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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
    v2(current)
    This version publication date
    12 Dec 2020
    First version publication date
    26 Jul 2018
    Other versions
    v1
    Version creation reason
    • Correction of full data set
    Alignment with final posting on ClinicalTrials.gov after NIH review.

    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) for 12 weeks in the treatment of participants 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 Participants 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. Participants 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 Participants 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 participants 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. Participants 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
    Efficacy, Safety
    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
    Czechia: 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 participants in August 2016 and concluded in July 2017.

    Pre-assignment
    Screening details
    The study included a 2-4 week Screening Period and a 12-week Treatment Period. Completed study was defined as completed the 12-week double-blind Treatment Period. After Treatment Period participants either enrolled in an extension study (PS0011) or entered a 20-week Safety Follow-Up Period. Participant Flow refers to the Randomized Set.

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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    Placebo
    Arm description
    Participants 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 participants entering the open-label extension study.

    Arm title
    Bimekizumab 64 mg Q4W
    Arm description
    Participants were randomized to receive subcutaneous injections of 64 mg bimekizumab 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 participants entering the open-label extension study.

    Arm title
    Bimekizumab 160 mg Q4W
    Arm description
    Participants were randomized to receive subcutaneous injections of 160 mg bimekizumab 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 participants entering the open-label extension study.

    Arm title
    Bimekizumab 160 mg w/ LD Q4W
    Arm description
    Participants were randomized to receive subcutaneous injections of 320 mg bimekizumab loading dose at Baseline followed by 160 mg bimekizumab 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 participants entering the open-label extension study.

    Arm title
    Bimekizumab 320 mg Q4W
    Arm description
    Participants were randomized to receive subcutaneous injections of 320 mg bimekizumab 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 participants entering the open-label extension study.

    Arm title
    Bimekizumab 480 mg Q4W
    Arm description
    Participants were randomized to receive subcutaneous injections of 480 mg bimekizumab 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 participants entering the open-label extension study.

    Number of subjects in period 1
    Placebo Bimekizumab 64 mg Q4W Bimekizumab 160 mg Q4W Bimekizumab 160 mg w/ LD Q4W Bimekizumab 320 mg Q4W Bimekizumab 480 mg Q4W
    Started
    42
    39
    43
    40
    43
    43
    Completed Treatment period
    37
    36
    38
    34
    40
    39
    Enrolled in extension study (PS0011)
    38
    35 [1]
    39
    38
    42
    40
    Entered Safety Follow-up Period
    4 [2]
    4 [3]
    4 [4]
    2 [5]
    1 [6]
    3 [7]
    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
    -
    Notes
    [1] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left.
    Justification: Number of participants at the milestones reflects those who enrolled in the extension study (PS0011).
    [2] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left.
    Justification: Number of participants at the milestones reflects those who entered a 20-week Safety Follow-Up Period.
    [3] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left.
    Justification: Number of participants at the milestones reflects those who entered a 20-week Safety Follow-Up Period.
    [4] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left.
    Justification: Number of participants at the milestones reflects those who entered a 20-week Safety Follow-Up Period.
    [5] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left.
    Justification: Number of participants at the milestones reflects those who entered a 20-week Safety Follow-Up Period.
    [6] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left.
    Justification: Number of participants at the milestones reflects those who entered a 20-week Safety Follow-Up Period.
    [7] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left.
    Justification: Number of participants at the milestones reflects those who entered a 20-week Safety Follow-Up Period.

    Baseline characteristics

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

    Reporting group title
    Bimekizumab 64 mg Q4W
    Reporting group description
    Participants were randomized to receive subcutaneous injections of 64 mg bimekizumab Q4W.

    Reporting group title
    Bimekizumab 160 mg Q4W
    Reporting group description
    Participants were randomized to receive subcutaneous injections of 160 mg bimekizumab Q4W.

    Reporting group title
    Bimekizumab 160 mg w/ LD Q4W
    Reporting group description
    Participants were randomized to receive subcutaneous injections of 320 mg bimekizumab loading dose at Baseline followed by 160 mg bimekizumab Q4W.

    Reporting group title
    Bimekizumab 320 mg Q4W
    Reporting group description
    Participants were randomized to receive subcutaneous injections of 320 mg bimekizumab Q4W.

    Reporting group title
    Bimekizumab 480 mg Q4W
    Reporting group description
    Participants were randomized to receive subcutaneous injections of 480 mg bimekizumab Q4W.

    Reporting group values
    Placebo Bimekizumab 64 mg Q4W Bimekizumab 160 mg Q4W Bimekizumab 160 mg w/ LD Q4W Bimekizumab 320 mg Q4W Bimekizumab 480 mg Q4W Total
    Number of subjects
    42 39 43 40 43 43 250
    Age categorical
    Units: Subjects
        <=18 years
    0 1 0 0 0 2 3
        Between 18 and 65 years
    39 36 40 35 39 36 225
        >=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
    Participants randomized to the placebo group, received a combination of several injections of placebo, subcutaneously every 4 weeks (Q4W).

    Reporting group title
    Bimekizumab 64 mg Q4W
    Reporting group description
    Participants were randomized to receive subcutaneous injections of 64 mg bimekizumab Q4W.

    Reporting group title
    Bimekizumab 160 mg Q4W
    Reporting group description
    Participants were randomized to receive subcutaneous injections of 160 mg bimekizumab Q4W.

    Reporting group title
    Bimekizumab 160 mg w/ LD Q4W
    Reporting group description
    Participants were randomized to receive subcutaneous injections of 320 mg bimekizumab loading dose at Baseline followed by 160 mg bimekizumab Q4W.

    Reporting group title
    Bimekizumab 320 mg Q4W
    Reporting group description
    Participants were randomized to receive subcutaneous injections of 320 mg bimekizumab Q4W.

    Reporting group title
    Bimekizumab 480 mg Q4W
    Reporting group description
    Participants were randomized to receive subcutaneous injections of 480 mg bimekizumab Q4W.

    Subject analysis set title
    Placebo (FAS)
    Subject analysis set type
    Full analysis
    Subject analysis set description
    Participants randomized to the placebo group, received a combination of several injections of placebo, subcutaneously every 4 weeks (Q4W). Participants formed the Full Analysis Set (FAS).

    Subject analysis set title
    Bimekizumab 64 mg Q4W (FAS)
    Subject analysis set type
    Full analysis
    Subject analysis set description
    Participants were randomized to receive subcutaneous injections of 64 mg bimekizumab Q4W. Participants formed the FAS.

    Subject analysis set title
    Bimekizumab 160 mg Q4W (FAS)
    Subject analysis set type
    Full analysis
    Subject analysis set description
    Participants were randomized to receive subcutaneous injections of 160 mg bimekizumab Q4W. Participants formed the FAS.

    Subject analysis set title
    Bimekizumab 160 mg w/ LD Q4W (FAS)
    Subject analysis set type
    Full analysis
    Subject analysis set description
    Participants were randomized to receive subcutaneous injections of 320 mg bimekizumab loading dose at Baseline followed by 160 mg bimekizumab Q4W. Participants formed the FAS.

    Subject analysis set title
    Bimekizumab 320 mg Q4W (FAS)
    Subject analysis set type
    Full analysis
    Subject analysis set description
    Participants were randomized to receive subcutaneous injections of 320 mg bimekizumab Q4W. Participants formed the FAS.

    Subject analysis set title
    Bimekizumab 480 mg Q4W (FAS)
    Subject analysis set type
    Full analysis
    Subject analysis set description
    Participants were randomized to receive subcutaneous injections of 480 mg bimekizumab Q4W. Participants formed the FAS.

    Subject analysis set title
    Placebo (PK-PPS)
    Subject analysis set type
    Per protocol
    Subject analysis set description
    Participants randomized to the placebo group, received a combination of several injections of placebo, subcutaneously every 4 weeks (Q4W). Participants formed the Pharmacokinetics Per-Protocol Set (PK-PPS).

    Subject analysis set title
    Bimekizumab 64 mg Q4W (PK-PPS)
    Subject analysis set type
    Per protocol
    Subject analysis set description
    Participants were randomized to receive subcutaneous injections of 64 mg bimekizumab Q4W. Participants formed the PK-PPS.

    Subject analysis set title
    Bimekizumab 160 mg Q4W (PK-PPS)
    Subject analysis set type
    Per protocol
    Subject analysis set description
    Participants were randomized to receive subcutaneous injections of 160 mg bimekizumab Q4W. Participants formed the PK-PPS.

    Subject analysis set title
    Bimekizumab 160 mg w/ LD Q4W (PK-PPS)
    Subject analysis set type
    Per protocol
    Subject analysis set description
    Participants were randomized to receive subcutaneous injections of 320 mg bimekizumab loading dose at Baseline followed by 160 mg bimekizumab Q4W. Participants formed the PK-PPS.

    Subject analysis set title
    Bimekizumab 320 mg Q4W (PK-PPS)
    Subject analysis set type
    Per protocol
    Subject analysis set description
    Participants were randomized to receive subcutaneous injections of 320 mg bimekizumab Q4W. Participants formed the PK-PPS.

    Subject analysis set title
    Bimekizumab 480 mg Q4W (PK-PPS)
    Subject analysis set type
    Per protocol
    Subject analysis set description
    Participants were randomized to receive subcutaneous injections of 480 mg bimekizumab Q4W. Participants formed the PK-PPS.

    Subject analysis set title
    Placebo (SS)
    Subject analysis set type
    Safety analysis
    Subject analysis set description
    Participants randomized to the placebo group, received a combination of several injections of placebo, subcutaneously every 4 weeks (Q4W). Participants formed the Safety Set (SS).

    Subject analysis set title
    Bimekizumab 64 mg Q4W (SS)
    Subject analysis set type
    Safety analysis
    Subject analysis set description
    Participants were randomized to receive subcutaneous injections of 64 mg bimekizumab Q4W. Participants formed the SS.

    Subject analysis set title
    Bimekizumab 160 mg Q4W (SS)
    Subject analysis set type
    Safety analysis
    Subject analysis set description
    Participants were randomized to receive subcutaneous injections of 160 mg bimekizumab Q4W. Participants formed the SS.

    Subject analysis set title
    Bimekizumab 160 mg w/ LD Q4W (SS)
    Subject analysis set type
    Safety analysis
    Subject analysis set description
    Participants were randomized to receive subcutaneous injections of 320 mg bimekizumab loading dose at Baseline followed by 160 mg bimekizumab Q4W. Participants formed the SS.

    Subject analysis set title
    Bimekizumab 320 mg Q4W (SS)
    Subject analysis set type
    Safety analysis
    Subject analysis set description
    Participants were randomized to receive subcutaneous injections of 320 mg bimekizumab Q4W. Participants formed the SS.

    Subject analysis set title
    Bimekizumab 480 mg Q4W (SS)
    Subject analysis set type
    Safety analysis
    Subject analysis set description
    Participants were randomized to receive subcutaneous injections of 480 mg bimekizumab Q4W. Participants formed the SS.

    Subject analysis set title
    Placebo (SS) Treatment Period
    Subject analysis set type
    Safety analysis
    Subject analysis set description
    During the Treatment Period participants randomized to the placebo group, received a combination of several injections of placebo, subcutaneously every 4 weeks (Q4W). Participants formed the Safety Set (SS).

    Subject analysis set title
    Bimekizumab 64 mg Q4W (SS) Treatment Period
    Subject analysis set type
    Safety analysis
    Subject analysis set description
    During the Treatment Period participants were randomized to receive subcutaneous injections of 64 mg bimekizumab Q4W. Participants formed the SS.

    Subject analysis set title
    Bimekizumab 160 mg Q4W (SS) Treatment Period
    Subject analysis set type
    Safety analysis
    Subject analysis set description
    During the Treatment Period participants were randomized to receive subcutaneous injections of 160 mg bimekizumab Q4W. Participants formed the SS.

    Subject analysis set title
    Bimekizumab 160 mg w/ LD Q4W (SS) Treatment Period
    Subject analysis set type
    Safety analysis
    Subject analysis set description
    During the Treatment Period participants were randomized to receive subcutaneous injections of 320 mg bimekizumab loading dose at Baseline followed by 160 mg bimekizumab Q4W. Participants formed the SS.

    Subject analysis set title
    Bimekizumab 320 mg Q4W (SS) Treatment Period
    Subject analysis set type
    Safety analysis
    Subject analysis set description
    During the Treatment Period participants were randomized to receive subcutaneous injections of 320 mg bimekizumab Q4W. Participants formed the SS.

    Subject analysis set title
    Bimekizumab 480 mg Q4W (SS) Treatment Period
    Subject analysis set type
    Safety analysis
    Subject analysis set description
    During the Treatment Period participants were randomized to receive subcutaneous injections of 480 mg bimekizumab Q4W. Participants formed the SS.

    Subject analysis set title
    Placebo (SS) Post-Treatment Period
    Subject analysis set type
    Safety analysis
    Subject analysis set description
    At Week 12, participants who were randomized to receive Placebo during the Treatment Period and who enrolled in the extension study (PS0011), underwent the Week 12 study assessments and then received their first extension study dose of study treatment. All participants who did not enroll in the extension study had the Week 12 study assessments and entered the Safety Follow-Up (SFU) Period, 20 weeks after the last dose of study medication. Participants did not receive any treatment during the Post-Treatment Period. Participants formed the SS.

    Subject analysis set title
    Bimekizumab 64 mg Q4W (SS) Post-Treatment Period
    Subject analysis set type
    Safety analysis
    Subject analysis set description
    At Week 12, participants who were randomized to receive 64 mg bimekizumab Q4W during the Treatment Period and who enrolled in the extension study (PS0011), underwent the Week 12 study assessments and then received their first extension study dose of study treatment. All participants who did not enroll in the extension study had the Week 12 study assessments and entered the Safety Follow-Up (SFU) Period, 20 weeks after the last dose of study medication. Participants did not receive any treatment during the Post-Treatment Period. Participants formed the SS.

    Subject analysis set title
    Bimekizumab 160 mg Q4W (SS) Post-Treatment Period
    Subject analysis set type
    Safety analysis
    Subject analysis set description
    At Week 12, participants who were randomized to receive 160 mg bimekizumab Q4W during the Treatment Period and who enrolled in the extension study (PS0011), underwent the Week 12 study assessments and then received their first extension study dose of study treatment. All participants who did not enroll in the extension study had the Week 12 study assessments and entered the Safety Follow-Up (SFU) Period, 20 weeks after the last dose of study medication. Participants did not receive any treatment during the Post-Treatment Period. Participants formed the SS.

    Subject analysis set title
    Bimekizumab 160 mg w/ LD Q4W (SS) Post-Treatment Period
    Subject analysis set type
    Safety analysis
    Subject analysis set description
    At Week 12, participants who were randomized to receive 320 mg bimekizumab loading dose at Baseline followed by 160 mg bimekizumab Q4W during the Treatment Period and who enrolled in the extension study (PS0011), underwent the Week 12 study assessments and then received their first extension study dose of study treatment. All participants who did not enroll in the extension study had the Week 12 study assessments and entered the Safety Follow-Up (SFU) Period, 20 weeks after the last dose of study medication. Participants did not receive any treatment during the Post-Treatment Period. Participants formed the SS.

    Subject analysis set title
    Bimekizumab 320 mg Q4W (SS) Post-Treatment Period
    Subject analysis set type
    Safety analysis
    Subject analysis set description
    At Week 12, participants who were randomized to receive 320 mg bimekizumab Q4W during the Treatment Period and who enrolled in the extension study (PS0011), underwent the Week 12 study assessments and then received their first extension study dose of study treatment. All participants who did not enroll in the extension study had the Week 12 study assessments and entered the Safety Follow-Up (SFU) Period, 20 weeks after the last dose of study medication. Participants did not receive any treatment during the Post-Treatment Period. Participants formed the SS.

    Subject analysis set title
    Bimekizumab 480 mg Q4W (SS) Post-Treatment Period
    Subject analysis set type
    Safety analysis
    Subject analysis set description
    At Week 12, participants who were randomized to receive 480 mg bimekizumab Q4W during the Treatment Period and who enrolled in the extension study (PS0011), underwent the Week 12 study assessments and then received their first extension study dose of study treatment. All participants who did not enroll in the extension study had the Week 12 study assessments and entered the Safety Follow-Up (SFU) Period, 20 weeks after the last dose of study medication. Participants did not receive any treatment during the Post-Treatment Period. Participants formed the SS.

    Subject analysis set title
    All participants (PK-PPS)
    Subject analysis set type
    Per protocol
    Subject analysis set description
    Participants were randomized to receive subcutaneous injections of placebo or bimekizumab in different dosages: 64 mg Q4W, 160 mg Q4W, 320 mg loading dose at Baseline followed by 160 mg Q4W, 320 mg Q4W, 480 mg Q4W during the 12-week Treatment Period. Participants formed the PK-PPS.

    Primary: Percentage of participants 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 participants achieving a 90% or higher improvement from Baseline in Psoriasis Area and Severity Index (PASI) score at Week 12
    End point description
    PASI90 response assessments are based on at least 90% improvement in PASI score from Baseline. This scoring system averages the redness/thickness/scaliness of the psoriatic lesions and weights the resulting score by the area of skin involved. Body divided into 4 areas: head/arms/trunk to groin/legs to top of buttocks. Assignment of an average score for the redness/thickness/scaling for each of the 4 body areas with a score of 0 (clear)-4 (very marked). Determining the percentage of skin covered with PSO for each of the body areas and converting to a 0-6 scale. Final PASI=average redness/thickness/scaliness of psoriatic skin lesions multiplied by the involved psoriasis area score and weighted by the percentage of the person’s affected skin for the respective section. Min PASI score is 0=no disease, max score is 72=maximal disease. The FAS consisted of all randomized participants who received at least 1 dose of medication and had a valid measurement of the primary efficacy at Baseline.
    End point type
    Primary
    End point timeframe
    Week 12
    End point values
    Placebo (FAS) Bimekizumab 64 mg Q4W (FAS) Bimekizumab 160 mg Q4W (FAS) Bimekizumab 160 mg w/ LD Q4W (FAS) Bimekizumab 320 mg Q4W (FAS) Bimekizumab 480 mg Q4W (FAS)
    Number of subjects analysed
    42
    39
    43
    40
    43
    43
    Units: percentage of participants
        number (not applicable)
    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 Q4W (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 Dose 3 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 Q4W (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 Dose 3 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 Q4W (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 Dose 3 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 Q4W (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 Dose 3 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 participants with Investigator's Global Assessment (IGA) (Clear or Almost Clear with at least 2 category improvement from Baseline) response at Week 12

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    End point title
    Percentage of participants with Investigator's Global Assessment (IGA) (Clear or Almost Clear with at least 2 category improvement from Baseline) 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. The Full Analysis Set (FAS) consisted of all randomized participants who received at least 1 dose of the study medication and had a valid measurement of the primary efficacy variable at Baseline.
    End point type
    Secondary
    End point timeframe
    Week 12
    End point values
    Placebo (FAS) Bimekizumab 64 mg Q4W (FAS) Bimekizumab 160 mg Q4W (FAS) Bimekizumab 160 mg w/ LD Q4W (FAS) Bimekizumab 320 mg Q4W (FAS) Bimekizumab 480 mg Q4W (FAS)
    Number of subjects analysed
    42
    39
    43
    40
    43
    43
    Units: percentage of participants
        number (not applicable)
    4.8
    51.3
    74.4
    75.0
    86.0
    76.7
    Statistical analysis title
    Statistical analysis 1
    Statistical analysis description
    Confidence intervals, odds ratios, p-values derived from a logistic regression model with fixed effects for treatment, region, prior bio-exposure.
    Comparison groups
    Placebo (FAS) v Bimekizumab 64 mg Q4W (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
    Statistical analysis description
    Confidence intervals, odds ratios, p-values derived from a logistic regression model with fixed effects for treatment, region, prior bio-exposure.
    Comparison groups
    Placebo (FAS) v Bimekizumab 160 mg Q4W (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
    Statistical analysis description
    Confidence intervals, odds ratios, p-values derived from a logistic regression model with fixed effects for treatment, region, prior bio-exposure.
    Comparison groups
    Placebo (FAS) v Bimekizumab 160 mg w/ LD Q4W (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
    Statistical analysis description
    Confidence intervals, odds ratios, p-values derived from a logistic regression model with fixed effects for treatment, region, prior bio-exposure.
    Comparison groups
    Placebo (FAS) v Bimekizumab 320 mg Q4W (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
    Statistical analysis description
    Confidence intervals, odds ratios, p-values derived from a logistic regression model with fixed effects for treatment, region, prior bio-exposure.
    Comparison groups
    Placebo (FAS) v Bimekizumab 480 mg Q4W (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 participants with Investigator's Global Assessment (IGA) (Clear or Almost Clear with at least 2 category improvement from Baseline) response at Week 8

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    End point title
    Percentage of participants with Investigator's Global Assessment (IGA) (Clear or Almost Clear with at least 2 category improvement from Baseline) 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. The Full Analysis Set (FAS) consisted of all randomized participants who received at least 1 dose of the study medication and had a valid measurement of the primary efficacy variable at Baseline.
    End point type
    Secondary
    End point timeframe
    Week 8
    End point values
    Placebo (FAS) Bimekizumab 64 mg Q4W (FAS) Bimekizumab 160 mg Q4W (FAS) Bimekizumab 160 mg w/ LD Q4W (FAS) Bimekizumab 320 mg Q4W (FAS) Bimekizumab 480 mg Q4W (FAS)
    Number of subjects analysed
    42
    39
    43
    40
    43
    43
    Units: percentage of participants
        number (not applicable)
    4.8
    46.2
    62.8
    77.5
    86.0
    72.1
    Statistical analysis title
    Statistical analysis 1
    Statistical analysis description
    Confidence intervals, odds ratios, p-values derived from a logistic regression model with fixed effects for treatment, region, prior bio-exposure.
    Comparison groups
    Placebo (FAS) v Bimekizumab 64 mg Q4W (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
    Statistical analysis description
    Confidence intervals, odds ratios, p-values derived from a logistic regression model with fixed effects for treatment, region, prior bio-exposure.
    Comparison groups
    Placebo (FAS) v Bimekizumab 160 mg Q4W (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
    Statistical analysis description
    Confidence intervals, odds ratios, p-values derived from a logistic regression model with fixed effects for treatment, region, prior bio-exposure.
    Comparison groups
    Placebo (FAS) v Bimekizumab 160 mg w/ LD Q4W (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
    Statistical analysis description
    Confidence intervals, odds ratios, p-values derived from a logistic regression model with fixed effects for treatment, region, prior bio-exposure.
    Comparison groups
    Placebo (FAS) v Bimekizumab 320 mg Q4W (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
    Statistical analysis description
    Confidence intervals, odds ratios, p-values derived from a logistic regression model with fixed effects for treatment, region, prior bio-exposure.
    Comparison groups
    Placebo (FAS) v Bimekizumab 480 mg Q4W (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 participants 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 participants achieving a 90% or higher improvement from Baseline in Psoriasis Area and Severity Index (PASI) score at Week 8
    End point description
    PASI90 response assessments are based on at least 90% improvement in PASI score from Baseline. This scoring system averages the redness/thickness/scaliness of the psoriatic lesions and weights the resulting score by the area of skin involved. Body divided into 4 areas: head/arms/trunk to groin/legs to top of buttocks. Assignment of an average score for the redness/thickness/scaling for each of the 4 body areas with a score of 0 (clear)-4 (very marked). Determining the percentage of skin covered with PSO for each of the body areas and converting to a 0-6 scale. Final PASI=average redness/thickness/scaliness of psoriatic skin lesions multiplied by the involved psoriasis area score and weighted by the percentage of the person’s affected skin for the respective section. Min PASI score is 0=no disease, max score is 72=maximal disease. The FAS consisted of all randomized participants who received at least 1 dose of medication and had a valid measurement of the primary efficacy at Baseline.
    End point type
    Secondary
    End point timeframe
    Week 8
    End point values
    Placebo (FAS) Bimekizumab 64 mg Q4W (FAS) Bimekizumab 160 mg Q4W (FAS) Bimekizumab 160 mg w/ LD Q4W (FAS) Bimekizumab 320 mg Q4W (FAS) Bimekizumab 480 mg Q4W (FAS)
    Number of subjects analysed
    42
    39
    43
    40
    43
    43
    Units: percentage of participants
        number (not applicable)
    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 Q4W (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 Q4W (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 Q4W (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 Q4W (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 Q4W (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 participants 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 participants achieving a 75% or higher improvement in Psoriasis Area and Severity Index (PASI) score at Week 12
    End point description
    PASI75 response assessments are based on at least 75% improvement in PASI score from Baseline. This scoring system averages the redness/thickness/scaliness of the psoriatic lesions and weights the resulting score by the area of skin involved. Body divided into 4 areas: head/arms/trunk to groin/legs to top of buttocks. Assignment of an average score for the redness/thickness/scaling for each of the 4 body areas with a score of 0 (clear)-4 (very marked). Determining the percentage of skin covered with PSO for each of the body areas and converting to a 0-6 scale. Final PASI=average redness/thickness/scaliness of psoriatic skin lesions multiplied by the involved psoriasis area score and weighted by the percentage of the person’s affected skin for the respective section. Min PASI score is 0=no disease, max score is 72=maximal disease. The FAS consisted of all randomized participants who received at least 1 dose of medication and had a valid measurement of the primary efficacy at Baseline.
    End point type
    Secondary
    End point timeframe
    Week 12
    End point values
    Placebo (FAS) Bimekizumab 64 mg Q4W (FAS) Bimekizumab 160 mg Q4W (FAS) Bimekizumab 160 mg w/ LD Q4W (FAS) Bimekizumab 320 mg Q4W (FAS) Bimekizumab 480 mg Q4W (FAS)
    Number of subjects analysed
    42
    39
    43
    40
    43
    43
    Units: percentage of participants
        number (not applicable)
    4.8
    61.5
    81.4
    85.0
    93.0
    83.7
    Statistical analysis title
    Statistical analysis 1
    Statistical analysis description
    Confidence intervals, odds ratios, p-values derived from a logistic regression model with fixed effects for treatment, region, prior bio-exposure.
    Comparison groups
    Placebo (FAS) v Bimekizumab 64 mg Q4W (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
    Statistical analysis description
    Confidence intervals, odds ratios, p-values derived from a logistic regression model with fixed effects for treatment, region, prior bio-exposure.
    Comparison groups
    Placebo (FAS) v Bimekizumab 160 mg Q4W (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
    Statistical analysis description
    Confidence intervals, odds ratios, p-values derived from a logistic regression model with fixed effects for treatment, region, prior bio-exposure.
    Comparison groups
    Placebo (FAS) v Bimekizumab 160 mg w/ LD Q4W (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
    Statistical analysis description
    Confidence intervals, odds ratios, p-values derived from a logistic regression model with fixed effects for treatment, region, prior bio-exposure.
    Comparison groups
    Placebo (FAS) v Bimekizumab 320 mg Q4W (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
    Statistical analysis description
    Confidence intervals, odds ratios, p-values derived from a logistic regression model with fixed effects for treatment, region, prior bio-exposure.
    Comparison groups
    Placebo (FAS) v Bimekizumab 480 mg Q4W (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 participants 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 participants 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. The Full Analysis Set (FAS) consisted of all randomized participants who received at least 1 dose of the study medication and had a valid measurement of the primary efficacy variable at Baseline.
    End point type
    Secondary
    End point timeframe
    Week 12
    End point values
    Placebo (FAS) Bimekizumab 64 mg Q4W (FAS) Bimekizumab 160 mg Q4W (FAS) Bimekizumab 160 mg w/ LD Q4W (FAS) Bimekizumab 320 mg Q4W (FAS) Bimekizumab 480 mg Q4W (FAS)
    Number of subjects analysed
    42
    39
    43
    40
    43
    43
    Units: percentage of participants
        number (not applicable)
    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 Q4W (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 Q4W (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 Q4W (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 Q4W (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 Q4W (FAS)
    Number of subjects included in analysis
    85
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.0001
    Method
    Fisher exact
    Confidence interval

    Secondary: Plasma concentrations of bimekizumab during the study

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    End point title
    Plasma concentrations of bimekizumab during the study
    End point description
    Bimekizumab plasma concentration was expressed in micrograms per milliliter (μg/mL). Values Below Limit of Quantification (BLQ) were replaced by the value of lower limit of quantification (LLOQ) divided by 2 = 0.075 μg/mL in the calculations of geometric mean and CIs. Geometric mean was only calculated if at least two-thirds of the concentrations were quantified at the respective time point. The PK-PPS consisted of all randomized participants who took at least 1 dose of the IMP and provided at least 1 quantifiable plasma concentration postdose and had no important protocol deviations affecting the PK variables. Note 1: 999 is used as a placeholder for values below the level of detection since participants had no prior BKZ treatment (Baseline) and for values below the level of detection. Note 2: The number of participants analyzed for each timepoint is presented in parentheses following this model (BKZ 64 mg Q4W, BKZ 160 mg Q4W, BKZ 160 mg w/ LD Q4W, BKZ 320 mg Q4W, BKZ 480 mg Q4W).
    End point type
    Secondary
    End point timeframe
    Baseline (Week 0), Week 1, Week 2, Week 4, Week 8, Week 12, and Safety Follow-Up visit (20 weeks after the last dose)
    End point values
    Bimekizumab 64 mg Q4W (PK-PPS) Bimekizumab 160 mg Q4W (PK-PPS) Bimekizumab 160 mg w/ LD Q4W (PK-PPS) Bimekizumab 320 mg Q4W (PK-PPS) Bimekizumab 480 mg Q4W (PK-PPS)
    Number of subjects analysed
    39
    42
    40
    43
    43
    Units: µg/mL
    geometric mean (confidence interval 95%)
        Baseline (39, 42, 40, 43, 43)
    999 (999 to 999)
    999 (999 to 999)
    999 (999 to 999)
    999 (999 to 999)
    999 (999 to 999)
        Week 1 (39, 42, 40, 43, 43)
    4.4490 (3.7526 to 5.2746)
    9.2481 (6.9779 to 12.2569)
    20.7892 (14.9192 to 28.9688)
    21.8622 (16.0624 to 29.7563)
    31.8019 (23.3488 to 43.3154)
        Week 2 (39, 41, 39, 42, 42)
    3.4704 (3.0167 to 3.9923)
    8.6862 (7.5316 to 10.0179)
    19.0428 (16.5381 to 21.9267)
    19.0324 (16.8925 to 21.4434)
    27.5641 (23.8485 to 31.8586)
        Week 4 (39, 41, 39, 41, 40)
    2.1282 (1.8398 to 2.4617)
    5.3751 (4.5233 to 6.3872)
    11.2903 (9.4809 to 13.4450)
    11.9194 (10.4503 to 13.5951)
    17.1811 (14.7612 to 19.9977)
        Week 8 (38, 38, 37, 40, 40)
    2.3069 (1.7780 to 2.9931)
    7.1859 (5.3747 to 9.6075)
    10.2208 (8.8561 to 11.7957)
    16.3187 (13.9947 to 19.0285)
    23.3285 (19.8863 to 27.3665)
        Week 12 (38, 38, 33, 40, 39)
    2.3121 (1.6037 to 3.3335)
    9.5278 (8.0614 to 11.2608)
    10.2557 (8.6807 to 12.1165)
    18.3166 (15.1652 to 22.1228)
    28.0908 (23.2463 to 33.9448)
        SFU (4, 4, 2, 1, 3)
    999 (999 to 999)
    999 (999 to 999)
    999 (999 to 999)
    999 (999 to 999)
    0.5165 (0.0032 to 84.5222)
    No statistical analyses for this end point

    Secondary: Population PK (apparent total clearance (CL/F)) of bimekizumab

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    End point title
    Population PK (apparent total clearance (CL/F)) of bimekizumab
    End point description
    The data were presented as population estimates of CL/F. Given the sparse nature of PK sampling, CL/F cannot be estimated for each treatment group. It was prespecified in the data analysis plan to combine doses to perform Population PK and PK/PD analysis based on a prior determination that the PK parameters are not dose-dependent. The PK-PPS consisted of all randomized participants who took at least 1 dose of the IMP and provided at least 1 quantifiable plasma concentration postdose and had no important protocol deviations affecting the PK variables. Given the sparse nature of PK sampling, CL/F cannot be estimated for each treatment group.
    End point type
    Secondary
    End point timeframe
    From Baseline (Week 0) until Safety Follow-Up Visit (20 weeks after the last dose; Up to Week 28)
    End point values
    All participants (PK-PPS)
    Number of subjects analysed
    249
    Units: L/Day
        geometric mean (geometric coefficient of variation)
    0.362 ± 41.7
    No statistical analyses for this end point

    Secondary: Population PK (apparent volume of distribution (V/F)) of bimekizumab

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    End point title
    Population PK (apparent volume of distribution (V/F)) of bimekizumab
    End point description
    The data were presented as population estimates of V/F. Given the sparse nature of PK sampling, V/F cannot be estimated for each treatment group. It was prespecified in the data analysis plan to combine doses to perform Population PK and PK/PD analysis based on a prior determination that the PK parameters are not dose-dependent. The PK-PPS consisted of all randomized participants who took at least 1 dose of the IMP and provided at least 1 quantifiable plasma concentration postdose and had no important protocol deviations affecting the PK variables. Given the sparse nature of PK sampling, V/F cannot be estimated for each treatment group.
    End point type
    Secondary
    End point timeframe
    From Baseline (Week 0) until Safety Follow-Up Visit (20 weeks after the last dose; Up to Week 28)
    End point values
    All participants (PK-PPS)
    Number of subjects analysed
    249
    Units: liters
        geometric mean (geometric coefficient of variation)
    11.5 ± 146
    No statistical analyses for this end point

    Secondary: Concentration of bimekizumab leading to 50% of maximum effect (EC50)

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    End point title
    Concentration of bimekizumab leading to 50% of maximum effect (EC50)
    End point description
    The data were presented as population estimates of EC50. EC50 was estimated based on all available data and cannot be derived for each treatment arm. It was prespecified in the data analysis plan to combine doses to perform Population PK and PK/PD analysis based on a prior determination that the PK parameters are not dose-dependent. The PK-PPS consisted of all randomized participants who took at least 1 dose of the IMP and provided at least 1 quantifiable plasma concentration postdose and had no important protocol deviations affecting the PK variables. EC50 was estimated based on all available data and cannot be derived for each treatment arm.
    End point type
    Secondary
    End point timeframe
    From Baseline (Week 0) until Safety Follow-Up Visit (20 weeks after the last dose; Up to Week 28)
    End point values
    All participants (PK-PPS)
    Number of subjects analysed
    249
    Units: µg/mL
        geometric mean (geometric coefficient of variation)
    0.55 ± 126
    No statistical analyses for this end point

    Secondary: Percentage of participants with a positive anti-bimekizumab antibody (AbAb) status prior to study treatment

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    End point title
    Percentage of participants with a positive anti-bimekizumab antibody (AbAb) status prior to study treatment
    End point description
    Antibody positive status prior study treatment was defined as having an antibody level greater than (>) 28.5% at Baseline (Week 0). The Pharmacokinetics Per-Protocol Set (PK-PPS) consisted of all randomized participants who took at least 1 dose of the IMP and provided at least 1 quantifiable plasma concentration postdose and had no important protocol deviations affecting the PK variables.
    End point type
    Secondary
    End point timeframe
    Baseline (Week 0)
    End point values
    Placebo (PK-PPS) Bimekizumab 64 mg Q4W (PK-PPS) Bimekizumab 160 mg Q4W (PK-PPS) Bimekizumab 160 mg w/ LD Q4W (PK-PPS) Bimekizumab 320 mg Q4W (PK-PPS) Bimekizumab 480 mg Q4W (PK-PPS)
    Number of subjects analysed
    42
    39
    42
    40
    43
    43
    Units: percentage of participants
        number (not applicable)
    0
    0
    0
    2.5
    0
    0
    No statistical analyses for this end point

    Secondary: Percentage of participants with an overall positive anti-bimekizumab antibody (AbAb) status following study treatment

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    End point title
    Percentage of participants with an overall positive anti-bimekizumab antibody (AbAb) status following study treatment
    End point description
    Overall antibody positive was defined as having a value of > 28.5% at any time in the Treatment Period. The Treatment Period did not include Baseline/pretreatment samples. The Pharmacokinetics Per-Protocol Set (PK-PPS) consisted of all randomized participants who took at least 1 dose of the IMP and provided at least 1 quantifiable plasma concentration postdose and had no important protocol deviations affecting the PK variables.
    End point type
    Secondary
    End point timeframe
    From Week 4 until the Safety Follow-Up visit (20 weeks after the last dose; Up to Week 28)
    End point values
    Placebo (PK-PPS) Bimekizumab 64 mg Q4W (PK-PPS) Bimekizumab 160 mg Q4W (PK-PPS) Bimekizumab 160 mg w/ LD Q4W (PK-PPS) Bimekizumab 320 mg Q4W (PK-PPS) Bimekizumab 480 mg Q4W (PK-PPS)
    Number of subjects analysed
    42
    39
    42
    40
    43
    43
    Units: percentage of participants
        number (not applicable)
    0
    10.3
    4.8
    5.0
    0
    0
    No statistical analyses for this end point

    Secondary: Percentage of participants with at least one adverse event (AE) during the study

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    End point title
    Percentage of participants with at least one adverse event (AE) during the study
    End point description
    An adverse event (AE) was any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of investigational medicinal product (IMP), whether or not considered related to the IMP. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of IMP. The Safety Set (SS) consisted of all participants who received at least 1 dose of the IMP.
    End point type
    Secondary
    End point timeframe
    From Screening to End of Safety Follow-up (up to Week 32)
    End point values
    Placebo (SS) Bimekizumab 64 mg Q4W (SS) Bimekizumab 160 mg Q4W (SS) Bimekizumab 160 mg w/ LD Q4W (SS) Bimekizumab 320 mg Q4W (SS) Bimekizumab 480 mg Q4W (SS)
    Number of subjects analysed
    42
    39
    43
    40
    43
    43
    Units: percentage of participants
        number (not applicable)
    38.1
    76.9
    55.8
    65.0
    60.5
    60.5
    No statistical analyses for this end point

    Secondary: Percentage of participants with at least one adverse event (AE) during the study by severity

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    End point title
    Percentage of participants with at least one adverse event (AE) during the study by severity
    End point description
    An adverse event (AE) was any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of investigational medicinal product (IMP), whether or not considered related to the IMP. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of IMP. The Safety Set (SS) consisted of all participants who received at least 1 dose of the IMP.
    End point type
    Secondary
    End point timeframe
    From Screening to End of Safety Follow-up (up to Week 32)
    End point values
    Placebo (SS) Bimekizumab 64 mg Q4W (SS) Bimekizumab 160 mg Q4W (SS) Bimekizumab 160 mg w/ LD Q4W (SS) Bimekizumab 320 mg Q4W (SS) Bimekizumab 480 mg Q4W (SS)
    Number of subjects analysed
    42
    39
    43
    40
    43
    43
    Units: percentage of participants
    number (not applicable)
        Mild
    11.9
    43.6
    27.9
    22.5
    39.5
    44.2
        Moderate
    26.2
    30.8
    27.9
    40.0
    20.9
    11.6
        Severe
    0
    2.6
    0
    2.5
    0
    4.7
    No statistical analyses for this end point

    Secondary: Change from Baseline until Safety Follow-up Visit in hematology parameters (platelets)

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    End point title
    Change from Baseline until Safety Follow-up Visit in hematology parameters (platelets)
    End point description
    Platelets was measured in number of platelets per liter (10^9/L). The Safety Set (SS) consisted of all participants who received at least 1 dose of the IMP. Note 1: 999 is used as a placeholder for values not evaluable because only one participant was analyzed. Note 2: The number of participants analyzed for each timepoint is presented in parentheses following this model (PBO, BKZ 64 mg Q4W, BKZ 160 mg Q4W, BKZ 160 mg w/ LD Q4W, BKZ 320 mg Q4W, BKZ 480 mg Q4W).
    End point type
    Secondary
    End point timeframe
    Baseline (Week 0), Week 1, Week 2, Week 4, Week 6, Week 8, Week 12, and Safety Follow-Up visit (20 weeks after the last dose)
    End point values
    Placebo (SS) Bimekizumab 64 mg Q4W (SS) Bimekizumab 160 mg Q4W (SS) Bimekizumab 160 mg w/ LD Q4W (SS) Bimekizumab 320 mg Q4W (SS) Bimekizumab 480 mg Q4W (SS)
    Number of subjects analysed
    42
    39
    42
    40
    43
    42
    Units: 10^9 platelets per liter
    arithmetic mean (standard deviation)
        Week 1 (42, 39, 42, 40, 43, 42)
    12.1 ± 34.7
    3.2 ± 21.0
    -4.6 ± 30.8
    -14.0 ± 30.8
    3.5 ± 25.2
    -0.1 ± 35.0
        Week 2 (41, 39, 40, 39, 41, 41)
    6.4 ± 37.8
    -8.6 ± 26.8
    -5.6 ± 36.4
    -8.9 ± 27.8
    7.8 ± 31.2
    -3.9 ± 41.8
        Week 4 (41, 39, 41, 39, 40, 40)
    -0.1 ± 32.0
    -5.8 ± 28.3
    -8.6 ± 40.1
    -11.4 ± 21.8
    -7.0 ± 28.9
    -7.5 ± 36.8
        Week 6 (40, 38, 38, 36, 39, 40)
    5.6 ± 47.5
    -5.2 ± 26.3
    -13.6 ± 34.3
    -5.6 ± 30.3
    -0.3 ± 44.0
    -7.6 ± 37.3
        Week 8 (39, 37, 38, 35, 40, 40)
    6.9 ± 37.6
    -2.3 ± 44.7
    -6.1 ± 43.7
    6.3 ± 35.6
    0.7 ± 39.5
    -4.7 ± 36.4
        Week 12 (39, 38, 37, 35, 40, 38)
    2.8 ± 36.7
    -6.0 ± 36.2
    -13.2 ± 40.1
    -3.6 ± 37.5
    -5.4 ± 36.1
    -5.5 ± 38.8
        SFU (4, 4, 4, 2, 1, 3)
    14.8 ± 33.3
    -30.3 ± 71.6
    7.8 ± 20.0
    -33.0 ± 31.1
    39.0 ± 999
    39.3 ± 27.4
    No statistical analyses for this end point

    Secondary: Change from Baseline until Safety Follow-up Visit in hematology parameters (erythrocytes mean corpuscular hemoglobin (HGB) concentration, hemoglobin)

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    End point title
    Change from Baseline until Safety Follow-up Visit in hematology parameters (erythrocytes mean corpuscular hemoglobin (HGB) concentration, hemoglobin)
    End point description
    Erythrocytes mean corpuscular hemoglobin concentration (MCHC) and hemoglobin were measured in grams per liter (g/L). The Safety Set (SS) consisted of all participants who received at least 1 dose of the IMP. Note 1: 999 is used as a placeholder for values not evaluable because only one participant was analyzed. Note 2: The number of participants analyzed for each timepoint is presented in parentheses following this model (PBO, BKZ 64 mg Q4W, BKZ 160 mg Q4W, BKZ 160 mg w/ LD Q4W, BKZ 320 mg Q4W, BKZ 480 mg Q4W).
    End point type
    Secondary
    End point timeframe
    Baseline (Week 0), Week 1, Week 2, Week 4, Week 6, Week 8, Week 12, and Safety Follow-Up visit (20 weeks after the last dose)
    End point values
    Placebo (SS) Bimekizumab 64 mg Q4W (SS) Bimekizumab 160 mg Q4W (SS) Bimekizumab 160 mg w/ LD Q4W (SS) Bimekizumab 320 mg Q4W (SS) Bimekizumab 480 mg Q4W (SS)
    Number of subjects analysed
    42
    39
    42
    40
    43
    42
    Units: g/L
    arithmetic mean (standard deviation)
        MCHC Week 1 (42, 39, 42, 40, 43, 42)
    0.1 ± 8.1
    -2.0 ± 10.3
    -0.3 ± 8.8
    -1.0 ± 11.6
    0.5 ± 8.6
    0.3 ± 8.1
        MCHC Week 2 (41, 39, 41, 39, 41, 41)
    0.1 ± 7.9
    1.1 ± 6.6
    1.6 ± 9.4
    -0.3 ± 9.8
    2.6 ± 7.9
    1.8 ± 8.8
        MCHC Week 4 (41, 39, 41, 39, 41, 40)
    -0.2 ± 9.1
    0.2 ± 8.3
    -0.1 ± 9.9
    -2.9 ± 6.3
    0.1 ± 8.0
    -0.4 ± 11.7
        MCHC Week 6 (40, 38, 38, 37, 40, 40)
    -2.5 ± 11.0
    -1.7 ± 8.6
    -0.5 ± 9.4
    -2.9 ± 7.0
    -0.5 ± 7.8
    -1.3 ± 8.9
        MCHC Week 8 (39, 37, 38, 35, 40, 40)
    -2.2 ± 8.0
    -1.4 ± 12.7
    0.3 ± 10.3
    -2.5 ± 7.9
    -2.1 ± 9.2
    -2.9 ± 9.2
        MCHC Week 12 (39, 38, 37, 35, 40, 38)
    -6.3 ± 12.5
    -2.2 ± 14.7
    -1.6 ± 9.1
    -4.5 ± 10.1
    -2.0 ± 12.7
    -3.6 ± 13.7
        MCHC Week SFU (4, 4, 4, 2, 1, 3)
    -12.5 ± 11.0
    5.3 ± 26.2
    -5.5 ± 10.6
    -9.5 ± 7.8
    -2.0 ± 999
    -22.0 ± 18.0
        Hemoglobin Week 1 (42, 39, 42, 40, 43, 42)
    -2.9 ± 7.3
    0.1 ± 6.1
    1.0 ± 6.8
    -2.6 ± 5.2
    -1.0 ± 7.0
    -0.8 ± 5.0
        Hemoglobin Week 2 (41, 39, 41, 39, 41, 41)
    -3.0 ± 6.7
    0.5 ± 5.3
    0.6 ± 6.0
    -1.5 ± 7.5
    -1.1 ± 7.0
    0.5 ± 6.6
        Hemoglobin Week 4 (41, 39, 41, 39, 41, 40)
    -2.9 ± 8.2
    0.8 ± 6.1
    -0.9 ± 6.2
    -2.1 ± 5.9
    -1.8 ± 8.7
    -0.4 ± 6.3
        Hemoglobin Week 6 (40, 38, 38, 37, 40, 40)
    -2.4 ± 7.8
    0.7 ± 6.3
    -0.3 ± 6.6
    -1.2 ± 4.8
    -2.1 ± 8.4
    0.9 ± 6.3
        Hemoglobin Week 8 (39, 37, 38, 35, 40, 40)
    -2.7 ± 8.0
    1.1 ± 7.6
    0.8 ± 7.1
    -0.6 ± 7.5
    -1.8 ± 8.1
    0.9 ± 6.5
        Hemoglobin Week 12 (39, 38, 37, 35, 40, 38)
    -1.8 ± 9.1
    3.2 ± 9.6
    -0.1 ± 8.1
    -1.0 ± 8.5
    -1.2 ± 9.3
    0.3 ± 7.1
        Hemoglobin SFU (4, 4, 4, 2, 1, 3)
    -4.8 ± 7.4
    7.8 ± 31.0
    -6.5 ± 4.7
    -8.5 ± 2.1
    6.0 ± 999
    -6.7 ± 11.0
    No statistical analyses for this end point

    Secondary: Change from Baseline until Safety Follow-up Visit in hematology parameters (erythrocytes mean corpuscular hemoglobin (HGB))

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    End point title
    Change from Baseline until Safety Follow-up Visit in hematology parameters (erythrocytes mean corpuscular hemoglobin (HGB))
    End point description
    Erythrocytes mean corpuscular hemoglobin (HGB) was measured in picograms (pg). The Safety Set (SS) consisted of all participants who received at least 1 dose of the IMP. Note 1: 999 is used as a placeholder for values not evaluable because only one participant was analyzed. Note 2: The number of participants analyzed for each timepoint is presented in parentheses following this model (PBO, BKZ 64 mg Q4W, BKZ 160 mg Q4W, BKZ 160 mg w/ LD Q4W, BKZ 320 mg Q4W, BKZ 480 mg Q4W).
    End point type
    Secondary
    End point timeframe
    Baseline (Week 0), Week 1, Week 2, Week 4, Week 6, Week 8, Week 12, and Safety Follow-Up visit (20 weeks after the last dose)
    End point values
    Placebo (SS) Bimekizumab 64 mg Q4W (SS) Bimekizumab 160 mg Q4W (SS) Bimekizumab 160 mg w/ LD Q4W (SS) Bimekizumab 320 mg Q4W (SS) Bimekizumab 480 mg Q4W (SS)
    Number of subjects analysed
    42
    39
    42
    40
    43
    42
    Units: picograms (pg)
    arithmetic mean (standard deviation)
        Week 1 (42, 39, 42, 40, 43, 42)
    -0.09 ± 0.57
    -0.01 ± 0.56
    -0.10 ± 0.55
    0.07 ± 0.51
    -0.09 ± 0.87
    0.00 ± 0.53
        Week 2 (41, 39, 41, 39, 41, 41)
    -0.04 ± 0.59
    0.04 ± 0.54
    0.05 ± 0.49
    0.10 ± 0.78
    -0.03 ± 0.60
    0.14 ± 0.54
        Week 4 (41, 39, 41, 39, 41, 40)
    -0.07 ± 0.66
    0.10 ± 0.84
    -0.07 ± 0.63
    -0.01 ± 0.42
    -0.10 ± 0.68
    0.04 ± 0.50
        Week 6 (40, 38, 38, 37, 40, 40)
    -0.17 ± 0.64
    -0.09 ± 0.84
    -0.16 ± 0.61
    -0.11 ± 0.47
    -0.12 ± 0.84
    -0.04 ± 0.60
        Week 8 (39, 37, 38, 35, 40, 40)
    -0.19 ± 0.64
    0.09 ± 1.09
    -0.16 ± 1.10
    -0.16 ± 0.64
    -0.26 ± 0.99
    -0.16 ± 0.53
        Week 12 (39, 38, 37, 35, 40, 38)
    -0.34 ± 0.71
    0.09 ± 1.53
    -0.08 ± 0.58
    -0.14 ± 0.66
    -0.09 ± 1.14
    -0.16 ± 0.67
        SFU (4, 4, 4, 2, 1, 3)
    -0.33 ± 0.79
    2.93 ± 6.66
    -0.15 ± 0.17
    -0.55 ± 0.78
    0.70 ± 999
    -0.60 ± 1.10
    No statistical analyses for this end point

    Secondary: Change from Baseline until Safety Follow-up Visit in hematology parameters (erythrocytes mean corpuscular volume)

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    End point title
    Change from Baseline until Safety Follow-up Visit in hematology parameters (erythrocytes mean corpuscular volume)
    End point description
    Erythrocytes mean corpuscular volume was measured in femtolitres (fL). The Safety Set (SS) consisted of all participants who received at least 1 dose of the IMP. Note 1: 999 is used as a placeholder for values not evaluable because only one participant was analyzed. Note 2: The number of participants analyzed for each timepoint is presented in parentheses following this model (PBO, BKZ 64 mg Q4W, BKZ 160 mg Q4W, BKZ 160 mg w/ LD Q4W, BKZ 320 mg Q4W, BKZ 480 mg Q4W).
    End point type
    Secondary
    End point timeframe
    Baseline (Week 0), Week 1, Week 2, Week 4, Week 6, Week 8, Week 12, and Safety Follow-Up visit (20 weeks after the last dose)
    End point values
    Placebo (SS) Bimekizumab 64 mg Q4W (SS) Bimekizumab 160 mg Q4W (SS) Bimekizumab 160 mg w/ LD Q4W (SS) Bimekizumab 320 mg Q4W (SS) Bimekizumab 480 mg Q4W (SS)
    Number of subjects analysed
    42
    39
    42
    40
    43
    42
    Units: femtolitres (fL)
    arithmetic mean (standard deviation)
        Week 1 (42, 39, 42, 40, 43, 42)
    -0.35 ± 1.55
    0.52 ± 2.29
    -0.25 ± 1.64
    0.51 ± 2.63
    -0.23 ± 2.14
    -0.04 ± 1.37
        Week 2 (41, 39, 41, 39, 41, 41)
    -0.14 ± 1.65
    -0.16 ± 1.31
    -0.33 ± 1.96
    0.31 ± 1.32
    -0.64 ± 1.40
    -0.05 ± 1.60
        Week 4 (41, 39, 41, 39, 41, 40)
    -0.11 ± 1.60
    0.23 ± 1.89
    -0.25 ± 1.81
    0.67 ± 1.76
    -0.10 ± 1.64
    0.22 ± 2.87
        Week 6 (40, 38, 38, 37, 40, 40)
    0.20 ± 2.84
    0.14 ± 2.47
    -0.29 ± 1.90
    0.39 ± 1.79
    -0.02 ± 1.92
    0.25 ± 1.85
        Week 8 (39, 37, 38, 35, 40, 40)
    0.05 ± 2.11
    0.71 ± 2.88
    -0.54 ± 2.57
    0.16 ± 2.57
    -0.02 ± 2.29
    0.36 ± 2.37
        Week 12 (39, 38, 37, 35, 40, 38)
    0.76 ± 3.81
    0.87 ± 3.23
    0.17 ± 2.39
    0.78 ± 2.55
    0.47 ± 2.88
    0.51 ± 3.89
        SFU (4, 4, 4, 2, 1, 3)
    2.58 ± 5.10
    7.80 ± 14.07
    0.90 ± 2.38
    0.85 ± 0.35
    2.80 ± 999
    4.87 ± 8.46
    No statistical analyses for this end point

    Secondary: Change from Baseline until Safety Follow-up Visit in hematology parameters (erythrocytes)

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    End point title
    Change from Baseline until Safety Follow-up Visit in hematology parameters (erythrocytes)
    End point description
    Erythrocytes was measured in number of red blood cells per liter (10^12/L). The Safety Set (SS) consisted of all participants who received at least 1 dose of the IMP. Note 1: 999 is used as a placeholder for values not evaluable because only one participant was analyzed. Note 2: The number of participants analyzed for each timepoint is presented in parentheses following this model (PBO, BKZ 64 mg Q4W, BKZ 160 mg Q4W, BKZ 160 mg w/ LD Q4W, BKZ 320 mg Q4W, BKZ 480 mg Q4W).
    End point type
    Secondary
    End point timeframe
    Baseline (Week 0), Week 1, Week 2, Week 4, Week 6, Week 8, Week 12, and Safety Follow-Up visit (20 weeks after the last dose)
    End point values
    Placebo (SS) Bimekizumab 64 mg Q4W (SS) Bimekizumab 160 mg Q4W (SS) Bimekizumab 160 mg w/ LD Q4W (SS) Bimekizumab 320 mg Q4W (SS) Bimekizumab 480 mg Q4W (SS)
    Number of subjects analysed
    42
    39
    42
    40
    43
    42
    Units: 10^12 red blood cells per liter
    arithmetic mean (standard deviation)
        Week 1 (42, 39, 42, 40, 43, 42)
    -0.081 ± 0.282
    0.004 ± 0.213
    0.047 ± 0.238
    -0.095 ± 0.184
    -0.029 ± 0.259
    -0.026 ± 0.178
        Week 2 (41, 39, 41, 39, 41, 41)
    -0.088 ± 0.220
    0.010 ± 0.193
    0.014 ± 0.215
    -0.060 ± 0.282
    -0.041 ± 0.231
    -0.001 ± 0.232
        Week 4 (41, 39, 41, 39, 41, 40)
    -0.085 ± 0.274
    0.019 ± 0.217
    -0.018 ± 0.193
    -0.066 ± 0.215
    -0.053 ± 0.281
    -0.015 ± 0.216
        Week 6 (40, 38, 38, 37, 40, 40)
    -0.053 ± 0.277
    0.038 ± 0.218
    0.011 ± 0.243
    -0.019 ± 0.145
    -0.060 ± 0.278
    0.035 ± 0.224
        Week 8 (39, 37, 38, 35, 40, 40)
    -0.062 ± 0.320
    0.022 ± 0.245
    0.048 ± 0.219
    0.009 ± 0.224
    -0.028 ± 0.240
    0.056 ± 0.238
        Week 12 (39, 38, 37, 35, 40, 38)
    -0.007 ± 0.314
    0.092 ± 0.258
    0.011 ± 0.271
    -0.005 ± 0.297
    -0.036 ± 0.297
    0.039 ± 0.228
        SFU (4, 4, 4, 2, 1, 3)
    -0.090 ± 0.346
    -0.135 ± 0.184
    -0.195 ± 0.165
    -0.215 ± 0.035
    0.080 ± 999
    -0.123 ± 0.491
    No statistical analyses for this end point

    Secondary: Change from Baseline until Safety Follow-up Visit in hematology parameters (hematocrit)

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    End point title
    Change from Baseline until Safety Follow-up Visit in hematology parameters (hematocrit)
    End point description
    Hematocrit was measured in volume percentage (%) of red blood cells in blood. The Safety Set (SS) consisted of all participants who received at least 1 dose of the IMP. Note 1: 999 is used as a placeholder for values not evaluable because only one participant was analyzed. Note 2: The number of participants analyzed for each timepoint is presented in parentheses following this model (PBO, BKZ 64 mg Q4W, BKZ 160 mg Q4W, BKZ 160 mg w/ LD Q4W, BKZ 320 mg Q4W, BKZ 480 mg Q4W).
    End point type
    Secondary
    End point timeframe
    Baseline (Week 0), Week 1, Week 2, Week 4, Week 6, Week 8, Week 12, and Safety Follow-Up visit (20 weeks after the last dose)
    End point values
    Placebo (SS) Bimekizumab 64 mg Q4W (SS) Bimekizumab 160 mg Q4W (SS) Bimekizumab 160 mg w/ LD Q4W (SS) Bimekizumab 320 mg Q4W (SS) Bimekizumab 480 mg Q4W (SS)
    Number of subjects analysed
    42
    39
    42
    40
    43
    42
    Units: volume % of red blood cells
    arithmetic mean (standard deviation)
        Week 1 (42, 39, 42, 40, 43, 42)
    -0.88 ± 2.49
    0.27 ± 2.07
    0.33 ± 2.31
    -0.58 ± 2.14
    -0.36 ± 2.31
    -0.23 ± 1.62
        Week 2 (41, 39, 41, 39, 41, 41)
    -0.86 ± 2.02
    0.00 ± 1.65
    -0.04 ± 2.15
    -0.42 ± 2.61
    -0.65 ± 2.09
    -0.02 ± 2.03
        Week 4 (41, 39, 41, 39, 41, 40)
    -0.81 ± 2.40
    0.24 ± 2.07
    -0.26 ± 1.86
    -0.26 ± 1.80
    -0.48 ± 2.57
    -0.03 ± 2.02
        Week 6 (40, 38, 38, 37, 40, 40)
    -0.33 ± 2.46
    0.41 ± 1.88
    -0.04 ± 2.18
    0.02 ± 1.73
    -0.51 ± 2.59
    0.44 ± 1.90
        Week 8 (39, 37, 38, 35, 40, 40)
    -0.52 ± 2.37
    0.55 ± 2.51
    0.18 ± 1.84
    0.14 ± 2.61
    -0.22 ± 2.46
    0.67 ± 2.03
        Week 12 (39, 38, 37, 35, 40, 38)
    0.32 ± 2.87
    1.25 ± 2.29
    0.18 ± 2.57
    0.30 ± 2.99
    -0.05 ± 2.75
    0.59 ± 2.02
        SFU (4, 4, 4, 2, 1, 3)
    0.20 ± 1.44
    1.98 ± 6.92
    -1.20 ± 1.90
    -1.50 ± 0.14
    2.10 ± 999
    1.00 ± 0.85
    No statistical analyses for this end point

    Secondary: Change from Baseline until Safety Follow-up Visit in hematology parameters (basophils, eosinophils, leukocytes, lymphocytes, monocytes, neutrophils)

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    End point title
    Change from Baseline until Safety Follow-up Visit in hematology parameters (basophils, eosinophils, leukocytes, lymphocytes, monocytes, neutrophils)
    End point description
    Basophils, eosinophils, leukocytes, lymphocytes, monocytes and neutrophils were measured in number of white blood cells per liter (10^9/L). The Safety Set (SS) consisted of all participants who received at least 1 dose of the IMP. Note 1: 999 is used as a placeholder for values not evaluable because only one participant was analyzed. Note 2: The number of participants analyzed for each timepoint is presented in parentheses following this model (PBO, BKZ 64 mg Q4W, BKZ 160 mg Q4W, BKZ 160 mg w/ LD Q4W, BKZ 320 mg Q4W, BKZ 480 mg Q4W).
    End point type
    Secondary
    End point timeframe
    Baseline (Week 0), Week 1, Week 2, Week 4, Week 6, Week 8, Week 12, and Safety Follow-Up visit (20 weeks after the last dose)
    End point values
    Placebo (SS) Bimekizumab 64 mg Q4W (SS) Bimekizumab 160 mg Q4W (SS) Bimekizumab 160 mg w/ LD Q4W (SS) Bimekizumab 320 mg Q4W (SS) Bimekizumab 480 mg Q4W (SS)
    Number of subjects analysed
    42
    39
    41
    40
    43
    42
    Units: 10^9 white blood cells per liter
    arithmetic mean (standard deviation)
        Basophils Week 1 (42, 39, 41, 40, 43, 42)
    0.01 ± 0.03
    0.01 ± 0.03
    0.00 ± 0.03
    0.01 ± 0.03
    0.00 ± 0.04
    0.01 ± 0.03
        Basophils Week 2 (41, 38, 41, 39, 40, 41)
    0.00 ± 0.02
    0.00 ± 0.04
    0.01 ± 0.04
    0.01 ± 0.04
    0.01 ± 0.04
    0.00 ± 0.03
        Basophils Week 4 (41, 39, 41, 39, 41, 40)
    0.00 ± 0.03
    0.00 ± 0.05
    0.00 ± 0.03
    0.01 ± 0.02
    0.01 ± 0.05
    0.00 ± 0.04
        Basophils Week 6 (40, 38, 38, 36, 40, 40)
    0.01 ± 0.03
    0.00 ± 0.04
    0.00 ± 0.04
    0.01 ± 0.02
    0.00 ± 0.04
    0.00 ± 0.04
        Basophils Week 8 (39, 37, 37, 34, 40, 40)
    0.00 ± 0.04
    -0.01 ± 0.04
    0.02 ± 0.01
    0.00 ± 0.00
    0.02 ± 0.04
    0.00 ± 0.05
        Basophils Week 12 (38, 38, 37, 34, 40, 38)
    0.00 ± 0.03
    0.00 ± 0.04
    0.01 ± 0.03
    0.00 ± 0.02
    0.01 ± 0.04
    0.00 ± 0.04
        Basophils SFU (4, 4, 4, 2, 1, 3)
    0.03 ± 0.05
    -0.03 ± 0.05
    0.00 ± 0.00
    0.00 ± 0.00
    0.00 ± 999
    0.03 ± 0.06
        Eosinophils Week 1 (42, 39, 43, 40, 43, 42)
    0.02 ± 0.06
    0.02 ± 0.12
    0.01 ± 0.07
    0.04 ± 0.10
    0.02 ± 0.11
    -0.02 ± 0.12
        Eosinophils Week 2 (41, 38, 41, 39, 40, 41)
    0.02 ± 0.08
    0.04 ± 0.26
    0.00 ± 0.08
    0.05 ± 0.11
    0.00 ± 0.11
    0.01 ± 0.11
        Eosinophils Week 4 (41, 39, 41, 39, 41, 40)
    0.03 ± 0.09
    0.04 ± 0.26
    0.01 ± 0.08
    0.02 ± 0.11
    0.03 ± 0.09
    0.00 ± 0.18
        Eosinophils Week 6 (40, 38, 38, 36, 40, 40)
    0.04 ± 0.10
    0.02 ± 0.19
    0.00 ± 0.08
    0.01 ± 0.09
    0.05 ± 0.16
    -0.01 ± 0.17
        Eosinophils Week 8 (39, 37, 37, 34, 40, 40)
    0.01 ± 0.09
    0.01 ± 0.18
    0.01 ± 0.08
    0.04 ± 0.17
    0.05 ± 0.18
    -0.03 ± 0.16
        Eosinophils Week 12 (38, 38, 37, 34, 40, 38)
    0.02 ± 0.09
    0.03 ± 0.22
    0.00 ± 0.09
    0.00 ± 0.08
    0.03 ± 0.13
    -0.03 ± 0.11
        Eosinophils SFU (4, 4, 4, 2, 1, 3)
    0.05 ± 0.06
    0.08 ± 0.10
    0.10 ± 0.00
    0.00 ± 0.00
    -0.10 ± 999
    0.07 ± 0.06
        Leukocytes Week 1 (42, 39, 42, 40, 43, 42)
    0.16 ± 1.30
    -0.59 ± 1.34
    -0.15 ± 1.43
    -0.63 ± 1.82
    -0.19 ± 1.51
    -0.48 ± 0.90
        Leukocytes Week 2 (41, 38, 41, 39, 40, 41)
    0.18 ± 1.36
    -0.56 ± 1.31
    -0.22 ± 1.43
    -0.42 ± 1.34
    -0.31 ± 1.80
    -0.46 ± 1.29
        Leukocytes Week 4 (41, 39, 41, 39, 41, 40)
    0.17 ± 1.51
    -0.36 ± 1.31
    -0.23 ± 1.38
    -0.54 ± 1.14
    -0.36 ± 1.73
    -0.34 ± 1.24
        Leukocytes Week 6 (40, 38, 38, 37, 40, 40)
    -0.22 ± 1.25
    -0.50 ± 1.95
    -0.47 ± 1.49
    -0.57 ± 1.34
    -0.45 ± 2.02
    -0.45 ± 1.12
        Leukocytes Week 8 (39, 37, 38, 35, 40, 40)
    -0.10 ± 1.34
    -0.67 ± 1.55
    -0.24 ± 1.94
    -0.37 ± 1.55
    -0.30 ± 1.76
    -0.45 ± 0.87
        Leukocytes Week 12 (39, 38, 37, 34, 40, 38)
    0.00 ± 1.37
    -0.28 ± 1.68
    -0.47 ± 1.67
    -0.51 ± 1.41
    -0.50 ± 1.44
    -0.48 ± 1.09
        Leukocytes SFU (4, 4, 4, 2, 1, 3)
    -0.05 ± 0.98
    1.15 ± 2.54
    0.95 ± 1.43
    -0.65 ± 0.78
    0.20 ± 999
    0.30 ± 0.40
        Lymphocytes Week 1 (42, 39, 41, 40, 43, 42)
    0.12 ± 0.36
    -0.05 ± 0.30
    0.15 ± 0.42
    0.13 ± 0.34
    0.14 ± 0.46
    0.00 ± 0.45
        Lymphocytes Week 2 (41, 38, 41, 39, 40, 41)
    0.08 ± 0.32
    -0.11 ± 0.30
    0.09 ± 0.34
    0.09 ± 0.40
    0.12 ± 0.34
    -0.08 ± 0.37
        Lymphocytes Week 4 (41, 39, 41, 39, 41, 40)
    0.06 ± 0.40
    -0.04 ± 0.33
    0.15 ± 0.43
    0.08 ± 0.42
    0.11 ± 0.36
    0.06 ± 0.36
        Lymphocytes Week 6 (40, 38, 38, 36, 40, 40)
    0.08 ± 0.46
    -0.08 ± 0.43
    0.03 ± 0.31
    0.04 ± 0.43
    0.05 ± 0.37
    -0.05 ± 0.40
        Lymphocytes Week 8 (39, 37, 37, 34, 40, 40)
    0.02 ± 0.37
    -0.04 ± 0.31
    0.09 ± 0.40
    0.11 ± 0.33
    0.15 ± 0.45
    0.06 ± 0.42
        Lymphocytes Week 12 (38, 38, 37, 34, 40, 38)
    0.08 ± 0.38
    0.01 ± 0.35
    0.06 ± 0.38
    0.07 ± 0.48
    0.14 ± 0.38
    -0.04 ± 0.37
        Lymphocytes SFU (4, 4, 4, 2, 1, 3)
    0.25 ± 0.24
    0.25 ± 0.40
    0.23 ± 0.19
    0.25 ± 0.21
    0.00 ± 999
    0.50 ± 0.44
        Monocytes Week 1 (42, 39, 41, 40, 43, 42)
    0.02 ± 0.16
    -0.01 ± 0.12
    0.02 ± 0.15
    0.02 ± 0.11
    0.02 ± 0.17
    -0.03 ± 0.14
        Monocytes Week 2 (41, 38, 41, 39, 40, 41)
    0.00 ± 0.14
    -0.04 ± 0.13
    0.00 ± 0.14
    0.04 ± 0.15
    -0.04 ± 0.17
    -0.03 ± 0.15
        Monocytes Week 4 (41, 39, 41, 39, 41, 40)
    0.03 ± 0.16
    -0.01 ± 0.11
    0.01 ± 0.15
    0.03 ± 0.13
    -0.01 ± 0.17
    0.02 ± 0.17
        Monocytes Week 6 (40, 38, 38, 36, 40, 40)
    0.01 ± 0.15
    -0.01 ± 0.18
    0.02 ± 0.15
    0.00 ± 0.11
    -0.02 ± 0.22
    -0.03 ± 0.18
        Monocytes Week 8 (39, 37, 37, 34, 40, 40)
    -0.02 ± 0.15
    -0.03 ± 0.11
    0.00 ± 0.16
    -0.01 ± 0.14
    -0.04 ± 0.17
    -0.02 ± 0.15
        Monocytes Week 12 (38, 38, 37, 34, 40, 38)
    0.01 ± 0.16
    0.00 ± 0.14
    -0.02 ± 0.15
    -0.01 ± 0.18
    -0.07 ± 0.17
    -0.01 ± 0.14
        Monocytes SFU (4, 4, 4, 2, 1, 3)
    0.10 ± 0.22
    0.10 ± 0.22
    0.03 ± 0.10
    0.00 ± 0.00
    -0.30 ± 999
    -0.07 ± 0.21
        Neutrophils Week 1 (42, 39, 41, 40, 43, 42)
    -0.02 ± 1.16
    -0.55 ± 1.12
    -0.32 ± 1.25
    -0.81 ± 1.81
    -0.37 ± 1.20
    -0.44 ± 0.76
        Neutrophils Week 2 (41, 38, 41, 39, 40, 41)
    0.09 ± 1.29
    -0.43 ± 1.05
    -0.31 ± 1.33
    -0.59 ± 1.09
    -0.41 ± 1.64
    -0.36 ± 1.13
        Neutrophils Week 4 (41, 39, 41, 39, 41, 40)
    0.04 ± 1.30
    -0.35 ± 1.07
    -0.39 ± 1.31
    -0.68 ± 1.02
    -0.48 ± 1.60
    -0.40 ± 1.18
        Neutrophils Week 6 (40, 38, 38, 36, 40, 40)
    -0.36 ± 0.98
    -0.43 ± 1.64
    -0.49 ± 1.38
    -0.54 ± 1.16
    -0.50 ± 1.78
    -0.36 ± 1.01
        Neutrophils Week 8 (39, 37, 37, 34, 40, 40)
    -0.13 ± 1.18
    -0.61 ± 1.40
    -0.34 ± 1.72
    -0.57 ± 1.28
    -0.45 ± 1.61
    -0.47 ± 0.80
        Neutrophils Week 12 (38, 38, 37, 34, 40, 38)
    -0.11 ± 1.17
    -0.33 ± 1.50
    -0.49 ± 1.50
    -0.57 ± 1.20
    -0.59 ± 1.28
    -0.39 ± 0.93
        Neutrophils SFU (4, 4, 4, 2, 1, 3)
    -0.45 ± 0.79
    0.75 ± 1.88
    0.65 ± 1.20
    -0.95 ± 0.49
    0.50 ± 999
    -0.13 ± 0.38
    No statistical analyses for this end point

    Secondary: Change from Baseline until Safety Follow-up Visit in biochemistry parameters (calcium, chloride, potassium, magnesium, sodium, urea nitrogen, cholesterol, glucose)

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    End point title
    Change from Baseline until Safety Follow-up Visit in biochemistry parameters (calcium, chloride, potassium, magnesium, sodium, urea nitrogen, cholesterol, glucose)
    End point description
    Calcium, chloride, potassium, magnesium, sodium, urea nitrogen, cholesterol and glucose were measured in millimoles per liter (mmol/L). The Safety Set (SS) consisted of all participants who received at least 1 dose of the IMP. Note 1: 999 is used as a placeholder for values not evaluable because only one participant was analyzed. Note 2: The number of participants analyzed for each timepoint is presented in parentheses following this model (PBO, BKZ 64 mg Q4W, BKZ 160 mg Q4W, BKZ 160 mg w/ LD Q4W, BKZ 320 mg Q4W, BKZ 480 mg Q4W).
    End point type
    Secondary
    End point timeframe
    Baseline (Week 0), Week 1, Week 2, Week 4, Week 6, Week 8, Week 12, and Safety Follow-Up visit (20 weeks after the last dose)
    End point values
    Placebo (SS) Bimekizumab 64 mg Q4W (SS) Bimekizumab 160 mg Q4W (SS) Bimekizumab 160 mg w/ LD Q4W (SS) Bimekizumab 320 mg Q4W (SS) Bimekizumab 480 mg Q4W (SS)
    Number of subjects analysed
    42
    39
    42
    40
    43
    43
    Units: mmol/L
    arithmetic mean (standard deviation)
        Calcium Week 1 (42, 39, 42, 40, 43, 43)
    -0.010 ± 0.076
    0.011 ± 0.088
    -0.021 ± 0.126
    -0.017 ± 0.076
    0.000 ± 0.077
    -0.010 ± 0.080
        Calcium Week 2 (42, 39, 41, 39, 42, 42)
    -0.003 ± 0.082
    0.034 ± 0.094
    -0.007 ± 0.092
    0.004 ± 0.074
    0.006 ± 0.088
    -0.006 ± 0.085
        Calcium Week 4 (41, 39, 41, 39, 41, 41)
    -0.029 ± 0.073
    0.012 ± 0.099
    -0.020 ± 0.106
    -0.008 ± 0.074
    0.005 ± 0.099
    -0.010 ± 0.084
        Calcium Week 6 (40, 38, 38, 37, 40, 40)
    -0.033 ± 0.070
    0.009 ± 0.079
    -0.019 ± 0.091
    -0.008 ± 0.092
    -0.026 ± 0.086
    -0.027 ± 0.100
        Calcium Week 8 (39, 38, 38, 34, 40, 40)
    -0.023 ± 0.084
    0.001 ± 0.106
    -0.027 ± 0.099
    0.019 ± 0.089
    -0.002 ± 0.089
    -0.016 ± 0.084
        Calcium Week 12 (39, 38, 38, 35, 40, 39)
    -0.011 ± 0.095
    0.025 ± 0.092
    -0.038 ± 0.120
    0.001 ± 0.093
    -0.019 ± 0.121
    -0.001 ± 0.092
        Calcium SFU (4, 4, 4, 2, 1, 3)
    -0.095 ± 0.083
    -0.050 ± 0.109
    -0.073 ± 0.045
    -0.125 ± 0.134
    0.020 ± 999
    0.020 ± 0.193
        Chloride Week 1 (42, 39, 42, 40, 43, 43)
    0.5 ± 1.8
    0.6 ± 2.0
    0.6 ± 2.3
    0.6 ± 2.5
    0.3 ± 2.1
    0.1 ± 1.8
        Chloride Week 2 (42, 39, 41, 39, 42, 43)
    0.0 ± 2.3
    0.1 ± 2.4
    -0.3 ± 2.2
    0.4 ± 2.3
    0.5 ± 2.1
    0.1 ± 1.9
        Chloride Week 4 (41, 39, 41, 39, 41, 41)
    0.1 ± 1.8
    0.8 ± 2.1
    0.0 ± 2.5
    0.2 ± 2.3
    -0.1 ± 2.6
    -0.1 ± 1.9
        Chloride Week 6 (40, 38, 38, 37, 40, 40)
    -0.1 ± 2.1
    0.0 ± 2.3
    -0.6 ± 1.7
    0.0 ± 2.4
    -0.1 ± 3.0
    0.1 ± 2.0
        Chloride Week 8 (39, 38, 38, 34, 40, 40)
    0.2 ± 2.1
    0.3 ± 2.3
    0.3 ± 2.0
    -0.1 ± 2.9
    0.1 ± 2.4
    0.1 ± 2.3
        Chloride Week 12 (39, 38, 38, 35, 40, 39)
    0.3 ± 1.7
    -0.1 ± 2.5
    -0.2 ± 2.0
    0.2 ± 2.3
    0.8 ± 2.4
    0.1 ± 2.2
        Chloride SFU (4, 4, 4, 2, 1, 3)
    1.0 ± 1.6
    3.0 ± 2.7
    0.5 ± 5.4
    2.0 ± 0.0
    0.0 ± 999
    0.3 ± 2.1
        Potassium Week 1 (42, 39, 42, 40, 43, 42)
    0.08 ± 0.45
    0.08 ± 0.33
    0.05 ± 0.41
    0.02 ± 0.36
    -0.03 ± 0.32
    0.04 ± 0.29
        Potassium Week 2 (42, 39, 41, 39, 42, 42)
    0.03 ± 0.30
    0.08 ± 0.33
    0.02 ± 0.32
    -0.06 ± 0.29
    0.05 ± 0.37
    -0.03 ± 0.39
        Potassium Week 4 (41, 39, 41, 39, 41, 40)
    0.09 ± 0.40
    0.12 ± 0.41
    0.09 ± 0.38
    0.01 ± 0.34
    0.05 ± 0.40
    0.03 ± 0.33
        Potassium Week 6 (39, 38, 38, 37, 40, 40)
    -0.04 ± 0.32
    0.11 ± 0.35
    -0.03 ± 0.31
    -0.07 ± 0.33
    -0.07 ± 0.34
    -0.02 ± 0.35
        Potassium Week 8 (39, 38, 38, 34, 40, 40)
    0.01 ± 0.39
    0.07 ± 0.36
    0.12 ± 0.38
    -0.06 ± 0.38
    -0.12 ± 0.40
    0.02 ± 0.35
        Potassium Week 12 (39, 37, 38, 35, 40, 39)
    -0.05 ± 0.35
    0.08 ± 0.34
    0.08 ± 0.37
    -0.06 ± 0.37
    -0.07 ± 0.37
    -0.06 ± 0.33
        Potassium SFU (4, 4, 4, 2, 1, 3)
    0.10 ± 0.36
    0.10 ± 0.37
    -0.10 ± 0.29
    -0.45 ± 0.07
    0.20 ± 999
    -0.20 ± 0.30
        Magnesium Week 1 (42, 39, 42, 40, 43, 43)
    -0.010 ± 0.074
    -0.002 ± 0.052
    -0.020 ± 0.069
    0.005 ± 0.079
    -0.007 ± 0.077
    -0.009 ± 0.064
        Magnesium Week 2 (41, 39, 41, 39, 42, 42)
    -0.012 ± 0.063
    -0.004 ± 0.064
    -0.010 ± 0.065
    0.001 ± 0.068
    -0.017 ± 0.086
    0.005 ± 0.075
        Magnesium Week 4 (41, 39, 41, 39, 41, 41)
    -0.023 ± 0.077
    -0.004 ± 0.062
    -0.017 ± 0.046
    0.008 ± 0.071
    -0.017 ± 0.067
    -0.013 ± 0.070
        Magnesium Week 6 (40, 38, 38, 37, 40, 40)
    -0.013 ± 0.054
    -0.014 ± 0.053
    -0.013 ± 0.057
    -0.008 ± 0.065
    -0.020 ± 0.073
    -0.017 ± 0.063
        Magnesium Week 8 (39, 38, 38, 34, 40, 40)
    -0.026 ± 0.070
    -0.023 ± 0.042
    -0.023 ± 0.063
    0.003 ± 0.071
    -0.019 ± 0.072
    -0.021 ± 0.058
        Magnesium Week 12 (39, 38, 38, 35, 40, 39)
    -0.014 ± 0.093
    0.007 ± 0.074
    -0.025 ± 0.069
    0.009 ± 0.074
    -0.017 ± 0.075
    -0.008 ± 0.056
        Magnesium SFU (4, 4, 4, 2, 1, 3)
    0.053 ± 0.093
    0.110 ± 0.295
    -0.035 ± 0.047
    -0.050 ± 0.057
    -0.060 ± 999
    -0.023 ± 0.025
        Sodium Week 1 (42, 39, 42, 40, 43, 43)
    -0.1 ± 1.8
    0.2 ± 1.7
    0.3 ± 2.7
    0.1 ± 1.9
    0.0 ± 2.2
    0.0 ± 1.4
        Sodium Week 2 (41, 39, 41, 39, 42, 42)
    -0.3 ± 1.7
    -0.2 ± 1.4
    -0.4 ± 1.8
    0.0 ± 2.0
    0.2 ± 2.3
    0.0 ± 1.5
        Sodium Week 4 (41, 39, 41, 39, 41, 41)
    -0.2 ± 1.7
    0.2 ± 1.7
    0.2 ± 1.7
    -0.2 ± 1.7
    -0.1 ± 2.3
    -0.2 ± 1.7
        Sodium Week 6 (40, 38, 38, 37, 40, 40)
    -0.5 ± 2.0
    -0.1 ± 2.1
    -0.8 ± 1.6
    -0.1 ± 1.9
    -0.1 ± 2.9
    -0.3 ± 1.7
        Sodium Week 8 (39, 38, 38, 34, 40, 40)
    -0.6 ± 2.0
    0.0 ± 2.8
    -0.2 ± 1.8
    -0.2 ± 2.0
    -0.1 ± 2.2
    -0.6 ± 2.0
        Sodium Week 12 (39, 38, 38, 35, 40, 39)
    -0.4 ± 2.0
    -0.2 ± 1.7
    -0.1 ± 1.7
    -0.2 ± 2.0
    -0.2 ± 2.4
    -0.3 ± 1.9
        Sodium SFU (4, 4, 4, 2, 1, 3)
    -0.5 ± 2.1
    0.8 ± 1.7
    -2.0 ± 2.2
    -2.0 ± 2.8
    -1.0 ± 999
    -1.7 ± 1.2
        Urea Nitrogen Week 1 (42, 39, 42, 40, 43, 43)
    -0.16 ± 1.09
    0.11 ± 1.12
    0.27 ± 1.19
    0.34 ± 1.22
    0.27 ± 1.24
    0.21 ± 0.88
        Urea Nitrogen Week 2 (42, 39, 41, 39, 42, 42)
    0.00 ± 1.16
    -0.03 ± 1.25
    0.24 ± 1.16
    0.16 ± 1.17
    0.27 ± 1.17
    0.37 ± 1.03
        Urea Nitrogen Week 4 (41, 39, 41, 39, 41, 41)
    -0.14 ± 1.16
    0.48 ± 1.52
    0.50 ± 1.31
    -0.03 ± 1.20
    -0.11 ± 1.08
    0.15 ± 1.04
        Urea Nitrogen Week 6 (40, 38, 38, 37, 40, 40)
    -0.12 ± 0.96
    0.21 ± 1.40
    0.41 ± 1.14
    0.19 ± 1.31
    0.29 ± 1.14
    0.12 ± 0.93
        Urea Nitrogen Week 8 (39, 38, 38, 34, 40, 40)
    -0.28 ± 1.29
    0.14 ± 1.33
    0.32 ± 1.08
    -0.08 ± 1.58
    0.33 ± 1.30
    0.35 ± 0.88
        Urea Nitrogen Week 12 (39, 38, 38, 35, 40, 39)
    -0.17 ± 1.35
    -0.04 ± 1.37
    0.39 ± 1.14
    0.08 ± 1.13
    0.13 ± 1.08
    0.01 ± 0.85
        Urea Nitrogen SFU (4, 4, 4, 2, 1, 3)
    0.65 ± 1.74
    0.80 ± 1.19
    0.78 ± 3.27
    -0.65 ± 2.05
    -0.30 ± 999
    0.77 ± 1.27
        Cholesterol Week 1 (42, 39, 42, 40, 43, 43)
    -0.04 ± 0.47
    -0.06 ± 0.54
    0.00 ± 0.65
    -0.09 ± 0.59
    0.12 ± 0.65
    0.06 ± 0.34
        Cholesterol Week 2 (42, 39, 41, 39, 42, 42)
    -0.13 ± 0.71
    0.03 ± 0.63
    0.12 ± 0.58
    -0.11 ± 0.52
    0.12 ± 1.04
    0.05 ± 0.57
        Cholesterol Week 4 (41, 39, 41, 39, 41, 41)
    -0.06 ± 0.59
    0.04 ± 0.63
    0.17 ± 0.55
    -0.31 ± 0.88
    0.00 ± 1.30
    0.05 ± 0.66
        Cholesterol Week 6 (40, 38, 38, 37, 40, 40)
    0.05 ± 0.46
    -0.02 ± 0.73
    0.17 ± 0.56
    -0.24 ± 0.70
    -0.24 ± 1.32
    0.08 ± 0.60
        Cholesterol Week 8 (39, 38, 38, 34, 40, 40)
    -0.08 ± 0.67
    -0.17 ± 0.68
    0.16 ± 0.64
    -0.13 ± 0.83
    -0.17 ± 1.22
    0.01 ± 0.48
        Cholesterol Week 12 (39, 38, 38, 35, 40, 39)
    -0.20 ± 0.88
    -0.07 ± 0.62
    0.11 ± 0.62
    -0.18 ± 0.77
    0.01 ± 1.29
    -0.05 ± 0.76
        Cholesterol SFU (4, 4, 4, 2, 1, 3)
    -0.28 ± 0.30
    -0.83 ± 1.56
    0.38 ± 0.52
    -0.80 ± 0.14
    0.20 ± 999
    0.40 ± 0.44
        Glucose Week 1 (42, 39, 42, 40, 43, 42)
    0.50 ± 1.59
    0.12 ± 0.82
    -0.14 ± 1.00
    -0.06 ± 1.14
    0.07 ± 1.10
    0.22 ± 0.70
        Glucose Week 2 (41, 39, 41, 39, 42, 42)
    0.29 ± 1.62
    0.17 ± 1.23
    -0.05 ± 0.92
    -0.20 ± 1.13
    0.03 ± 1.09
    0.05 ± 0.67
        Glucose Week 4 (41, 39, 41, 39, 41, 40)
    0.37 ± 1.42
    0.25 ± 1.22
    -0.12 ± 1.03
    -0.09 ± 1.24
    0.37 ± 1.20
    0.19 ± 0.92
        Glucose Week 6 (39, 38, 38, 37, 40, 40)
    0.44 ± 1.42
    0.30 ± 1.15
    -0.04 ± 1.26
    0.02 ± 1.60
    0.21 ± 1.30
    0.29 ± 1.27
        Glucose Week 8 (39, 38, 38, 34, 40, 40)
    0.37 ± 1.48
    0.22 ± 1.48
    -0.15 ± 0.87
    -0.06 ± 1.43
    0.11 ± 1.10
    0.03 ± 0.97
        Glucose Week 12 (39, 37, 38, 35, 40, 39)
    0.22 ± 1.27
    0.01 ± 1.08
    0.02 ± 1.35
    -0.17 ± 1.23
    -0.15 ± 0.88
    0.04 ± 0.95
        Glucose SFU (4, 4, 4, 2, 1, 3)
    -0.40 ± 0.48
    0.75 ± 0.89
    -0.33 ± 0.67
    -0.25 ± 0.49
    0.20 ± 999
    -0.17 ± 0.61
    No statistical analyses for this end point

    Secondary: Change from Baseline until Safety Follow-up Visit in biochemistry parameters (lactate dehydrogenase, alkaline phosphatase, alanine aminotransferase, aspartate aminotransferase, gamma glutamyl transferase)

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    End point title
    Change from Baseline until Safety Follow-up Visit in biochemistry parameters (lactate dehydrogenase, alkaline phosphatase, alanine aminotransferase, aspartate aminotransferase, gamma glutamyl transferase)
    End point description
    Lactate dehydrogenase (LDH), alkaline phosphatase (ALP), alanine aminotransferase (ALT), aspartate aminotransferase (AST) and gamma glutamyl transferase (GGT) were measured in units per liter (U/L). The Safety Set (SS) consisted of all participants who received at least 1 dose of the IMP. Note 1: 999 is used as a placeholder for values not evaluable because only one participant was analyzed. Note 2: The number of participants analyzed for each timepoint is presented in parentheses following this model (PBO, BKZ 64 mg Q4W, BKZ 160 mg Q4W, BKZ 160 mg w/ LD Q4W, BKZ 320 mg Q4W, BKZ 480 mg Q4W).
    End point type
    Secondary
    End point timeframe
    Baseline (Week 0), Week 1, Week 2, Week 4, Week 6, Week 8, Week 12, and Safety Follow-Up visit (20 weeks after the last dose)
    End point values
    Placebo (SS) Bimekizumab 64 mg Q4W (SS) Bimekizumab 160 mg Q4W (SS) Bimekizumab 160 mg w/ LD Q4W (SS) Bimekizumab 320 mg Q4W (SS) Bimekizumab 480 mg Q4W (SS)
    Number of subjects analysed
    42
    39
    42
    40
    43
    43
    Units: U/L
    arithmetic mean (standard deviation)
        LDH Week 1 (42, 39, 42, 40, 43, 43)
    -2.0 ± 29.4
    1.1 ± 24.8
    -5.0 ± 24.1
    -0.3 ± 21.4
    -4.6 ± 18.9
    -3.4 ± 19.7
        LDH Week 2 (42, 39, 41, 39, 42, 42)
    -4.9 ± 26.4
    -2.5 ± 25.2
    -3.5 ± 22.1
    0.4 ± 27.6
    -7.6 ± 27.4
    -5.1 ± 20.1
        LDH Week 4 (41, 39, 41, 39, 41, 41)
    -4.9 ± 22.4
    1.7 ± 31.9
    -8.1 ± 16.7
    5.0 ± 43.5
    -4.5 ± 37.7
    -4.4 ± 15.4
        LDH Week 6 (40, 38, 38, 37, 40, 40)
    -5.0 ± 27.7
    -1.4 ± 25.2
    -7.3 ± 20.3
    2.0 ± 16.2
    -11.0 ± 27.5
    -3.5 ± 22.6
        LDH Week 8 (39, 38, 38, 34, 40, 40)
    -5.5 ± 27.4
    0.5 ± 25.2
    -12.3 ± 22.2
    -0.8 ± 18.9
    -10.7 ± 33.1
    -3.7 ± 27.5
        LDH Week 12 (39, 38, 38, 35, 40, 39)
    -4.9 ± 28.1
    2.9 ± 26.7
    -7.5 ± 25.1
    -0.3 ± 20.6
    -5.6 ± 33.1
    -4.4 ± 24.8
        LDH SFU (4, 4, 4, 2, 1, 3)
    -1.5 ± 12.9
    -5.0 ± 18.4
    3.3 ± 81.2
    -45.5 ± 16.3
    15.0 ± 999
    32.3 ± 34.2
        ALP Week 1 (42, 39, 42, 40, 43, 43)
    -1.8 ± 6.3
    -0.5 ± 6.0
    -3.5 ± 8.2
    -3.8 ± 7.7
    -1.9 ± 5.3
    -2.3 ± 5.7
        ALP Week 2 (42, 39, 41, 39, 42, 42)
    -3.0 ± 12.7
    0.0 ± 7.4
    -2.5 ± 10.5
    -2.7 ± 8.2
    -1.6 ± 6.5
    -1.7 ± 7.7
        ALP Week 4 (41, 39, 41, 39, 41, 41)
    -2.4 ± 8.7
    -1.9 ± 9.2
    -6.2 ± 9.8
    -4.3 ± 9.4
    -2.6 ± 8.1
    -1.7 ± 7.8
        ALP Week 6 (40, 38, 38, 37, 40, 40)
    -3.0 ± 8.3
    -1.8 ± 9.0
    -5.5 ± 10.0
    -2.4 ± 8.6
    -2.1 ± 9.6
    -1.4 ± 7.5
        ALP Week 8 (39, 38, 38, 34, 40, 40)
    -4.3 ± 12.2
    -1.7 ± 8.0
    -4.2 ± 11.2
    -2.1 ± 10.0
    -1.1 ± 11.3
    -1.9 ± 7.2
        ALP Week 12 (39, 38, 38, 35, 40, 39)
    -2.0 ± 8.1
    0.3 ± 7.2
    -2.4 ± 11.8
    -0.4 ± 9.0
    -0.5 ± 10.4
    -0.4 ± 8.4
        ALP SFU (4, 4, 4, 2, 1, 3)
    -0.5 ± 7.4
    9.8 ± 8.9
    7.8 ± 15.3
    -3.0 ± 5.7
    3.0 ± 999
    3.0 ± 1.0
        ALT Week 1 (42, 39, 42, 40, 43, 43)
    2.0 ± 7.7
    2.1 ± 10.4
    -1.7 ± 13.7
    1.6 ± 12.2
    0.7 ± 8.9
    1.2 ± 9.1
        ALT Week 2 (42, 39, 41, 39, 42, 42)
    0.3 ± 6.5
    1.9 ± 9.0
    2.0 ± 29.8
    -0.9 ± 7.7
    -0.2 ± 10.2
    1.6 ± 11.5
        ALT Week 1 (41, 39, 41, 39, 41, 41)
    -0.2 ± 7.0
    1.1 ± 8.6
    0.8 ± 18.7
    -0.4 ± 10.2
    0.4 ± 14.7
    1.0 ± 13.3
        ALT Week 6 (40, 38, 38, 37, 40, 40)
    3.9 ± 18.9
    1.1 ± 8.9
    -0.6 ± 11.7
    3.5 ± 20.9
    -1.7 ± 13.7
    1.1 ± 12.5
        ALT Week 8 (39, 38, 38, 34, 40, 40)
    1.8 ± 10.8
    2.2 ± 10.2
    0.1 ± 10.5
    -0.4 ± 9.7
    -1.1 ± 14.5
    0.8 ± 9.0
        ALT Week 12 (39, 38, 38, 35, 40, 39)
    -1.3 ± 7.5
    1.8 ± 9.9
    -1.0 ± 10.8
    -0.9 ± 9.1
    -0.9 ± 14.6
    -0.4 ± 10.6
        ALT SFU (4, 4, 4, 2, 1, 3)
    -3.8 ± 3.0
    4.3 ± 3.4
    26.5 ± 42.1
    -6.0 ± 8.5
    16.0 ± 999
    -3.3 ± 3.1
        AST Week 1 (42, 39, 42, 40, 43, 43)
    0.5 ± 6.1
    2.0 ± 10.8
    -3.0 ± 15.2
    1.9 ± 11.5
    0.3 ± 6.3
    -0.5 ± 7.2
        AST Week 2 (42, 39, 41, 39, 42, 42)
    -1.0 ± 3.8
    0.4 ± 4.9
    -1.9 ± 19.1
    -0.9 ± 4.7
    -0.5 ± 6.1
    0.9 ± 13.4
        AST Week 4 (41, 39, 41, 39, 41, 41)
    -1.1 ± 4.8
    -0.1 ± 5.8
    -2.5 ± 17.5
    -0.4 ± 5.9
    0.6 ± 8.2
    -0.4 ± 7.5
        AST Week 6 (40, 38, 38, 37, 40, 40)
    1.5 ± 10.6
    0.8 ± 6.0
    -0.9 ± 9.5
    4.0 ± 15.7
    -1.4 ± 7.0
    -1.4 ± 6.5
        AST Week 8 (39, 38, 38, 34, 40, 40)
    0.0 ± 5.1
    0.2 ± 6.7
    -1.4 ± 5.4
    -1.4 ± 4.6
    -0.4 ± 8.3
    -0.8 ± 6.3
        AST Week 12 (39, 38, 38, 35, 40, 39)
    -1.3 ± 5.5
    1.1 ± 7.9
    -1.4 ± 8.3
    -0.3 ± 4.8
    -0.5 ± 7.3
    -0.9 ± 5.2
        AST SFU (4, 4, 4, 2, 1, 3)
    -2.8 ± 1.7
    -0.3 ± 2.1
    11.5 ± 23.5
    -4.0 ± 2.8
    9.0 ± 999
    0.7 ± 2.5
        GGT Week 1 (42, 39, 42, 40, 43, 43)
    0.6 ± 6.4
    -0.8 ± 14.1
    -2.0 ± 10.7
    -7.5 ± 42.1
    1.6 ± 22.9
    -0.8 ± 6.3
        GGT Week 2 (42, 39, 41, 39, 42, 42)
    0.2 ± 8.7
    -1.6 ± 11.1
    0.2 ± 14.2
    -1.2 ± 8.0
    -1.9 ± 6.5
    0.4 ± 15.0
        GGT Week 4 (41, 39, 41, 39, 41, 41)
    -0.7 ± 8.5
    -1.9 ± 11.8
    1.8 ± 18.6
    -2.6 ± 12.8
    -0.4 ± 8.4
    -1.4 ± 14.1
        GGT Week 6 (40, 38, 38, 37, 40, 40)
    1.8 ± 10.5
    -1.8 ± 13.8
    -2.9 ± 13.1
    -2.9 ± 7.3
    -2.1 ± 9.3
    -1.1 ± 12.9
        GGT Week 8 (39, 38, 38, 34, 40, 40)
    2.4 ± 13.7
    -1.9 ± 14.9
    -0.9 ± 18.4
    -2.6 ± 13.6
    -2.5 ± 9.4
    3.1 ± 29.5
        GGT Week 12 (39, 38, 38, 35, 40, 39)
    -0.4 ± 10.9
    -2.2 ± 13.3
    -1.1 ± 21.7
    -0.6 ± 11.2
    -0.4 ± 11.1
    -0.9 ± 12.2
        GGT SFU (4, 4, 4, 2, 1, 3)
    -8.0 ± 13.4
    1.3 ± 3.9
    19.8 ± 23.3
    -16.5 ± 24.7
    37.0 ± 999
    3.0 ± 3.5
    No statistical analyses for this end point

    Secondary: Change from Baseline until Safety Follow-up Visit in biochemistry parameters (creatinine, bilirubin)

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    End point title
    Change from Baseline until Safety Follow-up Visit in biochemistry parameters (creatinine, bilirubin)
    End point description
    Creatinine and bilirubin were measured in micromols per liter (μmol/L). The Safety Set (SS) consisted of all participants who received at least 1 dose of the IMP. Note 1: 999 is used as a placeholder for values not evaluable because only one participant was analyzed. Note 2: The number of participants analyzed for each timepoint is presented in parentheses following this model (PBO, BKZ 64 mg Q4W, BKZ 160 mg Q4W, BKZ 160 mg w/ LD Q4W, BKZ 320 mg Q4W, BKZ 480 mg Q4W).
    End point type
    Secondary
    End point timeframe
    Baseline (Week 0), Week 1, Week 2, Week 4, Week 6, Week 8, Week 12, and Safety Follow-Up visit (20 weeks after the last dose)
    End point values
    Placebo (SS) Bimekizumab 64 mg Q4W (SS) Bimekizumab 160 mg Q4W (SS) Bimekizumab 160 mg w/ LD Q4W (SS) Bimekizumab 320 mg Q4W (SS) Bimekizumab 480 mg Q4W (SS)
    Number of subjects analysed
    42
    39
    42
    40
    43
    43
    Units: μmol/L
    arithmetic mean (standard deviation)
        Creatinine Week 1 (42, 39, 42, 40, 43, 43)
    0.6 ± 7.0
    2.7 ± 10.1
    1.4 ± 8.6
    0.6 ± 8.1
    0.7 ± 8.4
    -0.7 ± 7.7
        Creatinine Week 2 (42, 39, 41, 39, 42, 42)
    0.0 ± 7.1
    -0.8 ± 8.2
    -0.4 ± 10.1
    -0.7 ± 8.5
    -0.1 ± 8.3
    0.0 ± 7.1
        Creatinine Week 4 (41, 39, 41, 39, 41, 41)
    0.0 ± 5.8
    1.3 ± 9.1
    0.6 ± 7.9
    -1.7 ± 8.1
    0.6 ± 8.1
    1.6 ± 7.2
        Creatinine Week 6 (40, 38, 38, 37, 40, 40)
    -1.1 ± 7.8
    1.6 ± 10.5
    -0.1 ± 10.6
    -0.6 ± 7.9
    -0.1 ± 8.1
    -0.5 ± 11.1
        Creatinine Week 8 (39, 38, 38, 34, 40, 40)
    -1.1 ± 6.2
    -0.4 ± 7.4
    -1.0 ± 9.6
    -2.6 ± 8.4
    -0.1 ± 7.6
    0.1 ± 8.3
        Creatinine Week 12 (39, 38, 38, 35, 40, 39)
    -1.6 ± 7.8
    -0.2 ± 7.0
    0.7 ± 12.0
    -0.7 ± 9.1
    0.1 ± 9.0
    -0.7 ± 7.2
        Creatinine SFU (4, 4, 4, 2, 1, 3)
    1.5 ± 4.4
    6.0 ± 4.3
    -6.5 ± 4.4
    -10.5 ± 16.3
    9.0 ± 999
    1.3 ± 6.4
        Bilirubin Week 1 (42, 39, 42, 40, 43, 43)
    -0.53 ± 3.10
    -1.79 ± 4.50
    -0.52 ± 2.81
    -0.55 ± 4.49
    0.57 ± 5.73
    0.14 ± 4.16
        Bilirubin Week 2 (42, 39, 41, 39, 42, 42)
    -0.35 ± 2.85
    -0.86 ± 5.05
    -0.48 ± 3.40
    -0.38 ± 3.60
    -0.99 ± 2.98
    0.27 ± 3.69
        Bilirubin Week 4 (41, 39, 41, 39, 41, 41)
    -0.70 ± 3.26
    -1.70 ± 4.92
    -0.26 ± 3.53
    -0.04 ± 2.74
    0.76 ± 4.27
    0.70 ± 4.52
        Bilirubin Week 6 (40, 38, 38, 37, 40, 40)
    -0.51 ± 3.13
    -1.15 ± 4.59
    0.35 ± 3.44
    -0.33 ± 3.94
    0.11 ± 4.19
    -0.30 ± 4.28
        Bilirubin Week 8 (39, 38, 38, 34, 40, 40)
    -0.21 ± 3.81
    -0.98 ± 4.68
    -0.30 ± 3.20
    -0.43 ± 4.52
    -0.15 ± 3.79
    -0.02 ± 4.41
        Bilirubin Week 12 (39, 38, 38, 35, 40, 39)
    -0.74 ± 3.43
    -1.02 ± 5.24
    -0.73 ± 2.98
    -1.20 ± 3.37
    -0.43 ± 3.68
    -0.34 ± 3.45
        Bilirubin SFU (4, 4, 4, 2, 1, 3)
    2.05 ± 2.16
    -1.23 ± 2.62
    -0.30 ± 3.87
    -0.25 ± 0.78
    -1.50 ± 999
    1.40 ± 2.96
    No statistical analyses for this end point

    Secondary: Change from Baseline until Safety Follow-up Visit in biochemistry parameters (C Reactive Protein)

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    End point title
    Change from Baseline until Safety Follow-up Visit in biochemistry parameters (C Reactive Protein)
    End point description
    C Reactive Protein was measured in milligrams per liters (mg/L). The Safety Set (SS) consisted of all participants who received at least 1 dose of the IMP. Note 1: 999 is used as a placeholder for values not evaluable because only one participant was analyzed and for groups that had 0 participants analyzed. Note 2: The number of participants analyzed for each timepoint is presented in parentheses following this model (PBO, BKZ 64 mg Q4W, BKZ 160 mg Q4W, BKZ 160 mg w/ LD Q4W, BKZ 320 mg Q4W, BKZ 480 mg Q4W).
    End point type
    Secondary
    End point timeframe
    Baseline (Week 0), Week 1, Week 2, Week 4, Week 6, Week 8, Week 12, and Safety Follow-Up visit (20 weeks after the last dose)
    End point values
    Placebo (SS) Bimekizumab 64 mg Q4W (SS) Bimekizumab 160 mg Q4W (SS) Bimekizumab 160 mg w/ LD Q4W (SS) Bimekizumab 320 mg Q4W (SS) Bimekizumab 480 mg Q4W (SS)
    Number of subjects analysed
    42
    39
    43
    40
    43
    43
    Units: mg/L
    arithmetic mean (standard deviation)
        Week 1 (15, 10, 6, 8, 12, 10)
    -2.110 ± 5.255
    -5.367 ± 11.806
    -0.775 ± 2.020
    -2.635 ± 2.550
    -5.108 ± 10.013
    -3.732 ± 3.997
        Week 2 (11, 10, 7, 9, 9, 9)
    1.821 ± 6.974
    -6.985 ± 11.064
    0.576 ± 2.898
    2.743 ± 15.212
    -6.763 ± 13.211
    -3.042 ± 1.989
        Week 4 (11, 10, 6, 7, 10, 8)
    1.338 ± 11.182
    -5.835 ± 8.594
    -1.722 ± 5.596
    0.929 ± 8.047
    -4.226 ± 9.865
    7.141 ± 32.344
        Week 6 (14, 8, 7, 4, 8, 6)
    2.978 ± 13.162
    -5.930 ± 9.560
    -4.516 ± 11.304
    -0.595 ± 7.346
    1.799 ± 14.635
    -6.598 ± 6.278
        Week 8 (12, 8, 7, 4, 9, 5)
    3.153 ± 18.764
    -6.891 ± 15.192
    -3.143 ± 10.844
    2.590 ± 7.755
    12.434 ± 47.447
    -1.104 ± 5.201
        Week 12 (10, 11, 6, 4, 8, 8)
    7.279 ± 13.546
    -5.193 ± 10.817
    0.695 ± 6.381
    -3.033 ± 7.261
    -9.890 ± 10.729
    -5.368 ± 5.322
        SFU (1, 0, 0, 0, 0, 0)
    8.000 ± 999
    999 ± 999
    999 ± 999
    999 ± 999
    999 ± 999
    999 ± 999
    No statistical analyses for this end point

    Secondary: Change from Baseline until Safety Follow-up Visit in urinalysis parameters (pH)

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    End point title
    Change from Baseline until Safety Follow-up Visit in urinalysis parameters (pH)
    End point description
    Urine pH was measured on a pH scale. The Safety Set (SS) consisted of all participants who received at least 1 dose of the IMP. Note 1: 999 is used as a placeholder for values not evaluable because only one participant was analyzed. Note 2: The number of participants analyzed for each timepoint is presented in parentheses following this model (PBO, BKZ 64 mg Q4W, BKZ 160 mg Q4W, BKZ 160 mg w/ LD Q4W, BKZ 320 mg Q4W, BKZ 480 mg Q4W).
    End point type
    Secondary
    End point timeframe
    Baseline (Week 0), Week 1, Week 2, Week 4, Week 6, Week 8, Week 12, and Safety Follow-Up visit (20 weeks after the last dose)
    End point values
    Placebo (SS) Bimekizumab 64 mg Q4W (SS) Bimekizumab 160 mg Q4W (SS) Bimekizumab 160 mg w/ LD Q4W (SS) Bimekizumab 320 mg Q4W (SS) Bimekizumab 480 mg Q4W (SS)
    Number of subjects analysed
    42
    39
    41
    40
    43
    43
    Units: ph
    arithmetic mean (standard deviation)
        Week 1 (42, 39, 41, 40, 43, 43)
    0.00 ± 0.79
    -0.10 ± 0.79
    -0.13 ± 0.88
    -0.20 ± 0.88
    -0.08 ± 0.82
    -0.07 ± 0.90
        Week 2 (42, 39, 39, 39, 42, 42)
    0.06 ± 0.86
    -0.06 ± 0.86
    -0.10 ± 0.77
    -0.23 ± 0.92
    -0.18 ± 0.76
    0.06 ± 0.65
        Week 4 (41, 39, 41, 39, 41, 40)
    0.05 ± 0.87
    -0.09 ± 0.76
    -0.11 ± 0.95
    -0.26 ± 0.89
    -0.07 ± 0.73
    -0.04 ± 0.74
        Week 6 (40, 38, 38, 37, 40, 40)
    -0.01 ± 0.73
    -0.03 ± 0.68
    -0.17 ± 0.69
    -0.18 ± 0.86
    -0.13 ± 0.81
    0.05 ± 0.86
        Week 8 (39, 38, 38, 35, 40, 40)
    -0.03 ± 0.92
    -0.07 ± 0.83
    -0.12 ± 1.07
    -0.34 ± 0.79
    -0.30 ± 0.91
    0.08 ± 0.75
        Week 12 (39, 38, 37, 34, 40, 39)
    -0.14 ± 0.79
    -0.01 ± 0.85
    0.01 ± 0.70
    -0.28 ± 0.85
    -0.21 ± 0.99
    -0.01 ± 0.85
        SFU (4, 4, 4, 2, 1, 3)
    0.25 ± 1.04
    -0.25 ± 0.87
    0.50 ± 1.22
    -1.00 ± 1.41
    0.50 ± 999
    -0.17 ± 0.29
    No statistical analyses for this end point

    Secondary: Percentage of participants who shifted from Baseline until Week 12 in urinalysis parameters (leukocyte esterase)

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    End point title
    Percentage of participants who shifted from Baseline until Week 12 in urinalysis parameters (leukocyte esterase)
    End point description
    Percentages were based on the number of participants with non-missing urinalysis results at Baseline and at Week 12. The Safety Set (SS) consisted of all participants who received at least 1 dose of the IMP. Number of participants reflect those with non-missing urinalysis results at Baseline and at Week 12.
    End point type
    Secondary
    End point timeframe
    From Baseline (Week 0) until Week 12
    End point values
    Placebo (SS) Bimekizumab 64 mg Q4W (SS) Bimekizumab 160 mg Q4W (SS) Bimekizumab 160 mg w/ LD Q4W (SS) Bimekizumab 320 mg Q4W (SS) Bimekizumab 480 mg Q4W (SS)
    Number of subjects analysed
    39
    38
    37
    34
    40
    39
    Units: percentage of participants
    number (not applicable)
        Baseline Low – Week 12 Low
    0
    0
    0
    0
    0
    0
        Baseline Low – Week 12 Normal
    0
    0
    0
    0
    0
    0
        Baseline Low – Week 12 High
    0
    0
    0
    0
    0
    0
        Baseline Normal – Week 12 Low
    0
    0
    0
    0
    0
    0
        Baseline Normal – Week 12 Normal
    84.6
    84.2
    97.3
    88.2
    90.0
    92.3
        Baseline Normal – Week 12 High
    2.6
    0
    2.7
    5.9
    5.0
    0
        Baseline High – Week 12 Low
    0
    0
    0
    0
    0
    0
        Baseline High – Week 12 Normal
    7.7
    15.8
    0
    2.9
    5.0
    7.7
        Baseline High – Week 12 High
    5.1
    0
    0
    2.9
    0
    0
    No statistical analyses for this end point

    Secondary: Percentage of participants who shifted from Baseline until Week 12 in urinalysis parameters (nitrite)

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    End point title
    Percentage of participants who shifted from Baseline until Week 12 in urinalysis parameters (nitrite)
    End point description
    Percentages were based on the number of participants with non-missing urinalysis results at Baseline and at Week 12. The Safety Set (SS) consisted of all participants who received at least 1 dose of the IMP. Number of participants reflect those with non-missing urinalysis results at Baseline and at Week 12.
    End point type
    Secondary
    End point timeframe
    From Baseline (Week 0) until Week 12
    End point values
    Placebo (SS) Bimekizumab 64 mg Q4W (SS) Bimekizumab 160 mg Q4W (SS) Bimekizumab 160 mg w/ LD Q4W (SS) Bimekizumab 320 mg Q4W (SS) Bimekizumab 480 mg Q4W (SS)
    Number of subjects analysed
    39
    38
    37
    34
    40
    39
    Units: percentage of participants
    number (not applicable)
        Baseline Low – Week 12 Low
    0
    0
    0
    0
    0
    0
        Baseline Low – Week 12 Normal
    0
    0
    0
    0
    0
    0
        Baseline Low – Week 12 High
    0
    0
    0
    0
    0
    0
        Baseline Normal – Week 12 Low
    0
    0
    0
    0
    0
    0
        Baseline Normal – Week 12 Normal
    97.4
    97.4
    100
    100
    95.0
    94.9
        Baseline Normal – Week 12 High
    0
    2.6
    0
    0
    2.5
    2.6
        Baseline High – Week 12 Low
    0
    0
    0
    0
    0
    0
        Baseline High – Week 12 Normal
    0
    0
    0
    0
    0
    2.6
        Baseline High – Week 12 High
    2.6
    0
    0
    0
    2.5
    0
    No statistical analyses for this end point

    Secondary: Percentage of participants who shifted from Baseline until Week 12 in urinalysis parameters (occult blood)

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    End point title
    Percentage of participants who shifted from Baseline until Week 12 in urinalysis parameters (occult blood)
    End point description
    Percentages were based on the number of participants with non-missing urinalysis results at Baseline and at Week 12. The Safety Set (SS) consisted of all participants who received at least 1 dose of the IMP. Number of participants reflect those with non-missing urinalysis results at Baseline and at Week 12.
    End point type
    Secondary
    End point timeframe
    From Baseline (Week 0) until Week 12
    End point values
    Placebo (SS) Bimekizumab 64 mg Q4W (SS) Bimekizumab 160 mg Q4W (SS) Bimekizumab 160 mg w/ LD Q4W (SS) Bimekizumab 320 mg Q4W (SS) Bimekizumab 480 mg Q4W (SS)
    Number of subjects analysed
    39
    38
    37
    34
    40
    39
    Units: percentage of participants
    number (not applicable)
        Baseline Low – Week 12 Low
    0
    0
    0
    0
    0
    0
        Baseline Low – Week 12 Normal
    0
    0
    0
    0
    0
    0
        Baseline Low – Week 12 High
    0
    0
    0
    0
    0
    0
        Baseline Normal – Week 12 Low
    0
    0
    0
    0
    0
    0
        Baseline Normal – Week 12 Normal
    76.9
    86.8
    83.8
    79.4
    77.5
    89.7
        Baseline Normal – Week 12 High
    0
    5.3
    0
    5.9
    5.0
    2.6
        Baseline High – Week 12 Low
    0
    0
    0
    0
    0
    0
        Baseline High – Week 12 Normal
    10.3
    5.3
    5.4
    8.8
    15.0
    5.1
        Baseline High – Week 12 High
    12.8
    2.6
    10.8
    5.9
    2.5
    2.6
    No statistical analyses for this end point

    Secondary: Percentage of participants who shifted from Baseline until Week 12 in urinalysis parameters (urine glucose)

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    End point title
    Percentage of participants who shifted from Baseline until Week 12 in urinalysis parameters (urine glucose)
    End point description
    Percentages were based on the number of participants with non-missing urinalysis results at Baseline and at Week 12. The Safety Set (SS) consisted of all participants who received at least 1 dose of the IMP. Number of participants reflect those with non-missing urinalysis results at Baseline and at Week 12.
    End point type
    Secondary
    End point timeframe
    From Baseline (Week 0) until Week 12
    End point values
    Placebo (SS) Bimekizumab 64 mg Q4W (SS) Bimekizumab 160 mg Q4W (SS) Bimekizumab 160 mg w/ LD Q4W (SS) Bimekizumab 320 mg Q4W (SS) Bimekizumab 480 mg Q4W (SS)
    Number of subjects analysed
    39
    38
    37
    34
    40
    39
    Units: percentage of participants
    number (not applicable)
        Baseline Low – Week 12 Low
    0
    0
    0
    0
    0
    0
        Baseline Low – Week 12 Normal
    0
    0
    0
    0
    0
    0
        Baseline Low – Week 12 High
    0
    0
    0
    0
    0
    0
        Baseline Normal – Week 12 Low
    0
    0
    0
    0
    0
    0
        Baseline Normal – Week 12 Normal
    94.9
    94.7
    97.3
    97.1
    95.0
    94.9
        Baseline Normal – Week 12 High
    0
    2.6
    2.7
    2.9
    0
    0
        Baseline High – Week 12 Low
    0
    0
    0
    0
    0
    0
        Baseline High – Week 12 Normal
    0
    0
    0
    0
    2.5
    0
        Baseline High – Week 12 High
    5.1
    2.6
    0
    0
    2.5
    5.1
    No statistical analyses for this end point

    Secondary: Percentage of participants who shifted from Baseline until Week 12 in urinalysis parameters (albumin)

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    End point title
    Percentage of participants who shifted from Baseline until Week 12 in urinalysis parameters (albumin)
    End point description
    Percentages were based on the number of participants with non-missing urinalysis results at Baseline and at Week 12. The Safety Set (SS) consisted of all participants who received at least 1 dose of the IMP. Number of participants reflect those with non-missing urinalysis results at Baseline and at Week 12.
    End point type
    Secondary
    End point timeframe
    From Baseline (Week 0) until Week 12
    End point values
    Placebo (SS) Bimekizumab 64 mg Q4W (SS) Bimekizumab 160 mg Q4W (SS) Bimekizumab 160 mg w/ LD Q4W (SS) Bimekizumab 320 mg Q4W (SS) Bimekizumab 480 mg Q4W (SS)
    Number of subjects analysed
    39
    38
    37
    34
    40
    39
    Units: percentage of participants
    number (not applicable)
        Baseline Low – Week 12 Low
    0
    0
    0
    0
    0
    0
        Baseline Low – Week 12 Normal
    0
    0
    0
    0
    0
    0
        Baseline Low – Week 12 High
    0
    0
    0
    0
    0
    0
        Baseline Normal – Week 12 Low
    0
    0
    0
    0
    0
    0
        Baseline Normal – Week 12 Normal
    94.9
    89.5
    86.5
    91.2
    95.0
    92.3
        Baseline Normal – Week 12 High
    0
    7.9
    2.7
    2.9
    2.5
    0
        Baseline High – Week 12 Low
    0
    0
    0
    0
    0
    0
        Baseline High – Week 12 Normal
    5.1
    2.6
    10.8
    5.9
    2.5
    2.6
        Baseline High – Week 12 High
    0
    0
    0
    0
    0
    5.1
    No statistical analyses for this end point

    Secondary: Change from Baseline until Safety Follow-up Visit in vital signs (blood pressure)

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    End point title
    Change from Baseline until Safety Follow-up Visit in vital signs (blood pressure)
    End point description
    Blood pressure (BP) was measured in millimeters of mercury (mmHg). The Safety Set (SS) consisted of all participants who received at least 1 dose of the IMP. Note 1: 999 is used as a placeholder for values not evaluable because only one participant was analyzed. Note 2: The number of participants analyzed for each timepoint is presented in parentheses following this model (PBO, BKZ 64 mg Q4W, BKZ 160 mg Q4W, BKZ 160 mg w/ LD Q4W, BKZ 320 mg Q4W, BKZ 480 mg Q4W).
    End point type
    Secondary
    End point timeframe
    Baseline (Week 0), Week 1, Week 2, Week 4, Week 6, Week 8, Week 12, and Safety Follow-Up visit (20 weeks after the last dose)
    End point values
    Placebo (SS) Bimekizumab 64 mg Q4W (SS) Bimekizumab 160 mg Q4W (SS) Bimekizumab 160 mg w/ LD Q4W (SS) Bimekizumab 320 mg Q4W (SS) Bimekizumab 480 mg Q4W (SS)
    Number of subjects analysed
    42
    39
    42
    40
    43
    43
    Units: mmHg
    arithmetic mean (standard deviation)
        Systolic BP Week 1 (42, 39, 42, 40, 43, 43)
    1.2 ± 10.7
    2.2 ± 7.1
    -3.9 ± 8.3
    1.7 ± 9.3
    0.2 ± 12.1
    -1.0 ± 9.9
        Systolic BP Week 2 (42, 39, 41, 39, 42, 42)
    -1.1 ± 9.7
    2.1 ± 9.4
    -2.7 ± 12.5
    0.2 ± 13.6
    -0.6 ± 8.4
    -3.2 ± 11.2
        Systolic BP Week 4 (42, 39, 41, 39, 41, 41)
    -2.3 ± 10.0
    2.1 ± 7.9
    -1.9 ± 11.3
    0.1 ± 12.4
    -0.1 ± 11.3
    -0.5 ± 10.8
        Systolic BP Week 6 (40, 38, 38, 37, 40, 40)
    -1.4 ± 9.8
    -1.3 ± 10.7
    -4.3 ± 10.6
    0.1 ± 12.8
    -0.9 ± 10.9
    -2.4 ± 9.2
        Systolic BP Week 8 (39, 38, 38, 37, 40, 40)
    -0.8 ± 12.1
    -1.3 ± 13.0
    -3.4 ± 8.0
    0.1 ± 12.3
    0.5 ± 12.5
    -1.0 ± 10.7
        Systolic BP Week 12 (39, 38, 38, 35, 40, 39)
    -1.3 ± 10.9
    2.2 ± 9.0
    -2.9 ± 10.3
    -0.3 ± 11.8
    -1.2 ± 10.4
    -2.4 ± 10.1
        Systolic BP SFU (4, 4, 4, 2, 1, 3)
    -7.0 ± 12.7
    -10.5 ± 17.0
    -1.3 ± 10.4
    4.5 ± 7.8
    -2.0 ± 999
    -2.0 ± 2.6
        Diastolic BP Week 1 (42, 39, 42, 40, 43, 43)
    -0.4 ± 7.4
    0.9 ± 10.0
    -2.1 ± 7.3
    0.6 ± 6.5
    0.3 ± 7.4
    0.1 ± 6.7
        Diastolic BP Week 2 (42, 39, 41, 39, 42, 42)
    -1.5 ± 6.9
    0.4 ± 8.7
    -1.2 ± 7.1
    2.1 ± 8.3
    0.0 ± 7.2
    0.2 ± 7.0
        Diastolic BP Week 4 (42, 39, 41, 39, 41, 41)
    -0.3 ± 7.8
    0.6 ± 9.2
    -0.3 ± 7.9
    0.6 ± 7.3
    0.0 ± 7.7
    0.3 ± 8.1
        Diastolic BP Week 6 (40, 38, 38, 37, 40, 40)
    0.3 ± 7.6
    0.0 ± 9.7
    -3.1 ± 7.9
    1.3 ± 8.6
    0.1 ± 7.3
    -1.6 ± 7.3
        Diastolic BP Week 8 (39, 38, 38, 37, 40, 40)
    -1.1 ± 8.9
    -0.3 ± 9.1
    -1.2 ± 7.3
    2.8 ± 8.7
    -0.7 ± 7.7
    -0.6 ± 8.2
        Diastolic BP Week 12 (39, 38, 38, 35, 40, 39)
    -2.3 ± 5.8
    0.5 ± 6.3
    -1.7 ± 6.4
    3.1 ± 8.4
    -1.1 ± 6.7
    -1.1 ± 7.3
        Diastolic BP SFU (4, 4, 4, 2, 1, 3)
    1.3 ± 8.5
    -9.0 ± 9.1
    0.8 ± 8.8
    -4.5 ± 0.7
    -9.0 ± 999
    -4.0 ± 6.6
    No statistical analyses for this end point

    Secondary: Change from Baseline until Safety Follow-up Visit in vital signs (pulse rate)

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    End point title
    Change from Baseline until Safety Follow-up Visit in vital signs (pulse rate)
    End point description
    Pulse rate was measured in beats per minute (beats/min). The Safety Set (SS) consisted of all participants who received at least 1 dose of the IMP. Note 1: 999 is used as a placeholder for values not evaluable because only one participant was analyzed. Note 2: The number of participants analyzed for each timepoint is presented in parentheses following this model (PBO, BKZ 64 mg Q4W, BKZ 160 mg Q4W, BKZ 160 mg w/ LD Q4W, BKZ 320 mg Q4W, BKZ 480 mg Q4W).
    End point type
    Secondary
    End point timeframe
    Baseline (Week 0), Week 1, Week 2, Week 4, Week 6, Week 8, Week 12, and Safety Follow-Up visit (20 weeks after the last dose)
    End point values
    Placebo (SS) Bimekizumab 64 mg Q4W (SS) Bimekizumab 160 mg Q4W (SS) Bimekizumab 160 mg w/ LD Q4W (SS) Bimekizumab 320 mg Q4W (SS) Bimekizumab 480 mg Q4W (SS)
    Number of subjects analysed
    42
    39
    42
    40
    43
    43
    Units: beats/min
    arithmetic mean (standard deviation)
        Week 1 (42, 39, 42, 40, 43, 43)
    1.7 ± 9.5
    -1.6 ± 9.1
    3.2 ± 8.0
    -1.8 ± 8.1
    0.1 ± 6.4
    -0.4 ± 7.7
        Week 2 (42, 39, 41, 39, 42, 42)
    1.2 ± 8.4
    -1.3 ± 9.9
    1.1 ± 7.8
    -1.0 ± 10.4
    -2.2 ± 7.9
    0.5 ± 9.5
        Week 4 (42, 39, 41, 39, 41, 41)
    1.0 ± 10.2
    -3.1 ± 9.9
    0.6 ± 7.8
    -3.6 ± 9.0
    -1.6 ± 6.5
    1.6 ± 8.0
        Week 6 (40, 38, 38, 37, 40, 40)
    0.9 ± 9.8
    1.2 ± 10.7
    1.4 ± 8.3
    -2.6 ± 9.7
    -1.7 ± 9.3
    2.6 ± 8.0
        Week 8 (39, 38, 38, 37, 40, 40)
    1.7 ± 8.9
    -3.2 ± 9.3
    0.4 ± 9.2
    -1.8 ± 8.5
    0.5 ± 8.2
    0.6 ± 6.7
        Week 12 (39, 38, 38, 35, 40, 39)
    0.9 ± 8.4
    -1.9 ± 6.8
    1.8 ± 11.0
    -3.1 ± 8.5
    -1.7 ± 9.1
    0.0 ± 7.5
        SFU (4, 4, 4, 2, 1, 3)
    -2.8 ± 2.6
    -2.5 ± 12.0
    2.3 ± 6.0
    1.5 ± 4.9
    -7.0 ± 999
    7.3 ± 3.2
    No statistical analyses for this end point

    Secondary: Change from Baseline until Safety Follow-up Visit in vital signs (temperature)

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    End point title
    Change from Baseline until Safety Follow-up Visit in vital signs (temperature)
    End point description
    Temperature was measured in degrees Celsius (°C). The Safety Set (SS) consisted of all participants who received at least 1 dose of the IMP. Note 1: 999 is used as a placeholder for values not evaluable because only one participant was analyzed. Note 2: The number of participants analyzed for each timepoint is presented in parentheses following this model (PBO, BKZ 64 mg Q4W, BKZ 160 mg Q4W, BKZ 160 mg w/ LD Q4W, BKZ 320 mg Q4W, BKZ 480 mg Q4W).
    End point type
    Secondary
    End point timeframe
    Baseline (Week 0), Week 1, Week 2, Week 4, Week 6, Week 8, Week 12, and Safety Follow-Up visit (20 weeks after the last dose)
    End point values
    Placebo (SS) Bimekizumab 64 mg Q4W (SS) Bimekizumab 160 mg Q4W (SS) Bimekizumab 160 mg w/ LD Q4W (SS) Bimekizumab 320 mg Q4W (SS) Bimekizumab 480 mg Q4W (SS)
    Number of subjects analysed
    42
    39
    42
    40
    43
    43
    Units: °C
    arithmetic mean (standard deviation)
        Week 1 (42, 39, 42, 40, 43, 43)
    -0.07 ± 0.23
    -0.04 ± 0.22
    0.02 ± 0.30
    -0.11 ± 0.32
    -0.07 ± 0.30
    0.02 ± 0.35
        Week 2 (42, 39, 41, 39, 42, 42)
    0.00 ± 0.26
    0.02 ± 0.26
    0.01 ± 0.33
    0.01 ± 0.35
    -0.04 ± 0.36
    -0.01 ± 0.35
        Week 4 (42, 39, 41, 39, 41, 41)
    -0.05 ± 0.29
    0.03 ± 0.24
    0.00 ± 0.42
    -0.04 ± 0.24
    -0.03 ± 0.26
    -0.01 ± 0.41
        Week 6 (40, 38, 38, 37, 40, 40)
    -0.03 ± 0.29
    -0.02 ± 0.25
    -0.01 ± 0.22
    -0.06 ± 0.43
    -0.03 ± 0.38
    0.07 ± 0.24
        Week 8 (39, 38, 38, 37, 40, 40)
    0.01 ± 0.24
    -0.02 ± 0.28
    0.00 ± 0.33
    -0.03 ± 0.41
    0.00 ± 0.35
    0.02 ± 0.31
        Week 12 (39, 38, 38, 35, 40, 39)
    0.10 ± 0.27
    0.00 ± 0.27
    0.06 ± 0.36
    -0.04 ± 0.28
    0.00 ± 0.33
    0.00 ± 0.30
        SFU (4, 4, 4, 2, 1, 3)
    0.08 ± 0.22
    0.15 ± 0.33
    -0.03 ± 0.05
    0.10 ± 0.00
    0.10 ± 999
    0.43 ± 0.31
    No statistical analyses for this end point

    Secondary: Percentage of participants with clinically significant physical examination abnormalities

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    End point title
    Percentage of participants with clinically significant physical examination abnormalities
    End point description
    The physical examination included general appearance; ear, nose, and throat; eyes, hair, and skin; respiratory; CV; GI; musculoskeletal; hepatic; neurological (including limb reflexes); and mental status. Any clinically significant abnormal findings during the study were captured as adverse events. The Safety Set (SS) consisted of all participants who received at least 1 dose of the IMP.
    End point type
    Secondary
    End point timeframe
    At Screening, Week 12/Early Withdrawal Visit and the Safety Follow-Up Visit (20 weeks after the last dose)
    End point values
    Placebo (SS) Bimekizumab 64 mg Q4W (SS) Bimekizumab 160 mg Q4W (SS) Bimekizumab 160 mg w/ LD Q4W (SS) Bimekizumab 320 mg Q4W (SS) Bimekizumab 480 mg Q4W (SS)
    Number of subjects analysed
    42
    39
    43
    40
    43
    43
    Units: percentage of participants
        number (not applicable)
    23.8
    7.7
    11.6
    10.0
    9.3
    0
    No statistical analyses for this end point

    Secondary: Percentage of participants with clinically significant abnormal 12-Lead electrocardiogram (ECG) findings

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    End point title
    Percentage of participants with clinically significant abnormal 12-Lead electrocardiogram (ECG) findings
    End point description
    Percentages were based on the number of participants with a non-missing measurement for that variable at the visit. The Safety Set (SS) consisted of all participants who received at least 1 dose of the IMP. Note: The number of participants analyzed for each timepoint is presented in parentheses following this model (PBO, BKZ 64 mg Q4W, BKZ 160 mg Q4W, BKZ 160 mg w/ LD Q4W, BKZ 320 mg Q4W, BKZ 480 mg Q4W).
    End point type
    Secondary
    End point timeframe
    Baseline (Week 0), Week 2, Week 4, Week 6, Week 12, and Safety Follow-Up visit (20 weeks after the last dose)
    End point values
    Placebo (SS) Bimekizumab 64 mg Q4W (SS) Bimekizumab 160 mg Q4W (SS) Bimekizumab 160 mg w/ LD Q4W (SS) Bimekizumab 320 mg Q4W (SS) Bimekizumab 480 mg Q4W (SS)
    Number of subjects analysed
    42
    39
    43
    40
    43
    43
    Units: percentage of participants
    number (not applicable)
        Baseline (42, 39, 43, 40, 43, 43)
    0
    0
    0
    2.5
    0
    0
        Week 2 (42, 39, 41, 39, 42, 42)
    0
    0
    0
    2.6
    0
    0
        Week 4 (42, 39, 41, 39, 41, 41)
    0
    0
    0
    0
    0
    0
        Week 6 (40, 38, 38, 36, 40, 40)
    0
    0
    0
    0
    0
    0
        Week 12 (39, 38, 38, 34, 39, 39)
    0
    0
    0
    0
    0
    0
        SFU (4, 4, 4, 2, 1, 3)
    0
    0
    0
    0
    0
    0
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Treatment-emergent adverse events (TEAEs) were collected from Baseline (Week 0) to End of Safety Follow-up (up to Week 28)
    Adverse event reporting additional description
    It was pre-specified to report AEs that have a start date on or following the first administration of treatment. TEAEs counts for each study period: Treatment Period (Wk1-12) for all participants who received at least 1 treatment and Post-Treatment Period for those who either enrolled in an extension study (PS0011) or entered a 20-week SFU Period.
    Assessment type
    Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    19.0
    Reporting groups
    Reporting group title
    Placebo (SS) Treatment Period
    Reporting group description
    During the Treatment Period participants randomized to the placebo group, received a combination of several injections of placebo, subcutaneously every 4 weeks (Q4W). Participants formed the Safety Set (SS).

    Reporting group title
    Bimekizumab 64 mg Q4W (SS) Treatment Period
    Reporting group description
    During the Treatment Period participants were randomized to receive subcutaneous injections of 64 mg bimekizumab Q4W. Participants formed the SS.

    Reporting group title
    Bimekizumab 160 mg Q4W (SS) Treatment Period
    Reporting group description
    During the Treatment Period participants were randomized to receive subcutaneous injections of 160 mg bimekizumab Q4W. Participants formed the SS.

    Reporting group title
    Bimekizumab 160 mg w/ LD Q4W (SS) Treatment Period
    Reporting group description
    During the Treatment Period participants were randomized to receive subcutaneous injections of 320 mg bimekizumab loading dose at Baseline followed by 160 mg bimekizumab Q4W. Participants formed the SS.

    Reporting group title
    Bimekizumab 320 mg Q4W (SS) Treatment Period
    Reporting group description
    During the Treatment Period participants were randomized to receive subcutaneous injections of 320 mg bimekizumab Q4W. Participants formed the SS.

    Reporting group title
    Bimekizumab 480 mg Q4W (SS) Treatment Period
    Reporting group description
    During the Treatment Period participants were randomized to receive subcutaneous injections of 480 mg bimekizumab Q4W. Participants formed the SS.

    Reporting group title
    Placebo (SS) Post-Treatment Period
    Reporting group description
    At Week 12, participants who were randomized to receive Placebo during the Treatment Period and who enrolled in the extension study (PS0011), underwent the Week 12 study assessments and then received their first extension study dose of study treatment. All participants who did not enroll in the extension study had the Week 12 study assessments and entered the Safety Follow-Up (SFU) Period, 20 weeks after the last dose of study medication. Participants did not receive any treatment during the Post-Treatment Period. Participants formed the SS.

    Reporting group title
    Bimekizumab 64 mg Q4W (SS) Post-Treatment Period
    Reporting group description
    At Week 12, participants who were randomized to receive 64 mg bimekizumab Q4W during the Treatment Period and who enrolled in the extension study (PS0011), underwent the Week 12 study assessments and then received their first extension study dose of study treatment. All participants who did not enroll in the extension study had the Week 12 study assessments and entered the Safety Follow-Up (SFU) Period, 20 weeks after the last dose of study medication. Participants did not receive any treatment during the Post-Treatment Period. Participants formed the SS.

    Reporting group title
    Bimekizumab 160 mg Q4W (SS) Post-Treatment Period
    Reporting group description
    At Week 12, participants who were randomized to receive 160 mg bimekizumab Q4W during the Treatment Period and who enrolled in the extension study (PS0011), underwent the Week 12 study assessments and then received their first extension study dose of study treatment. All participants who did not enroll in the extension study had the Week 12 study assessments and entered the Safety Follow-Up (SFU) Period, 20 weeks after the last dose of study medication. Participants did not receive any treatment during the Post-Treatment Period. Participants formed the SS.

    Reporting group title
    Bimekizumab 160 mg w/ LD Q4W (SS) Post-Treatment Period
    Reporting group description
    At Week 12, participants who were randomized to receive 320 mg bimekizumab loading dose at Baseline followed by 160 mg bimekizumab Q4W during the Treatment Period and who enrolled in the extension study (PS0011), underwent the Week 12 study assessments and then received their first extension study dose of study treatment. All participants who did not enroll in the extension study had the Week 12 study assessments and entered the Safety Follow-Up (SFU) Period, 20 weeks after the last dose of study medication. Participants did not receive any treatment during the Post-Treatment Period. Participants formed the SS.

    Reporting group title
    Bimekizumab 320 mg Q4W (SS) Post-Treatment Period
    Reporting group description
    At Week 12, participants who were randomized to receive 320 mg bimekizumab Q4W during the Treatment Period and who enrolled in the extension study (PS0011), underwent the Week 12 study assessments and then received their first extension study dose of study treatment. All participants who did not enroll in the extension study had the Week 12 study assessments and entered the Safety Follow-Up (SFU) Period, 20 weeks after the last dose of study medication. Participants did not receive any treatment during the Post-Treatment Period. Participants formed the SS.

    Reporting group title
    Bimekizumab 480 mg Q4W (SS) Post-Treatment Period
    Reporting group description
    At Week 12, participants who were randomized to receive 480 mg bimekizumab Q4W during the Treatment Period and who enrolled in the extension study (PS0011), underwent the Week 12 study assessments and then received their first extension study dose of study treatment. All participants who did not enroll in the extension study had the Week 12 study assessments and entered the Safety Follow-Up (SFU) Period, 20 weeks after the last dose of study medication. Participants did not receive any treatment during the Post-Treatment Period. Participants formed the SS.

    Serious adverse events
    Placebo (SS) Treatment Period Bimekizumab 64 mg Q4W (SS) Treatment Period Bimekizumab 160 mg Q4W (SS) Treatment Period Bimekizumab 160 mg w/ LD Q4W (SS) Treatment Period Bimekizumab 320 mg Q4W (SS) Treatment Period Bimekizumab 480 mg Q4W (SS) Treatment Period Placebo (SS) Post-Treatment Period Bimekizumab 64 mg Q4W (SS) Post-Treatment Period Bimekizumab 160 mg Q4W (SS) Post-Treatment Period Bimekizumab 160 mg w/ LD Q4W (SS) Post-Treatment Period Bimekizumab 320 mg Q4W (SS) Post-Treatment Period Bimekizumab 480 mg Q4W (SS) Post-Treatment Period
    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%)
    0 / 42 (0.00%)
    1 / 39 (2.56%)
    0 / 43 (0.00%)
    0 / 40 (0.00%)
    0 / 43 (0.00%)
    0 / 43 (0.00%)
         number of deaths (all causes)
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Cardiac disorders
    Myocardial infarction
         subjects affected / exposed
    0 / 42 (0.00%)
    0 / 39 (0.00%)
    0 / 43 (0.00%)
    0 / 40 (0.00%)
    0 / 43 (0.00%)
    0 / 43 (0.00%)
    0 / 42 (0.00%)
    1 / 39 (2.56%)
    0 / 43 (0.00%)
    0 / 40 (0.00%)
    0 / 43 (0.00%)
    0 / 43 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    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
    0 / 0
    0 / 0
    0 / 0
    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%)
    0 / 42 (0.00%)
    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 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    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
    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%)
    0 / 42 (0.00%)
    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 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    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
    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%)
    0 / 42 (0.00%)
    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
    0 / 0
    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
    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 (SS) Treatment Period Bimekizumab 64 mg Q4W (SS) Treatment Period Bimekizumab 160 mg Q4W (SS) Treatment Period Bimekizumab 160 mg w/ LD Q4W (SS) Treatment Period Bimekizumab 320 mg Q4W (SS) Treatment Period Bimekizumab 480 mg Q4W (SS) Treatment Period Placebo (SS) Post-Treatment Period Bimekizumab 64 mg Q4W (SS) Post-Treatment Period Bimekizumab 160 mg Q4W (SS) Post-Treatment Period Bimekizumab 160 mg w/ LD Q4W (SS) Post-Treatment Period Bimekizumab 320 mg Q4W (SS) Post-Treatment Period Bimekizumab 480 mg Q4W (SS) Post-Treatment Period
    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%)
    0 / 42 (0.00%)
    0 / 39 (0.00%)
    0 / 43 (0.00%)
    0 / 40 (0.00%)
    0 / 43 (0.00%)
    0 / 43 (0.00%)
    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%)
    0 / 42 (0.00%)
    0 / 39 (0.00%)
    0 / 43 (0.00%)
    0 / 40 (0.00%)
    0 / 43 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    3
    1
    1
    1
    0
    1
    0
    0
    0
    0
    0
    0
    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%)
    0 / 42 (0.00%)
    0 / 39 (0.00%)
    0 / 43 (0.00%)
    0 / 40 (0.00%)
    0 / 43 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    1
    0
    3
    2
    2
    0
    0
    0
    0
    0
    0
    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%)
    0 / 42 (0.00%)
    0 / 39 (0.00%)
    0 / 43 (0.00%)
    0 / 40 (0.00%)
    0 / 43 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    0
    2
    0
    1
    3
    0
    0
    0
    0
    0
    0
    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%)
    0 / 42 (0.00%)
    0 / 39 (0.00%)
    0 / 43 (0.00%)
    0 / 40 (0.00%)
    0 / 43 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    0
    3
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    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%)
    0 / 42 (0.00%)
    0 / 39 (0.00%)
    0 / 43 (0.00%)
    0 / 40 (0.00%)
    0 / 43 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    0
    2
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    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%)
    0 / 42 (0.00%)
    0 / 39 (0.00%)
    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
    0
    0
    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%)
    0 / 42 (0.00%)
    0 / 39 (0.00%)
    0 / 43 (0.00%)
    0 / 40 (0.00%)
    0 / 43 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    0
    2
    0
    1
    3
    5
    0
    0
    0
    0
    0
    0
    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%)
    0 / 42 (0.00%)
    0 / 39 (0.00%)
    0 / 43 (0.00%)
    0 / 40 (0.00%)
    0 / 43 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    2
    5
    3
    3
    6
    5
    0
    0
    0
    0
    0
    0
    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%)
    0 / 42 (0.00%)
    0 / 39 (0.00%)
    0 / 43 (0.00%)
    0 / 40 (0.00%)
    0 / 43 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    1
    5
    3
    3
    2
    0
    0
    0
    0
    0
    0
    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%)
    0 / 42 (0.00%)
    0 / 39 (0.00%)
    0 / 43 (0.00%)
    0 / 40 (0.00%)
    0 / 43 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    1
    2
    1
    1
    1
    0
    0
    0
    0
    0
    0
    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%)
    0 / 42 (0.00%)
    0 / 39 (0.00%)
    0 / 43 (0.00%)
    0 / 40 (0.00%)
    0 / 43 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    0
    3
    2
    0
    0
    0
    0
    0
    0
    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%)
    0 / 42 (0.00%)
    0 / 39 (0.00%)
    0 / 43 (0.00%)
    0 / 40 (0.00%)
    0 / 43 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    0
    0
    0
    1
    3
    0
    0
    0
    0
    0
    0
    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%)
    0 / 42 (0.00%)
    0 / 39 (0.00%)
    0 / 43 (0.00%)
    0 / 40 (0.00%)
    0 / 43 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    1
    2
    1
    0
    0
    1
    0
    0
    0
    0
    0
    0

    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 participants. Participants who lacked the capacity to consent were not included in the study. •Clarified the exclusion criterion regarding laboratory values. •Clarified that participants 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 participant in the Withdrawal Criteria. •Clarified withdrawal criteria regarding participants who developed illnesses that would have interfered with study participation and regarding the withdrawal of participants 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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