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    Clinical Trial Results:
    A Multicenter, 48-Week, Double-Blind, Placebo-Controlled, Parallel-Group Extension Study to Assess the Long-Term Safety, Tolerability, and Efficacy of Bimekizumab in Adult Subjects with Moderate to Severe Chronic Plaque Psoriasis

    Summary
    EudraCT number
    2016-001892-57
    Trial protocol
    HU   CZ   PL  
    Global end of trial date
    25 Sep 2018

    Results information
    Results version number
    v1(current)
    This version publication date
    12 Oct 2019
    First version publication date
    12 Oct 2019
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    PS0011
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    NCT03010527
    WHO universal trial number (UTN)
    -
    Sponsors
    Sponsor organisation name
    UCB Biopharma, SPRL
    Sponsor organisation address
    Allée de la Recherche 60, Brussels, Belgium, B-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
    20 Nov 2018
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    25 Sep 2018
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    Assess the long-term safety and tolerability of bimekizumab
    Protection of trial subjects
    During the conduct of the study all participants were closely monitored.
    Background therapy
    Background therapy as permitted in the protocol
    Evidence for comparator
    Not Applicable
    Actual start date of recruitment
    14 Dec 2016
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Canada: 36
    Country: Number of subjects enrolled
    Czech Republic: 20
    Country: Number of subjects enrolled
    Hungary: 16
    Country: Number of subjects enrolled
    Japan: 11
    Country: Number of subjects enrolled
    Poland: 99
    Country: Number of subjects enrolled
    United States: 35
    Worldwide total number of subjects
    217
    EEA total number of subjects
    135
    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)
    199
    From 65 to 84 years
    18
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    The study started to enroll participants in December 2016 and concluded in September 2018. Among the 217 participants in PS0011, no participants were assigned to receive placebo.

    Pre-assignment
    Screening details
    Participant Flow refers to the Full Analysis Set (FAS), which consisted of all enrolled participants who received at least 1 dose of the investigational medicinal product (IMP) and had a valid measurement of the primary efficacy variable at Baseline of PS0011.

    Period 1
    Period 1 title
    Overall Study (overall period)
    Is this the baseline period?
    Yes
    Allocation method
    Non-randomised - controlled
    Blinding used
    Double blind
    Roles blinded
    Subject, Investigator, Assessor

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    Bimekizumab Dose 1
    Arm description
    Participants received bimekizumab Dose 1 injections, sc every four weeks (Q4W). Participants who achieved PASI90 response at Week 12 and received bimekizumab Dose 1 Q4W in PS0010, were assigned to bimekizumab Dose 1 Q4W in PS0011. Participants who did not achieve PASI90 response at Week 12 and received bimekizumab Dose 1 Q4W in PS0010, were assigned to bimekizumab Dose 2 Q4W in PS0011.
    Arm type
    Experimental

    Investigational medicinal product name
    Bimekizumab
    Investigational medicinal product code
    BKZ
    Other name
    UCB4940
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Participants were administered different dosages of BKZ, by subcutaneous (sc) injection, every four weeks (Q4W).

    Arm title
    Bimekizumab Dose 2
    Arm description
    Participants received bimekizumab Dose 2 injections, sc every four weeks (Q4W). Participants who achieved PASI90 response at Week 12 and received bimekizumab Dose 2 Q4W or bimekizumab Dose 2 loading dose (w/LD) Q4W in PS0010, were assigned to bimekizumab Dose 2 Q4W in PS0011. Participants who did not achieve PASI90 response at Week 12 and received bimekizumab Dose 2 Q4W or bimekizumab Dose 2 w/LD Q4W in PS0010, were assigned to bimekizumab Dose 3 Q4W in PS0011.
    Arm type
    Experimental

    Investigational medicinal product name
    Bimekizumab
    Investigational medicinal product code
    BKZ
    Other name
    UCB4940
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Participants were administered different dosages of BKZ, by subcutaneous (sc) injection, every four weeks (Q4W).

    Arm title
    Bimekizumab Dose 3
    Arm description
    Participants received bimekizumab Dose 3 injections, sc every four weeks (Q4W). Participants receiving bimekizumab Dose 3 Q4W and bimekizumab Dose 4 Q4W, in PS0010 were assigned to receive bimekizumab Dose 3 Q4W in PS0011, regardless of their PASI90 response at Week 12 in PS0010.
    Arm type
    Experimental

    Investigational medicinal product name
    Bimekizumab
    Investigational medicinal product code
    BKZ
    Other name
    UCB4940
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Participants were administered different dosages of BKZ, by subcutaneous (sc) injection, every four weeks (Q4W).

    Number of subjects in period 1
    Bimekizumab Dose 1 Bimekizumab Dose 2 Bimekizumab Dose 3
    Started
    15
    111
    91
    Completed
    15
    92
    75
    Not completed
    0
    19
    16
         WITHDRAWAL CRITERIA #9
    -
    4
    6
         Protocol deviation
    -
    1
    -
         PDILI and WITHDRAWAL CRITERIA #9
    -
    1
    -
         Adverse event, serious fatal
    -
    -
    1
         WITHDRAWAL CRITERIA #12
    -
    4
    2
         Adverse event, non-fatal
    -
    4
    2
         Consent withdrawn by subject
    -
    3
    4
         Lost to follow-up
    -
    2
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Bimekizumab Dose 1
    Reporting group description
    Participants received bimekizumab Dose 1 injections, sc every four weeks (Q4W). Participants who achieved PASI90 response at Week 12 and received bimekizumab Dose 1 Q4W in PS0010, were assigned to bimekizumab Dose 1 Q4W in PS0011. Participants who did not achieve PASI90 response at Week 12 and received bimekizumab Dose 1 Q4W in PS0010, were assigned to bimekizumab Dose 2 Q4W in PS0011.

    Reporting group title
    Bimekizumab Dose 2
    Reporting group description
    Participants received bimekizumab Dose 2 injections, sc every four weeks (Q4W). Participants who achieved PASI90 response at Week 12 and received bimekizumab Dose 2 Q4W or bimekizumab Dose 2 loading dose (w/LD) Q4W in PS0010, were assigned to bimekizumab Dose 2 Q4W in PS0011. Participants who did not achieve PASI90 response at Week 12 and received bimekizumab Dose 2 Q4W or bimekizumab Dose 2 w/LD Q4W in PS0010, were assigned to bimekizumab Dose 3 Q4W in PS0011.

    Reporting group title
    Bimekizumab Dose 3
    Reporting group description
    Participants received bimekizumab Dose 3 injections, sc every four weeks (Q4W). Participants receiving bimekizumab Dose 3 Q4W and bimekizumab Dose 4 Q4W, in PS0010 were assigned to receive bimekizumab Dose 3 Q4W in PS0011, regardless of their PASI90 response at Week 12 in PS0010.

    Reporting group values
    Bimekizumab Dose 1 Bimekizumab Dose 2 Bimekizumab Dose 3 Total
    Number of subjects
    15 111 91 217
    Age categorical
    Units: Subjects
        <=18 years
    0 1 2 3
        Between 18 and 65 years
    14 105 77 196
        >=65 years
    1 5 12 18
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    44.5 ± 14.7 44.5 ± 12.8 43.5 ± 14.7 -
    Gender categorical
    Units: Subjects
        Male
    9 71 60 140
        Female
    6 40 31 77

    End points

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    End points reporting groups
    Reporting group title
    Bimekizumab Dose 1
    Reporting group description
    Participants received bimekizumab Dose 1 injections, sc every four weeks (Q4W). Participants who achieved PASI90 response at Week 12 and received bimekizumab Dose 1 Q4W in PS0010, were assigned to bimekizumab Dose 1 Q4W in PS0011. Participants who did not achieve PASI90 response at Week 12 and received bimekizumab Dose 1 Q4W in PS0010, were assigned to bimekizumab Dose 2 Q4W in PS0011.

    Reporting group title
    Bimekizumab Dose 2
    Reporting group description
    Participants received bimekizumab Dose 2 injections, sc every four weeks (Q4W). Participants who achieved PASI90 response at Week 12 and received bimekizumab Dose 2 Q4W or bimekizumab Dose 2 loading dose (w/LD) Q4W in PS0010, were assigned to bimekizumab Dose 2 Q4W in PS0011. Participants who did not achieve PASI90 response at Week 12 and received bimekizumab Dose 2 Q4W or bimekizumab Dose 2 w/LD Q4W in PS0010, were assigned to bimekizumab Dose 3 Q4W in PS0011.

    Reporting group title
    Bimekizumab Dose 3
    Reporting group description
    Participants received bimekizumab Dose 3 injections, sc every four weeks (Q4W). Participants receiving bimekizumab Dose 3 Q4W and bimekizumab Dose 4 Q4W, in PS0010 were assigned to receive bimekizumab Dose 3 Q4W in PS0011, regardless of their PASI90 response at Week 12 in PS0010.

    Subject analysis set title
    Bimekizumab Dose 1 (SS)
    Subject analysis set type
    Safety analysis
    Subject analysis set description
    Participants received bimekizumab Dose 1 injections, sc every four weeks (Q4W). Participants who achieved PASI90 response at Week 12 and received bimekizumab Dose 1 Q4W in PS0010, were assigned to bimekizumab Dose 1 Q4W in PS0011. Participants who did not achieve PASI90 response at Week 12 and received bimekizumab Dose 1 Q4W in PS0010, were assigned to bimekizumab Dose 2 Q4W in PS0011. Participants who received at least one dose of the IMP formed the Safety Set (SS).

    Subject analysis set title
    Bimekizumab Dose 2 (SS)
    Subject analysis set type
    Safety analysis
    Subject analysis set description
    Participants received bimekizumab Dose 2 injections, sc every four weeks (Q4W). Participants who achieved PASI90 response at Week 12 and received bimekizumab Dose 2 Q4W or bimekizumab Dose 2 loading dose (w/LD) Q4W in PS0010, were assigned to bimekizumab Dose 2 Q4W in PS0011. Participants who did not achieve PASI90 response at Week 12 and received bimekizumab Dose 2 Q4W or bimekizumab Dose 2 w/LD Q4W in PS0010, were assigned to bimekizumab Dose 3 Q4W in PS0011. Participants who received at least one dose of the IMP formed the SS.

    Subject analysis set title
    Bimekizumab Dose 3 (SS)
    Subject analysis set type
    Safety analysis
    Subject analysis set description
    Participants received bimekizumab Dose 3 injections, sc every four weeks (Q4W). Participants receiving bimekizumab Dose 3 Q4W and bimekizumab Dose 4 Q4W, in PS0010 were assigned to receive bimekizumab Dose 3 Q4W in PS0011, regardless of their PASI90 response at Week 12 in PS0010. Participants who received at least one dose of the IMP formed the SS.

    Subject analysis set title
    Bimekizumab Dose 1/Bimekizumab Dose 1/R (FAS)
    Subject analysis set type
    Full analysis
    Subject analysis set description
    Participants who achieved PASI90 response at Week 12 and received bimekizumab Dose 1 Q4W in PS0010, were assigned to bimekizumab Dose 1 Q4W in PS0011. Participants formed the Full Analysis Set (FAS).

    Subject analysis set title
    Bimekizumab Dose 2/Bimekizumab Dose 2/R (FAS)
    Subject analysis set type
    Full analysis
    Subject analysis set description
    Participants who achieved PASI90 response at Week 12 and received bimekizumab Dose 2 Q4W or bimekizumab Dose 2 loading dose (w/LD) Q4W in PS0010, were assigned to bimekizumab Dose 2 Q4W in PS0011. Participants formed the FAS.

    Subject analysis set title
    Bimekizumab Dose 3/Bimekizumab Dose 3/R (FAS)
    Subject analysis set type
    Full analysis
    Subject analysis set description
    Participants who achieved PASI90 response at Week 12 and received bimekizumab Dose 3 Q4W in PS0010, were assigned to bimekizumab Dose 3 Q4W in PS0011. Participants formed the FAS.

    Subject analysis set title
    Bimekizumab Dose 4/Bimekizumab Dose 3/R (FAS)
    Subject analysis set type
    Full analysis
    Subject analysis set description
    Participants who achieved PASI90 response at Week 12 and received bimekizumab Dose 4 Q4W in PS0010, were assigned to bimekizumab Dose 3 Q4W in PS0011. Participants formed the FAS.

    Subject analysis set title
    Placebo/Bimekizumab Dose 2/NR (FAS)
    Subject analysis set type
    Full analysis
    Subject analysis set description
    Participants who did not achieve PASI90 response at Week 12 and received placebo Q4W in PS0010, were assigned to bimekizumab Dose 2 Q4W in PS0011. Participants formed the FAS.

    Subject analysis set title
    Bimekizumab Dose 1/Bimekizumab Dose 2/NR (FAS)
    Subject analysis set type
    Full analysis
    Subject analysis set description
    Participants who did not achieve PASI90 response at Week 12 and received bimekizumab Dose 1 Q4W in PS0010, were assigned to bimekizumab Dose 2 Q4W in PS0011. Participants formed the FAS.

    Subject analysis set title
    Bimekizumab Dose 2/Bimekizumab Dose 3/NR (FAS)
    Subject analysis set type
    Full analysis
    Subject analysis set description
    Participants who did not achieve PASI90 response at Week 12 and received bimekizumab Dose 2 Q4W or bimekizumab Dose 2 w/LD Q4W in PS0010, were assigned to bimekizumab Dose 3 Q4W in PS0011. Participants formed the FAS.

    Subject analysis set title
    Bimekizumab Dose 3/Bimekizumab Dose 3/NR (FAS)
    Subject analysis set type
    Full analysis
    Subject analysis set description
    Participants who did not achieve PASI90 response at Week 12 and received bimekizumab Dose 3 Q4W in PS0010, were assigned to bimekizumab Dose 3 Q4W in PS0011. Participants formed the FAS.

    Subject analysis set title
    Bimekizumab Dose 4/Bimekizumab Dose 3/NR (FAS)
    Subject analysis set type
    Full analysis
    Subject analysis set description
    Participants who did not achieve PASI90 response at Week 12 and received bimekizumab Dose 4 Q4W in PS0010, were assigned to bimekizumab Dose 3 Q4W in PS0011. Participants formed the FAS.

    Primary: Incidence of Treatment Emergent Adverse Events (TEAEs) adjusted by duration of subject exposure to treatment

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    End point title
    Incidence of Treatment Emergent Adverse Events (TEAEs) adjusted by duration of subject exposure to treatment [1]
    End point description
    Treatment-emergent Adverse Events (TEAEs) were defined as those events which started on or after the date of first dose of PS0011 investigational medicinal product (IMP), or events in which severity worsened on or after the date of first dose of PS0011 study medication. The exposure adjusted incidence rate (EAIR) is defined as the number of subjects (n) with a specific AE adjusted for the exposure and was scaled to 100 subject-years: where the numerator is the total number of subjects experiencing the AE and the denominator is the total time at risk scaled to 100 subject-years; that is, the total summation of individual subject-years at risk up to the first occurrence of the AE for subjects with that AE, and the total subject-years at risk for those subjects not experiencing that AE, divided by 100.
    End point type
    Primary
    End point timeframe
    From Baseline until Safety Follow-Up Visit (up to Week 64)
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: No formal statistical hypothesis testing was planned for this study. Results were summarized as descriptive statistics only.
    End point values
    Bimekizumab Dose 1 (SS) Bimekizumab Dose 2 (SS) Bimekizumab Dose 3 (SS)
    Number of subjects analysed
    15
    111
    91
    Units: no. of new events per 100 subject-years
        number (confidence interval 95%)
    110.68 (53.08 to 203.55)
    225.26 (182.88 to 274.53)
    206.82 (162.95 to 258.86)
    No statistical analyses for this end point

    Secondary: Percentage of participants with Psoriasis Area Severity Index (PASI90) response over time

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    End point title
    Percentage of participants with Psoriasis Area Severity Index (PASI90) response over time
    End point description
    The PASI90 response assessments are based on at least 90% improvement in the PASI score from Baseline. It averages the redness, thickness, and scaliness of the psoriatic lesions (on a 0-4 scale) and weights the resulting score by the area of skin involved. Body divided into 4 areas: head, arms, trunk to groin, and 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) to 4 (very marked). The PASI score ranges from 0 to 72 with a higher score indicating increased disease severity. PASI90 response is defined to be equal to 1 if the percentage improvement from Baseline in the PASI scores is 90% or greater and 0 if the percentage improvement from Baseline is less than 90%. This Outcome Measure presents results relative to PS0010 Baseline starting at PS0011 Baseline by PS0010 Week 12 response status.
    End point type
    Secondary
    End point timeframe
    From Baseline during the Treatment Period (up to Week 48)
    End point values
    Bimekizumab Dose 1/Bimekizumab Dose 1/R (FAS) Bimekizumab Dose 2/Bimekizumab Dose 2/R (FAS) Bimekizumab Dose 3/Bimekizumab Dose 3/R (FAS) Bimekizumab Dose 4/Bimekizumab Dose 3/R (FAS) Placebo/Bimekizumab Dose 2/NR (FAS) Bimekizumab Dose 1/Bimekizumab Dose 2/NR (FAS) Bimekizumab Dose 2/Bimekizumab Dose 3/NR (FAS) Bimekizumab Dose 3/Bimekizumab Dose 3/NR (FAS) Bimekizumab Dose 4/Bimekizumab Dose 3/NR (FAS)
    Number of subjects analysed
    15
    55
    33
    30
    37
    19
    14
    6
    8
    Units: percentage of participants
    number (not applicable)
        PS0011 Baseline
    100
    100
    100
    100
    0
    0
    0
    0
    0
        Week 4
    100
    100
    97.0
    100
    45.9
    42.1
    42.9
    66.7
    50.0
        Week 8
    100
    96.4
    100
    100
    67.6
    73.7
    57.1
    83.3
    50.0
        Week 12
    100
    96.4
    100
    96.7
    81.1
    78.9
    64.3
    100
    62.5
        Week 16
    100
    92.7
    100
    96.7
    83.8
    78.9
    64.3
    100
    62.5
        Week 20
    100
    89.1
    93.9
    96.7
    89.2
    84.2
    78.6
    83.3
    62.5
        Week 24
    100
    85.5
    97.0
    96.7
    83.8
    78.9
    71.4
    83.3
    75.0
        Week 28
    93.3
    90.9
    97.0
    96.7
    91.9
    84.2
    71.4
    83.3
    50.0
        Week 32
    100
    89.1
    97.0
    93.3
    91.9
    73.7
    71.4
    83.3
    50.0
        Week 36
    100
    85.5
    97.0
    93.3
    91.9
    73.7
    71.4
    66.7
    50.0
        Week 40
    100
    83.6
    87.9
    86.7
    89.2
    78.9
    71.4
    83.3
    50.0
        Week 44
    100
    81.8
    87.9
    86.7
    89.2
    78.9
    71.4
    83.3
    50.0
        Week 48
    100
    80.0
    87.9
    86.7
    91.9
    68.4
    71.4
    66.7
    50.0
    No statistical analyses for this end point

    Secondary: Percentage of participants with Investigator´s Global Assessment response (Clear or Almost clear with at least a 2 category improvement from Baseline on a 5-point scale) over time

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    End point title
    Percentage of participants with Investigator´s Global Assessment response (Clear or Almost clear with at least a 2 category improvement from Baseline on a 5-point scale) over time
    End point description
    The Investigator's Global Assessment (IGA) measures the overall 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 is defined as clear (0) or almost clear (1) with at least a two category improvement from Baseline. This Outcome Measure presents results relative to PS0010 Baseline starting at PS0011 Baseline by PS0010 Week 12 response status.
    End point type
    Secondary
    End point timeframe
    From Baseline during the Treatment Period (up to Week 48)
    End point values
    Bimekizumab Dose 1/Bimekizumab Dose 1/R (FAS) Bimekizumab Dose 2/Bimekizumab Dose 2/R (FAS) Bimekizumab Dose 3/Bimekizumab Dose 3/R (FAS) Bimekizumab Dose 4/Bimekizumab Dose 3/R (FAS) Placebo/Bimekizumab Dose 2/NR (FAS) Bimekizumab Dose 1/Bimekizumab Dose 2/NR (FAS) Bimekizumab Dose 2/Bimekizumab Dose 3/NR (FAS) Bimekizumab Dose 3/Bimekizumab Dose 3/NR (FAS) Bimekizumab Dose 4/Bimekizumab Dose 3/NR (FAS)
    Number of subjects analysed
    15
    55
    33
    30
    37
    19
    14
    6
    8
    Units: percentage of participants
    number (not applicable)
        PS0011 Baseline
    100
    96.4
    100
    100
    5.4
    10.5
    35.7
    50.0
    25.0
        Week 4
    100
    98.2
    97.0
    100
    56.8
    57.9
    42.9
    66.7
    62.5
        Week 8
    100
    96.4
    97.0
    100
    75.7
    84.2
    57.1
    83.3
    62.5
        Week 12
    100
    92.7
    97.0
    96.7
    81.1
    89.5
    64.3
    83.3
    62.5
        Week 16
    100
    90.9
    97.0
    96.7
    83.8
    78.9
    57.1
    66.7
    62.5
        Week 20
    100
    85.5
    93.9
    96.7
    89.2
    84.2
    71.4
    66.7
    75.0
        Week 24
    100
    81.8
    97.0
    93.3
    83.8
    84.2
    64.3
    83.3
    62.5
        Week 28
    93.3
    89.1
    97.0
    93.3
    86.5
    84.2
    71.4
    66.7
    62.5
        Week 32
    100
    85.5
    93.9
    93.3
    89.2
    78.9
    71.4
    66.7
    50.0
        Week 36
    100
    81.8
    90.9
    93.3
    86.5
    78.9
    71.4
    66.7
    37.5
        Week 40
    100
    83.6
    87.9
    86.7
    86.5
    78.9
    71.4
    66.7
    50.0
        Week 44
    100
    81.8
    87.9
    86.7
    83.8
    78.9
    71.4
    66.7
    50.0
        Week 48
    100
    78.2
    87.9
    86.7
    89.2
    68.4
    71.4
    66.7
    62.5
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    From PS0011 Baseline and up to Safety-Follow Up (SFU)
    Assessment type
    Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    19.0
    Reporting groups
    Reporting group title
    Bimekizumab Dose 1 (SS)
    Reporting group description
    Participants received bimekizumab Dose 1 injections, sc every four weeks (Q4W). Participants who achieved PASI90 response at Week 12 and received bimekizumab Dose 1 Q4W in PS0010, were assigned to bimekizumab Dose 1 Q4W in PS0011. Participants who did not achieve PASI90 response at Week 12 and received bimekizumab Dose 1 Q4W in PS0010, were assigned to bimekizumab Dose 2 Q4W in PS0011. Participants who received at least one dose of the IMP formed the Safety Set (SS).

    Reporting group title
    Bimekizumab Dose 3 (SS)
    Reporting group description
    Participants received bimekizumab Dose 3 injections, sc every four weeks (Q4W). Participants receiving bimekizumab Dose 3 Q4W and bimekizumab Dose 4 Q4W, in PS0010 were assigned to receive bimekizumab Dose 3 Q4W in PS0011, regardless of their PASI90 response at Week 12 in PS0010. Participants who received at least one dose of the IMP formed the SS.

    Reporting group title
    Bimekizumab Dose 2 (SS)
    Reporting group description
    Participants received bimekizumab Dose 2 injections, sc every four weeks (Q4W). Participants who achieved PASI90 response at Week 12 and received bimekizumab Dose 2 Q4W or bimekizumab Dose 2 loading dose (w/LD) Q4W in PS0010, were assigned to bimekizumab Dose 2 Q4W in PS0011. Participants who did not achieve PASI90 response at Week 12 and received bimekizumab Dose 2 Q4W or bimekizumab Dose 2 w/LD Q4W in PS0010, were assigned to bimekizumab Dose 3 Q4W in PS0011. Participants who received at least one dose of the IMP formed the SS.

    Serious adverse events
    Bimekizumab Dose 1 (SS) Bimekizumab Dose 3 (SS) Bimekizumab Dose 2 (SS)
    Total subjects affected by serious adverse events
         subjects affected / exposed
    1 / 15 (6.67%)
    7 / 91 (7.69%)
    7 / 111 (6.31%)
         number of deaths (all causes)
    0
    2
    0
         number of deaths resulting from adverse events
    0
    0
    0
    Vascular disorders
    Circulatory collapse
         subjects affected / exposed
    0 / 15 (0.00%)
    1 / 91 (1.10%)
    0 / 111 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    Hypovolaemic shock
         subjects affected / exposed
    0 / 15 (0.00%)
    1 / 91 (1.10%)
    0 / 111 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    Surgical and medical procedures
    Abortion induced
         subjects affected / exposed
    0 / 15 (0.00%)
    1 / 91 (1.10%)
    0 / 111 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Acute myeloid leukaemia
         subjects affected / exposed
    0 / 15 (0.00%)
    0 / 91 (0.00%)
    1 / 111 (0.90%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Non-cardiac chest pain
         subjects affected / exposed
    1 / 15 (6.67%)
    0 / 91 (0.00%)
    0 / 111 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Reproductive system and breast disorders
    Uterine cervix stenosis
         subjects affected / exposed
    0 / 15 (0.00%)
    0 / 91 (0.00%)
    1 / 111 (0.90%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Humerus fracture
         subjects affected / exposed
    0 / 15 (0.00%)
    1 / 91 (1.10%)
    0 / 111 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Tibia fracture
         subjects affected / exposed
    0 / 15 (0.00%)
    1 / 91 (1.10%)
    0 / 111 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Investigations
    Hepatic enzyme increased
         subjects affected / exposed
    0 / 15 (0.00%)
    0 / 91 (0.00%)
    1 / 111 (0.90%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cardiac disorders
    Cardiac failure
         subjects affected / exposed
    0 / 15 (0.00%)
    0 / 91 (0.00%)
    1 / 111 (0.90%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Dyspnoea
         subjects affected / exposed
    0 / 15 (0.00%)
    1 / 91 (1.10%)
    0 / 111 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    Respiratory failure
         subjects affected / exposed
    0 / 15 (0.00%)
    1 / 91 (1.10%)
    0 / 111 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    Nervous system disorders
    Carpal tunnel syndrome
         subjects affected / exposed
    0 / 15 (0.00%)
    1 / 91 (1.10%)
    0 / 111 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Eye disorders
    Cataract
         subjects affected / exposed
    0 / 15 (0.00%)
    1 / 91 (1.10%)
    0 / 111 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Renal and urinary disorders
    IgA nephropathy
         subjects affected / exposed
    0 / 15 (0.00%)
    0 / 91 (0.00%)
    1 / 111 (0.90%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Nephrolithiasis
         subjects affected / exposed
    0 / 15 (0.00%)
    0 / 91 (0.00%)
    1 / 111 (0.90%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Ureterolithiasis
         subjects affected / exposed
    0 / 15 (0.00%)
    0 / 91 (0.00%)
    1 / 111 (0.90%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Renal colic
         subjects affected / exposed
    0 / 15 (0.00%)
    0 / 91 (0.00%)
    1 / 111 (0.90%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Otitis externa bacterial
         subjects affected / exposed
    0 / 15 (0.00%)
    1 / 91 (1.10%)
    0 / 111 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Staphylococcal abscess
         subjects affected / exposed
    0 / 15 (0.00%)
    0 / 91 (0.00%)
    1 / 111 (0.90%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    Bimekizumab Dose 1 (SS) Bimekizumab Dose 3 (SS) Bimekizumab Dose 2 (SS)
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    10 / 15 (66.67%)
    51 / 91 (56.04%)
    56 / 111 (50.45%)
    Vascular disorders
    Hypertension
         subjects affected / exposed
    2 / 15 (13.33%)
    4 / 91 (4.40%)
    8 / 111 (7.21%)
         occurrences all number
    2
    4
    10
    Injury, poisoning and procedural complications
    Joint injury
         subjects affected / exposed
    1 / 15 (6.67%)
    0 / 91 (0.00%)
    0 / 111 (0.00%)
         occurrences all number
    1
    0
    0
    Procedural pain
         subjects affected / exposed
    1 / 15 (6.67%)
    0 / 91 (0.00%)
    0 / 111 (0.00%)
         occurrences all number
    2
    0
    0
    Investigations
    Gamma-glutamyl-transferase increased
         subjects affected / exposed
    1 / 15 (6.67%)
    3 / 91 (3.30%)
    4 / 111 (3.60%)
         occurrences all number
    1
    4
    6
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Benign ovarian tumour
         subjects affected / exposed
    1 / 15 (6.67%)
    0 / 91 (0.00%)
    0 / 111 (0.00%)
         occurrences all number
    1
    0
    0
    Respiratory, thoracic and mediastinal disorders
    Oropharyngeal pain
         subjects affected / exposed
    0 / 15 (0.00%)
    6 / 91 (6.59%)
    6 / 111 (5.41%)
         occurrences all number
    0
    8
    6
    Ear and labyrinth disorders
    External ear inflammation
         subjects affected / exposed
    1 / 15 (6.67%)
    1 / 91 (1.10%)
    0 / 111 (0.00%)
         occurrences all number
    1
    1
    0
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed
    1 / 15 (6.67%)
    1 / 91 (1.10%)
    0 / 111 (0.00%)
         occurrences all number
    1
    1
    0
    Flatulence
         subjects affected / exposed
    1 / 15 (6.67%)
    0 / 91 (0.00%)
    0 / 111 (0.00%)
         occurrences all number
    1
    0
    0
    Hepatobiliary disorders
    Non-alcoholic fatty liver
         subjects affected / exposed
    1 / 15 (6.67%)
    0 / 91 (0.00%)
    1 / 111 (0.90%)
         occurrences all number
    1
    0
    1
    Skin and subcutaneous tissue disorders
    Dermatitis contact
         subjects affected / exposed
    1 / 15 (6.67%)
    3 / 91 (3.30%)
    5 / 111 (4.50%)
         occurrences all number
    1
    3
    6
    Seborrhoeic dermatitis
         subjects affected / exposed
    1 / 15 (6.67%)
    2 / 91 (2.20%)
    3 / 111 (2.70%)
         occurrences all number
    1
    2
    4
    Pruritus generalised
         subjects affected / exposed
    1 / 15 (6.67%)
    1 / 91 (1.10%)
    0 / 111 (0.00%)
         occurrences all number
    1
    1
    0
    Psoriasis
         subjects affected / exposed
    2 / 15 (13.33%)
    5 / 91 (5.49%)
    5 / 111 (4.50%)
         occurrences all number
    2
    5
    6
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    0 / 15 (0.00%)
    6 / 91 (6.59%)
    3 / 111 (2.70%)
         occurrences all number
    0
    7
    4
    Metabolism and nutrition disorders
    Hyperphagia
         subjects affected / exposed
    1 / 15 (6.67%)
    0 / 91 (0.00%)
    0 / 111 (0.00%)
         occurrences all number
    1
    0
    0
    Infections and infestations
    Oral candidiasis
         subjects affected / exposed
    1 / 15 (6.67%)
    15 / 91 (16.48%)
    13 / 111 (11.71%)
         occurrences all number
    2
    19
    17
    Skin candida
         subjects affected / exposed
    1 / 15 (6.67%)
    0 / 91 (0.00%)
    0 / 111 (0.00%)
         occurrences all number
    1
    0
    0
    Angular cheilitis
         subjects affected / exposed
    1 / 15 (6.67%)
    0 / 91 (0.00%)
    2 / 111 (1.80%)
         occurrences all number
    1
    0
    3
    Gingivitis
         subjects affected / exposed
    1 / 15 (6.67%)
    0 / 91 (0.00%)
    0 / 111 (0.00%)
         occurrences all number
    1
    0
    0
    Vulvovaginal mycotic infection
         subjects affected / exposed
    1 / 15 (6.67%)
    0 / 91 (0.00%)
    1 / 111 (0.90%)
         occurrences all number
    2
    0
    1
    Nasopharyngitis
         subjects affected / exposed
    2 / 15 (13.33%)
    11 / 91 (12.09%)
    15 / 111 (13.51%)
         occurrences all number
    4
    14
    20
    Upper respiratory tract infection
         subjects affected / exposed
    1 / 15 (6.67%)
    9 / 91 (9.89%)
    10 / 111 (9.01%)
         occurrences all number
    1
    12
    12
    Pharyngitis
         subjects affected / exposed
    1 / 15 (6.67%)
    3 / 91 (3.30%)
    1 / 111 (0.90%)
         occurrences all number
    1
    3
    1
    Urinary tract infection
         subjects affected / exposed
    2 / 15 (13.33%)
    1 / 91 (1.10%)
    1 / 111 (0.90%)
         occurrences all number
    3
    2
    1
    Respiratory tract infection viral
         subjects affected / exposed
    1 / 15 (6.67%)
    1 / 91 (1.10%)
    1 / 111 (0.90%)
         occurrences all number
    1
    1
    1

    More information

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    Substantial protocol amendments (globally)

    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    12 Aug 2016
    This substantial amendment revised the study design of PS0011 to allow participants who were responding to placebo or the lowest dose of bimekizumab (Dose 1 Q4W) in PS0010 to continue into PS0011 with no change in treatment, while protecting the study blind. The study design changed from an open-label to a double-blind, placebo-controlled, parallel-group extension study with additional treatment groups included for consistency with PS0010. Following other changes were made: •Added details on study revisions, including study type, description, rationale for the revised design, and addition of placebo. •Clarified treatment arms and criteria and methods for treatment assignment •Reduced number of secondary objectives and reassigned secondary variables to other objectives •Classified efficacy variables into secondary and other efficacy variables •Extended timing of SFU Visit and maximum duration of subject participation •Adjustment and/or clarification of schedule for hematology, biochemistry, urinalysis, bimekizumab plasma concentrations, anti bimekizumab antibody levels, and Hospital Anxiety and Depression Scale •Removed population PK, legal representative for consent and exclusion of pre-existing clinically active or medically significant infection •Adjusted details on contraception requirements •Included eligibility requirement for negative interferon-gamma release assay and for completion of PS0010 •Clarifications to withdrawal criteria regarding concurrent illness, pustular psoriasis, topical treatments, HADS and PASI thresholds, AEs, and clinical laboratory values. •Provided details on maintaining and emergency breaking of the study blinding •Provided additional detail for recording the severity of AEs, duration of AE follow-up and adverse events for special monitoring (AESM) •Removed alcohol test in the potential drug-induced liver injury urine toxicology screen •Added clarifications to the statistics section and adapted sections that impacted by design change.

    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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