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    Clinical Trial Results:
    A Multicenter, Phase 3, Randomized, Double-Blind, Placebo-Controlled Study Evaluating The Efficacy and Safety of Bimekizumab in The Treatment of Subjects With Active Psoriatic Arthritis

    Summary
    EudraCT number
    2017-002804-29
    Trial protocol
    DE   GB   CZ   IT   HU  
    Global end of trial date
    14 Feb 2022

    Results information
    Results version number
    v1(current)
    This version publication date
    26 Feb 2023
    First version publication date
    26 Feb 2023
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    PA0011
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    NCT03896581
    WHO universal trial number (UTN)
    -
    Sponsors
    Sponsor organisation name
    UCB Biopharma SRL
    Sponsor organisation address
    Allée de la Recherche 60, Brussels, Belgium,
    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
    04 Mar 2022
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    08 Dec 2021
    Global end of trial reached?
    Yes
    Global end of trial date
    14 Feb 2022
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    Demonstrate the clinical efficacy of bimekizumab administered subcutaneously compared with placebo in the treatment of tumor necrosis factor alpha-inadequate responders (TNFα-IR) participants with active Psoriatic Arthritis (PsA), as assessed by the American College of Rheumatology 50% improvement response.
    Protection of trial subjects
    Participants were closely monitored and were expected to be treated for any worsening as per investigator judgement. Moreover, rescue medication could be added if participant was not having benefit of therapy, as per investigator discretion.
    Background therapy
    No background therapy.
    Evidence for comparator
    -
    Actual start date of recruitment
    28 Mar 2019
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Australia: 1
    Country: Number of subjects enrolled
    Canada: 9
    Country: Number of subjects enrolled
    Czechia: 27
    Country: Number of subjects enrolled
    Germany: 22
    Country: Number of subjects enrolled
    Hungary: 8
    Country: Number of subjects enrolled
    Italy: 4
    Country: Number of subjects enrolled
    Japan: 12
    Country: Number of subjects enrolled
    Poland: 113
    Country: Number of subjects enrolled
    Russian Federation: 102
    Country: Number of subjects enrolled
    United Kingdom: 2
    Country: Number of subjects enrolled
    United States: 100
    Worldwide total number of subjects
    400
    EEA total number of subjects
    174
    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)
    337
    From 65 to 84 years
    62
    85 years and over
    1

    Subject disposition

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    Recruitment
    Recruitment details
    The study started to enroll study participants in March 2019 and concluded in February 2022.

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

    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
    Subject, Investigator, Assessor

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    Placebo
    Arm description
    Participants received placebo as a subcutaneous (sc) injection every 4 weeks (Q4W) for up to 16 weeks.
    Arm type
    Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection in pre-filled syringe
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Participants received placebo Q4W at prespecified time points.

    Arm title
    Bimekizumab 160mg
    Arm description
    Participants received bimekizumab (BKZ) 160 milligrams (mg) as a sc injection Q4W for up to 16 weeks.
    Arm type
    Experimental

    Investigational medicinal product name
    Bimekizumab
    Investigational medicinal product code
    UCB4940
    Other name
    Pharmaceutical forms
    Solution for injection in pre-filled syringe
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Participants received BKZ 160 mg Q4W at prespecified time points.

    Number of subjects in period 1
    Placebo Bimekizumab 160mg
    Started
    133
    267
    Completed
    125
    263
    Not completed
    8
    4
         Consent withdrawn by subject
    4
    1
         Adverse event, non-fatal
    -
    2
         Other (Covid-19 Pandemic Circumstances)
    1
    -
         Lost to follow-up
    1
    -
         Lack of efficacy
    2
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Placebo
    Reporting group description
    Participants received placebo as a subcutaneous (sc) injection every 4 weeks (Q4W) for up to 16 weeks.

    Reporting group title
    Bimekizumab 160mg
    Reporting group description
    Participants received bimekizumab (BKZ) 160 milligrams (mg) as a sc injection Q4W for up to 16 weeks.

    Reporting group values
    Placebo Bimekizumab 160mg Total
    Number of subjects
    133 267 400
    Age Categorical
    Units: participants
        <=18 years
    0 0 0
        Between 18 and 65 years
    111 226 337
        >=65 years
    22 41 63
    Age Continuous
    Units: years
        arithmetic mean (standard deviation)
    51.30 ± 12.876 50.13 ± 12.382 -
    Sex: Female, Male
    Units: participants
        Female
    73 137 210
        Male
    60 130 190

    End points

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    End points reporting groups
    Reporting group title
    Placebo
    Reporting group description
    Participants received placebo as a subcutaneous (sc) injection every 4 weeks (Q4W) for up to 16 weeks.

    Reporting group title
    Bimekizumab 160mg
    Reporting group description
    Participants received bimekizumab (BKZ) 160 milligrams (mg) as a sc injection Q4W for up to 16 weeks.

    Primary: Percentage of Participants with American College of Rheumatology 50 (ACR50) response

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    End point title
    Percentage of Participants with American College of Rheumatology 50 (ACR50) response
    End point description
    ACR50 response rate:50% or greater improvement of arthritis from Baseline. Those who met 3 conditions for improvement from Baseline met ACR50 response criteria: 1.Tender joint count (0-68 joints) ≥ 50% improvement; 2. Swollen joint count (0-66 joints) ≥ 50% improvement; and 3.≥ 50% improvement in at least 3 of the 5 below: Physician global assessment of disease activity [visual analog scale (VAS)(0-100 mm; no symptoms to severe)], Patient global assessment of disease activity [VAS-(0-100 mm; no limitation of normal activities to very poor)], Patient assessment of pain [VAS-(0-100 mm;no pain to most severe)], Health Assessment Questionnaire - Disability Index for degree of difficulty (20 queries from 8 domains of daily living activities scored 0-3, 0=less disability) High-sensitivity C-reactive protein (hsCRP). Analysis set:Randomized Set (RS). Non-responders: Those who missed ACR50 data at Week 16 or who discontinued study before Week 16 regardless of data present or not.
    End point type
    Primary
    End point timeframe
    From Baseline to Week 16
    End point values
    Placebo Bimekizumab 160mg
    Number of subjects analysed
    133
    267
    Units: percentage of participants
        number (not applicable)
    6.8
    43.4
    Statistical analysis title
    Statistical Analysis 1
    Comparison groups
    Placebo v Bimekizumab 160mg
    Number of subjects included in analysis
    400
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.001
    Method
    Regression, Logistic
    Parameter type
    Odds ratio (OR)
    Point estimate
    11.139
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    5.402
         upper limit
    22.969

    Secondary: Change from Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) at Week 16

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    End point title
    Change from Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) at Week 16
    End point description
    HAQ-DI contains 20 items that measured the degree of difficulty experienced in the following 8 categories of the daily living activities: dressing and grooming (2 items), arising (2 items), eating (3 items), walking (2 items), hygiene (3 items), reach (2 items), grip (3 items), and common daily activities (3 items). Each question was scored 0-3 (0 = without any difficulty, 1 = with some difficulty, 2 = with much difficulty, and 3 = unable to do). The overall HAQ-DI total score was calculated by dividing the sum of the highest category scores (0 to 24) by the number of categories with at least 1 question answered. Score ranges from 0 (no difficulty) to 3 (maximum difficulty). A lower HAQ-DI score indicated an improvement in function. A negative value in change from baseline indicated an improvement. RS consisted of all enrolled participants who had been randomized. Missing data and non-missing data preceded by a study treatment discontinuation were imputed using multiple imputation.
    End point type
    Secondary
    End point timeframe
    Baseline and Week 16
    End point values
    Placebo Bimekizumab 160mg
    Number of subjects analysed
    133
    267
    Units: score on a scale
        arithmetic mean (standard error)
    -0.0701 ± 0.0432
    -0.3751 ± 0.0286
    Statistical analysis title
    Statistical Analysis 1
    Comparison groups
    Placebo v Bimekizumab 160mg
    Number of subjects included in analysis
    400
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.001
    Method
    ANCOVA
    Parameter type
    Least square (LS) mean difference
    Point estimate
    -0.326
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -0.42
         upper limit
    -0.233

    Secondary: Psoriasis Area Severity Index 90 (PASI90) response at Week 4 in the subgroup of participants with psoriasis (PSO) involving at least 3% body surface area (BSA) at Baseline

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    End point title
    Psoriasis Area Severity Index 90 (PASI90) response at Week 4 in the subgroup of participants with psoriasis (PSO) involving at least 3% body surface area (BSA) at Baseline
    End point description
    The PASI90 response assessments are based on at least 90% improvement in PASI score from Baseline. Body divided into 4 areas: head, arms, trunk to groin, and legs to top of buttocks. Assignment of an average score for 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 respective section, and weighted by the percentage of the person's affected skin for respective section. The minimum possible PASI score is 0= no disease, the maximum score is 72= maximal disease. Subset of study participants in Randomized Set with psoriasis involving at least 3% BSA at Baseline. Non-responders: Missing PASI90 data at Week 4 or who discontinued study by Week 4 regardless of data present or not.
    End point type
    Secondary
    End point timeframe
    From Baseline to Week 4
    End point values
    Placebo Bimekizumab 160mg
    Number of subjects analysed
    88
    176
    Units: percentage of participants
        number (not applicable)
    0
    26.7
    No statistical analyses for this end point

    Secondary: Psoriasis Area Severity Index 90 response at Week 16 in the subgroup of participants with psoriasis involving at least 3% body surface area at Baseline

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    End point title
    Psoriasis Area Severity Index 90 response at Week 16 in the subgroup of participants with psoriasis involving at least 3% body surface area at Baseline
    End point description
    The PASI90 response assessments are based on at least 90% improvement in PASI score from Baseline. Body divided into 4 areas: head, arms, trunk to groin, and legs to top of buttocks. Assignment of an average score for 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 respective section, and weighted by the percentage of the person's affected skin for respective section. The minimum possible PASI score is 0= no disease, the maximum score is 72= maximal disease. Subset of study participants in Randomized Set with psoriasis involving at least 3% BSA at Baseline. Non-responders: Missing PASI90 data at Week 16 or who discontinued study by Week 16 regardless of data present or not.
    End point type
    Secondary
    End point timeframe
    From Baseline to Week 16
    End point values
    Placebo Bimekizumab 160mg
    Number of subjects analysed
    88
    176
    Units: percentage of participants
        number (not applicable)
    6.8
    68.8
    Statistical analysis title
    Statistical Analysis 1
    Comparison groups
    Placebo v Bimekizumab 160mg
    Number of subjects included in analysis
    264
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.001
    Method
    Regression, Logistic
    Parameter type
    Odds ratio (OR)
    Point estimate
    30.237
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    12.365
         upper limit
    73.94

    Secondary: Change from Baseline in the Short Form 36-item Health Survey (SF-36) Physical Component Summary (PCS) score at Week 16

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    End point title
    Change from Baseline in the Short Form 36-item Health Survey (SF-36) Physical Component Summary (PCS) score at Week 16
    End point description
    The SF-36 (version 2, standard recall) is a 36-item generic HRQoL instrument that uses a recall period of 4 weeks. The questionnaire has 36 questions composing the scale that represent 8 domains: 1) physical functioning, 2) role physical, 3) bodily pain, 4) general health, 5) vitality, 6) social functioning, 7) role emotional, and 8) mental health. The scores for the 8 domains were combined into two summary scores: the physical component summary (PCS) score and the mental component summary (MCS) score. Domains 1 to 4 primarily contribute to the PCS score of the SF-36. Domains 5-8 primarily contribute to the MCS score of the SF-36. Each of the 8 domain scores and the component summary score range from 0=worst to 100=best. Higher scores represent better health status. A positive change in value indicated improvement from baseline. Randomized Set consisted of all enrolled participants who had been randomized.
    End point type
    Secondary
    End point timeframe
    Baseline and Week 16
    End point values
    Placebo Bimekizumab 160mg
    Number of subjects analysed
    133
    267
    Units: score on a scale
        arithmetic mean (standard error)
    1.413 ± 0.714
    7.258 ± 0.531
    Statistical analysis title
    Statistical Analysis 1
    Comparison groups
    Placebo v Bimekizumab 160mg
    Number of subjects included in analysis
    400
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.001
    Method
    ANCOVA
    Parameter type
    LS mean difference
    Point estimate
    6.037
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    4.386
         upper limit
    7.688

    Secondary: Minimal Disease Activity (MDA) at Week 16

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    End point title
    Minimal Disease Activity (MDA) at Week 16
    End point description
    MDA is a measure to indicate disease remission and is based on a composite score of 7 domains. A participant is considered as having achieved the MDA if participant fulfills at least 5 of following 7 criteria: Tender joint count (0-68 joints) <=1; Swollen joint count (0-66 joints) <=1; PASI <=1 for participants with psoriasis covering BSA <=3% [PASI evaluates severity and extent of psoriasis. In PASI, body is divided into four parts and each area is assessed for erythema, induration and scaling, each rated on a scale of 0 to 4. The total score ranges from 0 (no disease) to 72 (maximal disease)]; Patient's Assessment of Arthritis Pain <=15 [using VAS on a scale of 0 (no pain) to 100 (serious pain)]; Patient's Global Assessment of Disease Activity <=20 [using VAS on a scale of 0 (very well) to 100 (very poor)]; HAQ-DI score <=0.5; Leeds Enthesitis Index score <=1 for participants with enthesitis at baseline. Randomized Set consisted of all enrolled participants who had been randomized.
    End point type
    Secondary
    End point timeframe
    Week 16
    End point values
    Placebo Bimekizumab 160mg
    Number of subjects analysed
    133
    267
    Units: percentage of participants
        number (not applicable)
    6.0
    44.2
    Statistical analysis title
    Statistical Analysis 1
    Comparison groups
    Placebo v Bimekizumab 160mg
    Number of subjects included in analysis
    400
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.001
    Method
    Regression, Logistic
    Parameter type
    Odds ratio (OR)
    Point estimate
    13.089
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    6.119
         upper limit
    27.999

    Secondary: Percentage of participants with American College of Rheumatology 70 (ACR70) response

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    End point title
    Percentage of participants with American College of Rheumatology 70 (ACR70) response
    End point description
    ACR70 response rate:70% or greater improvement of arthritis from Baseline. Those who met 3 conditions for improvement from Baseline met ACR70 response criteria: 1.Tender joint count (0-68 joints) ≥ 70% improvement; 2. Swollen joint count (0-66 joints) ≥ 70% improvement; and 3.≥ 70% improvement in at least 3 of the 5 below: Physician global assessment of disease activity [visual analog scale (VAS)(0-100 mm; no symptoms to severe)], Patient global assessment of disease activity [VAS-(0-100 mm; no limitation of normal activities to very poor)], Patient assessment of pain [VAS-(0-100 mm;no pain to most severe)], Health Assessment Questionnaire - Disability Index for degree of difficulty (20 queries from 8 domains of daily living activities scored 0-3, 0=less disability) High-sensitivity C-reactive protein (hsCRP). Analysis set:Randomized Set. Non-responders: Those who missed ACR70 data at Week 16 or who discontinued study before Week 16 regardless of data present or not.
    End point type
    Secondary
    End point timeframe
    From Baseline to Week 16
    End point values
    Placebo Bimekizumab 160mg
    Number of subjects analysed
    133
    267
    Units: percentage of participants
        number (not applicable)
    0.8
    26.6
    No statistical analyses for this end point

    Secondary: Percentage of participants with American College of Rheumatology 20 (ACR20) response

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    End point title
    Percentage of participants with American College of Rheumatology 20 (ACR20) response
    End point description
    ACR20 response rate:20% or greater improvement of arthritis from Baseline. Those who met 3 conditions for improvement from Baseline met ACR20 response criteria: 1.Tender joint count (0-68 joints) ≥ 20% improvement; 2. Swollen joint count (0-66 joints) ≥ 20% improvement; and 3.≥ 20% improvement in at least 3 of the 5 below: Physician global assessment of disease activity [visual analog scale (VAS)(0-100 mm; no symptoms to severe)], Patient global assessment of disease activity [VAS-(0-100 mm; no limitation of normal activities to very poor)], Patient assessment of pain [VAS-(0-100 mm;no pain to most severe)], Health Assessment Questionnaire - Disability Index for degree of difficulty (20 queries from 8 domains of daily living activities scored 0-3, 0=less disability) High-sensitivity C-reactive protein (hsCRP). Analysis set:Randomized Set. Non-responders: Those who missed ACR20 data at Week 16 or who discontinued study before Week 16 regardless of data present or not.
    End point type
    Secondary
    End point timeframe
    From Baseline to Week 16
    End point values
    Placebo Bimekizumab 160mg
    Number of subjects analysed
    133
    267
    Units: percentage of participants
        number (not applicable)
    15.8
    67.0
    No statistical analyses for this end point

    Secondary: Investigator Global Assessment (IGA) response defined as score of 0 (clear) or 1 (almost clear) and at least a 2-grade reduction from Baseline at Week 4 in the subset of participants with psoriatic skin lesions at Baseline

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    End point title
    Investigator Global Assessment (IGA) response defined as score of 0 (clear) or 1 (almost clear) and at least a 2-grade reduction from Baseline at Week 4 in the subset of participants with psoriatic skin lesions at Baseline
    End point description
    IGA assessed the overall severity of PSO using a 5-point scale with scores 0=clear (No signs of PSO; post-inflammatory hyperpigmentation may be present), 1=almost clear (No thickening; normal to pink coloration; no to minimal focal scaling), 2=mild (Just detectable to mild thickening; pink to light red coloration; predominately fine scaling), 3=moderate (Clearly distinguishable to moderate thickening; dull to bright red, moderate scaling), and 4=severe (Severe thickening with hard edges; bright to deep dark red coloration; severe/coarse scaling covering almost all or all lesions). The IGA response score of 0 (clear) or 1 (almost clear) indicated at least 2-category improvement relative to Baseline. Subset of study participants in Randomized Set with psoriatic skin lesions at Baseline. Non-responders: Participants who had missing data at the Week 4 or who discontinued study treatment before or at the Week 4 regardless of whether they had data or not.
    End point type
    Secondary
    End point timeframe
    Baseline and Week 4
    End point values
    Placebo Bimekizumab 160mg
    Number of subjects analysed
    82
    163
    Units: percentage of participants
        number (not applicable)
    1.2
    30.7
    No statistical analyses for this end point

    Secondary: Investigator Global Assessment (IGA) response defined as score of 0 (clear) or 1 (almost clear) AND at least a 2-grade reduction from Baseline at Week 16 in the subset of participants with psoriatic skin lesions at Baseline

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    End point title
    Investigator Global Assessment (IGA) response defined as score of 0 (clear) or 1 (almost clear) AND at least a 2-grade reduction from Baseline at Week 16 in the subset of participants with psoriatic skin lesions at Baseline
    End point description
    IGA assessed the overall severity of PSO using a 5-point scale with scores 0=clear (No signs of PSO; post-inflammatory hyperpigmentation may be present), 1=almost clear (No thickening; normal to pink coloration; no to minimal focal scaling), 2=mild (Just detectable to mild thickening; pink to light red coloration; predominately fine scaling), 3=moderate (Clearly distinguishable to moderate thickening; dull to bright red, moderate scaling), and 4=severe (Severe thickening with hard edges; bright to deep dark red coloration; severe/coarse scaling covering almost all or all lesions). The IGA response score of 0 (clear) or 1 (almost clear) indicated at least 2-category improvement relative to Baseline. Subset of study participants in Randomized Set with psoriatic skin lesions at Baseline. Non-responders: Participants who had missing data at the Week 16 or who discontinued study treatment before or at the Week 16 regardless of whether they had data or not.
    End point type
    Secondary
    End point timeframe
    Baseline and Week 16
    End point values
    Placebo Bimekizumab 160mg
    Number of subjects analysed
    82
    163
    Units: percentage of participants
        number (not applicable)
    3.7
    60.7
    No statistical analyses for this end point

    Secondary: Change from Baseline in the Patient's Assessment of Arthritis Pain (PtAAP) at Week 16

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    End point title
    Change from Baseline in the Patient's Assessment of Arthritis Pain (PtAAP) at Week 16
    End point description
    The PtAAP Visual Analog Scale (VAS) is part of the American College of Rheumatology core set of measures in arthritis. Participants assessed their arthritis pain using a VAS on a scale of 0 (very well) to 100 (very poor). A negative change from baseline indicates improvement. Randomized Set consisted of all enrolled participants who had been randomized.
    End point type
    Secondary
    End point timeframe
    Baseline and Week 16
    End point values
    Placebo Bimekizumab 160mg
    Number of subjects analysed
    133
    267
    Units: score on a scale
        arithmetic mean (standard error)
    -4.5 ± 2.1
    -27.7 ± 1.7
    No statistical analyses for this end point

    Secondary: Change from Baseline in Psoriatic Arthritis Impact of Disease-12 (PsAID-12) total score at Week 16

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    End point title
    Change from Baseline in Psoriatic Arthritis Impact of Disease-12 (PsAID-12) total score at Week 16
    End point description
    The PsAID-12 is a patient-reported outcome measure for assessing the impact of Psoriatic Arthritis (PsA) in 12 physical and psychological domains, including pain, fatigue, skin problems, work and/or leisure activities, functional capacity, discomfort, sleep disturbance, coping, anxiety/fear/uncertainty, embarrassment and/or shame, social participation, and depression. Each domain was assessed with a single question using a 0 to 10 numerical rating scale. Each domain score was multiplied by a weighting factor and the results were then summed to provide the total score. The total score ranged from 0 to 10, with higher scores indicating a worse status. A negative change from baseline indicates improvement. Randomized Set consisted of all enrolled participants who had been randomized.
    End point type
    Secondary
    End point timeframe
    Baseline and Week 16
    End point values
    Placebo Bimekizumab 160mg
    Number of subjects analysed
    133
    267
    Units: score on a scale
        arithmetic mean (standard error)
    -0.32 ± 0.16
    -2.24 ± 0.13
    No statistical analyses for this end point

    Secondary: Number of Participants with treatment-emergent adverse events (TEAEs) during the study

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    End point title
    Number of Participants with treatment-emergent adverse events (TEAEs) during the study
    End point description
    An Adverse Event (AE) is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. An AE could therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product. TEAEs were defined as any AEs with an onset date on or after the date of first IMP administration and up to 20 weeks after the last (most recent) dose of IMP. The Safety Set consisted of all participants who received at least 1 dose of the IMP.
    End point type
    Secondary
    End point timeframe
    From Baseline until Safety Follow-Up (up to 37 weeks)
    End point values
    Placebo Bimekizumab 160mg
    Number of subjects analysed
    132
    267
    Units: participants
    44
    108
    No statistical analyses for this end point

    Secondary: Number of Participants with treatment-emergent serious adverse events (SAEs) during the study

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    End point title
    Number of Participants with treatment-emergent serious adverse events (SAEs) during the study
    End point description
    A serious adverse event (SAE) is any untoward medical occurrence that at any dose: Results in death, Is life-threatening, Requires in patient hospitalization or prolongation of existing hospitalization; Is a congenital anomaly or birth defect; Is an infection that requires treatment parenteral antibiotics, Other important medical events which based on medical or scientific judgement may jeopardize the patients, or may require medical or surgical intervention to prevent any of the above. TEAEs were defined as any AEs with an onset date on or after the date of first IMP administration and up to 20 weeks after the last (most recent) dose of IMP. The Safety Set consisted of all participants who received at least 1 dose of the IMP.
    End point type
    Secondary
    End point timeframe
    From Baseline until Safety Follow-Up (up to 37 weeks)
    End point values
    Placebo Bimekizumab 160mg
    Number of subjects analysed
    132
    267
    Units: participants
    0
    5
    No statistical analyses for this end point

    Secondary: Number of Participants with treatment-emergent adverse events (TEAEs) leading to withdrawal from investigational medicinal product (IMP) during the study

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    End point title
    Number of Participants with treatment-emergent adverse events (TEAEs) leading to withdrawal from investigational medicinal product (IMP) during the study
    End point description
    An Adverse Event (AE) is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. An AE could therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product. TEAEs were defined as any AEs with an onset date on or after the date of first IMP administration and up to 20 weeks after the last (most recent) dose of IMP. The Safety Set consisted of all participants who received at least 1 dose of the IMP.
    End point type
    Secondary
    End point timeframe
    From Baseline until Safety Follow-Up (up to 37 weeks)
    End point values
    Placebo Bimekizumab 160mg
    Number of subjects analysed
    132
    267
    Units: participants
    0
    2
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    From Baseline until Safety Follow-Up (up to 37 weeks)
    Adverse event reporting additional description
    Treatment-emergent adverse events (TEAEs) were defined as any AEs with an onset date on or after the date of first IMP administration and up to 20 weeks after the last (most recent) dose of IMP. TEAEs were analyzed for Safety Set.
    Assessment type
    Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    19.0
    Reporting groups
    Reporting group title
    Bimekizumab 160mg
    Reporting group description
    Participants received bimekizumab 160 mg as a sc injection Q4W for up to 16 weeks.

    Reporting group title
    Placebo
    Reporting group description
    Participants received placebo as a sc injection Q4W for up to 16 weeks.

    Serious adverse events
    Bimekizumab 160mg Placebo
    Total subjects affected by serious adverse events
         subjects affected / exposed
    5 / 267 (1.87%)
    0 / 132 (0.00%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Injury, poisoning and procedural complications
    Joint injury
         subjects affected / exposed
    1 / 267 (0.37%)
    0 / 132 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nervous system disorders
    Toxic encephalopathy
         subjects affected / exposed
    1 / 267 (0.37%)
    0 / 132 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Intestinal obstruction
         subjects affected / exposed
    1 / 267 (0.37%)
    0 / 132 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Bronchitis
         subjects affected / exposed
    1 / 267 (0.37%)
    0 / 132 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonia
         subjects affected / exposed
    1 / 267 (0.37%)
    0 / 132 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 2%
    Non-serious adverse events
    Bimekizumab 160mg Placebo
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    34 / 267 (12.73%)
    15 / 132 (11.36%)
    Vascular disorders
    Hypertension
         subjects affected / exposed
    3 / 267 (1.12%)
    3 / 132 (2.27%)
         occurrences all number
    3
    3
    Infections and infestations
    Corona virus infection
         subjects affected / exposed
    5 / 267 (1.87%)
    6 / 132 (4.55%)
         occurrences all number
    5
    6
    Nasopharyngitis
         subjects affected / exposed
    10 / 267 (3.75%)
    1 / 132 (0.76%)
         occurrences all number
    11
    1
    Urinary tract infection
         subjects affected / exposed
    5 / 267 (1.87%)
    3 / 132 (2.27%)
         occurrences all number
    6
    3
    Upper respiratory tract infection
         subjects affected / exposed
    6 / 267 (2.25%)
    2 / 132 (1.52%)
         occurrences all number
    6
    2
    Oral candidiasis
         subjects affected / exposed
    7 / 267 (2.62%)
    0 / 132 (0.00%)
         occurrences all number
    9
    0

    More information

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    Substantial protocol amendments (globally)

    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    14 May 2020
    Protocol amendment 1 was implemented to update the completed and ongoing studies information, clarify study procedures, add re-screening rules, update the description of IMP, change the statistical hierarchy, and update the statistical section.
    01 Apr 2021
    Protocol Amendment 2 was implemented to modify the secondary variables and fixed sequence testing procedure, update the statistical section, and make other procedural clarifications.

    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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