xml: <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/NCT06011733</url>
    </required_header>
    <id_info>
      <org_study_id>PS0041</org_study_id>
      <nct_id>NCT06011733</nct_id>
    </id_info>
    <brief_title>A Study to Evaluate the Efficacy and Safety of Bimekizumab in Chinese Adult Study Participants With Moderate to Severe Plaque Psoriasis</brief_title>
    <acronym>BE SHINING</acronym>
    <official_title>A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of Bimekizumab in Chinese Adult Study Participants With Moderate to Severe 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>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        The primary purpose of this study is to compare the efficacy of bimekizumab administered&#xD;
        subcutaneously (sc) for 16 weeks versus placebo in the treatment of study participants with&#xD;
        moderate to severe plaque psoriasis (PSO).&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">November 24, 2023</start_date>
    <completion_date type="Anticipated">June 11, 2025</completion_date>
    <primary_completion_date type="Anticipated">June 11, 2025</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>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Psoriasis Area Severity Index 90 (PASI90) response at Week 16</measure>
      <time_frame>Week 16</time_frame>
      <description>The PASI90 response assessments are based on at least 90% improvement in PASI score from Baseline. Body divided into 4 areas: head, upper extremities, trunk and lower extremities. Assignment of an average score for redness, thickness, and scaling for each of the 4 body areas with a score of 0 (clear) to 4 (very marked). Determining the percentage of skin covered with PSO for each of the body areas and converting to a 0 to 6 scale. Final PASI= average redness, thickness, and scaliness of the psoriatic skin lesions, multiplied by the involved psoriasis area score of respective section, and weighted by the percentage of the person's affected skin for respective section. The minimum possible PASI score is 0= no disease, the maximum score is 72= maximal disease.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Investigator´s Global Assessment (IGA) 0/1 response at Week 16</measure>
      <time_frame>Week 16</time_frame>
      <description>The IGA measures the overall psoriasis severity using a 5-point scale (0-4), where 0=clear - no signs of psoriasis; post-inflammatory hyperpigmentation may be present, 1=almost clear - no thickening; normal to pink coloration; no to minimal focal scaling, 2=mild - just detectable to mild thickening; pink to light red coloration and predominately fine scaling, 3=moderate - clearly distinguishable to moderate thickening; dull to bright red, moderate scaling and 4=severe - severe thickening with hard edges; bright to deep dark red coloration; severe/coarse scaling covering almost all or all lesions. IGA response at week 16 is defined as a score of 0 or 1 with at least a two-category improvement from Baseline.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>PASI75 response at Week 4</measure>
      <time_frame>Week 4</time_frame>
      <description>The PASI75 response at Week 4 is a key secondary endpoint. PASI75 response assessments are based on at least 75% improvement in PASI score from Baseline. Body divided into 4 areas: head, upper extremities, trunk and lower extremities. Assignment of an average score for redness, thickness, and scaling for each of the 4 body areas with a score of 0 (clear) to 4 (very marked). Determining the percentage of skin covered with PSO for each of the body areas and converting to a 0 to 6 scale. Final PASI= average redness, thickness, and scaliness of the psoriatic skin lesions, multiplied by the involved psoriasis area score of respective section, and weighted by the percentage of the person's affected skin for respective section. The minimum possible PASI score is 0= no disease, the maximum score is 72= maximal disease.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>PASI100 response at Week 16</measure>
      <time_frame>Week 16</time_frame>
      <description>The PASI100 response at Week 16 is a key secondary endpoint. PASI100 response assessments are based on a 100% improvement in PASI score from Baseline. Body divided into 4 areas: head, upper extremities, trunk and lower extremities. Assignment of an average score for the redness, thickness, and scaling for each of the 4 body areas with a score of 0 (clear) to 4 (very marked). Determining the percentage of skin covered with PSO for each of body areas and converting to a 0 to 6 scale. Final PASI= average redness, thickness, and scaliness of the psoriatic skin lesions, multiplied by the involved psoriasis area score of the respective section, and weighted by the percentage of the person's affected skin for the respective section. The minimum possible PASI score is 0= no disease, the maximum score is 72= maximal disease</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Patient Symptom Diary (PSD) Psoriasis Symptom and Impact Measure (P-SIM) response for itch at Week 16</measure>
      <time_frame>Week 16</time_frame>
      <description>The PSD (P-SIM) is designed to collect data about the experience of patients with moderate to severe psoriasis related to the severity of signs, symptoms or impacts, at their worst during the past 24 hours, on a 0-10 point numeric rating scale (NRS) where 0 (no symptom/ impact) and 10 (very severe symptom/ worst impact). It consists of 14 items of which three were used as secondary endpoints: Skin pain, Itch and Scaling. Itch response is defined as a reduction from Baseline to week 16 of at least 4 points on the PSD itch score.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>PSD (P-SIM) response for pain at Week 16</measure>
      <time_frame>Week 16</time_frame>
      <description>The PSD (P-SIM) is designed to collect data about the experience of patients with moderate to severe psoriasis related to the severity of signs, symptoms or impacts, at their worst during the past 24 hours, on a 0-10 point numeric rating scale (NRS) where 0 (no symptom/ impact) and 10 (very severe symptom/ worst impact). It consists of 14 items of which three were used as secondary endpoints: Skin pain, Itch and Scaling. Pain response is defined as a reduction from Baseline to week 16 of at least 4 points on the PSD pain score.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>PSD (P-SIM) response for scaling at Week 16</measure>
      <time_frame>Week 16</time_frame>
      <description>The PSD (P-SIM) is designed to collect data about the experience of patients with moderate to severe psoriasis related to the severity of signs, symptoms or impacts, at their worst during the past 24 hours, on a 0-10 point numeric rating scale (NRS) where 0 (no symptom/ impact) and 10 (very severe symptom/ worst impact). It consists of 14 items of which three were used as secondary endpoints: Skin pain, Itch and Scaling. Scaling response is defined as a reduction from Baseline to week 16 of at least 4 points on the PSD scaling score.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Incidence of Treatment-emergent Adverse Events (TEAE)s through Week 16</measure>
      <time_frame>From Baseline to End of initial Treatment Period (up to Week 16)</time_frame>
      <description>An adverse event (AE) is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of investigational medicinal product (IMP), whether or not considered related to the IMP. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of IMP.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Incidence of serious TEAEs through Week 16</measure>
      <time_frame>From Baseline to End of initial Treatment Period (up to Week 16)</time_frame>
      <description>An SAE is any untoward medical occurrence that at any dose:&#xD;
  Results in death Is life-threatening Requires in patient hospitalisation or prolongation of existing hospitalisation Is a congenital anomaly or birth defect Is an infection that requires treatment with parenteral antibiotics Other important medical events which based on medical or scientific judgement may jeopardise the patients, or may require medical or surgical intervention to prevent any of the above</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Incidence of TEAEs leading to permanent discontinuation of Investigational Medicinal Product (IMP) through Week 16</measure>
      <time_frame>From Baseline to End of initial Treatment Period (up to Week 16)</time_frame>
      <description>An adverse event (AE) is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of investigational medicinal product (IMP), whether or not considered related to the IMP. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of IMP. TEAEs leading to withdrawal of study medication.</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">120</enrollment>
    <condition>Chronic Plaque Psoriasis</condition>
    <condition>Moderate to Severe Chronic Plaque Psoriasis</condition>
    <arm_group>
      <arm_group_label>bimekizumab</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Study participants randomized to this arm will receive bimekizumab (BKZ) dosage regimen 1 in the Initial Treatment Period (16 weeks) and switch to dosage regimen 2 and placebo to maintain the blinding in the Maintenance Treatment Period (16 weeks).</description>
    </arm_group>
    <arm_group>
      <arm_group_label>placebo</arm_group_label>
      <arm_group_type>Placebo Comparator</arm_group_type>
      <description>Study participants randomized to this arm will receive placebo comparator in the Initial Treatment Period (16 weeks) and switch to bimekizumab dosage regimen 1 in the Maintenance Treatment Period (16 weeks).</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Placebo</intervention_name>
      <description>Study participants will receive placebo subcutaneously at pre-specified time points in the placebo arm as comparator and in the bimekizumab arm to maintain the blinding.</description>
      <arm_group_label>bimekizumab</arm_group_label>
      <arm_group_label>placebo</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Bimekizumab</intervention_name>
      <description>Study participants will receive bimekizumab (dosage regimen 1 and 2) subcutaneously administered at pre-specified time points during the Initial and Maintenance Treatment Periods.</description>
      <arm_group_label>bimekizumab</arm_group_label>
      <arm_group_label>placebo</arm_group_label>
      <other_name>BKZ</other_name>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Study participant is Chinese male or female ≥18 years of age&#xD;
  &#xD;
            -  Study participant has plaque psoriasis (PSO) for ≥6 months prior to the Screening&#xD;
               Visit&#xD;
  &#xD;
            -  Study participant has Psoriasis Area and Severity Index (PASI) ≥12 and body surface&#xD;
               area (BSA) affected by PSO ≥10% and Investigator's Global Assessment (IGA) score ≥3 on&#xD;
               a 5-point scale.&#xD;
  &#xD;
            -  Study participant is a candidate for systemic PSO therapy and/or phototherapy&#xD;
  &#xD;
            -  Female study participants must be postmenopausal or permanently sterilized or if&#xD;
               childbearing potential must be willing to use protocol defined highly effective method&#xD;
               of contraception throughout the duration of the study until 17 weeks after last&#xD;
               administration of investigational medicinal product (IMP) and have a negative&#xD;
               pregnancy test at Screening and prior to first dose&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Female study participant who is breastfeeding, pregnant, or plans to become pregnant&#xD;
               during the study or within 17 weeks following the final dose of IMP&#xD;
  &#xD;
            -  Study participant has a form of PSO other than chronic plaque-type (eg, pustular,&#xD;
               erythrodermic, guttate, or drug-induced PSO)&#xD;
  &#xD;
            -  Study participant has an active infection or history of infection(s) as defined in the&#xD;
               protocol&#xD;
  &#xD;
            -  Study participant has known tuberculosis (TB) infection, is at high risk of acquiring&#xD;
               TB infection, or has current or history of nontuberculous mycobacterium (NTMB)&#xD;
               infection.Study participant has a past history of active TB involving any organ system&#xD;
               unless adequately treated and is proven to be fully recovered upon consult with a TB&#xD;
               specialist&#xD;
  &#xD;
            -  Study participant has a diagnosis of inflammatory conditions other than PSO vulgaris&#xD;
               or psoriatic arthritis (PsA)&#xD;
  &#xD;
            -  Study participant has presence of significant uncontrolled neuropsychiatric disorder.&#xD;
               Study participants with history of suicide attempt within the 5 years prior to the&#xD;
               Screening Visit must be excluded. Study participants with history of suicide attempt&#xD;
               more than 5 years prior to the Screening Visit must be evaluated by a mental health&#xD;
               care practitioner before enrollment.&#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>
    <overall_contact>
      <last_name>UCB Cares</last_name>
      <phone>1-844-599-2273 (USA)</phone>
      <email>UCBCares@ucb.com</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>UCB Cares</last_name>
      <phone>001 844 599 2273</phone>
      <email>UCBCares@ucb.com</email>
    </overall_contact_backup>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>August 21, 2023</study_first_submitted>
    <study_first_submitted_qc>August 21, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 25, 2023</study_first_posted>
    <last_update_submitted>September 13, 2023</last_update_submitted>
    <last_update_submitted_qc>September 13, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 14, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Psoriasis</keyword>
    <keyword>PSO</keyword>
    <keyword>Bimekizumab</keyword>
    <keyword>Chinese Adults Study Participants</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>Yes</sharing_ipd>
      <ipd_description>Data from this study may be requested by qualified researchers six months after product approval in the US and/or Europe, or global development is discontinued, and 18 months after trial completion. Investigators may request access to anonymized IPD and redacted study documents which may include: raw datasets, analysis-ready datasets, study protocol, blank case report form, annotated case report form, statistical analysis plan, dataset specifications, and clinical study report. Prior to use of the data, proposals need to be approved by an independent review panel at www.Vivli.org and a signed data sharing agreement will need to be executed. All documents are available in English only, for a pre-specified time, typically 12 months, on a password protected portal. This plan may change if a determination is made that the data cannot be adequately anonymized.</ipd_description>
      <ipd_info_type>Study Protocol</ipd_info_type>
      <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
      <ipd_info_type>Clinical Study Report (CSR)</ipd_info_type>
      <ipd_time_frame>Data from this study may be requested by qualified researchers six months after product approval in the US and/or Europe or global development is discontinued, and 18 months after trial completion.</ipd_time_frame>
      <ipd_access_criteria>Qualified researchers may request access to anonymized IPD and redacted study documents which may include: raw datasets, analysis-ready datasets, study protocol, blank case report form, annotated case report form, statistical analysis plan, dataset specifications, and clinical study report. Prior to use of the data, proposals need to be approved by an independent review panel at www.Vivli.org and a signed data sharing agreement will need to be executed. All documents are available in English only, for a pre-specified time, typically 12 months, on a password protected portal.</ipd_access_criteria>
      <ipd_url>http://www.Vivli.org</ipd_url>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06011733
  org study id: PS0041
  nct id: NCT06011733
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The primary purpose of this study is to compare the efficacy of bimekizumab administered
        subcutaneously (sc) for 16 weeks versus placebo in the treatment of study participants with
        moderate to severe plaque psoriasis (PSO).
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  measure: Psoriasis Area Severity Index 90 (PASI90) response at Week 16
  time frame: Week 16
  description: The PASI90 response assessments are based on at least 90% improvement in PASI score from Baseline. Body divided into 4 areas: head, upper extremities, trunk and lower extremities. Assignment of an average score for redness, thickness, and scaling for each of the 4 body areas with a score of 0 (clear) to 4 (very marked). Determining the percentage of skin covered with PSO for each of the body areas and converting to a 0 to 6 scale. Final PASI= average redness, thickness, and scaliness of the psoriatic skin lesions, multiplied by the involved psoriasis area score of respective section, and weighted by the percentage of the person's affected skin for respective section. The minimum possible PASI score is 0= no disease, the maximum score is 72= maximal disease.
  measure: Investigator´s Global Assessment (IGA) 0/1 response at Week 16
  time frame: Week 16
  description: The IGA measures the overall psoriasis severity using a 5-point scale (0-4), where 0=clear - no signs of psoriasis; post-inflammatory hyperpigmentation may be present, 1=almost clear - no thickening; normal to pink coloration; no to minimal focal scaling, 2=mild - just detectable to mild thickening; pink to light red coloration and predominately fine scaling, 3=moderate - clearly distinguishable to moderate thickening; dull to bright red, moderate scaling and 4=severe - severe thickening with hard edges; bright to deep dark red coloration; severe/coarse scaling covering almost all or all lesions. IGA response at week 16 is defined as a score of 0 or 1 with at least a two-category improvement from Baseline.
  measure: PASI75 response at Week 4
  time frame: Week 4
  description: The PASI75 response at Week 4 is a key secondary endpoint. PASI75 response assessments are based on at least 75% improvement in PASI score from Baseline. Body divided into 4 areas: head, upper extremities, trunk and lower extremities. Assignment of an average score for redness, thickness, and scaling for each of the 4 body areas with a score of 0 (clear) to 4 (very marked). Determining the percentage of skin covered with PSO for each of the body areas and converting to a 0 to 6 scale. Final PASI= average redness, thickness, and scaliness of the psoriatic skin lesions, multiplied by the involved psoriasis area score of respective section, and weighted by the percentage of the person's affected skin for respective section. The minimum possible PASI score is 0= no disease, the maximum score is 72= maximal disease.
  measure: PASI100 response at Week 16
  time frame: Week 16
  description: The PASI100 response at Week 16 is a key secondary endpoint. PASI100 response assessments are based on a 100% improvement in PASI score from Baseline. Body divided into 4 areas: head, upper extremities, trunk and lower extremities. Assignment of an average score for the redness, thickness, and scaling for each of the 4 body areas with a score of 0 (clear) to 4 (very marked). Determining the percentage of skin covered with PSO for each of body areas and converting to a 0 to 6 scale. Final PASI= average redness, thickness, and scaliness of the psoriatic skin lesions, multiplied by the involved psoriasis area score of the respective section, and weighted by the percentage of the person's affected skin for the respective section. The minimum possible PASI score is 0= no disease, the maximum score is 72= maximal disease
  measure: Patient Symptom Diary (PSD) Psoriasis Symptom and Impact Measure (P-SIM) response for itch at Week 16
  time frame: Week 16
  description: The PSD (P-SIM) is designed to collect data about the experience of patients with moderate to severe psoriasis related to the severity of signs, symptoms or impacts, at their worst during the past 24 hours, on a 0-10 point numeric rating scale (NRS) where 0 (no symptom/ impact) and 10 (very severe symptom/ worst impact). It consists of 14 items of which three were used as secondary endpoints: Skin pain, Itch and Scaling. Itch response is defined as a reduction from Baseline to week 16 of at least 4 points on the PSD itch score.
  measure: PSD (P-SIM) response for pain at Week 16
  time frame: Week 16
  description: The PSD (P-SIM) is designed to collect data about the experience of patients with moderate to severe psoriasis related to the severity of signs, symptoms or impacts, at their worst during the past 24 hours, on a 0-10 point numeric rating scale (NRS) where 0 (no symptom/ impact) and 10 (very severe symptom/ worst impact). It consists of 14 items of which three were used as secondary endpoints: Skin pain, Itch and Scaling. Pain response is defined as a reduction from Baseline to week 16 of at least 4 points on the PSD pain score.
  measure: PSD (P-SIM) response for scaling at Week 16
  time frame: Week 16
  description: The PSD (P-SIM) is designed to collect data about the experience of patients with moderate to severe psoriasis related to the severity of signs, symptoms or impacts, at their worst during the past 24 hours, on a 0-10 point numeric rating scale (NRS) where 0 (no symptom/ impact) and 10 (very severe symptom/ worst impact). It consists of 14 items of which three were used as secondary endpoints: Skin pain, Itch and Scaling. Scaling response is defined as a reduction from Baseline to week 16 of at least 4 points on the PSD scaling score.
  measure: Incidence of Treatment-emergent Adverse Events (TEAE)s through Week 16
  time frame: From Baseline to End of initial Treatment Period (up to Week 16)
  description: An adverse event (AE) is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of investigational medicinal product (IMP), whether or not considered related to the IMP. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of IMP.
  measure: Incidence of serious TEAEs through Week 16
  time frame: From Baseline to End of initial Treatment Period (up to Week 16)
  description: An SAE is any untoward medical occurrence that at any dose:
  Results in death Is life-threatening Requires in patient hospitalisation or prolongation of existing hospitalisation Is a congenital anomaly or birth defect Is an infection that requires treatment with parenteral antibiotics Other important medical events which based on medical or scientific judgement may jeopardise the patients, or may require medical or surgical intervention to prevent any of the above
  measure: Incidence of TEAEs leading to permanent discontinuation of Investigational Medicinal Product (IMP) through Week 16
  time frame: From Baseline to End of initial Treatment Period (up to Week 16)
  description: An adverse event (AE) is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of investigational medicinal product (IMP), whether or not considered related to the IMP. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of IMP. TEAEs leading to withdrawal of study medication.
  arm group label: bimekizumab
  arm group type: Experimental
  description: Study participants randomized to this arm will receive bimekizumab (BKZ) dosage regimen 1 in the Initial Treatment Period (16 weeks) and switch to dosage regimen 2 and placebo to maintain the blinding in the Maintenance Treatment Period (16 weeks).
  arm group label: placebo
  arm group type: Placebo Comparator
  description: Study participants randomized to this arm will receive placebo comparator in the Initial Treatment Period (16 weeks) and switch to bimekizumab dosage regimen 1 in the Maintenance Treatment Period (16 weeks).
  intervention type: Other
  intervention name: Placebo
  description: Study participants will receive placebo subcutaneously at pre-specified time points in the placebo arm as comparator and in the bimekizumab arm to maintain the blinding.
  arm group label: bimekizumab
  arm group label: placebo
  intervention type: Drug
  intervention name: Bimekizumab
  description: Study participants will receive bimekizumab (dosage regimen 1 and 2) subcutaneously administered at pre-specified time points during the Initial and Maintenance Treatment Periods.
  arm group label: bimekizumab
  arm group label: placebo
  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
  last name: UCB Cares
  phone: 1-844-599-2273 (USA)
  email: UCBCares@ucb.com
  last name: UCB Cares
  phone: 001 844 599 2273
  email: UCBCares@ucb.com
  responsible party type: Sponsor
  mesh term: Psoriasis
  sharing ipd: Yes
  ipd description: Data from this study may be requested by qualified researchers six months after product approval in the US and/or Europe, or global development is discontinued, and 18 months after trial completion. Investigators may request access to anonymized IPD and redacted study documents which may include: raw datasets, analysis-ready datasets, study protocol, blank case report form, annotated case report form, statistical analysis plan, dataset specifications, and clinical study report. Prior to use of the data, proposals need to be approved by an independent review panel at www.Vivli.org and a signed data sharing agreement will need to be executed. All documents are available in English only, for a pre-specified time, typically 12 months, on a password protected portal. This plan may change if a determination is made that the data cannot be adequately anonymized.
  ipd info type: Study Protocol
  ipd info type: Statistical Analysis Plan (SAP)
  ipd info type: Clinical Study Report (CSR)
  ipd time frame: Data from this study may be requested by qualified researchers six months after product approval in the US and/or Europe or global development is discontinued, and 18 months after trial completion.
  ipd access criteria: Qualified researchers may request access to anonymized IPD and redacted study documents which may include: raw datasets, analysis-ready datasets, study protocol, blank case report form, annotated case report form, statistical analysis plan, dataset specifications, and clinical study report. Prior to use of the data, proposals need to be approved by an independent review panel at www.Vivli.org and a signed data sharing agreement will need to be executed. All documents are available in English only, for a pre-specified time, typically 12 months, on a password protected portal.
  ipd url: http://www.Vivli.org