<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/NCT03010527</url>
  </required_header>
  <id_info>
    <org_study_id>PS0011</org_study_id>
    <secondary_id>2016-001892-57</secondary_id>
    <nct_id>NCT03010527</nct_id>
  </id_info>
  <brief_title>A Study to Evaluate the Long-term Safety, Tolerability and Efficacy of Bimekizumab in Patients With Chronic Plaque Psoriasis</brief_title>
  <acronym>BE ABLE 2</acronym>
  <official_title>A Multicenter, 48-Week, Double-Blind, Placebo-Controlled, Parallel-Group Extension Study to Assess the Long-Term Safety, Tolerability, and Efficacy 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>
  </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 multicenter extension study to assess the long-term safety, tolerability and&#xD;
      efficacy of bimekizumab in adult subjects with moderate to severe chronic plaque psoriasis&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 14, 2016</start_date>
  <completion_date type="Actual">September 25, 2018</completion_date>
  <primary_completion_date type="Actual">September 25, 2018</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Incidence of Treatment Emergent Adverse Events (TEAEs) Adjusted by Duration of Subject Exposure to Treatment</measure>
    <time_frame>From Baseline until Safety Follow-Up Visit (up to Week 64)</time_frame>
    <description>Treatment-emergent Adverse Events (TEAEs) were defined as those events which started on or after the date of first dose of PS0011 investigational medicinal product (IMP), or events in which severity worsened on or after the date of first dose of PS0011 study medication. The exposure adjusted incidence rate (EAIR) is defined as the number of subjects (n) with a specific AE adjusted for the exposure and was scaled to 100 subject-years: where the numerator is the total number of subjects experiencing the AE and the denominator is the total time at risk scaled to 100 subject-years; that is, the total summation of individual subject-years at risk up to the first occurrence of the AE for subjects with that AE, and the total subject-years at risk for those subjects not experiencing that AE, divided by 100.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With Psoriasis Area Severity Index (PASI90) Response Over Time</measure>
    <time_frame>From Baseline during the Treatment Period (up to Week 48)</time_frame>
    <description>The PASI90 response assessments are based on at least 90% improvement in the PASI score from Baseline. It 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). The PASI score ranges from 0 to 72 with a higher score indicating increased disease severity. PASI90 response is defined to be equal to 1 if the percentage improvement from Baseline in the PASI scores is 90% or greater and 0 if the percentage improvement from Baseline is less than 90%. This Outcome Measure presents results relative to PS0010 Baseline starting at PS0011 Baseline by PS0010 Week 12 response status.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With Investigator´s Global Assessment Response (Clear or Almost Clear With at Least a 2 Category Improvement From Baseline on a 5-point Scale) Over Time</measure>
    <time_frame>From Baseline during the Treatment Period (up to Week 48)</time_frame>
    <description>The Investigator's Global Assessment (IGA) measures the overall 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. IGA response is defined as clear (0) or almost clear (1) with at least a two category improvement from Baseline. This Outcome Measure presents results relative to PS0010 Baseline starting at PS0011 Baseline by PS0010 Week 12 response status.</description>
  </secondary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">217</enrollment>
  <condition>Chronic Plaque Psoriasis</condition>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Subjects with a PASI90 response at Week 12 and receiving Placebo in PS0010 entering PS0011 will receive Placebo.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Bimekizumab dosing regimen 1</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Subjects with a PASI90 response at Week 12 receiving dosing regimen 1 in PS0010 entering PS0011 will receive the same dosing regimen.&#xD;
Subjects who do not achieve PASI90 response at Week 12 receiving dosing regimen 1 in PS0010 will be assigned to a higher dosing regimen.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Bimekizumab dosing regimen 2</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Subjects with a PASI90 response at Week 12 receiving dosing regimen 2 in PS0010 entering PS0011 will receive the same dosing regimen.&#xD;
Subjects who do not achieve PASI90 response at Week 12 receiving dosing regimen 2 in PS0010 will be assigned to a higher dosing regimen.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Bimekizumab dosing regimen 3</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Subjects that were initially randomized to bimekizumab dosage regimen 3, 4 and 5 in PS0010 will receive bimekizumab dosing regimen 3.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Bimekizumab</intervention_name>
    <description>Subjects will receive bimekizumab injections every four weeks (Q4W)</description>
    <arm_group_label>Bimekizumab dosing regimen 1</arm_group_label>
    <arm_group_label>Bimekizumab dosing regimen 2</arm_group_label>
    <arm_group_label>Bimekizumab dosing regimen 3</arm_group_label>
    <other_name>UCB4940</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Subjects will receive Placebo injections every four weeks (Q4W)</description>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Subject has provided informed consent&#xD;
&#xD;
          -  Subject completes all dosing requirements in feeder study and completes PS0010 study&#xD;
             without meeting any withdrawal criteria&#xD;
&#xD;
          -  Female subjects of childbearing potential and male subjects with a partner of&#xD;
             childbearing potential must continue to use an acceptable method of contraception (as&#xD;
             detailed in PS0010) for up to 20 weeks after the last dose of study treatment in&#xD;
             PS0011&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Subject has previously participated in this study.&#xD;
&#xD;
          -  Female subjects who plan to become pregnant during the study or within 20 weeks&#xD;
             following last dose of study medication. Male subjects who are planning a partner&#xD;
             pregnancy during the study or within 20 weeks following the last dose&#xD;
&#xD;
          -  Subject has any medical or psychiatric condition that, in the opinion of the&#xD;
             Investigator, could jeopardize or would compromise the subject's ability to&#xD;
             participate in this study.&#xD;
&#xD;
          -  Subject must have a negative interferon gamma release assay (IGRA) as measured at Week&#xD;
             8 of PS0010&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</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>Ps0011 708</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>90045</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ps0011 706</name>
      <address>
        <city>Washington</city>
        <state>District of Columbia</state>
        <zip>20037</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ps0011 704</name>
      <address>
        <city>West Des Moines</city>
        <state>Iowa</state>
        <zip>50265</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ps0011 738</name>
      <address>
        <city>Wilmington</city>
        <state>North Carolina</state>
        <zip>28405</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ps0011 712</name>
      <address>
        <city>Portland</city>
        <state>Oregon</state>
        <zip>97223</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ps0011 733</name>
      <address>
        <city>Dallas</city>
        <state>Texas</state>
        <zip>75231</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ps0011 709</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77004</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ps0011 702</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77598</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ps0011 209</name>
      <address>
        <city>Edmonton</city>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ps0011 201</name>
      <address>
        <city>North Bay</city>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ps0011 206</name>
      <address>
        <city>Peterborough</city>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ps0011 214</name>
      <address>
        <city>Quebec City</city>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ps0011 203</name>
      <address>
        <city>Surrey</city>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ps0011 205</name>
      <address>
        <city>Waterloo</city>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ps0011 300</name>
      <address>
        <city>Ostrava</city>
        <country>Czechia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ps0011 303</name>
      <address>
        <city>Pardubice</city>
        <country>Czechia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ps0011 301</name>
      <address>
        <city>Praha 10</city>
        <country>Czechia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ps0011 304</name>
      <address>
        <city>Praha</city>
        <country>Czechia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ps0011 404</name>
      <address>
        <city>Kecskemet</city>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ps0011 400</name>
      <address>
        <city>Oroshaza</city>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ps0011 405</name>
      <address>
        <city>Szekszard</city>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ps0011 504</name>
      <address>
        <city>Chiyoda-ku</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ps0011 503</name>
      <address>
        <city>Minatoku</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ps0011 502</name>
      <address>
        <city>Nagoya</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ps0011 501</name>
      <address>
        <city>Shinagawa-ku</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ps0011 600</name>
      <address>
        <city>Bialystok</city>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ps0011 603</name>
      <address>
        <city>Bialystok</city>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ps0011 611</name>
      <address>
        <city>Bialystok</city>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ps0011 610</name>
      <address>
        <city>Gdynia</city>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ps0011 604</name>
      <address>
        <city>Kielce</city>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ps0011 608</name>
      <address>
        <city>Krakow</city>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ps0011 605</name>
      <address>
        <city>Lublin</city>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ps0011 606</name>
      <address>
        <city>Lublin</city>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ps0011 607</name>
      <address>
        <city>Warszawa</city>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ps0011 601</name>
      <address>
        <city>Wroclaw</city>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ps0011 609</name>
      <address>
        <city>Wroclaw</city>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
    <country>Czechia</country>
    <country>Hungary</country>
    <country>Japan</country>
    <country>Poland</country>
    <country>United States</country>
  </location_countries>
  <removed_countries>
    <country>Czech Republic</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>Blauvelt A, Papp KA, Merola JF, Gottlieb AB, Cross N, Madden C, Wang M, Cioffi C, Griffiths CEM. Bimekizumab for patients with moderate to severe plaque psoriasis: 60-week results from BE ABLE 2, a randomized, double-blinded, placebo-controlled, phase 2b extension study. J Am Acad Dermatol. 2020 Nov;83(5):1367-1374. doi: 10.1016/j.jaad.2020.05.105. Epub 2020 May 29.</citation>
    <PMID>32473974</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 3, 2017</study_first_submitted>
  <study_first_submitted_qc>January 3, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 5, 2017</study_first_posted>
  <results_first_submitted>September 24, 2021</results_first_submitted>
  <results_first_submitted_qc>September 24, 2021</results_first_submitted_qc>
  <results_first_posted type="Actual">October 25, 2021</results_first_posted>
  <disposition_first_submitted>September 24, 2019</disposition_first_submitted>
  <disposition_first_submitted_qc>September 24, 2019</disposition_first_submitted_qc>
  <disposition_first_posted type="Actual">October 8, 2019</disposition_first_posted>
  <last_update_submitted>September 27, 2022</last_update_submitted>
  <last_update_submitted_qc>September 27, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">October 18, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Chronic plaque psoriasis</keyword>
  <keyword>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>August 12, 2016</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/27/NCT03010527/Prot_000.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>June 7, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/27/NCT03010527/SAP_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <recruitment_details>The study started to enroll participants in December 2016 and concluded in September 2018. Among the 217 participants in PS0011, no participants were assigned to receive placebo.</recruitment_details>
      <pre_assignment_details>Participant Flow refers to the Full Analysis Set (FAS), which consisted of all enrolled participants who received at least 1 dose of the investigational medicinal product (IMP) and had a valid measurement of the primary efficacy variable at Baseline of PS0011.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Bimekizumab 64 mg Q4W</title>
          <description>Participants received bimekizumab 64 milligrams (mg) injections, sc every four weeks (Q4W). Participants who achieved PASI90 response at Week 12 and received bimekizumab 64 mg Q4W in PS0010, were assigned to bimekizumab 64 mg Q4W in PS0011. Participants who did not achieve PASI90 response at Week 12 and received bimekizumab 64 mg Q4W in PS0010, were assigned to bimekizumab 160 mg Q4W in PS0011.</description>
        </group>
        <group group_id="P2">
          <title>Bimekizumab 160 mg Q4W</title>
          <description>Participants received bimekizumab 160 mg injections, sc every four weeks (Q4W). Participants who achieved PASI90 response at Week 12 and received bimekizumab 160 mg Q4W or bimekizumab 160 mg with loading dose (w/LD) Q4W in PS0010, were assigned to bimekizumab 160 mg Q4W in PS0011. Participants who did not achieve PASI90 response at Week 12 and received bimekizumab 160 mg Q4W or bimekizumab 160 mg w/LD Q4W in PS0010, were assigned to bimekizumab 320 mg Q4W in PS0011.</description>
        </group>
        <group group_id="P3">
          <title>Bimekizumab 320 mg Q4W</title>
          <description>Participants received bimekizumab 320 mg injections, sc every four weeks (Q4W). Participants receiving bimekizumab 320 mg Q4W and bimekizumab 480 mg Q4W, in PS0010 were assigned to receive bimekizumab 320 mg Q4W in PS0011, regardless of their PASI90 response at Week 12 in PS0010.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="15"/>
                <participants group_id="P2" count="111"/>
                <participants group_id="P3" count="91"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="15"/>
                <participants group_id="P2" count="92"/>
                <participants group_id="P3" count="75"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="19"/>
                <participants group_id="P3" count="16"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Death</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Adverse Event</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="4"/>
                <participants group_id="P3" count="2"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Protocol Violation</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
                <participants group_id="P3" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="2"/>
                <participants group_id="P3" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="3"/>
                <participants group_id="P3" count="4"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>WITHDRAWAL CRITERIA #9</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="4"/>
                <participants group_id="P3" count="6"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>WITHDRAWAL CRITERIA #12</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="4"/>
                <participants group_id="P3" count="2"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>PDILI and WITHDRAWAL CRITERIA #9</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
                <participants group_id="P3" 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 investigational medicinal product (IMP) in PS0011.</population>
      <group_list>
        <group group_id="B1">
          <title>Bimekizumab 64 mg Q4W</title>
          <description>Participants received bimekizumab 64 milligrams (mg) injections, sc every four weeks (Q4W). Participants who achieved PASI90 response at Week 12 and received bimekizumab 64 mg Q4W in PS0010, were assigned to bimekizumab 64 mg Q4W in PS0011. Participants who did not achieve PASI90 response at Week 12 and received bimekizumab 64 mg Q4W in PS0010, were assigned to bimekizumab 160 mg Q4W in PS0011.</description>
        </group>
        <group group_id="B2">
          <title>Bimekizumab 160 mg Q4W</title>
          <description>Participants received bimekizumab 160 mg injections, sc every four weeks (Q4W). Participants who achieved PASI90 response at Week 12 and received bimekizumab 160 mg Q4W or bimekizumab 160 mg with loading dose (w/LD) Q4W in PS0010, were assigned to bimekizumab 160 mg Q4W in PS0011. Participants who did not achieve PASI90 response at Week 12 and received bimekizumab 160 mg Q4W or bimekizumab 160 mg w/LD Q4W in PS0010, were assigned to bimekizumab 320 mg Q4W in PS0011.</description>
        </group>
        <group group_id="B3">
          <title>Bimekizumab 320 mg Q4W</title>
          <description>Participants received bimekizumab 320 mg injections, sc every four weeks (Q4W). Participants receiving bimekizumab 320 mg Q4W and bimekizumab 480 mg Q4W, in PS0010 were assigned to receive bimekizumab 320 mg Q4W in PS0011, regardless of their PASI90 response at Week 12 in PS0010.</description>
        </group>
        <group group_id="B4">
          <title>Total Title</title>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="15"/>
            <count group_id="B2" value="111"/>
            <count group_id="B3" value="91"/>
            <count group_id="B4" value="217"/>
          </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="1"/>
                    <measurement group_id="B3" value="2"/>
                    <measurement group_id="B4" value="3"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="14"/>
                    <measurement group_id="B2" value="105"/>
                    <measurement group_id="B3" value="77"/>
                    <measurement group_id="B4" value="196"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="5"/>
                    <measurement group_id="B3" value="12"/>
                    <measurement group_id="B4" value="18"/>
                  </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="44.5" spread="14.7"/>
                    <measurement group_id="B2" value="44.5" spread="12.8"/>
                    <measurement group_id="B3" value="43.5" spread="14.7"/>
                    <measurement group_id="B4" value="44.1" spread="13.7"/>
                  </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="6"/>
                    <measurement group_id="B2" value="40"/>
                    <measurement group_id="B3" value="31"/>
                    <measurement group_id="B4" value="77"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="9"/>
                    <measurement group_id="B2" value="71"/>
                    <measurement group_id="B3" value="60"/>
                    <measurement group_id="B4" value="140"/>
                  </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>American Indian /Alaskan native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="1"/>
                    <measurement group_id="B4" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="11"/>
                    <measurement group_id="B3" value="6"/>
                    <measurement group_id="B4" value="18"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="1"/>
                    <measurement group_id="B4" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="13"/>
                    <measurement group_id="B2" value="99"/>
                    <measurement group_id="B3" value="83"/>
                    <measurement group_id="B4" value="195"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Incidence of Treatment Emergent Adverse Events (TEAEs) Adjusted by Duration of Subject Exposure to Treatment</title>
        <description>Treatment-emergent Adverse Events (TEAEs) were defined as those events which started on or after the date of first dose of PS0011 investigational medicinal product (IMP), or events in which severity worsened on or after the date of first dose of PS0011 study medication. The exposure adjusted incidence rate (EAIR) is defined as the number of subjects (n) with a specific AE adjusted for the exposure and was scaled to 100 subject-years: where the numerator is the total number of subjects experiencing the AE and the denominator is the total time at risk scaled to 100 subject-years; that is, the total summation of individual subject-years at risk up to the first occurrence of the AE for subjects with that AE, and the total subject-years at risk for those subjects not experiencing that AE, divided by 100.</description>
        <time_frame>From Baseline until Safety Follow-Up Visit (up to Week 64)</time_frame>
        <population>The Safety Set (SS) consisted of all participants who received at least 1 dose of the study medication in PS0011.</population>
        <group_list>
          <group group_id="O1">
            <title>Bimekizumab 64 mg Q4W (SS)</title>
            <description>Participants received bimekizumab 64 milligrams (mg) injections, sc every four weeks (Q4W). Participants who achieved PASI90 response at Week 12 and received bimekizumab 64 mg Q4W in PS0010, were assigned to bimekizumab 64 mg Q4W in PS0011. Participants who did not achieve PASI90 response at Week 12 and received bimekizumab 64 mg Q4W in PS0010, were assigned to bimekizumab 160 mg Q4W in PS0011. Participants who received at least one dose of the IMP formed the Safety Set (SS).</description>
          </group>
          <group group_id="O2">
            <title>Bimekizumab 160 mg Q4W (SS)</title>
            <description>Participants received bimekizumab 160 mg injections, sc every four weeks (Q4W). Participants who achieved PASI90 response at Week 12 and received bimekizumab 160 mg Q4W or bimekizumab 160 mg with loading dose (w/LD) Q4W in PS0010, were assigned to bimekizumab 160 mg Q4W in PS0011. Participants who did not achieve PASI90 response at Week 12 and received bimekizumab 160 mg Q4W or bimekizumab 160 mg w/LD Q4W in PS0010, were assigned to bimekizumab 320 mg Q4W in PS0011. Participants who received at least one dose of the IMP formed the SS.</description>
          </group>
          <group group_id="O3">
            <title>Bimekizumab 320 mg Q4W (SS)</title>
            <description>Participants received bimekizumab 320 mg injections, sc every four weeks (Q4W). Participants receiving bimekizumab 320 mg Q4W and bimekizumab 480 mg Q4W, in PS0010 were assigned to receive bimekizumab 320 mg Q4W in PS0011, regardless of their PASI90 response at Week 12 in PS0010. Participants who received at least one dose of the IMP formed the SS.</description>
          </group>
        </group_list>
        <measure>
          <title>Incidence of Treatment Emergent Adverse Events (TEAEs) Adjusted by Duration of Subject Exposure to Treatment</title>
          <description>Treatment-emergent Adverse Events (TEAEs) were defined as those events which started on or after the date of first dose of PS0011 investigational medicinal product (IMP), or events in which severity worsened on or after the date of first dose of PS0011 study medication. The exposure adjusted incidence rate (EAIR) is defined as the number of subjects (n) with a specific AE adjusted for the exposure and was scaled to 100 subject-years: where the numerator is the total number of subjects experiencing the AE and the denominator is the total time at risk scaled to 100 subject-years; that is, the total summation of individual subject-years at risk up to the first occurrence of the AE for subjects with that AE, and the total subject-years at risk for those subjects not experiencing that AE, divided by 100.</description>
          <population>The Safety Set (SS) consisted of all participants who received at least 1 dose of the study medication in PS0011.</population>
          <units>no. of new events per 100 subject-years</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="15"/>
                <count group_id="O2" value="111"/>
                <count group_id="O3" value="91"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="110.68" lower_limit="53.08" upper_limit="203.55"/>
                    <measurement group_id="O2" value="225.26" lower_limit="182.88" upper_limit="274.53"/>
                    <measurement group_id="O3" value="206.82" lower_limit="162.95" upper_limit="258.86"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants With Psoriasis Area Severity Index (PASI90) Response Over Time</title>
        <description>The PASI90 response assessments are based on at least 90% improvement in the PASI score from Baseline. It 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). The PASI score ranges from 0 to 72 with a higher score indicating increased disease severity. PASI90 response is defined to be equal to 1 if the percentage improvement from Baseline in the PASI scores is 90% or greater and 0 if the percentage improvement from Baseline is less than 90%. This Outcome Measure presents results relative to PS0010 Baseline starting at PS0011 Baseline by PS0010 Week 12 response status.</description>
        <time_frame>From Baseline during the Treatment Period (up to Week 48)</time_frame>
        <population>The Full Analysis Set (FAS) consisted of all enrolled participants who received at least 1 dose of the study medication in PS0011 and had a valid efficacy measurement for Psoriasis Area and Severity Index (PASI) at Baseline of PS0011.</population>
        <group_list>
          <group group_id="O1">
            <title>Bimekizumab 64 mg Q4W/Bimekizumab 64 mg Q4W/R (FAS)</title>
            <description>Participants who achieved PASI90 response at Week 12 and received bimekizumab 64 mg Q4W in PS0010, were assigned to bimekizumab 64 mg Q4W in PS0011. Participants formed the Full Analysis Set (FAS).</description>
          </group>
          <group group_id="O2">
            <title>Bimekizumab 160 mg Q4W/Bimekizumab 160 mg Q4W/R (FAS)</title>
            <description>Participants who achieved PASI90 response at Week 12 and received bimekizumab 160 mg Q4W or bimekizumab 160 mg with loading dose (w/LD) Q4W in PS0010, were assigned to bimekizumab 160 mg Q4W in PS0011. Participants formed the FAS.</description>
          </group>
          <group group_id="O3">
            <title>Bimekizumab 320 mg Q4W/Bimekizumab 320 mg Q4W/R (FAS)</title>
            <description>Participants who achieved PASI90 response at Week 12 and received bimekizumab 320 mg Q4W in PS0010, were assigned to bimekizumab 320 mg Q4W in PS0011. Participants formed the FAS.</description>
          </group>
          <group group_id="O4">
            <title>Bimekizumab 480 mg Q4W/Bimekizumab 320 mg Q4W/R (FAS)</title>
            <description>Participants who achieved PASI90 response at Week 12 and received bimekizumab 480 mg Q4W in PS0010, were assigned to bimekizumab 320 mg Q4W in PS0011. Participants formed the FAS.</description>
          </group>
          <group group_id="O5">
            <title>Placebo/Bimekizumab 160 mg Q4W/NR (FAS)</title>
            <description>Participants who did not achieve PASI90 response at Week 12 and received placebo Q4W in PS0010, were assigned to bimekizumab 160 mg Q4W in PS0011. Participants formed the FAS.</description>
          </group>
          <group group_id="O6">
            <title>Bimekizumab 64 mg Q4W/Bimekizumab 160 mg Q4W/NR (FAS)</title>
            <description>Participants who did not achieve PASI90 response at Week 12 and received bimekizumab 64 mg Q4W in PS0010, were assigned to bimekizumab 160 mg Q4W in PS0011. Participants formed the FAS.</description>
          </group>
          <group group_id="O7">
            <title>Bimekizumab 160 mg Q4W/Bimekizumab 320 mg Q4W/NR (FAS)</title>
            <description>Participants who did not achieve PASI90 response at Week 12 and received bimekizumab 160 mg Q4W or bimekizumab 160 mg w/LD Q4W in PS0010, were assigned to bimekizumab 320 mg Q4W in PS0011. Participants formed the FAS.</description>
          </group>
          <group group_id="O8">
            <title>Bimekizumab 320 mg Q4W/Bimekizumab 320 mg Q4W/NR (FAS)</title>
            <description>Participants who did not achieve PASI90 response at Week 12 and received bimekizumab 320 mg Q4W in PS0010, were assigned to bimekizumab 320 mg Q4W in PS0011. Participants formed the FAS.</description>
          </group>
          <group group_id="O9">
            <title>Bimekizumab 480 mg Q4W/Bimekizumab 320 mg Q4W/NR (FAS)</title>
            <description>Participants who did not achieve PASI90 response at Week 12 and received bimekizumab 480 mg Q4W in PS0010, were assigned to bimekizumab 320 mg Q4W in PS0011. Participants formed the FAS.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With Psoriasis Area Severity Index (PASI90) Response Over Time</title>
          <description>The PASI90 response assessments are based on at least 90% improvement in the PASI score from Baseline. It 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). The PASI score ranges from 0 to 72 with a higher score indicating increased disease severity. PASI90 response is defined to be equal to 1 if the percentage improvement from Baseline in the PASI scores is 90% or greater and 0 if the percentage improvement from Baseline is less than 90%. This Outcome Measure presents results relative to PS0010 Baseline starting at PS0011 Baseline by PS0010 Week 12 response status.</description>
          <population>The Full Analysis Set (FAS) consisted of all enrolled participants who received at least 1 dose of the study medication in PS0011 and had a valid efficacy measurement for Psoriasis Area and Severity Index (PASI) at Baseline of PS0011.</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="15"/>
                <count group_id="O2" value="55"/>
                <count group_id="O3" value="33"/>
                <count group_id="O4" value="30"/>
                <count group_id="O5" value="37"/>
                <count group_id="O6" value="19"/>
                <count group_id="O7" value="14"/>
                <count group_id="O8" value="6"/>
                <count group_id="O9" value="8"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>PS0011 Baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="100"/>
                    <measurement group_id="O2" value="100"/>
                    <measurement group_id="O3" value="100"/>
                    <measurement group_id="O4" value="100"/>
                    <measurement group_id="O5" value="0"/>
                    <measurement group_id="O6" value="0"/>
                    <measurement group_id="O7" value="0"/>
                    <measurement group_id="O8" value="0"/>
                    <measurement group_id="O9" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 4</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="100"/>
                    <measurement group_id="O2" value="100"/>
                    <measurement group_id="O3" value="97.0"/>
                    <measurement group_id="O4" value="100"/>
                    <measurement group_id="O5" value="45.9"/>
                    <measurement group_id="O6" value="42.1"/>
                    <measurement group_id="O7" value="42.9"/>
                    <measurement group_id="O8" value="66.7"/>
                    <measurement group_id="O9" value="50.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 8</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="100"/>
                    <measurement group_id="O2" value="96.4"/>
                    <measurement group_id="O3" value="100"/>
                    <measurement group_id="O4" value="100"/>
                    <measurement group_id="O5" value="67.6"/>
                    <measurement group_id="O6" value="73.7"/>
                    <measurement group_id="O7" value="57.1"/>
                    <measurement group_id="O8" value="83.3"/>
                    <measurement group_id="O9" value="50.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 12</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="100"/>
                    <measurement group_id="O2" value="96.4"/>
                    <measurement group_id="O3" value="100"/>
                    <measurement group_id="O4" value="96.7"/>
                    <measurement group_id="O5" value="81.1"/>
                    <measurement group_id="O6" value="78.9"/>
                    <measurement group_id="O7" value="64.3"/>
                    <measurement group_id="O8" value="100"/>
                    <measurement group_id="O9" value="62.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 16</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="100"/>
                    <measurement group_id="O2" value="92.7"/>
                    <measurement group_id="O3" value="100"/>
                    <measurement group_id="O4" value="96.7"/>
                    <measurement group_id="O5" value="83.8"/>
                    <measurement group_id="O6" value="78.9"/>
                    <measurement group_id="O7" value="64.3"/>
                    <measurement group_id="O8" value="100"/>
                    <measurement group_id="O9" value="62.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 20</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="100"/>
                    <measurement group_id="O2" value="89.1"/>
                    <measurement group_id="O3" value="93.9"/>
                    <measurement group_id="O4" value="96.7"/>
                    <measurement group_id="O5" value="89.2"/>
                    <measurement group_id="O6" value="84.2"/>
                    <measurement group_id="O7" value="78.6"/>
                    <measurement group_id="O8" value="83.3"/>
                    <measurement group_id="O9" value="62.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 24</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="100"/>
                    <measurement group_id="O2" value="85.5"/>
                    <measurement group_id="O3" value="97.0"/>
                    <measurement group_id="O4" value="96.7"/>
                    <measurement group_id="O5" value="83.8"/>
                    <measurement group_id="O6" value="78.9"/>
                    <measurement group_id="O7" value="71.4"/>
                    <measurement group_id="O8" value="83.3"/>
                    <measurement group_id="O9" value="75.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 28</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="93.3"/>
                    <measurement group_id="O2" value="90.9"/>
                    <measurement group_id="O3" value="97.0"/>
                    <measurement group_id="O4" value="96.7"/>
                    <measurement group_id="O5" value="91.9"/>
                    <measurement group_id="O6" value="84.2"/>
                    <measurement group_id="O7" value="71.4"/>
                    <measurement group_id="O8" value="83.3"/>
                    <measurement group_id="O9" value="50.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 32</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="100"/>
                    <measurement group_id="O2" value="89.1"/>
                    <measurement group_id="O3" value="97.0"/>
                    <measurement group_id="O4" value="93.3"/>
                    <measurement group_id="O5" value="91.9"/>
                    <measurement group_id="O6" value="73.7"/>
                    <measurement group_id="O7" value="71.4"/>
                    <measurement group_id="O8" value="83.3"/>
                    <measurement group_id="O9" value="50.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 36</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="100"/>
                    <measurement group_id="O2" value="85.5"/>
                    <measurement group_id="O3" value="97.0"/>
                    <measurement group_id="O4" value="93.3"/>
                    <measurement group_id="O5" value="91.9"/>
                    <measurement group_id="O6" value="73.7"/>
                    <measurement group_id="O7" value="71.4"/>
                    <measurement group_id="O8" value="66.7"/>
                    <measurement group_id="O9" value="50.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 40</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="100"/>
                    <measurement group_id="O2" value="83.6"/>
                    <measurement group_id="O3" value="87.9"/>
                    <measurement group_id="O4" value="86.7"/>
                    <measurement group_id="O5" value="89.2"/>
                    <measurement group_id="O6" value="78.9"/>
                    <measurement group_id="O7" value="71.4"/>
                    <measurement group_id="O8" value="83.3"/>
                    <measurement group_id="O9" value="50.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 44</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="100"/>
                    <measurement group_id="O2" value="81.8"/>
                    <measurement group_id="O3" value="87.9"/>
                    <measurement group_id="O4" value="86.7"/>
                    <measurement group_id="O5" value="89.2"/>
                    <measurement group_id="O6" value="78.9"/>
                    <measurement group_id="O7" value="71.4"/>
                    <measurement group_id="O8" value="83.3"/>
                    <measurement group_id="O9" value="50.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 48</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="100"/>
                    <measurement group_id="O2" value="80.0"/>
                    <measurement group_id="O3" value="87.9"/>
                    <measurement group_id="O4" value="86.7"/>
                    <measurement group_id="O5" value="91.9"/>
                    <measurement group_id="O6" value="68.4"/>
                    <measurement group_id="O7" value="71.4"/>
                    <measurement group_id="O8" value="66.7"/>
                    <measurement group_id="O9" value="50.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants With Investigator´s Global Assessment Response (Clear or Almost Clear With at Least a 2 Category Improvement From Baseline on a 5-point Scale) Over Time</title>
        <description>The Investigator's Global Assessment (IGA) measures the overall 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. IGA response is defined as clear (0) or almost clear (1) with at least a two category improvement from Baseline. This Outcome Measure presents results relative to PS0010 Baseline starting at PS0011 Baseline by PS0010 Week 12 response status.</description>
        <time_frame>From Baseline during the Treatment Period (up to Week 48)</time_frame>
        <population>The FAS consisted of all enrolled participants who received at least 1 dose of the study medication in PS0011 and had a valid efficacy measurement for PASI at Baseline of PS0011.</population>
        <group_list>
          <group group_id="O1">
            <title>Bimekizumab 64 mg Q4W/Bimekizumab 64 mg Q4W/R (FAS)</title>
            <description>Participants who achieved PASI90 response at Week 12 and received bimekizumab 64 mg Q4W in PS0010, were assigned to bimekizumab 64 mg Q4W in PS0011. Participants formed the Full Analysis Set (FAS).</description>
          </group>
          <group group_id="O2">
            <title>Bimekizumab 160 mg Q4W/Bimekizumab 160 mg Q4W/R (FAS)</title>
            <description>Participants who achieved PASI90 response at Week 12 and received bimekizumab 160 mg Q4W or bimekizumab 160 mg with loading dose (w/LD) Q4W in PS0010, were assigned to bimekizumab 160 mg Q4W in PS0011. Participants formed the FAS.</description>
          </group>
          <group group_id="O3">
            <title>Bimekizumab 320 mg Q4W/Bimekizumab 320 mg Q4W/R (FAS)</title>
            <description>Participants who achieved PASI90 response at Week 12 and received bimekizumab 320 mg Q4W in PS0010, were assigned to bimekizumab 320 mg Q4W in PS0011. Participants formed the FAS.</description>
          </group>
          <group group_id="O4">
            <title>Bimekizumab 480 mg Q4W/Bimekizumab 320 mg Q4W/R (FAS)</title>
            <description>Participants who achieved PASI90 response at Week 12 and received bimekizumab 480 mg Q4W in PS0010, were assigned to bimekizumab 320 mg Q4W in PS0011. Participants formed the FAS.</description>
          </group>
          <group group_id="O5">
            <title>Placebo/Bimekizumab 160 mg Q4W/NR (FAS)</title>
            <description>Participants who did not achieve PASI90 response at Week 12 and received placebo Q4W in PS0010, were assigned to bimekizumab 160 mg Q4W in PS0011. Participants formed the FAS.</description>
          </group>
          <group group_id="O6">
            <title>Bimekizumab 64 mg Q4W/Bimekizumab 160 mg Q4W/NR (FAS)</title>
            <description>Participants who did not achieve PASI90 response at Week 12 and received bimekizumab 64 mg Q4W in PS0010, were assigned to bimekizumab 160 mg Q4W in PS0011. Participants formed the FAS.</description>
          </group>
          <group group_id="O7">
            <title>Bimekizumab 160 mg Q4W/Bimekizumab 320 mg Q4W/NR (FAS)</title>
            <description>Participants who did not achieve PASI90 response at Week 12 and received bimekizumab 160 mg Q4W or bimekizumab 160 mg w/LD Q4W in PS0010, were assigned to bimekizumab 320 mg Q4W in PS0011. Participants formed the FAS.</description>
          </group>
          <group group_id="O8">
            <title>Bimekizumab 320 mg Q4W/Bimekizumab 320 mg Q4W/NR (FAS)</title>
            <description>Participants who did not achieve PASI90 response at Week 12 and received bimekizumab 320 mg Q4W in PS0010, were assigned to bimekizumab 320 mg Q4W in PS0011. Participants formed the FAS.</description>
          </group>
          <group group_id="O9">
            <title>Bimekizumab 480 mg Q4W/Bimekizumab 320 mg Q4W/NR (FAS)</title>
            <description>Participants who did not achieve PASI90 response at Week 12 and received bimekizumab 480 mg Q4W in PS0010, were assigned to bimekizumab 320 mg Q4W in PS0011. Participants formed the FAS.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With Investigator´s Global Assessment Response (Clear or Almost Clear With at Least a 2 Category Improvement From Baseline on a 5-point Scale) Over Time</title>
          <description>The Investigator's Global Assessment (IGA) measures the overall 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. IGA response is defined as clear (0) or almost clear (1) with at least a two category improvement from Baseline. This Outcome Measure presents results relative to PS0010 Baseline starting at PS0011 Baseline by PS0010 Week 12 response status.</description>
          <population>The FAS consisted of all enrolled participants who received at least 1 dose of the study medication in PS0011 and had a valid efficacy measurement for PASI at Baseline of PS0011.</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="15"/>
                <count group_id="O2" value="55"/>
                <count group_id="O3" value="33"/>
                <count group_id="O4" value="30"/>
                <count group_id="O5" value="37"/>
                <count group_id="O6" value="19"/>
                <count group_id="O7" value="14"/>
                <count group_id="O8" value="6"/>
                <count group_id="O9" value="8"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>PS0011 Baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="100"/>
                    <measurement group_id="O2" value="96.4"/>
                    <measurement group_id="O3" value="100"/>
                    <measurement group_id="O4" value="100"/>
                    <measurement group_id="O5" value="5.4"/>
                    <measurement group_id="O6" value="10.5"/>
                    <measurement group_id="O7" value="35.7"/>
                    <measurement group_id="O8" value="50.0"/>
                    <measurement group_id="O9" value="25.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 4</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="100"/>
                    <measurement group_id="O2" value="98.2"/>
                    <measurement group_id="O3" value="97.0"/>
                    <measurement group_id="O4" value="100"/>
                    <measurement group_id="O5" value="56.8"/>
                    <measurement group_id="O6" value="57.9"/>
                    <measurement group_id="O7" value="42.9"/>
                    <measurement group_id="O8" value="66.7"/>
                    <measurement group_id="O9" value="62.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 8</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="100"/>
                    <measurement group_id="O2" value="96.4"/>
                    <measurement group_id="O3" value="97.0"/>
                    <measurement group_id="O4" value="100"/>
                    <measurement group_id="O5" value="75.7"/>
                    <measurement group_id="O6" value="84.2"/>
                    <measurement group_id="O7" value="57.1"/>
                    <measurement group_id="O8" value="83.3"/>
                    <measurement group_id="O9" value="62.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 12</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="100"/>
                    <measurement group_id="O2" value="92.7"/>
                    <measurement group_id="O3" value="97.0"/>
                    <measurement group_id="O4" value="96.7"/>
                    <measurement group_id="O5" value="81.1"/>
                    <measurement group_id="O6" value="89.5"/>
                    <measurement group_id="O7" value="64.3"/>
                    <measurement group_id="O8" value="83.3"/>
                    <measurement group_id="O9" value="62.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 16</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="100"/>
                    <measurement group_id="O2" value="90.9"/>
                    <measurement group_id="O3" value="97.0"/>
                    <measurement group_id="O4" value="96.7"/>
                    <measurement group_id="O5" value="83.8"/>
                    <measurement group_id="O6" value="78.9"/>
                    <measurement group_id="O7" value="57.1"/>
                    <measurement group_id="O8" value="66.7"/>
                    <measurement group_id="O9" value="62.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 20</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="100"/>
                    <measurement group_id="O2" value="85.5"/>
                    <measurement group_id="O3" value="93.9"/>
                    <measurement group_id="O4" value="96.7"/>
                    <measurement group_id="O5" value="89.2"/>
                    <measurement group_id="O6" value="84.2"/>
                    <measurement group_id="O7" value="71.4"/>
                    <measurement group_id="O8" value="66.7"/>
                    <measurement group_id="O9" value="75.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 24</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="100"/>
                    <measurement group_id="O2" value="81.8"/>
                    <measurement group_id="O3" value="97.0"/>
                    <measurement group_id="O4" value="93.3"/>
                    <measurement group_id="O5" value="83.8"/>
                    <measurement group_id="O6" value="84.2"/>
                    <measurement group_id="O7" value="64.3"/>
                    <measurement group_id="O8" value="83.3"/>
                    <measurement group_id="O9" value="62.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 28</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="93.3"/>
                    <measurement group_id="O2" value="89.1"/>
                    <measurement group_id="O3" value="97.0"/>
                    <measurement group_id="O4" value="93.3"/>
                    <measurement group_id="O5" value="86.5"/>
                    <measurement group_id="O6" value="84.2"/>
                    <measurement group_id="O7" value="71.4"/>
                    <measurement group_id="O8" value="66.7"/>
                    <measurement group_id="O9" value="62.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 32</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="100"/>
                    <measurement group_id="O2" value="85.5"/>
                    <measurement group_id="O3" value="93.9"/>
                    <measurement group_id="O4" value="93.3"/>
                    <measurement group_id="O5" value="89.2"/>
                    <measurement group_id="O6" value="78.9"/>
                    <measurement group_id="O7" value="71.4"/>
                    <measurement group_id="O8" value="66.7"/>
                    <measurement group_id="O9" value="50.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 36</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="100"/>
                    <measurement group_id="O2" value="81.8"/>
                    <measurement group_id="O3" value="90.9"/>
                    <measurement group_id="O4" value="93.3"/>
                    <measurement group_id="O5" value="86.5"/>
                    <measurement group_id="O6" value="78.9"/>
                    <measurement group_id="O7" value="71.4"/>
                    <measurement group_id="O8" value="66.7"/>
                    <measurement group_id="O9" value="37.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 40</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="100"/>
                    <measurement group_id="O2" value="83.6"/>
                    <measurement group_id="O3" value="87.9"/>
                    <measurement group_id="O4" value="86.7"/>
                    <measurement group_id="O5" value="86.5"/>
                    <measurement group_id="O6" value="78.9"/>
                    <measurement group_id="O7" value="71.4"/>
                    <measurement group_id="O8" value="66.7"/>
                    <measurement group_id="O9" value="50.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 44</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="100"/>
                    <measurement group_id="O2" value="81.8"/>
                    <measurement group_id="O3" value="87.9"/>
                    <measurement group_id="O4" value="86.7"/>
                    <measurement group_id="O5" value="83.8"/>
                    <measurement group_id="O6" value="78.9"/>
                    <measurement group_id="O7" value="71.4"/>
                    <measurement group_id="O8" value="66.7"/>
                    <measurement group_id="O9" value="50.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 48</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="100"/>
                    <measurement group_id="O2" value="78.2"/>
                    <measurement group_id="O3" value="87.9"/>
                    <measurement group_id="O4" value="86.7"/>
                    <measurement group_id="O5" value="89.2"/>
                    <measurement group_id="O6" value="68.4"/>
                    <measurement group_id="O7" value="71.4"/>
                    <measurement group_id="O8" value="66.7"/>
                    <measurement group_id="O9" value="62.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>From PS0011 Baseline and up to Safety-Follow Up (SFU) (up to Week 64)</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Bimekizumab 64 mg Q4W (SS)</title>
          <description>Participants received bimekizumab 64 milligrams (mg) injections, sc every four weeks (Q4W). Participants who achieved PASI90 response at Week 12 and received bimekizumab 64 mg Q4W in PS0010, were assigned to bimekizumab 64 mg Q4W in PS0011. Participants who did not achieve PASI90 response at Week 12 and received bimekizumab 64 mg Q4W in PS0010, were assigned to bimekizumab 160 mg Q4W in PS0011. Participants who received at least one dose of the IMP formed the Safety Set (SS).</description>
        </group>
        <group group_id="E2">
          <title>Bimekizumab 160 mg Q4W (SS)</title>
          <description>Participants received bimekizumab 160 mg injections, sc every four weeks (Q4W). Participants who achieved PASI90 response at Week 12 and received bimekizumab 160 mg Q4W or bimekizumab 160 mg with loading dose (w/LD) Q4W in PS0010, were assigned to bimekizumab 160 mg Q4W in PS0011. Participants who did not achieve PASI90 response at Week 12 and received bimekizumab 160 mg Q4W or bimekizumab 160 mg w/LD Q4W in PS0010, were assigned to bimekizumab 320 mg Q4W in PS0011. Participants who received at least one dose of the IMP formed the SS.</description>
        </group>
        <group group_id="E3">
          <title>Bimekizumab 320 mg Q4W (SS)</title>
          <description>Participants received bimekizumab 320 mg injections, sc every four weeks (Q4W). Participants receiving bimekizumab 320 mg Q4W and bimekizumab 480 mg Q4W, in PS0010 were assigned to receive bimekizumab 320 mg Q4W in PS0011, regardless of their PASI90 response at Week 12 in PS0010. Participants who received at least one dose of the IMP formed the 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="15"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="111"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="91"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E2" subjects_affected="7" subjects_at_risk="111"/>
                <counts group_id="E3" subjects_affected="7" subjects_at_risk="91"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Cardiac failure</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="111"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="91"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Eye disorders</title>
            <event_list>
              <event>
                <sub_title>Cataract</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="111"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="91"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Non-cardiac chest pain</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="111"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="91"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Otitis externa bacterial</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="111"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="91"/>
              </event>
              <event>
                <sub_title>Staphylococcal abscess</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="111"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="91"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Humerus fracture</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="111"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="91"/>
              </event>
              <event>
                <sub_title>Tibia fracture</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="111"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="91"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Hepatic enzyme increased</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="111"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="91"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Neoplasms benign, malignant and unspecified (incl cysts and polyps)</title>
            <event_list>
              <event>
                <sub_title>Acute myeloid leukaemia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="111"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="91"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Carpal tunnel syndrome</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="111"/>
                <counts group_id="E3" events="2" subjects_affected="1" subjects_at_risk="91"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>IgA nephropathy</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="111"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="91"/>
              </event>
              <event>
                <sub_title>Nephrolithiasis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="111"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="91"/>
              </event>
              <event>
                <sub_title>Ureterolithiasis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="111"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="91"/>
              </event>
              <event>
                <sub_title>Renal colic</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E2" events="2" subjects_affected="1" subjects_at_risk="111"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="91"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Reproductive system and breast disorders</title>
            <event_list>
              <event>
                <sub_title>Uterine cervix stenosis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="111"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="91"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Dyspnoea</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="111"/>
                <counts group_id="E3" events="2" subjects_affected="1" subjects_at_risk="91"/>
              </event>
              <event>
                <sub_title>Respiratory failure</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="111"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="91"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Surgical and medical procedures</title>
            <event_list>
              <event>
                <sub_title>Abortion induced</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="111"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="91"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Circulatory collapse</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="111"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="91"/>
              </event>
              <event>
                <sub_title>Hypovolaemic shock</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="111"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="91"/>
              </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="10" subjects_at_risk="15"/>
                <counts group_id="E2" subjects_affected="56" subjects_at_risk="111"/>
                <counts group_id="E3" subjects_affected="51" subjects_at_risk="91"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Ear and labyrinth disorders</title>
            <event_list>
              <event>
                <sub_title>External ear inflammation</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="111"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="91"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Diarrhoea</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="111"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="91"/>
              </event>
              <event>
                <sub_title>Flatulence</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="111"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="91"/>
              </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="1" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="111"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="91"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Oral candidiasis</sub_title>
                <counts group_id="E1" events="2" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E2" events="17" subjects_affected="13" subjects_at_risk="111"/>
                <counts group_id="E3" events="19" subjects_affected="15" subjects_at_risk="91"/>
              </event>
              <event>
                <sub_title>Skin candida</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="111"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="91"/>
              </event>
              <event>
                <sub_title>Angular cheilitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E2" events="3" subjects_affected="2" subjects_at_risk="111"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="91"/>
              </event>
              <event>
                <sub_title>Gingivitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="111"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="91"/>
              </event>
              <event>
                <sub_title>Vulvovaginal mycotic infection</sub_title>
                <counts group_id="E1" events="2" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="111"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="91"/>
              </event>
              <event>
                <sub_title>Nasopharyngitis</sub_title>
                <counts group_id="E1" events="4" subjects_affected="2" subjects_at_risk="15"/>
                <counts group_id="E2" events="20" subjects_affected="15" subjects_at_risk="111"/>
                <counts group_id="E3" events="14" subjects_affected="11" subjects_at_risk="91"/>
              </event>
              <event>
                <sub_title>Upper respiratory tract infection</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E2" events="12" subjects_affected="10" subjects_at_risk="111"/>
                <counts group_id="E3" events="12" subjects_affected="9" subjects_at_risk="91"/>
              </event>
              <event>
                <sub_title>Pharyngitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="111"/>
                <counts group_id="E3" events="3" subjects_affected="3" subjects_at_risk="91"/>
              </event>
              <event>
                <sub_title>Urinary tract infection</sub_title>
                <counts group_id="E1" events="3" subjects_affected="2" subjects_at_risk="15"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="111"/>
                <counts group_id="E3" events="2" subjects_affected="1" subjects_at_risk="91"/>
              </event>
              <event>
                <sub_title>Respiratory tract infection viral</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="111"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="91"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Joint injury</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="111"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="91"/>
              </event>
              <event>
                <sub_title>Procedural pain</sub_title>
                <counts group_id="E1" events="2" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="111"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="91"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Gamma-glutamyl-transferase increased</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E2" events="6" subjects_affected="4" subjects_at_risk="111"/>
                <counts group_id="E3" events="4" subjects_affected="3" subjects_at_risk="91"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Hyperphagia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="111"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="91"/>
              </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="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E2" events="4" subjects_affected="3" subjects_at_risk="111"/>
                <counts group_id="E3" events="7" subjects_affected="6" subjects_at_risk="91"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Neoplasms benign, malignant and unspecified (incl cysts and polyps)</title>
            <event_list>
              <event>
                <sub_title>Benign ovarian tumour</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="111"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="91"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Oropharyngeal pain</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E2" events="6" subjects_affected="6" subjects_at_risk="111"/>
                <counts group_id="E3" events="8" subjects_affected="6" subjects_at_risk="91"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Dermatitis contact</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E2" events="6" subjects_affected="5" subjects_at_risk="111"/>
                <counts group_id="E3" events="3" subjects_affected="3" subjects_at_risk="91"/>
              </event>
              <event>
                <sub_title>Seborrhoeic dermatitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E2" events="4" subjects_affected="3" subjects_at_risk="111"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="91"/>
              </event>
              <event>
                <sub_title>Pruritus generalised</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="111"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="91"/>
              </event>
              <event>
                <sub_title>Psoriasis</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="15"/>
                <counts group_id="E2" events="6" subjects_affected="5" subjects_at_risk="111"/>
                <counts group_id="E3" events="5" subjects_affected="5" subjects_at_risk="91"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Hypertension</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="15"/>
                <counts group_id="E2" events="10" subjects_affected="8" subjects_at_risk="111"/>
                <counts group_id="E3" events="4" subjects_affected="4" subjects_at_risk="91"/>
              </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/NCT03010527
org study id: PS0011
secondary id: 2016-001892-57
nct id: NCT03010527
lead sponsor: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
This is a multicenter extension study to assess the long-term safety, tolerability and
      efficacy of bimekizumab in adult subjects with moderate to severe chronic plaque psoriasis
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Incidence of Treatment Emergent Adverse Events (TEAEs) Adjusted by Duration of Subject Exposure to Treatment
time frame: From Baseline until Safety Follow-Up Visit (up to Week 64)
description: Treatment-emergent Adverse Events (TEAEs) were defined as those events which started on or after the date of first dose of PS0011 investigational medicinal product (IMP), or events in which severity worsened on or after the date of first dose of PS0011 study medication. The exposure adjusted incidence rate (EAIR) is defined as the number of subjects (n) with a specific AE adjusted for the exposure and was scaled to 100 subject-years: where the numerator is the total number of subjects experiencing the AE and the denominator is the total time at risk scaled to 100 subject-years; that is, the total summation of individual subject-years at risk up to the first occurrence of the AE for subjects with that AE, and the total subject-years at risk for those subjects not experiencing that AE, divided by 100.
measure: Percentage of Participants With Psoriasis Area Severity Index (PASI90) Response Over Time
time frame: From Baseline during the Treatment Period (up to Week 48)
description: The PASI90 response assessments are based on at least 90% improvement in the PASI score from Baseline. It 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). The PASI score ranges from 0 to 72 with a higher score indicating increased disease severity. PASI90 response is defined to be equal to 1 if the percentage improvement from Baseline in the PASI scores is 90% or greater and 0 if the percentage improvement from Baseline is less than 90%. This Outcome Measure presents results relative to PS0010 Baseline starting at PS0011 Baseline by PS0010 Week 12 response status.
measure: Percentage of Participants With Investigator´s Global Assessment Response (Clear or Almost Clear With at Least a 2 Category Improvement From Baseline on a 5-point Scale) Over Time
time frame: From Baseline during the Treatment Period (up to Week 48)
description: The Investigator's Global Assessment (IGA) measures the overall 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. IGA response is defined as clear (0) or almost clear (1) with at least a two category improvement from Baseline. This Outcome Measure presents results relative to PS0010 Baseline starting at PS0011 Baseline by PS0010 Week 12 response status.
arm group label: Placebo
arm group type: Placebo Comparator
description: Subjects with a PASI90 response at Week 12 and receiving Placebo in PS0010 entering PS0011 will receive Placebo.
arm group label: Bimekizumab dosing regimen 1
arm group type: Experimental
description: Subjects with a PASI90 response at Week 12 receiving dosing regimen 1 in PS0010 entering PS0011 will receive the same dosing regimen.
Subjects who do not achieve PASI90 response at Week 12 receiving dosing regimen 1 in PS0010 will be assigned to a higher dosing regimen.
arm group label: Bimekizumab dosing regimen 2
arm group type: Experimental
description: Subjects with a PASI90 response at Week 12 receiving dosing regimen 2 in PS0010 entering PS0011 will receive the same dosing regimen.
Subjects who do not achieve PASI90 response at Week 12 receiving dosing regimen 2 in PS0010 will be assigned to a higher dosing regimen.
arm group label: Bimekizumab dosing regimen 3
arm group type: Experimental
description: Subjects that were initially randomized to bimekizumab dosage regimen 3, 4 and 5 in PS0010 will receive bimekizumab dosing regimen 3.
intervention type: Drug
intervention name: Bimekizumab
description: Subjects will receive bimekizumab injections every four weeks (Q4W)
arm group label: Bimekizumab dosing regimen 1
arm group label: Bimekizumab dosing regimen 2
arm group label: Bimekizumab dosing regimen 3
other name: UCB4940
intervention type: Other
intervention name: Placebo
description: Subjects will receive Placebo injections every four weeks (Q4W)
arm group label: Placebo
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: UCB Cares
role: Study Director
affiliation: 001 844 599 2273 (UCB)
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country: Canada
country: Czechia
country: Hungary
country: Japan
country: Poland
country: United States
country: Czech Republic
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: Blauvelt A, Papp KA, Merola JF, Gottlieb AB, Cross N, Madden C, Wang M, Cioffi C, Griffiths CEM. Bimekizumab for patients with moderate to severe plaque psoriasis: 60-week results from BE ABLE 2, a randomized, double-blinded, placebo-controlled, phase 2b extension study. J Am Acad Dermatol. 2020 Nov;83(5):1367-1374. doi: 10.1016/j.jaad.2020.05.105. Epub 2020 May 29.
PMID: 32473974
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: 