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    Clinical Trial Results:
    A Multicenter, Randomized, Subject-Blind, Investigator-Blind Study to Evaluate the Time Course of Pharmacodynamic Response, Safety and Pharmacokinetics of Bimekizumab in Adult Subjects With Moderate to Severe Chronic Plaque Psoriasis

    Summary
    EudraCT number
    2016-002368-15
    Trial protocol
    DE  
    Global end of trial date
    11 Dec 2017

    Results information
    Results version number
    v1(current)
    This version publication date
    16 Oct 2022
    First version publication date
    16 Oct 2022
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    PS0016
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    NCT03025542
    WHO universal trial number (UTN)
    -
    Sponsors
    Sponsor organisation name
    UCB Biopharma SRL
    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
    16 Apr 2018
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    11 Dec 2017
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To evaluate the time-course of Psoriasis Area and Severity Index (PASI) over a 28-week period following the administration of bimekizumab given at Baseline and Week 4 to subjects with moderate to severe chronic plaque psoriasis.
    Protection of trial subjects
    During the conduct of the study all subjects were closely monitored.
    Background therapy
    Not applicable
    Evidence for comparator
    Not applicable
    Actual start date of recruitment
    27 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: 12
    Country: Number of subjects enrolled
    Australia: 19
    Country: Number of subjects enrolled
    Moldova, Republic of: 17
    Country: Number of subjects enrolled
    United States: 1
    Worldwide total number of subjects
    49
    EEA total number of subjects
    0
    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)
    46
    From 65 to 84 years
    3
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    The study started to enroll patients in December 2016 and concluded in December 2017.

    Pre-assignment
    Screening details
    Participant Flow refers to the Safety Set (SS).

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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    BKZ 320 mg + PBO
    Arm description
    Bimekizumab 320 milligrams (mg) administered subcutaneously (sc) at Baseline and Week 4, and placebo administered at Week 16.
    Arm type
    Experimental

    Investigational medicinal product name
    Bimekizumab
    Investigational medicinal product code
    UCB4940
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Subjects were administered 320 milligrams (mg) of bimekizumab as a subcutaneous (sc) injection.

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    PBO
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Subjects were administered matching placebo subcutaneous injections.

    Arm title
    BKZ 320 mg
    Arm description
    Bimekizumab 320 mg administered sc at Baseline and Weeks 4 and 16.
    Arm type
    Experimental

    Investigational medicinal product name
    Bimekizumab
    Investigational medicinal product code
    UCB4940
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Subjects were administered 320 milligrams (mg) of bimekizumab as a subcutaneous (sc) injection.

    Number of subjects in period 1
    BKZ 320 mg + PBO BKZ 320 mg
    Started
    32
    17
    Completed
    30
    15
    Not completed
    2
    2
         Adverse event, non-fatal
    -
    2
         Consent withdrawn by subject
    1
    -
         Lost to follow-up
    1
    -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    BKZ 320 mg + PBO
    Reporting group description
    Bimekizumab 320 milligrams (mg) administered subcutaneously (sc) at Baseline and Week 4, and placebo administered at Week 16.

    Reporting group title
    BKZ 320 mg
    Reporting group description
    Bimekizumab 320 mg administered sc at Baseline and Weeks 4 and 16.

    Reporting group values
    BKZ 320 mg + PBO BKZ 320 mg Total
    Number of subjects
    32 17 49
    Age categorical
    Units: Subjects
        <=18 years
    0 0 0
        Between 18 and 65 years
    30 16 46
        >=65 years
    2 1 3
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    41.8 ± 14.1 45.9 ± 10.4 -
    Gender categorical
    Units: Subjects
        Female
    17 6 23
        Male
    15 11 26

    End points

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    End points reporting groups
    Reporting group title
    BKZ 320 mg + PBO
    Reporting group description
    Bimekizumab 320 milligrams (mg) administered subcutaneously (sc) at Baseline and Week 4, and placebo administered at Week 16.

    Reporting group title
    BKZ 320 mg
    Reporting group description
    Bimekizumab 320 mg administered sc at Baseline and Weeks 4 and 16.

    Subject analysis set title
    BKZ 320 mg + PBO (SS)
    Subject analysis set type
    Safety analysis
    Subject analysis set description
    Bimekizumab 320 milligrams (mg) administered subcutaneously (sc) at Baseline and Week 4, and placebo administered at Week 16.

    Subject analysis set title
    BKZ 320 mg (SS)
    Subject analysis set type
    Safety analysis
    Subject analysis set description
    Bimekizumab 320 mg administered sc at Baseline and Weeks 4 and 16.

    Subject analysis set title
    BKZ 320 mg + PBO (PK-PPS)
    Subject analysis set type
    Per protocol
    Subject analysis set description
    Bimekizumab 320 milligrams (mg) administered subcutaneously (sc) at Baseline and Week 4, and placebo administered at Week 16.

    Subject analysis set title
    BKZ 320 mg (PK-PPS)
    Subject analysis set type
    Per protocol
    Subject analysis set description
    Bimekizumab 320 mg administered sc at Baseline and Weeks 4 and 16.

    Subject analysis set title
    BKZ 320 mg + PBO (FAS)
    Subject analysis set type
    Full analysis
    Subject analysis set description
    Bimekizumab 320 milligrams (mg) administered subcutaneously (sc) at Baseline and Week 4, and placebo administered at Week 16.

    Subject analysis set title
    BKZ 320 mg (FAS)
    Subject analysis set type
    Full analysis
    Subject analysis set description
    Bimekizumab 320 mg administered sc at Baseline and Weeks 4 and 16.

    Primary: Change from Baseline in Psoriasis Area and Severity Index (PASI) at Week 28

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    End point title
    Change from Baseline in Psoriasis Area and Severity Index (PASI) at Week 28 [1]
    End point description
    The PASI is the most commonly used and validated assessment for grading the severity of psoriasis in clinical studies. The PASI quantifies the severity and extent of the disease and weighs these with the percentage of body surface area (BSA) involvement. The percent area of involvement (BSA%) is estimated across 4 body areas; head (10%), upper limbs (20%), trunk (30%), and lower limbs (40%) and then transferred into a grade. The Investigator assesses the average redness, thickness, and scaliness of lesions in each body area (each on a 5 point scale); 0=none, 1=slight, 2=moderate, 3=marked, and 4=very marked. The PASI score ranges from 0 to 72 with a higher score indicating increased disease severity.
    End point type
    Primary
    End point timeframe
    From Baseline to Week 28
    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
    BKZ 320 mg + PBO (FAS) BKZ 320 mg (FAS)
    Number of subjects analysed
    32
    17
    Units: scores on a scale
    arithmetic mean (standard deviation)
        Mean (Standard Deviation)
    -10.76 ± 7.58
    -19.74 ± 8.77
    No statistical analyses for this end point

    Primary: Mean plasma concentration of bimekizumab at Week 16

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    End point title
    Mean plasma concentration of bimekizumab at Week 16 [2]
    End point description
    Plasma concentration was expressed as geometric mean concentrations (GMCs) and measured in micrograms per milliliter (µg/mL). Note: Means, Lower confidence interval (LCI), Upper confidence interval (UCI) are only calculated if at least 2/3 of the concentrations were quantified at the respective time point. Values below limit of quantification (BLQ) are replaced by value of lower limit of quantification (LLOQ)/2 (=0.075ug/mL) in calculations of means.
    End point type
    Primary
    End point timeframe
    At Week 16
    Notes
    [2] - 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
    BKZ 320 mg + PBO (PK-PPS) BKZ 320 mg (PK-PPS)
    Number of subjects analysed
    31
    15
    Units: µg/mL
    geometric mean (confidence interval 95%)
        Geometric Mean (95% CI)
    2.200 (1.6 to 3.0)
    2.293 (1.4 to 3.7)
    No statistical analyses for this end point

    Primary: Percentage of participants reporting positive Anti-Drug-Antibodies (ADA) titre prior to and following study treatment with bimekizumab at Baseline

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    End point title
    Percentage of participants reporting positive Anti-Drug-Antibodies (ADA) titre prior to and following study treatment with bimekizumab at Baseline [3]
    End point description
    An ADA status of positive was concluded for any subject with an ADA level that was above cut point (ACP) and ‘confirmed positive’ (CP) at any time point. A subject was classified as having treatment-induced ADA positivity when meeting one of the following criteria: -The Baseline result was either below cut point (BCP) or ACP and ‘not confirmed positive’ (NCP), and at least 1 post Baseline time point was ACP and CP. -The Baseline result was positive (ACP and CP) and at least one post-Baseline measurement showed a pre-defined fold increase in titre from the Baseline value. Note: The overall status of a subject is ‘Positive’ if at any post-Baseline visit the result was ACP and confirmed positive.
    End point type
    Primary
    End point timeframe
    At Baseline
    Notes
    [3] - 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
    BKZ 320 mg + PBO (SS) BKZ 320 mg (SS)
    Number of subjects analysed
    32
    17
    Units: percentage of subjects
    number (not applicable)
        percentage of subjects
    3.1
    0
    No statistical analyses for this end point

    Primary: Percentage of participants reporting positive Anti-Drug-Antibodies (ADA) titre prior to and following study treatment with bimekizumab at Week 4

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    End point title
    Percentage of participants reporting positive Anti-Drug-Antibodies (ADA) titre prior to and following study treatment with bimekizumab at Week 4 [4]
    End point description
    An ADA status of positive was concluded for any subject with an ADA level that was above cut point (ACP) and ‘confirmed positive’ (CP) at any time point. A subject was classified as having treatment-induced ADA positivity when meeting one of the following criteria: -The Baseline result was either below cut point (BCP) or ACP and ‘not confirmed positive’ (NCP), and at least 1 post Baseline time point was ACP and CP. -The Baseline result was positive (ACP and CP) and at least one post-Baseline measurement showed a pre-defined fold increase in titre from the Baseline value. Note: The overall status of a subject is ‘Positive’ if at any post-Baseline visit the result was ACP and confirmed positive.
    End point type
    Primary
    End point timeframe
    At Week 4
    Notes
    [4] - 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
    BKZ 320 mg + PBO (SS) BKZ 320 mg (SS)
    Number of subjects analysed
    31
    17
    Units: percentage of subjects
    number (not applicable)
        percentage of subjects
    0
    0
    No statistical analyses for this end point

    Primary: Percentage of participants reporting positive Anti-Drug-Antibodies (ADA) titre prior to and following study treatment with bimekizumab at Week 8

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    End point title
    Percentage of participants reporting positive Anti-Drug-Antibodies (ADA) titre prior to and following study treatment with bimekizumab at Week 8 [5]
    End point description
    An ADA status of positive was concluded for any subject with an ADA level that was above cut point (ACP) and ‘confirmed positive’ (CP) at any time point. A subject was classified as having treatment-induced ADA positivity when meeting one of the following criteria: -The Baseline result was either below cut point (BCP) or ACP and ‘not confirmed positive’ (NCP), and at least 1 post Baseline time point was ACP and CP. -The Baseline result was positive (ACP and CP) and at least one post-Baseline measurement showed a pre-defined fold increase in titre from the Baseline value. Note: The overall status of a subject is ‘Positive’ if at any post-Baseline visit the result was ACP and confirmed positive.
    End point type
    Primary
    End point timeframe
    At Week 8
    Notes
    [5] - 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
    BKZ 320 mg + PBO (SS) BKZ 320 mg (SS)
    Number of subjects analysed
    31
    16
    Units: percentage of subjects
    number (not applicable)
        percentage of subjects
    0
    0
    No statistical analyses for this end point

    Primary: Percentage of participants reporting positive Anti-Drug-Antibodies (ADA) titre prior to and following study treatment with bimekizumab at Week 12

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    End point title
    Percentage of participants reporting positive Anti-Drug-Antibodies (ADA) titre prior to and following study treatment with bimekizumab at Week 12 [6]
    End point description
    An ADA status of positive was concluded for any subject with an ADA level that was above cut point (ACP) and ‘confirmed positive’ (CP) at any time point. A subject was classified as having treatment-induced ADA positivity when meeting one of the following criteria: -The Baseline result was either below cut point (BCP) or ACP and ‘not confirmed positive’ (NCP), and at least 1 post Baseline time point was ACP and CP. -The Baseline result was positive (ACP and CP) and at least one post-Baseline measurement showed a pre-defined fold increase in titre from the Baseline value. Note: The overall status of a subject is ‘Positive’ if at any post-Baseline visit the result was ACP and confirmed positive.
    End point type
    Primary
    End point timeframe
    At Week 12
    Notes
    [6] - 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
    BKZ 320 mg + PBO (SS) BKZ 320 mg (SS)
    Number of subjects analysed
    31
    15
    Units: percentage of subjects
    number (not applicable)
        percentage of subjects
    3.2
    0
    No statistical analyses for this end point

    Primary: Percentage of participants reporting positive Anti-Drug-Antibodies (ADA) titre prior to and following study treatment with bimekizumab at Week 16

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    End point title
    Percentage of participants reporting positive Anti-Drug-Antibodies (ADA) titre prior to and following study treatment with bimekizumab at Week 16 [7]
    End point description
    An ADA status of positive was concluded for any subject with an ADA level that was above cut point (ACP) and ‘confirmed positive’ (CP) at any time point. A subject was classified as having treatment-induced ADA positivity when meeting one of the following criteria: -The Baseline result was either below cut point (BCP) or ACP and ‘not confirmed positive’ (NCP), and at least 1 post Baseline time point was ACP and CP. -The Baseline result was positive (ACP and CP) and at least one post-Baseline measurement showed a pre-defined fold increase in titre from the Baseline value. Note: The overall status of a subject is ‘Positive’ if at any post-Baseline visit the result was ACP and confirmed positive.
    End point type
    Primary
    End point timeframe
    At Week 16
    Notes
    [7] - 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
    BKZ 320 mg + PBO (SS) BKZ 320 mg (SS)
    Number of subjects analysed
    31
    15
    Units: percentage of subjects
    number (not applicable)
        percentage of subjects
    3.2
    6.7
    No statistical analyses for this end point

    Primary: Percentage of participants reporting positive Anti-Drug-Antibodies (ADA) titre prior to and following study treatment with bimekizumab at Week 20

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    End point title
    Percentage of participants reporting positive Anti-Drug-Antibodies (ADA) titre prior to and following study treatment with bimekizumab at Week 20 [8]
    End point description
    An ADA status of positive was concluded for any subject with an ADA level that was above cut point (ACP) and ‘confirmed positive’ (CP) at any time point. A subject was classified as having treatment-induced ADA positivity when meeting one of the following criteria: -The Baseline result was either below cut point (BCP) or ACP and ‘not confirmed positive’ (NCP), and at least 1 post Baseline time point was ACP and CP. -The Baseline result was positive (ACP and CP) and at least one post-Baseline measurement showed a pre-defined fold increase in titre from the Baseline value. Note: The overall status of a subject is ‘Positive’ if at any post-Baseline visit the result was ACP and confirmed positive.
    End point type
    Primary
    End point timeframe
    At Week 20
    Notes
    [8] - 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
    BKZ 320 mg + PBO (SS) BKZ 320 mg (SS)
    Number of subjects analysed
    31
    15
    Units: percentage of subjects
    number (not applicable)
        percentage of subjects
    12.9
    0
    No statistical analyses for this end point

    Primary: Percentage of participants reporting positive Anti-Drug-Antibodies (ADA) titre prior to and following study treatment with bimekizumab at Week 24

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    End point title
    Percentage of participants reporting positive Anti-Drug-Antibodies (ADA) titre prior to and following study treatment with bimekizumab at Week 24 [9]
    End point description
    An ADA status of positive was concluded for any subject with an ADA level that was above cut point (ACP) and ‘confirmed positive’ (CP) at any time point. A subject was classified as having treatment-induced ADA positivity when meeting one of the following criteria: -The Baseline result was either below cut point (BCP) or ACP and ‘not confirmed positive’ (NCP), and at least 1 post Baseline time point was ACP and CP. -The Baseline result was positive (ACP and CP) and at least one post-Baseline measurement showed a pre-defined fold increase in titre from the Baseline value. Note: The overall status of a subject is ‘Positive’ if at any post-Baseline visit the result was ACP and confirmed positive.
    End point type
    Primary
    End point timeframe
    At Week 24
    Notes
    [9] - 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
    BKZ 320 mg + PBO (SS) BKZ 320 mg (SS)
    Number of subjects analysed
    28
    15
    Units: percentage of subjects
    number (not applicable)
        percentage of subjects
    14.3
    6.7
    No statistical analyses for this end point

    Primary: Percentage of participants reporting positive Anti-Drug-Antibodies (ADA) titre prior to and following study treatment with bimekizumab at Week 28

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    End point title
    Percentage of participants reporting positive Anti-Drug-Antibodies (ADA) titre prior to and following study treatment with bimekizumab at Week 28 [10]
    End point description
    An ADA status of positive was concluded for any subject with an ADA level that was above cut point (ACP) and ‘confirmed positive’ (CP) at any time point. A subject was classified as having treatment-induced ADA positivity when meeting one of the following criteria: -The Baseline result was either below cut point (BCP) or ACP and ‘not confirmed positive’ (NCP), and at least 1 post Baseline time point was ACP and CP. -The Baseline result was positive (ACP and CP) and at least one post-Baseline measurement showed a pre-defined fold increase in titre from the Baseline value. Note: The overall status of a subject is ‘Positive’ if at any post-Baseline visit the result was ACP and confirmed positive.
    End point type
    Primary
    End point timeframe
    At Week 28
    Notes
    [10] - 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
    BKZ 320 mg + PBO (SS) BKZ 320 mg (SS)
    Number of subjects analysed
    26
    13
    Units: percentage of subjects
    number (not applicable)
        percentage of subjects
    26.9
    30.8
    No statistical analyses for this end point

    Primary: Percentage of subjects who experienced at least one adverse events (AEs)

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    End point title
    Percentage of subjects who experienced at least one adverse events (AEs) [11]
    End point description
    An Adverse Event (AE) is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment.
    End point type
    Primary
    End point timeframe
    From Baseline to Safety Follow Up Visit (Week 36)
    Notes
    [11] - 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
    BKZ 320 mg + PBO (SS) BKZ 320 mg (SS)
    Number of subjects analysed
    32
    17
    Units: percentage of subjects
    number (not applicable)
        percentage of subjects
    87.5
    88.2
    No statistical analyses for this end point

    Secondary: Percentage of subjects achieving a 75% or higher improvement from Baseline in PASI (Psoriasis Area and Severity Index) score at Week 16

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    End point title
    Percentage of subjects achieving a 75% or higher improvement from Baseline in PASI (Psoriasis Area and Severity Index) score at Week 16
    End point description
    The PASI75 response assessments are based on at least 75% improvement in the PASI score from Baseline. This is a scoring system that 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). Determining the percentage of skin covered with PSO for each of the body areas and converting to a 0 to 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 minimum possible PASI score is 0= no disease, the maximum score is 72= maximal disease.
    End point type
    Secondary
    End point timeframe
    From Baseline to Week 16
    End point values
    BKZ 320 mg + PBO (FAS) BKZ 320 mg (FAS)
    Number of subjects analysed
    32
    17
    Units: percentage of subjects
    number (not applicable)
        percentage of responders
    93.8
    88.2
    No statistical analyses for this end point

    Secondary: Percentage of subjects achieving a 90% or higher improvement in PASI (Psoriasis Area and Severity Index) score at Week 16

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    End point title
    Percentage of subjects achieving a 90% or higher improvement in PASI (Psoriasis Area and Severity Index) score at Week 16
    End point description
    The PASI90 response assessments are based on at least 90% improvement in the PASI score from Baseline. This is a scoring system that 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). Determining the percentage of skin covered with PSO for each of the body areas and converting to a 0 to 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 minimum possible PASI score is 0= no disease, the maximum score is 72= maximal disease.
    End point type
    Secondary
    End point timeframe
    From Baseline to Week 16
    End point values
    BKZ 320 mg + PBO (FAS) BKZ 320 mg (FAS)
    Number of subjects analysed
    32
    17
    Units: percentage of subjects
    number (not applicable)
        percentage of responders
    84.4
    70.6
    No statistical analyses for this end point

    Secondary: Percentage of subjects achieving a 100% improvement from Baseline in PASI (Psoriasis Area and Severity Index) score at Week 16

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    End point title
    Percentage of subjects achieving a 100% improvement from Baseline in PASI (Psoriasis Area and Severity Index) score at Week 16
    End point description
    The PASI100 response assessments are based on at least 100% improvement in the PASI score from Baseline. This is a scoring system that 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). Determining the percentage of skin covered with PSO for each of the body areas and converting to a 0 to 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 minimum possible PASI score is 0= no disease, the maximum score is 72= maximal disease.
    End point type
    Secondary
    End point timeframe
    From Baseline to Week 16
    End point values
    BKZ 320 mg + PBO (FAS) BKZ 320 mg (FAS)
    Number of subjects analysed
    32
    17
    Units: percentage of subjects
    number (not applicable)
        percentage of responders
    46.9
    52.9
    No statistical analyses for this end point

    Secondary: Percentage of subjects with IGA (Investigator´s Global Assessment) response at Week 16

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    End point title
    Percentage of subjects with IGA (Investigator´s Global Assessment) 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.
    End point type
    Secondary
    End point timeframe
    At Week 16
    End point values
    BKZ 320 mg + PBO (FAS) BKZ 320 mg (FAS)
    Number of subjects analysed
    32
    17
    Units: percentage of subjects
    number (not applicable)
        percentage of responders
    81.3
    64.7
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    From Baseline to Week 36
    Assessment type
    Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    19.0
    Reporting groups
    Reporting group title
    BKZ 320 mg + PBO (SS)
    Reporting group description
    Bimekizumab 320 milligrams (mg) administered subcutaneously (sc) at Baseline and Week 4, and placebo administered at Week 16.

    Reporting group title
    BKZ 320 mg (SS)
    Reporting group description
    Bimekizumab 320 mg administered sc at Baseline and Weeks 4 and 16.

    Serious adverse events
    BKZ 320 mg + PBO (SS) BKZ 320 mg (SS)
    Total subjects affected by serious adverse events
         subjects affected / exposed
    2 / 32 (6.25%)
    1 / 17 (5.88%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Nervous system disorders
    Syncope
         subjects affected / exposed
    1 / 32 (3.13%)
    0 / 17 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Peripheral sensorimotor neuropathy
         subjects affected / exposed
    1 / 32 (3.13%)
    0 / 17 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Pancreatitis
         subjects affected / exposed
    0 / 32 (0.00%)
    1 / 17 (5.88%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatobiliary disorders
    Cholecystitis acute
         subjects affected / exposed
    0 / 32 (0.00%)
    1 / 17 (5.88%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    BKZ 320 mg + PBO (SS) BKZ 320 mg (SS)
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    28 / 32 (87.50%)
    15 / 17 (88.24%)
    Investigations
    Alanine aminotransferase increased
         subjects affected / exposed
    2 / 32 (6.25%)
    3 / 17 (17.65%)
         occurrences all number
    3
    3
    Gamma-glutamyltransferase increased
         subjects affected / exposed
    2 / 32 (6.25%)
    3 / 17 (17.65%)
         occurrences all number
    4
    7
    Aspartate aminotransferase increased
         subjects affected / exposed
    2 / 32 (6.25%)
    2 / 17 (11.76%)
         occurrences all number
    2
    4
    Neutrophil count decreased
         subjects affected / exposed
    1 / 32 (3.13%)
    3 / 17 (17.65%)
         occurrences all number
    1
    3
    Blood cholesterol increased
         subjects affected / exposed
    1 / 32 (3.13%)
    2 / 17 (11.76%)
         occurrences all number
    1
    2
    Blood bilirubin increased
         subjects affected / exposed
    0 / 32 (0.00%)
    1 / 17 (5.88%)
         occurrences all number
    0
    1
    Mean cell haemoglobin concentration decreased
         subjects affected / exposed
    0 / 32 (0.00%)
    1 / 17 (5.88%)
         occurrences all number
    0
    1
    Lymphocyte count decreased
         subjects affected / exposed
    0 / 32 (0.00%)
    1 / 17 (5.88%)
         occurrences all number
    0
    1
    Platelet count decreased
         subjects affected / exposed
    0 / 32 (0.00%)
    1 / 17 (5.88%)
         occurrences all number
    0
    3
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Seborrhoeic keratosis
         subjects affected / exposed
    0 / 32 (0.00%)
    1 / 17 (5.88%)
         occurrences all number
    0
    2
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    0 / 32 (0.00%)
    1 / 17 (5.88%)
         occurrences all number
    0
    1
    Immune system disorders
    Seasonal allergy
         subjects affected / exposed
    0 / 32 (0.00%)
    1 / 17 (5.88%)
         occurrences all number
    0
    2
    Blood and lymphatic system disorders
    Hypochromic anaemia
         subjects affected / exposed
    0 / 32 (0.00%)
    1 / 17 (5.88%)
         occurrences all number
    0
    1
    Nervous system disorders
    Headache
         subjects affected / exposed
    3 / 32 (9.38%)
    1 / 17 (5.88%)
         occurrences all number
    3
    1
    Tension headache
         subjects affected / exposed
    0 / 32 (0.00%)
    1 / 17 (5.88%)
         occurrences all number
    0
    1
    Gastrointestinal disorders
    Nausea
         subjects affected / exposed
    1 / 32 (3.13%)
    1 / 17 (5.88%)
         occurrences all number
    1
    1
    Abdominal discomfort
         subjects affected / exposed
    0 / 32 (0.00%)
    1 / 17 (5.88%)
         occurrences all number
    0
    1
    Anal pruritus
         subjects affected / exposed
    0 / 32 (0.00%)
    1 / 17 (5.88%)
         occurrences all number
    0
    1
    Irritable bowel syndrome
         subjects affected / exposed
    0 / 32 (0.00%)
    1 / 17 (5.88%)
         occurrences all number
    0
    1
    Dental necrosis
         subjects affected / exposed
    0 / 32 (0.00%)
    1 / 17 (5.88%)
         occurrences all number
    0
    1
    Hepatobiliary disorders
    Non-alcoholic fatty liver
         subjects affected / exposed
    0 / 32 (0.00%)
    1 / 17 (5.88%)
         occurrences all number
    0
    1
    Skin and subcutaneous tissue disorders
    Pruritus generalised
         subjects affected / exposed
    1 / 32 (3.13%)
    1 / 17 (5.88%)
         occurrences all number
    1
    1
    Psoriasis
         subjects affected / exposed
    1 / 32 (3.13%)
    1 / 17 (5.88%)
         occurrences all number
    1
    1
    Dermatitis
         subjects affected / exposed
    0 / 32 (0.00%)
    1 / 17 (5.88%)
         occurrences all number
    0
    1
    Musculoskeletal and connective tissue disorders
    Back pain
         subjects affected / exposed
    1 / 32 (3.13%)
    1 / 17 (5.88%)
         occurrences all number
    1
    1
    Arthralgia
         subjects affected / exposed
    1 / 32 (3.13%)
    1 / 17 (5.88%)
         occurrences all number
    1
    1
    Neck pain
         subjects affected / exposed
    0 / 32 (0.00%)
    1 / 17 (5.88%)
         occurrences all number
    0
    1
    Metabolism and nutrition disorders
    White blood cell count decreased
         subjects affected / exposed
    2 / 32 (6.25%)
    3 / 17 (17.65%)
         occurrences all number
    2
    5
    Hyperkalaemia
         subjects affected / exposed
    4 / 32 (12.50%)
    1 / 17 (5.88%)
         occurrences all number
    6
    1
    Infections and infestations
    Upper respiratory tract infection
         subjects affected / exposed
    6 / 32 (18.75%)
    3 / 17 (17.65%)
         occurrences all number
    8
    3
    Nasopharyngitis
         subjects affected / exposed
    2 / 32 (6.25%)
    4 / 17 (23.53%)
         occurrences all number
    2
    4
    Urinary tract infection
         subjects affected / exposed
    4 / 32 (12.50%)
    0 / 17 (0.00%)
         occurrences all number
    4
    0
    Viral upper respiratory tract infection
         subjects affected / exposed
    2 / 32 (6.25%)
    2 / 17 (11.76%)
         occurrences all number
    2
    3
    Gastroenteritis viral
         subjects affected / exposed
    2 / 32 (6.25%)
    1 / 17 (5.88%)
         occurrences all number
    2
    1
    Oral candidiasis
         subjects affected / exposed
    2 / 32 (6.25%)
    0 / 17 (0.00%)
         occurrences all number
    2
    0
    Bacterial diarrhoea
         subjects affected / exposed
    0 / 32 (0.00%)
    1 / 17 (5.88%)
         occurrences all number
    0
    1
    Viral infection
         subjects affected / exposed
    0 / 32 (0.00%)
    2 / 17 (11.76%)
         occurrences all number
    0
    2
    Conjunctivitis bacterial
         subjects affected / exposed
    0 / 32 (0.00%)
    1 / 17 (5.88%)
         occurrences all number
    0
    1
    Conjunctivitis
         subjects affected / exposed
    0 / 32 (0.00%)
    1 / 17 (5.88%)
         occurrences all number
    0
    1
    Ear infection
         subjects affected / exposed
    0 / 32 (0.00%)
    1 / 17 (5.88%)
         occurrences all number
    0
    1
    Localised infection
         subjects affected / exposed
    0 / 32 (0.00%)
    1 / 17 (5.88%)
         occurrences all number
    0
    1
    Postoperative wound infection
         subjects affected / exposed
    0 / 32 (0.00%)
    1 / 17 (5.88%)
         occurrences all number
    0
    1

    More information

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    Substantial protocol amendments (globally)

    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    23 Sep 2016
    The purpose of this amendment is the following: •Add an exclusion criterion to exclude subjects that had been admitted to a mental hospital or other institution by an order of the court •Clarify wording in the ribonucleic acid (RNA), proteins, and metabolite variables section •Add a Baseline blood sample for anti-bimekizumab antibodies •Specify the study stopping rules •Delete Section 4.3.4 header: Non-hereditary pharmacogenomics variables. This section had no content and the header was included in error.

    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.
    PS0016 has not been conducted in the European Economic Area (EEA) and therefore did not meet the criteria for the results posting on EudraCT. Nevertheless, due to data transparency reason, UCB decided to post the respective results.
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