysis results at Baseline and at Week 30. Note: The number of participants analyzed in Week 30 (Safety Follow-Up) for each parameter is presented in parentheses following this model (n= n1, n2, n3) where: n1 = number of participants analyzed in the Placebo (SS) group; n2 = number of participants analyzed in the Adalimumab (SS) group; n3 = number of participants analyzed in the Bimekizumab (SS) group.
    End point type
    Secondary
    End point timeframe
    From Screening to Safety Follow-Up (Week 30)
    End point values
    Placebo (SS) Adalimumab (SS) Bimekizumab (SS)
    Number of subjects analysed
    21
    21
    46
    Units: percentage of participants
    number (not applicable)
        Baseline Low – Week 30 Low (14, 16, 31)
    0
    0
    0
        Baseline Low – Week 30 Normal (14, 16, 31)
    0
    0
    0
        Baseline Low – Week 30 High (14, 16, 31)
    0
    0
    0
        Baseline Normal – Week 30 Low (14, 16, 31)
    0
    0
    0
        Baseline Normal – Week 30 Normal (14, 16, 31)
    64.3
    50.0
    80.6
        Baseline Normal – Week 30 High (14, 16, 31)
    0
    12.5
    3.2
        Baseline High – Week 30 Low (14, 16, 31)
    0
    0
    0
        Baseline High – Week 30 Normal (14, 16, 31)
    14.3
    18.8
    12.9
        Baseline High – Week 30 High (14, 16, 31)
    21.4
    18.8
    3.2
    No statistical analyses for this end point

    Secondary: Percentage of participants who shifted from Baseline until Safety Follow-up Visit in urinalysis parameters (urine ketones)

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    End point title
    Percentage of participants who shifted from Baseline until Safety Follow-up Visit in urinalysis parameters (urine ketones)
    End point description
    Percentages were based on the number of participants with non-missing urinalysis results at Baseline and at Week 30. Note: The number of participants analyzed in Week 30 (Safety Follow-Up) for each parameter is presented in parentheses following this model (n= n1, n2, n3) where: n1 = number of participants analyzed in the Placebo (SS) group; n2 = number of participants analyzed in the Adalimumab (SS) group; n3 = number of participants analyzed in the Bimekizumab (SS) group.
    End point type
    Secondary
    End point timeframe
    From Screening to Safety Follow-Up (Week 30)
    End point values
    Placebo (SS) Adalimumab (SS) Bimekizumab (SS)
    Number of subjects analysed
    21
    21
    46
    Units: percentage of participants
    number (not applicable)
        Baseline Low – Week 30 Low (14, 16, 31)
    0
    0
    0
        Baseline Low – Week 30 Normal (14, 16, 31)
    0
    0
    0
        Baseline Low – Week 30 High (14, 16, 31)
    0
    0
    0
        Baseline Normal – Week 30 Low (14, 16, 31)
    0
    0
    0
        Baseline Normal – Week 30 Normal (14, 16, 31)
    71.4
    87.5
    87.1
        Baseline Normal – Week 30 High (14, 16, 31)
    14.3
    6.3
    12.9
        Baseline High – Week 30 Low (14, 16, 31)
    0
    0
    0
        Baseline High – Week 30 Normal (14, 16, 31)
    7.1
    6.3
    0
        Baseline High – Week 30 High (14, 16, 31)
    7.1
    0
    0
    No statistical analyses for this end point

    Secondary: Percentage of participants who shifted from Baseline until Safety Follow-up Visit in urinalysis parameters (urine leukocyte esterase)

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    End point title
    Percentage of participants who shifted from Baseline until Safety Follow-up Visit in urinalysis parameters (urine leukocyte esterase)
    End point description
    Percentages were based on the number of participants with non-missing urinalysis results at Baseline and at Week 30. Note: The number of participants analyzed in Week 30 (Safety Follow-Up) for each parameter is presented in parentheses following this model (n= n1, n2, n3) where: n1 = number of participants analyzed in the Placebo (SS) group; n2 = number of participants analyzed in the Adalimumab (SS) group; n3 = number of participants analyzed in the Bimekizumab (SS) group.
    End point type
    Secondary
    End point timeframe
    From Screening to Safety Follow-Up (Week 30)
    End point values
    Placebo (SS) Adalimumab (SS) Bimekizumab (SS)
    Number of subjects analysed
    21
    21
    46
    Units: percentage of participants
    number (not applicable)
        Baseline Low – Week 30 Low (14, 16, 31)
    0
    0
    0
        Baseline Low – Week 30 Normal (14, 16, 31)
    0
    0
    0
        Baseline Low – Week 30 High (14, 16, 31)
    0
    0
    0
        Baseline Normal – Week 30 Low (14, 16, 31)
    0
    0
    0
        Baseline Normal – Week 30 Normal (14, 16, 31)
    57.1
    56.3
    61.3
        Baseline Normal – Week 30 High (14, 16, 31)
    14.3
    0
    19.4
        Baseline High – Week 30 Low (14, 16, 31)
    0
    0
    0
        Baseline High – Week 30 Normal (14, 16, 31)
    14.3
    18.8
    19.4
        Baseline High – Week 30 High (14, 16, 31)
    14.3
    25.0
    0
    No statistical analyses for this end point

    Secondary: Percentage of participants who shifted from Baseline until Safety Follow-up Visit in urinalysis parameters (urine nitrite)

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    End point title
    Percentage of participants who shifted from Baseline until Safety Follow-up Visit in urinalysis parameters (urine nitrite)
    End point description
    Percentages were based on the number of participants with non-missing urinalysis results at Baseline and at Week 30. Note: The number of participants analyzed in Week 30 (Safety Follow-Up) for each parameter is presented in parentheses following this model (n= n1, n2, n3) where: n1 = number of participants analyzed in the Placebo (SS) group; n2 = number of participants analyzed in the Adalimumab (SS) group; n3 = number of participants analyzed in the Bimekizumab (SS) group.
    End point type
    Secondary
    End point timeframe
    From Screening to Safety Follow-Up (Week 30)
    End point values
    Placebo (SS) Adalimumab (SS) Bimekizumab (SS)
    Number of subjects analysed
    21
    21
    46
    Units: percentage of participants
    number (not applicable)
        Baseline Low – Week 30 Low (14, 16, 31)
    0
    0
    0
        Baseline Low – Week 30 Normal (14, 16, 31)
    0
    0
    0
        Baseline Low – Week 30 High (14, 16, 31)
    0
    0
    0
        Baseline Normal – Week 30 Low (14, 16, 31)
    0
    0
    0
        Baseline Normal – Week 30 Normal (14, 16, 31)
    92.9
    93.8
    100
        Baseline Normal – Week 30 High (14, 16, 31)
    0
    0
    0
        Baseline High – Week 30 Low (14, 16, 31)
    0
    0
    0
        Baseline High – Week 30 Normal (14, 16, 31)
    7.1
    6.3
    0
        Baseline High – Week 30 High (14, 16, 31)
    0
    0
    0
    No statistical analyses for this end point

    Secondary: Percentage of participants who shifted from Baseline until Safety Follow-up Visit in urinalysis parameters (urine protein)

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    End point title
    Percentage of participants who shifted from Baseline until Safety Follow-up Visit in urinalysis parameters (urine protein)
    End point description
    Percentages were based on the number of participants with non-missing urinalysis results at Baseline and at Week 30. Note: The number of participants analyzed in Week 30 (Safety Follow-Up) for each parameter is presented in parentheses following this model (n= n1, n2, n3) where: n1 = number of participants analyzed in the Placebo (SS) group; n2 = number of participants analyzed in the Adalimumab (SS) group; n3 = number of participants analyzed in the Bimekizumab (SS) group.
    End point type
    Secondary
    End point timeframe
    From Screening to Safety Follow-Up (Week 30)
    End point values
    Placebo (SS) Adalimumab (SS) Bimekizumab (SS)
    Number of subjects analysed
    21
    21
    46
    Units: percentage of participants
    number (not applicable)
        Baseline Low – Week 30 Low (14, 16, 31)
    0
    0
    0
        Baseline Low – Week 30 Normal (14, 16, 31)
    0
    0
    0
        Baseline Low – Week 30 High (14, 16, 31)
    0
    0
    0
        Baseline Normal – Week 30 Low (14, 16, 31)
    0
    0
    0
        Baseline Normal – Week 30 Normal (14, 16, 31)
    50.0
    75.0
    61.3
        Baseline Normal – Week 30 High (14, 16, 31)
    14.3
    6.3
    19.4
        Baseline High – Week 30 Low (14, 16, 31)
    0
    0
    0
        Baseline High – Week 30 Normal (14, 16, 31)
    28.6
    12.5
    9.7
        Baseline High – Week 30 High (14, 16, 31)
    7.1
    6.3
    9.7
    No statistical analyses for this end point

    Secondary: Percentage of participants who shifted from Baseline until Safety Follow-up Visit in urinalysis parameters (urine bacteria)

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    End point title
    Percentage of participants who shifted from Baseline until Safety Follow-up Visit in urinalysis parameters (urine bacteria)
    End point description
    Percentages were based on the number of participants with non-missing urinalysis results at Baseline and at Week 30. Note: The number of participants analyzed in Week 30 (Safety Follow-Up) for each parameter is presented in parentheses following this model (n= n1, n2, n3) where: n1 = number of participants analyzed in the Placebo (SS) group; n2 = number of participants analyzed in the Adalimumab (SS) group; n3 = number of participants analyzed in the Bimekizumab (SS) group.
    End point type
    Secondary
    End point timeframe
    From Screening to Safety Follow-Up (Week 30)
    End point values
    Placebo (SS) Adalimumab (SS) Bimekizumab (SS)
    Number of subjects analysed
    21
    21
    46
    Units: percentage of participants
    number (not applicable)
        Baseline Low – Week 30 Low (3, 6, 2)
    0
    0
    0
        Baseline Low – Week 30 Normal (3, 6, 2)
    0
    0
    0
        Baseline Low – Week 30 High (3, 6, 2)
    0
    0
    0
        Baseline Normal – Week 30 Low (3, 6, 2)
    0
    0
    0
        Baseline Normal – Week 30 Normal (3, 6, 2)
    0
    0
    0
        Baseline Normal – Week 30 High (3, 6, 2)
    0
    0
    0
        Baseline High – Week 30 Low (3, 6, 2)
    0
    0
    0
        Baseline High – Week 30 Normal (3, 6, 2)
    0
    0
    0
        Baseline High – Week 30 High (3, 6, 2)
    100
    100
    100
    No statistical analyses for this end point

    Secondary: Percentage of participants who shifted from Baseline until Safety Follow-up Visit in urinalysis parameters (urine erythrocytes)

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    End point title
    Percentage of participants who shifted from Baseline until Safety Follow-up Visit in urinalysis parameters (urine erythrocytes)
    End point description
    Percentages were based on the number of participants with non-missing urinalysis results at Baseline and at Week 30. Note: The number of participants analyzed in Week 30 (Safety Follow-Up) for each parameter is presented in parentheses following this model (n= n1, n2, n3) where: n1 = number of participants analyzed in the Placebo (SS) group; n2 = number of participants analyzed in the Adalimumab (SS) group; n3 = number of participants analyzed in the Bimekizumab (SS) group.
    End point type
    Secondary
    End point timeframe
    From Screening to Safety Follow-Up (Week 30)
    End point values
    Placebo (SS) Adalimumab (SS) Bimekizumab (SS)
    Number of subjects analysed
    21
    21
    46
    Units: percentage of participants
    number (not applicable)
        Baseline Low – Week 30 Low (3, 1, 1)
    0
    0
    0
        Baseline Low – Week 30 Normal (3, 1, 1)
    0
    0
    0
        Baseline Low – Week 30 High (3, 1, 1)
    0
    0
    0
        Baseline Normal – Week 30 Low (3, 1, 1)
    0
    0
    0
        Baseline Normal – Week 30 Normal (3, 1, 1)
    33.3
    0
    100
        Baseline Normal – Week 30 High (3, 1, 1)
    0
    0
    0
        Baseline High – Week 30 Low (3, 1, 1)
    0
    0
    0
        Baseline High – Week 30 Normal (3, 1, 1)
    0
    0
    0
        Baseline High – Week 30 High (3, 1, 1)
    66.7
    100
    0
    No statistical analyses for this end point

    Secondary: Percentage of participants who shifted from Baseline until Safety Follow-up Visit in urinalysis parameters (urine mucus)

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    End point title
    Percentage of participants who shifted from Baseline until Safety Follow-up Visit in urinalysis parameters (urine mucus)
    End point description
    Percentages were based on the number of participants with non-missing urinalysis results at Baseline and at Week 30. Note: The number of participants analyzed in Week 30 (Safety Follow-Up) for each parameter is presented in parentheses following this model (n= n1, n2, n3) where: n1 = number of participants analyzed in the Placebo (SS) group; n2 = number of participants analyzed in the Adalimumab (SS) group; n3 = number of participants analyzed in the Bimekizumab (SS) group.
    End point type
    Secondary
    End point timeframe
    From Screening to Safety Follow-Up (Week 30)
    End point values
    Placebo (SS) Adalimumab (SS) Bimekizumab (SS)
    Number of subjects analysed
    21
    21
    46
    Units: percentage of participants
    number (not applicable)
        Baseline Low – Week 30 Low (0, 1, 3)
    0
    0
    0
        Baseline Low – Week 30 Normal (0, 1, 3)
    0
    0
    0
        Baseline Low – Week 30 High (0, 1, 3)
    0
    0
    0
        Baseline Normal – Week 30 Low (0, 1, 3)
    0
    0
    0
        Baseline Normal – Week 30 Normal (0, 1, 3)
    0
    100
    0
        Baseline Normal – Week 30 High (0, 1, 3)
    0
    0
    33.3
        Baseline High – Week 30 Low (0, 1, 3)
    0
    0
    0
        Baseline High – Week 30 Normal (0, 1, 3)
    0
    0
    33.3
        Baseline High – Week 30 High (0, 1, 3)
    0
    0
    33.3
    No statistical analyses for this end point

    Secondary: Percentage of participants who shifted from Baseline until Safety Follow-up Visit in urinalysis parameters (urine squamous epithelial cells)

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    End point title
    Percentage of participants who shifted from Baseline until Safety Follow-up Visit in urinalysis parameters (urine squamous epithelial cells)
    End point description
    Percentages were based on the number of participants with non-missing urinalysis results at Baseline and at Week 30. Note: The number of participants analyzed in Week 30 (Safety Follow-Up) for each parameter is presented in parentheses following this model (n= n1, n2, n3) where: n1 = number of participants analyzed in the Placebo (SS) group; n2 = number of participants analyzed in the Adalimumab (SS) group; n3 = number of participants analyzed in the Bimekizumab (SS) group.
    End point type
    Secondary
    End point timeframe
    From Screening to Safety Follow-Up (Week 30)
    End point values
    Placebo (SS) Adalimumab (SS) Bimekizumab (SS)
    Number of subjects analysed
    21
    21
    46
    Units: percentage of participants
    number (not applicable)
        Baseline Low – Week 30 Low (4, 6, 7)
    0
    0
    0
        Baseline Low – Week 30 Normal (4, 6, 7)
    0
    0
    0
        Baseline Low – Week 30 High (4, 6, 7)
    0
    0
    0
        Baseline Normal – Week 30 Low (4, 6, 7)
    0
    0
    0
        Baseline Normal – Week 30 Normal (4, 6, 7)
    0
    33.3
    28.6
        Baseline Normal – Week 30 High (4, 6, 7)
    25.0
    0
    28.6
        Baseline High – Week 30 Low (4, 6, 7)
    0
    0
    0
        Baseline High – Week 30 Normal (4, 6, 7)
    25.0
    0
    14.3
        Baseline High – Week 30 High (4, 6, 7)
    50.0
    66.7
    28.6
    No statistical analyses for this end point

    Secondary: Percentage of participants who shifted from Baseline until Safety Follow-up Visit in physical examination

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    End point title
    Percentage of participants who shifted from Baseline until Safety Follow-up Visit in physical examination
    End point description
    Percentages were based on the number of participants with non-missing physical exam results at Baseline and at Week 30 and on the number of participants with a normal/at least one abnormal physical examination assessment. Note: The number of participants analyzed in Week 30 (Safety Follow-Up) for each parameter is presented in parentheses following this model (n= n1, n2, n3) where: n1 = number of participants analyzed in the Placebo (SS) group; n2 = number of participants analyzed in the Adalimumab (SS) group; n3 = number of participants analyzed in the Bimekizumab (SS) group.
    End point type
    Secondary
    End point timeframe
    From Screening to Safety Follow-Up (Week 30)
    End point values
    Placebo (SS) Adalimumab (SS) Bimekizumab (SS)
    Number of subjects analysed
    21
    21
    46
    Units: percentage of participants
    number (not applicable)
        Baseline Normal – Week 30 Normal (18, 19, 38)
    77.8
    78.9
    73.7
        Baseline Normal – Week 30 Abnormal (18, 19, 38)
    5.6
    10.5
    13.2
        Baseline Abnormal – Week 30 Normal (18, 19, 38)
    5.6
    5.3
    2.6
        Baseline Abnormal – Week 30 Abnormal (18, 19, 38)
    11.1
    5.3
    10.5
    No statistical analyses for this end point

    Secondary: Percentage of participants with positive Bimekizumab anti-drug antibody (ADA) concentration at Day 1

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    End point title
    Percentage of participants with positive Bimekizumab anti-drug antibody (ADA) concentration at Day 1
    End point description
    The overall status of a study participant was ‘Positive’ if at any post-Baseline visit the result was positive. Percentages were based on the number of study participants with a non-missing measurement, from samples that did not contain BKZ concentration levels above the drug tolerance, at the visit.
    End point type
    Secondary
    End point timeframe
    Day 1
    End point values
    Bimekizumab (PK-PPS)
    Number of subjects analysed
    46
    Units: percentage of participants
        number (not applicable)
    4.3
    No statistical analyses for this end point

    Secondary: Percentage of participants with positive Bimekizumab anti-drug antibody (ADA) concentration at Week 2

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    End point title
    Percentage of participants with positive Bimekizumab anti-drug antibody (ADA) concentration at Week 2
    End point description
    The overall status of a study participant was ‘Positive’ if at any post-Baseline visit the result was positive. Percentages were based on the number of study participants with a non-missing measurement, from samples that did not contain BKZ concentration levels above the drug tolerance, at the visit.
    End point type
    Secondary
    End point timeframe
    Week 2
    End point values
    Bimekizumab (PK-PPS)
    Number of subjects analysed
    45
    Units: percentage of participants
        number (not applicable)
    4.4
    No statistical analyses for this end point

    Secondary: Percentage of participants with positive Bimekizumab anti-drug antibody (ADA) concentration at Week 4

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    End point title
    Percentage of participants with positive Bimekizumab anti-drug antibody (ADA) concentration at Week 4
    End point description
    The overall status of a study participant was ‘Positive’ if at any post-Baseline visit the result was positive. Percentages were based on the number of study participants with a non-missing measurement, from samples that did not contain BKZ concentration levels above the drug tolerance, at the visit.
    End point type
    Secondary
    End point timeframe
    Week 4
    End point values
    Bimekizumab (PK-PPS)
    Number of subjects analysed
    46
    Units: percentage of participants
        number (not applicable)
    4.3
    No statistical analyses for this end point

    Secondary: Percentage of participants with positive Bimekizumab anti-drug antibody (ADA) concentration at Week 8

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    End point title
    Percentage of participants with positive Bimekizumab anti-drug antibody (ADA) concentration at Week 8
    End point description
    The overall status of a study participant was ‘Positive’ if at any post-Baseline visit the result was positive. Percentages were based on the number of study participants with a non-missing measurement, from samples that did not contain BKZ concentration levels above the drug tolerance, at the visit.
    End point type
    Secondary
    End point timeframe
    Week 8
    End point values
    Bimekizumab (PK-PPS)
    Number of subjects analysed
    42
    Units: percentage of participants
        number (not applicable)
    0
    No statistical analyses for this end point

    Secondary: Percentage of participants with positive Bimekizumab anti-drug antibody (ADA) concentration at Week 12

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    End point title
    Percentage of participants with positive Bimekizumab anti-drug antibody (ADA) concentration at Week 12
    End point description
    The overall status of a study participant was ‘Positive’ if at any post-Baseline visit the result was positive. Percentages were based on the number of study participants with a non-missing measurement, from samples that did not contain BKZ concentration levels above the drug tolerance, at the visit.
    End point type
    Secondary
    End point timeframe
    Week 12
    End point values
    Bimekizumab (PK-PPS)
    Number of subjects analysed
    42
    Units: percentage of participants
        number (not applicable)
    9.5
    No statistical analyses for this end point

    Secondary: Percentage of participants with positive Bimekizumab anti-drug antibody (ADA) concentration at Week 30

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    End point title
    Percentage of participants with positive Bimekizumab anti-drug antibody (ADA) concentration at Week 30
    End point description
    The overall status of a study participant was ‘Positive’ if at any post-Baseline visit the result was positive. Percentages were based on the number of study participants with a non-missing measurement, from samples that did not contain BKZ concentration levels above the drug tolerance, at the visit
    End point type
    Secondary
    End point timeframe
    Week 30
    End point values
    Bimekizumab (PK-PPS)
    Number of subjects analysed
    36
    Units: percentage of participants
        number (not applicable)
    13.9
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Adverse events were collected from Baseline (Day 1) until the Safety Follow-Up Visit (Week 30)
    Assessment type
    Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    19.0
    Reporting groups
    Reporting group title
    Placebo (SS)
    Reporting group description
    Participants received several placebo applications to keep the blinding and as a control group, forming the Safety Set (SS).

    Reporting group title
    Adalimumab (SS)
    Reporting group description
    Participants received one Adalimumab loading dose 1, one Adalimumab dose 2 application and several Adalimumab dose 3 applications, forming the SS.

    Reporting group title
    Bimekizumab (SS)
    Reporting group description
    Participants received one Bimekizumab loading dose 1 and several Bimekizumab dose 2 applications, forming the SS.

    Serious adverse events
    Placebo (SS) Adalimumab (SS) Bimekizumab (SS)
    Total subjects affected by serious adverse events
         subjects affected / exposed
    2 / 21 (9.52%)
    1 / 21 (4.76%)
    2 / 46 (4.35%)
         number of deaths (all causes)
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    Cardiac disorders
    Myocardial infarction
         subjects affected / exposed
    1 / 21 (4.76%)
    0 / 21 (0.00%)
    0 / 46 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    0 / 21 (0.00%)
    0 / 21 (0.00%)
    1 / 46 (2.17%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Nervous system disorders
    Headache
         subjects affected / exposed
    1 / 21 (4.76%)
    0 / 21 (0.00%)
    0 / 46 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Dizziness
         subjects affected / exposed
    1 / 21 (4.76%)
    0 / 21 (0.00%)
    0 / 46 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hypoaesthesia
         subjects affected / exposed
    1 / 21 (4.76%)
    0 / 21 (0.00%)
    0 / 46 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Skin and subcutaneous tissue disorders
    Hidradenitis
         subjects affected / exposed
    0 / 21 (0.00%)
    1 / 21 (4.76%)
    0 / 46 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Empyema
         subjects affected / exposed
    0 / 21 (0.00%)
    0 / 21 (0.00%)
    1 / 46 (2.17%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    Placebo (SS) Adalimumab (SS) Bimekizumab (SS)
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    5 / 21 (23.81%)
    12 / 21 (57.14%)
    21 / 46 (45.65%)
    Vascular disorders
    Hypertension
         subjects affected / exposed
    0 / 21 (0.00%)
    0 / 21 (0.00%)
    3 / 46 (6.52%)
         occurrences all number
    0
    0
    3
    Nervous system disorders
    Headache
         subjects affected / exposed
    3 / 21 (14.29%)
    0 / 21 (0.00%)
    3 / 46 (6.52%)
         occurrences all number
    4
    0
    4
    General disorders and administration site conditions
    Fatigue
         subjects affected / exposed
    0 / 21 (0.00%)
    2 / 21 (9.52%)
    4 / 46 (8.70%)
         occurrences all number
    0
    2
    4
    Pyrexia
         subjects affected / exposed
    0 / 21 (0.00%)
    2 / 21 (9.52%)
    1 / 46 (2.17%)
         occurrences all number
    0
    2
    2
    Injection site reaction
         subjects affected / exposed
    0 / 21 (0.00%)
    0 / 21 (0.00%)
    3 / 46 (6.52%)
         occurrences all number
    0
    0
    4
    Injection site pain
         subjects affected / exposed
    0 / 21 (0.00%)
    0 / 21 (0.00%)
    3 / 46 (6.52%)
         occurrences all number
    0
    0
    3
    Injection site pruritus
         subjects affected / exposed
    0 / 21 (0.00%)
    2 / 21 (9.52%)
    2 / 46 (4.35%)
         occurrences all number
    0
    2
    2
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed
    0 / 21 (0.00%)
    1 / 21 (4.76%)
    3 / 46 (6.52%)
         occurrences all number
    0
    2
    5
    Nausea
         subjects affected / exposed
    0 / 21 (0.00%)
    1 / 21 (4.76%)
    3 / 46 (6.52%)
         occurrences all number
    0
    1
    3
    Skin and subcutaneous tissue disorders
    Hidradenitis
         subjects affected / exposed
    3 / 21 (14.29%)
    6 / 21 (28.57%)
    8 / 46 (17.39%)
         occurrences all number
    3
    6
    9
    Intertrigo
         subjects affected / exposed
    0 / 21 (0.00%)
    1 / 21 (4.76%)
    3 / 46 (6.52%)
         occurrences all number
    0
    1
    3
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    1 / 21 (4.76%)
    2 / 21 (9.52%)
    1 / 46 (2.17%)
         occurrences all number
    1
    2
    3
    Infections and infestations
    Oral candidiasis
         subjects affected / exposed
    0 / 21 (0.00%)
    1 / 21 (4.76%)
    3 / 46 (6.52%)
         occurrences all number
    0
    1
    4
    Influenza
         subjects affected / exposed
    0 / 21 (0.00%)
    3 / 21 (14.29%)
    0 / 46 (0.00%)
         occurrences all number
    0
    3
    0
    Nasopharyngitis
         subjects affected / exposed
    0 / 21 (0.00%)
    1 / 21 (4.76%)
    3 / 46 (6.52%)
         occurrences all number
    0
    1
    4
    Upper respiratory tract infection
         subjects affected / exposed
    0 / 21 (0.00%)
    2 / 21 (9.52%)
    2 / 46 (4.35%)
         occurrences all number
    0
    2
    2

    More information

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    Substantial protocol amendments (globally)

    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    08 Mar 2018
    Protocol Amendment 1 was dated 08 Mar 2018. The purpose of this substantial amendment was to revise the withdrawal criteria to provide instructions for the management of study participants with newly diagnosed inflammatory bowel disease (IBD) or with IBD flares during the study. Other key changes included the following: The statistical analysis section of the protocol was also updated to include text describing the planned analysis of the primary efficacy variable, and text describing the planned interim analyses and sample size re-estimation was revised. The rationale for this was that the observed pattern of study participant recruitment was not as expected at the time of study planning. Consequently, an insufficient number of study participants would have completed the Week 12 visit and would be evaluable for response at the time of the first interim analysis. The risk of performing an analysis with a very small amount of data was that the estimates obtained from the analysis would be unstable and the risk of committing a Type II error would be inflated. To mitigate these risks it was decided to remove the formal futility and sample size re-estimation aspects from the first interim analysis. Additional changes included updates to study contact information; minor formatting corrections were also made.

    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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