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

    Summary
    EudraCT number
    2016-003426-16
    Trial protocol
    GB   DE   HU  
    Global end of trial date
    07 Jan 2020

    Results information
    Results version number
    v1(current)
    This version publication date
    09 Jan 2021
    First version publication date
    09 Jan 2021
    Other versions

    Trial information

    Close Top of page
    Trial identification
    Sponsor protocol code
    PS0013
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    NCT03410992
    WHO universal trial number (UTN)
    -
    Sponsors
    Sponsor organisation name
    UCB Biopharma SRL
    Sponsor organisation address
    Allée de la Recherche 60, Brussels, Belgium, 1070
    Public contact
    Clin Trial Reg & Results Disclosure, UCB BIOSCIENCES GmbH, clinicaltrials@ucb.com
    Scientific contact
    Clin Trial Reg & Results Disclosure, UCB BIOSCIENCES GmbH, clinicaltrials@ucb.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    05 Mar 2020
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    07 Jan 2020
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    Compare the efficacy of bimekizumab versus placebo in the treatment of participants with moderate to severe plaque psoriasis (PSO)
    Protection of trial subjects
    During the conduct of the study all participants were closely monitored.
    Background therapy
    Not Applicable
    Evidence for comparator
    Not Applicable
    Actual start date of recruitment
    05 Feb 2018
    Long term follow-up planned
    Yes
    Long term follow-up rationale
    Safety
    Long term follow-up duration
    3 Years
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Australia: 10
    Country: Number of subjects enrolled
    Canada: 89
    Country: Number of subjects enrolled
    Germany: 38
    Country: Number of subjects enrolled
    Hungary: 31
    Country: Number of subjects enrolled
    Poland: 150
    Country: Number of subjects enrolled
    Russian Federation: 19
    Country: Number of subjects enrolled
    Korea, Republic of: 7
    Country: Number of subjects enrolled
    United Kingdom: 6
    Country: Number of subjects enrolled
    United States: 85
    Worldwide total number of subjects
    435
    EEA total number of subjects
    225
    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)
    410
    From 65 to 84 years
    25
    85 years and over
    0

    Subject disposition

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

    Pre-assignment
    Screening details
    Study has a 2-5 weeks Screening Period, a 16 weeks Initial Period, a 40 weeks Randomized-Withdrawal Period (RWP) and a SFU Period (20 weeks after final dose). Participants who did not achieve a PASI90 response at Wk16 or who relapsed at Wk20/later during the RWP, entered 12 weeks of escape treatment. Participant Flow refers to the Randomized Set.

    Period 1
    Period 1 title
    Initial Treatment Period: up to Wk16
    Is this the baseline period?
    Yes
    Allocation method
    Randomised - controlled
    Blinding used
    Double blind
    Roles blinded
    Carer, Investigator, Subject, Assessor

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    Placebo
    Arm description
    Participants received placebo for 16 weeks. Participants who achieved a Psoriasis Area Severity Index (PASI) 90 response criteria proceeded with placebo until Week 56. Participants who did not achieve a PASI90 response criteria at Week 16 or who relapsed at Week 20 or later, entered the escape arm and received open-label bimekizumab dose regimen 1 for 12 weeks.
    Arm type
    Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    PBO
    Other name
    Pharmaceutical forms
    Solution for injection in pre-filled syringe
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Participants received placebo, administered subcutaneously (sc) at pre-specified time points.

    Arm title
    Bimekizumab dose regimen 1
    Arm description
    Participants received bimekizumab dose regimen 1 for 16 weeks. Participants who achieved a PASI90 response criteria were re-randomized to either receive bimekizumab dose regimen 1 or bimekizumab dose regimen 2 or placebo until Week 56. Participants who did not achieve a PASI90 response criteria at Week 16 or who relapsed at Week 20 or later, entered the escape arm and received open-label bimekizumab dose regimen 1 for 12 weeks.
    Arm type
    Experimental

    Investigational medicinal product name
    Bimekizumab
    Investigational medicinal product code
    BKZ
    Other name
    UCB4940
    Pharmaceutical forms
    Solution for injection in pre-filled syringe
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Bimekizumab was provided at pre-specified time intervals.

    Number of subjects in period 1
    Placebo Bimekizumab dose regimen 1
    Started
    86
    349
    Completed
    82
    340
    Not completed
    4
    9
         Lack of efficacy
    2
    1
         Adverse event, non-fatal
    -
    5
         Consent withdrawn by subject
    1
    -
         Lost to follow-up
    1
    3
    Period 2
    Period 2 title
    Week 16 assessment
    Is this the baseline period?
    No
    Allocation method
    Randomised - controlled
    Blinding used
    Double blind
    Roles blinded
    Assessor, Carer, Investigator, Subject

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    Placebo
    Arm description
    Participants received placebo for 16 weeks. Participants who achieved a Psoriasis Area Severity Index (PASI) 90 response criteria proceeded with placebo until Week 56. Participants who did not achieve a PASI90 response criteria at Week 16 or who relapsed at Week 20 or later, entered the escape arm and received open-label bimekizumab dose regimen 1 for 12 weeks.
    Arm type
    Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    PBO
    Other name
    Pharmaceutical forms
    Solution for injection in pre-filled syringe
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Participants received placebo, administered subcutaneously (sc) at pre-specified time points.

    Arm title
    Bimekizumab dose regimen 1
    Arm description
    Participants received bimekizumab dose regimen 1 for 16 weeks. Participants who achieved a PASI90 response criteria were re-randomized to either receive bimekizumab dose regimen 1 or bimekizumab dose regimen 2 or placebo until Week 56. Participants who did not achieve a PASI90 response criteria at Week 16 or who relapsed at Week 20 or later, entered the escape arm and received open-label bimekizumab dose regimen 1 for 12 weeks.
    Arm type
    Experimental

    Investigational medicinal product name
    Bimekizumab
    Investigational medicinal product code
    BKZ
    Other name
    UCB4940
    Pharmaceutical forms
    Solution for injection in pre-filled syringe
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Bimekizumab was provided at pre-specified time intervals.

    Number of subjects in period 2
    Placebo Bimekizumab dose regimen 1
    Started
    82
    340
    Received escape treatment
    81
    23 [1]
    Completed
    1
    311
    Not completed
    81
    29
         Incorrect escapers
    -
    6
         PASI90 Non-Response at Week 16
    81
    23
    Notes
    [1] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left.
    Justification: Number of participants at the milestones reflects those who did not achieve a PASI90 response at Week 16 of the Initial Treatment Period and received open-label bimekizumab dose regime 1 for 12 weeks (ie, escape treatment).
    Period 3
    Period 3 title
    Randomized-Withdrawal Period: up to Wk56
    Is this the baseline period?
    No
    Allocation method
    Randomised - controlled
    Blinding used
    Double blind
    Roles blinded
    Assessor, Carer, Investigator, Subject

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    Placebo/Placebo
    Arm description
    Participants in this arm were randomized to placebo during the Initial Treatment Period, achieved a PASI90 response at Week 16 and continued to receive placebo during the Randomized-Withdrawal Period.
    Arm type
    Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    PBO
    Other name
    Pharmaceutical forms
    Solution for injection in pre-filled syringe
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Participants received placebo, administered subcutaneously (sc) at pre-specified time points.

    Arm title
    Bimekizumab dose regimen 1/Placebo
    Arm description
    Participants in this arm were randomized to bimekizumab dose regimen 1 during the Initial Treatment Period, achieved a PASI90 response at Week 16 and were re-randomized to receive placebo during the Randomized-Withdrawal Period.
    Arm type
    Placebo

    Investigational medicinal product name
    Bimekizumab
    Investigational medicinal product code
    BKZ
    Other name
    UCB4940
    Pharmaceutical forms
    Solution for injection in pre-filled syringe
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Bimekizumab was provided at pre-specified time intervals.

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    PBO
    Other name
    Pharmaceutical forms
    Solution for injection in pre-filled syringe
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Participants received placebo, administered subcutaneously (sc) at pre-specified time points.

    Arm title
    Bimekizumab dose regimen 1/dose regimen 2
    Arm description
    Participants in this arm were randomized to bimekizumab dose regimen 1 during the Initial Treatment Period, achieved a PASI90 response at Week 16 and were re-randomized to receive bimekizumab dose regimen 2 during the Randomized-Withdrawal Period. Participants receiving dose regimen 2 received placebo at pre-specified time points to maintain the blinding.
    Arm type
    Experimental

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    PBO
    Other name
    Pharmaceutical forms
    Solution for injection in pre-filled syringe
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Participants received placebo, administered subcutaneously (sc) at pre-specified time points.

    Investigational medicinal product name
    Bimekizumab
    Investigational medicinal product code
    BKZ
    Other name
    UCB4940
    Pharmaceutical forms
    Solution for injection in pre-filled syringe
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Bimekizumab was provided at pre-specified time intervals.

    Arm title
    Bimekizumab dose regimen 1/dose regimen 1
    Arm description
    Participants in this arm were randomized to bimekizumab dose regimen 1 during the Initial Treatment Period, achieved a PASI90 response at Week 16 and continued to receive bimekizumab dose regimen 1 during the Randomized-Withdrawal Period.
    Arm type
    Experimental

    Investigational medicinal product name
    Bimekizumab
    Investigational medicinal product code
    BKZ
    Other name
    UCB4940
    Pharmaceutical forms
    Solution for injection in pre-filled syringe
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Bimekizumab was provided at pre-specified time intervals.

    Number of subjects in period 3
    Placebo/Placebo Bimekizumab dose regimen 1/Placebo Bimekizumab dose regimen 1/dose regimen 2 Bimekizumab dose regimen 1/dose regimen 1
    Started
    1
    105
    100
    106
    Received escape treatment
    0 [2]
    67
    4 [3]
    7 [4]
    Completed
    1
    33
    93
    94
    Not completed
    0
    72
    7
    12
         Relapse at Week 20 or later
    -
    67
    4
    7
         Adverse event, non-fatal
    -
    3
    2
    -
         Consent withdrawn by subject
    -
    -
    -
    3
         Lost to follow-up
    -
    2
    1
    2
    Notes
    [2] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left.
    Justification: Number of participants at the milestones reflects those who relapse at Week 20 or later during the Randomized-Withdrawal Period (up to Week 56) and received open-label bimekizumab dose regime 1 for 12 weeks (ie, escape treatment).
    [3] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left.
    Justification: Number of participants at the milestones reflects those who relapse at Week 20 or later during the Randomized-Withdrawal Period (up to Week 56) and received open-label bimekizumab dose regime 1 for 12 weeks (ie, escape treatment).
    [4] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left.
    Justification: Number of participants at the milestones reflects those who relapse at Week 20 or later during the Randomized-Withdrawal Period (up to Week 56) and received open-label bimekizumab dose regime 1 for 12 weeks (ie, escape treatment).
    Period 4
    Period 4 title
    Escape Treatment: 12 Weeks
    Is this the baseline period?
    No
    Allocation method
    Not applicable
    Blinding used
    Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    Placebo Escape
    Arm description
    Participants in this arm were randomized to placebo during the Initial Treatment Period, did not achieve a PASI90 response at Week 16, entered the escape arm and received open-label bimekizumab dose regimen 1 for 12 weeks.
    Arm type
    Experimental

    Investigational medicinal product name
    Bimekizumab
    Investigational medicinal product code
    BKZ
    Other name
    UCB4940
    Pharmaceutical forms
    Solution for injection in pre-filled syringe
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Bimekizumab was provided at pre-specified time intervals.

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    PBO
    Other name
    Pharmaceutical forms
    Solution for injection in pre-filled syringe
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Participants received placebo, administered subcutaneously (sc) at pre-specified time points.

    Arm title
    Bimekizumab dose regimen 1 Escape
    Arm description
    Participants in this arm were randomized to bimekizumab dose regimen 1 during the Initial Treatment Period, did not achieve a PASI90 response at Week 16, entered the escape arm and received open-label bimekizumab dose regimen 1 for 12 weeks.
    Arm type
    Experimental

    Investigational medicinal product name
    Bimekizumab
    Investigational medicinal product code
    BKZ
    Other name
    UCB4940
    Pharmaceutical forms
    Solution for injection in pre-filled syringe
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Bimekizumab was provided at pre-specified time intervals.

    Arm title
    Bimekizumab dose regimen 1/ Placebo Escape
    Arm description
    Participants in this arm were randomized to bimekizumab dose regimen 1 during the Initial Treatment Period, achieved a PASI90 response at Week 16 and were re-randomized to receive placebo during the Randomized-Withdrawal Period. Participants relapsed at Week 20 or later, entered the escape arm and received open-label bimekizumab dose regimen 1 for 12 weeks.
    Arm type
    Experimental

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    PBO
    Other name
    Pharmaceutical forms
    Solution for injection in pre-filled syringe
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Participants received placebo, administered subcutaneously (sc) at pre-specified time points.

    Investigational medicinal product name
    Bimekizumab
    Investigational medicinal product code
    BKZ
    Other name
    UCB4940
    Pharmaceutical forms
    Solution for injection in pre-filled syringe
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Bimekizumab was provided at pre-specified time intervals.

    Arm title
    Bimekizumab dose regimen 1/dose regimen 2 Escape
    Arm description
    Participants in this arm were randomized to bimekizumab dose regimen 1 during the Initial Treatment Period, achieved a PASI90 response at Week 16 and were re-randomized to receive bimekizumab dose regimen 2 during the Randomized-Withdrawal Period. Participants relapsed at Week 20 or later, entered the escape arm and received open-label bimekizumab dose regimen 1 for 12 weeks. Participants receiving dose regimen 2 received placebo at pre-specified time points to maintain the blinding.
    Arm type
    Experimental

    Investigational medicinal product name
    Bimekizumab
    Investigational medicinal product code
    BKZ
    Other name
    UCB4940
    Pharmaceutical forms
    Solution for injection in pre-filled syringe
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Bimekizumab was provided at pre-specified time intervals.

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    PBO
    Other name
    Pharmaceutical forms
    Solution for injection in pre-filled syringe
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Participants received placebo, administered subcutaneously (sc) at pre-specified time points.

    Arm title
    Bimekizumab dose regimen 1/dose regimen 1 Escape
    Arm description
    Participants in this arm were randomized to bimekizumab dose regimen 1 during the Initial Treatment Period, achieved a PASI90 response at Week 16 and continued to receive bimekizumab dose regimen 1 during the Randomized-Withdrawal Period. Participants relapsed at Week 20 or later, entered the escape arm and received open-label bimekizumab dose regimen 1 for 12 weeks.
    Arm type
    Experimental

    Investigational medicinal product name
    Bimekizumab
    Investigational medicinal product code
    BKZ
    Other name
    UCB4940
    Pharmaceutical forms
    Solution for injection in pre-filled syringe
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Bimekizumab was provided at pre-specified time intervals.

    Number of subjects in period 4 [5]
    Placebo Escape Bimekizumab dose regimen 1 Escape Bimekizumab dose regimen 1/ Placebo Escape Bimekizumab dose regimen 1/dose regimen 2 Escape Bimekizumab dose regimen 1/dose regimen 1 Escape
    Started
    81
    23
    67
    4
    7
    Completed
    81
    22
    66
    4
    7
    Not completed
    0
    1
    1
    0
    0
         Adverse event, non-fatal
    -
    1
    -
    -
    -
         Consent withdrawn by subject
    -
    -
    1
    -
    -
    Notes
    [5] - 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: The Escape Treatment is not a subsequent period to the Randomized-Withdrawal period, but rather a separate period. It gives an overview of the participants who did not achieve a PASI90 response at Week 16 of the Initial Treatment Period and all participants who relapsed at Week 20 or later during the Randomized-Withdrawal Period (up to Week 56).

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Placebo
    Reporting group description
    Participants received placebo for 16 weeks. Participants who achieved a Psoriasis Area Severity Index (PASI) 90 response criteria proceeded with placebo until Week 56. Participants who did not achieve a PASI90 response criteria at Week 16 or who relapsed at Week 20 or later, entered the escape arm and received open-label bimekizumab dose regimen 1 for 12 weeks.

    Reporting group title
    Bimekizumab dose regimen 1
    Reporting group description
    Participants received bimekizumab dose regimen 1 for 16 weeks. Participants who achieved a PASI90 response criteria were re-randomized to either receive bimekizumab dose regimen 1 or bimekizumab dose regimen 2 or placebo until Week 56. Participants who did not achieve a PASI90 response criteria at Week 16 or who relapsed at Week 20 or later, entered the escape arm and received open-label bimekizumab dose regimen 1 for 12 weeks.

    Reporting group values
    Placebo Bimekizumab dose regimen 1 Total
    Number of subjects
    86 349 435
    Age categorical
    Units: Subjects
        <=18 years
    2 1 3
        Between 18 and 65 years
    80 327 407
        >=65 years
    4 21 25
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    43.5 ± 13.1 44.5 ± 12.9 -
    Gender categorical
    Units: Subjects
        Male
    58 255 313
        Female
    28 94 122

    End points

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    End points reporting groups
    Reporting group title
    Placebo
    Reporting group description
    Participants received placebo for 16 weeks. Participants who achieved a Psoriasis Area Severity Index (PASI) 90 response criteria proceeded with placebo until Week 56. Participants who did not achieve a PASI90 response criteria at Week 16 or who relapsed at Week 20 or later, entered the escape arm and received open-label bimekizumab dose regimen 1 for 12 weeks.

    Reporting group title
    Bimekizumab dose regimen 1
    Reporting group description
    Participants received bimekizumab dose regimen 1 for 16 weeks. Participants who achieved a PASI90 response criteria were re-randomized to either receive bimekizumab dose regimen 1 or bimekizumab dose regimen 2 or placebo until Week 56. Participants who did not achieve a PASI90 response criteria at Week 16 or who relapsed at Week 20 or later, entered the escape arm and received open-label bimekizumab dose regimen 1 for 12 weeks.
    Reporting group title
    Placebo
    Reporting group description
    Participants received placebo for 16 weeks. Participants who achieved a Psoriasis Area Severity Index (PASI) 90 response criteria proceeded with placebo until Week 56. Participants who did not achieve a PASI90 response criteria at Week 16 or who relapsed at Week 20 or later, entered the escape arm and received open-label bimekizumab dose regimen 1 for 12 weeks.

    Reporting group title
    Bimekizumab dose regimen 1
    Reporting group description
    Participants received bimekizumab dose regimen 1 for 16 weeks. Participants who achieved a PASI90 response criteria were re-randomized to either receive bimekizumab dose regimen 1 or bimekizumab dose regimen 2 or placebo until Week 56. Participants who did not achieve a PASI90 response criteria at Week 16 or who relapsed at Week 20 or later, entered the escape arm and received open-label bimekizumab dose regimen 1 for 12 weeks.
    Reporting group title
    Placebo/Placebo
    Reporting group description
    Participants in this arm were randomized to placebo during the Initial Treatment Period, achieved a PASI90 response at Week 16 and continued to receive placebo during the Randomized-Withdrawal Period.

    Reporting group title
    Bimekizumab dose regimen 1/Placebo
    Reporting group description
    Participants in this arm were randomized to bimekizumab dose regimen 1 during the Initial Treatment Period, achieved a PASI90 response at Week 16 and were re-randomized to receive placebo during the Randomized-Withdrawal Period.

    Reporting group title
    Bimekizumab dose regimen 1/dose regimen 2
    Reporting group description
    Participants in this arm were randomized to bimekizumab dose regimen 1 during the Initial Treatment Period, achieved a PASI90 response at Week 16 and were re-randomized to receive bimekizumab dose regimen 2 during the Randomized-Withdrawal Period. Participants receiving dose regimen 2 received placebo at pre-specified time points to maintain the blinding.

    Reporting group title
    Bimekizumab dose regimen 1/dose regimen 1
    Reporting group description
    Participants in this arm were randomized to bimekizumab dose regimen 1 during the Initial Treatment Period, achieved a PASI90 response at Week 16 and continued to receive bimekizumab dose regimen 1 during the Randomized-Withdrawal Period.
    Reporting group title
    Placebo Escape
    Reporting group description
    Participants in this arm were randomized to placebo during the Initial Treatment Period, did not achieve a PASI90 response at Week 16, entered the escape arm and received open-label bimekizumab dose regimen 1 for 12 weeks.

    Reporting group title
    Bimekizumab dose regimen 1 Escape
    Reporting group description
    Participants in this arm were randomized to bimekizumab dose regimen 1 during the Initial Treatment Period, did not achieve a PASI90 response at Week 16, entered the escape arm and received open-label bimekizumab dose regimen 1 for 12 weeks.

    Reporting group title
    Bimekizumab dose regimen 1/ Placebo Escape
    Reporting group description
    Participants in this arm were randomized to bimekizumab dose regimen 1 during the Initial Treatment Period, achieved a PASI90 response at Week 16 and were re-randomized to receive placebo during the Randomized-Withdrawal Period. Participants relapsed at Week 20 or later, entered the escape arm and received open-label bimekizumab dose regimen 1 for 12 weeks.

    Reporting group title
    Bimekizumab dose regimen 1/dose regimen 2 Escape
    Reporting group description
    Participants in this arm were randomized to bimekizumab dose regimen 1 during the Initial Treatment Period, achieved a PASI90 response at Week 16 and were re-randomized to receive bimekizumab dose regimen 2 during the Randomized-Withdrawal Period. Participants relapsed at Week 20 or later, entered the escape arm and received open-label bimekizumab dose regimen 1 for 12 weeks. Participants receiving dose regimen 2 received placebo at pre-specified time points to maintain the blinding.

    Reporting group title
    Bimekizumab dose regimen 1/dose regimen 1 Escape
    Reporting group description
    Participants in this arm were randomized to bimekizumab dose regimen 1 during the Initial Treatment Period, achieved a PASI90 response at Week 16 and continued to receive bimekizumab dose regimen 1 during the Randomized-Withdrawal Period. Participants relapsed at Week 20 or later, entered the escape arm and received open-label bimekizumab dose regimen 1 for 12 weeks.

    Subject analysis set title
    Placebo (RS)
    Subject analysis set type
    Full analysis
    Subject analysis set description
    Participants received placebo for 16 weeks. Participants who achieved a Psoriasis Area Severity Index (PASI) 90 response criteria proceeded with placebo until Week 56. Participants who did not achieve a PASI90 response criteria at Week 16 or who relapsed at Week 20 or later, entered the escape arm and received open-label bimekizumab dose regimen 1 for 12 weeks. Participants formed the Randomized Set (RS).

    Subject analysis set title
    Bimekizumab dose regimen 1 (RS)
    Subject analysis set type
    Full analysis
    Subject analysis set description
    Participants received bimekizumab dose regimen 1 for 16 weeks. Participants who achieved a PASI90 response criteria were re-randomized to either receive bimekizumab dose regimen 1 or bimekizumab dose regimen 2 or placebo until Week 56. Participants who did not achieve a PASI90 response criteria at Week 16 or who relapsed at Week 20 or later, entered the escape arm and received open-label bimekizumab dose regimen 1 for 12 weeks. Participants formed the RS.

    Subject analysis set title
    Placebo (SS)
    Subject analysis set type
    Safety analysis
    Subject analysis set description
    Participants received placebo for 16 weeks. Participants who achieved a Psoriasis Area Severity Index (PASI) 90 response criteria proceeded with placebo until Week 56. Participants who did not achieve a PASI90 response criteria at Week 16 or who relapsed at Week 20 or later, entered the escape arm and received open-label bimekizumab dose regimen 1 for 12 weeks. Participants formed the Safety Set (SS).

    Subject analysis set title
    Bimekizumab dose regimen 1 (SS)
    Subject analysis set type
    Safety analysis
    Subject analysis set description
    Participants received bimekizumab dose regimen 1 for 16 weeks. Participants who achieved a PASI90 response criteria were re-randomized to either receive bimekizumab dose regimen 1 or bimekizumab dose regimen 2 or placebo until Week 56. Participants who did not achieve a PASI90 response criteria at Week 16 or who relapsed at Week 20 or later, entered the escape arm and received open-label bimekizumab dose regimen 1 for 12 weeks. Participants formed the SS.

    Subject analysis set title
    Placebo/Placebo (WK16ResS)
    Subject analysis set type
    Sub-group analysis
    Subject analysis set description
    Participants in this arm were randomized to placebo during the Initial Treatment Period, achieved a PASI90 response at Week 16 and continued to receive placebo during the Randomized-Withdrawal Period. Participants formed the Week 16 Responder Set (WK16ResS).

    Subject analysis set title
    Bimekizumab dose regimen 1/Placebo (WK16ResS)
    Subject analysis set type
    Sub-group analysis
    Subject analysis set description
    Participants in this arm were randomized to bimekizumab dose regimen 1 during the Initial Treatment Period, achieved a PASI90 response at Week 16 and were re-randomized to receive placebo during the Randomized-Withdrawal Period. Participants formed the WK16ResS.

    Subject analysis set title
    Bimekizumab dose regimen 1/dose regimen 2 (WK16ResS)
    Subject analysis set type
    Sub-group analysis
    Subject analysis set description
    Participants in this arm were randomized to bimekizumab dose regimen 1 during the Initial Treatment Period, achieved a PASI90 response at Week 16 and were re-randomized to receive bimekizumab dose regimen 2 during the Randomized-Withdrawal Period. Participants formed the WK16ResS. Participants receiving dose regimen 2 received placebo at pre-specified time points to maintain the blinding.

    Subject analysis set title
    Bimekizumab dose regimen 1/dose regimen 1 (WK16ResS)
    Subject analysis set type
    Sub-group analysis
    Subject analysis set description
    Participants in this arm were randomized to bimekizumab dose regimen 1 during the Initial Treatment Period, achieved a PASI90 response at Week 16 and continued to receive bimekizumab dose regimen 1 during the Randomized-Withdrawal Period. Participants formed the WK16ResS.

    Subject analysis set title
    Placebo Escape (ESS)
    Subject analysis set type
    Sub-group analysis
    Subject analysis set description
    Participants in this arm were randomized to placebo during the Initial Treatment Period, did not achieve a PASI90 response at Week 16, entered the escape arm and received open-label bimekizumab dose regimen 1 for 12 weeks. Participants formed the Escape Study Participant Set (ESS).

    Subject analysis set title
    Bimekizumab dose regimen 1 Escape (ESS)
    Subject analysis set type
    Sub-group analysis
    Subject analysis set description
    Participants in this arm were randomized to bimekizumab dose regimen 1 during the Initial Treatment Period, did not achieve a PASI90 response at Week 16, entered the escape arm and received open-label bimekizumab dose regimen 1 for 12 weeks. Participants formed the ESS.

    Subject analysis set title
    Bimekizumab dose regimen 1/ Placebo Escape (ESS)
    Subject analysis set type
    Sub-group analysis
    Subject analysis set description
    Participants in this arm were randomized to bimekizumab dose regimen 1 during the Initial Treatment Period, achieved a PASI90 response at Week 16 and were re-randomized to receive placebo during the Randomized-Withdrawal Period. Participants relapsed at Week 20 or later, entered the escape arm and received open-label bimekizumab dose regimen 1 for 12 weeks. Participants formed the ESS.

    Subject analysis set title
    Bimekizumab dose regimen 1/dose regimen 2 Escape (ESS)
    Subject analysis set type
    Sub-group analysis
    Subject analysis set description
    Participants in this arm were randomized to bimekizumab dose regimen 1 during the Initial Treatment Period, achieved a PASI90 response at Week 16 and were re-randomized to receive bimekizumab dose regimen 2 during the Randomized-Withdrawal Period. Participants relapsed at Week 20 or later, entered the escape arm and received open-label bimekizumab dose regimen 1 for 12 weeks. Participants formed the ESS. Participants receiving dose regimen 2 received placebo at pre-specified time points to maintain the blinding.

    Subject analysis set title
    Bimekizumab dose regimen 1/dose regimen 1 Escape (ESS)
    Subject analysis set type
    Sub-group analysis
    Subject analysis set description
    Participants in this arm were randomized to bimekizumab dose regimen 1 during the Initial Treatment Period, achieved a PASI90 response at Week 16 and continued to receive bimekizumab dose regimen 1 during the Randomized-Withdrawal Period. Participants relapsed at Week 20 or later, entered the escape arm and received open-label bimekizumab dose regimen 1 for 12 weeks. Participants formed the ESS.

    Subject analysis set title
    Bimekizumab dose regimen 1/ 1 + dose regimen 1/ 2 (WK16ResS)
    Subject analysis set type
    Sub-group analysis
    Subject analysis set description
    This arm consists of participants who were randomized to bimekizumab dose regimen 1 during the Initial Treatment Period, achieved a PASI90 response at Week 16 and continued to receive bimekizumab dose regimen 1 during the Randomized-Withdrawal Period and those who were re-randomized to receive bimekizumab dose regimen 2 during the Randomized-Withdrawal Period. Participants formed the WK16ResS. Participants receiving dose regimen 2 received placebo at pre-specified time points to maintain the blinding.

    Primary: Percentage of participants with a Psoriasis Area and Severity Index 90 (PASI90) response at Week 16

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    End point title
    Percentage of participants with a Psoriasis Area and Severity Index 90 (PASI90) response at Week 16
    End point description
    A PASI90 responder was defined as a participant that achieved 90% reduction from Baseline in the PASI score. Body divided into 4 areas: head/arms/trunk to groin/legs to top of buttocks. Assignment of an average score for the redness, thickness, and scaling for each of the 4 body areas with a score of 0 (clear)-4 (very marked). Determining the percentage of skin covered with PSO for each of the body areas and converting to a 0-6 scale. Final PASI=average redness, thickness, and scaliness of the psoriatic skin lesions, multiplied by the involved psoriasis area score of the respective section, and weighted by the percentage of the person’s affected skin for the respective section. The min possible PASI score is 0=no disease, the max score is 72=maximal disease. Study participants with missing score at Week 16 were counted as nonresponders (NRI). The Randomized Set (RS) consisted of all randomized study participants.
    End point type
    Primary
    End point timeframe
    At Week 16
    End point values
    Placebo (RS) Bimekizumab dose regimen 1 (RS)
    Number of subjects analysed
    86
    349
    Units: percentage of participants
        number (not applicable)
    1.2
    90.8
    Statistical analysis title
    Statistical analysis 1
    Statistical analysis description
    Odds ratio: Bimekizumab/Placebo calculated using stratified Cochran-Mantel-Haenszel (CMH) test with region and prior biologic exposure as stratification variables.
    Comparison groups
    Bimekizumab dose regimen 1 (RS) v Placebo (RS)
    Number of subjects included in analysis
    435
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.001 [1]
    Method
    Cochran-Mantel-Haenszel
    Parameter type
    Odds ratio (OR)
    Point estimate
    496.318
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    82.798
         upper limit
    2975.086
    Notes
    [1] - P-values for the comparison of treatment groups were based on the CMH test from the general association.

    Primary: Percentage of participants with an Investigator's Global Assessment (IGA) response at Week 16

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    End point title
    Percentage of participants with an Investigator's Global Assessment (IGA) response at Week 16
    End point description
    The Investigator's Global Assessment (IGA) measures the overall psoriasis severity following a 5-point scale (0-4), where scale 0= clear, no signs of psoriasis; presence of post-Inflammatory hyperpigmentation, scale 1= almost clear, no thickening; normal to pink coloration; no to minimal focal scaling, scale 2= mild thickening, pink to light red coloration and predominately fine scaling, 3= moderate, clearly distinguishable to moderate thickening; dull to bright red, clearly distinguishable to moderate thickening; moderate scaling and 4= severe thickening with hard edges; bright to deep dark red coloration; severe/coarse scaling covering almost all or all lesions. IGA response was defined as Clear or Almost Clear with at least a 2-category improvement relative to Baseline. Study participants with missing score at Week 16 were counted as nonresponders (NRI). The Randomized Set (RS) consisted of all randomized study participants.
    End point type
    Primary
    End point timeframe
    At Week 16
    End point values
    Placebo (RS) Bimekizumab dose regimen 1 (RS)
    Number of subjects analysed
    86
    349
    Units: percentage of participants
        number (not applicable)
    1.2
    92.6
    Statistical analysis title
    Statistical analysis 1
    Statistical analysis description
    Odds ratio: Bimekizumab/Placebo calculated using stratified Cochran-Mantel-Haenszel (CMH) test with region and prior biologic exposure as stratification variables.
    Comparison groups
    Bimekizumab dose regimen 1 (RS) v Placebo (RS)
    Number of subjects included in analysis
    435
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.001 [2]
    Method
    Cochran-Mantel-Haenszel
    Parameter type
    Odds ratio (OR)
    Point estimate
    657.255
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    105.792
         upper limit
    4083.333
    Notes
    [2] - P-values for the comparison of treatment groups were based on the CMH test from the general association.

    Secondary: Percentage of participants with a PASI100 response at Week 16

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    End point title
    Percentage of participants with a PASI100 response at Week 16
    End point description
    A PASI100 responder was defined as a participant that achieved 100% reduction from Baseline in the PASI score. Body divided into 4 areas: head/arms/trunk to groin/legs to top of buttocks. Assignment of an average score for the redness, thickness, and scaling for each of the 4 body areas with a score of 0 (clear)-4 (very marked). Determining the percentage of skin covered with PSO for each of the body areas and converting to a 0-6 scale. Final PASI= average redness, thickness, and scaliness of the psoriatic skin lesions, multiplied by the involved psoriasis area score of the respective section, and weighted by the percentage of the person’s affected skin for the respective section. The min possible PASI score is 0=no disease, the max score is 72=maximal disease. Study participants with missing score at Week 16 were counted as nonresponders (NRI). The Randomized Set (RS) consisted of all randomized study participants.
    End point type
    Secondary
    End point timeframe
    At Week 16
    End point values
    Placebo (RS) Bimekizumab dose regimen 1 (RS)
    Number of subjects analysed
    86
    349
    Units: percentage of participants
        number (not applicable)
    1.2
    68.2
    Statistical analysis title
    Statistical analysis 1
    Statistical analysis description
    Odds ratio: Bimekizumab/Placebo calculated using stratified Cochran-Mantel-Haenszel (CMH) test with region and prior biologic exposure as stratification variables.
    Comparison groups
    Bimekizumab dose regimen 1 (RS) v Placebo (RS)
    Number of subjects included in analysis
    435
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.001 [3]
    Method
    Cochran-Mantel-Haenszel
    Parameter type
    Odds ratio (OR)
    Point estimate
    220.038
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    28.757
         upper limit
    1683.639
    Notes
    [3] - P-values for the comparison of treatment groups were based on the CMH test from the general association.

    Secondary: Percentage of participants with a IGA Clear response at Week 16

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    End point title
    Percentage of participants with a IGA Clear response at Week 16
    End point description
    The Investigator's Global Assessment (IGA) measures the overall psoriasis severity following a 5-point scale (0-4), where scale 0= clear, no signs of psoriasis; presence of post-inflammatory hyperpigmentation, scale 1= almost clear, no thickening; normal to pink coloration; no to minimal focal scaling, scale 2= mild thickening, pink to light red coloration and predominately fine scaling, 3= moderate, clearly distinguishable to moderate thickening; dull to bright red, clearly distinguishable to moderate thickening; moderate scaling and 4= severe thickening with hard edges; bright to deep dark red coloration; severe/coarse scaling covering almost all or all lesions. IGA response was defined as Clear with at least >= 2 category improvement relative to Baseline. Study participants with missing score at Week 16 were counted as nonresponders (NRI). The Randomized Set (RS) consisted of all randomized study participants.
    End point type
    Secondary
    End point timeframe
    At Week 16
    End point values
    Placebo (RS) Bimekizumab dose regimen 1 (RS)
    Number of subjects analysed
    86
    349
    Units: percentage of participants
        number (not applicable)
    1.2
    69.6
    Statistical analysis title
    Statistical analysis 1
    Statistical analysis description
    Odds ratio: Bimekizumab/Placebo calculated using stratified Cochran-Mantel-Haenszel (CMH) test with region and prior biologic exposure as stratification variables.
    Comparison groups
    Bimekizumab dose regimen 1 (RS) v Placebo (RS)
    Number of subjects included in analysis
    435
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.001 [4]
    Method
    Cochran-Mantel-Haenszel
    Parameter type
    Odds ratio (OR)
    Point estimate
    224.744
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    30.13
         upper limit
    1676.425
    Notes
    [4] - P-values for the comparison of treatment groups were based on the CMH test from the general association.

    Secondary: Percentage of participants with a PASI75 response at Week 4

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    End point title
    Percentage of participants with a PASI75 response at Week 4
    End point description
    A PASI75 responder was defined as a participant that achieved 75% reduction from Baseline in the PASI score. Body divided into 4 areas: head/arms/trunk to groin/legs to top of buttocks. Assignment of an average score for the redness, thickness, and scaling for each of the 4 body areas with a score of 0 (clear)-4 (very marked). Determining the percentage of skin covered with PSO for each of the body areas and converting to a 0-6 scale. Final PASI= average redness, thickness, and scaliness of the psoriatic skin lesions, multiplied by the involved psoriasis area score of the respective section, and weighted by the percentage of the person’s affected skin for the respective section. The min possible PASI score is 0=no disease, the max score is 72=maximal disease. Study participants with missing score at a given week were counted as nonresponders. The Randomized Set (RS) consisted of all randomized study participants.
    End point type
    Secondary
    End point timeframe
    At Week 4
    End point values
    Placebo (RS) Bimekizumab dose regimen 1 (RS)
    Number of subjects analysed
    86
    349
    Units: percentage of participants
        number (not applicable)
    1.2
    75.9
    Statistical analysis title
    Statistical analysis 1
    Statistical analysis description
    Odds ratio: Bimekizumab/Placebo calculated using stratified Cochran-Mantel-Haenszel (CMH) test with region and prior biologic exposure as stratification variables.
    Comparison groups
    Bimekizumab dose regimen 1 (RS) v Placebo (RS)
    Number of subjects included in analysis
    435
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.001 [5]
    Method
    Cochran-Mantel-Haenszel
    Parameter type
    Odds ratio (OR)
    Point estimate
    316.641
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    39.423
         upper limit
    2543.254
    Notes
    [5] - P-values for the comparison of treatment groups were based on the CMH test from the general association.

    Secondary: Percentage of participants with a Patient Symptom Diary response for pain at Week 16

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    End point title
    Percentage of participants with a Patient Symptom Diary response for pain at Week 16
    End point description
    A PRO measure, the PSD (further published as P-SIM) was used to assess key symptoms relevant to patients with moderate to severe plaque psoriasis. Site staff trained the participants on the use of the electronic device used to collect ePRO diary data at the Screening Visit, following which the device was dispensed to the participant for home use until the Week 16 Visit. The ePRO diary was completed on a daily basis from Screening to the Week 16 Visit. PSD score for pain was an average of daily values over the week prior to the visit. The response variable was characterized in terms of cumulative percent of participants demonstrating a prespecified point improvement (above the 1.98 response threshold) at Week 16. Analysis was limited to participants with a Baseline score at or above the 1.98 response threshold. The RS consisted of all randomized participants. Number of participants analyzed reflect those with a Baseline score at or above the 1.98 response threshold.
    End point type
    Secondary
    End point timeframe
    At Week 16
    End point values
    Placebo (RS) Bimekizumab dose regimen 1 (RS)
    Number of subjects analysed
    67
    255
    Units: percentage of participants
        number (not applicable)
    9.0
    78.8
    Statistical analysis title
    Statistical analysis 1
    Statistical analysis description
    Odds ratio: Bimekizumab/Placebo calculated using stratified Cochran-Mantel-Haenszel (CMH) test with region and prior biologic exposure as stratification variables.
    Comparison groups
    Bimekizumab dose regimen 1 (RS) v Placebo (RS)
    Number of subjects included in analysis
    322
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.001 [6]
    Method
    Cochran-Mantel-Haenszel
    Parameter type
    Odds ratio (OR)
    Point estimate
    34.325
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    14.22
         upper limit
    82.856
    Notes
    [6] - P-values for the comparison of treatment groups were based on the CMH test from the general association.

    Secondary: Percentage of participants with a Patient Symptom Diary response for itch at Week 16

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    End point title
    Percentage of participants with a Patient Symptom Diary response for itch at Week 16
    End point description
    A PRO measure, the PSD (further published as P-SIM) was used to assess key symptoms relevant to patients with moderate to severe plaque psoriasis. Site staff trained the participants on the use of the electronic device used to collect ePRO diary data at the Screening Visit, following which the device was dispensed to the participant for home use until the Week 16 Visit. The ePRO diary was completed on a daily basis from Screening to the Week 16 Visit. PSD score for itch was an average of daily values over the week prior to the visit. The response variable was characterized in terms of cumulative percent of participants demonstrating a prespecified point improvement (above the 2.39 response threshold) at Week 16. Analysis was limited to participants with a Baseline score at or above the 2.39 response threshold. The RS consisted of all randomized participants. Number of participants analyzed reflect those with a Baseline score at or above the 2.39 response threshold.
    End point type
    Secondary
    End point timeframe
    At Week 16
    End point values
    Placebo (RS) Bimekizumab dose regimen 1 (RS)
    Number of subjects analysed
    72
    278
    Units: percentage of participants
        number (not applicable)
    5.6
    75.5
    Statistical analysis title
    Statistical analysis 1
    Statistical analysis description
    Odds ratio: Bimekizumab/Placebo calculated using stratified Cochran-Mantel-Haenszel (CMH) test with region and prior biologic exposure as stratification variables.
    Comparison groups
    Bimekizumab dose regimen 1 (RS) v Placebo (RS)
    Number of subjects included in analysis
    350
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.001 [7]
    Method
    Cochran-Mantel-Haenszel
    Parameter type
    Odds ratio (OR)
    Point estimate
    43.497
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    15.728
         upper limit
    120.295
    Notes
    [7] - P-values for the comparison of treatment groups were based on the CMH test from the general association.

    Secondary: Percentage of participants with a Patient Symptom Diary response for scaling at Week 16

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    End point title
    Percentage of participants with a Patient Symptom Diary response for scaling at Week 16
    End point description
    A PRO measure, the PSD (further published as P-SIM) was used to assess key symptoms relevant to patients with moderate to severe plaque psoriasis. Site staff trained the participants on the use of the electronic device used to collect ePRO diary data at the Screening Visit, following which the device was dispensed to the participant for home use until the Week 16 Visit. The ePRO diary was completed on a daily basis from Screening to the Week 16 Visit. PSD score for scaling was an average of daily values over the week prior to the visit. The response variable was characterized in terms of cumulative percent of participants demonstrating a prespecified point improvement (above the 2.86 response threshold) at Week 16. Analysis was limited to participants with a Baseline score at or above the 2.86 response threshold. The RS consisted of all randomized participants. Number of participants analyzed reflect those with a Baseline score at or above the 2.86 response threshold.
    End point type
    Secondary
    End point timeframe
    At Week 16
    End point values
    Placebo (RS) Bimekizumab dose regimen 1 (RS)
    Number of subjects analysed
    70
    286
    Units: percentage of participants
        number (not applicable)
    5.7
    78.0
    Statistical analysis title
    Statistical analysis 1
    Statistical analysis description
    Odds ratio: Bimekizumab/Placebo calculated using stratified Cochran-Mantel-Haensze (CMH) test with region and prior biologic exposure as stratification variables.
    Comparison groups
    Bimekizumab dose regimen 1 (RS) v Placebo (RS)
    Number of subjects included in analysis
    356
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.001 [8]
    Method
    Cochran-Mantel-Haenszel
    Parameter type
    Odds ratio (OR)
    Point estimate
    60.946
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    20.56
         upper limit
    180.669
    Notes
    [8] - P-values for the comparison of treatment groups were based on the CMH test from the general association.

    Secondary: Percentage of participants with an IGA response (Clear or Almost Clear) at Week 16 for participants with scalp psoriasis (PSO) at Baseline

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    End point title
    Percentage of participants with an IGA response (Clear or Almost Clear) at Week 16 for participants with scalp psoriasis (PSO) at Baseline
    End point description
    Only participants with scalp involvement at Baseline completed the scalp IGA. Participants with scalp involvement at Baseline were defined as those with a scalp IGA score >0 at Baseline. Scalp lesions were assessed in terms of clinical signs of redness, thickness, and scaliness using a 5-point scale (0=Clear, 1=Almost Clear, 2=Mild, 3=Moderate, 4= Severe). Scalp IGA 0/1 response at Week 16 was defined as clear (0) or almost clear (1) with at least a 2-category improvement from Baseline to Week 16. The Randomized Set (RS) consisted of all randomized study participants.
    End point type
    Secondary
    End point timeframe
    At Week 16
    End point values
    Placebo (RS) Bimekizumab dose regimen 1 (RS)
    Number of subjects analysed
    74
    310
    Units: percentage of participants
        number (not applicable)
    6.8
    92.3
    Statistical analysis title
    Statistical analysis 1
    Statistical analysis description
    Odds ratio: Bimekizumab/Placebo calculated using stratified Cochran-Mantel-Haenszel (CMH) test with region and prior biologic exposure as stratification variables.
    Comparison groups
    Bimekizumab dose regimen 1 (RS) v Placebo (RS)
    Number of subjects included in analysis
    384
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.001 [9]
    Method
    Cochran-Mantel-Haenszel
    Parameter type
    Odds ratio (OR)
    Point estimate
    158
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    49.263
         upper limit
    506.745
    Notes
    [9] - P-values for the comparison of treatment groups were based on the CMH test from the general association.

    Secondary: Percentage of participants with a PASI90 response at Week 56 among Week 16 PASI90 responders

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    End point title
    Percentage of participants with a PASI90 response at Week 56 among Week 16 PASI90 responders
    End point description
    A PASI90 responder was defined as a participant that achieved 90% reduction from Baseline in the PASI score. Study participants with missing score at Week 56 or who met the criterion for relapse were counted as nonresponders (NRI). The Week 16 Responder Set (WK16ResS) consisted of all study participants who achieved a PASI90 response at Week 16 and received at least 1 dose of the IMP during the Randomized-Withdrawal Period at Week 16 or later. The hypothesis test for PASI90 at Week 56, based on Wk16ResS, compared pooled BKZ regimens (BKZ dose 1/1 + dose 1/2) versus placebo.
    End point type
    Secondary
    End point timeframe
    At Week 56
    End point values
    Bimekizumab dose regimen 1/Placebo (WK16ResS) Bimekizumab dose regimen 1/dose regimen 2 (WK16ResS) Bimekizumab dose regimen 1/dose regimen 1 (WK16ResS) Bimekizumab dose regimen 1/ 1 + dose regimen 1/ 2 (WK16ResS)
    Number of subjects analysed
    105
    100
    106
    206
    Units: percentage of participants
        number (not applicable)
    16.2
    91.0
    86.8
    88.8
    Statistical analysis title
    Statistical analysis 1
    Statistical analysis description
    Odds ratio: Bimekizumab/Placebo calculated using stratified Cochran-Mantel-Haenszel (CMH) test with region and prior biologic exposure as stratification variables. This statistical analysis is not controlled for multiplicity and is only nominal.
    Comparison groups
    Bimekizumab dose regimen 1/Placebo (WK16ResS) v Bimekizumab dose regimen 1/dose regimen 2 (WK16ResS)
    Number of subjects included in analysis
    205
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.001 [10]
    Method
    Cochran-Mantel-Haenszel
    Parameter type
    Odds ratio (OR)
    Point estimate
    45.192
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    18.622
         upper limit
    109.672
    Notes
    [10] - P-values for the comparison of treatment groups were based on the CMH test from the general association.
    Statistical analysis title
    Statistical analysis 2
    Statistical analysis description
    Odds ratio: Bimekizumab/Placebo calculated using stratified Cochran-Mantel-Haenszel (CMH) test with region and prior biologic exposure as stratification variables. This statistical analysis is not controlled for multiplicity and is only nominal.
    Comparison groups
    Bimekizumab dose regimen 1/Placebo (WK16ResS) v Bimekizumab dose regimen 1/dose regimen 1 (WK16ResS)
    Number of subjects included in analysis
    211
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.001 [11]
    Method
    Cochran-Mantel-Haenszel
    Parameter type
    Odds ratio (OR)
    Point estimate
    49.297
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    18.887
         upper limit
    128.673
    Notes
    [11] - P-values for the comparison of treatment groups were based on the CMH test from the general association.
    Statistical analysis title
    Statistical analysis 3
    Statistical analysis description
    Odds ratio: Bimekizumab/Placebo calculated using stratified Cochran-Mantel-Haenszel (CMH) test with region and prior biologic exposure as stratification variables. This statistical analysis is not controlled for multiplicity and is only nominal.
    Comparison groups
    Bimekizumab dose regimen 1/Placebo (WK16ResS) v Bimekizumab dose regimen 1/ 1 + dose regimen 1/ 2 (WK16ResS)
    Number of subjects included in analysis
    311
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.001 [12]
    Method
    Cochran-Mantel-Haenszel
    Parameter type
    Odds ratio (OR)
    Point estimate
    47.406
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    22.087
         upper limit
    101.75
    Notes
    [12] - P-values for the comparison of treatment groups were based on the CMH test from the general association.

    Secondary: Number of treatment-emergent adverse events (TEAEs) adjusted by duration of participant exposure to study treatment during the Initial Treatment Period

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    End point title
    Number of treatment-emergent adverse events (TEAEs) adjusted by duration of participant exposure to study treatment during the Initial Treatment Period
    End point description
    The number of TEAEs adjusted by duration of exposure to study treatment was scaled such that it provides an incidence rate per 100 patient-years. If a participant had multiple events, the time of exposure was calculated to the first occurrence of the adverse event (AE) being considered. If a participant had no events, the total time at risk was used. The Safety Set (SS) consisted of all study participants who received at least 1 dose of the IMP.
    End point type
    Secondary
    End point timeframe
    From Baseline to end of Initial Treatment Period (up to Week 16)
    End point values
    Placebo (SS) Bimekizumab dose regimen 1 (SS)
    Number of subjects analysed
    86
    349
    Units: no. of new events per 100 subject-years
        number (confidence interval 95%)
    177.38 (123.55 to 246.69)
    323.61 (281.60 to 370.11)
    No statistical analyses for this end point

    Secondary: Number of serious adverse events (SAEs) adjusted by duration of participant exposure to study treatment during the Initial Treatment Period

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    End point title
    Number of serious adverse events (SAEs) adjusted by duration of participant exposure to study treatment during the Initial Treatment Period
    End point description
    The number of SAEs adjusted by duration of exposure to study treatment was scaled such that it provides an incidence rate per 100 patient-years. If a participant had multiple events, the time of exposure was calculated to the first occurrence of the AE being considered. If a participant had no events, the total time at risk was used. The Safety Set (SS) consisted of all study participants who received at least 1 dose of the IMP.
    End point type
    Secondary
    End point timeframe
    From Baseline to end of Initial Treatment Period (up to Week 16)
    End point values
    Placebo (SS) Bimekizumab dose regimen 1 (SS)
    Number of subjects analysed
    86
    349
    Units: no. of new events per 100 subject-years
        number (confidence interval 95%)
    7.66 (0.93 to 27.68)
    5.59 (2.05 to 12.17)
    No statistical analyses for this end point

    Secondary: Number of TEAEs leading to withdrawal adjusted by duration of participant exposure to study treatment during the Initial Treatment Period

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    End point title
    Number of TEAEs leading to withdrawal adjusted by duration of participant exposure to study treatment during the Initial Treatment Period
    End point description
    The number of TEAEs leading to discontinuation adjusted by duration of exposure to study treatment was scaled such that it provides an incidence rate per 100 patient-years. If a participant had multiple events, the time of exposure was calculated to the first occurrence of the AE being considered. If a participant had no events, the total time at risk was used. The Safety Set (SS) consisted of all study participants who received at least 1 dose of the IMP. Here, '999' signifies that 95% CI could not be calculated for this outcome measure because number of TEAEs leading to withdrawal were 0.
    End point type
    Secondary
    End point timeframe
    From Baseline to end of Initial Treatment Period (up to Week 16)
    End point values
    Placebo (SS) Bimekizumab dose regimen 1 (SS)
    Number of subjects analysed
    86
    349
    Units: no. of new events per 100 subject-years
        number (confidence interval 95%)
    0 (-999 to 999)
    2.78 (0.57 to 8.12)
    No statistical analyses for this end point

    Secondary: Number of treatment-emergent adverse events (TEAEs) adjusted by duration of participant exposure to study treatment during the Randomized-Withdrawal Period

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    End point title
    Number of treatment-emergent adverse events (TEAEs) adjusted by duration of participant exposure to study treatment during the Randomized-Withdrawal Period
    End point description
    The number of TEAEs adjusted by duration of exposure to study treatment was scaled such that it provides an incidence rate per 100 patient-years. If a participant had multiple events, the time of exposure was calculated to the first occurrence of the adverse event (AE) being considered. If a participant had no events, the total time at risk was used. The Week 16 Responder Set (WK16ResS) consisted of all study participants who achieved a PASI90 response at Week 16 and received at least 1 dose of the IMP during the Randomized-Withdrawal Period at Week 16 or later.
    End point type
    Secondary
    End point timeframe
    From end of Initial Treatment Period (Week 16) until the Safety Follow-Up (up to 56 weeks duration)
    End point values
    Placebo/Placebo (WK16ResS) Bimekizumab dose regimen 1/Placebo (WK16ResS) Bimekizumab dose regimen 1/dose regimen 2 (WK16ResS) Bimekizumab dose regimen 1/dose regimen 1 (WK16ResS)
    Number of subjects analysed
    1
    105
    100
    106
    Units: no. of new events per 100 subject-years
        number (confidence interval 95%)
    144.37 (3.66 to 804.36)
    242.11 (189.44 to 304.90)
    224.87 (177.46 to 281.05)
    208.88 (165.11 to 260.69)
    No statistical analyses for this end point

    Secondary: Number of serious adverse events (SAEs) adjusted by duration of participant exposure to study treatment during the Randomized-Withdrawal Period

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    End point title
    Number of serious adverse events (SAEs) adjusted by duration of participant exposure to study treatment during the Randomized-Withdrawal Period
    End point description
    The number of SAEs adjusted by duration of exposure to study treatment was scaled such that it provides an incidence rate per 100 patient-years. If a participant had multiple events, the time of exposure was calculated to the first occurrence of the AE being considered. If a participant had no events, the total time at risk was used. The Week 16 Responder Set (WK16ResS) consisted of all study participants who achieved a PASI90 response at Week 16 and received at least 1 dose of the IMP during the Randomized-Withdrawal Period at Week 16 or later. Here, '999' signifies that 95% CI could not be calculated for this outcome measure because number of serious adverse events were 0.
    End point type
    Secondary
    End point timeframe
    From end of Initial Treatment Period (Week 16) until the Safety Follow-Up (up to 56 weeks duration)
    End point values
    Placebo/Placebo (WK16ResS) Bimekizumab dose regimen 1/Placebo (WK16ResS) Bimekizumab dose regimen 1/dose regimen 2 (WK16ResS) Bimekizumab dose regimen 1/dose regimen 1 (WK16ResS)
    Number of subjects analysed
    1
    105
    100
    106
    Units: no. of new events per 100 subject-years
        number (confidence interval 95%)
    0 (-999 to 999)
    7.20 (1.96 to 18.43)
    4.04 (0.83 to 11.80)
    6.64 (2.16 to 15.50)
    No statistical analyses for this end point

    Secondary: Number of TEAEs leading to withdrawal adjusted by duration of participant exposure to study treatment during the Randomized-Withdrawal Period

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    End point title
    Number of TEAEs leading to withdrawal adjusted by duration of participant exposure to study treatment during the Randomized-Withdrawal Period
    End point description
    The number of TEAEs leading to discontinuation adjusted by duration of exposure to study treatment was scaled such that it provides an incidence rate per 100 patient-years. If a participant had multiple events, the time of exposure was calculated to the first occurrence of the AE being considered. If a participant had no events, the total time at risk was used. The Week 16 Responder Set (WK16ResS) consisted of all study participants who achieved a PASI90 response at Week 16 and received at least 1 dose of the IMP during the Randomized-Withdrawal Period at Week 16 or later. Here, '999' signifies that 95% CI could not be calculated for this outcome measure because number of TEAEs leading to withdrawal were 0.
    End point type
    Secondary
    End point timeframe
    From end of Initial Treatment Period (Week 16) until the Safety Follow-Up (up to 56 weeks duration)
    End point values
    Placebo/Placebo (WK16ResS) Bimekizumab dose regimen 1/Placebo (WK16ResS) Bimekizumab dose regimen 1/dose regimen 2 (WK16ResS) Bimekizumab dose regimen 1/dose regimen 1 (WK16ResS)
    Number of subjects analysed
    1
    105
    100
    106
    Units: no. of new events per 100 subject-years
        number (confidence interval 95%)
    0 (-999 to 999)
    5.33 (1.10 to 15.58)
    2.69 (0.33 to 9.71)
    0 (-999 to 999)
    No statistical analyses for this end point

    Secondary: Number of treatment-emergent adverse events (TEAEs) adjusted by duration of participant exposure to study treatment during the Escape Treatment

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    End point title
    Number of treatment-emergent adverse events (TEAEs) adjusted by duration of participant exposure to study treatment during the Escape Treatment
    End point description
    The number of TEAEs adjusted by duration of exposure to study treatment was scaled such that it provides an incidence rate per 100 patient-years. If a participant had multiple events, the time of exposure was calculated to the first occurrence of the adverse event (AE) being considered. If a participant had no events, the total time at risk was used. The Escape Study Participant Set (ESS) consisted of all study participants who received at least 1 dose of escape bimekizumab treatment either due to not achieving a PASI90 response at Week 16 or experiencing a relapse after entering the Randomized-Withdrawal Period.
    End point type
    Secondary
    End point timeframe
    From Escape Baseline (Week 0) until Safety Follow-Up (up to 28 weeks duration)
    End point values
    Placebo Escape (ESS) Bimekizumab dose regimen 1 Escape (ESS) Bimekizumab dose regimen 1/ Placebo Escape (ESS) Bimekizumab dose regimen 1/dose regimen 2 Escape (ESS) Bimekizumab dose regimen 1/dose regimen 1 Escape (ESS)
    Number of subjects analysed
    81
    23
    67
    4
    7
    Units: no. of new events per 100 subject-years
        number (confidence interval 95%)
    235.86 (164.29 to 328.03)
    287.19 (143.36 to 513.86)
    180.89 (115.90 to 269.15)
    491.37 (101.33 to 1435.98)
    349.52 (95.23 to 894.91)
    No statistical analyses for this end point

    Secondary: Number of serious adverse events (SAEs) adjusted by duration of participant exposure to study treatment during the Escape Treatment

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    End point title
    Number of serious adverse events (SAEs) adjusted by duration of participant exposure to study treatment during the Escape Treatment
    End point description
    The number of SAEs adjusted by duration of exposure to study treatment was scaled such that it provides an incidence rate per 100 patient-years. If a participant had multiple events, the time of exposure was calculated to the first occurrence of the AE being considered. If a participant had no events, the total time at risk was used. The ESS consisted of all study participants who received at least 1 dose of escape bimekizumab treatment either due to not achieving a PASI90 response at Week 16 or experiencing a relapse after entering the Randomized-Withdrawal Period. Here, '999' signifies that 95% CI could not be calculated for this outcome measure because number of serious adverse events were 0.
    End point type
    Secondary
    End point timeframe
    From Escape Baseline (Week 0) until Safety Follow-Up (up to 28 weeks duration)
    End point values
    Placebo Escape (ESS) Bimekizumab dose regimen 1 Escape (ESS) Bimekizumab dose regimen 1/ Placebo Escape (ESS) Bimekizumab dose regimen 1/dose regimen 2 Escape (ESS) Bimekizumab dose regimen 1/dose regimen 1 Escape (ESS)
    Number of subjects analysed
    81
    23
    67
    4
    7
    Units: no. of new events per 100 subject-years
        number (confidence interval 95%)
    5.24 (0.13 to 29.22)
    0 (-999 to 999)
    0 (-999 to 999)
    0 (-999 to 999)
    0 (-999 to 999)
    No statistical analyses for this end point

    Secondary: Number of TEAEs leading to withdrawal adjusted by duration of participant exposure to study treatment during the Escape Treatment

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    End point title
    Number of TEAEs leading to withdrawal adjusted by duration of participant exposure to study treatment during the Escape Treatment
    End point description
    The number of TEAEs leading to discontinuation adjusted by duration of exposure to study treatment was scaled such that it provides an incidence rate per 100 patient-years. If a participant had multiple events, the time of exposure was calculated to the first occurrence of the AE being considered. If a participant had no events, the total time at risk was used. The ESS consisted of all study participants who received at least 1 dose of escape bimekizumab treatment either due to not achieving a PASI90 response at Week 16 or experiencing a relapse after entering the Randomized-Withdrawal Period. Here, '999' signifies that 95% CI could not be calculated for this outcome measure because number of TEAEs leading to withdrawal were 0.
    End point type
    Secondary
    End point timeframe
    From Escape Baseline (Week 0) until Safety Follow-Up (up to 28 weeks duration)
    End point values
    Placebo Escape (ESS) Bimekizumab dose regimen 1 Escape (ESS) Bimekizumab dose regimen 1/ Placebo Escape (ESS) Bimekizumab dose regimen 1/dose regimen 2 Escape (ESS) Bimekizumab dose regimen 1/dose regimen 1 Escape (ESS)
    Number of subjects analysed
    81
    23
    67
    4
    7
    Units: no. of new events per 100 subject-years
        number (confidence interval 95%)
    0 (-999 to 999)
    18.77 (0.48 to 104.58)
    0 (-999 to 999)
    0 (-999 to 999)
    0 (-999 to 999)
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Adverse events were collected from Baseline (Week 0) until Safety Follow-Up Visit (up to 80 weeks duration)
    Adverse event reporting additional description
    Treatment-emergent AEs were defined as those AEs that had a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week Safety Follow-Up Period).
    Assessment type
    Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    19.0
    Reporting groups
    Reporting group title
    Placebo (SS)
    Reporting group description
    Participants received placebo for 16 weeks. Participants who achieved a Psoriasis Area Severity Index (PASI) 90 response criteria proceeded with placebo until Week 56. Participants who did not achieve a PASI90 response criteria at Week 16 or who relapsed at Week 20 or later, entered the escape arm and received open-label bimekizumab dose regimen 1 for 12 weeks. Participants formed the Safety Set (SS).

    Reporting group title
    Bimekizumab dose regimen 1 (SS)
    Reporting group description
    Participants received bimekizumab dose regimen 1 for 16 weeks. Participants who achieved a PASI90 response criteria were re-randomized to either receive bimekizumab dose regimen 1 or bimekizumab dose regimen 2 or placebo until Week 56. Participants who did not achieve a PASI90 response criteria at Week 16 or who relapsed at Week 20 or later, entered the escape arm and received open-label bimekizumab dose regimen 1 for 12 weeks. Participants formed the SS.

    Reporting group title
    Placebo/Placebo (WK16ResS)
    Reporting group description
    Participants in this arm were randomized to placebo during the Initial Treatment Period, achieved a PASI90 response at Week 16 and continued to receive placebo during the Randomized-Withdrawal Period. Participants formed the Week 16 Responder Set (WK16ResS).

    Reporting group title
    Bimekizumab dose regimen 1/Placebo (WK16ResS)
    Reporting group description
    Participants in this arm were randomized to bimekizumab dose regimen 1 during the Initial Treatment Period, achieved a PASI90 response at Week 16 and were re-randomized to receive placebo during the Randomized-Withdrawal Period. Participants formed the WK16ResS.

    Reporting group title
    Bimekizumab dose regimen 1/dose regimen 2 (WK16ResS)
    Reporting group description
    Participants in this arm were randomized to bimekizumab dose regimen 1 during the Initial Treatment Period, achieved a PASI90 response at Week 16 and were re-randomized to receive bimekizumab dose regimen 2 during the Randomized-Withdrawal Period. Participants formed the WK16ResS. Participants receiving dose regimen 2 received placebo at pre-specified time points to maintain the blinding.

    Reporting group title
    Bimekizumab dose regimen 1/dose regimen 1 (WK16ResS)
    Reporting group description
    Participants in this arm were randomized to bimekizumab dose regimen 1 during the Initial Treatment Period, achieved a PASI90 response at Week 16 and continued to receive bimekizumab dose regimen 1 during the Randomized-Withdrawal Period. Participants formed the WK16ResS.

    Reporting group title
    Placebo Escape (ESS)
    Reporting group description
    Participants in this arm were randomized to placebo during the Initial Treatment Period, did not achieve a PASI90 response at Week 16, entered the escape arm and received open-label bimekizumab dose regimen 1 for 12 weeks. Participants formed the Escape Study Participant Set (ESS).

    Reporting group title
    Bimekizumab dose regimen 1 Escape (ESS)
    Reporting group description
    Participants in this arm were randomized to bimekizumab dose regimen 1 during the Initial Treatment Period, did not achieve a PASI90 response at Week 16, entered the escape arm and received open-label bimekizumab dose regimen 1 for 12 weeks. Participants formed the ESS.

    Reporting group title
    Bimekizumab dose regimen 1/ Placebo Escape (ESS)
    Reporting group description
    Participants in this arm were randomized to bimekizumab dose regimen 1 during the Initial Treatment Period, achieved a PASI90 response at Week 16 and were re-randomized to receive placebo during the Randomized-Withdrawal Period. Participants relapsed at Week 20 or later, entered the escape arm and received open-label bimekizumab dose regimen 1 for 12 weeks. Participants formed the ESS.

    Reporting group title
    Bimekizumab dose regimen 1/dose regimen 2 Escape (ESS)
    Reporting group description
    Participants in this arm were randomized to bimekizumab dose regimen 1 during the Initial Treatment Period, achieved a PASI90 response at Week 16 and were re-randomized to receive bimekizumab dose regimen 2 during the Randomized-Withdrawal Period. Participants relapsed at Week 20 or later, entered the escape arm and received open-label bimekizumab dose regimen 1 for 12 weeks. Participants formed the ESS. Participants receiving dose regimen 2 received placebo at pre-specified time points to maintain the blinding.

    Reporting group title
    Bimekizumab dose regimen 1/dose regimen 1 Escape (ESS)
    Reporting group description
    Participants in this arm were randomized to bimekizumab dose regimen 1 during the Initial Treatment Period, achieved a PASI90 response at Week 16 and continued to receive bimekizumab dose regimen 1 during the Randomized-Withdrawal Period. Participants relapsed at Week 20 or later, entered the escape arm and received open-label bimekizumab dose regimen 1 for 12 weeks. Participants formed the ESS.

    Serious adverse events
    Placebo (SS) Bimekizumab dose regimen 1 (SS) Placebo/Placebo (WK16ResS) Bimekizumab dose regimen 1/Placebo (WK16ResS) Bimekizumab dose regimen 1/dose regimen 2 (WK16ResS) Bimekizumab dose regimen 1/dose regimen 1 (WK16ResS) Placebo Escape (ESS) Bimekizumab dose regimen 1 Escape (ESS) Bimekizumab dose regimen 1/ Placebo Escape (ESS) Bimekizumab dose regimen 1/dose regimen 2 Escape (ESS) Bimekizumab dose regimen 1/dose regimen 1 Escape (ESS)
    Total subjects affected by serious adverse events
         subjects affected / exposed
    2 / 86 (2.33%)
    6 / 349 (1.72%)
    0 / 1 (0.00%)
    4 / 105 (3.81%)
    3 / 100 (3.00%)
    5 / 106 (4.72%)
    1 / 81 (1.23%)
    0 / 23 (0.00%)
    0 / 67 (0.00%)
    0 / 4 (0.00%)
    0 / 7 (0.00%)
         number of deaths (all causes)
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Injury, poisoning and procedural complications
    Humerus fracture
         subjects affected / exposed
    0 / 86 (0.00%)
    1 / 349 (0.29%)
    0 / 1 (0.00%)
    0 / 105 (0.00%)
    0 / 100 (0.00%)
    0 / 106 (0.00%)
    0 / 81 (0.00%)
    0 / 23 (0.00%)
    0 / 67 (0.00%)
    0 / 4 (0.00%)
    0 / 7 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Injury
         subjects affected / exposed
    0 / 86 (0.00%)
    0 / 349 (0.00%)
    0 / 1 (0.00%)
    0 / 105 (0.00%)
    0 / 100 (0.00%)
    1 / 106 (0.94%)
    0 / 81 (0.00%)
    0 / 23 (0.00%)
    0 / 67 (0.00%)
    0 / 4 (0.00%)
    0 / 7 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Ovarian adenoma
         subjects affected / exposed
    0 / 86 (0.00%)
    0 / 349 (0.00%)
    0 / 1 (0.00%)
    0 / 105 (0.00%)
    0 / 100 (0.00%)
    1 / 106 (0.94%)
    0 / 81 (0.00%)
    0 / 23 (0.00%)
    0 / 67 (0.00%)
    0 / 4 (0.00%)
    0 / 7 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Prostate cancer
         subjects affected / exposed
    0 / 86 (0.00%)
    0 / 349 (0.00%)
    0 / 1 (0.00%)
    1 / 105 (0.95%)
    0 / 100 (0.00%)
    0 / 106 (0.00%)
    0 / 81 (0.00%)
    0 / 23 (0.00%)
    0 / 67 (0.00%)
    0 / 4 (0.00%)
    0 / 7 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cardiac disorders
    Myocardial infarction
         subjects affected / exposed
    1 / 86 (1.16%)
    0 / 349 (0.00%)
    0 / 1 (0.00%)
    0 / 105 (0.00%)
    0 / 100 (0.00%)
    0 / 106 (0.00%)
    0 / 81 (0.00%)
    0 / 23 (0.00%)
    0 / 67 (0.00%)
    0 / 4 (0.00%)
    0 / 7 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Mitral valve prolapse
         subjects affected / exposed
    1 / 86 (1.16%)
    0 / 349 (0.00%)
    0 / 1 (0.00%)
    0 / 105 (0.00%)
    0 / 100 (0.00%)
    0 / 106 (0.00%)
    0 / 81 (0.00%)
    0 / 23 (0.00%)
    0 / 67 (0.00%)
    0 / 4 (0.00%)
    0 / 7 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Acute myocardial infarction
         subjects affected / exposed
    0 / 86 (0.00%)
    0 / 349 (0.00%)
    0 / 1 (0.00%)
    0 / 105 (0.00%)
    1 / 100 (1.00%)
    0 / 106 (0.00%)
    0 / 81 (0.00%)
    0 / 23 (0.00%)
    0 / 67 (0.00%)
    0 / 4 (0.00%)
    0 / 7 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Ischaemic cardiomyopathy
         subjects affected / exposed
    0 / 86 (0.00%)
    0 / 349 (0.00%)
    0 / 1 (0.00%)
    0 / 105 (0.00%)
    0 / 100 (0.00%)
    0 / 106 (0.00%)
    1 / 81 (1.23%)
    0 / 23 (0.00%)
    0 / 67 (0.00%)
    0 / 4 (0.00%)
    0 / 7 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Coronary artery disease
         subjects affected / exposed
    0 / 86 (0.00%)
    0 / 349 (0.00%)
    0 / 1 (0.00%)
    0 / 105 (0.00%)
    0 / 100 (0.00%)
    0 / 106 (0.00%)
    1 / 81 (1.23%)
    0 / 23 (0.00%)
    0 / 67 (0.00%)
    0 / 4 (0.00%)
    0 / 7 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Pulmonary hypertension
         subjects affected / exposed
    0 / 86 (0.00%)
    0 / 349 (0.00%)
    0 / 1 (0.00%)
    1 / 105 (0.95%)
    0 / 100 (0.00%)
    0 / 106 (0.00%)
    0 / 81 (0.00%)
    0 / 23 (0.00%)
    0 / 67 (0.00%)
    0 / 4 (0.00%)
    0 / 7 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Nervous system disorders
    Syncope
         subjects affected / exposed
    0 / 86 (0.00%)
    0 / 349 (0.00%)
    0 / 1 (0.00%)
    0 / 105 (0.00%)
    0 / 100 (0.00%)
    0 / 106 (0.00%)
    1 / 81 (1.23%)
    0 / 23 (0.00%)
    0 / 67 (0.00%)
    0 / 4 (0.00%)
    0 / 7 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Eye disorders
    Retinal detachment
         subjects affected / exposed
    0 / 86 (0.00%)
    1 / 349 (0.29%)
    0 / 1 (0.00%)
    1 / 105 (0.95%)
    0 / 100 (0.00%)
    0 / 106 (0.00%)
    0 / 81 (0.00%)
    0 / 23 (0.00%)
    0 / 67 (0.00%)
    0 / 4 (0.00%)
    0 / 7 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cataract
         subjects affected / exposed
    0 / 86 (0.00%)
    0 / 349 (0.00%)
    0 / 1 (0.00%)
    0 / 105 (0.00%)
    0 / 100 (0.00%)
    1 / 106 (0.94%)
    0 / 81 (0.00%)
    0 / 23 (0.00%)
    0 / 67 (0.00%)
    0 / 4 (0.00%)
    0 / 7 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Gastrointestinal inflammation
         subjects affected / exposed
    0 / 86 (0.00%)
    1 / 349 (0.29%)
    0 / 1 (0.00%)
    0 / 105 (0.00%)
    0 / 100 (0.00%)
    0 / 106 (0.00%)
    0 / 81 (0.00%)
    0 / 23 (0.00%)
    0 / 67 (0.00%)
    0 / 4 (0.00%)
    0 / 7 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Diverticular perforation
         subjects affected / exposed
    0 / 86 (0.00%)
    1 / 349 (0.29%)
    0 / 1 (0.00%)
    0 / 105 (0.00%)
    0 / 100 (0.00%)
    0 / 106 (0.00%)
    0 / 81 (0.00%)
    0 / 23 (0.00%)
    0 / 67 (0.00%)
    0 / 4 (0.00%)
    0 / 7 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Diarrhoea
         subjects affected / exposed
    0 / 86 (0.00%)
    0 / 349 (0.00%)
    0 / 1 (0.00%)
    0 / 105 (0.00%)
    2 / 100 (2.00%)
    0 / 106 (0.00%)
    0 / 81 (0.00%)
    0 / 23 (0.00%)
    0 / 67 (0.00%)
    0 / 4 (0.00%)
    0 / 7 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Duodenal ulcer haemorrhage
         subjects affected / exposed
    0 / 86 (0.00%)
    0 / 349 (0.00%)
    0 / 1 (0.00%)
    0 / 105 (0.00%)
    0 / 100 (0.00%)
    0 / 106 (0.00%)
    1 / 81 (1.23%)
    0 / 23 (0.00%)
    0 / 67 (0.00%)
    0 / 4 (0.00%)
    0 / 7 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hepatobiliary disorders
    Cholelithiasis
         subjects affected / exposed
    0 / 86 (0.00%)
    1 / 349 (0.29%)
    0 / 1 (0.00%)
    0 / 105 (0.00%)
    0 / 100 (0.00%)
    0 / 106 (0.00%)
    0 / 81 (0.00%)
    0 / 23 (0.00%)
    0 / 67 (0.00%)
    0 / 4 (0.00%)
    0 / 7 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Skin and subcutaneous tissue disorders
    Erythrodermic psoriasis
         subjects affected / exposed
    0 / 86 (0.00%)
    0 / 349 (0.00%)
    0 / 1 (0.00%)
    1 / 105 (0.95%)
    0 / 100 (0.00%)
    0 / 106 (0.00%)
    0 / 81 (0.00%)
    0 / 23 (0.00%)
    0 / 67 (0.00%)
    0 / 4 (0.00%)
    0 / 7 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    1 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Psoriatic arthropathy
         subjects affected / exposed
    0 / 86 (0.00%)
    0 / 349 (0.00%)
    0 / 1 (0.00%)
    0 / 105 (0.00%)
    0 / 100 (0.00%)
    1 / 106 (0.94%)
    0 / 81 (0.00%)
    0 / 23 (0.00%)
    0 / 67 (0.00%)
    0 / 4 (0.00%)
    0 / 7 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Type 2 diabetes mellitus
         subjects affected / exposed
    0 / 86 (0.00%)
    0 / 349 (0.00%)
    0 / 1 (0.00%)
    0 / 105 (0.00%)
    0 / 100 (0.00%)
    0 / 106 (0.00%)
    1 / 81 (1.23%)
    0 / 23 (0.00%)
    0 / 67 (0.00%)
    0 / 4 (0.00%)
    0 / 7 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Enterovirus infection
         subjects affected / exposed
    0 / 86 (0.00%)
    1 / 349 (0.29%)
    0 / 1 (0.00%)
    0 / 105 (0.00%)
    0 / 100 (0.00%)
    0 / 106 (0.00%)
    0 / 81 (0.00%)
    0 / 23 (0.00%)
    0 / 67 (0.00%)
    0 / 4 (0.00%)
    0 / 7 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pneumonia
         subjects affected / exposed
    0 / 86 (0.00%)
    1 / 349 (0.29%)
    0 / 1 (0.00%)
    0 / 105 (0.00%)
    0 / 100 (0.00%)
    0 / 106 (0.00%)
    0 / 81 (0.00%)
    0 / 23 (0.00%)
    0 / 67 (0.00%)
    0 / 4 (0.00%)
    0 / 7 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Otitis media chronic
         subjects affected / exposed
    0 / 86 (0.00%)
    0 / 349 (0.00%)
    0 / 1 (0.00%)
    0 / 105 (0.00%)
    0 / 100 (0.00%)
    1 / 106 (0.94%)
    0 / 81 (0.00%)
    0 / 23 (0.00%)
    0 / 67 (0.00%)
    0 / 4 (0.00%)
    0 / 7 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    Placebo (SS) Bimekizumab dose regimen 1 (SS) Placebo/Placebo (WK16ResS) Bimekizumab dose regimen 1/Placebo (WK16ResS) Bimekizumab dose regimen 1/dose regimen 2 (WK16ResS) Bimekizumab dose regimen 1/dose regimen 1 (WK16ResS) Placebo Escape (ESS) Bimekizumab dose regimen 1 Escape (ESS) Bimekizumab dose regimen 1/ Placebo Escape (ESS) Bimekizumab dose regimen 1/dose regimen 2 Escape (ESS) Bimekizumab dose regimen 1/dose regimen 1 Escape (ESS)
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    15 / 86 (17.44%)
    66 / 349 (18.91%)
    1 / 1 (100.00%)
    34 / 105 (32.38%)
    40 / 100 (40.00%)
    34 / 106 (32.08%)
    8 / 81 (9.88%)
    5 / 23 (21.74%)
    11 / 67 (16.42%)
    3 / 4 (75.00%)
    4 / 7 (57.14%)
    Injury, poisoning and procedural complications
    Rib fracture
         subjects affected / exposed
    0 / 86 (0.00%)
    0 / 349 (0.00%)
    0 / 1 (0.00%)
    0 / 105 (0.00%)
    0 / 100 (0.00%)
    1 / 106 (0.94%)
    0 / 81 (0.00%)
    0 / 23 (0.00%)
    0 / 67 (0.00%)
    1 / 4 (25.00%)
    0 / 7 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    0
    0
    0
    1
    0
    Blood and lymphatic system disorders
    Neutropenia
         subjects affected / exposed
    0 / 86 (0.00%)
    2 / 349 (0.57%)
    0 / 1 (0.00%)
    0 / 105 (0.00%)
    1 / 100 (1.00%)
    0 / 106 (0.00%)
    0 / 81 (0.00%)
    1 / 23 (4.35%)
    0 / 67 (0.00%)
    0 / 4 (0.00%)
    1 / 7 (14.29%)
         occurrences all number
    0
    2
    0
    0
    1
    0
    0
    1
    0
    0
    1
    Gastrointestinal disorders
    Dental caries
         subjects affected / exposed
    1 / 86 (1.16%)
    0 / 349 (0.00%)
    0 / 1 (0.00%)
    0 / 105 (0.00%)
    0 / 100 (0.00%)
    0 / 106 (0.00%)
    0 / 81 (0.00%)
    0 / 23 (0.00%)
    0 / 67 (0.00%)
    1 / 4 (25.00%)
    0 / 7 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    Skin and subcutaneous tissue disorders
    Psoriasis
         subjects affected / exposed
    4 / 86 (4.65%)
    1 / 349 (0.29%)
    0 / 1 (0.00%)
    3 / 105 (2.86%)
    0 / 100 (0.00%)
    1 / 106 (0.94%)
    0 / 81 (0.00%)
    1 / 23 (4.35%)
    0 / 67 (0.00%)
    0 / 4 (0.00%)
    1 / 7 (14.29%)
         occurrences all number
    5
    1
    0
    3
    0
    1
    0
    1
    0
    0
    1
    Seborrhoeic dermatitis
         subjects affected / exposed
    0 / 86 (0.00%)
    1 / 349 (0.29%)
    0 / 1 (0.00%)
    3 / 105 (2.86%)
    0 / 100 (0.00%)
    3 / 106 (2.83%)
    0 / 81 (0.00%)
    0 / 23 (0.00%)
    0 / 67 (0.00%)
    0 / 4 (0.00%)
    1 / 7 (14.29%)
         occurrences all number
    0
    1
    0
    4
    0
    4
    0
    0
    0
    0
    1
    Rash papular
         subjects affected / exposed
    0 / 86 (0.00%)
    0 / 349 (0.00%)
    0 / 1 (0.00%)
    0 / 105 (0.00%)
    0 / 100 (0.00%)
    0 / 106 (0.00%)
    0 / 81 (0.00%)
    0 / 23 (0.00%)
    0 / 67 (0.00%)
    0 / 4 (0.00%)
    1 / 7 (14.29%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    Infections and infestations
    Nasopharyngitis
         subjects affected / exposed
    4 / 86 (4.65%)
    23 / 349 (6.59%)
    0 / 1 (0.00%)
    20 / 105 (19.05%)
    23 / 100 (23.00%)
    11 / 106 (10.38%)
    1 / 81 (1.23%)
    1 / 23 (4.35%)
    2 / 67 (2.99%)
    0 / 4 (0.00%)
    0 / 7 (0.00%)
         occurrences all number
    4
    27
    0
    28
    31
    12
    1
    1
    2
    0
    0
    Oral candidiasis
         subjects affected / exposed
    0 / 86 (0.00%)
    21 / 349 (6.02%)
    0 / 1 (0.00%)
    6 / 105 (5.71%)
    9 / 100 (9.00%)
    12 / 106 (11.32%)
    4 / 81 (4.94%)
    1 / 23 (4.35%)
    7 / 67 (10.45%)
    0 / 4 (0.00%)
    0 / 7 (0.00%)
         occurrences all number
    0
    23
    0
    6
    18
    20
    5
    1
    8
    0
    0
    Upper respiratory tract infection
         subjects affected / exposed
    7 / 86 (8.14%)
    14 / 349 (4.01%)
    1 / 1 (100.00%)
    5 / 105 (4.76%)
    8 / 100 (8.00%)
    12 / 106 (11.32%)
    3 / 81 (3.70%)
    1 / 23 (4.35%)
    2 / 67 (2.99%)
    0 / 4 (0.00%)
    1 / 7 (14.29%)
         occurrences all number
    7
    14
    1
    6
    9
    17
    3
    1
    2
    0
    1
    Tinea pedis
         subjects affected / exposed
    0 / 86 (0.00%)
    4 / 349 (1.15%)
    0 / 1 (0.00%)
    0 / 105 (0.00%)
    0 / 100 (0.00%)
    1 / 106 (0.94%)
    0 / 81 (0.00%)
    0 / 23 (0.00%)
    0 / 67 (0.00%)
    0 / 4 (0.00%)
    1 / 7 (14.29%)
         occurrences all number
    0
    4
    0
    0
    0
    1
    0
    0
    0
    0
    1
    Impetigo
         subjects affected / exposed
    1 / 86 (1.16%)
    2 / 349 (0.57%)
    0 / 1 (0.00%)
    1 / 105 (0.95%)
    0 / 100 (0.00%)
    1 / 106 (0.94%)
    0 / 81 (0.00%)
    0 / 23 (0.00%)
    0 / 67 (0.00%)
    1 / 4 (25.00%)
    0 / 7 (0.00%)
         occurrences all number
    1
    2
    0
    1
    0
    1
    0
    0
    0
    1
    0
    Body tinea
         subjects affected / exposed
    0 / 86 (0.00%)
    1 / 349 (0.29%)
    0 / 1 (0.00%)
    0 / 105 (0.00%)
    1 / 100 (1.00%)
    0 / 106 (0.00%)
    0 / 81 (0.00%)
    0 / 23 (0.00%)
    0 / 67 (0.00%)
    0 / 4 (0.00%)
    1 / 7 (14.29%)
         occurrences all number
    0
    1
    0
    0
    1
    0
    0
    0
    0
    0
    1
    Tinea capitis
         subjects affected / exposed
    0 / 86 (0.00%)
    0 / 349 (0.00%)
    0 / 1 (0.00%)
    0 / 105 (0.00%)
    0 / 100 (0.00%)
    0 / 106 (0.00%)
    0 / 81 (0.00%)
    0 / 23 (0.00%)
    0 / 67 (0.00%)
    0 / 4 (0.00%)
    1 / 7 (14.29%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1

    More information

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    Substantial protocol amendments (globally)

    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    06 Apr 2018
    Protocol Amendment 2 (dated 06 Apr 2018) was implemented to incorporate the following key changes: • Updated name and contact information for Clinical Project Manager (CPM) • Extended the duration of the Screening Period, and therefore the overall study duration, by 1 week • Updated list of current treatment for psoriasis (PSO) to reflect changes in labeling and approved countries • Updated list of completed and ongoing bimekizumab studies to reflect completion of UP0042 • Clarified calculation of Psoriasis Area and Severity Index (PASI) response rates • Removed references to pharmacodynamic (PD) assessments as they were not conducted in this study • Updated Table 5-1 Schedule of study assessments to modify the visits at which the physical examination, tuberculosis (TB) questionnaire, body weight, electrocardiogram (ECG), and the Patient Symptom Diary (PSD) (daily) were assessed • Clarified that all visits from first dose through Week 24 would have a ±3 day visit window, while all visits from Week 28 through end of study would have a ±7 day window • Clarified the dosing window • Modified exclusion criterion to clarify exclusion of study participants who participated in other studies of bimekizumab, other medications (systemic or topical), or devices • Modified exclusion criteria pertaining to history of malignancy, systemic disease, and major depression • Added new withdrawal criteria for study participants with newly diagnosed inflammatory bowel disease (IBD) • Clarified withdrawal criteria for study participants with depression or suicidal ideation or behavior • Updated prohibited concomitant medications to include tildrakizumab and risankizumab • Corrected discrepancies between Section 8 Study procedures by visit and Table 5-1 Schedule of study assessments • Revised Psoriatic Arthritis Screening and Evaluation (PASE) questionnaire scoring • Clarified definition of abortion • Updated laboratory measurements to be performed
    06 Apr 2018
    Continuation of Protocol Amendment 2: • Provided additional details for requirements for investigational medicinal product (IMP) rechallenge in the event of potential drug-induced liver injury (PDILI) • Updated the definition of the Full Analysis Set (FAS) • Clarified regions for analyses In addition, minor spelling, editorial, and formatting changes were made, and the List of abbreviations was updated.

    Interruptions (globally)

    Were there any global interruptions to the trial? No

    Limitations and caveats

    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported
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