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    Clinical Trial Results:
    A MULTICENTER, PHASE 2B, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP, DOSE-RANGING STUDY TO EVALUATE THE EFFICACY AND SAFETY OF BIMEKIZUMAB IN SUBJECTS WITH ACTIVE ANKYLOSING SPONDYLITIS

    Summary
    EudraCT number
    2016-001102-42
    Trial protocol
    HU   ES   CZ   DE   BG   GB  
    Global end of trial date
    30 Aug 2018

    Results information
    Results version number
    v1(current)
    This version publication date
    21 Sep 2019
    First version publication date
    21 Sep 2019
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    AS0008
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    NCT02963506
    WHO universal trial number (UTN)
    -
    Sponsors
    Sponsor organisation name
    UCB Biopharma SPRL
    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
    12 Feb 2019
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    30 Aug 2018
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    Assess the dose-response based on the efficacy of bimekizumab
    Protection of trial subjects
    During the conduct of the study all subjects were closely monitored.
    Background therapy
    Background therapy as permitted in the protocol.
    Evidence for comparator
    Not Applicable
    Actual start date of recruitment
    27 Oct 2016
    Long term follow-up planned
    Yes
    Long term follow-up rationale
    Safety
    Long term follow-up duration
    4 Years
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Spain: 9
    Country: Number of subjects enrolled
    Ukraine: 21
    Country: Number of subjects enrolled
    United States: 12
    Country: Number of subjects enrolled
    Bulgaria: 9
    Country: Number of subjects enrolled
    Canada: 2
    Country: Number of subjects enrolled
    Czech Republic: 96
    Country: Number of subjects enrolled
    Germany: 13
    Country: Number of subjects enrolled
    Hungary: 7
    Country: Number of subjects enrolled
    Poland: 100
    Country: Number of subjects enrolled
    Russian Federation: 34
    Worldwide total number of subjects
    303
    EEA total number of subjects
    234
    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)
    291
    From 65 to 84 years
    12
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    The study started to enroll participants in October 2016 and concluded in August 2018.

    Pre-assignment
    Screening details
    The study included a 28-Day Screening Period, followed by a Double-blind Period from Day 1 to Week 12, prior to treatment re-randomization, a Dose-blind Period, from Week 12 after the treatment re-randomization and up to Week 48 and a Safety Follow-Up (SFU) Period, post Week 48. The Participant Flow refers to the Randomized Set and Dose-Blind Set.

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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    Placebo
    Arm description
    Participants received placebo during the 12 weeks Double-Blind Period.
    Arm type
    Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    PBO
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Participants were administered placebo, as 2 subcutaneous injections, in the lateral abdominal wall, or upper outer thigh.

    Arm title
    BKZ 16 mg
    Arm description
    Participants received Bimekizumab (BKZ) 16 milligrams (mg) every 4 weeks (Q4W) during the 12 weeks Double-Blind Period.
    Arm type
    Experimental

    Investigational medicinal product name
    Bimekizumab
    Investigational medicinal product code
    BKZ
    Other name
    UCB4940
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Participants were administered different BKZ dose regimens, as 2 subcutaneous injections, in the lateral abdominal wall, or upper outer thigh.

    Arm title
    BKZ 64 mg
    Arm description
    Participants received Bimekizumab (BKZ) 64 mg every 4 weeks (Q4W) during the 12 weeks Double-Blind Period.
    Arm type
    Experimental

    Investigational medicinal product name
    Bimekizumab
    Investigational medicinal product code
    BKZ
    Other name
    UCB4940
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Participants were administered different BKZ dose regimens, as 2 subcutaneous injections, in the lateral abdominal wall, or upper outer thigh.

    Arm title
    BKZ 160 mg
    Arm description
    Participants received Bimekizumab (BKZ) 160 mg every 4 weeks (Q4W) during the 12 weeks Double-Blind Period followed by the same dose during the 36 weeks Dose-Blind Period.
    Arm type
    Experimental

    Investigational medicinal product name
    Bimekizumab
    Investigational medicinal product code
    BKZ
    Other name
    UCB4940
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Participants were administered different BKZ dose regimens, as 2 subcutaneous injections, in the lateral abdominal wall, or upper outer thigh.

    Arm title
    BKZ 320 mg
    Arm description
    Participants received Bimekizumab (BKZ) 320 mg every 4 weeks (Q4W) during the 12 weeks Double-Blind Period followed by the same dose during the 36 weeks Dose-Blind Period.
    Arm type
    Experimental

    Investigational medicinal product name
    Bimekizumab
    Investigational medicinal product code
    BKZ
    Other name
    UCB4940
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Participants were administered different BKZ dose regimens, as 2 subcutaneous injections, in the lateral abdominal wall, or upper outer thigh.

    Number of subjects in period 1
    Placebo BKZ 16 mg BKZ 64 mg BKZ 160 mg BKZ 320 mg
    Started
    60
    61
    61
    60
    61
    Completed Double-Blind Period
    60
    59
    59
    58
    61
    Completed Week 12 - started Dose-Blind
    60
    58
    59
    58
    61
    Completed
    60
    58
    59
    58
    61
    Not completed
    0
    3
    2
    2
    0
         Adverse event, serious fatal
    -
    -
    -
    1
    -
         Adverse event, non fatal after Wk12
    -
    1
    -
    -
    -
         No compliance
    -
    1
    -
    -
    -
         Adverse event, non-fatal
    -
    -
    1
    -
    -
         Consent withdrawn by subject
    -
    -
    1
    1
    -
         Lost to follow-up
    -
    1
    -
    -
    -
    Period 2
    Period 2 title
    Dose-Blind Period
    Is this the baseline period?
    No
    Allocation method
    Randomised - controlled
    Blinding used
    Double blind
    Roles blinded
    Assessor, Investigator, Subject

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    Placebo - BKZ 160 mg
    Arm description
    After the 12 weeks Double-Blind Period participants randomized to placebo were re-randomized to receive Bimekizumab (BKZ) 160 mg every 4 weeks (Q4W) for 36 weeks in the Dose-Blind Period.
    Arm type
    Experimental

    Investigational medicinal product name
    Bimekizumab
    Investigational medicinal product code
    BKZ
    Other name
    UCB4940
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Participants were administered different BKZ dose regimens, as 2 subcutaneous injections, in the lateral abdominal wall, or upper outer thigh.

    Arm title
    Placebo - BKZ 320 mg
    Arm description
    After the 12 weeks Double-Blind Period participants randomized to placebo were re-randomized to receive Bimekizumab (BKZ) 320 mg every 4 weeks (Q4W) for 36 weeks in the Dose-Blind Period
    Arm type
    Experimental

    Investigational medicinal product name
    Bimekizumab
    Investigational medicinal product code
    BKZ
    Other name
    UCB4940
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Participants were administered different BKZ dose regimens, as 2 subcutaneous injections, in the lateral abdominal wall, or upper outer thigh.

    Arm title
    BKZ 16 mg - BKZ 160 mg
    Arm description
    After the 12 weeks Double-Blind Period participants randomized to Bimekizumab (BKZ) 16 mg every 4 weeks (Q4W) were re-randomized to receive BKZ 160 mg Q4W for 36 weeks in the Dose-Blind Period.
    Arm type
    Experimental

    Investigational medicinal product name
    Bimekizumab
    Investigational medicinal product code
    BKZ
    Other name
    UCB4940
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Participants were administered different BKZ dose regimens, as 2 subcutaneous injections, in the lateral abdominal wall, or upper outer thigh.

    Arm title
    BKZ 16 mg - BKZ 320 mg
    Arm description
    After the 12 weeks Double-Blind Period participants randomized to Bimekizumab (BKZ) 16 mg every 4 weeks (Q4W) were re-randomized to receive BKZ 320 mg Q4W for 36 weeks in the Dose-Blind Period.
    Arm type
    Experimental

    Investigational medicinal product name
    Bimekizumab
    Investigational medicinal product code
    BKZ
    Other name
    UCB4940
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Participants were administered different BKZ dose regimens, as 2 subcutaneous injections, in the lateral abdominal wall, or upper outer thigh.

    Arm title
    BKZ 64 mg - BKZ 160 mg
    Arm description
    After the 12 weeks Double-Blind Period participants randomized to Bimekizumab (BKZ) 64 mg every 4 weeks (Q4W) were re-randomized to receive BKZ 160 mg Q4W for 36 weeks in the Dose-Blind Period.
    Arm type
    Experimental

    Investigational medicinal product name
    Bimekizumab
    Investigational medicinal product code
    BKZ
    Other name
    UCB4940
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Participants were administered different BKZ dose regimens, as 2 subcutaneous injections, in the lateral abdominal wall, or upper outer thigh.

    Arm title
    BKZ 64 mg - BKZ 320 mg
    Arm description
    After the 12 weeks Double-Blind Period participants randomized to Bimekizumab (BKZ) 64 mg every 4 weeks (Q4W) were re-randomized to receive BKZ 320 mg Q4W for 36 weeks in the Dose-Blind Period.
    Arm type
    Experimental

    Investigational medicinal product name
    Bimekizumab
    Investigational medicinal product code
    BKZ
    Other name
    UCB4940
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Participants were administered different BKZ dose regimens, as 2 subcutaneous injections, in the lateral abdominal wall, or upper outer thigh.

    Arm title
    BKZ 160 mg - BKZ 160 mg
    Arm description
    Participants randomized to Bimekizumab (BKZ) 160 mg every 4 weeks (Q4W) in the 12 weeks Double-Blind Period, continued to receive BKZ 160 mg Q4W in the 36 weeks Dose-Blind Period.
    Arm type
    Experimental

    Investigational medicinal product name
    Bimekizumab
    Investigational medicinal product code
    BKZ
    Other name
    UCB4940
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Participants were administered different BKZ dose regimens, as 2 subcutaneous injections, in the lateral abdominal wall, or upper outer thigh.

    Arm title
    BKZ 320 mg - BKZ 320 mg
    Arm description
    Participants randomized to Bimekizumab (BKZ) 320 mg every 4 weeks (Q4W) in the 12 weeks Double-Blind Period, continued to receive BKZ 320 mg Q4W in the 36 weeks Dose-Blind Period.
    Arm type
    Experimental

    Investigational medicinal product name
    Bimekizumab
    Investigational medicinal product code
    BKZ
    Other name
    UCB4940
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Participants were administered different BKZ dose regimens, as 2 subcutaneous injections, in the lateral abdominal wall, or upper outer thigh.

    Number of subjects in period 2
    Placebo - BKZ 160 mg Placebo - BKZ 320 mg BKZ 16 mg - BKZ 160 mg BKZ 16 mg - BKZ 320 mg BKZ 64 mg - BKZ 160 mg BKZ 64 mg - BKZ 320 mg BKZ 160 mg - BKZ 160 mg BKZ 320 mg - BKZ 320 mg
    Started
    24
    36
    31
    27
    34
    25
    58
    61
    Completed
    20
    31
    26
    24
    30
    24
    56
    54
    Not completed
    4
    5
    5
    3
    4
    1
    2
    7
         Meeting exclusion criteria 9
    -
    -
    -
    -
    -
    -
    -
    1
         Lack of efficacy
    -
    -
    1
    -
    1
    -
    -
    -
         Adverse event, non-fatal
    1
    3
    2
    2
    2
    1
    1
    6
         Consent withdrawn by subject
    1
    2
    2
    -
    1
    -
    -
    -
         Sponsor decision
    1
    -
    -
    -
    -
    -
    -
    -
         Lost to follow-up
    1
    -
    -
    1
    -
    -
    1
    -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Placebo
    Reporting group description
    Participants received placebo during the 12 weeks Double-Blind Period.

    Reporting group title
    BKZ 16 mg
    Reporting group description
    Participants received Bimekizumab (BKZ) 16 milligrams (mg) every 4 weeks (Q4W) during the 12 weeks Double-Blind Period.

    Reporting group title
    BKZ 64 mg
    Reporting group description
    Participants received Bimekizumab (BKZ) 64 mg every 4 weeks (Q4W) during the 12 weeks Double-Blind Period.

    Reporting group title
    BKZ 160 mg
    Reporting group description
    Participants received Bimekizumab (BKZ) 160 mg every 4 weeks (Q4W) during the 12 weeks Double-Blind Period followed by the same dose during the 36 weeks Dose-Blind Period.

    Reporting group title
    BKZ 320 mg
    Reporting group description
    Participants received Bimekizumab (BKZ) 320 mg every 4 weeks (Q4W) during the 12 weeks Double-Blind Period followed by the same dose during the 36 weeks Dose-Blind Period.

    Reporting group values
    Placebo BKZ 16 mg BKZ 64 mg BKZ 160 mg BKZ 320 mg Total
    Number of subjects
    60 61 61 60 61 303
    Age categorical
    Units: Subjects
        <=18 years
    0 0 0 0 0 0
        Between 18 and 65 years
    60 56 59 56 60 291
        >=65 years
    0 5 2 4 1 12
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    39.65 ± 10.30 43.31 ± 12.59 40.41 ± 10.93 42.38 ± 13.11 45.02 ± 11.39 -
    Gender categorical
    Units: Subjects
        Male
    49 53 52 52 50 256
        Female
    11 8 9 8 11 47
    Subject analysis sets

    Subject analysis set title
    Placebo (FAS)
    Subject analysis set type
    Full analysis
    Subject analysis set description
    Participants received placebo during the 12 weeks Double-Blind Period, forming the Full Analysis Set (FAS).

    Subject analysis set title
    BKZ 16 mg (FAS)
    Subject analysis set type
    Full analysis
    Subject analysis set description
    Participants received Bimekizumab (BKZ) 16 milligrams (mg) every 4 weeks (Q4W) during the 12 weeks Double-Blind Period, forming the Full Analysis Set (FAS).

    Subject analysis set title
    BKZ 64 mg (FAS)
    Subject analysis set type
    Full analysis
    Subject analysis set description
    Participants received Bimekizumab (BKZ) 64 mg every 4 weeks (Q4W) during the 12 weeks Double-Blind Period, forming the Full Analysis Set (FAS).

    Subject analysis set title
    BKZ 160 mg (FAS)
    Subject analysis set type
    Full analysis
    Subject analysis set description
    Participants received Bimekizumab (BKZ) 160 mg every 4 weeks (Q4W) during the 12 weeks Double-Blind Period followed by the same dose during the 36 weeks Dose-Blind Period, forming the Full Analysis Set (FAS).

    Subject analysis set title
    BKZ 320 mg (FAS)
    Subject analysis set type
    Full analysis
    Subject analysis set description
    Participants received Bimekizumab (BKZ) 320 mg every 4 weeks (Q4W) during the 12 weeks Double-Blind Period followed by the same dose during the 36 weeks Dose-Blind Period, forming the Full Analysis Set (FAS).

    Subject analysis set title
    All subjects (SS)
    Subject analysis set type
    Full analysis
    Subject analysis set description
    Participants received placebo, Bimekizumab (BKZ) 16 mg every 4 weeks (Q4W) and BKZ 64 mg Q4W during the 12 weeks Double-Blind Period. At Week (Wk) 12, placebo, Bimekizumab (BKZ) 16 mg Q4W and BKZ 64 mg Q4W participants were re-randomized to receive either BKZ 160 mg Q4W or BKZ 320 mg Q4W for 36 weeks Dose-Blind Period. Participants randomized to BKZ 160 mg Q4W and BKZ 320 mg Q4W at Baseline were not re-randomized at Week 12 and remained on their original treatment. Participants formed the Safety Set (SS).

    Subject analysis sets values
    Placebo (FAS) BKZ 16 mg (FAS) BKZ 64 mg (FAS) BKZ 160 mg (FAS) BKZ 320 mg (FAS) All subjects (SS)
    Number of subjects
    60
    61
    61
    60
    61
    303
    Age categorical
    Units: Subjects
        <=18 years
    0
    0
    0
    0
    0
    0
        Between 18 and 65 years
    60
    56
    59
    56
    60
    291
        >=65 years
    0
    5
    2
    4
    1
    12
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    39.65 ± 10.30
    43.31 ± 12.59
    40.41 ± 10.93
    42.38 ± 13.11
    45.02 ± 11.39
    42.16 ± 11.80
    Gender categorical
    Units: Subjects
        Male
    49
    53
    52
    52
    50
    256
        Female
    11
    8
    9
    8
    11
    47

    End points

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    End points reporting groups
    Reporting group title
    Placebo
    Reporting group description
    Participants received placebo during the 12 weeks Double-Blind Period.

    Reporting group title
    BKZ 16 mg
    Reporting group description
    Participants received Bimekizumab (BKZ) 16 milligrams (mg) every 4 weeks (Q4W) during the 12 weeks Double-Blind Period.

    Reporting group title
    BKZ 64 mg
    Reporting group description
    Participants received Bimekizumab (BKZ) 64 mg every 4 weeks (Q4W) during the 12 weeks Double-Blind Period.

    Reporting group title
    BKZ 160 mg
    Reporting group description
    Participants received Bimekizumab (BKZ) 160 mg every 4 weeks (Q4W) during the 12 weeks Double-Blind Period followed by the same dose during the 36 weeks Dose-Blind Period.

    Reporting group title
    BKZ 320 mg
    Reporting group description
    Participants received Bimekizumab (BKZ) 320 mg every 4 weeks (Q4W) during the 12 weeks Double-Blind Period followed by the same dose during the 36 weeks Dose-Blind Period.
    Reporting group title
    Placebo - BKZ 160 mg
    Reporting group description
    After the 12 weeks Double-Blind Period participants randomized to placebo were re-randomized to receive Bimekizumab (BKZ) 160 mg every 4 weeks (Q4W) for 36 weeks in the Dose-Blind Period.

    Reporting group title
    Placebo - BKZ 320 mg
    Reporting group description
    After the 12 weeks Double-Blind Period participants randomized to placebo were re-randomized to receive Bimekizumab (BKZ) 320 mg every 4 weeks (Q4W) for 36 weeks in the Dose-Blind Period

    Reporting group title
    BKZ 16 mg - BKZ 160 mg
    Reporting group description
    After the 12 weeks Double-Blind Period participants randomized to Bimekizumab (BKZ) 16 mg every 4 weeks (Q4W) were re-randomized to receive BKZ 160 mg Q4W for 36 weeks in the Dose-Blind Period.

    Reporting group title
    BKZ 16 mg - BKZ 320 mg
    Reporting group description
    After the 12 weeks Double-Blind Period participants randomized to Bimekizumab (BKZ) 16 mg every 4 weeks (Q4W) were re-randomized to receive BKZ 320 mg Q4W for 36 weeks in the Dose-Blind Period.

    Reporting group title
    BKZ 64 mg - BKZ 160 mg
    Reporting group description
    After the 12 weeks Double-Blind Period participants randomized to Bimekizumab (BKZ) 64 mg every 4 weeks (Q4W) were re-randomized to receive BKZ 160 mg Q4W for 36 weeks in the Dose-Blind Period.

    Reporting group title
    BKZ 64 mg - BKZ 320 mg
    Reporting group description
    After the 12 weeks Double-Blind Period participants randomized to Bimekizumab (BKZ) 64 mg every 4 weeks (Q4W) were re-randomized to receive BKZ 320 mg Q4W for 36 weeks in the Dose-Blind Period.

    Reporting group title
    BKZ 160 mg - BKZ 160 mg
    Reporting group description
    Participants randomized to Bimekizumab (BKZ) 160 mg every 4 weeks (Q4W) in the 12 weeks Double-Blind Period, continued to receive BKZ 160 mg Q4W in the 36 weeks Dose-Blind Period.

    Reporting group title
    BKZ 320 mg - BKZ 320 mg
    Reporting group description
    Participants randomized to Bimekizumab (BKZ) 320 mg every 4 weeks (Q4W) in the 12 weeks Double-Blind Period, continued to receive BKZ 320 mg Q4W in the 36 weeks Dose-Blind Period.

    Subject analysis set title
    Placebo (FAS)
    Subject analysis set type
    Full analysis
    Subject analysis set description
    Participants received placebo during the 12 weeks Double-Blind Period, forming the Full Analysis Set (FAS).

    Subject analysis set title
    BKZ 16 mg (FAS)
    Subject analysis set type
    Full analysis
    Subject analysis set description
    Participants received Bimekizumab (BKZ) 16 milligrams (mg) every 4 weeks (Q4W) during the 12 weeks Double-Blind Period, forming the Full Analysis Set (FAS).

    Subject analysis set title
    BKZ 64 mg (FAS)
    Subject analysis set type
    Full analysis
    Subject analysis set description
    Participants received Bimekizumab (BKZ) 64 mg every 4 weeks (Q4W) during the 12 weeks Double-Blind Period, forming the Full Analysis Set (FAS).

    Subject analysis set title
    BKZ 160 mg (FAS)
    Subject analysis set type
    Full analysis
    Subject analysis set description
    Participants received Bimekizumab (BKZ) 160 mg every 4 weeks (Q4W) during the 12 weeks Double-Blind Period followed by the same dose during the 36 weeks Dose-Blind Period, forming the Full Analysis Set (FAS).

    Subject analysis set title
    BKZ 320 mg (FAS)
    Subject analysis set type
    Full analysis
    Subject analysis set description
    Participants received Bimekizumab (BKZ) 320 mg every 4 weeks (Q4W) during the 12 weeks Double-Blind Period followed by the same dose during the 36 weeks Dose-Blind Period, forming the Full Analysis Set (FAS).

    Subject analysis set title
    All subjects (SS)
    Subject analysis set type
    Full analysis
    Subject analysis set description
    Participants received placebo, Bimekizumab (BKZ) 16 mg every 4 weeks (Q4W) and BKZ 64 mg Q4W during the 12 weeks Double-Blind Period. At Week (Wk) 12, placebo, Bimekizumab (BKZ) 16 mg Q4W and BKZ 64 mg Q4W participants were re-randomized to receive either BKZ 160 mg Q4W or BKZ 320 mg Q4W for 36 weeks Dose-Blind Period. Participants randomized to BKZ 160 mg Q4W and BKZ 320 mg Q4W at Baseline were not re-randomized at Week 12 and remained on their original treatment. Participants formed the Safety Set (SS).

    Primary: Percentage of participants with Axial Spondyloarthritis International Society 40% response criteria (ASAS40) at Week 12

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    End point title
    Percentage of participants with Axial Spondyloarthritis International Society 40% response criteria (ASAS40) at Week 12
    End point description
    The ASAS40 response was defined as relative improvements of at least 40% and absolute improvement of at least 2 units on a 0 to 10 Numeric Rating Scale (NRS), where 0 is “not active” and 10 is “very active” in at least 3 of the 4 domains: Patient's Global Assessment of Disease Activity (PGADA), Pain assessment (total spinal pain NRS scores), Function (Bath Ankylosing Spondylitis Functional Index (BASFI)), Inflammation (mean of Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) questions 5 and 6 concerning morning stiffness intensity and duration) and no worsening at all in the remaining domain. Note: Participants with missing data or who discontinue study treatment prior to Week 12 were counted as non-responders.
    End point type
    Primary
    End point timeframe
    Week 12
    End point values
    Placebo (FAS) BKZ 16 mg (FAS) BKZ 64 mg (FAS) BKZ 160 mg (FAS) BKZ 320 mg (FAS)
    Number of subjects analysed
    60
    61
    61
    60
    61
    Units: percentage of participants
        number (not applicable)
    13.3
    29.5
    42.6
    46.7
    45.9
    Statistical analysis title
    Statistical analysis 1
    Statistical analysis description
    Statistic and p-value were calculated using a Cochran-Mantel-Haenszel test (test for non-zero correlation statistic) based on modified ridit scores and including geographic region and prior Tumor Necrosis Factor (TNF) inhibitor exposure as stratification factors. Note: 999 and 0% CI are used as placeholders. Using this methodology no point estimator will be calculated. The respective correlation statistic was 17.9.
    Comparison groups
    Placebo (FAS) v BKZ 16 mg (FAS) v BKZ 64 mg (FAS) v BKZ 160 mg (FAS) v BKZ 320 mg (FAS)
    Number of subjects included in analysis
    303
    Analysis specification
    Pre-specified
    Analysis type
    other
    P-value
    < 0.001
    Method
    Cochran-Mantel-Haenszel
    Parameter type
    Correlation statistic
    Point estimate
    999
    Confidence interval
         level
    0%
         sides
    2-sided
         lower limit
    999
         upper limit
    999
    Statistical analysis title
    Statistical analysis 2
    Statistical analysis description
    For differences in relation to Placebo: Odds Ratio, confidence interval and p-value were derived from a logistic regression model including fixed effects for treatment, geographic region and prior tumor necrosis factor (TNF) inhibitor exposure.
    Comparison groups
    Placebo (FAS) v BKZ 16 mg (FAS)
    Number of subjects included in analysis
    121
    Analysis specification
    Pre-specified
    Analysis type
    other [1]
    P-value
    = 0.04 [2]
    Method
    Regression, Logistic
    Parameter type
    Odds ratio (OR)
    Point estimate
    2.6
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    1.04
         upper limit
    6.48
    Notes
    [1] - The pairwise testing of each bimekizumab dose versus placebo accounted for multiplicity by using a fixed sequence testing procedure with each bimekizumab dose being tested sequentially from the highest dose to the lowest dose. If the sequential testing failed to reach significance at a significance level of alpha=0.05, then the pairwise testing continued and the comparison was seen as non-significant.
    [2] - The p-values were displayed as nominal p-values.
    Statistical analysis title
    Statistical analysis 3
    Statistical analysis description
    For differences in relation to Placebo: Odds Ratio, confidence interval and p-value were derived from a logistic regression model including fixed effects for treatment, geographic region and prior TNF inhibitor exposure.
    Comparison groups
    Placebo (FAS) v BKZ 64 mg (FAS)
    Number of subjects included in analysis
    121
    Analysis specification
    Pre-specified
    Analysis type
    other [3]
    P-value
    = 0.001 [4]
    Method
    Regression, Logistic
    Parameter type
    Odds ratio (OR)
    Point estimate
    4.5
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    1.83
         upper limit
    10.86
    Notes
    [3] - The pairwise testing of each bimekizumab dose versus placebo accounted for multiplicity by using a fixed sequence testing procedure with each bimekizumab dose being tested sequentially from the highest dose to the lowest dose. If the sequential testing failed to reach significance at a significance level of alpha=0.05, then the pairwise testing continued and the comparison was seen as non-significant.
    [4] - The p-values were displayed as nominal p-values.
    Statistical analysis title
    Statistical analysis 4
    Statistical analysis description
    For differences in relation to Placebo: Odds Ratio, confidence interval and p-value were derived from a logistic regression model including fixed effects for treatment, geographic region and prior TNF inhibitor exposure.
    Comparison groups
    Placebo (FAS) v BKZ 160 mg (FAS)
    Number of subjects included in analysis
    120
    Analysis specification
    Pre-specified
    Analysis type
    other [5]
    P-value
    < 0.001 [6]
    Method
    Regression, Logistic
    Parameter type
    Odds ratio (OR)
    Point estimate
    5.5
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    2.27
         upper limit
    13.48
    Notes
    [5] - The pairwise testing of each bimekizumab dose versus placebo accounted for multiplicity by using a fixed sequence testing procedure with each bimekizumab dose being tested sequentially from the highest dose to the lowest dose. If the sequential testing failed to reach significance at a significance level of alpha=0.05, then the pairwise testing continued and the comparison was seen as non-significant.
    [6] - The p-values were displayed as nominal p-values.
    Statistical analysis title
    Statistical analysis 5
    Statistical analysis description
    For differences in relation to Placebo: Odds Ratio, confidence interval and p-value were derived from a logistic regression model including fixed effects for treatment, geographic region and prior TNF inhibitor exposure.
    Comparison groups
    Placebo (FAS) v BKZ 320 mg (FAS)
    Number of subjects included in analysis
    121
    Analysis specification
    Pre-specified
    Analysis type
    other [7]
    P-value
    < 0.001 [8]
    Method
    Regression, Logistic
    Parameter type
    Odds ratio (OR)
    Point estimate
    5.3
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    2.19
         upper limit
    12.92
    Notes
    [7] - The pairwise testing of each bimekizumab dose versus placebo accounted for multiplicity by using a fixed sequence testing procedure with each bimekizumab dose being tested sequentially from the highest dose to the lowest dose. If the sequential testing failed to reach significance at a significance level of alpha=0.05, then the pairwise testing continued and the comparison was seen as non-significant.
    [8] - The p-values were displayed as nominal p-values.

    Secondary: Change from Baseline in Ankylosing Spondylitis Disease Activity Score - C-Reactive Protein (ASDAS [CRP]) at Week 12

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    End point title
    Change from Baseline in Ankylosing Spondylitis Disease Activity Score - C-Reactive Protein (ASDAS [CRP]) at Week 12
    End point description
    The ASDAS was calculated as the sum of the following components: 0.121 x Back pain (BASDAI Q2 result) 0.058 x Duration of morning stiffness (BASDAI Q6 result) 0.110 x PGADA 0.073 x Peripheral pain/swelling (BASDAI Q3 result) 0.579 × (natural logarithm [ln] of the (CRP [mg/L] + 1)) Back pain, PGADA, duration of morning stiffness, peripheral pain/swelling and fatigue were all assessed on a numerical scale (0 to 10 units, where 0 is “not active” and 10 is “very active”). The change from Baseline is calculated, a negative value indicating improvement and a positive value worsening. Note: Missing data was imputed using multiple imputation based on the Markov-Chain Monte Carlo method for the intermittent missing data, followed by monotone regression for the monotone missing data assuming missing at random.
    End point type
    Secondary
    End point timeframe
    From Baseline to Week 12
    End point values
    Placebo (FAS) BKZ 16 mg (FAS) BKZ 64 mg (FAS) BKZ 160 mg (FAS) BKZ 320 mg (FAS)
    Number of subjects analysed
    60
    61
    61
    60
    61
    Units: units on a scale
        least squares mean (standard error)
    -0.3 ± 0.17
    -0.8 ± 0.17
    -1.4 ± 0.17
    -1.3 ± 0.17
    -1.4 ± 0.17
    Statistical analysis title
    Statistical analysis 1
    Statistical analysis description
    Least squares (LS) Mean, standard error, confidence interval and p-value were derived using the analysis of covariance (ANCOVA) model with treatment, geographic region and prior TNF inhibitor exposure as fixed effects and the Baseline value as covariate.
    Comparison groups
    Placebo (FAS) v BKZ 16 mg (FAS)
    Number of subjects included in analysis
    121
    Analysis specification
    Pre-specified
    Analysis type
    other
    P-value
    < 0.001
    Method
    ANCOVA
    Parameter type
    LS Mean Difference vs Placebo
    Point estimate
    -0.5
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -0.86
         upper limit
    -0.24
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.16
    Statistical analysis title
    Statistical analysis 2
    Statistical analysis description
    LS Mean, standard error, confidence interval and p-value were derived using the ANCOVA model with treatment, geographic region and prior TNF inhibitor exposure as fixed effects and the Baseline value as covariate.
    Comparison groups
    Placebo (FAS) v BKZ 64 mg (FAS)
    Number of subjects included in analysis
    121
    Analysis specification
    Pre-specified
    Analysis type
    other
    P-value
    < 0.001
    Method
    ANCOVA
    Parameter type
    LS Mean Difference vs Placebo
    Point estimate
    -1.2
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -1.47
         upper limit
    -0.83
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.16
    Statistical analysis title
    Statistical analysis 3
    Statistical analysis description
    LS Mean, standard error, confidence interval and p-value were derived using the ANCOVA model with treatment, geographic region and prior TNF inhibitor exposure as fixed effects and the Baseline value as covariate.
    Comparison groups
    Placebo (FAS) v BKZ 160 mg (FAS)
    Number of subjects included in analysis
    120
    Analysis specification
    Pre-specified
    Analysis type
    other
    P-value
    < 0.001
    Method
    ANCOVA
    Parameter type
    LS Mean Difference vs Placebo
    Point estimate
    -1
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -1.35
         upper limit
    -0.72
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.16
    Statistical analysis title
    Statistical analysis 4
    Statistical analysis description
    LS Mean, standard error, confidence interval and p-value were derived using the ANCOVA model with treatment, geographic region and prior TNF inhibitor exposure as fixed effects and the Baseline value as covariate.
    Comparison groups
    Placebo (FAS) v BKZ 320 mg (FAS)
    Number of subjects included in analysis
    121
    Analysis specification
    Pre-specified
    Analysis type
    other
    P-value
    < 0.001
    Method
    ANCOVA
    Parameter type
    LS Mean Difference vs Placebo
    Point estimate
    -1.1
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -1.45
         upper limit
    -0.82
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.16

    Secondary: Percentage of participants with Axial Spondyloarthritis International Society 20% response criteria (ASAS20) at Week 12

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    End point title
    Percentage of participants with Axial Spondyloarthritis International Society 20% response criteria (ASAS20) at Week 12
    End point description
    The ASAS20 response was defined as an improvement of at least 20% and absolute improvement of at least 1 unit on a 0 to 10 NRS, where 0 is “not active” and 10 is “very active” in at least 3 of the 4 domains: PGADA, Pain assessment (total spinal pain NRS scores), Function (BASFI), Inflammation (mean of BASDAI questions 5 and 6 concerning morning stiffness intensity and duration) and absence of deterioration in the potential remaining domain [deterioration was defined as a relative worsening of at least 20% and an absolute worsening of at least 1 unit]. Note: Participants with missing data or who discontinue study treatment prior to Week 12 were counted as non-responders.
    End point type
    Secondary
    End point timeframe
    Week 12
    End point values
    Placebo (FAS) BKZ 16 mg (FAS) BKZ 64 mg (FAS) BKZ 160 mg (FAS) BKZ 320 mg (FAS)
    Number of subjects analysed
    60
    61
    61
    60
    61
    Units: percentage of participants
        number (not applicable)
    28.3
    41.0
    62.3
    58.3
    72.1
    Statistical analysis title
    Statistical analysis 1
    Statistical analysis description
    For differences in relation to Placebo: Odds Ratio, confidence interval and p-value were derived from a logistic regression model including fixed effects for treatment, geographic region and prior TNF inhibitor exposure.
    Comparison groups
    Placebo (FAS) v BKZ 16 mg (FAS)
    Number of subjects included in analysis
    121
    Analysis specification
    Pre-specified
    Analysis type
    other
    P-value
    = 0.163 [9]
    Method
    Regression, Logistic
    Parameter type
    Odds ratio (OR)
    Point estimate
    1.7
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    0.8
         upper limit
    3.67
    Notes
    [9] - The p-values were displayed as nominal p-values.
    Statistical analysis title
    Statistical analysis 2
    Statistical analysis description
    For differences in relation to Placebo: Odds Ratio, confidence interval and p-value were derived from a logistic regression model including fixed effects for treatment, geographic region and prior TNF inhibitor exposure.
    Comparison groups
    Placebo (FAS) v BKZ 64 mg (FAS)
    Number of subjects included in analysis
    121
    Analysis specification
    Pre-specified
    Analysis type
    other
    P-value
    < 0.001 [10]
    Method
    Regression, Logistic
    Parameter type
    Odds ratio (OR)
    Point estimate
    3.9
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    1.84
         upper limit
    8.48
    Notes
    [10] - The p-values were displayed as nominal p-values.
    Statistical analysis title
    Statistical analysis 3
    Statistical analysis description
    For differences in relation to Placebo: Odds Ratio, confidence interval and p-value were derived from a logistic regression model including fixed effects for treatment, geographic region and prior TNF inhibitor exposure.
    Comparison groups
    Placebo (FAS) v BKZ 160 mg (FAS)
    Number of subjects included in analysis
    120
    Analysis specification
    Pre-specified
    Analysis type
    other
    P-value
    = 0.001 [11]
    Method
    Regression, Logistic
    Parameter type
    Odds ratio (OR)
    Point estimate
    3.5
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    1.66
         upper limit
    7.61
    Notes
    [11] - The p-values were displayed as nominal p-values.
    Statistical analysis title
    Statistical analysis 4
    Statistical analysis description
    For differences in relation to Placebo: Odds Ratio, confidence interval and p-value were derived from a logistic regression model including fixed effects for treatment, geographic region and prior TNF inhibitor exposure.
    Comparison groups
    Placebo (FAS) v BKZ 320 mg (FAS)
    Number of subjects included in analysis
    121
    Analysis specification
    Pre-specified
    Analysis type
    other
    P-value
    < 0.001 [12]
    Method
    Regression, Logistic
    Parameter type
    Odds ratio (OR)
    Point estimate
    6.5
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    2.92
         upper limit
    14.28
    Notes
    [12] - The p-values were displayed as nominal p-values.

    Secondary: Percentage of participants with Axial Spondyloarthritis International Society (ASAS) 5/6 response at Week 12

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    End point title
    Percentage of participants with Axial Spondyloarthritis International Society (ASAS) 5/6 response at Week 12
    End point description
    The ASAS 5/6 response was defined as at least 20% improvement in at least 5 of the 6 domains: PGADA, Pain assessment (total spinal pain NRS scores), Function (BASFI), Inflammation (mean of BASDAI questions 5 and 6 concerning morning stiffness intensity and duration), spinal mobility (lateral spinal flexion) and high sensitivity C-reactive protein (hs-CRP). Note: Participants with missing data or who discontinue study treatment prior to Week 12 were counted as non-responders.
    End point type
    Secondary
    End point timeframe
    Week 12
    End point values
    Placebo (FAS) BKZ 16 mg (FAS) BKZ 64 mg (FAS) BKZ 160 mg (FAS) BKZ 320 mg (FAS)
    Number of subjects analysed
    60
    61
    61
    60
    61
    Units: percentage of participants
        number (not applicable)
    6.7
    29.5
    49.2
    53.3
    54.1
    Statistical analysis title
    Statistical analysis 1
    Statistical analysis description
    For differences in relation to Placebo: Odds Ratio, confidence interval and p-value were derived from a logistic regression model including fixed effects for treatment, geographic region and prior TNF inhibitor exposure.
    Comparison groups
    Placebo (FAS) v BKZ 16 mg (FAS)
    Number of subjects included in analysis
    121
    Analysis specification
    Pre-specified
    Analysis type
    other
    P-value
    = 0.003 [13]
    Method
    Regression, Logistic
    Parameter type
    Odds ratio (OR)
    Point estimate
    5.3
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    1.74
         upper limit
    15.96
    Notes
    [13] - The p-values were displayed as nominal p-values.
    Statistical analysis title
    Statistical analysis 2
    Statistical analysis description
    For differences in relation to Placebo: Odds Ratio, confidence interval and p-value were derived from a logistic regression model including fixed effects for treatment, geographic region and prior TNF inhibitor exposure.
    Comparison groups
    Placebo (FAS) v BKZ 64 mg (FAS)
    Number of subjects included in analysis
    121
    Analysis specification
    Pre-specified
    Analysis type
    other
    P-value
    < 0.001 [14]
    Method
    Regression, Logistic
    Parameter type
    Odds ratio (OR)
    Point estimate
    11.9
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    4.03
         upper limit
    35.38
    Notes
    [14] - The p-values were displayed as nominal p-values.
    Statistical analysis title
    Statistical analysis 3
    Statistical analysis description
    For differences in relation to Placebo: Odds Ratio, confidence interval and p-value were derived from a logistic regression model including fixed effects for treatment, geographic region and prior TNF inhibitor exposure.
    Comparison groups
    Placebo (FAS) v BKZ 160 mg (FAS)
    Number of subjects included in analysis
    120
    Analysis specification
    Pre-specified
    Analysis type
    other
    P-value
    < 0.001 [15]
    Method
    Regression, Logistic
    Parameter type
    Odds ratio (OR)
    Point estimate
    14.3
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    4.81
         upper limit
    42.46
    Notes
    [15] - The p-values were displayed as nominal p-values.
    Statistical analysis title
    Statistical analysis 4
    Statistical analysis description
    For differences in relation to Placebo: Odds Ratio, confidence interval and p-value were derived from a logistic regression model including fixed effects for treatment, geographic region and prior TNF inhibitor exposure.
    Comparison groups
    Placebo (FAS) v BKZ 320 mg (FAS)
    Number of subjects included in analysis
    121
    Analysis specification
    Pre-specified
    Analysis type
    other
    P-value
    < 0.001 [16]
    Method
    Regression, Logistic
    Parameter type
    Odds ratio (OR)
    Point estimate
    14.9
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    5.02
         upper limit
    44.27
    Notes
    [16] - The p-values were displayed as nominal p-values.

    Secondary: Change from Baseline to Week 12 in the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)

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    End point title
    Change from Baseline to Week 12 in the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)
    End point description
    The BASDAI is a validated self-reported instrument, which consists of six 10-unit horizontal Numeric Rating Scales (NRS) to measure severity of fatigue, spinal and peripheral joint pain and swelling, enthesitis, and morning stiffness (both severity and duration, respectively) over the last week. The final BASDAI score ranges from 0 to 10, with lower scores indicating lower disease activity. The change from Baseline is calculated, a negative value indicating improvement and a positive value worsening. Note: Missing data was imputed using multiple imputation based on the Markov-Chain Monte Carlo method for the intermittent missing data, followed by monotone regression for the monotone missing data assuming missing at random.
    End point type
    Secondary
    End point timeframe
    From Baseline to Week 12
    End point values
    Placebo (FAS) BKZ 16 mg (FAS) BKZ 64 mg (FAS) BKZ 160 mg (FAS) BKZ 320 mg (FAS)
    Number of subjects analysed
    60
    61
    61
    60
    61
    Units: scores on a scale
        least squares mean (standard error)
    -1.0 ± 0.38
    -1.6 ± 0.38
    -2.6 ± 0.38
    -2.6 ± 0.38
    -2.9 ± 0.38
    Statistical analysis title
    Statistical analysis 1
    Statistical analysis description
    LS Mean, standard error, confidence interval and p-value were derived using the ANCOVA model with treatment, geographic region and prior TNF inhibitor exposure as fixed effects and the Baseline value as covariate.
    Comparison groups
    Placebo (FAS) v BKZ 16 mg (FAS)
    Number of subjects included in analysis
    121
    Analysis specification
    Pre-specified
    Analysis type
    other
    P-value
    = 0.094
    Method
    ANCOVA
    Parameter type
    LS Mean Difference vs Placebo
    Point estimate
    -0.6
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -1.31
         upper limit
    0.1
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.36
    Statistical analysis title
    Statistical analysis 2
    Statistical analysis description
    LS Mean, standard error, confidence interval and p-value were derived using the ANCOVA model with treatment, geographic region and prior TNF inhibitor exposure as fixed effects and the Baseline value as covariate.
    Comparison groups
    Placebo (FAS) v BKZ 64 mg (FAS)
    Number of subjects included in analysis
    121
    Analysis specification
    Pre-specified
    Analysis type
    other
    P-value
    < 0.001
    Method
    ANCOVA
    Parameter type
    LS Mean Difference vs Placebo
    Point estimate
    -1.6
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -2.34
         upper limit
    -0.91
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.37
    Statistical analysis title
    Statistical analysis 3
    Statistical analysis description
    LS Mean, standard error, confidence interval and p-value were derived using the ANCOVA model with treatment, geographic region and prior TNF inhibitor exposure as fixed effects and the Baseline value as covariate.
    Comparison groups
    Placebo (FAS) v BKZ 160 mg (FAS)
    Number of subjects included in analysis
    120
    Analysis specification
    Pre-specified
    Analysis type
    other
    P-value
    < 0.001
    Method
    ANCOVA
    Parameter type
    LS Mean Difference vs Placebo
    Point estimate
    -1.6
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -2.35
         upper limit
    -0.91
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.37
    Statistical analysis title
    Statistical analysis 4
    Statistical analysis description
    LS Mean, standard error, confidence interval and p-value were derived using the ANCOVA model with treatment, geographic region and prior TNF inhibitor exposure as fixed effects and the Baseline value as covariate.
    Comparison groups
    Placebo (FAS) v BKZ 320 mg (FAS)
    Number of subjects included in analysis
    121
    Analysis specification
    Pre-specified
    Analysis type
    other
    P-value
    < 0.001
    Method
    ANCOVA
    Parameter type
    LS Mean Difference vs Placebo
    Point estimate
    -1.9
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -2.6
         upper limit
    -1.18
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.36

    Secondary: Change from Baseline to Week 12 in the Bath Ankylosing Spondylitis Functional Index (BASFI)

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    End point title
    Change from Baseline to Week 12 in the Bath Ankylosing Spondylitis Functional Index (BASFI)
    End point description
    The BASFI is a validated disease-specific instrument for assessing physical function. The BASFI comprises 10 items relating to the past week. The BASFI is the mean of the 10 scores such that the total score ranges from 0 (Easy) to 10 (Impossible), with lower scores indicating better physical function. The change from Baseline is calculated, a negative value indicating improvement and a positive value worsening. Note: Missing data was imputed using multiple imputation based on the Markov-Chain Monte Carlo method for the intermittent missing data, followed by monotone regression for the monotone missing data assuming missing at random.
    End point type
    Secondary
    End point timeframe
    From Baseline to Week 12
    End point values
    Placebo (FAS) BKZ 16 mg (FAS) BKZ 64 mg (FAS) BKZ 160 mg (FAS) BKZ 320 mg (FAS)
    Number of subjects analysed
    60
    61
    61
    60
    61
    Units: scores on a scale
        least squares mean (standard error)
    -0.7 ± 0.39
    -1.4 ± 0.38
    -1.8 ± 0.38
    -1.9 ± 0.38
    -2.2 ± 0.38
    Statistical analysis title
    Statistical analysis 1
    Statistical analysis description
    LS Mean, standard error, confidence interval and p-value were derived using the ANCOVA model with treatment, geographic region and prior TNF inhibitor exposure as fixed effects and the Baseline value as covariate.
    Comparison groups
    Placebo (FAS) v BKZ 16 mg (FAS)
    Number of subjects included in analysis
    121
    Analysis specification
    Pre-specified
    Analysis type
    other
    P-value
    = 0.074
    Method
    ANCOVA
    Parameter type
    LS Mean Difference vs Placebo
    Point estimate
    -0.6
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -1.35
         upper limit
    0.06
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.36
    Statistical analysis title
    Statistical analysis 2
    Statistical analysis description
    LS Mean, standard error, confidence interval and p-value were derived using the ANCOVA model with treatment, geographic region and prior TNF inhibitor exposure as fixed effects and the Baseline value as covariate.
    Comparison groups
    Placebo (FAS) v BKZ 64 mg (FAS)
    Number of subjects included in analysis
    121
    Analysis specification
    Pre-specified
    Analysis type
    other
    P-value
    = 0.003
    Method
    ANCOVA
    Parameter type
    LS Mean Difference vs Placebo
    Point estimate
    -1.1
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -1.82
         upper limit
    -0.39
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.36
    Statistical analysis title
    Statistical analysis 3
    Statistical analysis description
    LS Mean, standard error, confidence interval and p-value were derived using the ANCOVA model with treatment, geographic region and prior TNF inhibitor exposure as fixed effects and the Baseline value as covariate.
    Comparison groups
    Placebo (FAS) v BKZ 160 mg (FAS)
    Number of subjects included in analysis
    120
    Analysis specification
    Pre-specified
    Analysis type
    other
    P-value
    = 0.002
    Method
    ANCOVA
    Parameter type
    LS Mean Difference vs Placebo
    Point estimate
    -1.1
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -1.84
         upper limit
    -0.42
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.36
    Statistical analysis title
    Statistical analysis 4
    Statistical analysis description
    LS Mean, standard error, confidence interval and p-value were derived using the ANCOVA model with treatment, geographic region and prior TNF inhibitor exposure as fixed effects and the Baseline value as covariate.
    Comparison groups
    Placebo (FAS) v BKZ 320 mg (FAS)
    Number of subjects included in analysis
    121
    Analysis specification
    Pre-specified
    Analysis type
    other
    P-value
    < 0.001
    Method
    ANCOVA
    Parameter type
    LS Mean Difference vs Placebo
    Point estimate
    -1.5
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -2.22
         upper limit
    -0.8
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.36

    Secondary: Percentage of participants with at least one Adverse Event (AE) during the study

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    End point title
    Percentage of participants with at least one Adverse Event (AE) during the study
    End point description
    An Adverse Event (AE) is any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.
    End point type
    Secondary
    End point timeframe
    From Screening at Day -28 until Safety Follow-Up Visit (up to Week 72)
    End point values
    All subjects (SS)
    Number of subjects analysed
    303
    Units: percentage of participants
        number (not applicable)
    78.2
    No statistical analyses for this end point

    Secondary: Percentage of participants with at least one Serious Adverse Event (SAE) during the study

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    End point title
    Percentage of participants with at least one Serious Adverse Event (SAE) during the study
    End point description
    A Serious Adverse Event (SAE) is any untoward medical occurrence that at any dose: - Results in death - Is life-threatening - Requires in patient hospitalisation or prolongation of existing hospitalisation - Is a congenital anomaly or birth defect - Is an infection that requires treatment parenteral antibiotics - Other important medical events which based on medical or scientific judgement may jeopardise the patients, or may require medical or surgical intervention to prevent any of the above.
    End point type
    Secondary
    End point timeframe
    From Screening at Day -28 until Safety Follow-Up Visit (up to Week 72)
    End point values
    All subjects (SS)
    Number of subjects analysed
    303
    Units: percentage of participants
        number (not applicable)
    4.3
    No statistical analyses for this end point

    Secondary: Percentage of participants who withdrew due to an Adverse Event (AE) during the study

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    End point title
    Percentage of participants who withdrew due to an Adverse Event (AE) during the study
    End point description
    An AE is any untoward medical occurrence in a participant or trial subject that is administered a drug or biologic (medicinal product) or that is using a medical device. The event does not necessarily have a causal relationship with that treatment or usage. The results of this Secondary Outcome Measure were summarized from the Adverse Event pages of the Case Report Forms.
    End point type
    Secondary
    End point timeframe
    From Screening at Day -28 until Safety Follow-Up Visit (up to Week 72)
    End point values
    All subjects (SS)
    Number of subjects analysed
    303
    Units: percentage of participants
        number (not applicable)
    6.6
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    From Baseline at Day 1 until the Safety Follow-Up Visit at 20 weeks after the final dose of IMP.
    Adverse event reporting additional description
    Participants randomized to placebo (PBO), BKZ 16 mg and BKZ 64 mg at Baseline switched to BKZ 160 mg Q4W or BKZ 320 mg Q4W at Week 12. The exposure imbalance across treatment arms could lead to misinterpretation & questionable conclusions comparing simple counts & percentages of AEs. Therefore, only overall BKZ time is included in this summary.
    Assessment type
    Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    19.0
    Reporting groups
    Reporting group title
    All subjects (SS)
    Reporting group description
    Participants received placebo, Bimekizumab (BKZ) 16 mg every 4 weeks (Q4W) and BKZ 64 mg Q4W during the 12 weeks Double-Blind Period. At Week (Wk) 12, placebo, Bimekizumab (BKZ) 16 mg Q4W and BKZ 64 mg Q4W participants were re-randomized to receive either BKZ 160 mg Q4W or BKZ 320 mg Q4W for 36 weeks Dose-Blind Period. Participants randomized to BKZ 160 mg Q4W and BKZ 320 mg Q4W at Baseline were not re-randomized at Week 12 and remained on their original treatment. Participants formed the Safety Set (SS).

    Serious adverse events
    All subjects (SS)
    Total subjects affected by serious adverse events
         subjects affected / exposed
    13 / 303 (4.29%)
         number of deaths (all causes)
    1
         number of deaths resulting from adverse events
    1
    Injury, poisoning and procedural complications
    Foot fracture
         subjects affected / exposed
    1 / 303 (0.33%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Laceration
         subjects affected / exposed
    1 / 303 (0.33%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Colon adenoma
         subjects affected / exposed
    1 / 303 (0.33%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Cardiac disorders
    Acute myocardial infarction
         subjects affected / exposed
    1 / 303 (0.33%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Cardiac arrest
         subjects affected / exposed
    1 / 303 (0.33%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    Respiratory, thoracic and mediastinal disorders
    Pneumonia aspiration
         subjects affected / exposed
    1 / 303 (0.33%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    1 / 303 (0.33%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Nervous system disorders
    Dizziness
         subjects affected / exposed
    1 / 303 (0.33%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Ear and labyrinth disorders
    Inner ear disorder
         subjects affected / exposed
    1 / 303 (0.33%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Gastrointestinal disorders
    Pancreatitis acute
         subjects affected / exposed
    1 / 303 (0.33%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Crohn's disease
         subjects affected / exposed
    1 / 303 (0.33%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Haemorrhoids
         subjects affected / exposed
    1 / 303 (0.33%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Intestinal haemorrhage
         subjects affected / exposed
    1 / 303 (0.33%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Musculoskeletal and connective tissue disorders
    Osteoarthritis
         subjects affected / exposed
    1 / 303 (0.33%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Infections and infestations
    Bursitis infective
         subjects affected / exposed
    1 / 303 (0.33%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Abscess limb
         subjects affected / exposed
    1 / 303 (0.33%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Pilonidal cyst
         subjects affected / exposed
    1 / 303 (0.33%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Erysipelas
         subjects affected / exposed
    1 / 303 (0.33%)
         occurrences causally related to treatment / all
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    Urinary tract infection
         subjects affected / exposed
    1 / 303 (0.33%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    All subjects (SS)
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    102 / 303 (33.66%)
    Infections and infestations
    Oral candidiasis
         subjects affected / exposed
    16 / 303 (5.28%)
         occurrences all number
    21
    Oral fungal infection
         subjects affected / exposed
    14 / 303 (4.62%)
         occurrences all number
    16
    Nasopharyngitis
         subjects affected / exposed
    34 / 303 (11.22%)
         occurrences all number
    44
    Bronchitis
         subjects affected / exposed
    18 / 303 (5.94%)
         occurrences all number
    18
    Upper respiratory tract infection
         subjects affected / exposed
    17 / 303 (5.61%)
         occurrences all number
    19
    Pharyngitis
         subjects affected / exposed
    18 / 303 (5.94%)
         occurrences all number
    18

    More information

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    Substantial protocol amendments (globally)

    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    09 Mar 2018
    The purpose of this substantial protocol amendment was the following: - To update the study contact details for the sponsor study physician and clinical trial biostatistician. - To revise the withdrawal criteria section to provide instructions for the management of participants with newly diagnosed inflammatory bowel disease (IBD) or with IBD flares during the study. - Amend the time window between doses during the Double-Blind Period of the study. - To revise and clarify the SAE criteria for pregnancy for consistency. - Amend the table for identification/exclusion of alternative etiology to include alanine aminotransferase (ALT) and aspartate aminotransferase (AST).

    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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