<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/NCT03766685</url>
  </required_header>
  <id_info>
    <org_study_id>DV0002</org_study_id>
    <nct_id>NCT03766685</nct_id>
  </id_info>
  <brief_title>A Study to Evaluate the Safe and Effective Use of the Prefilled Safety Syringe or the Auto-injector for the Subcutaneous Self-injection of Bimekizumab Solution by Subjects With Moderate to Severe Chronic Plaque Psoriasis (PSO)</brief_title>
  <official_title>A Multicenter, Randomized, Open-Label Study to Evaluate the Safe and Effective Use of the Prefilled Safety Syringe or the Auto-Injector for the Subcutaneous Self-Injection of Bimekizumab Solution by 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>No</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of the study is to evaluate the ability of subjects with moderate to severe&#xD;
      chronic plaque psoriasis (PSO) to safely and effectively self-inject bimekizumab at study&#xD;
      start and 8 weeks after training in self-injection technique using a prefilled safety syringe&#xD;
      or an auto-injector.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 20, 2018</start_date>
  <completion_date type="Actual">September 8, 2020</completion_date>
  <primary_completion_date type="Actual">July 14, 2020</primary_completion_date>
  <phase>Phase 3</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Percentage of Participants Able to Self-administer Safe and Effective Injections Using the Bimekizumab-safety Syringe (SS)-1mL or the Bimekizumab-auto-injector (AI)-1mL at Week 8, After Training in Self-injection Technique</measure>
    <time_frame>Week 8</time_frame>
    <description>Safe and effective self-injection was evaluated by the study personnel and was defined as: - Complete dose delivery: Participant self-injected the complete dose of bimekizumab as confirmed by a visual inspection of the bimekizumab-safety syringe (SS) or the bimekizumab-auto-injector (AI) which shows that the investigational medicinal product (IMP) was delivered completely (ie, container is empty), and - No Adverse Device Effects (ADEs) that would preclude continued use of the device for self-injection (ie, no serious ADEs (SADEs) and/or ADEs leading to withdrawal).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Percentage of Participants Able to Self-administer Safe and Effective Injections Using the Bimekizumab-SS-2mL or the Bimekizumab-AI-2mL at Week 8, After Training in Self-injection Technique</measure>
    <time_frame>Week 8</time_frame>
    <description>Safe and effective self-injection was evaluated by the study personnel and was defined as: - Complete dose delivery: Participant self-injected the complete dose of bimekizumab as confirmed by a visual inspection of the bimekizumab-SS or the bimekizumab-AI which shows that the IMP is delivered completely (ie, container is empty), and - No ADEs that would preclude continued use of the device for self-injection (ie, no serious ADEs (SADEs) and/or ADEs leading to withdrawal).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants Able to Self-administer Safe and Effective Injections Using the Bimekizumab-SS-1mL or the Bimekizumab-AI-1mL at Baseline, After Training in Self-injection Technique</measure>
    <time_frame>Baseline (the first self-injection visit)</time_frame>
    <description>Safe and effective self-injection was evaluated by the study personnel and was defined as: - Complete dose delivery: Participant self-injected the complete dose of bimekizumab as confirmed by a visual inspection of the bimekizumab-SS or the bimekizumab-AI which showed that the IMP was delivered completely (ie, container is empty), and - No ADEs that would preclude continued use of the device for self-injection (ie, no SADEs and/or ADEs leading to withdrawal).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants Able to Self-administer Safe and Effective Injections Using the Bimekizumab-SS-2mL or the Bimekizumab-AI-2mL at Baseline, After Training in Self-injection Technique</measure>
    <time_frame>Baseline (the first self-injection visit)</time_frame>
    <description>Safe and effective self-injection was evaluated by the study personnel and was defined as: - Complete dose delivery: Participant self-injected the complete dose of bimekizumab as confirmed by a visual inspection of the bimekizumab-SS or the bimekizumab-AI which shows that the IMP is delivered completely (ie, container is empty), and - No ADEs that would preclude continued use of the device for self-injection (ie, no SADEs and/or ADEs leading to withdrawal).</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">172</enrollment>
  <condition>Chronic Plaque Psoriasis</condition>
  <condition>Moderate to Severe Chronic Plaque Psoriasis</condition>
  <arm_group>
    <arm_group_label>Bimekizumab-SS</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Subjects will receive assigned bimekizumab dose regimen using a prefilled safety syringe (SS).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Bimekizumab-AI</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Subjects will receive assigned bimekizumab dose regimen using an auto-injector (AI).</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Bimekizumab</intervention_name>
    <description>Subjects will receive bimekizumab at pre-specified time-points.</description>
    <arm_group_label>Bimekizumab-AI</arm_group_label>
    <arm_group_label>Bimekizumab-SS</arm_group_label>
    <other_name>UCB4940</other_name>
    <other_name>BKZ</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Subject fulfills all inclusion criteria for the PS0014 [NCT03598790] study&#xD;
&#xD;
          -  Subject is considered reliable and capable of adhering to the DV0002 protocol (eg,&#xD;
             able to understand and complete questionnaires, willing to self-inject, able to use&#xD;
             investigational device according to the instructions for use (IFU), and able to adhere&#xD;
             to the visit schedule) according to the judgment of the Investigator&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Subjects are not permitted to enroll in DV0002 if any of the PS0014 [NCT03598790]&#xD;
             study exclusion criteria are met&#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</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Dv0002 946</name>
      <address>
        <city>Phoenix</city>
        <state>Arizona</state>
        <zip>85032</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Dv0002 910</name>
      <address>
        <city>Bakersfield</city>
        <state>California</state>
        <zip>93309</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Dv0002 955</name>
      <address>
        <city>San Diego</city>
        <state>California</state>
        <zip>92123</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Dv0002 943</name>
      <address>
        <city>San Luis Obispo</city>
        <state>California</state>
        <zip>93405</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Dv0002 967</name>
      <address>
        <city>Santa Monica</city>
        <state>California</state>
        <zip>90404</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Dv0002 906</name>
      <address>
        <city>Boca Raton</city>
        <state>Florida</state>
        <zip>33486</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Dv0002 907</name>
      <address>
        <city>Miami</city>
        <state>Florida</state>
        <zip>33144</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Dv0002 903</name>
      <address>
        <city>Ocala</city>
        <state>Florida</state>
        <zip>34471</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Dv0002 936</name>
      <address>
        <city>Tampa</city>
        <state>Florida</state>
        <zip>33624</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Dv0002 941</name>
      <address>
        <city>Alpharetta</city>
        <state>Georgia</state>
        <zip>30022</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Dv0002 954</name>
      <address>
        <city>Skokie</city>
        <state>Illinois</state>
        <zip>60077</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Dv0002 900</name>
      <address>
        <city>West Des Moines</city>
        <state>Iowa</state>
        <zip>50265</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Dv0002 905</name>
      <address>
        <city>Overland Park</city>
        <state>Kansas</state>
        <zip>66215</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Dv0002 962</name>
      <address>
        <city>Owensboro</city>
        <state>Kentucky</state>
        <zip>42301</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Dv0002 922</name>
      <address>
        <city>Baton Rouge</city>
        <state>Louisiana</state>
        <zip>70809</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Dv0002 925</name>
      <address>
        <city>Brighton</city>
        <state>Massachusetts</state>
        <zip>02135</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Dv0002 917</name>
      <address>
        <city>Troy</city>
        <state>Michigan</state>
        <zip>48084</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Dv0002 915</name>
      <address>
        <city>Saint Louis</city>
        <state>Missouri</state>
        <zip>63117</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Dv0002 901</name>
      <address>
        <city>Portsmouth</city>
        <state>New Hampshire</state>
        <zip>03801</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Dv0002 908</name>
      <address>
        <city>East Windsor</city>
        <state>New Jersey</state>
        <zip>08520</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Dv0002 913</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10029</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Dv0002 963</name>
      <address>
        <city>Rochester</city>
        <state>New York</state>
        <zip>14623</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Dv0002 920</name>
      <address>
        <city>Portland</city>
        <state>Oregon</state>
        <zip>97210</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Dv0002 929</name>
      <address>
        <city>Portland</city>
        <state>Oregon</state>
        <zip>97223</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Dv0002 937</name>
      <address>
        <city>Johnston</city>
        <state>Rhode Island</state>
        <zip>02919</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Dv0002 951</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77598</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Dv0002 914</name>
      <address>
        <city>San Antonio</city>
        <state>Texas</state>
        <zip>78213</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Dv0002 672</name>
      <address>
        <city>Edmonton</city>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Dv0002 673</name>
      <address>
        <city>Halifax</city>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Dv0002 671</name>
      <address>
        <city>Hamilton</city>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Dv0002 675</name>
      <address>
        <city>Markham</city>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Dv0002 663</name>
      <address>
        <city>Mississauga</city>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Dv0002 660</name>
      <address>
        <city>Montréal</city>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Dv0002 665</name>
      <address>
        <city>Québec City</city>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Dv0002 651</name>
      <address>
        <city>Richmond Hill</city>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Dv0002 653</name>
      <address>
        <city>Toronto</city>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Dv0002 662</name>
      <address>
        <city>Toronto</city>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Dv0002 657</name>
      <address>
        <city>Waterloo</city>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Dv0002 670</name>
      <address>
        <city>Windsor</city>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
    <country>United States</country>
  </location_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>
  <verification_date>July 2023</verification_date>
  <study_first_submitted>December 5, 2018</study_first_submitted>
  <study_first_submitted_qc>December 5, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 6, 2018</study_first_posted>
  <results_first_submitted>June 12, 2023</results_first_submitted>
  <results_first_submitted_qc>July 19, 2023</results_first_submitted_qc>
  <results_first_posted type="Actual">August 8, 2023</results_first_posted>
  <disposition_first_submitted>June 14, 2021</disposition_first_submitted>
  <disposition_first_submitted_qc>July 19, 2023</disposition_first_submitted_qc>
  <disposition_first_posted type="Actual">August 8, 2023</disposition_first_posted>
  <last_update_submitted>July 19, 2023</last_update_submitted>
  <last_update_submitted_qc>July 19, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">August 8, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Bimekizumab</keyword>
  <keyword>PSO</keyword>
  <keyword>Psoriasis</keyword>
  <keyword>Auto-Injector</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Psoriasis</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <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>October 28, 2019</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/85/NCT03766685/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>October 7, 2020</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/85/NCT03766685/SAP_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <recruitment_details>The study started to enroll study participants in December 2018 and concluded in September 2020. This study is a substudy to PS0014 (NCT03598790).</recruitment_details>
      <pre_assignment_details>Participant flow refers to Enrolled Set.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Bimekizumab-SS-1mL 320 mg</title>
          <description>Participants self-injected bimekizumab (BKZ) 320 milligrams (mg) solution as a subcutaneous (sc) injection with bimekizumab-Safety Syringe-1 milliliter (mL) (BKZ-SS-1mL) device presentation (ie. 2 self-injections) at Baseline and at Week 8 for participants on every 4 weeks (Q4W) and every 8 weeks (Q8W) dosing. For Q4W dosing, participants were injected by study personnel with 320 mg BKZ using the 1ml prefilled syringe (PFS) at Week 4, 12 and 16. For Q8W dosing, participants were injected by study personnel with 320 mg BKZ using the 1ml PFS at Week 16.</description>
        </group>
        <group group_id="P2">
          <title>Bimekizumab-AI-1mL 320 mg</title>
          <description>Participants self-injected BKZ 320 mg solution as a sc injection with bimekizumab-Auto-Injector-1mL (BKZ-AI-1mL) device presentation (ie. 2 self-injections) at Baseline and at Week 8 for participants on Q4W and Q8W dosing. For Q4W dosing, participants were injected by study personnel with 320 mg BKZ using the 1ml PFS at Week 4, 12 and 16. For Q8W dosing, participants were injected by study personnel with 320 mg BKZ using the 1ml PFS at Week 16.</description>
        </group>
        <group group_id="P3">
          <title>Bimekizumab-SS-2mL 320 mg</title>
          <description>Participants self-injected BKZ 320 mg solution as a sc injection with BKZ-SS-2mL device presentation (ie. 1 self-injection) at Baseline and at Week 8 for participants on Q4W and Q8W dosing. For Q4W dosing, participants were injected by study personnel with 320 mg BKZ using the 2ml PFS at Week 4, 12 and 16. For Q8W dosing, participants were injected by study personnel with 320 mg BKZ using the 2ml PFS at Week 16.</description>
        </group>
        <group group_id="P4">
          <title>Bimekizumab-AI-2mL 320 mg</title>
          <description>Participants self-injected BKZ 320 mg solution as a sc injection with BKZ-AI-2mL device presentation (ie. 1 self-injection) at Baseline and at Week 8 for participants on Q4W and Q8W dosing. For Q4W dosing, participants were injected by study personnel with 320 mg BKZ using the 2ml PFS at Week 4, 12 and 16. For Q8W dosing, participants were injected by study personnel with 320 mg BKZ using the 2ml PFS at Week 16.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="66"/>
                <participants group_id="P2" count="68"/>
                <participants group_id="P3" count="19"/>
                <participants group_id="P4" count="19"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="65"/>
                <participants group_id="P2" count="61"/>
                <participants group_id="P3" count="19"/>
                <participants group_id="P4" count="18"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="7"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="1"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="1"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Adverse Event, not fatal</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" 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="2"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
              </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 group_id="P4" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Non-compliance</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="2"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" 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) consisted of all study participants who received at least 1 dose of bimekizumab by the indicated self-injection investigational device presentation (bimekizumab-SS-1mL SS [SS-s], bimekizumab-AI-1mL SS [SS-a], bimekizumab-SS-2mL SS [SS-s] and bimekizumab-AI-2mL SS [SS-a]). One study participant included in the Enrolled Set did not self-inject at any time during the study and is therefore not included in the Safety Set (SS-s-1mL).</population>
      <group_list>
        <group group_id="B1">
          <title>Bimekizumab-SS-1mL 320 mg (SS-s-1mL)</title>
          <description>Participants self-injected BKZ 320 mg solution as a sc injection with BKZ-SS-1mL device presentation (ie. 2 self-injections) at Baseline and at Week 8 for participants on Q4W and Q8W dosing. For Q4W dosing, participants were injected by study personnel with 320 mg BKZ using the 1ml PFS at Week 4, 12 and 16. For Q8W dosing, participants were injected by study personnel with 320 mg BKZ using the 1ml PFS at Week 16. Participants formed the Safety Set (SS) for the 1mL safety syringe (s) device presentation (SS-s-1mL).</description>
        </group>
        <group group_id="B2">
          <title>Bimekizumab AI-1mL 320 mg (SS-a-1mL)</title>
          <description>Participants self-injected BKZ 320 mg solution as a sc injection with bimekizumab-Auto-Injector-1mL (BKZ-AI-1mL) device presentation (ie. 2 self-injections) at Baseline and at Week 8 for participants on Q4W and Q8W dosing. For Q4W dosing, participants were injected by study personnel with 320 mg BKZ using the 1ml PFS at Week 4, 12 and 16. For Q8W dosing, participants were injected by study personnel with 320 mg BKZ using the 1ml PFS at Week 16. Participants formed the SS for the 1mL auto-injector (a) device presentation (SS-a-1mL).</description>
        </group>
        <group group_id="B3">
          <title>Bimekizumab-SS-2mL 320 mg (SS-s-2mL)</title>
          <description>Participants self-injected BKZ 320 mg solution as a sc injection with BKZ-SS-2mL device presentation (ie. 1 self-injection) at Baseline and at Week 8 for participants on Q4W and Q8W dosing. For Q4W dosing, participants were injected by study personnel with 320 mg BKZ using the 2ml PFS at Week 4, 12 and 16. For Q8W dosing, participants were injected by study personnel with 320 mg BKZ using the 2ml PFS at Week 16. Participants formed the SS for the 2mL safety syringe (s) device presentation (SS-s-2mL).</description>
        </group>
        <group group_id="B4">
          <title>Bimekizumab-AI-2mL 320 mg (SS-a-2mL)</title>
          <description>Participants self-injected BKZ 320 mg solution as a sc injection with BKZ-AI-2mL device presentation (ie. 1 self-injection) at Baseline and at Week 8 for participants on Q4W and Q8W dosing. For Q4W dosing, participants were injected by study personnel with 320 mg BKZ using the 2ml PFS at Week 4, 12 and 16. For Q8W dosing, participants were injected by study personnel with 320 mg BKZ using the 2ml PFS at Week 16. Participants formed the SS for the 2mL auto-injector (a) device presentation (SS-a-2mL).</description>
        </group>
        <group group_id="B5">
          <title>Total Title</title>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="65"/>
            <count group_id="B2" value="68"/>
            <count group_id="B3" value="19"/>
            <count group_id="B4" value="19"/>
            <count group_id="B5" value="171"/>
          </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="1"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="57"/>
                    <measurement group_id="B2" value="59"/>
                    <measurement group_id="B3" value="16"/>
                    <measurement group_id="B4" value="18"/>
                    <measurement group_id="B5" value="150"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="7"/>
                    <measurement group_id="B2" value="8"/>
                    <measurement group_id="B3" value="3"/>
                    <measurement group_id="B4" value="1"/>
                    <measurement group_id="B5" value="19"/>
                  </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="49.7" spread="13.4"/>
                    <measurement group_id="B2" value="46.8" spread="14.0"/>
                    <measurement group_id="B3" value="50.3" spread="15.8"/>
                    <measurement group_id="B4" value="43.0" spread="12.4"/>
                    <measurement group_id="B5" value="47.9" spread="13.9"/>
                  </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="22"/>
                    <measurement group_id="B2" value="19"/>
                    <measurement group_id="B3" value="9"/>
                    <measurement group_id="B4" value="9"/>
                    <measurement group_id="B5" value="59"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="43"/>
                    <measurement group_id="B2" value="49"/>
                    <measurement group_id="B3" value="10"/>
                    <measurement group_id="B4" value="10"/>
                    <measurement group_id="B5" value="112"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race/Ethnicity, Customized</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="1"/>
                    <measurement group_id="B4" value="2"/>
                    <measurement group_id="B5" value="7"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="1"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="5"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="1"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="60"/>
                    <measurement group_id="B2" value="61"/>
                    <measurement group_id="B3" value="16"/>
                    <measurement group_id="B4" value="16"/>
                    <measurement group_id="B5" value="153"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Other or Mixed</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="1"/>
                    <measurement group_id="B5" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Percentage of Participants Able to Self-administer Safe and Effective Injections Using the Bimekizumab-safety Syringe (SS)-1mL or the Bimekizumab-auto-injector (AI)-1mL at Week 8, After Training in Self-injection Technique</title>
        <description>Safe and effective self-injection was evaluated by the study personnel and was defined as: - Complete dose delivery: Participant self-injected the complete dose of bimekizumab as confirmed by a visual inspection of the bimekizumab-safety syringe (SS) or the bimekizumab-auto-injector (AI) which shows that the investigational medicinal product (IMP) was delivered completely (ie, container is empty), and - No Adverse Device Effects (ADEs) that would preclude continued use of the device for self-injection (ie, no serious ADEs (SADEs) and/or ADEs leading to withdrawal).</description>
        <time_frame>Week 8</time_frame>
        <population>The Full Analysis Set for device presentation bimekizumab-SS-1mL (FAS-s-1mL) and bimekizumab-AI-1mL (FAS-a-1mL) consisted of all study participants in the SS-s-1mL and SS-a-1mL who self-injected at least 1 dose of bimekizumab using the given device presentation and who had an assessment of self-injection. Here, number of participants were included who were evaluable for the assessment.</population>
        <group_list>
          <group group_id="O1">
            <title>Bimekizumab-SS-1mL 320 mg (FAS-s-1mL)</title>
            <description>Participants self-injected BKZ 320 mg solution as a sc injection with BKZ-SS-1mL device presentation (ie. 2 self-injections) at Baseline and at Week 8 for participants on Q4W and Q8W dosing. For Q4W dosing, participants were injected by study personnel with 320 mg BKZ using the 1ml PFS at Week 4, 12 and 16. For Q8W dosing, participants were injected by study personnel with 320 mg BKZ using the 1ml PFS at Week 16. Participants formed the Full Analysis Set (FAS) for the 1mL safety syringe (s) device presentation (FAS-s-1mL).</description>
          </group>
          <group group_id="O2">
            <title>Bimekizumab -AI-1mL 320 mg (FAS-a-1mL)</title>
            <description>Participants self-injected BKZ 320 mg solution as a sc injection with BKZ-AI-1mL device presentation (ie. 2 self-injections) at Baseline and at Week 8 for participants on Q4W and Q8W dosing. For Q4W dosing, participants were injected by study personnel with 320 mg BKZ using the 1ml PFS at Week 4, 12 and 16. For Q8W dosing, participants were injected by study personnel with 320 mg BKZ using the 1ml PFS at Week 16. Participants formed the FAS for the 1mL auto-injector (a) device presentation (FAS-a-1mL).</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants Able to Self-administer Safe and Effective Injections Using the Bimekizumab-safety Syringe (SS)-1mL or the Bimekizumab-auto-injector (AI)-1mL at Week 8, After Training in Self-injection Technique</title>
          <description>Safe and effective self-injection was evaluated by the study personnel and was defined as: - Complete dose delivery: Participant self-injected the complete dose of bimekizumab as confirmed by a visual inspection of the bimekizumab-safety syringe (SS) or the bimekizumab-auto-injector (AI) which shows that the investigational medicinal product (IMP) was delivered completely (ie, container is empty), and - No Adverse Device Effects (ADEs) that would preclude continued use of the device for self-injection (ie, no serious ADEs (SADEs) and/or ADEs leading to withdrawal).</description>
          <population>The Full Analysis Set for device presentation bimekizumab-SS-1mL (FAS-s-1mL) and bimekizumab-AI-1mL (FAS-a-1mL) consisted of all study participants in the SS-s-1mL and SS-a-1mL who self-injected at least 1 dose of bimekizumab using the given device presentation and who had an assessment of self-injection. Here, number of participants were included who were evaluable for the assessment.</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <dispersion>90% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="63"/>
                <count group_id="O2" value="62"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="100" lower_limit="95.4" upper_limit="100"/>
                    <measurement group_id="O2" value="100" lower_limit="95.3" upper_limit="100"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Percentage of Participants Able to Self-administer Safe and Effective Injections Using the Bimekizumab-SS-2mL or the Bimekizumab-AI-2mL at Week 8, After Training in Self-injection Technique</title>
        <description>Safe and effective self-injection was evaluated by the study personnel and was defined as: - Complete dose delivery: Participant self-injected the complete dose of bimekizumab as confirmed by a visual inspection of the bimekizumab-SS or the bimekizumab-AI which shows that the IMP is delivered completely (ie, container is empty), and - No ADEs that would preclude continued use of the device for self-injection (ie, no serious ADEs (SADEs) and/or ADEs leading to withdrawal).</description>
        <time_frame>Week 8</time_frame>
        <population>The Full Analysis Set for device presentation bimekizumab-SS-2mL (FAS-s-2mL) and bimekizumab-AI-2mL (FAS-a-2mL) consisted of all study participants in the SS-s-2mL and SS-a-2mL who self-injected at least 1 dose of bimekizumab using the given device presentation and who had an assessment of self-injection.</population>
        <group_list>
          <group group_id="O1">
            <title>Bimekizumab-SS-2mL 320 mg (FAS-s-2mL)</title>
            <description>Participants self-injected BKZ 320 mg solution as a sc injection with BKZ-SS-2mL device presentation (ie. 1 self-injection) at Baseline and at Week 8 for participants on Q4W and Q8W dosing. For Q4W dosing, participants were injected by study personnel with 320 mg BKZ using the 2ml PFS at Week 4, 12 and 16. For Q8W dosing, participants were injected by study personnel with 320 mg BKZ using the 2ml PFS at Week 16. Participants formed the FAS for the 2mL safety syringe (s) device presentation (FAS-s-2mL).</description>
          </group>
          <group group_id="O2">
            <title>Bimekizumab-AI-2mL 320 mg (FAS-a-2mL)</title>
            <description>Participants self-injected BKZ 320 mg solution as a sc injection with BKZ-AI-2mL device presentation (ie. 1 self-injection) at Baseline and at Week 8 for participants on Q4W and Q8W dosing. For Q4W dosing, participants were injected by study personnel with 320 mg BKZ using the 2ml PFS at Week 4, 12 and 16. For Q8W dosing, participants were injected by study personnel with 320 mg BKZ using the 2ml PFS at Week 16. Participants formed the FAS for the 2mL auto-injector (a) device presentation (FAS-a-2mL).</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants Able to Self-administer Safe and Effective Injections Using the Bimekizumab-SS-2mL or the Bimekizumab-AI-2mL at Week 8, After Training in Self-injection Technique</title>
          <description>Safe and effective self-injection was evaluated by the study personnel and was defined as: - Complete dose delivery: Participant self-injected the complete dose of bimekizumab as confirmed by a visual inspection of the bimekizumab-SS or the bimekizumab-AI which shows that the IMP is delivered completely (ie, container is empty), and - No ADEs that would preclude continued use of the device for self-injection (ie, no serious ADEs (SADEs) and/or ADEs leading to withdrawal).</description>
          <population>The Full Analysis Set for device presentation bimekizumab-SS-2mL (FAS-s-2mL) and bimekizumab-AI-2mL (FAS-a-2mL) consisted of all study participants in the SS-s-2mL and SS-a-2mL who self-injected at least 1 dose of bimekizumab using the given device presentation and who had an assessment of self-injection.</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <dispersion>90% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="19"/>
                <count group_id="O2" value="19"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="100" lower_limit="85.4" upper_limit="100"/>
                    <measurement group_id="O2" value="94.7" lower_limit="77.4" upper_limit="99.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants Able to Self-administer Safe and Effective Injections Using the Bimekizumab-SS-1mL or the Bimekizumab-AI-1mL at Baseline, After Training in Self-injection Technique</title>
        <description>Safe and effective self-injection was evaluated by the study personnel and was defined as: - Complete dose delivery: Participant self-injected the complete dose of bimekizumab as confirmed by a visual inspection of the bimekizumab-SS or the bimekizumab-AI which showed that the IMP was delivered completely (ie, container is empty), and - No ADEs that would preclude continued use of the device for self-injection (ie, no SADEs and/or ADEs leading to withdrawal).</description>
        <time_frame>Baseline (the first self-injection visit)</time_frame>
        <population>The Full Analysis Set for device presentation bimekizumab-SS-1mL (FAS-s-1mL) and bimekizumab-AI-1mL (FAS-a-1mL) consisted of all study participants in the SS-s-1mL and SS-a-1mL who self-injected at least 1 dose of bimekizumab using the given device presentation and who had an assessment of self-injection. Here, number of participants were included who were evaluable for the assessment.</population>
        <group_list>
          <group group_id="O1">
            <title>Bimekizumab-SS-1mL 320 mg (FAS-s-1mL)</title>
            <description>Participants self-injected BKZ 320 mg solution as a sc injection with BKZ-SS-1mL device presentation (ie. 2 self-injections) at Baseline and at Week 8 for participants on Q4W and Q8W dosing. For Q4W dosing, participants were injected by study personnel with 320 mg BKZ using the 1ml PFS at Week 4, 12 and 16. For Q8W dosing, participants were injected by study personnel with 320 mg BKZ using the 1ml PFS at Week 16. Participants formed the FAS for the 1mL safety syringe (s) device presentation (FAS-s-1mL).</description>
          </group>
          <group group_id="O2">
            <title>Bimekizumab -AI-1mL 320 mg (FAS-a-1mL)</title>
            <description>Participants self-injected BKZ 320 mg solution as a sc injection with BKZ-AI-1mL device presentation (ie. 2 self-injections) at Baseline and at Week 8 for participants on Q4W and Q8W dosing. For Q4W dosing, participants were injected by study personnel with 320 mg BKZ using the 1ml PFS at Week 4, 12 and 16. For Q8W dosing, participants were injected by study personnel with 320 mg BKZ using the 1ml PFS at Week 16. Participants formed the FAS for the 1mL auto-injector (a) device presentation (FAS-a-1mL).</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants Able to Self-administer Safe and Effective Injections Using the Bimekizumab-SS-1mL or the Bimekizumab-AI-1mL at Baseline, After Training in Self-injection Technique</title>
          <description>Safe and effective self-injection was evaluated by the study personnel and was defined as: - Complete dose delivery: Participant self-injected the complete dose of bimekizumab as confirmed by a visual inspection of the bimekizumab-SS or the bimekizumab-AI which showed that the IMP was delivered completely (ie, container is empty), and - No ADEs that would preclude continued use of the device for self-injection (ie, no SADEs and/or ADEs leading to withdrawal).</description>
          <population>The Full Analysis Set for device presentation bimekizumab-SS-1mL (FAS-s-1mL) and bimekizumab-AI-1mL (FAS-a-1mL) consisted of all study participants in the SS-s-1mL and SS-a-1mL who self-injected at least 1 dose of bimekizumab using the given device presentation and who had an assessment of self-injection. Here, number of participants were included who were evaluable for the assessment.</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <dispersion>90% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="64"/>
                <count group_id="O2" value="68"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="100" lower_limit="95.4" upper_limit="100"/>
                    <measurement group_id="O2" value="97.1" lower_limit="91.0" upper_limit="99.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants Able to Self-administer Safe and Effective Injections Using the Bimekizumab-SS-2mL or the Bimekizumab-AI-2mL at Baseline, After Training in Self-injection Technique</title>
        <description>Safe and effective self-injection was evaluated by the study personnel and was defined as: - Complete dose delivery: Participant self-injected the complete dose of bimekizumab as confirmed by a visual inspection of the bimekizumab-SS or the bimekizumab-AI which shows that the IMP is delivered completely (ie, container is empty), and - No ADEs that would preclude continued use of the device for self-injection (ie, no SADEs and/or ADEs leading to withdrawal).</description>
        <time_frame>Baseline (the first self-injection visit)</time_frame>
        <population>The Full Analysis Set for device presentation bimekizumab-SS-2mL (FAS-s-2mL) and bimekizumab-AI-2mL (FAS-a-2mL) consisted of all study participants in the SS-s-2mL and SS-a-2mL who self-injected at least 1 dose of bimekizumab using the given device presentation and who had an assessment of self-injection.</population>
        <group_list>
          <group group_id="O1">
            <title>Bimekizumab-SS-2mL 320 mg (FAS-s-2mL)</title>
            <description>Participants self-injected BKZ 320 mg solution as a sc injection with BKZ-SS-2mL device presentation (ie. 1 self-injection) at Baseline and at Week 8 for participants on Q4W and Q8W dosing. For Q4W dosing, participants were injected by study personnel with 320 mg BKZ using the 2ml PFS at Week 4, 12 and 16. For Q8W dosing, participants were injected by study personnel with 320 mg BKZ using the 2ml PFS at Week 16. Participants formed the FAS for the 2mL safety syringe (s) device presentation (FAS-s-2mL).</description>
          </group>
          <group group_id="O2">
            <title>Bimekizumab-AI-2mL 320 mg (FAS-a-2mL)</title>
            <description>Participants self-injected BKZ 320 mg solution as a sc injection with BKZ-AI-2mL device presentation (ie. 1 self-injection) at Baseline and at Week 8 for participants on Q4W and Q8W dosing. For Q4W dosing, participants were injected by study personnel with 320 mg BKZ using the 2ml PFS at Week 4, 12 and 16. For Q8W dosing, participants were injected by study personnel with 320 mg BKZ using the 2ml PFS at Week 16. Participants formed the FAS for the 2mL auto-injector (a) device presentation (FAS-a-2mL).</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants Able to Self-administer Safe and Effective Injections Using the Bimekizumab-SS-2mL or the Bimekizumab-AI-2mL at Baseline, After Training in Self-injection Technique</title>
          <description>Safe and effective self-injection was evaluated by the study personnel and was defined as: - Complete dose delivery: Participant self-injected the complete dose of bimekizumab as confirmed by a visual inspection of the bimekizumab-SS or the bimekizumab-AI which shows that the IMP is delivered completely (ie, container is empty), and - No ADEs that would preclude continued use of the device for self-injection (ie, no SADEs and/or ADEs leading to withdrawal).</description>
          <population>The Full Analysis Set for device presentation bimekizumab-SS-2mL (FAS-s-2mL) and bimekizumab-AI-2mL (FAS-a-2mL) consisted of all study participants in the SS-s-2mL and SS-a-2mL who self-injected at least 1 dose of bimekizumab using the given device presentation and who had an assessment of self-injection.</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <dispersion>90% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="19"/>
                <count group_id="O2" value="19"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="100" lower_limit="85.4" upper_limit="100"/>
                    <measurement group_id="O2" value="100" lower_limit="85.4" upper_limit="100"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>From Baseline up to Week 16</time_frame>
      <desc>As pre-specified in protocol and SAP, this sub-study collected only specific Adverse Events (AEs) indicated as injection site reactions during selfinjection and investigational device-related AEs - i.e., adverse device effects (ADEs) and serious ADEs, which are reported.Treatment-Emergent (TE)ADEs were defined as AEs related to study device that have a start date on or following the first self-administration of study treatment through the final self-administration of study treatment plus 7 days.</desc>
      <group_list>
        <group group_id="E1">
          <title>Bimekizumab-SS-1mL 320 mg (SS-s-1mL)</title>
          <description>Participants self-injected BKZ 320 mg solution as a sc injection with BKZ-SS-1mL device presentation (ie. 2 self-injections) at Baseline and at Week 8 for participants on Q4W and Q8W dosing. For Q4W dosing, participants were injected by study personnel with 320 mg BKZ using the 1ml PFS at Week 4, 12 and 16. For Q8W dosing, participants were injected by study personnel with 320 mg BKZ using the 1ml PFS at Week 16. Participants formed the SS for the 1mL safety syringe (s) device presentation (SS-s-1mL).</description>
        </group>
        <group group_id="E2">
          <title>Bimekizumab AI-1mL 320 mg (SS-a-1mL)</title>
          <description>Participants self-injected BKZ 320 mg solution as a sc injection with BKZ-AI-1mL device presentation (ie. 2 self-injections) at Baseline and at Week 8 for participants on Q4W and Q8W dosing. For Q4W dosing, participants were injected by study personnel with 320 mg BKZ using the 1ml PFS at Week 4, 12 and 16. For Q8W dosing, participants were injected by study personnel with 320 mg BKZ using the 1ml PFS at Week 16. Participants formed the SS for the 1mL auto-injector (a) device presentation (SS-a-1mL).</description>
        </group>
        <group group_id="E3">
          <title>Bimekizumab-SS-2mL 320 mg (SS-s-2mL)</title>
          <description>Participants self-injected BKZ 320 mg solution as a sc injection with BKZ-SS-2mL device presentation (ie. 1 self-injection) at Baseline and at Week 8 for participants on Q4W and Q8W dosing. For Q4W dosing, participants were injected by study personnel with 320 mg BKZ using the 2ml PFS at Week 4, 12 and 16. For Q8W dosing, participants were injected by study personnel with 320 mg BKZ using the 2ml PFS at Week 16. Participants formed the SS for the 2mL safety syringe (s) device presentation (SS-s-2mL).</description>
        </group>
        <group group_id="E4">
          <title>Bimekizumab-AI-2mL 320 mg (SS-a-2mL)</title>
          <description>Participants self-injected BKZ 320 mg solution as a sc injection with BKZ-AI-2mL device presentation (ie. 1 self-injection) at Baseline and at Week 8 for participants on Q4W and Q8W dosing. For Q4W dosing, participants were injected by study personnel with 320 mg BKZ using the 2ml PFS at Week 4, 12 and 16. For Q8W dosing, participants were injected by study personnel with 320 mg BKZ using the 2ml PFS at Week 16. Participants formed the SS for the 2mL auto-injector (a) device presentation (SS-a-2mL).</description>
        </group>
      </group_list>
      <serious_events>
        <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="65"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="19"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="65"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="19"/>
              </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="0" subjects_at_risk="65"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="19"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="19"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Injection site reaction</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="65"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="19"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="19"/>
              </event>
              <event>
                <sub_title>Injection site pain</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="65"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="19"/>
              </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/NCT03766685
org study id: DV0002
nct id: NCT03766685
lead sponsor: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
is us export: No
The purpose of the study is to evaluate the ability of subjects with moderate to severe
      chronic plaque psoriasis (PSO) to safely and effectively self-inject bimekizumab at study
      start and 8 weeks after training in self-injection technique using a prefilled safety syringe
      or an auto-injector.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Percentage of Participants Able to Self-administer Safe and Effective Injections Using the Bimekizumab-safety Syringe (SS)-1mL or the Bimekizumab-auto-injector (AI)-1mL at Week 8, After Training in Self-injection Technique
time frame: Week 8
description: Safe and effective self-injection was evaluated by the study personnel and was defined as: - Complete dose delivery: Participant self-injected the complete dose of bimekizumab as confirmed by a visual inspection of the bimekizumab-safety syringe (SS) or the bimekizumab-auto-injector (AI) which shows that the investigational medicinal product (IMP) was delivered completely (ie, container is empty), and - No Adverse Device Effects (ADEs) that would preclude continued use of the device for self-injection (ie, no serious ADEs (SADEs) and/or ADEs leading to withdrawal).
measure: Percentage of Participants Able to Self-administer Safe and Effective Injections Using the Bimekizumab-SS-2mL or the Bimekizumab-AI-2mL at Week 8, After Training in Self-injection Technique
time frame: Week 8
description: Safe and effective self-injection was evaluated by the study personnel and was defined as: - Complete dose delivery: Participant self-injected the complete dose of bimekizumab as confirmed by a visual inspection of the bimekizumab-SS or the bimekizumab-AI which shows that the IMP is delivered completely (ie, container is empty), and - No ADEs that would preclude continued use of the device for self-injection (ie, no serious ADEs (SADEs) and/or ADEs leading to withdrawal).
measure: Percentage of Participants Able to Self-administer Safe and Effective Injections Using the Bimekizumab-SS-1mL or the Bimekizumab-AI-1mL at Baseline, After Training in Self-injection Technique
time frame: Baseline (the first self-injection visit)
description: Safe and effective self-injection was evaluated by the study personnel and was defined as: - Complete dose delivery: Participant self-injected the complete dose of bimekizumab as confirmed by a visual inspection of the bimekizumab-SS or the bimekizumab-AI which showed that the IMP was delivered completely (ie, container is empty), and - No ADEs that would preclude continued use of the device for self-injection (ie, no SADEs and/or ADEs leading to withdrawal).
measure: Percentage of Participants Able to Self-administer Safe and Effective Injections Using the Bimekizumab-SS-2mL or the Bimekizumab-AI-2mL at Baseline, After Training in Self-injection Technique
time frame: Baseline (the first self-injection visit)
description: Safe and effective self-injection was evaluated by the study personnel and was defined as: - Complete dose delivery: Participant self-injected the complete dose of bimekizumab as confirmed by a visual inspection of the bimekizumab-SS or the bimekizumab-AI which shows that the IMP is delivered completely (ie, container is empty), and - No ADEs that would preclude continued use of the device for self-injection (ie, no SADEs and/or ADEs leading to withdrawal).
arm group label: Bimekizumab-SS
arm group type: Experimental
description: Subjects will receive assigned bimekizumab dose regimen using a prefilled safety syringe (SS).
arm group label: Bimekizumab-AI
arm group type: Experimental
description: Subjects will receive assigned bimekizumab dose regimen using an auto-injector (AI).
intervention type: Drug
intervention name: Bimekizumab
description: Subjects will receive bimekizumab at pre-specified time-points.
arm group label: Bimekizumab-AI
arm group label: Bimekizumab-SS
other name: UCB4940
other name: BKZ
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
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: Canada
country: United States
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
responsible party type: Sponsor
mesh term: Psoriasis
sharing ipd: No
provided document: 
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 