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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 ANKYLOSING SPONDYLITIS

    Summary
    EudraCT number
    2017-003065-95
    Trial protocol
    DE   BE   HU   GB   BG   FR   ES   CZ   NL  
    Global end of trial date
    08 Aug 2022

    Results information
    Results version number
    v1(current)
    This version publication date
    19 Aug 2023
    First version publication date
    19 Aug 2023
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    AS0011
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    NCT03928743
    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
    UCB BIOSCIENCES GmbH, Clin Trial Reg & Results Disclosure, clinicaltrials@ucb.com
    Scientific contact
    Clin Trial Reg & Results Disclosure, UCB BIOSCIENCES GmbH, clinicaltrials@ucb.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    09 Sep 2022
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    03 Sep 2021
    Global end of trial reached?
    Yes
    Global end of trial date
    08 Aug 2022
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    Demonstrate the efficacy of bimekizumab administered subcutaneously (sc) compared to placebo in the treatment of subjects with active ankylosing spondylitis (AS)
    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
    United Kingdom: 12
    Country: Number of subjects enrolled
    United States: 9
    Country: Number of subjects enrolled
    Belgium: 10
    Country: Number of subjects enrolled
    Bulgaria: 15
    Country: Number of subjects enrolled
    China: 44
    Country: Number of subjects enrolled
    Czechia: 56
    Country: Number of subjects enrolled
    France: 4
    Country: Number of subjects enrolled
    Germany: 37
    Country: Number of subjects enrolled
    Hungary: 5
    Country: Number of subjects enrolled
    Japan: 12
    Country: Number of subjects enrolled
    Netherlands: 2
    Country: Number of subjects enrolled
    Poland: 87
    Country: Number of subjects enrolled
    Spain: 34
    Country: Number of subjects enrolled
    Turkey: 5
    Worldwide total number of subjects
    332
    EEA total number of subjects
    250
    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)
    321
    From 65 to 84 years
    11
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    The study started to enroll study participants in April 2019 and concluded in August 2022.

    Pre-assignment
    Screening details
    The Participant Flow refers to the Randomized Set.

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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    Placebo (up to Week 16)
    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)
    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.

    Number of subjects in period 1
    Placebo (up to Week 16) Bimekizumab 160 mg Q4W (up to Week 16)
    Started
    111
    221
    Completed
    109
    213
    Not completed
    2
    8
         Due To COVID-19 Pandemic and Site Restrictions
    1
    1
         Consent withdrawn by subject
    1
    3
         Adverse Event, serious non-fatal
    -
    1
         Adverse event
    -
    2
         Lack of efficacy
    -
    1
    Period 2
    Period 2 title
    Maintenance Period: Weeks 16-52
    Is this the baseline period?
    No
    Allocation method
    Randomised - controlled
    Blinding used
    Double blind
    Roles blinded
    Subject, Investigator, Carer, Assessor

    Arms
    Arm title
    Bimekizumab 160 mg Q4W (Week 16 up to Week 52)
    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 received bimekizumab 160 mg Q4W subcutaneously from Week 16 until Week 48.
    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 [1]
    Bimekizumab 160 mg Q4W (Week 16 up to Week 52)
    Started
    319
    Completed
    298
    Not completed
    21
         Consent withdrawn by subject
    4
         Adverse Event, serious non-fatal
    2
         Adverse event
    9
         Lost to follow-up
    2
         PI Decision Due To Non-Compliance and COVID 19
    1
         Lack of efficacy
    3
    Notes
    [1] - The number of subjects starting the period is not consistent with the number completing the preceding period. It is expected the number of subjects starting the subsequent period will be the same as the number completing the preceding period.
    Justification: 3 participants completed the Double blind treatment period but did not enter the Maintenance Period because of the below reason for discontinuation: Adverse event: 1; Withdrawal by study participants: 2

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Placebo (up to Week 16)
    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)
    Reporting group description
    Participants received bimekizumab 160 mg Q4W subcutaneously until Week 16.

    Reporting group values
    Placebo (up to Week 16) Bimekizumab 160 mg Q4W (up to Week 16) Total
    Number of subjects
    111 221 332
    Age Categorical
    Units: participants
        <=18 years
    0 0 0
        Between 18 and 65 years
    109 212 321
        >=65 years
    2 9 11
    Age Continuous
    Units: years
        arithmetic mean (standard deviation)
    39.2 ± 12.6 41.0 ± 12.1 -
    Sex: Female, Male
    Units: participants
        Female
    31 61 92
        Male
    80 160 240
    Subject analysis sets

    Subject analysis set title
    Double Blind Treatment Period (up to Week 16): Placebo
    Subject analysis set type
    Safety analysis
    Subject analysis set description
    Participants received placebo matched to bimekizumab 160 mg Q4W subcutaneously until Week 16.

    Subject analysis set title
    Double Blind Treatment Period(up to Week 16):Bimekizumab160 mg
    Subject analysis set type
    Safety analysis
    Subject analysis set description
    Participants received bimekizumab 160 mg Q4W subcutaneously until Week 16.

    Subject analysis set title
    Maintenance Period (Weeks 16 to 52): Bimekizumab 160 mg
    Subject analysis set type
    Safety analysis
    Subject analysis set 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. All Participants received bimekizumab 160 mg Q4W subcutaneously from Week 16 until Week 48.

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

    Subject analysis sets values
    Double Blind Treatment Period (up to Week 16): Placebo Double Blind Treatment Period(up to Week 16):Bimekizumab160 mg Maintenance Period (Weeks 16 to 52): Bimekizumab 160 mg Overall Period (up to Week 48+20 Weeks SFU):Bimekizumab 160 mg
    Number of subjects
    111
    221
    319
    330
    Age Categorical
    Units: participants
        <=18 years
        Between 18 and 65 years
        >=65 years
    Age Continuous
    Units: years
        arithmetic mean (standard deviation)
    43.2 ±
    54.3 ±
    68.3 ±
    ±
    Sex: Female, Male
    Units: participants
        Female
        Male

    End points

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    End points reporting groups
    Reporting group title
    Placebo (up to Week 16)
    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)
    Reporting group description
    Participants received bimekizumab 160 mg Q4W subcutaneously until Week 16.
    Reporting group title
    Bimekizumab 160 mg Q4W (Week 16 up to Week 52)
    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 received bimekizumab 160 mg Q4W subcutaneously from Week 16 until Week 48.

    Subject analysis set title
    Double Blind Treatment Period (up to Week 16): Placebo
    Subject analysis set type
    Safety analysis
    Subject analysis set description
    Participants received placebo matched to bimekizumab 160 mg Q4W subcutaneously until Week 16.

    Subject analysis set title
    Double Blind Treatment Period(up to Week 16):Bimekizumab160 mg
    Subject analysis set type
    Safety analysis
    Subject analysis set description
    Participants received bimekizumab 160 mg Q4W subcutaneously until Week 16.

    Subject analysis set title
    Maintenance Period (Weeks 16 to 52): Bimekizumab 160 mg
    Subject analysis set type
    Safety analysis
    Subject analysis set 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. All Participants received bimekizumab 160 mg Q4W subcutaneously from Week 16 until Week 48.

    Subject analysis set title
    Overall Period (up to Week 48+20 Weeks SFU):Bimekizumab 160 mg
    Subject analysis set type
    Safety analysis
    Subject analysis set description
    Participants who received bimekizumab 160 mg Q4W subcutaneously from Day 1 and participants who switched from placebo arm at Week 16 to receive bimekizumab 160 mg Q4W subcutaneously 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: relative improvement of at least 40% and absolute improvement of at least 2 units on a 0 to 10 Numeric Rating Scale (NRS), where 0 (not active) and 10 (very active) in at least 3 of 4 domains:Patient's Global Assessment of Disease Activity (PGADA) assessed disease activity on a scale of 0 [not active] to 10 [very active], higher score=more disease activity, Pain assessment on a scale of 0 [no pain] to 10 [most severe pain], higher score=more severity), Function (Bath Ankylosing Spondylitis Functional Index (BASFI)) assessed participant's level of ability on a scale of 0 [easy] to 10 [impossible], Inflammation (morning stiffness intensity and duration, mean of Q5 and Q6 of Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) defined as 6 item questionnaire: measured disease activity on a scale of 0 [none] to 10 [severe], higher score=more disease activity) and no worsening at all in remaining domain.Randomized Set consisted of all randomized study participants.
    End point type
    Primary
    End point timeframe
    Week 16
    End point values
    Placebo (up to Week 16) Bimekizumab 160 mg Q4W (up to Week 16)
    Number of subjects analysed
    111
    221
    Units: percentage of participants
        number (not applicable)
    22.5
    44.8
    Statistical analysis title
    Statistical Analysis 1
    Comparison groups
    Placebo (up to Week 16) v Bimekizumab 160 mg Q4W (up to Week 16)
    Number of subjects included in analysis
    332
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.001
    Method
    Regression, Logistic
    Parameter type
    Odds ratio (OR)
    Point estimate
    2.88
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    1.71
         upper limit
    4.87

    Secondary: Percentage of Participants With Assessment of SpondyloArthritis International Society 40% response criteria (ASAS40) response in TNFα inhibitor-naïve participants 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 participants at Week 16
    End point description
    ASAS40 response was defined as relative improvement of at least 40% and absolute improvement of at least 2 units on a 0 to 10 NRS, where 0 (not active) and 10 (very active) in at least 3 of the 4 domains: PGADA assessed disease activity on a scale of 0 [not active] to 10 [very active], higher score=more disease activity, Pain assessment on a scale of 0 [no pain] to 10 [most severe pain], higher score=more severity), Function (BASFI) assessed participant's level of ability on a scale of 0 [easy] to 10 [impossible], Inflammation (morning stiffness intensity and duration, mean of Q5 and Q6 of BASDAI defined as 6 item questionnaire: measured disease activity on a scale of 0 [none] to 10 [severe], higher score=more disease activity) and no worsening at all in the remaining domain. The Randomized Set consisted of all randomized study participants. Here, Number of Participants Analyzed signifies those who were evaluable for this outcome measure.
    End point type
    Secondary
    End point timeframe
    Week 16
    End point values
    Placebo (up to Week 16) Bimekizumab 160 mg Q4W (up to Week 16)
    Number of subjects analysed
    94
    184
    Units: percentage of participants
        number (not applicable)
    23.4
    45.7
    Statistical analysis title
    Statistical Analysis 1
    Comparison groups
    Placebo (up to Week 16) v Bimekizumab 160 mg Q4W (up to Week 16)
    Number of subjects included in analysis
    278
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.001
    Method
    Regression, Logistic
    Parameter type
    Odds ratio (OR)
    Point estimate
    2.8
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    1.59
         upper limit
    4.93

    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 was defined as relative improvements of at least 20% and absolute improvement of at least 1 unit on a 0 to 10 NRS, where 0 (not active) and 10 (very active) in at least 3 of the 4 domains: PGADA assessed disease activity on a scale of 0 [not active] to 10 [very active], higher score=more disease activity, Pain assessment on a scale of 0 [no pain] to 10 [most severe pain], higher score=more severity), Function (BASFI) assessed participant's level of ability on a scale of 0 [easy] to 10 [impossible], Inflammation (morning stiffness intensity and duration, mean of Q5 and Q6 of BASDAI defined as 6 item questionnaire: measured disease activity on a scale of 0 [none] to 10 [severe], higher score=more disease activity) and no worsening at all in the remaining domain. 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) Bimekizumab 160 mg Q4W (up to Week 16)
    Number of subjects analysed
    111
    221
    Units: percentage of participants
        number (not applicable)
    43.2
    66.1
    Statistical analysis title
    Statistical Analysis 1
    Comparison groups
    Placebo (up to Week 16) v Bimekizumab 160 mg Q4W (up to Week 16)
    Number of subjects included in analysis
    332
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.001
    Method
    Regression, Logistic
    Parameter type
    Odds ratio (OR)
    Point estimate
    2.66
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    1.65
         upper limit
    4.28

    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 validated self-reported instrument, which consisted of 6 questions to measure the disease activity of ankylosing spondylitis (AS) from the participant's perspective. It measured the severity of fatigue, spinal and peripheral joint pain and swelling, enthesitis, and morning stiffness (both severity and duration). Each question was rated using a numerical rating scale from 0 (none) to 10 (very severe), higher score=high disease activity. The BASDAI score was calculated by computing the mean of questions 5 and 6 and adding it to the sum of questions 1 to 4. This score was then divided by 5. The total BASDAI score was ranged from 0=none to 10= very severe, where higher score indicated high disease activity. A negative value indicated improvement and a positive value indicated worsening. 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) Bimekizumab 160 mg Q4W (up to Week 16)
    Number of subjects analysed
    111
    221
    Units: scores on a scale
        least squares mean (standard error)
    -1.70 ± 0.21
    -2.74 ± 0.17
    Statistical analysis title
    Statistical Analysis 1
    Comparison groups
    Placebo (up to Week 16) v Bimekizumab 160 mg Q4W (up to Week 16)
    Number of subjects included in analysis
    332
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.001
    Method
    Regression, Logistic
    Parameter type
    LS Mean difference
    Point estimate
    -1.04
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -1.48
         upper limit
    -0.59

    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 was defined as a score of less than or equal to (<=) 2 units (on a scale of 0-10, where 0=no disease activity and 10=high disease activity) in each of the 4 domains. These 4 domains included: PGADA assessed disease activity on a scale of 0 [not active] to 10 [very active], higher score=more disease activity, Pain assessment on a scale of 0 [no pain] to 10 [most severe pain], higher score=more severity), Function (BASFI) assessed participant's level of ability on a scale of 0 [easy] to 10 [impossible], Inflammation (morning stiffness intensity and duration, mean of Q5 and Q6 of BASDAI defined as 6 item questionnaire: measured disease activity on a scale of 0 [none] to 10 [severe], higher score=more disease activity). 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) Bimekizumab 160 mg Q4W (up to Week 16)
    Number of subjects analysed
    111
    221
    Units: percentage of participants
        number (not applicable)
    7.2
    24.0
    Statistical analysis title
    Statistical Analysis 1
    Comparison groups
    Placebo (up to Week 16) v Bimekizumab 160 mg Q4W (up to Week 16)
    Number of subjects included in analysis
    332
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.001
    Method
    Regression, Logistic
    Parameter type
    Odds ratio (OR)
    Point estimate
    4.26
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    1.93
         upper limit
    9.39

    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) of greater than or equal to (>=) 2.0 in the Ankylosing Spondylitis Disease Activity Score (ASDAS) relative to Baseline. ASDAS is calculated as the sum of the following components: 1) 0.121 × Total back pain (Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Q2 result), 2) 0.058 × Duration of morning stiffness (BASDAI Q6 result), 3) 0.110 × Patient's Global Assessment of Disease Activity (PGADA), 4) 0.073 × Peripheral pain/swelling (BASDAI Q3 result), 5) 0.579 × (natural logarithm of the C-reactive protein (CRP) [mg/L] + 1). Total back pain, PGADA, duration of morning stiffness, peripheral pain/swelling and fatigue are all assessed on a numerical scale (0 to 10 units). High ASDAS scores mean worse disease. If a participant achieves the ASDAS-MI it indicates a major improvement of 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) Bimekizumab 160 mg Q4W (up to Week 16)
    Number of subjects analysed
    111
    221
    Units: percentage of participants
        number (not applicable)
    5.4
    25.8
    Statistical analysis title
    Statistical Analysis 1
    Comparison groups
    Placebo (up to Week 16) v Bimekizumab 160 mg Q4W (up to Week 16)
    Number of subjects included in analysis
    332
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.001
    Method
    Regression, Logistic
    Parameter type
    Odds ratio (OR)
    Point estimate
    6.47
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    2.67
         upper limit
    15.65

    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
    The Assessment of SpondyloArthritis International Society (ASAS) 5/6 response is defined as achieving at least 20% improvement in 5 of 6 domains: PGADA assessed disease activity on a scale of 0 [not active] to 10 [very active], higher score=more disease activity, Pain assessment on a scale of 0 [no pain] to 10 [most severe pain], higher score=more severity), Function (BASFI) assessed participant's level of ability on a scale of 0 [easy] to 10 [impossible], Inflammation (morning stiffness intensity and duration, mean of Q5 and Q6 of BASDAI defined as 6 item questionnaire: measured disease activity on a scale of 0 [none] to 10 [severe], higher score=more disease activity), spinal mobility (lateral spinal flexion) and high sensitivity C-reactive protein (hs-CRP)]. 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) Bimekizumab 160 mg Q4W (up to Week 16)
    Number of subjects analysed
    111
    221
    Units: percentage of participants
        number (not applicable)
    18.9
    49.3
    Statistical analysis title
    Statistical Analysis 1
    Comparison groups
    Placebo (up to Week 16) v Bimekizumab 160 mg Q4W (up to Week 16)
    Number of subjects included in analysis
    332
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.001
    Method
    Regression, Logistic
    Parameter type
    Odds ratio (OR)
    Point estimate
    4.65
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    2.51
         upper limit
    7.57

    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 Bath Ankylosing Spondylitis Functional Index (BASFI) assesses physical function in comprising 10 items relating to activities during the past week. Each item ranged from 0 ('Easy') to 10 ('Impossible'). The BASFI is the mean of the 10 scores such that the total score ranges from 0 to 10, with lower scores indicating better physical function. A negative value in BASFI 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) Bimekizumab 160 mg Q4W (up to Week 16)
    Number of subjects analysed
    111
    221
    Units: scores on a scale
        least squares mean (standard error)
    -0.95 ± 0.20
    -2.00 ± 0.16
    Statistical analysis title
    Statistical Analysis 1
    Comparison groups
    Placebo (up to Week 16) v Bimekizumab 160 mg Q4W (up to Week 16)
    Number of subjects included in analysis
    332
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.001
    Method
    Regression, Logistic
    Parameter type
    LS Mean difference
    Point estimate
    -1.05
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -1.48
         upper limit
    -0.63

    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 ankylosing spondylitis (AS) participants is measured by one question: pain in the spine at night due to AS?. When responding, the participant is to consider the average amount of pain in the preceding week. It is assessed on a numerical scale of 0 to 10 units. A lower score indicates less pain and a negative change represents an 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) Bimekizumab 160 mg Q4W (up to Week 16)
    Number of subjects analysed
    111
    221
    Units: scores on a scale
        least squares mean (standard error)
    -1.68 ± 0.25
    -3.16 ± 0.20
    Statistical analysis title
    Statistical Analysis 1
    Comparison groups
    Placebo (up to Week 16) v Bimekizumab 160 mg Q4W (up to Week 16)
    Number of subjects included in analysis
    332
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.001
    Method
    Regression, Logistic
    Parameter type
    LS Mean difference
    Point estimate
    -1.48
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -2
         upper limit
    -0.96

    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
    The SF-36 is a 36-item health-related quality of life instrument that uses a recall period of 4 weeks. Items are grouped into 8 domains as follows: 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), and 1 item for perceived stability or change in health (Health Transition) during the last year. In addition to domain scores, the PCS and Mental Component Summary (MCS) scores are calculated from the 8 domains (excluding the Health Transition item). Each of the SF-36 derived raw scores range from 0 to 100 with a higher score indicating better function. The 2 component summary scores and the 8 domains scores are standardized with a mean of 50 and a standard deviation of 10 in the general US population (Maruish, 2011). A positive change reflects 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) Bimekizumab 160 mg Q4W (up to Week 16)
    Number of subjects analysed
    111
    221
    Units: scores on a scale
        least squares mean (standard error)
    5.17 ± 0.82
    8.54 ± 0.67
    Statistical analysis title
    Statistical Analysis 1
    Comparison groups
    Placebo (up to Week 16) v Bimekizumab 160 mg Q4W (up to Week 16)
    Number of subjects included in analysis
    332
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.001
    Method
    Regression, Logistic
    Parameter type
    LS Mean difference
    Point estimate
    3.38
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    1.67
         upper limit
    5.09

    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), a validated disease-specific 18-item questionnaire, has been developed specifically for measuring health-related quality of life (HRQoL) in participants with ankylosing spondylitis and has shown to be responsive in axial spondyloarthritis (axSpA). Each statement on the ASQoL is given a score of 1=Yes or 0=No. A score of "1" was given where the item was affirmed, indicating adverse quality of life. All item scores were summed to generate the total score ranging from 0 to 18 with a higher score indicating worse health-related quality of life. A negative change from baseline represents an 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) Bimekizumab 160 mg Q4W (up to Week 16)
    Number of subjects analysed
    111
    221
    Units: scores on a scale
        least squares mean (standard error)
    -3.07 ± 0.41
    -4.59 ± 0.32
    Statistical analysis title
    Statistical Analysis 1
    Comparison groups
    Placebo (up to Week 16) v Bimekizumab 160 mg Q4W (up to Week 16)
    Number of subjects included in analysis
    332
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.001
    Method
    Regression, Logistic
    Parameter type
    LS Mean difference
    Point estimate
    -1.52
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -2.36
         upper limit
    -0.68

    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 Bath Ankylosing Spondylitis Disease Metrology Index 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) Bimekizumab 160 mg Q4W (up to Week 16)
    Number of subjects analysed
    111
    221
    Units: scores on a scale
        least squares mean (standard error)
    -0.17 ± 0.09
    -0.45 ± 0.07
    Statistical analysis title
    Statistical Analysis 1
    Comparison groups
    Placebo (up to Week 16) v Bimekizumab 160 mg Q4W (up to Week 16)
    Number of subjects included in analysis
    332
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.006
    Method
    Regression, Logistic
    Parameter type
    LS Mean difference
    Point estimate
    -0.28
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -0.47
         upper limit
    -0.08

    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. Subset of study participants in Randomized Set with enthesitis at Baseline.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 16
    End point values
    Placebo (up to Week 16) Bimekizumab 160 mg Q4W (up to Week 16)
    Number of subjects analysed
    67
    132
    Units: scores on a scale
        least squares mean (standard error)
    -1.04 ± 0.33
    -2.12 ± 0.26
    Statistical analysis title
    Statistical Analysis 1
    Comparison groups
    Placebo (up to Week 16) v Bimekizumab 160 mg Q4W (up to Week 16)
    Number of subjects included in analysis
    199
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.003
    Method
    Regression, Logistic
    Parameter type
    LS Mean difference
    Point estimate
    -1.08
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -1.79
         upper limit
    -0.38

    Secondary: Percentage of Participants With Enthesitis-free state at Week 16 based on the Maastricht Ankylosing Spondylitis Enthesitis 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 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. Subset of study participants in Randomized Set with enthesitis at Baseline.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 16
    End point values
    Placebo (up to Week 16) Bimekizumab 160 mg Q4W (up to Week 16)
    Number of subjects analysed
    67
    132
    Units: percentage of participants
        number (not applicable)
    32.8
    51.5
    Statistical analysis title
    Statistical Analysis 1
    Comparison groups
    Placebo (up to Week 16) v Bimekizumab 160 mg Q4W (up to Week 16)
    Number of subjects included in analysis
    199
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.006
    Method
    Regression, Logistic
    Parameter type
    Odds ratio (OR)
    Point estimate
    2.47
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    1.3
         upper limit
    4.68

    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) period). TEAEs were analyzed and reported for DBTP (Safety set), MP (Maintenance Set) and Overall Period (Safety set) which includes all participants who received BKZ 60 mg Q4W during the study. The Safety Set consisted of all randomized study participants who received at least one dose of the IMP.
    End point type
    Secondary
    End point timeframe
    From Baseline (Day 1) until Safety-Follow-Up (up to Week 68)
    End point values
    Double Blind Treatment Period (up to Week 16): Placebo Double Blind Treatment Period(up to Week 16):Bimekizumab160 mg Maintenance Period (Weeks 16 to 52): Bimekizumab 160 mg Overall Period (up to Week 48+20 Weeks SFU):Bimekizumab 160 mg
    Number of subjects analysed
    111
    221
    319
    330
    Units: percentage of participants
        number (not applicable)
    43.2
    54.3
    68.3
    75.8
    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
    A serious adverse event (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 1 of the other outcomes listed in the definition of serious (Important medical events may include, but are not limited to, potential Hy’s Law [see allergic bronchospasm requiring intensive treatment in an emergency room or at home, blood dyscrasias that do not result in inpatient hospitalization, or the development of drug dependency or drug abuse.) The Safety Set consisted of all randomized study participants who received at least one dose of the IMP.
    End point type
    Secondary
    End point timeframe
    From Baseline (Day 1) until Safety-Follow-Up (up to Week 68)
    End point values
    Double Blind Treatment Period (up to Week 16): Placebo Double Blind Treatment Period(up to Week 16):Bimekizumab160 mg Maintenance Period (Weeks 16 to 52): Bimekizumab 160 mg Overall Period (up to Week 48+20 Weeks SFU):Bimekizumab 160 mg
    Number of subjects analysed
    111
    221
    319
    330
    Units: percentage of participants
        number (not applicable)
    0.9
    2.3
    4.7
    6.1
    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 Safety Set consisted of all randomized study participants who received at least one dose of the IMP.
    End point type
    Secondary
    End point timeframe
    From Baseline (Day 1) until Safety-Follow-Up (up to Week 68)
    End point values
    Double Blind Treatment Period (up to Week 16): Placebo Double Blind Treatment Period(up to Week 16):Bimekizumab160 mg Maintenance Period (Weeks 16 to 52): Bimekizumab 160 mg Overall Period (up to Week 48+20 Weeks SFU):Bimekizumab 160 mg
    Number of subjects analysed
    111
    221
    319
    330
    Units: percentage of participants
        number (not applicable)
    0
    3.2
    2.8
    4.8
    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 pre-specified in SAP, Maintenance Period (MP) included AEs of SFU for participants who did not enter the open label extension or discontinued early in MP. TEAEs were analyzed and reported for DBTP (Safety set), MP (Maintenance Set) and Overall Period (Safety set) which includes all participants who received BKZ 60 mg Q4W during the study.
    Assessment type
    Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    19.0
    Reporting groups
    Reporting group title
    Double Blind Treatment Period (up to Week 16): Placebo
    Reporting group description
    Participants received placebo matched to bimekizumab 160 mg Q4W subcutaneously until Week 16.

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

    Reporting group title
    Maintenance Period (Weeks 16 to 52): Bimekizumab 160 mg
    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. All Participants received bimekizumab 160 mg Q4W subcutaneously from Week 16 until Week 48.

    Reporting group title
    Double Blind Treatment Period(up to Week 16):Bimekizumab160 mg
    Reporting group description
    Participants received bimekizumab 160 mg Q4W subcutaneously until Week 16.

    Serious adverse events
    Double Blind Treatment Period (up to Week 16): Placebo Overall Period (up to Week 48+20 Weeks SFU):Bimekizumab 160 mg Maintenance Period (Weeks 16 to 52): Bimekizumab 160 mg Double Blind Treatment Period(up to Week 16):Bimekizumab160 mg
    Total subjects affected by serious adverse events
         subjects affected / exposed
    1 / 111 (0.90%)
    20 / 330 (6.06%)
    15 / 319 (4.70%)
    5 / 221 (2.26%)
         number of deaths (all causes)
    0
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Uterine leiomyoma
         subjects affected / exposed
    0 / 111 (0.00%)
    1 / 330 (0.30%)
    1 / 319 (0.31%)
    0 / 221 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Superficial spreading melanoma stage I
         subjects affected / exposed
    0 / 111 (0.00%)
    1 / 330 (0.30%)
    1 / 319 (0.31%)
    0 / 221 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Radius fracture
         subjects affected / exposed
    0 / 111 (0.00%)
    1 / 330 (0.30%)
    1 / 319 (0.31%)
    0 / 221 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cardiac disorders
    Sinus node dysfunction
         subjects affected / exposed
    0 / 111 (0.00%)
    1 / 330 (0.30%)
    1 / 319 (0.31%)
    0 / 221 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Surgical and medical procedures
    Rhinoplasty
         subjects affected / exposed
    0 / 111 (0.00%)
    1 / 330 (0.30%)
    1 / 319 (0.31%)
    0 / 221 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Nervous system disorders
    Syncope
         subjects affected / exposed
    0 / 111 (0.00%)
    4 / 330 (1.21%)
    4 / 319 (1.25%)
    0 / 221 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 4
    1 / 4
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Crohn's disease
         subjects affected / exposed
    0 / 111 (0.00%)
    1 / 330 (0.30%)
    0 / 319 (0.00%)
    1 / 221 (0.45%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Colitis ulcerative
         subjects affected / exposed
    0 / 111 (0.00%)
    1 / 330 (0.30%)
    0 / 319 (0.00%)
    1 / 221 (0.45%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Ileus paralytic
         subjects affected / exposed
    0 / 111 (0.00%)
    1 / 330 (0.30%)
    1 / 319 (0.31%)
    0 / 221 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hiatus hernia
         subjects affected / exposed
    0 / 111 (0.00%)
    1 / 330 (0.30%)
    1 / 319 (0.31%)
    0 / 221 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hepatobiliary disorders
    Cholelithiasis
         subjects affected / exposed
    0 / 111 (0.00%)
    1 / 330 (0.30%)
    0 / 319 (0.00%)
    1 / 221 (0.45%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Psychiatric disorders
    Depression
         subjects affected / exposed
    1 / 111 (0.90%)
    0 / 330 (0.00%)
    0 / 319 (0.00%)
    0 / 221 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Suicidal ideation
         subjects affected / exposed
    0 / 111 (0.00%)
    1 / 330 (0.30%)
    1 / 319 (0.31%)
    0 / 221 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Endocrine disorders
    Goitre
         subjects affected / exposed
    0 / 111 (0.00%)
    1 / 330 (0.30%)
    0 / 319 (0.00%)
    1 / 221 (0.45%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Hepatitis A
         subjects affected / exposed
    0 / 111 (0.00%)
    1 / 330 (0.30%)
    0 / 319 (0.00%)
    1 / 221 (0.45%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Viral infection
         subjects affected / exposed
    1 / 111 (0.90%)
    0 / 330 (0.00%)
    0 / 319 (0.00%)
    0 / 221 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Diverticulitis
         subjects affected / exposed
    0 / 111 (0.00%)
    1 / 330 (0.30%)
    1 / 319 (0.31%)
    0 / 221 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Erysipelas
         subjects affected / exposed
    0 / 111 (0.00%)
    1 / 330 (0.30%)
    1 / 319 (0.31%)
    0 / 221 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Infectious pleural effusion
         subjects affected / exposed
    0 / 111 (0.00%)
    1 / 330 (0.30%)
    1 / 319 (0.31%)
    0 / 221 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Otitis media
         subjects affected / exposed
    0 / 111 (0.00%)
    1 / 330 (0.30%)
    1 / 319 (0.31%)
    0 / 221 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cellulitis
         subjects affected / exposed
    0 / 111 (0.00%)
    1 / 330 (0.30%)
    1 / 319 (0.31%)
    0 / 221 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    Double Blind Treatment Period (up to Week 16): Placebo Overall Period (up to Week 48+20 Weeks SFU):Bimekizumab 160 mg Maintenance Period (Weeks 16 to 52): Bimekizumab 160 mg Double Blind Treatment Period(up to Week 16):Bimekizumab160 mg
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    16 / 111 (14.41%)
    95 / 330 (28.79%)
    64 / 319 (20.06%)
    43 / 221 (19.46%)
    Nervous system disorders
    Headache
         subjects affected / exposed
    5 / 111 (4.50%)
    18 / 330 (5.45%)
    11 / 319 (3.45%)
    9 / 221 (4.07%)
         occurrences all number
    5
    23
    13
    10
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed
    1 / 111 (0.90%)
    18 / 330 (5.45%)
    12 / 319 (3.76%)
    7 / 221 (3.17%)
         occurrences all number
    1
    22
    15
    7
    Infections and infestations
    Oral candidiasis
         subjects affected / exposed
    0 / 111 (0.00%)
    20 / 330 (6.06%)
    12 / 319 (3.76%)
    10 / 221 (4.52%)
         occurrences all number
    0
    25
    14
    11
    Upper respiratory tract infection
         subjects affected / exposed
    8 / 111 (7.21%)
    21 / 330 (6.36%)
    16 / 319 (5.02%)
    6 / 221 (2.71%)
         occurrences all number
    11
    23
    17
    6
    Nasopharyngitis
         subjects affected / exposed
    4 / 111 (3.60%)
    30 / 330 (9.09%)
    17 / 319 (5.33%)
    17 / 221 (7.69%)
         occurrences all number
    4
    39
    18
    21

    More information

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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 joint 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 and spine after 16 or 52 weeks in study participants who were MRI-negative at Baseline and on early signals such as the impact on active inflammation 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 optional participation in the MRI substudy was expanded to all study participants without restriction.
    17 Oct 2019
    Protocol Amendment 2 (17 Oct 2019) implemented an update of 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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