<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03025542</url>
  </required_header>
  <id_info>
    <org_study_id>PS0016</org_study_id>
    <secondary_id>2016-002368-15</secondary_id>
    <nct_id>NCT03025542</nct_id>
  </id_info>
  <brief_title>A Study to Evaluate the Pharmacokinetics (PK), Pharmacodynamics (PD), and Safety of Bimekizumab in Patients With Chronic Plaque Psoriasis</brief_title>
  <official_title>A Multicenter, Randomized, Subject-Blind, Investigator-Blind Study to Evaluate the Time Course of Pharmacodynamic Response, Safety and Pharmacokinetics of Bimekizumab in Adult Subjects With Moderate to Severe Chronic Plaque Psoriasis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>UCB Biopharma SRL</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Parexel</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>UCB Pharma</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a Phase 2a, multicenter, randomized, subject-blind, investigator-blind, study to&#xD;
      investigate the pharmacokinetics (PK), pharmacodynamics (PD), and safety of bimekizumab in&#xD;
      adult subjects with moderate to severe chronic plaque psoriasis&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 27, 2016</start_date>
  <completion_date type="Actual">December 11, 2017</completion_date>
  <primary_completion_date type="Actual">December 11, 2017</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
    <masking_description>This is an Investigator- and Subject-blind study.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Change From Baseline in Psoriasis Area and Severity Index (PASI) at Week 28</measure>
    <time_frame>From Baseline to Week 28</time_frame>
    <description>The PASI is the most commonly used and validated assessment for grading the severity of psoriasis in clinical studies. The PASI quantifies the severity and extent of the disease and weighs these with the percentage of body surface area (BSA) involvement. The percent area of involvement (BSA%) is estimated across 4 body areas; head (10%), upper limbs (20%), trunk (30%), and lower limbs (40%) and then transferred into a grade. The Investigator assesses the average redness, thickness, and scaliness of lesions in each body area (each on a 5 point scale); 0=none, 1=slight, 2=moderate, 3=marked, and 4=very marked. The PASI score ranges from 0 to 72 with a higher score indicating increased disease severity.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Plasma Concentration of Bimekizumab at Baseline</measure>
    <time_frame>at Baseline</time_frame>
    <description>Plasma concentration was expressed as geometric mean concentrations (GMCs) and measured in micrograms per milliliter (μg/mL). Note: Means, Lower confidence interval (LCI), Upper confidence interval (UCI) are only calculated if at least 2/3 of the concentrations were quantified at the respective time point. Values below limit of quantification (BLQ) are replaced by value of lower limit of quantification (LLOQ)/2 (=0.075ug/mL) in calculations of means.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Plasma Concentration of Bimekizumab at Week 2</measure>
    <time_frame>at Week 2</time_frame>
    <description>Plasma concentration was expressed as geometric mean concentrations (GMCs) and measured in micrograms per milliliter (μg/mL). Note: Means, Lower confidence interval (LCI), Upper confidence interval (UCI) are only calculated if at least 2/3 of the concentrations were quantified at the respective time point. Values below limit of quantification (BLQ) are replaced by value of lower limit of quantification (LLOQ)/2 (=0.075ug/mL) in calculations of means.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Plasma Concentration of Bimekizumab at Week 4</measure>
    <time_frame>at Week 4</time_frame>
    <description>Plasma concentration was expressed as geometric mean concentrations (GMCs) and measured in micrograms per milliliter (μg/mL). Note: Means, Lower confidence interval (LCI), Upper confidence interval (UCI) are only calculated if at least 2/3 of the concentrations were quantified at the respective time point. Values below limit of quantification (BLQ) are replaced by value of lower limit of quantification (LLOQ)/2 (=0.075ug/mL) in calculations of means.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Plasma Concentration of Bimekizumab at Week 8</measure>
    <time_frame>at Week 8</time_frame>
    <description>Plasma concentration was expressed as geometric mean concentrations (GMCs) and measured in micrograms per milliliter (μg/mL). Note: Means, Lower confidence interval (LCI), Upper confidence interval (UCI) are only calculated if at least 2/3 of the concentrations were quantified at the respective time point. Values below limit of quantification (BLQ) are replaced by value of lower limit of quantification (LLOQ)/2 (=0.075ug/mL) in calculations of means.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Plasma Concentration of Bimekizumab at Week 12</measure>
    <time_frame>at Week 12</time_frame>
    <description>Plasma concentration was expressed as geometric mean concentrations (GMCs) and measured in micrograms per milliliter (μg/mL). Note: Means, Lower confidence interval (LCI), Upper confidence interval (UCI) are only calculated if at least 2/3 of the concentrations were quantified at the respective time point. Values below limit of quantification (BLQ) are replaced by value of lower limit of quantification (LLOQ)/2 (=0.075ug/mL) in calculations of means.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Plasma Concentration of Bimekizumab at Week 16</measure>
    <time_frame>at Week 16</time_frame>
    <description>Plasma concentration was expressed as geometric mean concentrations (GMCs) and measured in micrograms per milliliter (µg/mL). Note: Means, Lower confidence interval (LCI), Upper confidence interval (UCI) are only calculated if at least 2/3 of the concentrations were quantified at the respective time point. Values below limit of quantification (BLQ) are replaced by value of lower limit of quantification (LLOQ)/2 (=0.075ug/mL) in calculations of means.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Plasma Concentration of Bimekizumab at Week 20</measure>
    <time_frame>at Week 20</time_frame>
    <description>Plasma concentration was expressed as geometric mean concentrations (GMCs) and measured in micrograms per milliliter (μg/mL). Note: Means, Lower confidence interval (LCI), Upper confidence interval (UCI) are only calculated if at least 2/3 of the concentrations were quantified at the respective time point. Values below limit of quantification (BLQ) are replaced by value of lower limit of quantification (LLOQ)/2 (=0.075ug/mL) in calculations of means.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Plasma Concentration of Bimekizumab at Week 24</measure>
    <time_frame>at Week 24</time_frame>
    <description>Plasma concentration was expressed as geometric mean concentrations (GMCs) and measured in micrograms per milliliter (μg/mL). Note: Means, Lower confidence interval (LCI), Upper confidence interval (UCI) are only calculated if at least 2/3 of the concentrations were quantified at the respective time point. Values below limit of quantification (BLQ) are replaced by value of lower limit of quantification (LLOQ)/2 (=0.075ug/mL) in calculations of means.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Plasma Concentration of Bimekizumab at Week 28</measure>
    <time_frame>at Week 28</time_frame>
    <description>Plasma concentration was expressed as geometric mean concentrations (GMCs) and measured in micrograms per milliliter (μg/mL). Note: Means, Lower confidence interval (LCI), Upper confidence interval (UCI) are only calculated if at least 2/3 of the concentrations were quantified at the respective time point. Values below limit of quantification (BLQ) are replaced by value of lower limit of quantification (LLOQ)/2 (=0.075ug/mL) in calculations of means.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Plasma Concentration of Bimekizumab at Week 36</measure>
    <time_frame>at Week 36</time_frame>
    <description>Plasma concentration was expressed as geometric mean concentrations (GMCs) and measured in micrograms per milliliter (μg/mL). Note: Means, Lower confidence interval (LCI), Upper confidence interval (UCI) are only calculated if at least 2/3 of the concentrations were quantified at the respective time point. Values below limit of quantification (BLQ) are replaced by value of lower limit of quantification (LLOQ)/2 (=0.075ug/mL) in calculations of means.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Percentage of Participants Reporting Positive Anti-Drug-Antibodies (ADA) Titre Prior to Study Treatment With Bimekizumab at Baseline</measure>
    <time_frame>at Baseline</time_frame>
    <description>An ADA status of positive was concluded for any participant with an ADA level that was above cut point (ACP) and 'confirmed positive' (CP) at any time point. A participant was classified as having treatment-induced ADA positivity when meeting one of the following criteria: -The Baseline result was either below cut point (BCP) or ACP and 'not confirmed positive' (NCP), and at least 1 post Baseline time point was ACP and CP. -The Baseline result was positive (ACP and CP) and at least one post-Baseline measurement showed a pre-defined fold increase in titre from the Baseline value. Note: The overall status of a participant is 'Positive' if at any post-Baseline visit the result was ACP and confirmed positive.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Percentage of Participants Reporting an Overall Positive Anti-Drug-Antibodies (ADA) Titre Following Study Treatment With Bimekizumab</measure>
    <time_frame>From Baseline to Safety Follow-Up Visit (Week 36)</time_frame>
    <description>An ADA status of positive was concluded for any participant with an ADA level that was above cut point (ACP) and 'confirmed positive' (CP) at any time point. A participant was classified as having treatment-induced ADA positivity when meeting one of the following criteria: -The Baseline result was either below cut point (BCP) or ACP and 'not confirmed positive' (NCP), and at least 1 post Baseline time point was ACP and CP. -The Baseline result was positive (ACP and CP) and at least one post-Baseline measurement showed a pre-defined fold increase in titre from the Baseline value. Note: The overall status of a participant is 'Positive' if at any post-Baseline visit the result was ACP and confirmed positive.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Percentage of Participants Who Experienced at Least One Adverse Events (AEs)</measure>
    <time_frame>From Screening to Safety Follow-Up Visit (Week 36)</time_frame>
    <description>An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment. Within the Safety Set, this trial reported a total of 164 occurences of adverse events, of which 7 were pre-treatment adverse events and 157 were treatment-emergent adverse events (TEAEs).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants Achieving a 75% or Higher Improvement From Baseline in PASI (Psoriasis Area and Severity Index) Score at Week 16</measure>
    <time_frame>From Baseline to Week 16</time_frame>
    <description>The PASI75 response assessments are based on at least 75% improvement in the PASI score from Baseline. This is a scoring system that averages the redness, thickness, and scaliness of the psoriatic lesions (on a 0-4 scale), and weights the resulting score by the area of skin involved. Body divided into 4 areas: head, arms, trunk to groin, and legs to top of buttocks. Assignment of an average score for the redness, thickness, and scaling for each of the 4 body areas with a score of 0 (clear) to 4 (very marked). Determining the percentage of skin covered with PSO for each of the body areas and converting to a 0 to 6 scale. Final PASI= average redness, thickness, and scaliness of the psoriatic skin lesions, multiplied by the involved psoriasis area score of the respective section, and weighted by the percentage of the person's affected skin for the respective section. The minimum possible PASI score is 0= no disease, the maximum score is 72= maximal disease.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants Achieving a 90% or Higher Improvement From Baseline in PASI (Psoriasis Area and Severity Index) Score at Week 16</measure>
    <time_frame>From Baseline to Week 16</time_frame>
    <description>The PASI90 response assessments are based on at least 90% improvement in the PASI score from Baseline. This is a scoring system that averages the redness, thickness, and scaliness of the psoriatic lesions (on a 0-4 scale), and weights the resulting score by the area of skin involved. Body divided into 4 areas: head, arms, trunk to groin, and legs to top of buttocks. Assignment of an average score for the redness, thickness, and scaling for each of the 4 body areas with a score of 0 (clear) to 4 (very marked). Determining the percentage of skin covered with PSO for each of the body areas and converting to a 0 to 6 scale. Final PASI= average redness, thickness, and scaliness of the psoriatic skin lesions, multiplied by the involved psoriasis area score of the respective section, and weighted by the percentage of the person's affected skin for the respective section. The minimum possible PASI score is 0= no disease, the maximum score is 72= maximal disease.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants Achieving a 100% Improvement From Baseline in PASI (Psoriasis Area and Severity Index) Score at Week 16</measure>
    <time_frame>From Baseline to Week 16</time_frame>
    <description>The PASI100 response assessments are based on at least 100% improvement in the PASI score from Baseline. This is a scoring system that averages the redness, thickness, and scaliness of the psoriatic lesions (on a 0-4 scale), and weights the resulting score by the area of skin involved. Body divided into 4 areas: head, arms, trunk to groin, and legs to top of buttocks. Assignment of an average score for the redness, thickness, and scaling for each of the 4 body areas with a score of 0 (clear) to 4 (very marked). Determining the percentage of skin covered with PSO for each of the body areas and converting to a 0 to 6 scale. Final PASI= average redness, thickness, and scaliness of the psoriatic skin lesions, multiplied by the involved psoriasis area score of the respective section, and weighted by the percentage of the person's affected skin for the respective section. The minimum possible PASI score is 0= no disease, the maximum score is 72= maximal disease.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With IGA (Investigator´s Global Assessment) Response at Week 16</measure>
    <time_frame>at Week 16</time_frame>
    <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.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">49</enrollment>
  <condition>Chronic Plaque Psoriasis</condition>
  <arm_group>
    <arm_group_label>Treatment Arm 1</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Subjects randomized in this arm will receive a combination of Bimekizumab and Placebo injections.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Treatment Arm 2</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Subjects randomized in this arm will receive Bimekizumab injections.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Bimekizumab</intervention_name>
    <description>Based on their randomization subjects will receive a combination of several injections of Bimekizumab.</description>
    <arm_group_label>Treatment Arm 1</arm_group_label>
    <arm_group_label>Treatment Arm 2</arm_group_label>
    <other_name>UCB4940</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Subjects will receive injections of Placebo.</description>
    <arm_group_label>Treatment Arm 1</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Male or female at least 18 years of age and less than or equal to 70&#xD;
&#xD;
          -  Chronic plaque psoriasis for at least 6 months prior to Screening&#xD;
&#xD;
          -  Psoriasis Area and Severity Index (PASI) &gt;=12 and body surface area (BSA) &gt;=10% and&#xD;
             Investigator's Global Assessment (IGA) score &gt;=3 on a 5-point scale&#xD;
&#xD;
          -  Candidates for systemic psoriasis therapy and/or phototherapy and/or chemophototherapy&#xD;
&#xD;
          -  Female subjects must be postmenopausal, permanently sterilized or, if of childbearing&#xD;
             potential, must be willing to use a highly effective method of contraception up till&#xD;
             20 weeks after last administration of study drug, and have a negative pregnancy test&#xD;
             at Visit 1 (Screening) and immediately prior to first dose&#xD;
&#xD;
          -  Male subjects with a partner of childbearing potential must be willing to use a condom&#xD;
             when sexually active, up till 20 weeks after the last administration of study&#xD;
             medication (anticipated 5 half-lives)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Subjects previously participating in a bimekizumab study&#xD;
&#xD;
          -  Subjects with erythrodermic, guttate, pustular form of psoriasis, or drug-induced&#xD;
             psoriasis&#xD;
&#xD;
          -  History of chronic or recurrent infections, or a serious or life-threatening infection&#xD;
             within the 6 months prior to the Baseline Visit (including herpes zoster)&#xD;
&#xD;
          -  High risk of infection in the Investigator's opinion&#xD;
&#xD;
          -  Current sign or symptom that may indicate an active infection&#xD;
&#xD;
          -  Concurrent acute or chronic viral hepatitis B or C or human immunodeficiency virus&#xD;
             (HIV) infection&#xD;
&#xD;
          -  Live (includes attenuated) vaccination within the 8 weeks prior to Baseline&#xD;
&#xD;
          -  Subjects with concurrent malignancy or history of malignancy during the past 5 years&#xD;
             (except for specific malignant condition as defined in the protocol)&#xD;
&#xD;
          -  Primary immunosuppressive conditions&#xD;
&#xD;
          -  TB infection, high risk of acquiring TB infection, latent TB infection (LTBI), or&#xD;
             current or history of NTMB infection&#xD;
&#xD;
          -  Laboratory abnormalities, as defined in the study protocol&#xD;
&#xD;
          -  Any condition which, in the Investigator's judgement, would make the subject&#xD;
             unsuitable for inclusion in the study&#xD;
&#xD;
          -  Exposure to more than 1 biological response modifier (limited to anti-TNF or&#xD;
             IL-12/-23) or any biologic response modifier during the three months prior to the&#xD;
             Baseline Visit&#xD;
&#xD;
          -  Subjects have received previous treatment with any anti-IL-17 therapy for the&#xD;
             treatment of psoriasis or psoriatic arthritis&#xD;
&#xD;
          -  Subjects with a diagnosis of inflammatory conditions other than psoriasis or psoriatic&#xD;
             arthritis, including but not limited to rheumatoid arthritis, sarcoidosis, or systemic&#xD;
             lupus erythematosus. Subjects with a diagnosis of Crohn's disease or ulcerative&#xD;
             colitis are allowed as long as they have no active symptomatic disease at Screening or&#xD;
             Baseline&#xD;
&#xD;
          -  Subjects taking psoriatic arthritis medications other than nonsteroidal&#xD;
             anti-inflammatory drugs (NSAIDs) or analgesics&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>UCB Cares</last_name>
    <role>Study Director</role>
    <affiliation>001 844 599 2273(UCB)</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Ps0016 704</name>
      <address>
        <city>Bexley</city>
        <state>Ohio</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ps0016 102</name>
      <address>
        <city>Kogarah</city>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ps0016 101</name>
      <address>
        <city>Melbourne</city>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ps0016 104</name>
      <address>
        <city>Woolloongabba</city>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ps0016 201</name>
      <address>
        <city>Ajax</city>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ps0016 203</name>
      <address>
        <city>London</city>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ps0016 202</name>
      <address>
        <city>Windsor</city>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ps0016 501</name>
      <address>
        <city>Chisinau</city>
        <country>Moldova, Republic of</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Australia</country>
    <country>Canada</country>
    <country>Moldova, Republic of</country>
    <country>United States</country>
  </location_countries>
  <removed_countries>
    <country>Germany</country>
  </removed_countries>
  <link>
    <url>https://www.ema.europa.eu/en/documents/product-information/bimzelx-epar-product-information_en.pdf</url>
    <description>Product Information</description>
  </link>
  <link>
    <url>http://www.fda.gov/Safety/MedWatch/SafetyInformation/default.htm</url>
    <description>FDA Safety Alerts and Recalls</description>
  </link>
  <results_reference>
    <citation>Oliver R, Krueger JG, Glatt S, Vajjah P, Mistry C, Page M, Edwards H, Garcet S, Li X, Dizier B, Maroof A, Watling M, El Baghdady A, Baeten D, Ionescu L, Shaw S. Bimekizumab for the treatment of moderate-to-severe plaque psoriasis: efficacy, safety, pharmacokinetics, pharmacodynamics and transcriptomics from a phase IIa, randomized, double-blind multicentre study. Br J Dermatol. 2022 Apr;186(4):652-663. doi: 10.1111/bjd.20827. Epub 2021 Dec 27.</citation>
    <PMID>34687214</PMID>
  </results_reference>
  <results_reference>
    <citation>Gordon KB, Langley RG, Warren RB, Okubo Y, Stein Gold L, Merola JF, Peterson L, Wixted K, Cross N, Deherder D, Thaci D. Bimekizumab Safety in Patients With Moderate to Severe Plaque Psoriasis: Pooled Results From Phase 2 and Phase 3 Randomized Clinical Trials. JAMA Dermatol. 2022 Jul 1;158(7):735-744. doi: 10.1001/jamadermatol.2022.1185.</citation>
    <PMID>35544084</PMID>
  </results_reference>
  <verification_date>September 2022</verification_date>
  <study_first_submitted>January 17, 2017</study_first_submitted>
  <study_first_submitted_qc>January 18, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 19, 2017</study_first_posted>
  <results_first_submitted>December 9, 2020</results_first_submitted>
  <results_first_submitted_qc>December 9, 2020</results_first_submitted_qc>
  <results_first_posted type="Actual">January 6, 2021</results_first_posted>
  <disposition_first_submitted>December 10, 2018</disposition_first_submitted>
  <disposition_first_submitted_qc>December 10, 2018</disposition_first_submitted_qc>
  <disposition_first_posted type="Actual">December 11, 2018</disposition_first_posted>
  <last_update_submitted>September 30, 2022</last_update_submitted>
  <last_update_submitted_qc>September 30, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">October 28, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Psoriasis</keyword>
  <keyword>Chronic Plaque Psoriasis</keyword>
  <keyword>Bimekizumab</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Psoriasis</mesh_term>
  </condition_browse>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>September 23, 2016</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/42/NCT03025542/Prot_002.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Statistical Analysis Plan</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>November 30, 2017</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/42/NCT03025542/SAP_003.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <recruitment_details>The study started to enroll patients in December 2016 and concluded in December 2017.</recruitment_details>
      <pre_assignment_details>Participant Flow refers to the Safety Set (SS).</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Bimekizumab 320 mg + PBO</title>
          <description>Bimekizumab 320 milligrams (mg) administered subcutaneously (sc) at Baseline and Week 4, and placebo administered at Week 16.</description>
        </group>
        <group group_id="P2">
          <title>Bimekizumab 320 mg</title>
          <description>Bimekizumab 320 mg administered sc at Baseline and Weeks 4 and 16.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="32"/>
                <participants group_id="P2" count="17"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="30"/>
                <participants group_id="P2" count="15"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="2"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Adverse Event</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="2"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>Baseline Characteristics refer to the Safety Set (SS) which consisted of all participants who received at least 1 dose of the study medication.</population>
      <group_list>
        <group group_id="B1">
          <title>Bimekizumab 320 mg + PBO</title>
          <description>Bimekizumab 320 milligrams (mg) administered subcutaneously (sc) at Baseline and Week 4, and placebo administered at Week 16.</description>
        </group>
        <group group_id="B2">
          <title>Bimekizumab 320 mg</title>
          <description>Bimekizumab 320 mg administered sc at Baseline and Weeks 4 and 16.</description>
        </group>
        <group group_id="B3">
          <title>Total Title</title>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="32"/>
            <count group_id="B2" value="17"/>
            <count group_id="B3" value="49"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>&lt;=18 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="30"/>
                    <measurement group_id="B2" value="16"/>
                    <measurement group_id="B3" value="46"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="41.8" spread="14.1"/>
                    <measurement group_id="B2" value="45.9" spread="10.4"/>
                    <measurement group_id="B3" value="43.2" spread="13.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="17"/>
                    <measurement group_id="B2" value="6"/>
                    <measurement group_id="B3" value="23"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="15"/>
                    <measurement group_id="B2" value="11"/>
                    <measurement group_id="B3" value="26"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race/Ethnicity, Customized</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="4"/>
                    <measurement group_id="B3" value="5"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="30"/>
                    <measurement group_id="B2" value="12"/>
                    <measurement group_id="B3" value="42"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Change From Baseline in Psoriasis Area and Severity Index (PASI) at Week 28</title>
        <description>The PASI is the most commonly used and validated assessment for grading the severity of psoriasis in clinical studies. The PASI quantifies the severity and extent of the disease and weighs these with the percentage of body surface area (BSA) involvement. The percent area of involvement (BSA%) is estimated across 4 body areas; head (10%), upper limbs (20%), trunk (30%), and lower limbs (40%) and then transferred into a grade. The Investigator assesses the average redness, thickness, and scaliness of lesions in each body area (each on a 5 point scale); 0=none, 1=slight, 2=moderate, 3=marked, and 4=very marked. The PASI score ranges from 0 to 72 with a higher score indicating increased disease severity.</description>
        <time_frame>From Baseline to Week 28</time_frame>
        <population>The Full Analysis Set (FAS) consisted of all randomized participants who received at least 1 dose of the study medication and have a valid measurement of the primary efficacy variable post Baseline.</population>
        <group_list>
          <group group_id="O1">
            <title>Bimekizumab 320 mg + PBO (FAS)</title>
            <description>Bimekizumab 320 mg administered subcutaneously (sc) at Baseline and Week 4, and placebo administered at Week 16. Participants formed the Full Analysis Set (FAS).</description>
          </group>
          <group group_id="O2">
            <title>Bimekizumab 320 mg (FAS)</title>
            <description>Bimekizumab 320 mg administered sc at Baseline and Weeks 4 and 16. Participants formed the Full Analysis Set (FAS).</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Psoriasis Area and Severity Index (PASI) at Week 28</title>
          <description>The PASI is the most commonly used and validated assessment for grading the severity of psoriasis in clinical studies. The PASI quantifies the severity and extent of the disease and weighs these with the percentage of body surface area (BSA) involvement. The percent area of involvement (BSA%) is estimated across 4 body areas; head (10%), upper limbs (20%), trunk (30%), and lower limbs (40%) and then transferred into a grade. The Investigator assesses the average redness, thickness, and scaliness of lesions in each body area (each on a 5 point scale); 0=none, 1=slight, 2=moderate, 3=marked, and 4=very marked. The PASI score ranges from 0 to 72 with a higher score indicating increased disease severity.</description>
          <population>The Full Analysis Set (FAS) consisted of all randomized participants who received at least 1 dose of the study medication and have a valid measurement of the primary efficacy variable post Baseline.</population>
          <units>scores on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="32"/>
                <count group_id="O2" value="17"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-10.76" spread="7.58"/>
                    <measurement group_id="O2" value="-19.74" spread="8.77"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Plasma Concentration of Bimekizumab at Baseline</title>
        <description>Plasma concentration was expressed as geometric mean concentrations (GMCs) and measured in micrograms per milliliter (μg/mL). Note: Means, Lower confidence interval (LCI), Upper confidence interval (UCI) are only calculated if at least 2/3 of the concentrations were quantified at the respective time point. Values below limit of quantification (BLQ) are replaced by value of lower limit of quantification (LLOQ)/2 (=0.075ug/mL) in calculations of means.</description>
        <time_frame>at Baseline</time_frame>
        <population>The Pharmacokinetics Per-Protocol Set (PK-PPS) consisted of all randomized participants who received at least 1 dose of the study medication and provided at least 1 quantifiable plasma concentration post-dose. Number of participants analyzed reflects Baseline.</population>
        <group_list>
          <group group_id="O1">
            <title>Bimekizumab 320 mg + PBO (PK-PPS)</title>
            <description>Bimekizumab 320 mg administered subcutaneously (sc) at Baseline and Week 4, and placebo administered at Week 16. Participants formed the Pharmacokinetics Per-Protocol Set (PK-PPS).</description>
          </group>
          <group group_id="O2">
            <title>Bimekizumab 320 mg (PK-PPS)</title>
            <description>Bimekizumab 320 mg administered sc at Baseline and Weeks 4 and 16. Participants formed the Pharmacokinetics Per-Protocol Set (PK-PPS).</description>
          </group>
        </group_list>
        <measure>
          <title>Plasma Concentration of Bimekizumab at Baseline</title>
          <description>Plasma concentration was expressed as geometric mean concentrations (GMCs) and measured in micrograms per milliliter (μg/mL). Note: Means, Lower confidence interval (LCI), Upper confidence interval (UCI) are only calculated if at least 2/3 of the concentrations were quantified at the respective time point. Values below limit of quantification (BLQ) are replaced by value of lower limit of quantification (LLOQ)/2 (=0.075ug/mL) in calculations of means.</description>
          <population>The Pharmacokinetics Per-Protocol Set (PK-PPS) consisted of all randomized participants who received at least 1 dose of the study medication and provided at least 1 quantifiable plasma concentration post-dose. Number of participants analyzed reflects Baseline.</population>
          <units>μg/mL</units>
          <param>Geometric Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="32"/>
                <count group_id="O2" value="17"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="NA" lower_limit="NA" upper_limit="NA">Values were below the level of detection; Participants had no prior BKZ treatment.</measurement>
                    <measurement group_id="O2" value="NA" lower_limit="NA" upper_limit="NA">Values were below the level of detection; Participants had no prior BKZ treatment.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Plasma Concentration of Bimekizumab at Week 2</title>
        <description>Plasma concentration was expressed as geometric mean concentrations (GMCs) and measured in micrograms per milliliter (μg/mL). Note: Means, Lower confidence interval (LCI), Upper confidence interval (UCI) are only calculated if at least 2/3 of the concentrations were quantified at the respective time point. Values below limit of quantification (BLQ) are replaced by value of lower limit of quantification (LLOQ)/2 (=0.075ug/mL) in calculations of means.</description>
        <time_frame>at Week 2</time_frame>
        <population>The Pharmacokinetics Per-Protocol Set (PK-PPS) consisted of all randomized participants who received at least 1 dose of the study medication and provided at least 1 quantifiable plasma concentration post-dose. Number of participants analyzed reflects Week 2.</population>
        <group_list>
          <group group_id="O1">
            <title>Bimekizumab 320 mg + PBO (PK-PPS)</title>
            <description>Bimekizumab 320 mg administered subcutaneously (sc) at Baseline and Week 4, and placebo administered at Week 16. Participants formed the Pharmacokinetics Per-Protocol Set (PK-PPS).</description>
          </group>
          <group group_id="O2">
            <title>Bimekizumab 320 mg (PK-PPS)</title>
            <description>Bimekizumab 320 mg administered sc at Baseline and Weeks 4 and 16. Participants formed the Pharmacokinetics Per-Protocol Set (PK-PPS).</description>
          </group>
        </group_list>
        <measure>
          <title>Plasma Concentration of Bimekizumab at Week 2</title>
          <description>Plasma concentration was expressed as geometric mean concentrations (GMCs) and measured in micrograms per milliliter (μg/mL). Note: Means, Lower confidence interval (LCI), Upper confidence interval (UCI) are only calculated if at least 2/3 of the concentrations were quantified at the respective time point. Values below limit of quantification (BLQ) are replaced by value of lower limit of quantification (LLOQ)/2 (=0.075ug/mL) in calculations of means.</description>
          <population>The Pharmacokinetics Per-Protocol Set (PK-PPS) consisted of all randomized participants who received at least 1 dose of the study medication and provided at least 1 quantifiable plasma concentration post-dose. Number of participants analyzed reflects Week 2.</population>
          <units>μg/mL</units>
          <param>Geometric Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="32"/>
                <count group_id="O2" value="16"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="19.749" lower_limit="17.0" upper_limit="23.0"/>
                    <measurement group_id="O2" value="14.437" lower_limit="10.8" upper_limit="19.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Plasma Concentration of Bimekizumab at Week 4</title>
        <description>Plasma concentration was expressed as geometric mean concentrations (GMCs) and measured in micrograms per milliliter (μg/mL). Note: Means, Lower confidence interval (LCI), Upper confidence interval (UCI) are only calculated if at least 2/3 of the concentrations were quantified at the respective time point. Values below limit of quantification (BLQ) are replaced by value of lower limit of quantification (LLOQ)/2 (=0.075ug/mL) in calculations of means.</description>
        <time_frame>at Week 4</time_frame>
        <population>The Pharmacokinetics Per-Protocol Set (PK-PPS) consisted of all randomized participants who received at least 1 dose of the study medication and provided at least 1 quantifiable plasma concentration post-dose. Number of participants analyzed reflects Week 4.</population>
        <group_list>
          <group group_id="O1">
            <title>Bimekizumab 320 mg + PBO (PK-PPS)</title>
            <description>Bimekizumab 320 mg administered subcutaneously (sc) at Baseline and Week 4, and placebo administered at Week 16. Participants formed the Pharmacokinetics Per-Protocol Set (PK-PPS).</description>
          </group>
          <group group_id="O2">
            <title>Bimekizumab 320 mg (PK-PPS)</title>
            <description>Bimekizumab 320 mg administered sc at Baseline and Weeks 4 and 16. Participants formed the Pharmacokinetics Per-Protocol Set (PK-PPS).</description>
          </group>
        </group_list>
        <measure>
          <title>Plasma Concentration of Bimekizumab at Week 4</title>
          <description>Plasma concentration was expressed as geometric mean concentrations (GMCs) and measured in micrograms per milliliter (μg/mL). Note: Means, Lower confidence interval (LCI), Upper confidence interval (UCI) are only calculated if at least 2/3 of the concentrations were quantified at the respective time point. Values below limit of quantification (BLQ) are replaced by value of lower limit of quantification (LLOQ)/2 (=0.075ug/mL) in calculations of means.</description>
          <population>The Pharmacokinetics Per-Protocol Set (PK-PPS) consisted of all randomized participants who received at least 1 dose of the study medication and provided at least 1 quantifiable plasma concentration post-dose. Number of participants analyzed reflects Week 4.</population>
          <units>μg/mL</units>
          <param>Geometric Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="31"/>
                <count group_id="O2" value="17"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="11.402" lower_limit="9.7" upper_limit="13.4"/>
                    <measurement group_id="O2" value="9.077" lower_limit="7.2" upper_limit="11.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Plasma Concentration of Bimekizumab at Week 8</title>
        <description>Plasma concentration was expressed as geometric mean concentrations (GMCs) and measured in micrograms per milliliter (μg/mL). Note: Means, Lower confidence interval (LCI), Upper confidence interval (UCI) are only calculated if at least 2/3 of the concentrations were quantified at the respective time point. Values below limit of quantification (BLQ) are replaced by value of lower limit of quantification (LLOQ)/2 (=0.075ug/mL) in calculations of means.</description>
        <time_frame>at Week 8</time_frame>
        <population>The Pharmacokinetics Per-Protocol Set (PK-PPS) consisted of all randomized participants who received at least 1 dose of the study medication and provided at least 1 quantifiable plasma concentration post-dose. Number of participants analyzed reflects Week 8.</population>
        <group_list>
          <group group_id="O1">
            <title>Bimekizumab 320 mg + PBO (PK-PPS)</title>
            <description>Bimekizumab 320 mg administered subcutaneously (sc) at Baseline and Week 4, and placebo administered at Week 16. Participants formed the Pharmacokinetics Per-Protocol Set (PK-PPS).</description>
          </group>
          <group group_id="O2">
            <title>Bimekizumab 320 mg (PK-PPS)</title>
            <description>Bimekizumab 320 mg administered sc at Baseline and Weeks 4 and 16. Participants formed the Pharmacokinetics Per-Protocol Set (PK-PPS).</description>
          </group>
        </group_list>
        <measure>
          <title>Plasma Concentration of Bimekizumab at Week 8</title>
          <description>Plasma concentration was expressed as geometric mean concentrations (GMCs) and measured in micrograms per milliliter (μg/mL). Note: Means, Lower confidence interval (LCI), Upper confidence interval (UCI) are only calculated if at least 2/3 of the concentrations were quantified at the respective time point. Values below limit of quantification (BLQ) are replaced by value of lower limit of quantification (LLOQ)/2 (=0.075ug/mL) in calculations of means.</description>
          <population>The Pharmacokinetics Per-Protocol Set (PK-PPS) consisted of all randomized participants who received at least 1 dose of the study medication and provided at least 1 quantifiable plasma concentration post-dose. Number of participants analyzed reflects Week 8.</population>
          <units>μg/mL</units>
          <param>Geometric Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="31"/>
                <count group_id="O2" value="16"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="16.728" lower_limit="14.4" upper_limit="19.5"/>
                    <measurement group_id="O2" value="13.969" lower_limit="11.1" upper_limit="17.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Plasma Concentration of Bimekizumab at Week 12</title>
        <description>Plasma concentration was expressed as geometric mean concentrations (GMCs) and measured in micrograms per milliliter (μg/mL). Note: Means, Lower confidence interval (LCI), Upper confidence interval (UCI) are only calculated if at least 2/3 of the concentrations were quantified at the respective time point. Values below limit of quantification (BLQ) are replaced by value of lower limit of quantification (LLOQ)/2 (=0.075ug/mL) in calculations of means.</description>
        <time_frame>at Week 12</time_frame>
        <population>The Pharmacokinetics Per-Protocol Set (PK-PPS) consisted of all randomized participants who received at least 1 dose of the study medication and provided at least 1 quantifiable plasma concentration post-dose. Number of participants analyzed reflects Week 12.</population>
        <group_list>
          <group group_id="O1">
            <title>Bimekizumab 320 mg + PBO (PK-PPS)</title>
            <description>Bimekizumab 320 mg administered subcutaneously (sc) at Baseline and Week 4, and placebo administered at Week 16. Participants formed the Pharmacokinetics Per-Protocol Set (PK-PPS).</description>
          </group>
          <group group_id="O2">
            <title>Bimekizumab 320 mg (PK-PPS)</title>
            <description>Bimekizumab 320 mg administered sc at Baseline and Weeks 4 and 16. Participants formed the Pharmacokinetics Per-Protocol Set (PK-PPS).</description>
          </group>
        </group_list>
        <measure>
          <title>Plasma Concentration of Bimekizumab at Week 12</title>
          <description>Plasma concentration was expressed as geometric mean concentrations (GMCs) and measured in micrograms per milliliter (μg/mL). Note: Means, Lower confidence interval (LCI), Upper confidence interval (UCI) are only calculated if at least 2/3 of the concentrations were quantified at the respective time point. Values below limit of quantification (BLQ) are replaced by value of lower limit of quantification (LLOQ)/2 (=0.075ug/mL) in calculations of means.</description>
          <population>The Pharmacokinetics Per-Protocol Set (PK-PPS) consisted of all randomized participants who received at least 1 dose of the study medication and provided at least 1 quantifiable plasma concentration post-dose. Number of participants analyzed reflects Week 12.</population>
          <units>μg/mL</units>
          <param>Geometric Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="31"/>
                <count group_id="O2" value="15"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.972" lower_limit="4.9" upper_limit="7.3"/>
                    <measurement group_id="O2" value="5.466" lower_limit="3.9" upper_limit="7.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Plasma Concentration of Bimekizumab at Week 16</title>
        <description>Plasma concentration was expressed as geometric mean concentrations (GMCs) and measured in micrograms per milliliter (µg/mL). Note: Means, Lower confidence interval (LCI), Upper confidence interval (UCI) are only calculated if at least 2/3 of the concentrations were quantified at the respective time point. Values below limit of quantification (BLQ) are replaced by value of lower limit of quantification (LLOQ)/2 (=0.075ug/mL) in calculations of means.</description>
        <time_frame>at Week 16</time_frame>
        <population>The Pharmacokinetics Per-Protocol Set (PK-PPS) consisted of all randomized participants who received at least 1 dose of the study medication and provided at least 1 quantifiable plasma concentration post-dose. Number of participants analyzed reflects Week 16.</population>
        <group_list>
          <group group_id="O1">
            <title>Bimekizumab 320 mg + PBO (PK-PPS)</title>
            <description>Bimekizumab 320 mg administered subcutaneously (sc) at Baseline and Week 4, and placebo administered at Week 16. Participants formed the Pharmacokinetics Per-Protocol Set (PK-PPS).</description>
          </group>
          <group group_id="O2">
            <title>Bimekizumab 320 mg (PK-PPS)</title>
            <description>Bimekizumab 320 mg administered sc at Baseline and Weeks 4 and 16. Participants formed the Pharmacokinetics Per-Protocol Set (PK-PPS).</description>
          </group>
        </group_list>
        <measure>
          <title>Plasma Concentration of Bimekizumab at Week 16</title>
          <description>Plasma concentration was expressed as geometric mean concentrations (GMCs) and measured in micrograms per milliliter (µg/mL). Note: Means, Lower confidence interval (LCI), Upper confidence interval (UCI) are only calculated if at least 2/3 of the concentrations were quantified at the respective time point. Values below limit of quantification (BLQ) are replaced by value of lower limit of quantification (LLOQ)/2 (=0.075ug/mL) in calculations of means.</description>
          <population>The Pharmacokinetics Per-Protocol Set (PK-PPS) consisted of all randomized participants who received at least 1 dose of the study medication and provided at least 1 quantifiable plasma concentration post-dose. Number of participants analyzed reflects Week 16.</population>
          <units>µg/mL</units>
          <param>Geometric Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="31"/>
                <count group_id="O2" value="15"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.200" lower_limit="1.6" upper_limit="3.0"/>
                    <measurement group_id="O2" value="2.293" lower_limit="1.4" upper_limit="3.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Plasma Concentration of Bimekizumab at Week 20</title>
        <description>Plasma concentration was expressed as geometric mean concentrations (GMCs) and measured in micrograms per milliliter (μg/mL). Note: Means, Lower confidence interval (LCI), Upper confidence interval (UCI) are only calculated if at least 2/3 of the concentrations were quantified at the respective time point. Values below limit of quantification (BLQ) are replaced by value of lower limit of quantification (LLOQ)/2 (=0.075ug/mL) in calculations of means.</description>
        <time_frame>at Week 20</time_frame>
        <population>The Pharmacokinetics Per-Protocol Set (PK-PPS) consisted of all randomized participants who received at least 1 dose of the study medication and provided at least 1 quantifiable plasma concentration post-dose. Number of participants analyzed reflects Week 20.</population>
        <group_list>
          <group group_id="O1">
            <title>Bimekizumab 320 mg + PBO (PK-PPS)</title>
            <description>Bimekizumab 320 mg administered subcutaneously (sc) at Baseline and Week 4, and placebo administered at Week 16. Participants formed the Pharmacokinetics Per-Protocol Set (PK-PPS).</description>
          </group>
          <group group_id="O2">
            <title>Bimekizumab 320 mg (PK-PPS)</title>
            <description>Bimekizumab 320 mg administered sc at Baseline and Weeks 4 and 16. Participants formed the Pharmacokinetics Per-Protocol Set (PK-PPS).</description>
          </group>
        </group_list>
        <measure>
          <title>Plasma Concentration of Bimekizumab at Week 20</title>
          <description>Plasma concentration was expressed as geometric mean concentrations (GMCs) and measured in micrograms per milliliter (μg/mL). Note: Means, Lower confidence interval (LCI), Upper confidence interval (UCI) are only calculated if at least 2/3 of the concentrations were quantified at the respective time point. Values below limit of quantification (BLQ) are replaced by value of lower limit of quantification (LLOQ)/2 (=0.075ug/mL) in calculations of means.</description>
          <population>The Pharmacokinetics Per-Protocol Set (PK-PPS) consisted of all randomized participants who received at least 1 dose of the study medication and provided at least 1 quantifiable plasma concentration post-dose. Number of participants analyzed reflects Week 20.</population>
          <units>μg/mL</units>
          <param>Geometric Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="31"/>
                <count group_id="O2" value="15"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.798" lower_limit="0.5" upper_limit="1.2"/>
                    <measurement group_id="O2" value="9.702" lower_limit="7.3" upper_limit="13.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Plasma Concentration of Bimekizumab at Week 24</title>
        <description>Plasma concentration was expressed as geometric mean concentrations (GMCs) and measured in micrograms per milliliter (μg/mL). Note: Means, Lower confidence interval (LCI), Upper confidence interval (UCI) are only calculated if at least 2/3 of the concentrations were quantified at the respective time point. Values below limit of quantification (BLQ) are replaced by value of lower limit of quantification (LLOQ)/2 (=0.075ug/mL) in calculations of means.</description>
        <time_frame>at Week 24</time_frame>
        <population>The Pharmacokinetics Per-Protocol Set (PK-PPS) consisted of all randomized participants who received at least 1 dose of the study medication and provided at least 1 quantifiable plasma concentration post-dose. Number of participants analyzed reflects Week 24.</population>
        <group_list>
          <group group_id="O1">
            <title>Bimekizumab 320 mg + PBO (PK-PPS)</title>
            <description>Bimekizumab 320 mg administered subcutaneously (sc) at Baseline and Week 4, and placebo administered at Week 16. Participants formed the Pharmacokinetics Per-Protocol Set (PK-PPS).</description>
          </group>
          <group group_id="O2">
            <title>Bimekizumab 320 mg (PK-PPS)</title>
            <description>Bimekizumab 320 mg administered sc at Baseline and Weeks 4 and 16. Participants formed the Pharmacokinetics Per-Protocol Set (PK-PPS).</description>
          </group>
        </group_list>
        <measure>
          <title>Plasma Concentration of Bimekizumab at Week 24</title>
          <description>Plasma concentration was expressed as geometric mean concentrations (GMCs) and measured in micrograms per milliliter (μg/mL). Note: Means, Lower confidence interval (LCI), Upper confidence interval (UCI) are only calculated if at least 2/3 of the concentrations were quantified at the respective time point. Values below limit of quantification (BLQ) are replaced by value of lower limit of quantification (LLOQ)/2 (=0.075ug/mL) in calculations of means.</description>
          <population>The Pharmacokinetics Per-Protocol Set (PK-PPS) consisted of all randomized participants who received at least 1 dose of the study medication and provided at least 1 quantifiable plasma concentration post-dose. Number of participants analyzed reflects Week 24.</population>
          <units>μg/mL</units>
          <param>Geometric Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="29"/>
                <count group_id="O2" value="15"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="NA" lower_limit="NA" upper_limit="NA">Values were below the level of detection.</measurement>
                    <measurement group_id="O2" value="4.377" lower_limit="3.2" upper_limit="6.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Plasma Concentration of Bimekizumab at Week 28</title>
        <description>Plasma concentration was expressed as geometric mean concentrations (GMCs) and measured in micrograms per milliliter (μg/mL). Note: Means, Lower confidence interval (LCI), Upper confidence interval (UCI) are only calculated if at least 2/3 of the concentrations were quantified at the respective time point. Values below limit of quantification (BLQ) are replaced by value of lower limit of quantification (LLOQ)/2 (=0.075ug/mL) in calculations of means.</description>
        <time_frame>at Week 28</time_frame>
        <population>The Pharmacokinetics Per-Protocol Set (PK-PPS) consisted of all randomized participants who received at least 1 dose of the study medication and provided at least 1 quantifiable plasma concentration post-dose. Number of participants analyzed reflects Week 28.</population>
        <group_list>
          <group group_id="O1">
            <title>Bimekizumab 320 mg + PBO (PK-PPS)</title>
            <description>Bimekizumab 320 mg administered subcutaneously (sc) at Baseline and Week 4, and placebo administered at Week 16. Participants formed the Pharmacokinetics Per-Protocol Set (PK-PPS).</description>
          </group>
          <group group_id="O2">
            <title>Bimekizumab 320 mg (PK-PPS)</title>
            <description>Bimekizumab 320 mg administered sc at Baseline and Weeks 4 and 16. Participants formed the Pharmacokinetics Per-Protocol Set (PK-PPS).</description>
          </group>
        </group_list>
        <measure>
          <title>Plasma Concentration of Bimekizumab at Week 28</title>
          <description>Plasma concentration was expressed as geometric mean concentrations (GMCs) and measured in micrograms per milliliter (μg/mL). Note: Means, Lower confidence interval (LCI), Upper confidence interval (UCI) are only calculated if at least 2/3 of the concentrations were quantified at the respective time point. Values below limit of quantification (BLQ) are replaced by value of lower limit of quantification (LLOQ)/2 (=0.075ug/mL) in calculations of means.</description>
          <population>The Pharmacokinetics Per-Protocol Set (PK-PPS) consisted of all randomized participants who received at least 1 dose of the study medication and provided at least 1 quantifiable plasma concentration post-dose. Number of participants analyzed reflects Week 28.</population>
          <units>μg/mL</units>
          <param>Geometric Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="26"/>
                <count group_id="O2" value="13"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="NA" lower_limit="NA" upper_limit="NA">Values were below the level of detection.</measurement>
                    <measurement group_id="O2" value="1.933" lower_limit="1.2" upper_limit="3.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Plasma Concentration of Bimekizumab at Week 36</title>
        <description>Plasma concentration was expressed as geometric mean concentrations (GMCs) and measured in micrograms per milliliter (μg/mL). Note: Means, Lower confidence interval (LCI), Upper confidence interval (UCI) are only calculated if at least 2/3 of the concentrations were quantified at the respective time point. Values below limit of quantification (BLQ) are replaced by value of lower limit of quantification (LLOQ)/2 (=0.075ug/mL) in calculations of means.</description>
        <time_frame>at Week 36</time_frame>
        <population>The Pharmacokinetics Per-Protocol Set (PK-PPS) consisted of all randomized participants who received at least 1 dose of the study medication and provided at least 1 quantifiable plasma concentration post-dose. Number of participants analyzed reflects Week 36.</population>
        <group_list>
          <group group_id="O1">
            <title>Bimekizumab 320 mg + PBO (PK-PPS)</title>
            <description>Bimekizumab 320 mg administered subcutaneously (sc) at Baseline and Week 4, and placebo administered at Week 16. Participants formed the Pharmacokinetics Per-Protocol Set (PK-PPS).</description>
          </group>
          <group group_id="O2">
            <title>Bimekizumab 320 mg (PK-PPS)</title>
            <description>Bimekizumab 320 mg administered sc at Baseline and Weeks 4 and 16. Participants formed the Pharmacokinetics Per-Protocol Set (PK-PPS).</description>
          </group>
        </group_list>
        <measure>
          <title>Plasma Concentration of Bimekizumab at Week 36</title>
          <description>Plasma concentration was expressed as geometric mean concentrations (GMCs) and measured in micrograms per milliliter (μg/mL). Note: Means, Lower confidence interval (LCI), Upper confidence interval (UCI) are only calculated if at least 2/3 of the concentrations were quantified at the respective time point. Values below limit of quantification (BLQ) are replaced by value of lower limit of quantification (LLOQ)/2 (=0.075ug/mL) in calculations of means.</description>
          <population>The Pharmacokinetics Per-Protocol Set (PK-PPS) consisted of all randomized participants who received at least 1 dose of the study medication and provided at least 1 quantifiable plasma concentration post-dose. Number of participants analyzed reflects Week 36.</population>
          <units>μg/mL</units>
          <param>Geometric Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="24"/>
                <count group_id="O2" value="14"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="NA" lower_limit="NA" upper_limit="NA">Values were below the level of detection.</measurement>
                    <measurement group_id="O2" value="0.322" lower_limit="0.2" upper_limit="0.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Percentage of Participants Reporting Positive Anti-Drug-Antibodies (ADA) Titre Prior to Study Treatment With Bimekizumab at Baseline</title>
        <description>An ADA status of positive was concluded for any participant with an ADA level that was above cut point (ACP) and 'confirmed positive' (CP) at any time point. A participant was classified as having treatment-induced ADA positivity when meeting one of the following criteria: -The Baseline result was either below cut point (BCP) or ACP and 'not confirmed positive' (NCP), and at least 1 post Baseline time point was ACP and CP. -The Baseline result was positive (ACP and CP) and at least one post-Baseline measurement showed a pre-defined fold increase in titre from the Baseline value. Note: The overall status of a participant is 'Positive' if at any post-Baseline visit the result was ACP and confirmed positive.</description>
        <time_frame>at Baseline</time_frame>
        <population>The Safety Set (SS) consisted of all participants who received at least 1 dose of the study medication. Percentages were based on the number of participants with a non-missing measurement at Baseline.</population>
        <group_list>
          <group group_id="O1">
            <title>Bimekizumab 320 mg + PBO (SS)</title>
            <description>Bimekizumab 320 mg administered subcutaneously (sc) at Baseline and Week 4, and placebo administered at Week 16. Participants formed the Safety Set (SS).</description>
          </group>
          <group group_id="O2">
            <title>Bimekizumab 320 mg (SS)</title>
            <description>Bimekizumab 320 mg administered sc at Baseline and Weeks 4 and 16. Participants formed the Safety Set (SS).</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants Reporting Positive Anti-Drug-Antibodies (ADA) Titre Prior to Study Treatment With Bimekizumab at Baseline</title>
          <description>An ADA status of positive was concluded for any participant with an ADA level that was above cut point (ACP) and 'confirmed positive' (CP) at any time point. A participant was classified as having treatment-induced ADA positivity when meeting one of the following criteria: -The Baseline result was either below cut point (BCP) or ACP and 'not confirmed positive' (NCP), and at least 1 post Baseline time point was ACP and CP. -The Baseline result was positive (ACP and CP) and at least one post-Baseline measurement showed a pre-defined fold increase in titre from the Baseline value. Note: The overall status of a participant is 'Positive' if at any post-Baseline visit the result was ACP and confirmed positive.</description>
          <population>The Safety Set (SS) consisted of all participants who received at least 1 dose of the study medication. Percentages were based on the number of participants with a non-missing measurement at Baseline.</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="32"/>
                <count group_id="O2" value="17"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.1"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Percentage of Participants Reporting an Overall Positive Anti-Drug-Antibodies (ADA) Titre Following Study Treatment With Bimekizumab</title>
        <description>An ADA status of positive was concluded for any participant with an ADA level that was above cut point (ACP) and 'confirmed positive' (CP) at any time point. A participant was classified as having treatment-induced ADA positivity when meeting one of the following criteria: -The Baseline result was either below cut point (BCP) or ACP and 'not confirmed positive' (NCP), and at least 1 post Baseline time point was ACP and CP. -The Baseline result was positive (ACP and CP) and at least one post-Baseline measurement showed a pre-defined fold increase in titre from the Baseline value. Note: The overall status of a participant is 'Positive' if at any post-Baseline visit the result was ACP and confirmed positive.</description>
        <time_frame>From Baseline to Safety Follow-Up Visit (Week 36)</time_frame>
        <population>The Safety Set (SS) consisted of all participants who received at least 1 dose of the study medication.</population>
        <group_list>
          <group group_id="O1">
            <title>Bimekizumab 320 mg + PBO (SS)</title>
            <description>Bimekizumab 320 mg administered subcutaneously (sc) at Baseline and Week 4, and placebo administered at Week 16. Participants formed the Safety Set (SS).</description>
          </group>
          <group group_id="O2">
            <title>Bimekizumab 320 mg (SS)</title>
            <description>Bimekizumab 320 mg administered sc at Baseline and Weeks 4 and 16. Participants formed the Safety Set (SS).</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants Reporting an Overall Positive Anti-Drug-Antibodies (ADA) Titre Following Study Treatment With Bimekizumab</title>
          <description>An ADA status of positive was concluded for any participant with an ADA level that was above cut point (ACP) and 'confirmed positive' (CP) at any time point. A participant was classified as having treatment-induced ADA positivity when meeting one of the following criteria: -The Baseline result was either below cut point (BCP) or ACP and 'not confirmed positive' (NCP), and at least 1 post Baseline time point was ACP and CP. -The Baseline result was positive (ACP and CP) and at least one post-Baseline measurement showed a pre-defined fold increase in titre from the Baseline value. Note: The overall status of a participant is 'Positive' if at any post-Baseline visit the result was ACP and confirmed positive.</description>
          <population>The Safety Set (SS) consisted of all participants who received at least 1 dose of the study medication.</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="32"/>
                <count group_id="O2" value="17"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="34.4"/>
                    <measurement group_id="O2" value="47.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Percentage of Participants Who Experienced at Least One Adverse Events (AEs)</title>
        <description>An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment. Within the Safety Set, this trial reported a total of 164 occurences of adverse events, of which 7 were pre-treatment adverse events and 157 were treatment-emergent adverse events (TEAEs).</description>
        <time_frame>From Screening to Safety Follow-Up Visit (Week 36)</time_frame>
        <population>The Safety Set (SS) consisted of all participants who received at least 1 dose of the study medication.</population>
        <group_list>
          <group group_id="O1">
            <title>Bimekizumab 320 mg + PBO (SS)</title>
            <description>Bimekizumab 320 mg administered subcutaneously (sc) at Baseline and Week 4, and placebo administered at Week 16. Participants formed the Safety Set (SS).</description>
          </group>
          <group group_id="O2">
            <title>Bimekizumab 320 mg (SS)</title>
            <description>Bimekizumab 320 mg administered sc at Baseline and Weeks 4 and 16. Participants formed the Safety Set (SS).</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants Who Experienced at Least One Adverse Events (AEs)</title>
          <description>An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment. Within the Safety Set, this trial reported a total of 164 occurences of adverse events, of which 7 were pre-treatment adverse events and 157 were treatment-emergent adverse events (TEAEs).</description>
          <population>The Safety Set (SS) consisted of all participants who received at least 1 dose of the study medication.</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="32"/>
                <count group_id="O2" value="17"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="87.5"/>
                    <measurement group_id="O2" value="88.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants Achieving a 75% or Higher Improvement From Baseline in PASI (Psoriasis Area and Severity Index) Score at Week 16</title>
        <description>The PASI75 response assessments are based on at least 75% improvement in the PASI score from Baseline. This is a scoring system that averages the redness, thickness, and scaliness of the psoriatic lesions (on a 0-4 scale), and weights the resulting score by the area of skin involved. Body divided into 4 areas: head, arms, trunk to groin, and legs to top of buttocks. Assignment of an average score for the redness, thickness, and scaling for each of the 4 body areas with a score of 0 (clear) to 4 (very marked). Determining the percentage of skin covered with PSO for each of the body areas and converting to a 0 to 6 scale. Final PASI= average redness, thickness, and scaliness of the psoriatic skin lesions, multiplied by the involved psoriasis area score of the respective section, and weighted by the percentage of the person's affected skin for the respective section. The minimum possible PASI score is 0= no disease, the maximum score is 72= maximal disease.</description>
        <time_frame>From Baseline to Week 16</time_frame>
        <population>The Full Analysis Set (FAS) consisted of all randomized participants who received at least 1 dose of the study medication and have a valid measurement of the primary efficacy variable post Baseline.</population>
        <group_list>
          <group group_id="O1">
            <title>Bimekizumab 320 mg + PBO (FAS)</title>
            <description>Bimekizumab 320 mg administered subcutaneously (sc) at Baseline and Week 4, and placebo administered at Week 16. Participants formed the Full Analysis Set (FAS).</description>
          </group>
          <group group_id="O2">
            <title>Bimekizumab 320 mg (FAS)</title>
            <description>Bimekizumab 320 mg administered sc at Baseline and Weeks 4 and 16. Participants formed the Full Analysis Set (FAS).</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants Achieving a 75% or Higher Improvement From Baseline in PASI (Psoriasis Area and Severity Index) Score at Week 16</title>
          <description>The PASI75 response assessments are based on at least 75% improvement in the PASI score from Baseline. This is a scoring system that averages the redness, thickness, and scaliness of the psoriatic lesions (on a 0-4 scale), and weights the resulting score by the area of skin involved. Body divided into 4 areas: head, arms, trunk to groin, and legs to top of buttocks. Assignment of an average score for the redness, thickness, and scaling for each of the 4 body areas with a score of 0 (clear) to 4 (very marked). Determining the percentage of skin covered with PSO for each of the body areas and converting to a 0 to 6 scale. Final PASI= average redness, thickness, and scaliness of the psoriatic skin lesions, multiplied by the involved psoriasis area score of the respective section, and weighted by the percentage of the person's affected skin for the respective section. The minimum possible PASI score is 0= no disease, the maximum score is 72= maximal disease.</description>
          <population>The Full Analysis Set (FAS) consisted of all randomized participants who received at least 1 dose of the study medication and have a valid measurement of the primary efficacy variable post Baseline.</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="32"/>
                <count group_id="O2" value="17"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="93.8"/>
                    <measurement group_id="O2" value="88.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants Achieving a 90% or Higher Improvement From Baseline in PASI (Psoriasis Area and Severity Index) Score at Week 16</title>
        <description>The PASI90 response assessments are based on at least 90% improvement in the PASI score from Baseline. This is a scoring system that averages the redness, thickness, and scaliness of the psoriatic lesions (on a 0-4 scale), and weights the resulting score by the area of skin involved. Body divided into 4 areas: head, arms, trunk to groin, and legs to top of buttocks. Assignment of an average score for the redness, thickness, and scaling for each of the 4 body areas with a score of 0 (clear) to 4 (very marked). Determining the percentage of skin covered with PSO for each of the body areas and converting to a 0 to 6 scale. Final PASI= average redness, thickness, and scaliness of the psoriatic skin lesions, multiplied by the involved psoriasis area score of the respective section, and weighted by the percentage of the person's affected skin for the respective section. The minimum possible PASI score is 0= no disease, the maximum score is 72= maximal disease.</description>
        <time_frame>From Baseline to Week 16</time_frame>
        <population>The Full Analysis Set (FAS) consisted of all randomized participants who received at least 1 dose of the study medication and have a valid measurement of the primary efficacy variable post Baseline.</population>
        <group_list>
          <group group_id="O1">
            <title>Bimekizumab 320 mg + PBO (FAS)</title>
            <description>Bimekizumab 320 mg administered subcutaneously (sc) at Baseline and Week 4, and placebo administered at Week 16. Participants formed the Full Analysis Set (FAS).</description>
          </group>
          <group group_id="O2">
            <title>Bimekizumab 320 mg (FAS)</title>
            <description>Bimekizumab 320 mg administered sc at Baseline and Weeks 4 and 16. Participants formed the Full Analysis Set (FAS).</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants Achieving a 90% or Higher Improvement From Baseline in PASI (Psoriasis Area and Severity Index) Score at Week 16</title>
          <description>The PASI90 response assessments are based on at least 90% improvement in the PASI score from Baseline. This is a scoring system that averages the redness, thickness, and scaliness of the psoriatic lesions (on a 0-4 scale), and weights the resulting score by the area of skin involved. Body divided into 4 areas: head, arms, trunk to groin, and legs to top of buttocks. Assignment of an average score for the redness, thickness, and scaling for each of the 4 body areas with a score of 0 (clear) to 4 (very marked). Determining the percentage of skin covered with PSO for each of the body areas and converting to a 0 to 6 scale. Final PASI= average redness, thickness, and scaliness of the psoriatic skin lesions, multiplied by the involved psoriasis area score of the respective section, and weighted by the percentage of the person's affected skin for the respective section. The minimum possible PASI score is 0= no disease, the maximum score is 72= maximal disease.</description>
          <population>The Full Analysis Set (FAS) consisted of all randomized participants who received at least 1 dose of the study medication and have a valid measurement of the primary efficacy variable post Baseline.</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="32"/>
                <count group_id="O2" value="17"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="84.4"/>
                    <measurement group_id="O2" value="70.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants Achieving a 100% Improvement From Baseline in PASI (Psoriasis Area and Severity Index) Score at Week 16</title>
        <description>The PASI100 response assessments are based on at least 100% improvement in the PASI score from Baseline. This is a scoring system that averages the redness, thickness, and scaliness of the psoriatic lesions (on a 0-4 scale), and weights the resulting score by the area of skin involved. Body divided into 4 areas: head, arms, trunk to groin, and legs to top of buttocks. Assignment of an average score for the redness, thickness, and scaling for each of the 4 body areas with a score of 0 (clear) to 4 (very marked). Determining the percentage of skin covered with PSO for each of the body areas and converting to a 0 to 6 scale. Final PASI= average redness, thickness, and scaliness of the psoriatic skin lesions, multiplied by the involved psoriasis area score of the respective section, and weighted by the percentage of the person's affected skin for the respective section. The minimum possible PASI score is 0= no disease, the maximum score is 72= maximal disease.</description>
        <time_frame>From Baseline to Week 16</time_frame>
        <population>The Full Analysis Set (FAS) consisted of all randomized participants who received at least 1 dose of the study medication and have a valid measurement of the primary efficacy variable post Baseline.</population>
        <group_list>
          <group group_id="O1">
            <title>Bimekizumab 320 mg + PBO (FAS)</title>
            <description>Bimekizumab 320 mg administered subcutaneously (sc) at Baseline and Week 4, and placebo administered at Week 16. Participants formed the Full Analysis Set (FAS).</description>
          </group>
          <group group_id="O2">
            <title>Bimekizumab 320 mg (FAS)</title>
            <description>Bimekizumab 320 mg administered sc at Baseline and Weeks 4 and 16. Participants formed the Full Analysis Set (FAS).</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants Achieving a 100% Improvement From Baseline in PASI (Psoriasis Area and Severity Index) Score at Week 16</title>
          <description>The PASI100 response assessments are based on at least 100% improvement in the PASI score from Baseline. This is a scoring system that averages the redness, thickness, and scaliness of the psoriatic lesions (on a 0-4 scale), and weights the resulting score by the area of skin involved. Body divided into 4 areas: head, arms, trunk to groin, and legs to top of buttocks. Assignment of an average score for the redness, thickness, and scaling for each of the 4 body areas with a score of 0 (clear) to 4 (very marked). Determining the percentage of skin covered with PSO for each of the body areas and converting to a 0 to 6 scale. Final PASI= average redness, thickness, and scaliness of the psoriatic skin lesions, multiplied by the involved psoriasis area score of the respective section, and weighted by the percentage of the person's affected skin for the respective section. The minimum possible PASI score is 0= no disease, the maximum score is 72= maximal disease.</description>
          <population>The Full Analysis Set (FAS) consisted of all randomized participants who received at least 1 dose of the study medication and have a valid measurement of the primary efficacy variable post Baseline.</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="32"/>
                <count group_id="O2" value="17"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="46.9"/>
                    <measurement group_id="O2" value="52.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants With IGA (Investigator´s Global Assessment) Response at Week 16</title>
        <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.</description>
        <time_frame>at Week 16</time_frame>
        <population>The Full Analysis Set (FAS) consisted of all randomized participants who received at least 1 dose of the study medication and have a valid measurement of the primary efficacy variable post Baseline.</population>
        <group_list>
          <group group_id="O1">
            <title>Bimekizumab 320 mg + PBO (FAS)</title>
            <description>Bimekizumab 320 mg administered subcutaneously (sc) at Baseline and Week 4, and placebo administered at Week 16. Participants formed the Full Analysis Set (FAS).</description>
          </group>
          <group group_id="O2">
            <title>Bimekizumab 320 mg (FAS)</title>
            <description>Bimekizumab 320 mg administered sc at Baseline and Weeks 4 and 16. Participants formed the Full Analysis Set (FAS).</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With IGA (Investigator´s Global Assessment) Response at Week 16</title>
          <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.</description>
          <population>The Full Analysis Set (FAS) consisted of all randomized participants who received at least 1 dose of the study medication and have a valid measurement of the primary efficacy variable post Baseline.</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="32"/>
                <count group_id="O2" value="17"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="81.3"/>
                    <measurement group_id="O2" value="64.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>From Baseline to Week 36</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Bimekizumab 320 mg + PBO (SS)</title>
          <description>Bimekizumab 320 mg administered subcutaneously (sc) at Baseline and Week 4, and placebo administered at Week 16. Participants formed the Safety Set (SS).</description>
        </group>
        <group group_id="E2">
          <title>Bimekizumab 320 mg (SS)</title>
          <description>Bimekizumab 320 mg administered sc at Baseline and Weeks 4 and 16. Participants formed the Safety Set (SS).</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>MedDRA19.0</default_vocab>
        <default_assessment>Non-systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="17"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="32"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="17"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Pancreatitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="17"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Hepatobiliary disorders</title>
            <event_list>
              <event>
                <sub_title>Cholecystitis acute</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="17"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Syncope</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="32"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="17"/>
              </event>
              <event>
                <sub_title>Peripheral sensorimotor neuropathy</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="32"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="17"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <default_vocab>MedDRA19.0</default_vocab>
        <default_assessment>Non-systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="28" subjects_at_risk="32"/>
                <counts group_id="E2" subjects_affected="15" subjects_at_risk="17"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Blood and lymphatic system disorders</title>
            <event_list>
              <event>
                <sub_title>Hypochromic anaemia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="17"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="32"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="17"/>
              </event>
              <event>
                <sub_title>Abdominal discomfort</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="17"/>
              </event>
              <event>
                <sub_title>Anal pruritus</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="17"/>
              </event>
              <event>
                <sub_title>Dental necrosis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="17"/>
              </event>
              <event>
                <sub_title>Irritable bowel syndrome</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="17"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Hepatobiliary disorders</title>
            <event_list>
              <event>
                <sub_title>Non-alcoholic fatty liver</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="17"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Immune system disorders</title>
            <event_list>
              <event>
                <sub_title>Seasonal allergy</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E2" events="2" subjects_affected="1" subjects_at_risk="17"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Upper respiratory tract infection</sub_title>
                <counts group_id="E1" events="8" subjects_affected="6" subjects_at_risk="32"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="17"/>
              </event>
              <event>
                <sub_title>Nasopharyngitis</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="32"/>
                <counts group_id="E2" events="4" subjects_affected="4" subjects_at_risk="17"/>
              </event>
              <event>
                <sub_title>Urinary tract infection</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="32"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="17"/>
              </event>
              <event>
                <sub_title>Viral upper respiratory tract infection</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="32"/>
                <counts group_id="E2" events="3" subjects_affected="2" subjects_at_risk="17"/>
              </event>
              <event>
                <sub_title>Gastroenteritis viral</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="32"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="17"/>
              </event>
              <event>
                <sub_title>Oral candidiasis</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="32"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="17"/>
              </event>
              <event>
                <sub_title>Viral infection</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="17"/>
              </event>
              <event>
                <sub_title>Bacterial diarrhoea</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="17"/>
              </event>
              <event>
                <sub_title>Conjunctivitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="17"/>
              </event>
              <event>
                <sub_title>Conjunctivitis bacterial</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="17"/>
              </event>
              <event>
                <sub_title>Ear infection</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="17"/>
              </event>
              <event>
                <sub_title>Localised infection</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="17"/>
              </event>
              <event>
                <sub_title>Postoperative wound infection</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="17"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Alanine aminotransferase increased</sub_title>
                <counts group_id="E1" events="3" subjects_affected="2" subjects_at_risk="32"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="17"/>
              </event>
              <event>
                <sub_title>Gamma-glutamyltransferase increased</sub_title>
                <counts group_id="E1" events="4" subjects_affected="2" subjects_at_risk="32"/>
                <counts group_id="E2" events="7" subjects_affected="3" subjects_at_risk="17"/>
              </event>
              <event>
                <sub_title>Aspartate aminotransferase increased</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="32"/>
                <counts group_id="E2" events="4" subjects_affected="2" subjects_at_risk="17"/>
              </event>
              <event>
                <sub_title>Neutrophil count decreased</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="32"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="17"/>
              </event>
              <event>
                <sub_title>Blood cholesterol increased</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="32"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="17"/>
              </event>
              <event>
                <sub_title>Blood bilirubin increased</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="17"/>
              </event>
              <event>
                <sub_title>Lymphocyte count decreased</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="17"/>
              </event>
              <event>
                <sub_title>Mean cell haemoglobin concentration decreased</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="17"/>
              </event>
              <event>
                <sub_title>Platelet count decreased</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E2" events="3" subjects_affected="1" subjects_at_risk="17"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>White blood cell count decreased</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="32"/>
                <counts group_id="E2" events="5" subjects_affected="3" subjects_at_risk="17"/>
              </event>
              <event>
                <sub_title>Hyperkalaemia</sub_title>
                <counts group_id="E1" events="6" subjects_affected="4" subjects_at_risk="32"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="17"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Arthralgia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="32"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="17"/>
              </event>
              <event>
                <sub_title>Back pain</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="32"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="17"/>
              </event>
              <event>
                <sub_title>Neck pain</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="17"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Neoplasms benign, malignant and unspecified (incl cysts and polyps)</title>
            <event_list>
              <event>
                <sub_title>Seborrhoeic keratosis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E2" events="2" subjects_affected="1" subjects_at_risk="17"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="32"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="17"/>
              </event>
              <event>
                <sub_title>Tension headache</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="17"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Cough</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="17"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Pruritus generalised</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="32"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="17"/>
              </event>
              <event>
                <sub_title>Psoriasis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="32"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="17"/>
              </event>
              <event>
                <sub_title>Dermatitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="17"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.</restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>UCB</name_or_title>
      <organization>Cares</organization>
      <phone>001 844 599 2273</phone>
      <email>UCBCares@ucb.com</email>
    </point_of_contact>
  </clinical_results>
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03025542
org study id: PS0016
secondary id: 2016-002368-15
nct id: NCT03025542
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
This is a Phase 2a, multicenter, randomized, subject-blind, investigator-blind, study to
      investigate the pharmacokinetics (PK), pharmacodynamics (PD), and safety of bimekizumab in
      adult subjects with moderate to severe chronic plaque psoriasis
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
masking description: This is an Investigator- and Subject-blind study.
measure: Change From Baseline in Psoriasis Area and Severity Index (PASI) at Week 28
time frame: From Baseline to Week 28
description: The PASI is the most commonly used and validated assessment for grading the severity of psoriasis in clinical studies. The PASI quantifies the severity and extent of the disease and weighs these with the percentage of body surface area (BSA) involvement. The percent area of involvement (BSA%) is estimated across 4 body areas; head (10%), upper limbs (20%), trunk (30%), and lower limbs (40%) and then transferred into a grade. The Investigator assesses the average redness, thickness, and scaliness of lesions in each body area (each on a 5 point scale); 0=none, 1=slight, 2=moderate, 3=marked, and 4=very marked. The PASI score ranges from 0 to 72 with a higher score indicating increased disease severity.
measure: Plasma Concentration of Bimekizumab at Baseline
time frame: at Baseline
description: Plasma concentration was expressed as geometric mean concentrations (GMCs) and measured in micrograms per milliliter (μg/mL). Note: Means, Lower confidence interval (LCI), Upper confidence interval (UCI) are only calculated if at least 2/3 of the concentrations were quantified at the respective time point. Values below limit of quantification (BLQ) are replaced by value of lower limit of quantification (LLOQ)/2 (=0.075ug/mL) in calculations of means.
measure: Plasma Concentration of Bimekizumab at Week 2
time frame: at Week 2
description: Plasma concentration was expressed as geometric mean concentrations (GMCs) and measured in micrograms per milliliter (μg/mL). Note: Means, Lower confidence interval (LCI), Upper confidence interval (UCI) are only calculated if at least 2/3 of the concentrations were quantified at the respective time point. Values below limit of quantification (BLQ) are replaced by value of lower limit of quantification (LLOQ)/2 (=0.075ug/mL) in calculations of means.
measure: Plasma Concentration of Bimekizumab at Week 4
time frame: at Week 4
description: Plasma concentration was expressed as geometric mean concentrations (GMCs) and measured in micrograms per milliliter (μg/mL). Note: Means, Lower confidence interval (LCI), Upper confidence interval (UCI) are only calculated if at least 2/3 of the concentrations were quantified at the respective time point. Values below limit of quantification (BLQ) are replaced by value of lower limit of quantification (LLOQ)/2 (=0.075ug/mL) in calculations of means.
measure: Plasma Concentration of Bimekizumab at Week 8
time frame: at Week 8
description: Plasma concentration was expressed as geometric mean concentrations (GMCs) and measured in micrograms per milliliter (μg/mL). Note: Means, Lower confidence interval (LCI), Upper confidence interval (UCI) are only calculated if at least 2/3 of the concentrations were quantified at the respective time point. Values below limit of quantification (BLQ) are replaced by value of lower limit of quantification (LLOQ)/2 (=0.075ug/mL) in calculations of means.
measure: Plasma Concentration of Bimekizumab at Week 12
time frame: at Week 12
description: Plasma concentration was expressed as geometric mean concentrations (GMCs) and measured in micrograms per milliliter (μg/mL). Note: Means, Lower confidence interval (LCI), Upper confidence interval (UCI) are only calculated if at least 2/3 of the concentrations were quantified at the respective time point. Values below limit of quantification (BLQ) are replaced by value of lower limit of quantification (LLOQ)/2 (=0.075ug/mL) in calculations of means.
measure: Plasma Concentration of Bimekizumab at Week 16
time frame: at Week 16
description: Plasma concentration was expressed as geometric mean concentrations (GMCs) and measured in micrograms per milliliter (µg/mL). Note: Means, Lower confidence interval (LCI), Upper confidence interval (UCI) are only calculated if at least 2/3 of the concentrations were quantified at the respective time point. Values below limit of quantification (BLQ) are replaced by value of lower limit of quantification (LLOQ)/2 (=0.075ug/mL) in calculations of means.
measure: Plasma Concentration of Bimekizumab at Week 20
time frame: at Week 20
description: Plasma concentration was expressed as geometric mean concentrations (GMCs) and measured in micrograms per milliliter (μg/mL). Note: Means, Lower confidence interval (LCI), Upper confidence interval (UCI) are only calculated if at least 2/3 of the concentrations were quantified at the respective time point. Values below limit of quantification (BLQ) are replaced by value of lower limit of quantification (LLOQ)/2 (=0.075ug/mL) in calculations of means.
measure: Plasma Concentration of Bimekizumab at Week 24
time frame: at Week 24
description: Plasma concentration was expressed as geometric mean concentrations (GMCs) and measured in micrograms per milliliter (μg/mL). Note: Means, Lower confidence interval (LCI), Upper confidence interval (UCI) are only calculated if at least 2/3 of the concentrations were quantified at the respective time point. Values below limit of quantification (BLQ) are replaced by value of lower limit of quantification (LLOQ)/2 (=0.075ug/mL) in calculations of means.
measure: Plasma Concentration of Bimekizumab at Week 28
time frame: at Week 28
description: Plasma concentration was expressed as geometric mean concentrations (GMCs) and measured in micrograms per milliliter (μg/mL). Note: Means, Lower confidence interval (LCI), Upper confidence interval (UCI) are only calculated if at least 2/3 of the concentrations were quantified at the respective time point. Values below limit of quantification (BLQ) are replaced by value of lower limit of quantification (LLOQ)/2 (=0.075ug/mL) in calculations of means.
measure: Plasma Concentration of Bimekizumab at Week 36
time frame: at Week 36
description: Plasma concentration was expressed as geometric mean concentrations (GMCs) and measured in micrograms per milliliter (μg/mL). Note: Means, Lower confidence interval (LCI), Upper confidence interval (UCI) are only calculated if at least 2/3 of the concentrations were quantified at the respective time point. Values below limit of quantification (BLQ) are replaced by value of lower limit of quantification (LLOQ)/2 (=0.075ug/mL) in calculations of means.
measure: Percentage of Participants Reporting Positive Anti-Drug-Antibodies (ADA) Titre Prior to Study Treatment With Bimekizumab at Baseline
time frame: at Baseline
description: An ADA status of positive was concluded for any participant with an ADA level that was above cut point (ACP) and 'confirmed positive' (CP) at any time point. A participant was classified as having treatment-induced ADA positivity when meeting one of the following criteria: -The Baseline result was either below cut point (BCP) or ACP and 'not confirmed positive' (NCP), and at least 1 post Baseline time point was ACP and CP. -The Baseline result was positive (ACP and CP) and at least one post-Baseline measurement showed a pre-defined fold increase in titre from the Baseline value. Note: The overall status of a participant is 'Positive' if at any post-Baseline visit the result was ACP and confirmed positive.
measure: Percentage of Participants Reporting an Overall Positive Anti-Drug-Antibodies (ADA) Titre Following Study Treatment With Bimekizumab
time frame: From Baseline to Safety Follow-Up Visit (Week 36)
description: An ADA status of positive was concluded for any participant with an ADA level that was above cut point (ACP) and 'confirmed positive' (CP) at any time point. A participant was classified as having treatment-induced ADA positivity when meeting one of the following criteria: -The Baseline result was either below cut point (BCP) or ACP and 'not confirmed positive' (NCP), and at least 1 post Baseline time point was ACP and CP. -The Baseline result was positive (ACP and CP) and at least one post-Baseline measurement showed a pre-defined fold increase in titre from the Baseline value. Note: The overall status of a participant is 'Positive' if at any post-Baseline visit the result was ACP and confirmed positive.
measure: Percentage of Participants Who Experienced at Least One Adverse Events (AEs)
time frame: From Screening to Safety Follow-Up Visit (Week 36)
description: An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment. Within the Safety Set, this trial reported a total of 164 occurences of adverse events, of which 7 were pre-treatment adverse events and 157 were treatment-emergent adverse events (TEAEs).
measure: Percentage of Participants Achieving a 75% or Higher Improvement From Baseline in PASI (Psoriasis Area and Severity Index) Score at Week 16
time frame: From Baseline to Week 16
description: The PASI75 response assessments are based on at least 75% improvement in the PASI score from Baseline. This is a scoring system that averages the redness, thickness, and scaliness of the psoriatic lesions (on a 0-4 scale), and weights the resulting score by the area of skin involved. Body divided into 4 areas: head, arms, trunk to groin, and legs to top of buttocks. Assignment of an average score for the redness, thickness, and scaling for each of the 4 body areas with a score of 0 (clear) to 4 (very marked). Determining the percentage of skin covered with PSO for each of the body areas and converting to a 0 to 6 scale. Final PASI= average redness, thickness, and scaliness of the psoriatic skin lesions, multiplied by the involved psoriasis area score of the respective section, and weighted by the percentage of the person's affected skin for the respective section. The minimum possible PASI score is 0= no disease, the maximum score is 72= maximal disease.
measure: Percentage of Participants Achieving a 90% or Higher Improvement From Baseline in PASI (Psoriasis Area and Severity Index) Score at Week 16
time frame: From Baseline to Week 16
description: The PASI90 response assessments are based on at least 90% improvement in the PASI score from Baseline. This is a scoring system that averages the redness, thickness, and scaliness of the psoriatic lesions (on a 0-4 scale), and weights the resulting score by the area of skin involved. Body divided into 4 areas: head, arms, trunk to groin, and legs to top of buttocks. Assignment of an average score for the redness, thickness, and scaling for each of the 4 body areas with a score of 0 (clear) to 4 (very marked). Determining the percentage of skin covered with PSO for each of the body areas and converting to a 0 to 6 scale. Final PASI= average redness, thickness, and scaliness of the psoriatic skin lesions, multiplied by the involved psoriasis area score of the respective section, and weighted by the percentage of the person's affected skin for the respective section. The minimum possible PASI score is 0= no disease, the maximum score is 72= maximal disease.
measure: Percentage of Participants Achieving a 100% Improvement From Baseline in PASI (Psoriasis Area and Severity Index) Score at Week 16
time frame: From Baseline to Week 16
description: The PASI100 response assessments are based on at least 100% improvement in the PASI score from Baseline. This is a scoring system that averages the redness, thickness, and scaliness of the psoriatic lesions (on a 0-4 scale), and weights the resulting score by the area of skin involved. Body divided into 4 areas: head, arms, trunk to groin, and legs to top of buttocks. Assignment of an average score for the redness, thickness, and scaling for each of the 4 body areas with a score of 0 (clear) to 4 (very marked). Determining the percentage of skin covered with PSO for each of the body areas and converting to a 0 to 6 scale. Final PASI= average redness, thickness, and scaliness of the psoriatic skin lesions, multiplied by the involved psoriasis area score of the respective section, and weighted by the percentage of the person's affected skin for the respective section. The minimum possible PASI score is 0= no disease, the maximum score is 72= maximal disease.
measure: Percentage of Participants With IGA (Investigator´s Global Assessment) Response at Week 16
time frame: at Week 16
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.
arm group label: Treatment Arm 1
arm group type: Experimental
description: Subjects randomized in this arm will receive a combination of Bimekizumab and Placebo injections.
arm group label: Treatment Arm 2
arm group type: Experimental
description: Subjects randomized in this arm will receive Bimekizumab injections.
intervention type: Drug
intervention name: Bimekizumab
description: Based on their randomization subjects will receive a combination of several injections of Bimekizumab.
arm group label: Treatment Arm 1
arm group label: Treatment Arm 2
other name: UCB4940
intervention type: Other
intervention name: Placebo
description: Subjects will receive injections of Placebo.
arm group label: Treatment Arm 1
criteria: 
gender: All
minimum age: 18 Years
maximum age: 70 Years
healthy volunteers: No
last name: UCB Cares
role: Study Director
affiliation: 001 844 599 2273(UCB)
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: Australia
country: Canada
country: Moldova, Republic of
country: United States
country: Germany
url: https://www.ema.europa.eu/en/documents/product-information/bimzelx-epar-product-information_en.pdf
description: Product Information
url: http://www.fda.gov/Safety/MedWatch/SafetyInformation/default.htm
description: FDA Safety Alerts and Recalls
citation: Oliver R, Krueger JG, Glatt S, Vajjah P, Mistry C, Page M, Edwards H, Garcet S, Li X, Dizier B, Maroof A, Watling M, El Baghdady A, Baeten D, Ionescu L, Shaw S. Bimekizumab for the treatment of moderate-to-severe plaque psoriasis: efficacy, safety, pharmacokinetics, pharmacodynamics and transcriptomics from a phase IIa, randomized, double-blind multicentre study. Br J Dermatol. 2022 Apr;186(4):652-663. doi: 10.1111/bjd.20827. Epub 2021 Dec 27.
PMID: 34687214
citation: Gordon KB, Langley RG, Warren RB, Okubo Y, Stein Gold L, Merola JF, Peterson L, Wixted K, Cross N, Deherder D, Thaci D. Bimekizumab Safety in Patients With Moderate to Severe Plaque Psoriasis: Pooled Results From Phase 2 and Phase 3 Randomized Clinical Trials. JAMA Dermatol. 2022 Jul 1;158(7):735-744. doi: 10.1001/jamadermatol.2022.1185.
PMID: 35544084
responsible party type: Sponsor
mesh term: Psoriasis
provided document: 
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 