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    Clinical Trial Results:
    A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Dose Ranging Study to Evaluate the Safety, Efficacy, Pharmacokinetics, and Pharmacodynamics of Bimekizumab in Adult subjects With Moderate to Severe Chronic Plaque Psoriasis

    Summary
    EudraCT number
    2016-001891-31
    Trial protocol
    HU   CZ   PL  
    Global end of trial date
    10 Jul 2017

    Results information
    Results version number
    v1(current)
    This version publication date
    26 Jul 2018
    First version publication date
    26 Jul 2018
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    PS0010
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    NCT02905006
    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
    31 Jul 2017
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    10 Jul 2017
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To evaluate the dose response of bimekizumab administered subcutaneously (sc) every 4 weeks for 12 weeks in the treatment of subjects with moderate to severe chronic plaque psoriasis.
    Protection of trial subjects
    Patients were given the opportunity to discuss the study with the study doctor and ask questions before deciding to participate. The Study doctors asked about any problems patients had since the last visit, and what medications patients were taking. Routine safety blood and urine samples taken, electrocardiography (ECG), physical examinations and vital signs were taken, as well as questions about mental health were being asked to monitor the patient’s safety.
    Background therapy
    Topical medications Subjects continued to use topical moisturizers or emollients, bath oils, or oatmeal bath preparations for skin conditions during the study, as needed. Over-the-counter shampoos for the treatment of psoriasis of the scalp were also permitted. Subjects who used prohibited topical medications were allowed to stay in the study but were counseled to not use them further. No other topical preparations were allowed in the 2 weeks before randomization or during the study unless medically required to treat an Adverse Event (AE). Other medications Subjects who were already receiving an established non-steroidal anti-inflammatory drug (NSAID) regimen (at least 8 weeks prior to Baseline) and have been on a stable dose for at least 4 weeks prior to Baseline continued the use during the study. However, initiation of, or increase in dosage of, NSAIDs during the study (especially in subjects with a history of gastrointestinal [GI] intolerance to NSAIDs or a history of GI ulceration) should have been done with caution. Intra-articular steroid injections for arthritis of the knee were allowed. Subjects who were already receiving an established anti-depressant regimen should have been on a stable dose of anti-depressant for 12 weeks prior to Baseline.
    Evidence for comparator
    Not applicable
    Actual start date of recruitment
    25 Aug 2016
    Long term follow-up planned
    Yes
    Long term follow-up rationale
    Safety, Efficacy
    Long term follow-up duration
    11 Months
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Canada: 39
    Country: Number of subjects enrolled
    Czech Republic: 22
    Country: Number of subjects enrolled
    Hungary: 18
    Country: Number of subjects enrolled
    Japan: 12
    Country: Number of subjects enrolled
    Poland: 115
    Country: Number of subjects enrolled
    United States: 44
    Worldwide total number of subjects
    250
    EEA total number of subjects
    155
    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)
    228
    From 65 to 84 years
    22
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    The study started to enroll subjects in August 2016 and concluded in July 2017.

    Pre-assignment
    Screening details
    The study included a 2-4 weeks Screening Period, a 12 weeks Treatment Period and a 20 weeks Safety Follow-Up Period. 250 subjects were included in the Safety Set, shown in the Participant Flow.

    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, Monitor, Investigator, Carer, Assessor

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    Placebo
    Arm description
    Subjects randomized to the placebo group, received a combination of several injections of placebo, subcutaneously every 4 weeks (Q4W).
    Arm type
    Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    PBO
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    The study medication was administered in the clinic by study site staff as 3 subcutaneous (sc) injections. Suitable areas for sc injections were the lateral abdominal wall and upper outer thigh. During each dosing visit (Baseline, Week 4, and Week 8), each of the 3 injections were administered at a separate injection site. Study medication were also be administered at Week 12 for all subjects entering the open-label extension study.

    Arm title
    Bimekizumab 64 mg
    Arm description
    Subjects were randomized to receive subcutaneous injections of 64 milligrams (mg) bimekizumab, every 4 weeks (Q4W).
    Arm type
    Experimental

    Investigational medicinal product name
    Bimekizumab
    Investigational medicinal product code
    UCB4940
    Other name
    UCB4940
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    The study medication was administered in the clinic by study site staff as 3 subcutaneous (sc) injections. Suitable areas for sc injections were the lateral abdominal wall and upper outer thigh. During each dosing visit (Baseline, Week 4, and Week 8), each of the 3 injections were administered at a separate injection site. Study medication were also administered at Week 12 for all subjects entering the open-label extension study.

    Arm title
    Bimekizumab 160 mg
    Arm description
    Subjects were randomized to receive subcutaneous injections of 160 milligrams (mg) bimekizumab, every 4 weeks (Q4W).
    Arm type
    Experimental

    Investigational medicinal product name
    Bimekizumab
    Investigational medicinal product code
    UCB4940
    Other name
    UCB4940
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    The study medication was administered in the clinic by study site staff as 3 subcutaneous (sc) injections. Suitable areas for sc injections were the lateral abdominal wall and upper outer thigh. During each dosing visit (Baseline, Week 4, and Week 8), each of the 3 injections were administered at a separate injection site. Study medication were also administered at Week 12 for all subjects entering the open-label extension study.

    Arm title
    Bimekizumab 160 mg w/ LD
    Arm description
    Subjects were randomized to receive 320 milligrams (mg) loading dose subcutaneous injections of bimekizumab at Baseline, followed by 160 mg bimekizumab every 4 weeks (Q4W).
    Arm type
    Experimental

    Investigational medicinal product name
    Bimekizumab
    Investigational medicinal product code
    UCB4940
    Other name
    UCB4940
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    The study medication was administered in the clinic by study site staff as 3 subcutaneous (sc) injections. Suitable areas for sc injections were the lateral abdominal wall and upper outer thigh. During each dosing visit (Baseline, Week 4, and Week 8), each of the 3 injections were administered at a separate injection site. Study medication were also administered at Week 12 for all subjects entering the open-label extension study.

    Arm title
    Bimekizumab 320 mg
    Arm description
    Subjects were randomized to receive 320 milligrams (mg) subcutaneous injections of bimekizumab, every 4 weeks (Q4W).
    Arm type
    Experimental

    Investigational medicinal product name
    Bimekizumab
    Investigational medicinal product code
    UCB4940
    Other name
    UCB4940
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    The study medication was administered in the clinic by study site staff as 3 subcutaneous (sc) injections. Suitable areas for sc injections were the lateral abdominal wall and upper outer thigh. During each dosing visit (Baseline, Week 4, and Week 8), each of the 3 injections were administered at a separate injection site. Study medication were also administered at Week 12 for all subjects entering the open-label extension study.

    Arm title
    Bimekizumab 480 mg
    Arm description
    Subjects were randomized to receive 480 milligrams (mg) subcutaneous injections of bimekizumab, every 4 weeks (Q4W).
    Arm type
    Experimental

    Investigational medicinal product name
    Bimekizumab
    Investigational medicinal product code
    UCB4940
    Other name
    UCB4940
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    The study medication was administered in the clinic by study site staff as 3 subcutaneous (sc) injections. Suitable areas for sc injections were the lateral abdominal wall and upper outer thigh. During each dosing visit (Baseline, Week 4, and Week 8), each of the 3 injections were administered at a separate injection site. Study medication were also administered at Week 12 for all subjects entering the open-label extension study.

    Number of subjects in period 1
    Placebo Bimekizumab 64 mg Bimekizumab 160 mg Bimekizumab 160 mg w/ LD Bimekizumab 320 mg Bimekizumab 480 mg
    Started
    42
    39
    43
    40
    43
    43
    Completed
    37
    36
    38
    34
    40
    39
    Not completed
    5
    3
    5
    6
    3
    4
         Patient moved abroad
             -
             -
             -
             1
             -
             -
         Protocol deviation
             2
             -
             -
             -
             -
             -
         Lack of efficacy
             1
             -
             -
             -
             -
             -
         Patient randomized by mistake
             -
             -
             -
             -
             -
             1
         Positive for Tuberculosis
             -
             1
             -
             -
             -
             -
         Screening exclusion criteria met
             1
             -
             -
             -
             -
             -
         Lab withdrawal criterion met
             -
             1
             2
             2
             2
             1
         Adverse event, non-fatal
             1
             1
             1
             1
             -
             1
         Consent withdrawn by subject
             -
             -
             1
             1
             -
             1
         Subject positive for Hep B
             -
             -
             1
             -
             -
             -
         Lost to follow-up
             -
             -
             -
             1
             1
             -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Placebo
    Reporting group description
    Subjects randomized to the placebo group, received a combination of several injections of placebo, subcutaneously every 4 weeks (Q4W).

    Reporting group title
    Bimekizumab 64 mg
    Reporting group description
    Subjects were randomized to receive subcutaneous injections of 64 milligrams (mg) bimekizumab, every 4 weeks (Q4W).

    Reporting group title
    Bimekizumab 160 mg
    Reporting group description
    Subjects were randomized to receive subcutaneous injections of 160 milligrams (mg) bimekizumab, every 4 weeks (Q4W).

    Reporting group title
    Bimekizumab 160 mg w/ LD
    Reporting group description
    Subjects were randomized to receive 320 milligrams (mg) loading dose subcutaneous injections of bimekizumab at Baseline, followed by 160 mg bimekizumab every 4 weeks (Q4W).

    Reporting group title
    Bimekizumab 320 mg
    Reporting group description
    Subjects were randomized to receive 320 milligrams (mg) subcutaneous injections of bimekizumab, every 4 weeks (Q4W).

    Reporting group title
    Bimekizumab 480 mg
    Reporting group description
    Subjects were randomized to receive 480 milligrams (mg) subcutaneous injections of bimekizumab, every 4 weeks (Q4W).

    Reporting group values
    Placebo Bimekizumab 64 mg Bimekizumab 160 mg Bimekizumab 160 mg w/ LD Bimekizumab 320 mg Bimekizumab 480 mg Total
    Number of subjects
    42 39 43 40 43 43 250
    Age categorical
    Units: Subjects
        <=18 years
    0 0 0 0 0 0 0
        Between 18 and 65 years
    39 37 40 35 39 38 228
        >=65 years
    3 2 3 5 4 5 22
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    46.7 ± 12.3 44.2 ± 13.8 43.4 ± 12.4 46.5 ± 15.2 42.6 ± 13.6 42.9 ± 15.2 -
    Gender categorical
    Units: Subjects
        Female
    17 19 11 11 15 14 87
        Male
    25 20 32 29 28 29 163

    End points

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    End points reporting groups
    Reporting group title
    Placebo
    Reporting group description
    Subjects randomized to the placebo group, received a combination of several injections of placebo, subcutaneously every 4 weeks (Q4W).

    Reporting group title
    Bimekizumab 64 mg
    Reporting group description
    Subjects were randomized to receive subcutaneous injections of 64 milligrams (mg) bimekizumab, every 4 weeks (Q4W).

    Reporting group title
    Bimekizumab 160 mg
    Reporting group description
    Subjects were randomized to receive subcutaneous injections of 160 milligrams (mg) bimekizumab, every 4 weeks (Q4W).

    Reporting group title
    Bimekizumab 160 mg w/ LD
    Reporting group description
    Subjects were randomized to receive 320 milligrams (mg) loading dose subcutaneous injections of bimekizumab at Baseline, followed by 160 mg bimekizumab every 4 weeks (Q4W).

    Reporting group title
    Bimekizumab 320 mg
    Reporting group description
    Subjects were randomized to receive 320 milligrams (mg) subcutaneous injections of bimekizumab, every 4 weeks (Q4W).

    Reporting group title
    Bimekizumab 480 mg
    Reporting group description
    Subjects were randomized to receive 480 milligrams (mg) subcutaneous injections of bimekizumab, every 4 weeks (Q4W).

    Subject analysis set title
    Placebo (FAS)
    Subject analysis set type
    Full analysis
    Subject analysis set description
    Subjects randomized to the placebo group, received a combination of several injections of placebo, subcutaneously every 4 weeks (Q4W) and had a valid measurement of the primary efficacy variable at Baseline, forming the Full Analysis Set (FAS).

    Subject analysis set title
    Bimekizumab 64 mg (FAS)
    Subject analysis set type
    Full analysis
    Subject analysis set description
    Subjects were randomized to receive subcutaneous injections of 64 milligrams (mg) bimekizumab, every 4 weeks (Q4W) and had a valid measurement of the primary efficacy variable at Baseline, forming the Full Analysis Set (FAS).

    Subject analysis set title
    Bimekizumab 160 mg (FAS)
    Subject analysis set type
    Full analysis
    Subject analysis set description
    Subjects were randomized to receive subcutaneous injections of 160 milligrams (mg) bimekizumab, every 4 weeks (Q4W) and had a valid measurement of the primary efficacy variable at Baseline, forming the Full Analysis Set (FAS).

    Subject analysis set title
    Bimekizumab 160 mg w/ LD (FAS)
    Subject analysis set type
    Full analysis
    Subject analysis set description
    Subjects were randomized to receive 320 milligrams (mg) loading dose subcutaneous injections of bimekizumab at Baseline, followed by 160 mg bimekizumab every 4 weeks (Q4W) and had a valid measurement of the primary efficacy variable at Baseline, forming the Full Analysis Set (FAS).

    Subject analysis set title
    Bimekizumab 320 mg (FAS)
    Subject analysis set type
    Full analysis
    Subject analysis set description
    Subjects were randomized to receive 320 milligrams (mg) subcutaneous injections of bimekizumab, every 4 weeks (Q4W) and had a valid measurement of the primary efficacy variable at Baseline, forming the Full Analysis Set (FAS).

    Subject analysis set title
    Bimekizumab 480 mg (FAS)
    Subject analysis set type
    Full analysis
    Subject analysis set description
    Subjects were randomized to receive 480 milligrams (mg) subcutaneous injections of bimekizumab, every 4 weeks (Q4W) and had a valid measurement of the primary efficacy variable at Baseline, forming the Full Analysis Set (FAS).

    Primary: Percentage of subjects achieving a 90% or higher improvement from Baseline in Psoriasis Area and Severity Index (PASI) score at Week 12

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    End point title
    Percentage of subjects achieving a 90% or higher improvement from Baseline in Psoriasis Area and Severity Index (PASI) score at Week 12
    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
    Primary
    End point timeframe
    Week 12
    End point values
    Placebo (FAS) Bimekizumab 64 mg (FAS) Bimekizumab 160 mg (FAS) Bimekizumab 160 mg w/ LD (FAS) Bimekizumab 320 mg (FAS) Bimekizumab 480 mg (FAS)
    Number of subjects analysed
    42
    39
    43
    40
    43
    43
    Units: percentage of subjects
    number (not applicable)
        percentage of subjects
    0
    46.2
    67.4
    75.0
    79.1
    72.1
    Statistical analysis title
    Statistical analysis 1
    Comparison groups
    Placebo (FAS) v Bimekizumab 64 mg (FAS)
    Number of subjects included in analysis
    81
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.0001 [1]
    Method
    Regression, Logistic
    Confidence interval
    Notes
    [1] - P-value evaluating dose response excludes the BKZ 160mg w/LD group; is based on a logistic regression model with fixed effects for region, prior biologic exposure, continuous treatment variable with values of -2, -1, 0, 1, 2 for the remaining groups.
    Statistical analysis title
    Statistical analysis 2
    Comparison groups
    Placebo (FAS) v Bimekizumab 160 mg (FAS)
    Number of subjects included in analysis
    85
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.0001 [2]
    Method
    Regression, Logistic
    Confidence interval
    Notes
    [2] - P-value evaluating dose response excludes the BKZ 160mg w/LD group; is based on a logistic regression model with fixed effects for region, prior biologic exposure, continuous treatment variable with values of -2, -1, 0, 1, 2 for the remaining groups.
    Statistical analysis title
    Statistical analysis 3
    Comparison groups
    Placebo (FAS) v Bimekizumab 320 mg (FAS)
    Number of subjects included in analysis
    85
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.0001 [3]
    Method
    Regression, Logistic
    Confidence interval
    Notes
    [3] - P-value evaluating dose response excludes the BKZ 160mg w/LD group; is based on a logistic regression model with fixed effects for region, prior biologic exposure, continuous treatment variable with values of -2, -1, 0, 1, 2 for the remaining groups.
    Statistical analysis title
    Statistical analysis 4
    Comparison groups
    Placebo (FAS) v Bimekizumab 480 mg (FAS)
    Number of subjects included in analysis
    85
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.0001 [4]
    Method
    Regression, Logistic
    Confidence interval
    Notes
    [4] - P-value evaluating dose response excludes the BKZ 160mg w/LD group; is based on a logistic regression model with fixed effects for region, prior biologic exposure, continuous treatment variable with values of -2, -1, 0, 1, 2 for the remaining groups.

    Secondary: Percentage of subjects with Investigator's Global Assessment (IGA) response at Week 12

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    End point title
    Percentage of subjects with Investigator's Global Assessment (IGA) response at Week 12
    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
    Week 12
    End point values
    Placebo (FAS) Bimekizumab 64 mg (FAS) Bimekizumab 160 mg (FAS) Bimekizumab 160 mg w/ LD (FAS) Bimekizumab 320 mg (FAS) Bimekizumab 480 mg (FAS)
    Number of subjects analysed
    42
    39
    43
    40
    43
    43
    Units: percentage of subjects
    number (not applicable)
        percentage of subjects
    4.8
    51.3
    74.4
    75.0
    86.0
    76.7
    Statistical analysis title
    Statistical analysis 1
    Comparison groups
    Placebo (FAS) v Bimekizumab 64 mg (FAS)
    Number of subjects included in analysis
    81
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.0001
    Method
    Regression, Logistic
    Parameter type
    Odds ratio (OR)
    Point estimate
    21.43
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    4.51
         upper limit
    101.88
    Statistical analysis title
    Statistical analysis 2
    Comparison groups
    Placebo (FAS) v Bimekizumab 160 mg (FAS)
    Number of subjects included in analysis
    85
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.0001
    Method
    Regression, Logistic
    Parameter type
    Odds ratio (OR)
    Point estimate
    63.21
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    12.9
         upper limit
    309.83
    Statistical analysis title
    Statistical analysis 3
    Comparison groups
    Placebo (FAS) v Bimekizumab 160 mg w/ LD (FAS)
    Number of subjects included in analysis
    82
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.0001
    Method
    Regression, Logistic
    Parameter type
    Odds ratio (OR)
    Point estimate
    62.35
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    12.61
         upper limit
    308.29
    Statistical analysis title
    Statistical analysis 4
    Comparison groups
    Placebo (FAS) v Bimekizumab 320 mg (FAS)
    Number of subjects included in analysis
    85
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.0001
    Method
    Regression, Logistic
    Parameter type
    Odds ratio (OR)
    Point estimate
    130.35
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    24.5
         upper limit
    693.51
    Statistical analysis title
    Statistical analysis 5
    Comparison groups
    Placebo (FAS) v Bimekizumab 480 mg (FAS)
    Number of subjects included in analysis
    85
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.0001
    Method
    Regression, Logistic
    Parameter type
    Odds ratio (OR)
    Point estimate
    69.4
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    14.07
         upper limit
    342.4

    Secondary: Percentage of subjects with Investigator's Global Assessment (IGA) response at Week 8

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    End point title
    Percentage of subjects with Investigator's Global Assessment (IGA) response at Week 8
    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
    Week 8
    End point values
    Placebo (FAS) Bimekizumab 64 mg (FAS) Bimekizumab 160 mg (FAS) Bimekizumab 160 mg w/ LD (FAS) Bimekizumab 320 mg (FAS) Bimekizumab 480 mg (FAS)
    Number of subjects analysed
    42
    39
    43
    40
    43
    43
    Units: percentage of subjects
    number (not applicable)
        percentage of subjects
    4.8
    46.2
    62.8
    77.5
    86.0
    72.1
    Statistical analysis title
    Statistical analysis 1
    Comparison groups
    Placebo (FAS) v Bimekizumab 64 mg (FAS)
    Number of subjects included in analysis
    81
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.0003
    Method
    Regression, Logistic
    Parameter type
    Odds ratio (OR)
    Point estimate
    18.23
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    3.79
         upper limit
    87.76
    Statistical analysis title
    Statistical analysis 2
    Comparison groups
    Placebo (FAS) v Bimekizumab 160 mg (FAS)
    Number of subjects included in analysis
    85
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.0001
    Method
    Regression, Logistic
    Parameter type
    Odds ratio (OR)
    Point estimate
    39.6
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    8.19
         upper limit
    191.59
    Statistical analysis title
    Statistical analysis 3
    Comparison groups
    Placebo (FAS) v Bimekizumab 160 mg w/ LD (FAS)
    Number of subjects included in analysis
    82
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.0001
    Method
    Regression, Logistic
    Parameter type
    Odds ratio (OR)
    Point estimate
    77.27
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    15.19
         upper limit
    392.93
    Statistical analysis title
    Statistical analysis 4
    Comparison groups
    Placebo (FAS) v Bimekizumab 320 mg (FAS)
    Number of subjects included in analysis
    85
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.0001
    Method
    Regression, Logistic
    Parameter type
    Odds ratio (OR)
    Point estimate
    141.99
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    26.26
         upper limit
    767.72
    Statistical analysis title
    Statistical analysis 5
    Comparison groups
    Placebo (FAS) v Bimekizumab 480 mg (FAS)
    Number of subjects included in analysis
    85
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.0001
    Method
    Regression, Logistic
    Parameter type
    Odds ratio (OR)
    Point estimate
    58.52
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    11.89
         upper limit
    288

    Secondary: Percentage of subjects achieving a 90% or higher improvement from Baseline in Psoriasis Area and Severity Index (PASI) score at Week 8

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    End point title
    Percentage of subjects achieving a 90% or higher improvement from Baseline in Psoriasis Area and Severity Index (PASI) score at Week 8
    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
    Week 8
    End point values
    Placebo (FAS) Bimekizumab 64 mg (FAS) Bimekizumab 160 mg (FAS) Bimekizumab 160 mg w/ LD (FAS) Bimekizumab 320 mg (FAS) Bimekizumab 480 mg (FAS)
    Number of subjects analysed
    42
    39
    43
    40
    43
    43
    Units: percentage of subjects
    number (not applicable)
        percentage of subjects
    0
    41.0
    58.1
    67.5
    86.0
    69.8
    Statistical analysis title
    Statistical analysis 1
    Comparison groups
    Placebo (FAS) v Bimekizumab 64 mg (FAS)
    Number of subjects included in analysis
    81
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.0001 [5]
    Method
    Fisher exact
    Confidence interval
    Notes
    [5] - The placebo treatment group contained no PASI90 responders and as such the p-values for the pairwise comparisons are based upon the Fisher's exact test.
    Statistical analysis title
    Statistical analysis 2
    Comparison groups
    Placebo (FAS) v Bimekizumab 160 mg (FAS)
    Number of subjects included in analysis
    85
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.0001 [6]
    Method
    Fisher exact
    Confidence interval
    Notes
    [6] - The placebo treatment group contained no PASI90 responders and as such the p-values for the pairwise comparisons are based upon the Fisher's exact test.
    Statistical analysis title
    Statistical analysis 3
    Comparison groups
    Placebo (FAS) v Bimekizumab 160 mg w/ LD (FAS)
    Number of subjects included in analysis
    82
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.0001 [7]
    Method
    Fisher exact
    Confidence interval
    Notes
    [7] - The placebo treatment group contained no PASI90 responders and as such the p-values for the pairwise comparisons are based upon the Fisher's exact test.
    Statistical analysis title
    Statistical analysis 4
    Comparison groups
    Placebo (FAS) v Bimekizumab 320 mg (FAS)
    Number of subjects included in analysis
    85
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.0001 [8]
    Method
    Fisher exact
    Confidence interval
    Notes
    [8] - The placebo treatment group contained no PASI90 responders and as such the p-values for the pairwise comparisons are based upon the Fisher's exact test.
    Statistical analysis title
    Statistical analysis 5
    Comparison groups
    Placebo (FAS) v Bimekizumab 480 mg (FAS)
    Number of subjects included in analysis
    85
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.0001 [9]
    Method
    Fisher exact
    Confidence interval
    Notes
    [9] - The placebo treatment group contained no PASI90 responders and as such the p-values for the pairwise comparisons are based upon the Fisher's exact test.

    Secondary: Percentage of subjects achieving a 75% or higher improvement in Psoriasis Area and Severity Index (PASI) score at Week 12

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    End point title
    Percentage of subjects achieving a 75% or higher improvement in Psoriasis Area and Severity Index (PASI) score at Week 12
    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
    Week 12
    End point values
    Placebo (FAS) Bimekizumab 64 mg (FAS) Bimekizumab 160 mg (FAS) Bimekizumab 160 mg w/ LD (FAS) Bimekizumab 320 mg (FAS) Bimekizumab 480 mg (FAS)
    Number of subjects analysed
    42
    39
    43
    40
    43
    43
    Units: percentage of subjects
    number (not applicable)
        percentage of subjects
    4.8
    61.5
    81.4
    85.0
    93.0
    83.7
    Statistical analysis title
    Statistical analysis 1
    Comparison groups
    Placebo (FAS) v Bimekizumab 64 mg (FAS)
    Number of subjects included in analysis
    81
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.0001
    Method
    Regression, Logistic
    Parameter type
    Odds ratio (OR)
    Point estimate
    32.65
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    6.82
         upper limit
    156.38
    Statistical analysis title
    Statistical analysis 2
    Comparison groups
    Placebo (FAS) v Bimekizumab 160 mg (FAS)
    Number of subjects included in analysis
    85
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.0001
    Method
    Regression, Logistic
    Parameter type
    Odds ratio (OR)
    Point estimate
    94.51
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    18.54
         upper limit
    481.86
    Statistical analysis title
    Statistical analysis 3
    Comparison groups
    Placebo (FAS) v Bimekizumab 160 mg w/ LD (FAS)
    Number of subjects included in analysis
    82
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.0001
    Method
    Regression, Logistic
    Parameter type
    Odds ratio (OR)
    Point estimate
    117.66
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    22.08
         upper limit
    626.89
    Statistical analysis title
    Statistical analysis 4
    Comparison groups
    Placebo (FAS) v Bimekizumab 320 mg (FAS)
    Number of subjects included in analysis
    85
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.0001
    Method
    Regression, Logistic
    Parameter type
    Odds ratio (OR)
    Point estimate
    280.76
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    44.06
         upper limit
    1789.24
    Statistical analysis title
    Statistical analysis 5
    Comparison groups
    Placebo (FAS) v Bimekizumab 480 mg (FAS)
    Number of subjects included in analysis
    85
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.0001
    Method
    Regression, Logistic
    Parameter type
    Odds ratio (OR)
    Point estimate
    107.83
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    20.82
         upper limit
    558.57

    Secondary: Percentage of subjects achieving a 100% improvement from Baseline in Psoriasis Area and Severity Index (PASI) score at Week 12

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    End point title
    Percentage of subjects achieving a 100% improvement from Baseline in Psoriasis Area and Severity Index (PASI) score at Week 12
    End point description
    PASI correlates to the physician's assessment of psoriasis symptoms including redness of lesions, thickness of lesions, scaliness of lesions and extent of disease. Each parameter is graded from 0-4, 0 refers to no disease and 4 to severe involvement. The body is divided into 4 areas for scoring (head, arms, trunk to groin, legs to top of buttocks), and the final score ranges from 0-72. The PASI 100 response rate at Week 12 is measured as the percentage of participants who achieved 100% improvement from baseline PASI at Week 12.
    End point type
    Secondary
    End point timeframe
    Week 12
    End point values
    Placebo (FAS) Bimekizumab 64 mg (FAS) Bimekizumab 160 mg (FAS) Bimekizumab 160 mg w/ LD (FAS) Bimekizumab 320 mg (FAS) Bimekizumab 480 mg (FAS)
    Number of subjects analysed
    42
    39
    43
    40
    43
    43
    Units: percentage of subjects
    number (not applicable)
        percentage of subjects
    0
    28.2
    27.9
    60.0
    55.8
    48.8
    Statistical analysis title
    Statistical analysis 1
    Statistical analysis description
    The placebo treatment group contained no PASI100 responders and as such the p-values for the pairwise comparisons are based upon the Fisher's exact test.
    Comparison groups
    Placebo (FAS) v Bimekizumab 64 mg (FAS)
    Number of subjects included in analysis
    81
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.0001
    Method
    Fisher exact
    Confidence interval
    Statistical analysis title
    Statistical analysis 2
    Statistical analysis description
    The placebo treatment group contained no PASI100 responders and as such the p-values for the pairwise comparisons are based upon the Fisher's exact test.
    Comparison groups
    Placebo (FAS) v Bimekizumab 160 mg (FAS)
    Number of subjects included in analysis
    85
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.0002
    Method
    Fisher exact
    Confidence interval
    Statistical analysis title
    Statistical analysis 3
    Statistical analysis description
    The placebo treatment group contained no PASI100 responders and as such the p-values for the pairwise comparisons are based upon the Fisher's exact test.
    Comparison groups
    Placebo (FAS) v Bimekizumab 160 mg w/ LD (FAS)
    Number of subjects included in analysis
    82
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.0001
    Method
    Fisher exact
    Confidence interval
    Statistical analysis title
    Statistical analysis 4
    Statistical analysis description
    The placebo treatment group contained no PASI100 responders and as such the p-values for the pairwise comparisons are based upon the Fisher's exact test.
    Comparison groups
    Placebo (FAS) v Bimekizumab 320 mg (FAS)
    Number of subjects included in analysis
    85
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.0001
    Method
    Fisher exact
    Confidence interval
    Statistical analysis title
    Statistical analysis 5
    Statistical analysis description
    The placebo treatment group contained no PASI100 responders and as such the p-values for the pairwise comparisons are based upon the Fisher's exact test.
    Comparison groups
    Placebo (FAS) v Bimekizumab 480 mg (FAS)
    Number of subjects included in analysis
    85
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.0001
    Method
    Fisher exact
    Confidence interval

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    During Treatment Period (up to 12 weeks)
    Assessment type
    Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    19.0
    Reporting groups
    Reporting group title
    Placebo (FAS)
    Reporting group description
    Subjects randomized to the placebo group, received a combination of several injections of placebo, subcutaneously every 4 weeks (Q4W) and had a valid measurement of the primary efficacy variable at Baseline, forming the Full Analysis Set (FAS).

    Reporting group title
    Bimekizumab 64 mg (FAS)
    Reporting group description
    Subjects were randomized to receive subcutaneous injections of 64 milligrams (mg) bimekizumab, every 4 weeks (Q4W) and had a valid measurement of the primary efficacy variable at Baseline, forming the Full Analysis Set (FAS).

    Reporting group title
    Bimekizumab 160 mg (FAS)
    Reporting group description
    Subjects were randomized to receive subcutaneous injections of 160 milligrams (mg) bimekizumab, every 4 weeks (Q4W) and had a valid measurement of the primary efficacy variable at Baseline, forming the Full Analysis Set (FAS).

    Reporting group title
    Bimekizumab 160 mg w/ LD (FAS)
    Reporting group description
    Subjects were randomized to receive 320 milligrams (mg) loading dose subcutaneous injections of bimekizumab at Baseline, followed by 160 mg bimekizumab every 4 weeks (Q4W) and had a valid measurement of the primary efficacy variable at Baseline, forming the Full Analysis Set (FAS).

    Reporting group title
    Bimekizumab 320 mg (FAS)
    Reporting group description
    Subjects were randomized to receive 320 milligrams (mg) subcutaneous injections of bimekizumab, every 4 weeks (Q4W) and had a valid measurement of the primary efficacy variable at Baseline, forming the Full Analysis Set (FAS).

    Reporting group title
    Bimekizumab 480 mg (FAS)
    Reporting group description
    Subjects were randomized to receive 480 milligrams (mg) subcutaneous injections of bimekizumab, every 4 weeks (Q4W) and had a valid measurement of the primary efficacy variable at Baseline, forming the Full Analysis Set (FAS).

    Serious adverse events
    Placebo (FAS) Bimekizumab 64 mg (FAS) Bimekizumab 160 mg (FAS) Bimekizumab 160 mg w/ LD (FAS) Bimekizumab 320 mg (FAS) Bimekizumab 480 mg (FAS)
    Total subjects affected by serious adverse events
         subjects affected / exposed
    1 / 42 (2.38%)
    0 / 39 (0.00%)
    0 / 43 (0.00%)
    0 / 40 (0.00%)
    0 / 43 (0.00%)
    1 / 43 (2.33%)
         number of deaths (all causes)
    0
    0
    0
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    0
    0
    0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Colon cancer
         subjects affected / exposed
    0 / 42 (0.00%)
    0 / 39 (0.00%)
    0 / 43 (0.00%)
    0 / 40 (0.00%)
    0 / 43 (0.00%)
    1 / 43 (2.33%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Large intestine polyp
         subjects affected / exposed
    0 / 42 (0.00%)
    0 / 39 (0.00%)
    0 / 43 (0.00%)
    0 / 40 (0.00%)
    0 / 43 (0.00%)
    1 / 43 (2.33%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Meningitis viral
         subjects affected / exposed
    1 / 42 (2.38%)
    0 / 39 (0.00%)
    0 / 43 (0.00%)
    0 / 40 (0.00%)
    0 / 43 (0.00%)
    0 / 43 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    Placebo (FAS) Bimekizumab 64 mg (FAS) Bimekizumab 160 mg (FAS) Bimekizumab 160 mg w/ LD (FAS) Bimekizumab 320 mg (FAS) Bimekizumab 480 mg (FAS)
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    8 / 42 (19.05%)
    16 / 39 (41.03%)
    12 / 43 (27.91%)
    12 / 40 (30.00%)
    14 / 43 (32.56%)
    10 / 43 (23.26%)
    Vascular disorders
    Hypertension
         subjects affected / exposed
    3 / 42 (7.14%)
    1 / 39 (2.56%)
    1 / 43 (2.33%)
    1 / 40 (2.50%)
    0 / 43 (0.00%)
    1 / 43 (2.33%)
         occurrences all number
    3
    1
    1
    1
    0
    1
    Investigations
    Gamma-glutamyltransferase increased
         subjects affected / exposed
    1 / 42 (2.38%)
    0 / 39 (0.00%)
    3 / 43 (6.98%)
    2 / 40 (5.00%)
    1 / 43 (2.33%)
    0 / 43 (0.00%)
         occurrences all number
    1
    0
    3
    2
    2
    0
    Blood and lymphatic system disorders
    Neutropenia
         subjects affected / exposed
    0 / 42 (0.00%)
    2 / 39 (5.13%)
    0 / 43 (0.00%)
    1 / 40 (2.50%)
    2 / 43 (4.65%)
    0 / 43 (0.00%)
         occurrences all number
    0
    2
    0
    1
    3
    0
    Leukopenia
         subjects affected / exposed
    0 / 42 (0.00%)
    2 / 39 (5.13%)
    0 / 43 (0.00%)
    0 / 40 (0.00%)
    0 / 43 (0.00%)
    1 / 43 (2.33%)
         occurrences all number
    0
    3
    0
    0
    0
    1
    Nervous system disorders
    Headache
         subjects affected / exposed
    0 / 42 (0.00%)
    2 / 39 (5.13%)
    0 / 43 (0.00%)
    0 / 40 (0.00%)
    0 / 43 (0.00%)
    1 / 43 (2.33%)
         occurrences all number
    0
    2
    0
    0
    0
    1
    Gastrointestinal disorders
    Vomiting
         subjects affected / exposed
    0 / 42 (0.00%)
    2 / 39 (5.13%)
    0 / 43 (0.00%)
    0 / 40 (0.00%)
    0 / 43 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    0
    2
    0
    0
    0
    0
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    0 / 42 (0.00%)
    2 / 39 (5.13%)
    0 / 43 (0.00%)
    1 / 40 (2.50%)
    1 / 43 (2.33%)
    3 / 43 (6.98%)
         occurrences all number
    0
    2
    0
    1
    3
    5
    Infections and infestations
    Nasopharyngitis
         subjects affected / exposed
    2 / 42 (4.76%)
    5 / 39 (12.82%)
    3 / 43 (6.98%)
    3 / 40 (7.50%)
    6 / 43 (13.95%)
    4 / 43 (9.30%)
         occurrences all number
    2
    5
    3
    3
    6
    5
    Upper respiratory tract infection
         subjects affected / exposed
    1 / 42 (2.38%)
    5 / 39 (12.82%)
    2 / 43 (4.65%)
    3 / 40 (7.50%)
    2 / 43 (4.65%)
    0 / 43 (0.00%)
         occurrences all number
    1
    5
    3
    3
    2
    0
    Respiratory tract infection
         subjects affected / exposed
    1 / 42 (2.38%)
    2 / 39 (5.13%)
    1 / 43 (2.33%)
    1 / 40 (2.50%)
    1 / 43 (2.33%)
    0 / 43 (0.00%)
         occurrences all number
    1
    2
    1
    1
    1
    0
    Tonsillitis
         subjects affected / exposed
    0 / 42 (0.00%)
    2 / 39 (5.13%)
    2 / 43 (4.65%)
    0 / 40 (0.00%)
    0 / 43 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    0
    3
    2
    0
    0
    0
    Oral candidiasis
         subjects affected / exposed
    0 / 42 (0.00%)
    0 / 39 (0.00%)
    0 / 43 (0.00%)
    1 / 40 (2.50%)
    3 / 43 (6.98%)
    0 / 43 (0.00%)
         occurrences all number
    0
    0
    0
    1
    3
    0
    Rhinitis
         subjects affected / exposed
    1 / 42 (2.38%)
    2 / 39 (5.13%)
    1 / 43 (2.33%)
    0 / 40 (0.00%)
    0 / 43 (0.00%)
    1 / 43 (2.33%)
         occurrences all number
    1
    2
    1
    0
    0
    1

    More information

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    Substantial protocol amendments (globally)

    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    08 Jul 2016
    Protocol Amendment 1, dated 08 Jul 2016, was implemented to make the following substantial changes: •Extended the timing of the Safety Follow Up (SFU) Visit to 20 weeks after the last dose of investigational medicinal product (IMP). •Removed references to legal representatives being able to provide consent on behalf of subjects. Subjects who lacked the capacity to consent were not included in the study. •Clarified the exclusion criterion regarding laboratory values. •Clarified that subjects with any pustular psoriasis (ie, localized or generalized) were ineligible for study participation and that development of any form of pustular psoriasis (ie, localized or generalized) during the study would have resulted in withdrawal from the study. •Clarified the Hospital Anxiety and Depression Scale (HADS) thresholds for study eligibility in the Exclusion Criteria and for withdrawal of a subject in the Withdrawal Criteria. •Clarified withdrawal criteria regarding subjects who developed illnesses that would have interfered with study participation and regarding the withdrawal of subjects due to Adverse Events (AEs) and clinical laboratory values. •Clarified the timing of the optional study exit interview. •Clarified the AEs for special monitoring. •Provided additional detail and a reference for recording the severity of AEs. •Removed the requirement to test for alcohol in the potential drug-induced liver injury (PDILI) urine toxicology screen. •Clarified the subgroup analyses that were performed.

    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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