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    Clinical Trial Results:
    A multicenter, 48-week, open-label extension study to assess the long-term safety, tolerability, and efficacy of bimekizumab in adult subjects with moderate to severe chronic plaque psoriasis

    Summary
    EudraCT number
    2016-002934-57
    Trial protocol
    DE  
    Global end of trial date
    06 Mar 2019

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

    Trial information

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    Trial identification
    Sponsor protocol code
    PS0018
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    NCT03230292
    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
    17 May 2019
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    06 Mar 2019
    Global end of trial reached?
    Yes
    Global end of trial date
    06 Mar 2019
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The primary objective of the study is to assess the long-term safety and tolerability of bimekizumab.
    Protection of trial subjects
    During the conduct of the study all participants were closely monitored.
    Background therapy
    Background therapy as permitted in the protocol.
    Evidence for comparator
    Not Applicable
    Actual start date of recruitment
    03 Jul 2017
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Australia: 17
    Country: Number of subjects enrolled
    Canada: 12
    Country: Number of subjects enrolled
    Moldova, Republic of: 13
    Country: Number of subjects enrolled
    United States: 1
    Worldwide total number of subjects
    43
    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)
    40
    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 July 2017 and concluded in March 2019.

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

    Period 1
    Period 1 title
    Overall Study (overall period)
    Is this the baseline period?
    Yes
    Allocation method
    Not applicable
    Blinding used
    Not blinded

    Arms
    Arm title
    BKZ All participants
    Arm description
    Participants received bimekizumab (BKZ) 160 milligrams (mg) every 4 weeks (Q4W) subcutaneously (sc) during the 48-week Open Label Treatment Period. The Investigator could increase the dose to BKZ 320 mg Q4W if the participant's Psoriasis Area and Severity Index (PASI) response was greater than or equal to (>=) 50% to less than (<) 75% reduction from the Baseline of PS0016 at Week 12 or later. If the participant’s disease was adequately controlled on BKZ 320 mg Q4W, they could return to BKZ 160 mg Q4W at the discretion of the Investigator.
    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
    Bimekizumab (BKZ) was administered as one sc injection for 160 mg Q4W or as 2 sc injections for 320 mg Q4W. Suitable areas for sc injections were the lateral abdominal wall and upper outer thigh.

    Number of subjects in period 1
    BKZ All participants
    Started
    43
    Completed
    37
    Not completed
    6
         Protocol deviation
    1
         Adverse event, non-fatal
    1
         Consent withdrawn by subject
    3
         Lost to follow-up
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    BKZ All participants
    Reporting group description
    Participants received bimekizumab (BKZ) 160 milligrams (mg) every 4 weeks (Q4W) subcutaneously (sc) during the 48-week Open Label Treatment Period. The Investigator could increase the dose to BKZ 320 mg Q4W if the participant's Psoriasis Area and Severity Index (PASI) response was greater than or equal to (>=) 50% to less than (<) 75% reduction from the Baseline of PS0016 at Week 12 or later. If the participant’s disease was adequately controlled on BKZ 320 mg Q4W, they could return to BKZ 160 mg Q4W at the discretion of the Investigator.

    Reporting group values
    BKZ All participants Total
    Number of subjects
    43 43
    Age categorical
    Units: Subjects
        <=18 years
    0 0
        Between 18 and 65 years
    40 40
        >=65 years
    3 3
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    45.0 ± 12.8 -
    Gender categorical
    Units: Subjects
        Male
    23 23
        Female
    20 20

    End points

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    End points reporting groups
    Reporting group title
    BKZ All participants
    Reporting group description
    Participants received bimekizumab (BKZ) 160 milligrams (mg) every 4 weeks (Q4W) subcutaneously (sc) during the 48-week Open Label Treatment Period. The Investigator could increase the dose to BKZ 320 mg Q4W if the participant's Psoriasis Area and Severity Index (PASI) response was greater than or equal to (>=) 50% to less than (<) 75% reduction from the Baseline of PS0016 at Week 12 or later. If the participant’s disease was adequately controlled on BKZ 320 mg Q4W, they could return to BKZ 160 mg Q4W at the discretion of the Investigator.

    Subject analysis set title
    BKZ All participants (SS)
    Subject analysis set type
    Safety analysis
    Subject analysis set description
    Participants received BKZ 160 mg Q4W sc during the 48-week Open Label Treatment Period. The Investigator could increase the dose to BKZ 320 mg Q4W if the participant's PASI response was >= 50% to < 75% reduction from the Baseline of PS0016 at Week 12 or later. If the participant’s disease was adequately controlled on BKZ 320 mg Q4W, they could return to BKZ 160 mg Q4W at the discretion of the Investigator. Participants formed the Safety Set (SS).

    Subject analysis set title
    BKZ All participants (PK-PPS)
    Subject analysis set type
    Per protocol
    Subject analysis set description
    Participants received BKZ 160 mg Q4W sc during the 48-week Open Label Treatment Period. The Investigator could increase the dose to BKZ 320 mg Q4W if the participant's PASI response was >= 50% to < 75% reduction from the Baseline of PS0016 at Week 12 or later. If the participant’s disease was adequately controlled on BKZ 320 mg Q4W, they could return to BKZ 160 mg Q4W at the discretion of the Investigator. Participants formed the Pharmacokinetic-Per Protocol Set (PK-PPS).

    Subject analysis set title
    BKZ All participants (FAS)
    Subject analysis set type
    Full analysis
    Subject analysis set description
    Participants received BKZ 160 mg Q4W sc during the 48-week Open Label Treatment Period. The Investigator could increase the dose to BKZ 320 mg Q4W if the participant's PASI response was >= 50% to < 75% reduction from the Baseline of PS0016 at Week 12 or later. If the participant’s disease was adequately controlled on BKZ 320 mg Q4W, they could return to BKZ 160 mg Q4W at the discretion of the Investigator. Participants formed the Full Analysis Set (FAS).

    Primary: Incidence of Treatment Emergent Adverse Event (TEAE) adjusted by duration of participant exposure to treatment

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    End point title
    Incidence of Treatment Emergent Adverse Event (TEAE) adjusted by duration of participant exposure to treatment [1]
    End point description
    TEAEs were events that had a start date on or after the first administration of study treatment in PS0018 until the last received dose of investigational medicinal product (IMP) +140 days [which covered the 20-week Safety Follow-Up (SFU) Visit]. The number of TEAEs adjusted by duration of exposure to study treatment was scaled such that it provides an incidence rate per 100 patient-years. If a participant had multiple events, the time of exposure was calculated to the first occurrence of the adverse event (AE) being considered. If a participant had no events, the total time at risk was used. The Safety Set consisted of all participants who received at least 1 dose of the study medication in PS0018.
    End point type
    Primary
    End point timeframe
    From Baseline (Week 0) until Safety Follow Up Visit (up to Week 64)
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: No formal statistical hypothesis testing was planned for this outcome. Results were summarized as descriptive statistics only.
    End point values
    BKZ All participants (SS)
    Number of subjects analysed
    43
    Units: no. of new events per 100 subject-years
        number (confidence interval 95%)
    76.00 (53.8 to 104.3)
    No statistical analyses for this end point

    Secondary: Plasma concentration of bimekizumab during the study

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    End point title
    Plasma concentration of bimekizumab during the study
    End point description
    Plasma concentration of Bimekizumab was expressed in micrograms per milliliter (μg/mL). Values Below Limit of Quantification (BLQ) were replaced by value of Lower Limit of Quantification (LLOQ) divided by 2 (=0.075 μg/mL) in calculations of Means and Coefficient of Variations (CVs). Means and CVs were only calculated if at least 2/3 of the concentrations were quantified at the respective timepoint. The Pharmacokinetics Per-Protocol Set consisted of all enrolled participants who received at least 1 dose of the study medication and provided at least 1 quantifiable plasma concentration postdose in PS0018. Here, 'n' signifies participants who were evaluable at specified time points. Note: 999 was used a placeholder for the value that was not calculated (Participants had no prior BKZ treatment and thus no BKZ levels at Baseline).
    End point type
    Secondary
    End point timeframe
    From Baseline (Week 0) until Safety Follow Up Visit (up to Week 64)
    End point values
    BKZ All participants (PK-PPS)
    Number of subjects analysed
    43
    Units: μg/mL
    geometric mean (geometric coefficient of variation)
        PS0018 Week 0 (n=43)
    999 ± 999
        Week 4 (n=42)
    5.309 ± 47.8
        Week 8 (n=40)
    7.304 ± 60.7
        Week 12 (n=39)
    7.994 ± 53.9
        Week 16 (n=37)
    8.700 ± 53.7
        Week 28 (n=37)
    9.285 ± 49.7
        Week 40 (n=36)
    9.238 ± 51.3
        Week 48/ Withdrawal (n=36)
    9.056 ± 52.5
        Follow-up (n=35)
    0.310 ± 164.8
    No statistical analyses for this end point

    Secondary: Percentage of participants with positive anti-bimekizumab (BZK) antibody levels prior to study treatment

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    End point title
    Percentage of participants with positive anti-bimekizumab (BZK) antibody levels prior to study treatment
    End point description
    For a given visit / time point, an Anti-BKZ status of positive was concluded for any participant with an anti-drug antibody (ADA) level that was above cut point (ACP) and CP at that visit/ time point. A participant was classified as overall positive if at least one PS0018 measurement is ACP and CP (this included participants who had negative results at PS0016 Baseline). Percentages were based on the number of participants with a non-missing measurement, from samples that did not contain BKZ concentration levels above the drug tolerance, at the visit. Baseline was defined as the last available value prior to the first injection of study medication in the PS0016 study. The Safety Set consisted of all participants who received at least 1 dose of the study medication in PS0018.
    End point type
    Secondary
    End point timeframe
    Baseline of study PS0016 [NCT03025542]
    End point values
    BKZ All participants (SS)
    Number of subjects analysed
    43
    Units: percentage of participants
        number (not applicable)
    2.3
    No statistical analyses for this end point

    Secondary: Percentage of participants with overall positive anti-bimekizumab (BZK) antibody levels following study treatment

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    End point title
    Percentage of participants with overall positive anti-bimekizumab (BZK) antibody levels following study treatment
    End point description
    For a given visit / time point, an Anti-BKZ status of positive was concluded for any participant with an anti-drug antibody (ADA) level that was above cut point (ACP) and CP at that visit/ time point. A participant was classified as overall positive if at least one PS0018 measurement is ACP and CP (this included participants who had negative results at PS0016 Baseline). Percentages were based on the number of participants with a non-missing measurement, from samples that did not contain BKZ concentration levels above the drug tolerance, at the visit. Baseline was defined as the last available value prior to the first injection of study medication in the PS0016 study. The Safety Set consisted of all participants who received at least 1 dose of the study medication in PS0018. The number of participants analyzed reflects participants with a non-missing measurement.
    End point type
    Secondary
    End point timeframe
    From Baseline of study PS0016 [NCT03025542] until Safety Follow Up Visit (up to Week 64) of study PS0018
    End point values
    BKZ All participants (SS)
    Number of subjects analysed
    39
    Units: percentage of participants
        number (not applicable)
    25.6
    No statistical analyses for this end point

    Secondary: Percentage of participants achieving a 50% or higher improvement in Psoriasis Area and Severity Index (PASI) during the study

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    End point title
    Percentage of participants achieving a 50% or higher improvement in Psoriasis Area and Severity Index (PASI) during the study
    End point description
    The PASI quantifies the severity and extent of the disease and weighs these with the percentage of body surface area (BSA) involvement. The degree of involvement is estimated across 4 body areas; head, upper limbs, trunk, and lower limbs and then transferred into a grade. The Investigator assessed 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. The PASI50 responses were based on at least 50% improvement in the PASI score at the Baseline of PS0016. Baseline was defined as the last available value prior to the first injection of study medication in the PS0016 study. The Full Analysis Set consisted of all enrolled participants who received at least 1 dose of the study medication and had a valid efficacy measurement for PASI at Baseline of PS0018.
    End point type
    Secondary
    End point timeframe
    From Baseline of study PS0016 [NCT03025542] until Safety Follow Up Visit (up to Week 64) of study PS0018
    End point values
    BKZ All participants (FAS)
    Number of subjects analysed
    43
    Units: percentage of participants
    number (confidence interval 95%)
        PS0018 Week 0
    60.5 (45.6 to 73.6)
        Week 4
    95.3 (84.5 to 98.7)
        Week 8
    95.3 (84.5 to 98.7)
        Week 12
    95.3 (84.5 to 98.7)
        Week 16
    97.7 (87.9 to 99.6)
        Week 20
    95.3 (84.5 to 98.7)
        Week 24
    93.0 (81.4 to 97.6)
        Week 28
    93.0 (81.4 to 97.6)
        Week 32
    90.7 (78.4 to 96.3)
        Week 36
    90.7 (78.4 to 96.3)
        Week 40
    88.4 (75.5 to 94.9)
        Week 44
    90.7 (78.4 to 96.3)
        Week 48/ Withdrawal
    88.4 (75.5 to 94.9)
        Follow-Up
    79.1 (64.8 to 88.6)
    No statistical analyses for this end point

    Secondary: Percentage of participants achieving a 75% or higher improvement in Psoriasis Area and Severity Index (PASI) during the study

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    End point title
    Percentage of participants achieving a 75% or higher improvement in Psoriasis Area and Severity Index (PASI) during the study
    End point description
    The PASI quantifies the severity and extent of the disease and weighs these with the percentage of body surface area (BSA) involvement. The degree of involvement is estimated across 4 body areas; head, upper limbs, trunk, and lower limbs and then transferred into a grade. The Investigator assessed 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. The PASI75 responses were based on at least 75% improvement in the PASI score at the Baseline of PS0016. Baseline was defined as the last available value prior to the first injection of study medication in the PS0016 study. The Full Analysis Set consisted of all enrolled participants who received at least 1 dose of the study medication and had a valid efficacy measurement for PASI at Baseline of PS0018.
    End point type
    Secondary
    End point timeframe
    From Baseline of study PS0016 [NCT03025542] until Safety Follow Up Visit (up to Week 64) of study PS0018
    End point values
    BKZ All participants (FAS)
    Number of subjects analysed
    43
    Units: percentage of participants
    number (confidence interval 95%)
        PS0018 Week 0
    44.2 (30.4 to 58.9)
        Week 4
    88.4 (75.5 to 94.9)
        Week 8
    95.3 (84.5 to 98.7)
        Week 12
    90.7 (78.4 to 96.3)
        Week 16
    93.0 (81.4 to 97.6)
        Week 20
    90.7 (78.4 to 96.3)
        Week 24
    90.7 (78.4 to 96.3)
        Week 28
    88.4 (75.5 to 94.9)
        Week 32
    90.7 (78.4 to 96.3)
        Week 36
    90.7 (78.4 to 96.3)
        Week 40
    86.0 (72.7 to 93.4)
        Week 44
    90.7 (78.4 to 96.3)
        Week 48/ Withdrawal
    86.0 (72.7 to 93.4)
        Follow-up
    65.1 (50.2 to 77.6)
    No statistical analyses for this end point

    Secondary: Percentage of participants achieving a 90% or higher improvement in Psoriasis Area and Severity Index (PASI) during the study

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    End point title
    Percentage of participants achieving a 90% or higher improvement in Psoriasis Area and Severity Index (PASI) during the study
    End point description
    The PASI quantifies the severity and extent of the disease and weighs these with the percentage of body surface area (BSA) involvement. The degree of involvement is estimated across 4 body areas; head, upper limbs, trunk, and lower limbs and then transferred into a grade. The Investigator assessed 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. The PASI90 responses were based on at least 90% improvement in the PASI score at the Baseline of PS0016. Baseline was defined as the last available value prior to the first injection of study medication in the PS0016 study. The Full Analysis Set consisted of all enrolled participants who received at least 1 dose of the study medication and had a valid efficacy measurement for PASI at Baseline of PS0018.
    End point type
    Secondary
    End point timeframe
    From Baseline of study PS0016 [NCT03025542] until Safety Follow Up Visit (up to Week 64) of study PS0018
    End point values
    BKZ All participants (FAS)
    Number of subjects analysed
    43
    Units: percentage of participants
    number (confidence interval 95%)
        PS0018 Week 0
    20.9 (11.4 to 35.2)
        Week 4
    53.5 (38.9 to 67.5)
        Week 8
    79.1 (64.8 to 88.6)
        Week 12
    79.1 (64.8 to 88.6)
        Week 16
    86.0 (72.7 to 93.4)
        Week 20
    79.1 (64.8 to 88.6)
        Week 24
    79.1 (64.8 to 88.6)
        Week 28
    81.4 (67.4 to 90.3)
        Week 32
    81.4 (67.4 to 90.3)
        Week 36
    86.0 (72.7 to 93.4)
        Week 40
    76.7 (62.3 to 86.8)
        Week 44
    86.0 (72.7 to 93.4)
        Week 48/ Withdrawal
    79.1 (64.8 to 88.6)
        Follow-up
    58.1 (43.3 to 71.6)
    No statistical analyses for this end point

    Secondary: Percentage of participants achieving a 100% improvement in Psoriasis Area and Severity Index (PASI) during the study

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    End point title
    Percentage of participants achieving a 100% improvement in Psoriasis Area and Severity Index (PASI) during the study
    End point description
    The PASI quantifies the severity and extent of the disease and weighs these with the percentage of body surface area (BSA) involvement. The degree of involvement is estimated across 4 body areas; head, upper limbs, trunk, and lower limbs and then transferred into a grade. The Investigator assessed 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. The PASI100 responses were based on 100% improvement in the PASI score at the Baseline of PS0016. Baseline was defined as the last available value prior to the first injection of study medication in the PS0016 study. The Full Analysis Set consisted of all enrolled participants who received at least 1 dose of the study medication and had a valid efficacy measurement for PASI at Baseline of PS0018.
    End point type
    Secondary
    End point timeframe
    From Baseline of study PS0016 [NCT03025542] until Safety Follow Up Visit (up to Week 64) of study PS0018
    End point values
    BKZ All participants (FAS)
    Number of subjects analysed
    43
    Units: percentage of participants
    number (confidence interval 95%)
        PS0018 Week 0
    4.7 (1.3 to 15.5)
        Week 4
    23.3 (13.2 to 37.7)
        Week 8
    37.2 (24.4 to 52.1)
        Week 12
    46.5 (32.5 to 61.1)
        Week 16
    39.5 (26.4 to 54.4)
        Week 20
    48.8 (34.6 to 63.2)
        Week 24
    41.9 (28.4 to 56.7)
        Week 28
    46.5 (32.5 to 61.1)
        Week 32
    41.9 (28.4 to 56.7)
        Week 36
    41.9 (28.4 to 56.7)
        Week 40
    46.5 (32.5 to 61.1)
        Week 44
    46.5 (32.5 to 61.1)
        Week 48/ Withdrawal
    46.5 (32.5 to 61.1)
        Follow-up
    18.6 (9.7 to 32.6)
    No statistical analyses for this end point

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

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    End point title
    Percentage of participants with Investigator´s Global Assessment response (Clear or Almost clear with at least a 2 category improvement from Baseline on a 5-point scale) during the study
    End point description
    A static IGA for Psoriasis (PSO) was used to assess disease severity in all study participants during the study. IGA is a 5 point scale ranging from 0=Clear to 4=Severe. The response was defined as clear [0] or almost clear [1] with at least 2 category improvement from PS0016 Baseline. Clear was defined as no signs of PSO; post-inflammatory hyperpigmentation may be present. Almost clear was defined as no thickening; normal to pink coloration; no to minimal focal scaling. Baseline was defined as the last available value prior to the first injection of study medication in the PS0016 study. The Full Analysis Set consisted of all enrolled participants who received at least 1 dose of the study medication and have a valid efficacy measurement for PASI at Baseline of PS0018.
    End point type
    Secondary
    End point timeframe
    From Baseline of study PS0016 [NCT03025542] until Safety Follow Up Visit (up to Week 64) of study PS0018
    End point values
    BKZ All participants (FAS)
    Number of subjects analysed
    43
    Units: percentage of participants
    number (confidence interval 95%)
        PS0018 Week 0
    18.6 (9.7 to 32.6)
        Week 4
    62.8 (47.9 to 75.6)
        Week 8
    79.1 (64.8 to 88.6)
        Week 12
    79.1 (64.8 to 88.6)
        Week 16
    81.4 (67.4 to 90.3)
        Week 20
    79.1 (64.8 to 88.6)
        Week 24
    76.7 (62.3 to 86.8)
        Week 28
    79.1 (64.8 to 88.6)
        Week 32
    86.0 (72.7 to 93.4)
        Week 36
    81.4 (67.4 to 90.3)
        Week 40
    79.1 (64.8 to 88.6)
        Week 44
    83.7 (70.0 to 91.9)
        Week 48/ Withdrawal
    79.1 (64.8 to 88.6)
        Follow-Up
    51.2 (36.8 to 65.4)
    No statistical analyses for this end point

    Secondary: Mean change from PS0016 [NCT03025542] Baseline in PASI score during the study

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    End point title
    Mean change from PS0016 [NCT03025542] Baseline in PASI score during the study
    End point description
    The total PASI score ranges from 0 to 72 with a reduction from PS0016 Baseline indicating improvement. Missing data was imputed using Last observation carried forward (LOCF) at all visits. Baseline was defined as the last available value prior to the first injection of study medication in the PS0016 study. The Full Analysis Set consisted of all enrolled participants who received at least 1 dose of the study medication and have a valid efficacy measurement for PASI at Baseline of PS0018.
    End point type
    Secondary
    End point timeframe
    From Baseline of study PS0016 [NCT03025542] until Safety Follow Up Visit (up to Week 64) of study PS0018
    End point values
    BKZ All participants (FAS)
    Number of subjects analysed
    43
    Units: score on a scale
    arithmetic mean (standard deviation)
        PS0018 Week 0
    -11.21 ± 9.13
        Week 4
    -16.79 ± 6.72
        Week 8
    -18.12 ± 7.41
        Week 12
    -18.70 ± 7.89
        Week 16
    -19.01 ± 8.70
        Week 20
    -18.91 ± 8.70
        Week 24
    -19.08 ± 8.66
        Week 28
    -19.13 ± 8.79
        Week 32
    -19.30 ± 8.66
        Week 36
    -19.27 ± 8.68
        Week 40
    -19.22 ± 8.82
        Week 44
    -19.32 ± 8.68
        Week 48/ Withdrawal
    -19.20 ± 8.76
        Follow-Up
    -15.93 ± 9.29
    No statistical analyses for this end point

    Secondary: Mean percentage change from PS0016 [NCT03025542] Baseline in PASI score during the study

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    End point title
    Mean percentage change from PS0016 [NCT03025542] Baseline in PASI score during the study
    End point description
    A negative percentage change from PS0016 baseline indicated improvement in Total PASI score. The total PASI score ranges from 0 to 72 with a reduction from PS0016 Baseline indicating improvement. Missing data was imputed using Last Observation Carried Forward (LOCF) at all visits. Baseline was defined as the last available value prior to the first injection of study medication in the PS0016 study. The Full Analysis Set consisted of all enrolled participants who received at least 1 dose of the study medication and have a valid efficacy measurement for PASI at Baseline of PS0018.
    End point type
    Secondary
    End point timeframe
    From Baseline of study PS0016 [NCT03025542] until Safety Follow Up Visit (up to Week 64) of study PS0018
    End point values
    BKZ All participants (FAS)
    Number of subjects analysed
    43
    Units: percentage change
    arithmetic mean (standard deviation)
        PS0018 Week 0
    -56.45 ± 38.26
        Week 4
    -87.71 ± 15.52
        Week 8
    -93.28 ± 12.13
        Week 12
    -94.50 ± 8.22
        Week 16
    -95.15 ± 8.43
        Week 20
    -94.84 ± 9.02
        Week 24
    -95.69 ± 6.77
        Week 28
    -95.72 ± 7.35
        Week 32
    -96.85 ± 4.81
        Week 36
    -96.66 ± 4.88
        Week 40
    -96.13 ± 6.38
        Week 44
    -96.98 ± 4.14
        Week 48/ Withdrawal
    -96.10 ± 7.45
        Follow-Up
    -81.98 ± 25.45
    No statistical analyses for this end point

    Secondary: Percentage of participants who shifted from moderate Investigator´s Global Assessment (IGA) score at PS0016 [NCT03025542] Baseline to clear IGA score during the study

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    End point title
    Percentage of participants who shifted from moderate Investigator´s Global Assessment (IGA) score at PS0016 [NCT03025542] Baseline to clear IGA score during the study
    End point description
    A static IGA for Psoriasis (PSO) was used to assess disease severity in all study participants during the study. IGA is a 5 point scale ranging from 0 = Clear to 4 = Severe. Moderate IGA was defined as clearly distinguishable to moderate thickening; dull to bright red, clearly distinguishable to moderate thickening; moderate scaling. Clear IGA was defined as no signs of PSO; post-inflammatory hyperpigmentation may be present. Baseline was defined as the last available value prior to the first injection of study medication in the PS0016 study. The Full Analysis Set consisted of all enrolled participants who received at least 1 dose of the study medication and have a valid efficacy measurement for PASI at Baseline of PS0018.
    End point type
    Secondary
    End point timeframe
    From Baseline of study PS0016 [NCT03025542] until Safety Follow Up Visit (up to Week 64) of study PS0018
    End point values
    BKZ All participants (FAS)
    Number of subjects analysed
    43
    Units: percentage of participants
    number (not applicable)
        PS0018 Week 0
    4.7
        Week 4
    23.3
        Week 8
    37.2
        Week 12
    44.2
        Week 16
    34.9
        Week 20
    41.9
        Week 24
    37.2
        Week 28
    39.5
        Week 32
    37.2
        Week 36
    37.2
        Week 40
    37.2
        Week 44
    37.2
        Week 48/ Withdrawal
    39.5
        Follow-up
    18.6
    No statistical analyses for this end point

    Secondary: Percentage of participants who shifted from moderate Investigator´s Global Assessment (IGA) score at PS0016 [NCT03025542] Baseline to almost clear IGA score during the study

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    End point title
    Percentage of participants who shifted from moderate Investigator´s Global Assessment (IGA) score at PS0016 [NCT03025542] Baseline to almost clear IGA score during the study
    End point description
    A static IGA for Psoriasis (PSO) was used to assess disease severity in all study participants during the study. IGA is a 5 point scale ranging from 0 = Clear to 4 = Severe. Moderate IGA was defined as clearly distinguishable to moderate thickening; dull to bright red, clearly distinguishable to moderate thickening; moderate scaling. Almost clear was defined as no thickening; normal to pink coloration; no to minimal focal scaling. Baseline was defined as the last available value prior to the first injection of study medication in the PS0016 study. The Full Analysis Set consisted of all enrolled participants who received at least 1 dose of the study medication and have a valid efficacy measurement for PASI at Baseline of PS0018.
    End point type
    Secondary
    End point timeframe
    From Baseline of study PS0016 [NCT03025542] until Safety Follow Up Visit (up to Week 64) of study PS0018
    End point values
    BKZ All participants (FAS)
    Number of subjects analysed
    43
    Units: percentage of participants
    number (not applicable)
        PS0018 Week 0
    11.6
        Week 4
    37.2
        Week 8
    32.6
        Week 12
    23.3
        Week 16
    37.2
        Week 20
    23.3
        Week 24
    30.2
        Week 28
    30.2
        Week 32
    37.2
        Week 36
    30.2
        Week 40
    27.9
        Week 44
    32.6
        Week 48/ Withdrawal
    25.6
        Follow-up
    30.2
    No statistical analyses for this end point

    Secondary: Percentage of participants who shifted from moderate Investigator´s Global Assessment (IGA) score at PS0016 [NCT03025542] Baseline to mild IGA score during the study

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    End point title
    Percentage of participants who shifted from moderate Investigator´s Global Assessment (IGA) score at PS0016 [NCT03025542] Baseline to mild IGA score during the study
    End point description
    A static IGA for Psoriasis (PSO) was used to assess disease severity in all study participants during the study. IGA is a 5 point scale ranging from 0 = Clear to 4 = Severe. Moderate IGA was defined as clearly distinguishable to moderate thickening; dull to bright red, clearly distinguishable to moderate thickening; moderate scaling. Mild was defined as just detectable to mild thickening; pink to light red coloration; predominately fine scaling. Baseline was defined as the last available value prior to the first injection of study medication in the PS0016 study. The Full Analysis Set consisted of all enrolled participants who received at least 1 dose of the study medication and have a valid efficacy measurement for PASI at Baseline of PS0018.
    End point type
    Secondary
    End point timeframe
    From Baseline of study PS0016 [NCT03025542] until Safety Follow Up Visit (up to Week 64) of study PS0018
    End point values
    BKZ All participants (FAS)
    Number of subjects analysed
    43
    Units: percentage of participants
    number (not applicable)
        PS0018 Week 0
    25.6
        Week 4
    18.6
        Week 8
    14.0
        Week 12
    11.6
        Week 16
    9.3
        Week 20
    14.0
        Week 24
    9.3
        Week 28
    7.0
        Week 32
    2.3
        Week 36
    9.3
        Week 40
    9.3
        Week 44
    2.3
        Week 48/ Withdrawal
    7.0
        Follow-up
    11.6
    No statistical analyses for this end point

    Secondary: Percentage of participants who shifted from moderate Investigator´s Global Assessment (IGA) score at PS0016 [NCT03025542] Baseline to moderate IGA score during the study

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    End point title
    Percentage of participants who shifted from moderate Investigator´s Global Assessment (IGA) score at PS0016 [NCT03025542] Baseline to moderate IGA score during the study
    End point description
    A static IGA for Psoriasis (PSO) was used to assess disease severity in all study participants during the study. IGA is a 5 point scale ranging from 0 = Clear to 4 = Severe. Moderate IGA was defined as clearly distinguishable to moderate thickening; dull to bright red, clearly distinguishable to moderate thickening; moderate scaling. Baseline was defined as the last available value prior to the first injection of study medication in the PS0016 study. The Full Analysis Set consisted of all enrolled participants who received at least 1 dose of the study medication and have a valid efficacy measurement for PASI at Baseline of PS0018.
    End point type
    Secondary
    End point timeframe
    From Baseline of study PS0016 [NCT03025542] until Safety Follow Up Visit (up to Week 64) of study PS0018
    End point values
    BKZ All participants (FAS)
    Number of subjects analysed
    43
    Units: percentage of participants
    number (not applicable)
        PS0018 Week 0
    25.6
        Week 4
    4.7
        Week 8
    0
        Week 12
    2.3
        Week 16
    2.3
        Week 20
    2.3
        Week 24
    2.3
        Week 28
    2.3
        Week 32
    0
        Week 36
    0
        Week 40
    2.3
        Week 44
    4.7
        Week 48/ Withdrawal
    4.7
        Follow-up
    11.6
    No statistical analyses for this end point

    Secondary: Percentage of participants who shifted from moderate Investigator´s Global Assessment (IGA) score at PS0016 [NCT03025542] Baseline to severe IGA score during the study

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    End point title
    Percentage of participants who shifted from moderate Investigator´s Global Assessment (IGA) score at PS0016 [NCT03025542] Baseline to severe IGA score during the study
    End point description
    A static IGA for Psoriasis (PSO) was used to assess disease severity in all study participants during the study. IGA is a 5 point scale ranging from 0 = Clear to 4 = Severe. Moderate IGA was defined as clearly distinguishable to moderate thickening; dull to bright red, clearly distinguishable to moderate thickening; moderate scaling. Severe was defined as severe thickening with hard edges; bright to deep dark red coloration; severe/coarse scaling covering almost all or all lesions. Baseline was defined as the last available value prior to the first injection of study medication in the PS0016 study. The Full Analysis Set consisted of all enrolled participants who received at least 1 dose of the study medication and have a valid efficacy measurement for PASI at Baseline of PS0018.
    End point type
    Secondary
    End point timeframe
    From Baseline of study PS0016 [NCT03025542] until Safety Follow Up Visit (up to Week 64) of study PS0018
    End point values
    BKZ All participants (FAS)
    Number of subjects analysed
    43
    Units: percentage of participants
    number (not applicable)
        PS0018 Week 0
    16.3
        Week 4
    0
        Week 8
    0
        Week 12
    0
        Week 16
    0
        Week 20
    0
        Week 24
    0
        Week 28
    0
        Week 32
    0
        Week 36
    0
        Week 40
    0
        Week 44
    0
        Week 48/ Withdrawal
    0
        Follow-up
    4.7
    No statistical analyses for this end point

    Secondary: Percentage of participants who shifted from severe Investigator´s Global Assessment (IGA) score at PS0016 [NCT03025542] Baseline to clear IGA score during the study

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    End point title
    Percentage of participants who shifted from severe Investigator´s Global Assessment (IGA) score at PS0016 [NCT03025542] Baseline to clear IGA score during the study
    End point description
    A static IGA for Psoriasis (PSO) was used to assess disease severity in all study participants during the study. IGA is a 5 point scale ranging from 0 = Clear to 4 = Severe. Severe IGA was defined as severe thickening with hard edges; bright to deep dark red coloration; severe/coarse scaling covering almost all or all lesions. Clear was defined as no signs of PSO; post-inflammatory hyperpigmentation may be present. Baseline was defined as the last available value prior to the first injection of study medication in the PS0016 study. The Full Analysis Set consisted of all enrolled participants who received at least 1 dose of the study medication and have a valid efficacy measurement for PASI at Baseline of PS0018.
    End point type
    Secondary
    End point timeframe
    From Baseline of study PS0016 [NCT03025542] until Safety Follow Up Visit (up to Week 64) of study PS0018
    End point values
    BKZ All participants (FAS)
    Number of subjects analysed
    43
    Units: percentage of participants
    number (not applicable)
        PS0018 Week 0
    0
        Week 4
    0
        Week 8
    0
        Week 12
    2.3
        Week 16
    4.7
        Week 20
    7.0
        Week 24
    4.7
        Week 28
    7.0
        Week 32
    4.7
        Week 36
    7.0
        Week 40
    11.6
        Week 44
    9.3
        Week 48/ Withdrawal
    9.3
        Follow-up
    0
    No statistical analyses for this end point

    Secondary: Percentage of participants who shifted from severe Investigator´s Global Assessment (IGA) score at PS0016 [NCT03025542] Baseline to almost clear IGA score during the study

    Close Top of page
    End point title
    Percentage of participants who shifted from severe Investigator´s Global Assessment (IGA) score at PS0016 [NCT03025542] Baseline to almost clear IGA score during the study
    End point description
    A static IGA for Psoriasis (PSO) was used to assess disease severity in all study participants during the study. IGA is a 5 point scale ranging from 0 = Clear to 4 = Severe. Severe IGA was defined as severe thickening with hard edges; bright to deep dark red coloration; severe/coarse scaling covering almost all or all lesions. Almost clear was defined as no thickening; normal to pink coloration; no to minimal focal scaling. Baseline was defined as the last available value prior to the first injection of study medication in the PS0016 study. The Full Analysis Set consisted of all enrolled participants who received at least 1 dose of the study medication and have a valid efficacy measurement for PASI at Baseline of PS0018.
    End point type
    Secondary
    End point timeframe
    From Baseline of study PS0016 [NCT03025542] until Safety Follow Up Visit (up to Week 64) of study PS0018
    End point values
    BKZ All participants (FAS)
    Number of subjects analysed
    43
    Units: percentage of participants
    number (not applicable)
        PS0018 Week 0
    2.3
        Week 4
    2.3
        Week 8
    9.3
        Week 12
    9.3
        Week 16
    4.7
        Week 20
    7.0
        Week 24
    4.7
        Week 28
    2.3
        Week 32
    7.0
        Week 36
    7.0
        Week 40
    2.3
        Week 44
    4.7
        Week 48/ Withdrawal
    4.7
        Follow-up
    2.3
    No statistical analyses for this end point

    Secondary: Percentage of participants who shifted from severe Investigator´s Global Assessment (IGA) score at PS0016 [NCT03025542] Baseline to mild IGA score during the study

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    End point title
    Percentage of participants who shifted from severe Investigator´s Global Assessment (IGA) score at PS0016 [NCT03025542] Baseline to mild IGA score during the study
    End point description
    A static IGA for Psoriasis (PSO) was used to assess disease severity in all study participants during the study. IGA is a 5 point scale ranging from 0 = Clear to 4 = Severe. Severe IGA was defined as severe thickening with hard edges; bright to deep dark red coloration; severe/coarse scaling covering almost all or all lesions. Mild was defined as just detectable to mild thickening; pink to light red coloration; predominately fine scaling. Baseline was defined as the last available value prior to the first injection of study medication in the PS0016 study. The Full Analysis Set consisted of all enrolled participants who received at least 1 dose of the study medication and have a valid efficacy measurement for PASI at Baseline of PS0018.
    End point type
    Secondary
    End point timeframe
    From Baseline of study PS0016 [NCT03025542] until Safety Follow Up Visit (up to Week 64) of study PS0018
    End point values
    BKZ All participants (FAS)
    Number of subjects analysed
    43
    Units: percentage of participants
    number (not applicable)
        PS0018 Week 0
    2.3
        Week 4
    9.3
        Week 8
    2.3
        Week 12
    0
        Week 16
    4.7
        Week 20
    0
        Week 24
    4.7
        Week 28
    4.7
        Week 32
    2.3
        Week 36
    0
        Week 40
    0
        Week 44
    0
        Week 48/ Withdrawal
    0
        Follow-up
    7.0
    No statistical analyses for this end point

    Secondary: Percentage of participants who shifted from severe Investigator´s Global Assessment (IGA) score at PS0016 [NCT03025542] Baseline to moderate IGA score during the study

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    End point title
    Percentage of participants who shifted from severe Investigator´s Global Assessment (IGA) score at PS0016 [NCT03025542] Baseline to moderate IGA score during the study
    End point description
    A static IGA for Psoriasis (PSO) was used to assess disease severity in all study participants during the study. IGA is a 5 point scale ranging from 0 = Clear to 4 = Severe. Severe IGA was defined as severe thickening with hard edges; bright to deep dark red coloration; severe/coarse scaling covering almost all or all lesions. Moderate was defined as clearly distinguishable to moderate thickening; dull to bright red, clearly distinguishable to moderate thickening; moderate scaling. Baseline was defined as the last available value prior to the first injection of study medication in the PS0016 study. The Full Analysis Set consisted of all enrolled participants who received at least 1 dose of the study medication and have a valid efficacy measurement for PASI at Baseline of PS0018.
    End point type
    Secondary
    End point timeframe
    From Baseline of study PS0016 [NCT03025542] until Safety Follow Up Visit (up to Week 64) of study PS0018
    End point values
    BKZ All participants (FAS)
    Number of subjects analysed
    43
    Units: percentage of participants
    number (not applicable)
        PS0018 Week 0
    2.3
        Week 4
    2.3
        Week 8
    0
        Week 12
    2.3
        Week 16
    0
        Week 20
    0
        Week 24
    0
        Week 28
    0
        Week 32
    0
        Week 36
    0
        Week 40
    0
        Week 44
    0
        Week 48/ Withdrawal
    0
        Follow-up
    2.3
    No statistical analyses for this end point

    Secondary: Percentage of participants who shifted from severe Investigator´s Global Assessment (IGA) score at PS0016 [NCT03025542] Baseline to severe IGA score during the study

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    End point title
    Percentage of participants who shifted from severe Investigator´s Global Assessment (IGA) score at PS0016 [NCT03025542] Baseline to severe IGA score during the study
    End point description
    A static IGA for Psoriasis (PSO) was used to assess disease severity in all study participants during the study. IGA is a 5 point scale ranging from 0 = Clear to 4 = Severe. Severe IGA was defined as severe thickening with hard edges; bright to deep dark red coloration; severe/coarse scaling covering almost all or all lesions. Baseline was defined as the last available value prior to the first injection of study medication in the PS0016 study. The Full Analysis Set consisted of all enrolled participants who received at least 1 dose of the study medication and have a valid efficacy measurement for PASI at Baseline of PS0018.
    End point type
    Secondary
    End point timeframe
    From Baseline of study PS0016 [NCT03025542] until Safety Follow Up Visit (up to Week 64) of study PS0018
    End point values
    BKZ All participants (FAS)
    Number of subjects analysed
    43
    Units: percentage of participants
    number (not applicable)
        PS0018 Week 0
    9.3
        Week 4
    2.3
        Week 8
    2.3
        Week 12
    0
        Week 16
    0
        Week 20
    0
        Week 24
    0
        Week 28
    0
        Week 32
    0
        Week 36
    0
        Week 40
    0
        Week 44
    0
        Week 48/ Withdrawal
    0
        Follow-up
    2.3
    No statistical analyses for this end point

    Secondary: Mean percentage in the Body Surface Area (BSA) affected by psoriasis during the study

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    End point title
    Mean percentage in the Body Surface Area (BSA) affected by psoriasis during the study
    End point description
    The BSA palm method was used for the evaluation of BSA as follows: Body surface area estimation used the palm (study participant’s flat hand and thumb together, fingers included) as representing around 1% of the total BSA. Missing data was imputed using Last Observation Carried forward (LOCF) at all visits. Baseline was defined as the last available value prior to the first injection of study medication in the PS0016 study. The Full Analysis Set consisted of all enrolled participants who received at least 1 dose of the study medication and have a valid efficacy measurement for PASI at Baseline of PS0018.
    End point type
    Secondary
    End point timeframe
    From Baseline of study PS0016 [NCT03025542] until Safety Follow Up Visit (up to Week 64) of study PS0018
    End point values
    BKZ All participants (FAS)
    Number of subjects analysed
    43
    Units: percentage of BSA
    arithmetic mean (standard deviation)
        PS0016 Baseline
    25.8 ± 17.5
        PS0018 Week 0
    8.6 ± 10.7
        Week 4
    5.2 ± 12.6
        Week 8
    3.0 ± 10.9
        Week 12
    2.0 ± 4.8
        Week 16
    1.0 ± 1.6
        Week 20
    1.2 ± 2.2
        Week 24
    1.2 ± 1.9
        Week 28
    0.9 ± 1.6
        Week 32
    0.8 ± 1.1
        Week 36
    0.7 ± 1.1
        Week 40
    0.8 ± 1.2
        Week 44
    0.7 ± 1.0
        Week 48/ Withdrawal
    0.7 ± 1.2
        Follow-up
    4.8 ± 13.0
    No statistical analyses for this end point

    Secondary: Mean percentage change from PS0016 [NCT03025542] Baseline in the Body Surface Area (BSA) affected by psoriasis during the study

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    End point title
    Mean percentage change from PS0016 [NCT03025542] Baseline in the Body Surface Area (BSA) affected by psoriasis during the study
    End point description
    The percentage BSA (0 to 100 %) affected by PSO was listed by PS0016 randomized treatment, by study participant and visit including the percentage change from PS0016 Baseline. The BSA palm method was used for the evaluation of BSA as follows: Body surface area estimation used the palm (study participant’s flat hand and thumb together, fingers included) as representing around 1% of the total BSA. Missing data was imputed using Last observation carried forward (LOCF) at all visits. Baseline was defined as the last available value prior to the first injection of study medication in the PS0016 study. The Full Analysis Set consisted of all enrolled participants who received at least 1 dose of the study medication and have a valid efficacy measurement for PASI at Baseline of PS0018.
    End point type
    Secondary
    End point timeframe
    From Baseline of study PS0016 [NCT03025542] until Safety Follow Up Visit (up to Week 64) of study PS0018
    End point values
    BKZ All participants (FAS)
    Number of subjects analysed
    43
    Units: percentage change
    arithmetic mean (standard deviation)
        PS0018 Week 0
    -61.0 ± 41.5
        Week 4
    -83.0 ± 23.7
        Week 8
    -91.1 ± 15.9
        Week 12
    -92.9 ± 10.9
        Week 16
    -95.5 ± 7.4
        Week 20
    -94.4 ± 9.1
        Week 24
    -94.8 ± 7.8
        Week 28
    -95.4 ± 8.7
        Week 32
    -96.1 ± 6.7
        Week 36
    -96.5 ± 5.7
        Week 40
    -95.8 ± 8.5
        Week 44
    -96.3 ± 6.2
        Week 48/ Withdrawal
    -95.6 ± 10.0
        Follow-up
    -81.5 ± 33.9
    No statistical analyses for this end point

    Secondary: Mean change from PS0016 [NCT03025542] Baseline in Hospital Anxiety and Depression Scale – Anxiety (HADS-A) score during the study

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    End point title
    Mean change from PS0016 [NCT03025542] Baseline in Hospital Anxiety and Depression Scale – Anxiety (HADS-A) score during the study
    End point description
    HADS-A score is the sum of the 7 individual scores in the anxiety domain and ranges from 0 to 21 with higher scores indicating worse state. A score below 8 was considered normal whereas a score of 15 and above was considered severe. Baseline was defined as the last available value prior to the first injection of study medication in the PS0016 study. The Full Analysis Set consisted of all enrolled participants who received at least 1 dose of the study medication and have a valid efficacy measurement for PASI at Baseline of PS0018.
    End point type
    Secondary
    End point timeframe
    Week 0, 12, 24, 36, and 48 of study PS0018, Relative to Baseline of study PS0016 [NCT03025542]
    End point values
    BKZ All participants (FAS)
    Number of subjects analysed
    43
    Units: score on a scale
    arithmetic mean (standard deviation)
        PS0018 Week 0
    -1.5 ± 2.3
        Week 12
    -2.0 ± 1.8
        Week 24
    -2.0 ± 2.4
        Week 36
    -2.0 ± 2.4
        Week 48/ Withdrawal
    -1.5 ± 2.2
    No statistical analyses for this end point

    Secondary: Mean change from PS0016 [NCT03025542] Baseline in Hospital Anxiety and Depression Scale – Depression (HADS-D) score during the study

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    End point title
    Mean change from PS0016 [NCT03025542] Baseline in Hospital Anxiety and Depression Scale – Depression (HADS-D) score during the study
    End point description
    HADS-D score is the sum of the 7 individual scores in the depression domain and ranges from 0 to 21 with higher scores indicating worse state. A score below 8 was considered normal whereas a score of 15 and above was considered severe. Baseline was defined as the last available value prior to the first injection of study medication in the PS0016 study. The Full Analysis Set consisted of all enrolled participants who received at least 1 dose of the study medication and have a valid efficacy measurement for PASI at Baseline of PS0018.
    End point type
    Secondary
    End point timeframe
    Week 0, 12, 24, 36, and 48 of study PS0018, Relative to Baseline of study PS0016 [NCT03025542]
    End point values
    BKZ All participants (FAS)
    Number of subjects analysed
    43
    Units: score on a scale
    arithmetic mean (standard deviation)
        PS0018 Week 0
    -1.0 ± 1.4
        Week 12
    -0.8 ± 2.1
        Week 24
    -1.0 ± 1.7
        Week 36
    -1.1 ± 1.7
        Week 48/ Withdrawal
    -1.0 ± 1.8
    No statistical analyses for this end point

    Secondary: Percentage of participants with scores below 8 in HADS-A (participants with normal scores) during the study

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    End point title
    Percentage of participants with scores below 8 in HADS-A (participants with normal scores) during the study
    End point description
    HADS-A score is the sum of the 7 individual scores in the anxiety domain and ranges from 0 to 21 with higher scores indicating worse state. A score below 8 was considered normal. Percentages were based on the number of participants with a non-missing measurement at the visit. Baseline was defined as the last available value prior to the first injection of study medication in the PS0016 study. The Full Analysis Set consisted of all enrolled participants who received at least 1 dose of the study medication and have a valid efficacy measurement for PASI at Baseline of PS0018. Here, 'n' signifies participants who were evaluable at specified time points.
    End point type
    Secondary
    End point timeframe
    Baseline of study PS0016 [NCT03025542], Week 0, 12, 24, 36, and 48 of study PS0018
    End point values
    BKZ All participants (FAS)
    Number of subjects analysed
    43
    Units: percentage of participants
    number (not applicable)
        PS0016 Baseline (n=43)
    83.7
        PS0018 Week 0 (n=43)
    88.4
        Week 12 (n=42)
    95.2
        Week 24 (n=42)
    90.5
        Week 36 (n=39)
    89.7
        Week 48/ Withdrawal (n=39)
    87.2
    No statistical analyses for this end point

    Secondary: Percentage of participants with scores below 8 in HADS-D (participants with normal scores) during the study

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    End point title
    Percentage of participants with scores below 8 in HADS-D (participants with normal scores) during the study
    End point description
    HADS-D score is the sum of the 7 individual scores in the depression domain and ranges from 0 to 21 with higher scores indicating worse state. A score below 8 was considered normal. Percentages were based on the number of participants with a non-missing measurement at the visit. Baseline was defined as the last available value prior to the first injection of study medication in the PS0016 study. The Full Analysis Set consisted of all enrolled participants who received at least 1 dose of the study medication and have a valid efficacy measurement for PASI at Baseline of PS0018. Here, 'n' signifies participants who were evaluable at specified time points.
    End point type
    Secondary
    End point timeframe
    Baseline of study PS0016 [NCT03025542], Week 0, 12, 24, 36, and 48 of study PS0018
    End point values
    BKZ All participants (FAS)
    Number of subjects analysed
    43
    Units: percentage of participants
    number (not applicable)
        PS0016 Baseline (n=43)
    93.0
        PS0018 Week 0 (n=43)
    97.7
        Week 12 (n=42)
    95.2
        Week 24 (n=42)
    97.6
        Week 36 (n=39)
    94.9
        Week 48/ Withdrawal (n=39)
    97.4
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Adverse events were collected from the PS0018 Baseline until the Safety Follow-Up Visit [20 weeks after the last dose (up to Week 64)]
    Assessment type
    Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    19.0
    Reporting groups
    Reporting group title
    BKZ All participants (SS)
    Reporting group description
    Participants received BKZ 160 mg Q4W sc during the 48-week Open Label Treatment Period. The Investigator could increase the dose to BKZ 320 mg Q4W if the participant's PASI response was >= 50% to < 75% reduction from the Baseline of PS0016 at Week 12 or later. If the participant’s disease was adequately controlled on BKZ 320 mg Q4W, they could return to BKZ 160 mg Q4W at the discretion of the Investigator. Participants formed the Safety Set (SS).

    Serious adverse events
    BKZ All participants (SS)
    Total subjects affected by serious adverse events
         subjects affected / exposed
    3 / 43 (6.98%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    0
    Injury, poisoning and procedural complications
    Anaemia postoperative
         subjects affected / exposed
    1 / 43 (2.33%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Cardiac disorders
    Acute myocardial infarction
         subjects affected / exposed
    1 / 43 (2.33%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Nervous system disorders
    Syncope
         subjects affected / exposed
    1 / 43 (2.33%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    BKZ All participants (SS)
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    27 / 43 (62.79%)
    Investigations
    Gamma-glutamyltransferase increased
         subjects affected / exposed
    5 / 43 (11.63%)
         occurrences all number
    7
    Alanine aminotransferase increased
         subjects affected / exposed
    4 / 43 (9.30%)
         occurrences all number
    5
    Infections and infestations
    Upper respiratory tract infection
         subjects affected / exposed
    8 / 43 (18.60%)
         occurrences all number
    12
    Nasopharyngitis
         subjects affected / exposed
    7 / 43 (16.28%)
         occurrences all number
    10
    Viral upper respiratory tract infection
         subjects affected / exposed
    5 / 43 (11.63%)
         occurrences all number
    6
    Oral candidiasis
         subjects affected / exposed
    4 / 43 (9.30%)
         occurrences all number
    6
    Pharyngitis
         subjects affected / exposed
    3 / 43 (6.98%)
         occurrences all number
    3
    Staphylococcal pharyngitis
         subjects affected / exposed
    3 / 43 (6.98%)
         occurrences all number
    3

    More information

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    Substantial protocol amendments (globally)

    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    16 Feb 2018
    Protocol amendment 3, dated 16 Feb 2018, was implemented to make the following changes: • Revised the withdrawal criteria to provide instructions for the management of study participants with newly diagnosed inflammatory bowel disease or with inflammatory bowel disease flares during the study • Updated the study contact information.

    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.
    PS0018 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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