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    Clinical Trial Results:
    A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Efficacy and Safety of Bimekizumab in Subjects With Active Nonradiographic Axial Spondyloarthritis

    Summary
    EudraCT number
    2017-003064-13
    Trial protocol
    DE   BE   CZ   FR   HU   GB   BG   NL  
    Global end of trial date
    17 Apr 2023

    Results information
    Results version number
    v1(current)
    This version publication date
    02 May 2024
    First version publication date
    02 May 2024
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    AS0010
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    NCT03928704
    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
    05 May 2023
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    29 Jun 2022
    Global end of trial reached?
    Yes
    Global end of trial date
    17 Apr 2023
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    Demonstrate the efficacy of bimekizumab (BKZ) administered subcutaneously (sc) compared to placebo in the treatment of participants with active nonradiographic axial spondyloarthritis (nr-axSpA).
    Protection of trial subjects
    During the conduct of the study all participants were closely monitored.
    Background therapy
    Background therapy as permitted in the protocol.
    Evidence for comparator
    Not applicable
    Actual start date of recruitment
    25 Apr 2019
    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
    China: 36
    Country: Number of subjects enrolled
    Belgium: 5
    Country: Number of subjects enrolled
    Bulgaria: 9
    Country: Number of subjects enrolled
    Czechia: 53
    Country: Number of subjects enrolled
    France: 2
    Country: Number of subjects enrolled
    Germany: 24
    Country: Number of subjects enrolled
    Hungary: 11
    Country: Number of subjects enrolled
    Japan: 12
    Country: Number of subjects enrolled
    Poland: 71
    Country: Number of subjects enrolled
    Spain: 26
    Country: Number of subjects enrolled
    United Kingdom: 7
    Country: Number of subjects enrolled
    United States: 18
    Worldwide total number of subjects
    274
    EEA total number of subjects
    201
    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)
    268
    From 65 to 84 years
    6
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    Among total of 274 participants, a total of 254 were enrolled under global study protocol by June 2021, including 16 enrolled in China. The enrolment was extended in China to achieve the target of 36 participants as agreed with the local agency and additional 20 Chinese participants were enrolled by February 2022 in the China Extension population.

    Pre-assignment
    Screening details
    The study started to enroll participants in April 2019 and concluded in April 2023. The Participant Flow refers to Randomized Set. Out of 36 Chinese participants, 16 participants were included in the analysis of global population and the results of the remaining 20 Chinese participants are reported separately as the China extension population.

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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    Placebo (up to Week 16) (Global Population)
    Arm description
    Participants received placebo matched to bimekizumab 160 milligrams (mg) every 4 weeks (Q4W) subcutaneously until Week 16.
    Arm type
    Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection in pre-filled syringe
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Participants received placebo Q4W at prespecified time points.

    Arm title
    Bimekizumab 160 mg Q4W (up to Week 16) (Global Population)
    Arm description
    Participants received bimekizumab 160 mg Q4W subcutaneously until Week 16.
    Arm type
    Experimental

    Investigational medicinal product name
    Bimekizumab
    Investigational medicinal product code
    UCB4940
    Other name
    Pharmaceutical forms
    Solution for injection in pre-filled syringe
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Participants received bimekizumab 160 mg Q4W at prespecified time points.

    Arm title
    Placebo (up to Week 16) (China Extension Population)
    Arm description
    Participants in the China Extension Population received placebo matched to bimekizumab 160 mg Q4W subcutaneously until Week 16.
    Arm type
    Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection in pre-filled syringe
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Participants received placebo Q4W at prespecified time points.

    Arm title
    BKZ 160 mg Q4W (up to Week 16) (China Extension Population)
    Arm description
    Participants in the China Extension Population received bimekizumab 160 mg Q4W subcutaneously until Week 16.
    Arm type
    Experimental

    Investigational medicinal product name
    Bimekizumab
    Investigational medicinal product code
    UCB4940
    Other name
    Pharmaceutical forms
    Solution for injection in pre-filled syringe
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Participants received bimekizumab 160 mg Q4W at prespecified time points.

    Number of subjects in period 1
    Placebo (up to Week 16) (Global Population) Bimekizumab 160 mg Q4W (up to Week 16) (Global Population) Placebo (up to Week 16) (China Extension Population) BKZ 160 mg Q4W (up to Week 16) (China Extension Population)
    Started
    126
    128
    11
    9
    Started Chinese participants
    7 [1]
    9 [2]
    11
    9
    Completed
    118
    126
    11
    9
    Not completed
    8
    2
    0
    0
         Consent withdrawn by subject
    4
    -
    -
    -
         Adverse Event
    3
    1
    -
    -
         Patient Compliance
    -
    1
    -
    -
         Lack of efficacy
    1
    -
    -
    -
    Notes
    [1] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left.
    Justification: The number of participants in the milestone reflect the number of chinese participants in the study.
    [2] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left.
    Justification: The number of participants in the milestone reflect the number of chinese participants in the study.
    Period 2
    Period 2 title
    Maintenance Period: Week 16-52
    Is this the baseline period?
    No
    Allocation method
    Randomised - controlled
    Blinding used
    Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    BKZ 160 mg Q4W (Weeks 16 up to 52) (Global Population)
    Arm description
    At the end of the 16-week Double-Blind Treatment Period, study participants receiving placebo were re-allocated to bimekizumab treatment at Week 16. Participants from both placebo and bimekizumab arm received bimekizumab 160 mg Q4W subcutaneously from Week 16 until Week 48 during maintenance period. Participants entering the extension study received bimekizumab 160 mg Q4W subcutaneously until Week 52.
    Arm type
    Experimental

    Investigational medicinal product name
    Bimekizumab
    Investigational medicinal product code
    UCB4940
    Other name
    Pharmaceutical forms
    Solution for injection in pre-filled syringe
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Participants received bimekizumab 160 mg Q4W at prespecified time points.

    Arm title
    BKZ 160 mg Q4W (Weeks 16 up to 52)(China Extension Population)
    Arm description
    At the end of the 16-week Double-Blind Treatment Period, study participants in China Extension Population receiving placebo were re-allocated to bimekizumab treatment at Week 16. Participants from both placebo and bimekizumab arm received bimekizumab 160 mg Q4W subcutaneously from Week 16 until Week 48 during maintenance period. Participants entering the extension study received bimekizumab 160 mg Q4W subcutaneously until Week 52.
    Arm type
    Experimental

    Investigational medicinal product name
    Bimekizumab
    Investigational medicinal product code
    UCB4940
    Other name
    Pharmaceutical forms
    Solution for injection in pre-filled syringe
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Participants received bimekizumab 160 mg Q4W at prespecified time points.

    Number of subjects in period 2 [3]
    BKZ 160 mg Q4W (Weeks 16 up to 52) (Global Population) BKZ 160 mg Q4W (Weeks 16 up to 52)(China Extension Population)
    Started
    242
    20
    Completed
    220
    17
    Not completed
    22
    3
         Consent withdrawn by subject
    12
    -
         Adverse Event
    5
    -
         Lost to follow-up
    1
    -
         Non- Compliance
    -
    1
         Lack of efficacy
    4
    -
         COVID-19 pandemic situation & site restrictions
    -
    2
    Notes
    [3] - The number of subjects starting the period is not consistent with the number completing the preceding period. It is expected the number of subjects starting the subsequent period will be the same as the number completing the preceding period.
    Justification: Placebo=116+ BKZ=126. 2 participants Completed the 16-Week Double-Blind Period but did not enter the Maintenance Period because of the below reason: Adverse event.

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Placebo (up to Week 16) (Global Population)
    Reporting group description
    Participants received placebo matched to bimekizumab 160 milligrams (mg) every 4 weeks (Q4W) subcutaneously until Week 16.

    Reporting group title
    Bimekizumab 160 mg Q4W (up to Week 16) (Global Population)
    Reporting group description
    Participants received bimekizumab 160 mg Q4W subcutaneously until Week 16.

    Reporting group title
    Placebo (up to Week 16) (China Extension Population)
    Reporting group description
    Participants in the China Extension Population received placebo matched to bimekizumab 160 mg Q4W subcutaneously until Week 16.

    Reporting group title
    BKZ 160 mg Q4W (up to Week 16) (China Extension Population)
    Reporting group description
    Participants in the China Extension Population received bimekizumab 160 mg Q4W subcutaneously until Week 16.

    Reporting group values
    Placebo (up to Week 16) (Global Population) Bimekizumab 160 mg Q4W (up to Week 16) (Global Population) Placebo (up to Week 16) (China Extension Population) BKZ 160 mg Q4W (up to Week 16) (China Extension Population) Total
    Number of subjects
    126 128 11 9 274
    Age Categorical
    Units: Participants
        18 - <65
    123 125 11 9 268
        65 - <85
    3 3 0 0 6
        >= 85
    0 0 0 0 0
    Sex: Female, Male
    Units: Participants
        Female
    61 55 7 2 125
        Male
    65 73 4 7 149

    End points

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    End points reporting groups
    Reporting group title
    Placebo (up to Week 16) (Global Population)
    Reporting group description
    Participants received placebo matched to bimekizumab 160 milligrams (mg) every 4 weeks (Q4W) subcutaneously until Week 16.

    Reporting group title
    Bimekizumab 160 mg Q4W (up to Week 16) (Global Population)
    Reporting group description
    Participants received bimekizumab 160 mg Q4W subcutaneously until Week 16.

    Reporting group title
    Placebo (up to Week 16) (China Extension Population)
    Reporting group description
    Participants in the China Extension Population received placebo matched to bimekizumab 160 mg Q4W subcutaneously until Week 16.

    Reporting group title
    BKZ 160 mg Q4W (up to Week 16) (China Extension Population)
    Reporting group description
    Participants in the China Extension Population received bimekizumab 160 mg Q4W subcutaneously until Week 16.
    Reporting group title
    BKZ 160 mg Q4W (Weeks 16 up to 52) (Global Population)
    Reporting group description
    At the end of the 16-week Double-Blind Treatment Period, study participants receiving placebo were re-allocated to bimekizumab treatment at Week 16. Participants from both placebo and bimekizumab arm received bimekizumab 160 mg Q4W subcutaneously from Week 16 until Week 48 during maintenance period. Participants entering the extension study received bimekizumab 160 mg Q4W subcutaneously until Week 52.

    Reporting group title
    BKZ 160 mg Q4W (Weeks 16 up to 52)(China Extension Population)
    Reporting group description
    At the end of the 16-week Double-Blind Treatment Period, study participants in China Extension Population receiving placebo were re-allocated to bimekizumab treatment at Week 16. Participants from both placebo and bimekizumab arm received bimekizumab 160 mg Q4W subcutaneously from Week 16 until Week 48 during maintenance period. Participants entering the extension study received bimekizumab 160 mg Q4W subcutaneously until Week 52.

    Subject analysis set title
    Overall Period (up to Week 48+20 Weeks SFU):BKZ 160 mg Q4W(GP)
    Subject analysis set type
    Safety analysis
    Subject analysis set description
    Participants who received bimekizumab 160 mg Q4W subcutaneously from Day 1 up to Week 48 and participants who switched from placebo arm at Week 16 to receive bimekizumab 160 mg Q4W subcutaneously up to Week 48 were included in this group.

    Subject analysis set title
    Overall Period (up to Week 48+20 Weeks SFU):BKZ 160 mg Q4W(CP)
    Subject analysis set type
    Safety analysis
    Subject analysis set description
    Participants in the China Extension Population who received bimekizumab 160 mg Q4W subcutaneously from Day 1 up to Week 48 and participants who switched from placebo arm at Week 16 to receive bimekizumab 160 mg Q4W subcutaneously up to Week 48 were included in this group.

    Primary: Percentage of Participants With Assessment of SpondyloArthritis International Society 40% response criteria (ASAS40) response at Week 16

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    End point title
    Percentage of Participants With Assessment of SpondyloArthritis International Society 40% response criteria (ASAS40) response at Week 16
    End point description
    ASAS40 response is defined as relative improvements of at least 40% and absolute improvement of at least 2 units in at least 3 of the 4 following components:1)Patient's Global Assessment of Disease Activity (PGADA) assessed on a scale ranging from 0 [not active] to 10 [very active], higher score=higher disease activity, 2)Spinal Pain assessed on a scale ranging from 0 [no pain] to 10 [most severe pain], higher score= higher pain intensity, 3)Bath Ankylosing Spondylitis Functional Index (BASFI) assessing participant's level of ability on a scale ranging from of 0 [easy] to 10 [impossible] on 10 physical activities, 4)morning stiffness, assessed as the mean of Q5 (intensity) and Q6 (duration) from the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI), each assessed on a scale ranging from 0 [none / 0 hour] to 10 [very severe / 2 or more hours], higher score=higher severity; and no worsening at all in the remaining component. RS consisted of all randomized study participants.
    End point type
    Primary
    End point timeframe
    Week 16
    End point values
    Placebo (up to Week 16) (Global Population) Bimekizumab 160 mg Q4W (up to Week 16) (Global Population) Placebo (up to Week 16) (China Extension Population) BKZ 160 mg Q4W (up to Week 16) (China Extension Population)
    Number of subjects analysed
    126
    128
    11
    9
    Units: percentage of participants
        number (not applicable)
    21.4
    47.7
    27.3
    33.3
    Statistical analysis title
    Statistical Analysis 1
    Comparison groups
    Placebo (up to Week 16) (Global Population) v Bimekizumab 160 mg Q4W (up to Week 16) (Global Population)
    Number of subjects included in analysis
    254
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.001
    Method
    Regression, Logistic
    Parameter type
    Odds ratio (OR)
    Point estimate
    3.51
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    2
         upper limit
    6.16

    Secondary: Percentage of Participants With Assessment of SpondyloArthritis International Society 40% response criteria (ASAS40) response in TNFα inhibitor-naïve subjects at Week 16

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    End point title
    Percentage of Participants With Assessment of SpondyloArthritis International Society 40% response criteria (ASAS40) response in TNFα inhibitor-naïve subjects at Week 16
    End point description
    ASAS40 response is defined as relative improvements of at least 40% and absolute improvement of at least 2 units in at least 3 of the 4 following components:1) PGADA assessed on a scale ranging from 0 [not active] to 10 [very active], higher score=higher disease activity, 2) Spinal Pain assessed on a scale ranging from 0 [no pain] to 10 [most severe pain], higher score= higher pain intensity, 3) BASFI assessing participant's level of ability on a scale ranging from of 0 [easy] to 10 [impossible] on 10 physical activities, 4) morning stiffness, assessed as the mean of Q5 (intensity) and Q6 (duration) from the BASDAI, each assessed on a scale ranging from 0 [none / 0 hour] to 10 [very severe / 2 or more hours], higher score=higher severity; and no worsening at all in the remaining component. The Randomized (RS) Set consisted of all randomized study participants. Participants analyzed are those from the RS who are TNFα inhibitor-naïve.
    End point type
    Secondary
    End point timeframe
    Week 16
    End point values
    Placebo (up to Week 16) (Global Population) Bimekizumab 160 mg Q4W (up to Week 16) (Global Population) Placebo (up to Week 16) (China Extension Population) BKZ 160 mg Q4W (up to Week 16) (China Extension Population)
    Number of subjects analysed
    109
    118
    11
    8
    Units: percentage of Participants
        number (not applicable)
    22.9
    46.6
    27.3
    37.5
    Statistical analysis title
    Statistical analysis 1
    Comparison groups
    Placebo (up to Week 16) (Global Population) v Bimekizumab 160 mg Q4W (up to Week 16) (Global Population)
    Number of subjects included in analysis
    227
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.001
    Method
    Regression, Logistic
    Parameter type
    Odds ratio (OR)
    Point estimate
    3.08
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    1.71
         upper limit
    5.54

    Secondary: Change from Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) total score at Week 16

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    End point title
    Change from Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) total score at Week 16
    End point description
    BASDAI is a well-established patient-reported outcome measure assessing severity of AS symptoms. It is made of 6 items assessing severity of fatigue, spinal pain, peripheral joint pain & swelling, enthesitis, & morning stiffness (both severity & duration). Each question is rated using a numerical rating scale ranging from 0 (none) to 10 (very severe), higher score=higher symptom severity. BASDAI score is calculated by computing mean of questions 5 & 6 and adding it to the sum of questions 1 to 4. This score is then divided by 5. Total BASDAI score ranges from 0=no disease activity to 10=maximal disease activity, where higher score indicates higher symptom severity. A negative change reflects improvement. Missing & non-missing data after intercurrent event are imputed using multiple imputation (MI) based on a reference-based (RB) approach.RS=all randomized participants.99999=Analysis was planned to be performed based on RB MI.No imputation done for CEP, so, no data has been presented.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 16
    End point values
    Placebo (up to Week 16) (Global Population) Bimekizumab 160 mg Q4W (up to Week 16) (Global Population) Placebo (up to Week 16) (China Extension Population) BKZ 160 mg Q4W (up to Week 16) (China Extension Population)
    Number of subjects analysed
    126
    128
    11
    9
    Units: score on a scale
        least squares mean (standard error)
    -1.55 ( 0.22 )
    -3.07 ( 0.21 )
    99999 ( 99999 )
    99999 ( 99999 )
    Statistical analysis title
    Statistical analysis 1
    Comparison groups
    Placebo (up to Week 16) (Global Population) v Bimekizumab 160 mg Q4W (up to Week 16) (Global Population)
    Number of subjects included in analysis
    254
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.001
    Method
    ANCOVA
    Parameter type
    LS Mean difference
    Point estimate
    -1.51
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -2.04
         upper limit
    -0.98

    Secondary: Percentage of Participants With Ankylosing Spondylitis Disease Activity Score major improvement (ASDAS-MI) at Week 16

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    End point title
    Percentage of Participants With Ankylosing Spondylitis Disease Activity Score major improvement (ASDAS-MI) at Week 16
    End point description
    ASDAS-MI is achieved when there is a reduction (improvement) greater or equal to (>=) 2.0 in ASDAS relative to Baseline. ASDAS is calculated by adding the 5 following components: 1) 0.121 × Neck, back or hip pain (BASDAI Q2), 2) 0.058 × Duration of morning stiffness (BASDAI Q6), 3) 0.110 × Patient's Global Assessment of Disease Activity (PGADA), 4) 0.073 × Peripheral pain/swelling in joints (BASDAI Q3), 5) 0.579 × (natural logarithm of the C-reactive protein (CRP) [mg/L] + 1). Q2, Q3 and Q6 from BASDAI and PGADA, are all assessed on a numerical scale from 0 [none / not active] to 10 [very severe / very active]. There is a minimum score of 0.980 for ASDAS (as a fixed value of 2 is assumed for values of hs-CRP below the LLOQ), but no defined upper score. Higher ASDAS scores reflect higher disease activity and participants achieving ASDAS-MI are considered to have a major improvement in their disease. The Randomized Set consisted of all randomized study participants.
    End point type
    Secondary
    End point timeframe
    Week 16
    End point values
    Placebo (up to Week 16) (Global Population) Bimekizumab 160 mg Q4W (up to Week 16) (Global Population) Placebo (up to Week 16) (China Extension Population) BKZ 160 mg Q4W (up to Week 16) (China Extension Population)
    Number of subjects analysed
    126
    128
    11
    9
    Units: percentage of participants
        number (not applicable)
    7.1
    27.3
    9.1
    11.1
    Statistical analysis title
    Statistical analysis 1
    Comparison groups
    Placebo (up to Week 16) (Global Population) v Bimekizumab 160 mg Q4W (up to Week 16) (Global Population)
    Number of subjects included in analysis
    254
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.001
    Method
    Regression, Logistic
    Parameter type
    Odds ratio (OR)
    Point estimate
    5.43
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    2.41
         upper limit
    12.23

    Secondary: Percentage of Participants With Assessment of SpondyloArthritis International Society 20% response criteria (ASAS20) response at Week 16

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    End point title
    Percentage of Participants With Assessment of SpondyloArthritis International Society 20% response criteria (ASAS20) response at Week 16
    End point description
    ASAS20 response is defined as relative improvements of at least 20% and absolute improvement of at least 1 unit in at least 3 of the 4 following components:1) PGADA assessed on a scale ranging from 0 [not active] to 10 [very active], higher score=higher disease activity, 2) Spinal Pain assessed on a scale ranging from 0 [no pain] to 10 [most severe pain], higher score= higher pain intensity, 3) BASFI assessing participant's level of ability on a scale ranging from 0 [easy] to 10 [impossible] on 10 physical activities, 4) morning stiffness, assessed as the mean of Q5 (intensity) and Q6 (duration) from the BASDAI, each assessed on a scale ranging from 0 [none / 0 hour] to 10 [very severe / 2 or more hours], higher score=higher severity; and no worsening at all in the remaining component. The Randomized Set consisted of all randomized study participants.
    End point type
    Secondary
    End point timeframe
    Week 16
    End point values
    Placebo (up to Week 16) (Global Population) Bimekizumab 160 mg Q4W (up to Week 16) (Global Population) Placebo (up to Week 16) (China Extension Population) BKZ 160 mg Q4W (up to Week 16) (China Extension Population)
    Number of subjects analysed
    126
    128
    11
    9
    Units: percentage of participants
        number (not applicable)
    38.1
    68.8
    54.5
    44.4
    Statistical analysis title
    Statistical analysis 1
    Comparison groups
    Placebo (up to Week 16) (Global Population) v Bimekizumab 160 mg Q4W (up to Week 16) (Global Population)
    Number of subjects included in analysis
    254
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.001
    Method
    Regression, Logistic
    Parameter type
    Odds ratio (OR)
    Point estimate
    3.69
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    2.17
         upper limit
    6.26

    Secondary: Percentage of Participants With Assessment of SpondyloArthritis International Society (ASAS) partial remission (PR) at Week 16

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    End point title
    Percentage of Participants With Assessment of SpondyloArthritis International Society (ASAS) partial remission (PR) at Week 16
    End point description
    The Assessment of SpondyloArthritis International Society partial remission (ASAS-PR) is defined as a score of less than or equal to (<=) 2 units in each of the 4 following components: 1) PGADA assessed on a scale ranging from 0 [not active] to 10 [very active], higher score=higher disease activity, 2) Spinal Pain assessed on a scale ranging from 0 [no pain] to 10 [most severe pain], higher score= higher pain intensity, 3) BASFI assessing participant's level of ability on a scale ranging from 0 [easy] to 10 [impossible] on 10 physical activities, and 4) morning stiffness, assessed as the mean of Q5 (intensity) and Q6 (duration) from the BASDAI scale, each assessed on a scale ranging from 0 [none / 0 hour] to 10 [very severe / 2 or more hours], higher score=higher severity. The Randomized Set consisted of all randomized study participants.
    End point type
    Secondary
    End point timeframe
    Week 16
    End point values
    Placebo (up to Week 16) (Global Population) Bimekizumab 160 mg Q4W (up to Week 16) (Global Population) Placebo (up to Week 16) (China Extension Population) BKZ 160 mg Q4W (up to Week 16) (China Extension Population)
    Number of subjects analysed
    126
    128
    11
    9
    Units: percentage of participants
        number (not applicable)
    7.1
    25.8
    9.1
    33.3
    Statistical analysis title
    Statistical analysis 1
    Comparison groups
    Placebo (up to Week 16) (Global Population) v Bimekizumab 160 mg Q4W (up to Week 16) (Global Population)
    Number of subjects included in analysis
    254
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.001
    Method
    Regression, Logistic
    Parameter type
    Odds ratio (OR)
    Point estimate
    4.52
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    2.06
         upper limit
    9.93

    Secondary: Change from Baseline in Bath Ankylosing Spondylitis Functional Index (BASFI) at Week 16

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    End point title
    Change from Baseline in Bath Ankylosing Spondylitis Functional Index (BASFI) at Week 16
    End point description
    The BASFI is a well-established PRO measure of physical functioning used in AxSpA trials. It assesses participants' level of ability during the past week in conducting 10 physical activities on a scale ranging from 0 [easy] to 10 [impossible]. The BASFI score is the mean of the 10 item scores and ranges from 0 to 10, with lower scores indicating better physical function. A negative change in BASFI indicates improvement. The higher the negative value the better the improvement. Missing data at Week 16 and non-missing data after intercurrent event (which are reset to missing) are imputed using MI based on a reference-based approach, in which the MI model is based on data from the placebo group. The Randomized Set consisted of all randomized study participants.99999=Analysis was planned to be performed based on RB MI.No imputation done for CEP, so, no data has been presented.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 16
    End point values
    Placebo (up to Week 16) (Global Population) Bimekizumab 160 mg Q4W (up to Week 16) (Global Population) Placebo (up to Week 16) (China Extension Population) BKZ 160 mg Q4W (up to Week 16) (China Extension Population)
    Number of subjects analysed
    126
    128
    11
    9
    Units: score on a scale
        least squares mean (standard error)
    -0.91 ( 0.22 )
    -2.39 ( 0.21 )
    99999 ( 99999 )
    99999 ( 99999 )
    Statistical analysis title
    Statistical analysis 1
    Comparison groups
    Placebo (up to Week 16) (Global Population) v Bimekizumab 160 mg Q4W (up to Week 16) (Global Population)
    Number of subjects included in analysis
    254
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    < 0.001
    Method
    ANCOVA
    Parameter type
    LS Mean difference
    Point estimate
    -1.48
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -1.99
         upper limit
    -0.97

    Secondary: Percentage of Participants With Assessment of SpondyloArthritis International Society (ASAS) 5/6 response at Week 16

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    End point title
    Percentage of Participants With Assessment of SpondyloArthritis International Society (ASAS) 5/6 response at Week 16
    End point description
    ASAS 5/6 response is defined as achieving at least 20% improvement in 5 of the following 6 components: 1)PGADA assessed on a scale ranging from 0 [not active] to 10 [very active], higher score=higher disease activity, 2)Spinal Pain assessed on a scale ranging from 0 [no pain] to 10 [most intense pain], higher score=higher pain intensity, 3)BASFI assessing participant's level of ability on a scale ranging from 0 [easy] to 10 [impossible] on 10 physical activities, 4)morning stiffness, assessed as mean of Q5 (intensity) and Q6 (duration) from BASDAI scale, each assessed on a scale ranging from 0 [none/ 0 hour] to 10 [very severe / 2 or more hours], higher score=higher severity; 5)spinal mobility (ie, lateral spinal flexion component of Bath Ankylosing Spondylitis Disease Metrology Index) on a scale ranging from 0 [no limitation of movement] to 10 [very severe limitation of movement] and 6) high sensitivity C-reactive protein (hs-CRP). RS consisted of all randomized study participants.
    End point type
    Secondary
    End point timeframe
    Week 16
    End point values
    Placebo (up to Week 16) (Global Population) Bimekizumab 160 mg Q4W (up to Week 16) (Global Population) Placebo (up to Week 16) (China Extension Population) BKZ 160 mg Q4W (up to Week 16) (China Extension Population)
    Number of subjects analysed
    126
    128
    11
    9
    Units: percentage of participants
        number (not applicable)
    20.6
    45.3
    18.2
    44.4
    Statistical analysis title
    Statistical analysis 1
    Comparison groups
    Placebo (up to Week 16) (Global Population) v Bimekizumab 160 mg Q4W (up to Week 16) (Global Population)
    Number of subjects included in analysis
    254
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.001
    Method
    Regression, Logistic
    Parameter type
    Odds ratio (OR)
    Point estimate
    3.31
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    1.87
         upper limit
    5.84

    Secondary: Change from Baseline in Ankylosing Spondylitis Quality of Life (ASQoL) total score at Week 16

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    End point title
    Change from Baseline in Ankylosing Spondylitis Quality of Life (ASQoL) total score at Week 16
    End point description
    The Ankylosing Spondylitis Quality of Life (ASQoL) is an 18-item PRO measure developed specifically for measuring health-related quality of life (HRQoL) in participants with ankylosing spondylitis and validated in the full spectrum of axial spondyloarthritis (axSpA). Each item is given a score of 1 for positive responses indicating impaired quality of life, and a score of 0 for negative responses. All item scores are summed to generate the total score ranging from 0 to 18 with a higher score indicating worse HRQoL. A negative change represents an improvement. Missing data at Week 16 and non-missing data after intercurrent event (which are reset to missing) are imputed using MI based on a reference-based approach, in which the MI model is based on data from the placebo group. The Randomized Set consisted of all randomized study participants.99999=Analysis was planned to be performed based on RB MI.No imputation done for CEP, so, no data has been presented.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 16
    End point values
    Placebo (up to Week 16) (Global Population) Bimekizumab 160 mg Q4W (up to Week 16) (Global Population) Placebo (up to Week 16) (China Extension Population) BKZ 160 mg Q4W (up to Week 16) (China Extension Population)
    Number of subjects analysed
    126
    128
    11
    9
    Units: score on a scale
        least squares mean (standard error)
    -2.30 ( 0.43 )
    -4.94 ( 0.42 )
    99999 ( 99999 )
    99999 ( 99999 )
    Statistical analysis title
    Statistical analysis 1
    Comparison groups
    Placebo (up to Week 16) (Global Population) v Bimekizumab 160 mg Q4W (up to Week 16) (Global Population)
    Number of subjects included in analysis
    254
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.001
    Method
    ANCOVA
    Parameter type
    LS Mean difference
    Point estimate
    -2.63
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -3.66
         upper limit
    -1.61

    Secondary: Change from Baseline in nocturnal spinal pain score Numeric Rating Scale (NRS) at Week 16

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    End point title
    Change from Baseline in nocturnal spinal pain score Numeric Rating Scale (NRS) at Week 16
    End point description
    Nocturnal spinal pain experienced by participants with axial spondyloarthritis (axSpA) was assessed on a numerical rating scale ranging from of 0 (no pain) to 10 (most severe pain). A lower score indicates less pain and a negative change represents an improvement. Missing data at Week 16 and non-missing data after intercurrent event(s) (which are reset to missing) are imputed using MI based on a reference-based approach, in which the MI model is based on data from the placebo group.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 16
    End point values
    Placebo (up to Week 16) (Global Population) Bimekizumab 160 mg Q4W (up to Week 16) (Global Population) Placebo (up to Week 16) (China Extension Population) BKZ 160 mg Q4W (up to Week 16) (China Extension Population)
    Number of subjects analysed
    126
    128
    11
    9
    Units: score on a scale
        least squares mean (standard error)
    -1.71 ( 0.27 )
    -3.51 ( 0.25 )
    99999 ( 99999 )
    99999 ( 99999 )
    Statistical analysis title
    Statistical analysis 1
    Comparison groups
    Placebo (up to Week 16) (Global Population) v Bimekizumab 160 mg Q4W (up to Week 16) (Global Population)
    Number of subjects included in analysis
    254
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.001
    Method
    ANCOVA
    Parameter type
    LS Mean difference
    Point estimate
    -1.8
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -2.42
         upper limit
    -1.18

    Secondary: Change from Baseline in Bath Ankylosing Spondylitis Disease Metrology Index (BASMI) at Week 16

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    End point title
    Change from Baseline in Bath Ankylosing Spondylitis Disease Metrology Index (BASMI) at Week 16
    End point description
    The BASMI characterizes the spinal mobility of participants with axial Spondyloarthritis (SpA) and Ankylosing Spondylitis. It is a disease-specific measure consisting of 5 clinical measures to reflect participant axial status: cervical rotation; tragus to wall distance; lateral lumbar flexion; lumbar flexion (modified Schober test); intermalleolar distance. According to the linear definition of the BASMI a score of 0 to 10 was calculated for each item based on the measurement. The mean of the 5 scores provides the total BASMI score (ranging from 0 to 10). The higher the BASMI score, the more severe the participant's limitation of movement due to their axial SpA. A negative value in BASMI change from Baseline indicates an improvement from Baseline. The higher the negative value, the better the improvement. The Randomized Set consisted of all randomized study participants.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 16
    End point values
    Placebo (up to Week 16) (Global Population) Bimekizumab 160 mg Q4W (up to Week 16) (Global Population) Placebo (up to Week 16) (China Extension Population) BKZ 160 mg Q4W (up to Week 16) (China Extension Population)
    Number of subjects analysed
    126
    128
    11
    9
    Units: score on a scale
        least squares mean (standard error)
    -0.11 ( 0.08 )
    -0.44 ( 0.08 )
    0.12 ( 0.211 )
    -0.38 ( 0.232 )
    Statistical analysis title
    Statistical analysis 1
    Comparison groups
    Placebo (up to Week 16) (Global Population) v Bimekizumab 160 mg Q4W (up to Week 16) (Global Population)
    Number of subjects included in analysis
    254
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.001
    Method
    ANCOVA
    Parameter type
    LS Mean difference
    Point estimate
    -0.33
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -0.52
         upper limit
    -0.14

    Secondary: Change from Baseline in the Short Form 36-Item Health Survey (SF-36) physical component summary (PCS) score at Week 16

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    End point title
    Change from Baseline in the Short Form 36-Item Health Survey (SF-36) physical component summary (PCS) score at Week 16
    End point description
    SF-36 is a 36-item HRQoL instrument that uses a recall period of 4 weeks. Items are grouped into 8 domains: Physical Functioning (10 items), Role Physical (4 items), Bodily Pain (2 items), General Health (5 items),Vitality (4 items), Social Functioning (2 items), Role Emotional (3 items), Mental Health (5 items), & 1 item for perceived stability or change in health (Health Transition). In addition to domain scores, PCS & MCS scores are calculated from 8 domains (excluding Health Transition item). Each of SF-36 derived raw scores & domain scores range from 0 to 100 with a higher score=better function.2 component summary scores & 8 domains scores are standardized with a mean of 50 & S.D. of 10 in general US population (Maruish, 2011). A positive change reflects improvement. Missing & non-missing data are imputed using MI based on a RB approach. Analysis set was RS.99999=Analysis was planned to be performed based on RB MI.No imputation done for CEP,so,no data has been presented.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 16
    End point values
    Placebo (up to Week 16) (Global Population) Bimekizumab 160 mg Q4W (up to Week 16) (Global Population) Placebo (up to Week 16) (China Extension Population) BKZ 160 mg Q4W (up to Week 16) (China Extension Population)
    Number of subjects analysed
    126
    128
    11
    9
    Units: score on a scale
        least squares mean (standard error)
    5.36 ( 0.79 )
    9.32 ( 0.76 )
    99999 ( 99999 )
    99999 ( 99999 )
    Statistical analysis title
    Statistical analysis 1
    Comparison groups
    Placebo (up to Week 16) (Global Population) v Bimekizumab 160 mg Q4W (up to Week 16) (Global Population)
    Number of subjects included in analysis
    254
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.001
    Method
    ANCOVA
    Parameter type
    LS Mean difference
    Point estimate
    3.96
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    2.08
         upper limit
    5.83

    Secondary: Percentage of Participants With Enthesitis-free state at Week 16 based on the Maastricht Ankylosing Spondylitis Enthesitis Index (MASES) Index in the subgroup of participants with enthesitis at Baseline

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    End point title
    Percentage of Participants With Enthesitis-free state at Week 16 based on the Maastricht Ankylosing Spondylitis Enthesitis Index (MASES) Index in the subgroup of participants with enthesitis at Baseline
    End point description
    The Maastricht Ankylosing Spondylitis Enthesitis is an index that measures the severity (ie, intensity and extent) of enthesitis through the assessment of 13 entheses (bilateral costochondral 1, costochondral 7, anterior superior iliac spine, posterior iliac spine, iliac crest and proximal insertion of the Achilles tendon sites, and the fifth lumbar vertebral body spinous process) each scored as 0 or 1 and then summed for a possible score of 0 to 13. Enthesitis free state is defined as having a MASES score of 0. A higher score reflects higher severity and a negative change represents an improvement. Subgroup of study participants in Randomized Set with enthesitis at Baseline (MASES index score > 0).
    End point type
    Secondary
    End point timeframe
    Baseline, Week 16
    End point values
    Placebo (up to Week 16) (Global Population) Bimekizumab 160 mg Q4W (up to Week 16) (Global Population) Placebo (up to Week 16) (China Extension Population) BKZ 160 mg Q4W (up to Week 16) (China Extension Population)
    Number of subjects analysed
    92
    94
    5
    3
    Units: percentage of participants
        number (not applicable)
    23.9
    51.1
    60.0
    66.7
    Statistical analysis title
    Statistical analysis 1
    Comparison groups
    Placebo (up to Week 16) (Global Population) v Bimekizumab 160 mg Q4W (up to Week 16) (Global Population)
    Number of subjects included in analysis
    186
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.001
    Method
    Regression, Logistic
    Parameter type
    Odds ratio (OR)
    Point estimate
    3.49
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    1.84
         upper limit
    6.62

    Secondary: Change from Baseline in the Maastricht Ankylosing Spondylitis Enthesitis (MASES) Index in the subgroup of participants with enthesitis at Baseline at Week 16

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    End point title
    Change from Baseline in the Maastricht Ankylosing Spondylitis Enthesitis (MASES) Index in the subgroup of participants with enthesitis at Baseline at Week 16
    End point description
    The Maastricht Ankylosing Spondylitis Enthesitis is an index that measures the severity (ie, intensity and extent) of enthesitis through the assessment of 13 entheses (bilateral costochondral 1, costochondral 7, anterior superior iliac spine, posterior iliac spine, iliac crest and proximal insertion of the Achilles tendon sites, and the fifth lumbar vertebral body spinous process), each scored as 0 or 1 and then summed for a possible score of 0 to 13. A higher score reflects higher severity and a negative change represents an improvement. Subgroup of study participants in Randomized Set with enthesitis at Baseline (MASES index score > 0).
    End point type
    Secondary
    End point timeframe
    Baseline, Week 16
    End point values
    Placebo (up to Week 16) (Global Population) Bimekizumab 160 mg Q4W (up to Week 16) (Global Population) Placebo (up to Week 16) (China Extension Population) BKZ 160 mg Q4W (up to Week 16) (China Extension Population)
    Number of subjects analysed
    92
    94
    5
    3
    Units: score on a scale
        least squares mean (standard error)
    -1.11 ( 0.38 )
    -2.16 ( 0.37 )
    -1.35 ( 0.692 )
    -1.80 ( 0.871 )
    Statistical analysis title
    Statistical analysis 1
    Comparison groups
    Placebo (up to Week 16) (Global Population) v Bimekizumab 160 mg Q4W (up to Week 16) (Global Population)
    Number of subjects included in analysis
    186
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.013
    Method
    ANCOVA
    Parameter type
    LS Mean difference
    Point estimate
    -1.06
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -1.88
         upper limit
    -0.23

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

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    End point title
    Percentage of participants with treatment-emergent adverse events (TEAEs) during the study
    End point description
    TEAEs are defined as those AEs that have a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week Safety follow up (SFU)). TEAEs were analyzed and have been reported separately for Double-Blind Treatment Period (Safety set),Maintenance Period (MP) (Maintenance Set) and Overall Period (Safety set) which includes all participants who received BKZ 160 mg Q4W during the study. The overall period arm reports repeated TEAEs from the double blind treatment period arm and maintenance period arm. As pre-specified in SAP, Maintenance Period (MP) included AEs of Safety follow up period for participants who did not enter the open label extension or discontinued early in MP. The Safety Set consisted of all randomized study participants who received at least 1 dose of investigational medicinal product (IMP).
    End point type
    Secondary
    End point timeframe
    From Baseline (Day 1) until Safety-Follow-Up (up to Week 68) (Week 48 last IMP intake + 20 weeks SFU)
    End point values
    Placebo (up to Week 16) (Global Population) BKZ 160 mg Q4W (Weeks 16 up to 52) (Global Population) Bimekizumab 160 mg Q4W (up to Week 16) (Global Population) BKZ 160 mg Q4W (Weeks 16 up to 52)(China Extension Population) Placebo (up to Week 16) (China Extension Population) BKZ 160 mg Q4W (up to Week 16) (China Extension Population) Overall Period (up to Week 48+20 Weeks SFU):BKZ 160 mg Q4W(GP) Overall Period (up to Week 48+20 Weeks SFU):BKZ 160 mg Q4W(CP)
    Number of subjects analysed
    126
    242
    128
    20
    11
    9
    244
    20
    Units: percentage of participants
        number (not applicable)
    56.3
    67.8
    62.5
    80.0
    72.7
    100
    75.0
    90.0
    No statistical analyses for this end point

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

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    End point title
    Percentage of participants with treatment-emergent serious adverse events (SAEs) during the study
    End point description
    SAE is any untoward medical occurrence that at any dose resulted in 1) Death, 2) Life-threatening (Life-threatening does not include a reaction that might have caused death had it occurred in a more severe form.), 3) Significant or persistent disability/incapacity, 4) Congenital anomaly/birth defect (including that occurring in a fetus), 5) Important medical event that, based upon appropriate medical judgment, may jeopardize the participant or participant may require medical or surgical intervention to prevent any of the above, 6) Initial inpatient hospitalization or prolongation of hospitalization. The overall period arm reports repeated SAEs from the double blind treatment period arm and maintenance period arm. As pre-specified in SAP, MP included SAEs of Safety follow up period for participants who did not enter the open label extension or discontinued early in MP. The Safety Set consisted of all randomized study participants who received at least 1 dose of IMP.
    End point type
    Secondary
    End point timeframe
    From Baseline (Day 1) until Safety Follow-Up (up to Week 68)
    End point values
    Placebo (up to Week 16) (Global Population) BKZ 160 mg Q4W (Weeks 16 up to 52) (Global Population) Bimekizumab 160 mg Q4W (up to Week 16) (Global Population) BKZ 160 mg Q4W (Weeks 16 up to 52)(China Extension Population) Placebo (up to Week 16) (China Extension Population) BKZ 160 mg Q4W (up to Week 16) (China Extension Population) Overall Period (up to Week 48+20 Weeks SFU):BKZ 160 mg Q4W(GP) Overall Period (up to Week 48+20 Weeks SFU):BKZ 160 mg Q4W(CP)
    Number of subjects analysed
    126
    242
    128
    20
    11
    9
    244
    20
    Units: percentage of participants
        number (not applicable)
    0.8
    3.7
    0
    15.0
    0
    0
    3.7
    15.0
    No statistical analyses for this end point

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

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    End point title
    Percentage of participants with treatment-emergent adverse events (TEAEs) leading to withdrawal from investigational medicinal product (IMP) during the study
    End point description
    TEAEs are defined as those AEs that have a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week SFU period). The overall period arm reports repeated events from the double blind treatment period arm and maintenance period arm. As pre-specified in SAP, MP included events of Safety follow up period for participants who did not enter the open label extension or discontinued early in MP. The Safety Set consisted of all randomized study participants who received at least 1 dose of IMP.
    End point type
    Secondary
    End point timeframe
    From Baseline (Day 1) until Safety-Follow-Up (up to Week 68)
    End point values
    Placebo (up to Week 16) (Global Population) BKZ 160 mg Q4W (Weeks 16 up to 52) (Global Population) Bimekizumab 160 mg Q4W (up to Week 16) (Global Population) BKZ 160 mg Q4W (Weeks 16 up to 52)(China Extension Population) Placebo (up to Week 16) (China Extension Population) BKZ 160 mg Q4W (up to Week 16) (China Extension Population) Overall Period (up to Week 48+20 Weeks SFU):BKZ 160 mg Q4W(GP) Overall Period (up to Week 48+20 Weeks SFU):BKZ 160 mg Q4W(CP)
    Number of subjects analysed
    126
    242
    128
    20
    11
    9
    244
    20
    Units: percentage of participants
        number (not applicable)
    4.0
    2.5
    1.6
    0
    0
    0
    3.3
    0
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    From Baseline (Day 1) until Safety Follow-Up (up to Week 68)
    Adverse event reporting additional description
    As prespecified in SAP, Maintenance Period (MP) included AEs of SFU period for participants who did not enter OLE or discontinued early in MP. participants who rolled over to OLE study did not have SFU visit. TEAEs have been reported separately for DBTP (SS), MP (MS) and Overall Period (OP) (SS). OP arm reports repeated TEAEs from the DBTP and MP.
    Assessment type
    Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    19.0
    Reporting groups
    Reporting group title
    Placebo (up to Week 16) (Global Population)
    Reporting group description
    Participants received placebo matched to bimekizumab 160 mg Q4W subcutaneously until Week 16.

    Reporting group title
    BKZ 160 mg Q4W (Weeks 16 up to 52)(Global Population)
    Reporting group description
    At the end of the 16-week Double-Blind Treatment Period, study participants receiving placebo were re-allocated to bimekizumab treatment at Week 16. Participants from both placebo and bimekizumab arm received bimekizumab 160 mg Q4W subcutaneously from Week 16 until Week 48 during maintenance period. Participants entering the extension study received bimekizumab 160 mg Q4W subcutaneously until Week 52.

    Reporting group title
    Overall Period (up to Week 48+20 Week SFU):BKZ 160 mg Q4W(CP)
    Reporting group description
    Participants in the China Extension Population who received bimekizumab 160 mg Q4W subcutaneously from Day 1 up to Week 48 and participants who switched from placebo arm at Week 16 to receive bimekizumab 160 mg Q4W subcutaneously up to Week 48 were included in this group.

    Reporting group title
    Placebo (up to Week 16) (China Extension Population)
    Reporting group description
    Participants in the China Extension Population received placebo matched to bimekizumab 160 mg Q4W subcutaneously until Week 16.

    Reporting group title
    BKZ 160 mg Q4W (up to Week 16) (China Extension Population)
    Reporting group description
    Participants in the China Extension Population received bimekizumab 160 mg Q4W subcutaneously until Week 16.

    Reporting group title
    BKZ 160 mg Q4W (Weeks 16 up to 52)(China Extension Population)
    Reporting group description
    At the end of the 16-week Double-Blind Treatment Period, study participants in China Extension Population receiving placebo were re-allocated to bimekizumab treatment at Week 16. Participants from both placebo and bimekizumab arm received bimekizumab 160 mg Q4W subcutaneously from Week 16 until Week 48 during maintenance period. Participants entering the extension study received bimekizumab 160 mg Q4W subcutaneously until Week 52.

    Reporting group title
    Bimekizumab 160 mg Q4W (up to Week 16) (Global Population)
    Reporting group description
    Participants received bimekizumab 160 mg Q4W subcutaneously until Week 16.

    Reporting group title
    Overall Period(up to Week 48+20 Weeks SFU):BKZ 160 mg Q4W(GP)
    Reporting group description
    Participants who received bimekizumab 160 mg Q4W subcutaneously from Day 1 up to Week 48 and participants who switched from placebo arm at Week 16 to receive bimekizumab 160 mg Q4W subcutaneously up to Week 48 were included in this group.

    Serious adverse events
    Placebo (up to Week 16) (Global Population) BKZ 160 mg Q4W (Weeks 16 up to 52)(Global Population) Overall Period (up to Week 48+20 Week SFU):BKZ 160 mg Q4W(CP) Placebo (up to Week 16) (China Extension Population) BKZ 160 mg Q4W (up to Week 16) (China Extension Population) BKZ 160 mg Q4W (Weeks 16 up to 52)(China Extension Population) Bimekizumab 160 mg Q4W (up to Week 16) (Global Population) Overall Period(up to Week 48+20 Weeks SFU):BKZ 160 mg Q4W(GP)
    Total subjects affected by serious adverse events
         subjects affected / exposed
    1 / 126 (0.79%)
    9 / 242 (3.72%)
    3 / 20 (15.00%)
    0 / 11 (0.00%)
    0 / 9 (0.00%)
    3 / 20 (15.00%)
    0 / 128 (0.00%)
    9 / 244 (3.69%)
         number of deaths (all causes)
    0
    0
    0
    0
    0
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    0
    0
    0
    0
    0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Clear cell renal cell carcinoma
         subjects affected / exposed
    0 / 126 (0.00%)
    1 / 242 (0.41%)
    0 / 20 (0.00%)
    0 / 11 (0.00%)
    0 / 9 (0.00%)
    0 / 20 (0.00%)
    0 / 128 (0.00%)
    1 / 244 (0.41%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Ear and labyrinth disorders
    Deafness unilateral
         subjects affected / exposed
    0 / 126 (0.00%)
    1 / 242 (0.41%)
    0 / 20 (0.00%)
    0 / 11 (0.00%)
    0 / 9 (0.00%)
    0 / 20 (0.00%)
    0 / 128 (0.00%)
    1 / 244 (0.41%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Abdominal adhesions
         subjects affected / exposed
    1 / 126 (0.79%)
    0 / 242 (0.00%)
    0 / 20 (0.00%)
    0 / 11 (0.00%)
    0 / 9 (0.00%)
    0 / 20 (0.00%)
    0 / 128 (0.00%)
    0 / 244 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Reproductive system and breast disorders
    Cervical dysplasia
         subjects affected / exposed
    0 / 126 (0.00%)
    0 / 242 (0.00%)
    1 / 20 (5.00%)
    0 / 11 (0.00%)
    0 / 9 (0.00%)
    1 / 20 (5.00%)
    0 / 128 (0.00%)
    0 / 244 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Abortion induced
         subjects affected / exposed
    0 / 126 (0.00%)
    0 / 242 (0.00%)
    1 / 20 (5.00%)
    0 / 11 (0.00%)
    0 / 9 (0.00%)
    1 / 20 (5.00%)
    0 / 128 (0.00%)
    0 / 244 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Nasal crusting
         subjects affected / exposed
    0 / 126 (0.00%)
    1 / 242 (0.41%)
    0 / 20 (0.00%)
    0 / 11 (0.00%)
    0 / 9 (0.00%)
    0 / 20 (0.00%)
    0 / 128 (0.00%)
    1 / 244 (0.41%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Psychiatric disorders
    Intentional self-injury
         subjects affected / exposed
    0 / 126 (0.00%)
    1 / 242 (0.41%)
    0 / 20 (0.00%)
    0 / 11 (0.00%)
    0 / 9 (0.00%)
    0 / 20 (0.00%)
    0 / 128 (0.00%)
    1 / 244 (0.41%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Osteoarthritis
         subjects affected / exposed
    0 / 126 (0.00%)
    1 / 242 (0.41%)
    0 / 20 (0.00%)
    0 / 11 (0.00%)
    0 / 9 (0.00%)
    0 / 20 (0.00%)
    0 / 128 (0.00%)
    1 / 244 (0.41%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Appendicitis
         subjects affected / exposed
    0 / 126 (0.00%)
    2 / 242 (0.83%)
    1 / 20 (5.00%)
    0 / 11 (0.00%)
    0 / 9 (0.00%)
    1 / 20 (5.00%)
    0 / 128 (0.00%)
    2 / 244 (0.82%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 2
    1 / 1
    0 / 0
    0 / 0
    1 / 1
    0 / 0
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Erysipelas
         subjects affected / exposed
    0 / 126 (0.00%)
    1 / 242 (0.41%)
    0 / 20 (0.00%)
    0 / 11 (0.00%)
    0 / 9 (0.00%)
    0 / 20 (0.00%)
    0 / 128 (0.00%)
    1 / 244 (0.41%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Tonsillitis bacterial
         subjects affected / exposed
    0 / 126 (0.00%)
    1 / 242 (0.41%)
    0 / 20 (0.00%)
    0 / 11 (0.00%)
    0 / 9 (0.00%)
    0 / 20 (0.00%)
    0 / 128 (0.00%)
    1 / 244 (0.41%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    Placebo (up to Week 16) (Global Population) BKZ 160 mg Q4W (Weeks 16 up to 52)(Global Population) Overall Period (up to Week 48+20 Week SFU):BKZ 160 mg Q4W(CP) Placebo (up to Week 16) (China Extension Population) BKZ 160 mg Q4W (up to Week 16) (China Extension Population) BKZ 160 mg Q4W (Weeks 16 up to 52)(China Extension Population) Bimekizumab 160 mg Q4W (up to Week 16) (Global Population) Overall Period(up to Week 48+20 Weeks SFU):BKZ 160 mg Q4W(GP)
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    30 / 126 (23.81%)
    94 / 242 (38.84%)
    16 / 20 (80.00%)
    8 / 11 (72.73%)
    9 / 9 (100.00%)
    13 / 20 (65.00%)
    40 / 128 (31.25%)
    114 / 244 (46.72%)
    Investigations
    Blood cholesterol increased
         subjects affected / exposed
    0 / 126 (0.00%)
    1 / 242 (0.41%)
    0 / 20 (0.00%)
    1 / 11 (9.09%)
    0 / 9 (0.00%)
    0 / 20 (0.00%)
    0 / 128 (0.00%)
    1 / 244 (0.41%)
         occurrences all number
    0
    2
    0
    1
    0
    0
    0
    2
    Low density lipoprotein increased
         subjects affected / exposed
    0 / 126 (0.00%)
    0 / 242 (0.00%)
    0 / 20 (0.00%)
    1 / 11 (9.09%)
    0 / 9 (0.00%)
    0 / 20 (0.00%)
    0 / 128 (0.00%)
    0 / 244 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    0
    0
    Lymphocyte count decreased
         subjects affected / exposed
    0 / 126 (0.00%)
    1 / 242 (0.41%)
    1 / 20 (5.00%)
    0 / 11 (0.00%)
    1 / 9 (11.11%)
    0 / 20 (0.00%)
    0 / 128 (0.00%)
    1 / 244 (0.41%)
         occurrences all number
    0
    1
    1
    0
    1
    0
    0
    1
    Weight decreased
         subjects affected / exposed
    0 / 126 (0.00%)
    3 / 242 (1.24%)
    1 / 20 (5.00%)
    0 / 11 (0.00%)
    1 / 9 (11.11%)
    0 / 20 (0.00%)
    0 / 128 (0.00%)
    3 / 244 (1.23%)
         occurrences all number
    0
    3
    1
    0
    1
    0
    0
    3
    Blood bilirubin increased
         subjects affected / exposed
    0 / 126 (0.00%)
    1 / 242 (0.41%)
    1 / 20 (5.00%)
    1 / 11 (9.09%)
    0 / 9 (0.00%)
    1 / 20 (5.00%)
    0 / 128 (0.00%)
    1 / 244 (0.41%)
         occurrences all number
    0
    1
    1
    1
    0
    1
    0
    1
    Liver function test increased
         subjects affected / exposed
    1 / 126 (0.79%)
    0 / 242 (0.00%)
    1 / 20 (5.00%)
    0 / 11 (0.00%)
    1 / 9 (11.11%)
    0 / 20 (0.00%)
    1 / 128 (0.78%)
    1 / 244 (0.41%)
         occurrences all number
    1
    0
    2
    0
    2
    0
    1
    1
    Liver function test abnormal
         subjects affected / exposed
    0 / 126 (0.00%)
    1 / 242 (0.41%)
    3 / 20 (15.00%)
    0 / 11 (0.00%)
    2 / 9 (22.22%)
    1 / 20 (5.00%)
    0 / 128 (0.00%)
    1 / 244 (0.41%)
         occurrences all number
    0
    1
    3
    0
    2
    1
    0
    1
    Injury, poisoning and procedural complications
    Chillblains
         subjects affected / exposed
    0 / 126 (0.00%)
    0 / 242 (0.00%)
    0 / 20 (0.00%)
    1 / 11 (9.09%)
    0 / 9 (0.00%)
    0 / 20 (0.00%)
    0 / 128 (0.00%)
    0 / 244 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    0
    0
    Nervous system disorders
    Headache
         subjects affected / exposed
    2 / 126 (1.59%)
    10 / 242 (4.13%)
    0 / 20 (0.00%)
    0 / 11 (0.00%)
    0 / 9 (0.00%)
    0 / 20 (0.00%)
    4 / 128 (3.13%)
    14 / 244 (5.74%)
         occurrences all number
    5
    12
    0
    0
    0
    0
    6
    18
    General disorders and administration site conditions
    Injection site pain
         subjects affected / exposed
    2 / 126 (1.59%)
    3 / 242 (1.24%)
    0 / 20 (0.00%)
    2 / 11 (18.18%)
    0 / 9 (0.00%)
    0 / 20 (0.00%)
    2 / 128 (1.56%)
    5 / 244 (2.05%)
         occurrences all number
    3
    7
    0
    2
    0
    0
    2
    9
    Blood and lymphatic system disorders
    Thrombocytopenia
         subjects affected / exposed
    0 / 126 (0.00%)
    1 / 242 (0.41%)
    1 / 20 (5.00%)
    0 / 11 (0.00%)
    1 / 9 (11.11%)
    1 / 20 (5.00%)
    2 / 128 (1.56%)
    3 / 244 (1.23%)
         occurrences all number
    0
    1
    2
    0
    1
    1
    2
    3
    Leukopenia
         subjects affected / exposed
    0 / 126 (0.00%)
    3 / 242 (1.24%)
    2 / 20 (10.00%)
    0 / 11 (0.00%)
    0 / 9 (0.00%)
    2 / 20 (10.00%)
    1 / 128 (0.78%)
    3 / 244 (1.23%)
         occurrences all number
    0
    4
    3
    0
    0
    3
    1
    5
    Eye disorders
    Vision blurred
         subjects affected / exposed
    0 / 126 (0.00%)
    0 / 242 (0.00%)
    1 / 20 (5.00%)
    0 / 11 (0.00%)
    1 / 9 (11.11%)
    0 / 20 (0.00%)
    0 / 128 (0.00%)
    0 / 244 (0.00%)
         occurrences all number
    0
    0
    1
    0
    1
    0
    0
    0
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed
    2 / 126 (1.59%)
    6 / 242 (2.48%)
    1 / 20 (5.00%)
    0 / 11 (0.00%)
    1 / 9 (11.11%)
    0 / 20 (0.00%)
    3 / 128 (2.34%)
    9 / 244 (3.69%)
         occurrences all number
    2
    6
    1
    0
    1
    0
    4
    10
    Gastritis
         subjects affected / exposed
    1 / 126 (0.79%)
    0 / 242 (0.00%)
    1 / 20 (5.00%)
    0 / 11 (0.00%)
    1 / 9 (11.11%)
    0 / 20 (0.00%)
    0 / 128 (0.00%)
    0 / 244 (0.00%)
         occurrences all number
    1
    0
    1
    0
    1
    0
    0
    0
    Abdominal pain
         subjects affected / exposed
    1 / 126 (0.79%)
    7 / 242 (2.89%)
    1 / 20 (5.00%)
    0 / 11 (0.00%)
    1 / 9 (11.11%)
    0 / 20 (0.00%)
    0 / 128 (0.00%)
    7 / 244 (2.87%)
         occurrences all number
    1
    8
    1
    0
    1
    0
    0
    8
    Mouth ulceration
         subjects affected / exposed
    0 / 126 (0.00%)
    0 / 242 (0.00%)
    2 / 20 (10.00%)
    0 / 11 (0.00%)
    0 / 9 (0.00%)
    2 / 20 (10.00%)
    0 / 128 (0.00%)
    0 / 244 (0.00%)
         occurrences all number
    0
    0
    2
    0
    0
    2
    0
    0
    Reproductive system and breast disorders
    Oligomenorrhoea
         subjects affected / exposed
    0 / 126 (0.00%)
    0 / 242 (0.00%)
    0 / 20 (0.00%)
    1 / 11 (9.09%)
    0 / 9 (0.00%)
    0 / 20 (0.00%)
    0 / 128 (0.00%)
    0 / 244 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    0
    0
    Skin and subcutaneous tissue disorders
    Dermal cyst
         subjects affected / exposed
    0 / 126 (0.00%)
    0 / 242 (0.00%)
    0 / 20 (0.00%)
    1 / 11 (9.09%)
    0 / 9 (0.00%)
    0 / 20 (0.00%)
    0 / 128 (0.00%)
    0 / 244 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    0
    0
    Eczema
         subjects affected / exposed
    0 / 126 (0.00%)
    4 / 242 (1.65%)
    1 / 20 (5.00%)
    1 / 11 (9.09%)
    0 / 9 (0.00%)
    1 / 20 (5.00%)
    0 / 128 (0.00%)
    4 / 244 (1.64%)
         occurrences all number
    0
    4
    1
    1
    0
    1
    0
    4
    Musculoskeletal and connective tissue disorders
    Intervertebral disc protrusion
         subjects affected / exposed
    0 / 126 (0.00%)
    1 / 242 (0.41%)
    0 / 20 (0.00%)
    1 / 11 (9.09%)
    0 / 9 (0.00%)
    0 / 20 (0.00%)
    0 / 128 (0.00%)
    1 / 244 (0.41%)
         occurrences all number
    0
    1
    0
    1
    0
    0
    0
    1
    Musculoskeletal pain
         subjects affected / exposed
    0 / 126 (0.00%)
    0 / 242 (0.00%)
    1 / 20 (5.00%)
    1 / 11 (9.09%)
    0 / 9 (0.00%)
    1 / 20 (5.00%)
    3 / 128 (2.34%)
    3 / 244 (1.23%)
         occurrences all number
    0
    0
    1
    1
    0
    1
    3
    3
    Musculoskeletal stiffness
         subjects affected / exposed
    0 / 126 (0.00%)
    1 / 242 (0.41%)
    1 / 20 (5.00%)
    1 / 11 (9.09%)
    0 / 9 (0.00%)
    1 / 20 (5.00%)
    0 / 128 (0.00%)
    1 / 244 (0.41%)
         occurrences all number
    0
    1
    1
    1
    0
    1
    0
    1
    Synovial cyst
         subjects affected / exposed
    0 / 126 (0.00%)
    1 / 242 (0.41%)
    0 / 20 (0.00%)
    1 / 11 (9.09%)
    0 / 9 (0.00%)
    0 / 20 (0.00%)
    0 / 128 (0.00%)
    1 / 244 (0.41%)
         occurrences all number
    0
    1
    0
    1
    0
    0
    0
    1
    Axial spondyloarthritis
         subjects affected / exposed
    2 / 126 (1.59%)
    2 / 242 (0.83%)
    2 / 20 (10.00%)
    0 / 11 (0.00%)
    0 / 9 (0.00%)
    2 / 20 (10.00%)
    0 / 128 (0.00%)
    2 / 244 (0.82%)
         occurrences all number
    2
    2
    2
    0
    0
    2
    0
    2
    Infections and infestations
    Nasopharyngitis
         subjects affected / exposed
    6 / 126 (4.76%)
    18 / 242 (7.44%)
    0 / 20 (0.00%)
    1 / 11 (9.09%)
    0 / 9 (0.00%)
    0 / 20 (0.00%)
    13 / 128 (10.16%)
    30 / 244 (12.30%)
         occurrences all number
    6
    21
    0
    1
    0
    0
    13
    34
    Upper respiratory tract infection
         subjects affected / exposed
    10 / 126 (7.94%)
    15 / 242 (6.20%)
    4 / 20 (20.00%)
    3 / 11 (27.27%)
    1 / 9 (11.11%)
    3 / 20 (15.00%)
    9 / 128 (7.03%)
    23 / 244 (9.43%)
         occurrences all number
    11
    17
    4
    5
    1
    3
    9
    26
    Corona virus infection
         subjects affected / exposed
    1 / 126 (0.79%)
    17 / 242 (7.02%)
    4 / 20 (20.00%)
    0 / 11 (0.00%)
    0 / 9 (0.00%)
    4 / 20 (20.00%)
    1 / 128 (0.78%)
    17 / 244 (6.97%)
         occurrences all number
    1
    17
    4
    0
    0
    4
    1
    18
    Helicobacter infection
         subjects affected / exposed
    0 / 126 (0.00%)
    0 / 242 (0.00%)
    2 / 20 (10.00%)
    0 / 11 (0.00%)
    1 / 9 (11.11%)
    1 / 20 (5.00%)
    0 / 128 (0.00%)
    0 / 244 (0.00%)
         occurrences all number
    0
    0
    2
    0
    1
    1
    0
    0
    Oral candidiasis
         subjects affected / exposed
    0 / 126 (0.00%)
    17 / 242 (7.02%)
    0 / 20 (0.00%)
    0 / 11 (0.00%)
    0 / 9 (0.00%)
    0 / 20 (0.00%)
    4 / 128 (3.13%)
    18 / 244 (7.38%)
         occurrences all number
    0
    20
    0
    0
    0
    0
    5
    25
    Urinary tract infection
         subjects affected / exposed
    2 / 126 (1.59%)
    4 / 242 (1.65%)
    1 / 20 (5.00%)
    0 / 11 (0.00%)
    1 / 9 (11.11%)
    0 / 20 (0.00%)
    3 / 128 (2.34%)
    7 / 244 (2.87%)
         occurrences all number
    2
    6
    1
    0
    1
    0
    3
    9
    Tinea versicolour
         subjects affected / exposed
    0 / 126 (0.00%)
    0 / 242 (0.00%)
    2 / 20 (10.00%)
    0 / 11 (0.00%)
    1 / 9 (11.11%)
    1 / 20 (5.00%)
    0 / 128 (0.00%)
    0 / 244 (0.00%)
         occurrences all number
    0
    0
    2
    0
    1
    1
    0
    0
    Tinea pedis
         subjects affected / exposed
    0 / 126 (0.00%)
    1 / 242 (0.41%)
    2 / 20 (10.00%)
    0 / 11 (0.00%)
    1 / 9 (11.11%)
    1 / 20 (5.00%)
    0 / 128 (0.00%)
    1 / 244 (0.41%)
         occurrences all number
    0
    1
    2
    0
    1
    1
    0
    1
    Metabolism and nutrition disorders
    Hypercholesterolaemia
         subjects affected / exposed
    2 / 126 (1.59%)
    2 / 242 (0.83%)
    2 / 20 (10.00%)
    0 / 11 (0.00%)
    1 / 9 (11.11%)
    1 / 20 (5.00%)
    2 / 128 (1.56%)
    3 / 244 (1.23%)
         occurrences all number
    2
    2
    4
    0
    2
    2
    2
    4
    Hyperlipidaemia
         subjects affected / exposed
    0 / 126 (0.00%)
    3 / 242 (1.24%)
    1 / 20 (5.00%)
    0 / 11 (0.00%)
    1 / 9 (11.11%)
    0 / 20 (0.00%)
    0 / 128 (0.00%)
    3 / 244 (1.23%)
         occurrences all number
    0
    3
    1
    0
    1
    0
    0
    3

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    Substantial protocol amendments (globally)

    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    11 Sep 2019
    Protocol Amendment 1 (11 Sep 2019) implemented changes in response to scientific discussions and feedback provided at meetings with Investigators and advisors or for clarifications. Mainly, imaging assessments were amended with sacroiliac joints and spine MRIs performed at Weeks 16 and 52 for all consenting study participants participating in the MRI substudy regardless of MRI positivity at Baseline. These additional MRIs allowed an exploratory evaluation of any changes in the sacroiliac joints or spine after 16 or 52 weeks in study participants who were MRI-negative at Baseline and on early signals such as the impact on erosions and fatty lesions at Week 16. Additionally, including MRI-positive and MRI-negative study participants in the substudy was considered a more holistic strategy comparable to the approach used for other compounds. At the same time, the number of participating study participants was expanded to include study participants in the substudy without restriction.
    17 Oct 2019
    Protocol Amendment 2 (17 Oct 2019) was implemented to update Inclusion Criterion to reflect the treatment guidelines for axSpA, as presented in the recent European League Against Rheumatism/ASAS and American College of Rheumatology/Spondyloarthritis Research and Treatment Network guidelines. In addition, a minor update for consistency was made.
    16 Feb 2021
    Protocol Amendment 4 (16 Feb 2021) updated the handling of missing data for the statistical analysis of the primary endpoint in response to an agency request. The COVID-19 Free Set (CFS) was added in response to industry recommendations for evaluating the impact of the pandemic. In addition, other previously planned supportive analyses defined in the Statistical Analysis Plan (SAP) were added for completeness.

    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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