<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/NCT03248531</url>
  </required_header>
  <id_info>
    <org_study_id>HS0001</org_study_id>
    <secondary_id>2017-000892-10</secondary_id>
    <nct_id>NCT03248531</nct_id>
  </id_info>
  <brief_title>A Study to Test the Efficacy, Safety and Pharmacokinetics of Bimekizumab in Subjects With Moderate to Severe Hidradenitis Suppurativa.</brief_title>
  <official_title>A Phase 2 Multicenter, Investigator-Blind, Subject-Blind, Placebo-Controlled Study of the Efficacy, Safety, and Pharmacokinetics of Bimekizumab in Subjects With Moderate to Severe Hidradenitis Suppurativa</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>UCB Biopharma SRL</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>UCB Pharma</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>Yes</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      Hidradenitis suppurativa (HS) is a painful, long-term skin condition that causes abscesses&#xD;
      and scarring on the skin.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 22, 2017</start_date>
  <completion_date type="Actual">February 21, 2019</completion_date>
  <primary_completion_date type="Actual">November 23, 2018</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Percentage of Participants Achieving Clinical Response as Measured by Hidradenitis Suppurativa Clinical Response (HiSCR) at Week 12</measure>
    <time_frame>Week 12</time_frame>
    <description>HiSCR was defined as at least a 50 % reduction from Baseline in the total abscess and inflammatory nodule (AN) count, with no increase from Baseline in abscess or draining fistula count. Results were based on a Bayesian logistic regression model where the number of responders were assumed to follow a binomial distribution. Participants with missing data at Week 12 were considered as nonresponders in the analysis. Posterior mean response rates and 95% credible intervals in each group are presented.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Bimekizumab Plasma Concentration at Day 1 (Prior to First Dose)</measure>
    <time_frame>Day 1 (Prior to first dose)</time_frame>
    <description>Plasma concentration of Bimekizumab was expressed in nanograms per milliliter (ng/mL). Values Below Limit of Quantification (BLQ) were replaced by value of Lower Limit of Quantification (LLOQ) divided by 2 (75 ng/mL) in calculations of Means and Coefficient of Variations (CVs).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Bimekizumab Plasma Concentration at Week 2</measure>
    <time_frame>Week 2</time_frame>
    <description>Plasma concentration of Bimekizumab was expressed in ng/mL. Values BLQ were replaced by value of LLOQ/2 (75 ng/mL) in calculations of Means and CVs.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Bimekizumab Plasma Concentration at Week 4</measure>
    <time_frame>Week 4</time_frame>
    <description>Plasma concentration of Bimekizumab was expressed in ng/mL. Values BLQ were replaced by value of LLOQ/2 (75 ng/mL) in calculations of Means and CVs.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Bimekizumab Plasma Concentration at Week 8</measure>
    <time_frame>Week 8</time_frame>
    <description>Plasma concentration of Bimekizumab was expressed in ng/mL. Values BLQ were replaced by value of LLOQ/2 (75 ng/mL) in calculations of Means and CVs.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Bimekizumab Plasma Concentration at Week 12</measure>
    <time_frame>Week 12</time_frame>
    <description>Plasma concentration of Bimekizumab was expressed in ng/mL. Values BLQ were replaced by value of LLOQ/2 (75 ng/mL) in calculations of Means and CVs.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Bimekizumab Plasma Concentration at Week 30</measure>
    <time_frame>Week 30</time_frame>
    <description>Plasma concentration of Bimekizumab was expressed in ng/mL. Values BLQ were replaced by value of LLOQ/2 (75 ng/mL) in calculations of Means and CVs.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With at Least One Adverse Event During the Study</measure>
    <time_frame>From Screening to Safety Follow-Up (Week 30)</time_frame>
    <description>An adverse event (AE) was any untoward medical occurrence in a patient or clinical investigation study participant administered a pharmaceutical product that did not necessarily have a causal relationship with this treatment. An AE could therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With at Least One Adverse Event Categorized by Maximum Severity During the Study</measure>
    <time_frame>From Screening to Safety Follow-Up (Week 30)</time_frame>
    <description>An adverse event (AE) was any untoward medical occurrence in a patient or clinical investigation study participant administered a pharmaceutical product that did not necessarily have a causal relationship with this treatment. An AE could therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product. To record the intensity of an AE Investigator used the following criteria: Mild: the study participant was aware of sign or symptom (syndrome), but it did not interfere with his/her usual activities and/or was of no clinical consequence; Moderate: AE interfered with the usual activities of the study participant or it was of some clinical consequence; Severe: the study participant was unable to work normally or to carry out his/her usual activities, or the AE was of definite clinical consequence.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With at Least One Serious Adverse Event During the Study</measure>
    <time_frame>From Screening to Safety Follow-Up (Week 30)</time_frame>
    <description>A serious adverse event (SAE) was any untoward medical occurrence that at any dose: Resulted in death, was life-threatening, required in patient hospitalization or prolongation of existing hospitalisation, was a congenital anomaly or birth defect, was an infection that required treatment parenteral antibiotics, other important medical events which based on medical or scientific judgement may have jeopardised the patients, or may have required medical or surgical intervention to prevent any of the above.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With at Least One Serious Adverse Event Categorized by Severity During the Study</measure>
    <time_frame>From Screening to Safety Follow-Up (Week 30)</time_frame>
    <description>A serious adverse event (SAE) was any untoward medical occurrence that at any dose: Resulted in death, was life-threatening, required in patient hospitalization or prolongation of existing hospitalization, was a congenital anomaly or birth defect, was an infection that required treatment parenteral antibiotics, other important medical events which based on medical or scientific judgement may have jeopardised the patients, or may have required medical or surgical intervention to prevent any of the above. To record the intensity of an AE Investigator used the following criteria: Mild: study participant was aware of sign or symptom (syndrome), but it did not interfere with his/her usual activities and/or was of no clinical consequence; Moderate: AE interfered with usual activities of study participant or it was of some clinical consequence; Severe: the study participant was unable to work normally or to carry out his/her usual activities, or the AE was of definite clinical consequence.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants That Withdrew Due to Adverse Events During the Study</measure>
    <time_frame>From Screening to Safety Follow-Up (Week 30)</time_frame>
    <description>An adverse event (AE) was any untoward medical occurrence in a patient or clinical investigation study participant administered a pharmaceutical product that did not necessarily have a causal relationship with this treatment. An AE could therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline Until Safety Follow-up Visit in Vital Signs (Blood Pressure)</measure>
    <time_frame>From Baseline to Safety Follow-Up (Week 30)</time_frame>
    <description>Blood pressure was measured in millimeters of mercury (mmHg).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline Until Safety Follow-up Visit in Vital Signs (Pulse Rate)</measure>
    <time_frame>From Baseline to Safety Follow-Up (Week 30)</time_frame>
    <description>Pulse rate was measured in beats per minute (beats/min).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline Until Safety Follow-up Visit in Body Weight</measure>
    <time_frame>From Baseline to Safety Follow-Up (Week 30)</time_frame>
    <description>Body weight was measured in kilograms (kg).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline Until Safety Follow-up Visit in ECG Parameters (ECG Mean Heart Rate)</measure>
    <time_frame>From Baseline to Safety Follow-Up (Week 30)</time_frame>
    <description>Electrocardiogram (ECG) Mean Heart Rate was measured in beats/min.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline Until Safety Follow-up Visit in ECG Parameters (PR Interval, QRS Duration, QT Interval, QTcF Interval)</measure>
    <time_frame>From Baseline to Safety Follow-Up (Week 30)</time_frame>
    <description>PR Interval, QRS duration, QT interval and QT corrected for heart rate using Fridericia's correction (QTcF) Interval were measured in milliseconds (msec).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Erythrocytes)</measure>
    <time_frame>From Baseline to Safety Follow-Up (Week 30)</time_frame>
    <description>Erythrocytes was measured in number of red blood cells per liter (10^12/L).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Hematocrit)</measure>
    <time_frame>From Baseline to Safety Follow-Up (Week 30)</time_frame>
    <description>Hematocrit was measured in volume percentage (%) of red blood cells in blood.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Hemoglobin, Erythrocytes Mean Corpuscular Hemoglobin (HGB) Concentration)</measure>
    <time_frame>From Baseline to Safety Follow-Up (Week 30)</time_frame>
    <description>Hemoglobin, erythrocytes mean corpuscular hemoglobin (HGB) concentration were measured in grams per liter (g/L).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Erythrocytes Mean Corpuscular Hemoglobin (HGB))</measure>
    <time_frame>From Baseline to Safety Follow-Up (Week 30)</time_frame>
    <description>Erythrocytes mean corpuscular hemoglobin (HGB) was measured in picograms (pg).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Erythrocytes Mean Corpuscular Volume)</measure>
    <time_frame>From Baseline to Safety Follow-Up (Week 30)</time_frame>
    <description>Erythrocytes mean corpuscular volume was measured in femtoliters (fL).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Platelets)</measure>
    <time_frame>From Baseline to Safety Follow-Up (Week 30)</time_frame>
    <description>Platelets was measured in number of platelets per liter (10^9/L).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Leukocytes, Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils)</measure>
    <time_frame>From Baseline to Safety Follow-Up (Week 30)</time_frame>
    <description>Leukocytes, basophils, eosinophils, lymphocytes, monocytes and neutrophils were measured in number of white blood cells per liter (10^9/L).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Basophils/Leukocytes, Eosinophils/Leukocytes, Lymphocytes/Leukocytes, Monocytes/Leukocytes, Neutrophils/Leukocytes)</measure>
    <time_frame>From Baseline to Safety Follow-Up (Week 30)</time_frame>
    <description>Basophils/leukocytes, eosinophils/leukocytes, lymphocytes/leukocytes, monocytes/leukocytes and neutrophils/leukocytes were measured in percentages (%).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Bicarbonate, Chloride, Potassium, Sodium, Calcium, Magnesium, Urea Nitrogen, Cholesterol, Glucose)</measure>
    <time_frame>From Baseline to Safety Follow-Up (Week 30)</time_frame>
    <description>Bicarbonate, chloride, potassium, sodium, calcium, magnesium, urea nitrogen, cholesterol and glucose were measured in millimoles per liter (mmol/L).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Creatinine, Bilirubin, Urate)</measure>
    <time_frame>From Baseline to Safety Follow-Up (Week 30)</time_frame>
    <description>Creatinine, bilirubin, and urate were measured in micromols per liter (μmol/L).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (C Reactive Protein High Sensitivity)</measure>
    <time_frame>From Baseline to Safety Follow-Up (Week 30)</time_frame>
    <description>C reactive protein high sensitivity was measured in milligrams per liter (mg/L).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase, Lactate Dehydrogenase)</measure>
    <time_frame>From Baseline to Safety Follow-Up (Week 30)</time_frame>
    <description>Alanine aminotransferase, alkaline phosphatase, aspartate aminotransferase, gamma glutamyl transferase, lactate dehydrogenase were measured in units per liter (U/L).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline Until Safety Follow-up Visit in Urinalysis Parameters (Urine pH)</measure>
    <time_frame>From Baseline to Safety Follow-Up (Week 30)</time_frame>
    <description>Urine pH was measured on a pH scale.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline Until Safety Follow-up Visit in Urinalysis Parameters (Urine Albumin)</measure>
    <time_frame>From Baseline to Safety Follow-Up (Week 30)</time_frame>
    <description>Urine albumin was measured in milligrams per liter (mg/L).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants Who Shifted From Baseline Until Safety Follow-up Visit in Urinalysis Parameters (Urine Glucose)</measure>
    <time_frame>From Baseline to Safety Follow-Up (Week 30)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants Who Shifted From Baseline Until Safety Follow-up Visit in Urinalysis Parameters (Urine Leukocyte Esterase)</measure>
    <time_frame>From Baseline to Safety Follow-Up (Week 30)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants Who Shifted From Baseline Until Safety Follow-up Visit in Urinalysis Parameters (Urine Bacteria)</measure>
    <time_frame>From Baseline to Safety Follow-Up (Week 30)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants Who Shifted From Baseline Until Safety Follow-up Visit in Urinalysis Parameters (Urine Erythrocytes)</measure>
    <time_frame>From Baseline to Safety Follow-Up (Week 30)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants Who Shifted From Baseline Until Safety Follow-up Visit in Physical Examination</measure>
    <time_frame>From Baseline to Safety Follow-Up (Week 30)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With Positive Bimekizumab Anti-drug Antibody (ADA) Concentration at Day 1</measure>
    <time_frame>Day 1</time_frame>
    <description>The overall status of a study participant was 'Positive' if at any post-Baseline visit the result was positive. Percentages were based on the number of study participants with a non-missing measurement, from samples that did not contain BKZ concentration levels above the drug tolerance, at the visit.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With Positive Bimekizumab Anti-drug Antibody (ADA) Concentration at Week 2</measure>
    <time_frame>Week 2</time_frame>
    <description>The overall status of a study participant was 'Positive' if at any post-Baseline visit the result was positive. Percentages were based on the number of study participants with a non-missing measurement, from samples that did not contain BKZ concentration levels above the drug tolerance, at the visit.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With Positive Bimekizumab Anti-drug Antibody (ADA) Concentration at Week 4</measure>
    <time_frame>Week 4</time_frame>
    <description>The overall status of a study participant was 'Positive' if at any post-Baseline visit the result was positive. Percentages were based on the number of study participants with a non-missing measurement, from samples that did not contain BKZ concentration levels above the drug tolerance, at the visit.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With Positive Bimekizumab Anti-drug Antibody (ADA) Concentration at Week 8</measure>
    <time_frame>Week 8</time_frame>
    <description>The overall status of a study participant was 'Positive' if at any post-Baseline visit the result was positive. Percentages were based on the number of study participants with a non-missing measurement, from samples that did not contain BKZ concentration levels above the drug tolerance, at the visit.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With Positive Bimekizumab Anti-drug Antibody (ADA) Concentration at Week 12</measure>
    <time_frame>Week 12</time_frame>
    <description>The overall status of a study participant was 'Positive' if at any post-Baseline visit the result was positive. Percentages were based on the number of study participants with a non-missing measurement, from samples that did not contain BKZ concentration levels above the drug tolerance, at the visit.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With Positive Bimekizumab Anti-drug Antibody (ADA) Concentration at Week 30</measure>
    <time_frame>Week 30</time_frame>
    <description>The overall status of a study participant was 'Positive' if at any post-Baseline visit the result was positive. Percentages were based on the number of study participants with a non-missing measurement, from samples that did not contain BKZ concentration levels above the drug tolerance, at the visit.</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">90</enrollment>
  <condition>Hidradenitis Suppurativa</condition>
  <arm_group>
    <arm_group_label>Bimekizumab</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Subjects will receive one Bimekizumab loading dose 1 and several Bimekizumab dose 2 applications.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Adalimumab</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Subjects will receive one Adalimumab loading (dose 1) and several Adalimumab dose 2 and dose 3 applications.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Subjects will receive several placebo applications to keep the blinding.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Bimekizumab</intervention_name>
    <description>Bimekizumab in different dosages (dose 1 and 2).</description>
    <arm_group_label>Bimekizumab</arm_group_label>
    <other_name>UCB4940</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Adalimumab</intervention_name>
    <description>Adalimumab in different dosages (dose 1, 2 and 3).</description>
    <arm_group_label>Adalimumab</arm_group_label>
    <other_name>Humira®</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Placebo will be provided matching Bimekizumab.</description>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Adult subjects (18 to 70 years of age, inclusive) must have a diagnosis of HS for at&#xD;
             least&#xD;
&#xD;
             1 year prior to Baseline&#xD;
&#xD;
          -  Stable HS for at least 2 months prior to Screening and also at the Baseline Visit&#xD;
&#xD;
          -  Inadequate response to at least a 3-month study of an oral antibiotic for treatment of&#xD;
             HS&#xD;
&#xD;
          -  Total abscess and inflammatory nodule count &gt;=3 at the Baseline Visit&#xD;
&#xD;
          -  Subject must agree to daily use (and throughout the entirety of the study) of 1&#xD;
             pre-specified over-the-counter topical antiseptics on their HS lesions&#xD;
&#xD;
          -  Female subjects must be postmenopausal, permanently sterilized or, if of childbearing&#xD;
             potential, must be willing to use a highly effective method of contraception up till&#xD;
             20 weeks after last administration of study drug and have a negative pregnancy test at&#xD;
             Visit 1 (Screening) and immediately prior to first dose&#xD;
&#xD;
          -  Male subjects must be willing to use a method of contraception when sexually active,&#xD;
             up till 20 weeks after the last administration of study medication&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Prior treatment with anti-IL17s or participation in an anti-IL17 study&#xD;
&#xD;
          -  Previously received anti-TNFs&#xD;
&#xD;
          -  Subject requires, or is expected to require, opioid analgesics for any reason&#xD;
             (excluding tramadol)&#xD;
&#xD;
          -  Subject received prescription topical therapies for the treatment of HS within 14 days&#xD;
             prior to the Baseline Visit&#xD;
&#xD;
          -  Subject received systemic non-biologic therapies for HS with potential therapeutic&#xD;
             impact for HS less than 28 days prior to Baseline Visit&#xD;
&#xD;
          -  Draining fistula count &gt;20 at the Baseline Visit&#xD;
&#xD;
          -  Diagnosis of inflammatory conditions other than HS&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <gender_based>Yes</gender_based>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>UCB Cares</last_name>
    <role>Study Director</role>
    <affiliation>+1-844-599-2273 (UCB)</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Hs0001 121</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>90033</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hs0001 119</name>
      <address>
        <city>Coral Gables</city>
        <state>Florida</state>
        <zip>33134</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hs0001 111</name>
      <address>
        <city>Orange</city>
        <state>Florida</state>
        <zip>32073</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hs0001 117</name>
      <address>
        <city>Tampa</city>
        <state>Florida</state>
        <zip>33624</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hs0001 112</name>
      <address>
        <city>Sandy Springs</city>
        <state>Georgia</state>
        <zip>30328</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hs0001 113</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02215</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hs0001 115</name>
      <address>
        <city>Las Vegas</city>
        <state>Nevada</state>
        <zip>89074</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hs0001 126</name>
      <address>
        <city>Manhasset</city>
        <state>New York</state>
        <zip>11030</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hs0001 125</name>
      <address>
        <city>Chapel Hill</city>
        <state>North Carolina</state>
        <zip>27599</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hs0001 123</name>
      <address>
        <city>Hershey</city>
        <state>Pennsylvania</state>
        <zip>17033</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hs0001 120</name>
      <address>
        <city>Nashville</city>
        <state>Tennessee</state>
        <zip>37215</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hs0001 103</name>
      <address>
        <city>East Melbourne</city>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hs0001 101</name>
      <address>
        <city>Fremantle</city>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hs0001 104</name>
      <address>
        <city>Saint Leonards</city>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hs0001 100</name>
      <address>
        <city>Westmead</city>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hs0001 102</name>
      <address>
        <city>Woolloongabba</city>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hs0001 203</name>
      <address>
        <city>Brussels</city>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hs0001 202</name>
      <address>
        <city>Liège</city>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hs0001 300</name>
      <address>
        <city>Copenhagen</city>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hs0001 408</name>
      <address>
        <city>Berlin</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hs0001 405</name>
      <address>
        <city>Bochum</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hs0001 407</name>
      <address>
        <city>Darmstadt</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hs0001 400</name>
      <address>
        <city>Dessau</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hs0001 404</name>
      <address>
        <city>Erlangen</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hs0001 406</name>
      <address>
        <city>Würzburg</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hs0001 503</name>
      <address>
        <city>Athens</city>
        <country>Greece</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hs0001 701</name>
      <address>
        <city>Harstad</city>
        <country>Norway</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hs0001 700</name>
      <address>
        <city>Tromsø</city>
        <country>Norway</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hs0001 901</name>
      <address>
        <city>Moscow</city>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hs0001 903</name>
      <address>
        <city>Saint Petersburg</city>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hs0001 900</name>
      <address>
        <city>Yaroslavl</city>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Australia</country>
    <country>Belgium</country>
    <country>Denmark</country>
    <country>Germany</country>
    <country>Greece</country>
    <country>Norway</country>
    <country>Russian Federation</country>
    <country>United States</country>
  </location_countries>
  <results_reference>
    <citation>Glatt S, Jemec GBE, Forman S, Sayed C, Schmieder G, Weisman J, Rolleri R, Seegobin S, Baeten D, Ionescu L, Zouboulis CC, Shaw S. Efficacy and Safety of Bimekizumab in Moderate to Severe Hidradenitis Suppurativa: A Phase 2, Double-blind, Placebo-Controlled Randomized Clinical Trial. JAMA Dermatol. 2021 Nov 1;157(11):1279-1288. doi: 10.1001/jamadermatol.2021.2905. Erratum In: JAMA Dermatol. 2021 Nov 1;157(11):1384.</citation>
    <PMID>34406364</PMID>
  </results_reference>
  <verification_date>January 2022</verification_date>
  <study_first_submitted>August 2, 2017</study_first_submitted>
  <study_first_submitted_qc>August 11, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 14, 2017</study_first_posted>
  <results_first_submitted>November 22, 2021</results_first_submitted>
  <results_first_submitted_qc>January 13, 2022</results_first_submitted_qc>
  <results_first_posted type="Actual">February 9, 2022</results_first_posted>
  <disposition_first_submitted>November 22, 2019</disposition_first_submitted>
  <disposition_first_submitted_qc>January 13, 2022</disposition_first_submitted_qc>
  <disposition_first_posted type="Actual">February 9, 2022</disposition_first_posted>
  <last_update_submitted>March 14, 2022</last_update_submitted>
  <last_update_submitted_qc>March 14, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">April 11, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Hidradenitis Suppurativa</keyword>
  <keyword>Bimekizumab</keyword>
  <keyword>HS</keyword>
  <keyword>Moderate to Severe HS</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hidradenitis Suppurativa</mesh_term>
    <mesh_term>Hidradenitis</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Adalimumab</mesh_term>
  </intervention_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>March 8, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/31/NCT03248531/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>February 19, 2019</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/31/NCT03248531/SAP_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <recruitment_details>The study started to enroll patients in September 2017 and concluded in February 2019.</recruitment_details>
      <pre_assignment_details>The study included a Screening Period (≥ 2 weeks up to a maximum of 4 weeks prior to randomization), a Treatment Period (12 weeks), and a Safety Follow-Up (SFU) Visit (20 weeks after the last dose of investigational medicinal product (IMP)). Participant Flow refers to the Randomized Set.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Placebo</title>
          <description>Participants received matching placebo subcutaneous (SC) injections at Baseline, followed by Week 2, 4, 5, 6, 7, 8, 9, and 10 to maintain study blinding.</description>
        </group>
        <group group_id="P2">
          <title>Adalimumab</title>
          <description>Participants received one adalimumab 160 milligrams (mg) SC injection as loading dose started from Baseline, followed by adalimumab 80 mg SC injection at Week 2 and adalimumab 40 mg SC injections from Weeks 4 to 10. Participants also received matching placebo SC injection at Week 4, 6, 8 and 10 to maintain study blinding.</description>
        </group>
        <group group_id="P3">
          <title>Bimekizumab</title>
          <description>Participants received one bimekizumab 640 mg SC injection as loading dose started from Baseline, followed by bimekizumab 320 mg SC injections at Weeks 2, 4, 6, 8 and 10. Participants also received matching placebo SC injections at Week 5, 7 and 9 to maintain study blinding.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="22"/>
                <participants group_id="P2" count="22"/>
                <participants group_id="P3" count="46"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Completed Week 12</title>
              <participants_list>
                <participants group_id="P1" count="19"/>
                <participants group_id="P2" count="18"/>
                <participants group_id="P3" count="42"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="18"/>
                <participants group_id="P2" count="17"/>
                <participants group_id="P3" count="38"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="4"/>
                <participants group_id="P2" count="5"/>
                <participants group_id="P3" count="8"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Adverse Event</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="5"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
                <participants group_id="P2" count="3"/>
                <participants group_id="P3" count="2"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Sponsor Request</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="2"/>
                <participants group_id="P3" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>Baseline Characteristics refer to the Randomized Set (RS) which consisted of all study participants randomized into the study.</population>
      <group_list>
        <group group_id="B1">
          <title>Placebo</title>
          <description>Participants received matching placebo subcutaneous (SC) injections at Baseline, followed by Week 2, 4, 5, 6, 7, 8, 9, and 10 to maintain study blinding.</description>
        </group>
        <group group_id="B2">
          <title>Adalimumab</title>
          <description>Participants received one adalimumab 160 milligrams (mg) SC injection as loading dose started from Baseline, followed by adalimumab 80 mg SC injection at Week 2 and adalimumab 40 mg SC injections from Weeks 4 to 10. Participants also received matching placebo SC injection at Week 4, 6, 8 and 10 to maintain study blinding.</description>
        </group>
        <group group_id="B3">
          <title>Bimekizumab</title>
          <description>Participants received one bimekizumab 640 mg SC injection as loading dose started from Baseline, followed by bimekizumab 320 mg SC injections at Weeks 2, 4, 6, 8 and 10. Participants also received matching placebo SC injections at Week 5, 7 and 9 to maintain study blinding.</description>
        </group>
        <group group_id="B4">
          <title>Total Title</title>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="22"/>
            <count group_id="B2" value="22"/>
            <count group_id="B3" value="46"/>
            <count group_id="B4" value="90"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>&lt;=18 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="2"/>
                    <measurement group_id="B4" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="21"/>
                    <measurement group_id="B2" value="22"/>
                    <measurement group_id="B3" value="44"/>
                    <measurement group_id="B4" value="87"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="1"/>
                  </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="40.7" spread="12.5"/>
                    <measurement group_id="B2" value="31.0" spread="9.2"/>
                    <measurement group_id="B3" value="37.4" spread="11.9"/>
                    <measurement group_id="B4" value="36.6" spread="11.9"/>
                  </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="15"/>
                    <measurement group_id="B2" value="18"/>
                    <measurement group_id="B3" value="30"/>
                    <measurement group_id="B4" value="63"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="7"/>
                    <measurement group_id="B2" value="4"/>
                    <measurement group_id="B3" value="16"/>
                    <measurement group_id="B4" value="27"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race/Ethnicity, Customized</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaskan Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="4"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="6"/>
                    <measurement group_id="B2" value="5"/>
                    <measurement group_id="B3" value="10"/>
                    <measurement group_id="B4" value="21"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="12"/>
                    <measurement group_id="B2" value="14"/>
                    <measurement group_id="B3" value="35"/>
                    <measurement group_id="B4" value="61"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Other or Mixed</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="1"/>
                    <measurement group_id="B4" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Percentage of Participants Achieving Clinical Response as Measured by Hidradenitis Suppurativa Clinical Response (HiSCR) at Week 12</title>
        <description>HiSCR was defined as at least a 50 % reduction from Baseline in the total abscess and inflammatory nodule (AN) count, with no increase from Baseline in abscess or draining fistula count. Results were based on a Bayesian logistic regression model where the number of responders were assumed to follow a binomial distribution. Participants with missing data at Week 12 were considered as nonresponders in the analysis. Posterior mean response rates and 95% credible intervals in each group are presented.</description>
        <time_frame>Week 12</time_frame>
        <population>The Per-Protocol Set (PPS) was a subset of the Full Analysis Set (FAS), consisting of those study participants who had no important protocol deviations affecting the primary efficacy variable, as confirmed during a pre-analysis review prior to unblinding of the data (at each of the interim and final analyses).</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo (PPS)</title>
            <description>Participants received matching placebo subcutaneous (SC) injections at Baseline, followed by Week 2, 4, 5, 6, 7, 8, 9, and 10 to maintain study blinding, forming the Per-Protocol Set (PPS).</description>
          </group>
          <group group_id="O2">
            <title>Adalimumab (PPS)</title>
            <description>Participants received one adalimumab 160 milligrams (mg) SC injection as loading dose started from Baseline, followed by adalimumab 80 mg SC injection at Week 2 and adalimumab 40 mg SC injections from Weeks 4 to 10. Participants also received matching placebo SC injection at Week 4, 6, 8 and 10 to maintain study blinding, forming the PPS.</description>
          </group>
          <group group_id="O3">
            <title>Bimekizumab (PPS)</title>
            <description>Participants received one bimekizumab 640 mg SC injection as loading dose started from Baseline, followed by bimekizumab 320 mg SC injections at Weeks 2, 4, 6, 8 and 10. Participants also received matching placebo SC injections at Week 5, 7 and 9 to maintain study blinding, forming the PPS.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants Achieving Clinical Response as Measured by Hidradenitis Suppurativa Clinical Response (HiSCR) at Week 12</title>
          <description>HiSCR was defined as at least a 50 % reduction from Baseline in the total abscess and inflammatory nodule (AN) count, with no increase from Baseline in abscess or draining fistula count. Results were based on a Bayesian logistic regression model where the number of responders were assumed to follow a binomial distribution. Participants with missing data at Week 12 were considered as nonresponders in the analysis. Posterior mean response rates and 95% credible intervals in each group are presented.</description>
          <population>The Per-Protocol Set (PPS) was a subset of the Full Analysis Set (FAS), consisting of those study participants who had no important protocol deviations affecting the primary efficacy variable, as confirmed during a pre-analysis review prior to unblinding of the data (at each of the interim and final analyses).</population>
          <units>Percentage of responders</units>
          <param>Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="20"/>
                <count group_id="O2" value="20"/>
                <count group_id="O3" value="44"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="26.1" lower_limit="13.8" upper_limit="40.5"/>
                    <measurement group_id="O2" value="59.5" lower_limit="44.2" upper_limit="73.9"/>
                    <measurement group_id="O3" value="57.3" lower_limit="42.4" upper_limit="71.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Results were based on a Bayesian logistic regression model where the number of responders were assumed to follow a binomial distribution. Treatment and Baseline Hurley Stage were included as predictors in the model. 95% credible intervals were presented for the bimekizumab (BKZ) vs placebo (PBO) comparison.</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>Mean posterior difference</param_type>
            <param_value>31.2</param_value>
            <dispersion_type>Standard Deviation</dispersion_type>
            <dispersion_value>10.1</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>11.0</ci_lower_limit>
            <ci_upper_limit>50.4</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Results were based on a Bayesian logistic regression model where the number of responders were assumed to follow a binomial distribution. Treatment and Baseline Hurley Stage were included as predictors in the model. 60% credible intervals were presented for the BKZ vs adalimumab (ADA) comparison.</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>Mean posterior difference</param_type>
            <param_value>-2.2</param_value>
            <dispersion_type>Standard Deviation</dispersion_type>
            <dispersion_value>10.6</dispersion_value>
            <ci_percent>60</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-11.2</ci_lower_limit>
            <ci_upper_limit>6.6</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Results were based on a Bayesian logistic regression model where the number of responders were assumed to follow a binomial distribution. Treatment and Baseline Hurley Stage were included as predictors in the model.</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>Pr [Diff&gt;0%] (%)</param_type>
            <param_value>99.8</param_value>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Results were based on a Bayesian logistic regression model where the number of responders were assumed to follow a binomial distribution. Treatment and Baseline Hurley Stage were included as predictors in the model.</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>Pr[Diff &gt; 0%](%)</param_type>
            <param_value>42.1</param_value>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Bimekizumab Plasma Concentration at Day 1 (Prior to First Dose)</title>
        <description>Plasma concentration of Bimekizumab was expressed in nanograms per milliliter (ng/mL). Values Below Limit of Quantification (BLQ) were replaced by value of Lower Limit of Quantification (LLOQ) divided by 2 (75 ng/mL) in calculations of Means and Coefficient of Variations (CVs).</description>
        <time_frame>Day 1 (Prior to first dose)</time_frame>
        <population>The Pharmacokinetic Per-Protocol Set (PK-PPS) consisted of all randomized study participants who received at least 1 dose of investigational medicinal product (IMP) and had at least 1 quantifiable postdose plasma concentration.</population>
        <group_list>
          <group group_id="O1">
            <title>Bimekizumab (PK-PPS)</title>
            <description>Participants received one bimekizumab 640 mg SC injection as loading dose started from Baseline, followed by bimekizumab 320 mg SC injections at Weeks 2, 4, 6, 8 and 10. Participants also received matching placebo SC injections at Week 5, 7 and 9 to maintain study blinding, forming the Pharmacokinetic Per-Protocol Set (PK-PPS).</description>
          </group>
        </group_list>
        <measure>
          <title>Bimekizumab Plasma Concentration at Day 1 (Prior to First Dose)</title>
          <description>Plasma concentration of Bimekizumab was expressed in nanograms per milliliter (ng/mL). Values Below Limit of Quantification (BLQ) were replaced by value of Lower Limit of Quantification (LLOQ) divided by 2 (75 ng/mL) in calculations of Means and Coefficient of Variations (CVs).</description>
          <population>The Pharmacokinetic Per-Protocol Set (PK-PPS) consisted of all randomized study participants who received at least 1 dose of investigational medicinal product (IMP) and had at least 1 quantifiable postdose plasma concentration.</population>
          <units>ng/mL</units>
          <param>Geometric Mean</param>
          <dispersion>Geometric Coefficient of Variation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="46"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="NA" spread="NA">Here, NA signifies that geometric means and geometric CVs were only calculated if at least 2/3 of the concentrations were above lower limit of quantification (LLOQ).</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Bimekizumab Plasma Concentration at Week 2</title>
        <description>Plasma concentration of Bimekizumab was expressed in ng/mL. Values BLQ were replaced by value of LLOQ/2 (75 ng/mL) in calculations of Means and CVs.</description>
        <time_frame>Week 2</time_frame>
        <population>The Pharmacokinetic Per-Protocol Set (PK-PPS) consisted of all randomized study participants who received at least 1 dose of investigational medicinal product (IMP) and had at least 1 quantifiable postdose plasma concentration. Here, number of participants analyzed included all participants who were evaluable for this Outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>Bimekizumab (PK-PPS)</title>
            <description>Participants received one bimekizumab 640 mg SC injection as loading dose started from Baseline, followed by bimekizumab 320 mg SC injections at Weeks 2, 4, 6, 8 and 10. Participants also received matching placebo SC injections at Week 5, 7 and 9 to maintain study blinding, forming the PK-PPS.</description>
          </group>
        </group_list>
        <measure>
          <title>Bimekizumab Plasma Concentration at Week 2</title>
          <description>Plasma concentration of Bimekizumab was expressed in ng/mL. Values BLQ were replaced by value of LLOQ/2 (75 ng/mL) in calculations of Means and CVs.</description>
          <population>The Pharmacokinetic Per-Protocol Set (PK-PPS) consisted of all randomized study participants who received at least 1 dose of investigational medicinal product (IMP) and had at least 1 quantifiable postdose plasma concentration. Here, number of participants analyzed included all participants who were evaluable for this Outcome measure.</population>
          <units>ng/mL</units>
          <param>Geometric Mean</param>
          <dispersion>Geometric Coefficient of Variation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="45"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="24086.4" spread="56.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Bimekizumab Plasma Concentration at Week 4</title>
        <description>Plasma concentration of Bimekizumab was expressed in ng/mL. Values BLQ were replaced by value of LLOQ/2 (75 ng/mL) in calculations of Means and CVs.</description>
        <time_frame>Week 4</time_frame>
        <population>The Pharmacokinetic Per-Protocol Set (PK-PPS) consisted of all randomized study participants who received at least 1 dose of investigational medicinal product (IMP) and had at least 1 quantifiable postdose plasma concentration.</population>
        <group_list>
          <group group_id="O1">
            <title>Bimekizumab (PK-PPS)</title>
            <description>Participants received one bimekizumab 640 mg SC injection as loading dose started from Baseline, followed by bimekizumab 320 mg SC injections at Weeks 2, 4, 6, 8 and 10. Participants also received matching placebo SC injections at Week 5, 7 and 9 to maintain study blinding, forming the PK-PPS.</description>
          </group>
        </group_list>
        <measure>
          <title>Bimekizumab Plasma Concentration at Week 4</title>
          <description>Plasma concentration of Bimekizumab was expressed in ng/mL. Values BLQ were replaced by value of LLOQ/2 (75 ng/mL) in calculations of Means and CVs.</description>
          <population>The Pharmacokinetic Per-Protocol Set (PK-PPS) consisted of all randomized study participants who received at least 1 dose of investigational medicinal product (IMP) and had at least 1 quantifiable postdose plasma concentration.</population>
          <units>ng/mL</units>
          <param>Geometric Mean</param>
          <dispersion>Geometric Coefficient of Variation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="46"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="26572.6" spread="57.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Bimekizumab Plasma Concentration at Week 8</title>
        <description>Plasma concentration of Bimekizumab was expressed in ng/mL. Values BLQ were replaced by value of LLOQ/2 (75 ng/mL) in calculations of Means and CVs.</description>
        <time_frame>Week 8</time_frame>
        <population>The Pharmacokinetic Per-Protocol Set (PK-PPS) consisted of all randomized study participants who received at least 1 dose of investigational medicinal product (IMP) and had at least 1 quantifiable postdose plasma concentration. Here, number of participants analyzed included all participants who were evaluable for this Outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>Bimekizumab (PK-PPS)</title>
            <description>Participants received one bimekizumab 640 mg SC injection as loading dose started from Baseline, followed by bimekizumab 320 mg SC injections at Weeks 2, 4, 6, 8 and 10. Participants also received matching placebo SC injections at Week 5, 7 and 9 to maintain study blinding, forming the PK-PPS.</description>
          </group>
        </group_list>
        <measure>
          <title>Bimekizumab Plasma Concentration at Week 8</title>
          <description>Plasma concentration of Bimekizumab was expressed in ng/mL. Values BLQ were replaced by value of LLOQ/2 (75 ng/mL) in calculations of Means and CVs.</description>
          <population>The Pharmacokinetic Per-Protocol Set (PK-PPS) consisted of all randomized study participants who received at least 1 dose of investigational medicinal product (IMP) and had at least 1 quantifiable postdose plasma concentration. Here, number of participants analyzed included all participants who were evaluable for this Outcome measure.</population>
          <units>ng/mL</units>
          <param>Geometric Mean</param>
          <dispersion>Geometric Coefficient of Variation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="43"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="30222.6" spread="54.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Bimekizumab Plasma Concentration at Week 12</title>
        <description>Plasma concentration of Bimekizumab was expressed in ng/mL. Values BLQ were replaced by value of LLOQ/2 (75 ng/mL) in calculations of Means and CVs.</description>
        <time_frame>Week 12</time_frame>
        <population>The Pharmacokinetic Per-Protocol Set (PK-PPS) consisted of all randomized study participants who received at least 1 dose of investigational medicinal product (IMP) and had at least 1 quantifiable postdose plasma concentration. Here, number of participants analyzed included all participants who were evaluable for this Outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>Bimekizumab (PK-PPS)</title>
            <description>Participants received one bimekizumab 640 mg SC injection as loading dose started from Baseline, followed by bimekizumab 320 mg SC injections at Weeks 2, 4, 6, 8 and 10. Participants also received matching placebo SC injections at Week 5, 7 and 9 to maintain study blinding, forming the PK-PPS.</description>
          </group>
        </group_list>
        <measure>
          <title>Bimekizumab Plasma Concentration at Week 12</title>
          <description>Plasma concentration of Bimekizumab was expressed in ng/mL. Values BLQ were replaced by value of LLOQ/2 (75 ng/mL) in calculations of Means and CVs.</description>
          <population>The Pharmacokinetic Per-Protocol Set (PK-PPS) consisted of all randomized study participants who received at least 1 dose of investigational medicinal product (IMP) and had at least 1 quantifiable postdose plasma concentration. Here, number of participants analyzed included all participants who were evaluable for this Outcome measure.</population>
          <units>ng/mL</units>
          <param>Geometric Mean</param>
          <dispersion>Geometric Coefficient of Variation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="42"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="25319.0" spread="116.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Bimekizumab Plasma Concentration at Week 30</title>
        <description>Plasma concentration of Bimekizumab was expressed in ng/mL. Values BLQ were replaced by value of LLOQ/2 (75 ng/mL) in calculations of Means and CVs.</description>
        <time_frame>Week 30</time_frame>
        <population>The Pharmacokinetic Per-Protocol Set (PK-PPS) consisted of all randomized study participants who received at least 1 dose of investigational medicinal product (IMP) and had at least 1 quantifiable postdose plasma concentration. Here, number of participants analyzed included all participants who were evaluable for this Outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>Bimekizumab (PK-PPS)</title>
            <description>Participants received one bimekizumab 640 mg SC injection as loading dose started from Baseline, followed by bimekizumab 320 mg SC injections at Weeks 2, 4, 6, 8 and 10. Participants also received matching placebo SC injections at Week 5, 7 and 9 to maintain study blinding, forming the PK-PPS.</description>
          </group>
        </group_list>
        <measure>
          <title>Bimekizumab Plasma Concentration at Week 30</title>
          <description>Plasma concentration of Bimekizumab was expressed in ng/mL. Values BLQ were replaced by value of LLOQ/2 (75 ng/mL) in calculations of Means and CVs.</description>
          <population>The Pharmacokinetic Per-Protocol Set (PK-PPS) consisted of all randomized study participants who received at least 1 dose of investigational medicinal product (IMP) and had at least 1 quantifiable postdose plasma concentration. Here, number of participants analyzed included all participants who were evaluable for this Outcome measure.</population>
          <units>ng/mL</units>
          <param>Geometric Mean</param>
          <dispersion>Geometric Coefficient of Variation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="35"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="NA" spread="NA">Here, NA signifies that geometric means and geometric CVs were only calculated if at least 2/3 of the concentrations were above lower limit of quantification (LLOQ).</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants With at Least One Adverse Event During the Study</title>
        <description>An adverse event (AE) was any untoward medical occurrence in a patient or clinical investigation study participant administered a pharmaceutical product that did not necessarily have a causal relationship with this treatment. An AE could therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.</description>
        <time_frame>From Screening to Safety Follow-Up (Week 30)</time_frame>
        <population>The Safety Set (SS) consisted of all study participants who received at least 1 dose (full or partial) of IMP.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo (SS)</title>
            <description>Participants received matching placebo subcutaneous (SC) injections at Baseline, followed by Week 2, 4, 5, 6, 7, 8, 9, and 10 to maintain study blinding, forming the Safety Set (SS).</description>
          </group>
          <group group_id="O2">
            <title>Adalimumab (SS)</title>
            <description>Participants received one adalimumab 160 milligrams (mg) SC injection as loading dose started from Baseline, followed by adalimumab 80 mg SC injection at Week 2 and adalimumab 40 mg SC injections from Weeks 4 to 10. Participants also received matching placebo SC injection at Week 4, 6, 8 and 10 to maintain study blinding, forming the SS.</description>
          </group>
          <group group_id="O3">
            <title>Bimekizumab (SS)</title>
            <description>Participants received one bimekizumab 640 mg SC injection as loading dose started from Baseline, followed by bimekizumab 320 mg SC injections at Weeks 2, 4, 6, 8 and 10. Participants also received matching placebo SC injections at Week 5, 7 and 9 to maintain study blinding, forming the SS.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With at Least One Adverse Event During the Study</title>
          <description>An adverse event (AE) was any untoward medical occurrence in a patient or clinical investigation study participant administered a pharmaceutical product that did not necessarily have a causal relationship with this treatment. An AE could therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.</description>
          <population>The Safety Set (SS) consisted of all study participants who received at least 1 dose (full or partial) of IMP.</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="21"/>
                <count group_id="O2" value="21"/>
                <count group_id="O3" value="46"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="61.9"/>
                    <measurement group_id="O2" value="71.4"/>
                    <measurement group_id="O3" value="71.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants With at Least One Adverse Event Categorized by Maximum Severity During the Study</title>
        <description>An adverse event (AE) was any untoward medical occurrence in a patient or clinical investigation study participant administered a pharmaceutical product that did not necessarily have a causal relationship with this treatment. An AE could therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product. To record the intensity of an AE Investigator used the following criteria: Mild: the study participant was aware of sign or symptom (syndrome), but it did not interfere with his/her usual activities and/or was of no clinical consequence; Moderate: AE interfered with the usual activities of the study participant or it was of some clinical consequence; Severe: the study participant was unable to work normally or to carry out his/her usual activities, or the AE was of definite clinical consequence.</description>
        <time_frame>From Screening to Safety Follow-Up (Week 30)</time_frame>
        <population>The Safety Set (SS) consisted of all study participants who received at least 1 dose (full or partial) of IMP.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo (SS)</title>
            <description>Participants received matching placebo subcutaneous (SC) injections at Baseline, followed by Week 2, 4, 5, 6, 7, 8, 9, and 10 to maintain study blinding, forming the Safety Set (SS).</description>
          </group>
          <group group_id="O2">
            <title>Adalimumab (SS)</title>
            <description>Participants received one adalimumab 160 milligrams (mg) SC injection as loading dose started from Baseline, followed by adalimumab 80 mg SC injection at Week 2 and adalimumab 40 mg SC injections from Weeks 4 to 10. Participants also received matching Placebo SC injection at Week 4, 6, 8 and 10 to maintain study blinding, forming the SS.</description>
          </group>
          <group group_id="O3">
            <title>Bimekizumab (SS)</title>
            <description>Participants received one bimekizumab 640 mg SC injection as loading dose started from Baseline, followed by bimekizumab 320 mg SC injections at Weeks 2, 4, 6, 8 and 10. Participants also received matching Placebo SC injections at Week 5, 7 and 9 to maintain study blinding, forming the SS.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With at Least One Adverse Event Categorized by Maximum Severity During the Study</title>
          <description>An adverse event (AE) was any untoward medical occurrence in a patient or clinical investigation study participant administered a pharmaceutical product that did not necessarily have a causal relationship with this treatment. An AE could therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product. To record the intensity of an AE Investigator used the following criteria: Mild: the study participant was aware of sign or symptom (syndrome), but it did not interfere with his/her usual activities and/or was of no clinical consequence; Moderate: AE interfered with the usual activities of the study participant or it was of some clinical consequence; Severe: the study participant was unable to work normally or to carry out his/her usual activities, or the AE was of definite clinical consequence.</description>
          <population>The Safety Set (SS) consisted of all study participants who received at least 1 dose (full or partial) of IMP.</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="21"/>
                <count group_id="O2" value="21"/>
                <count group_id="O3" value="46"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Mild</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="47.6"/>
                    <measurement group_id="O2" value="66.7"/>
                    <measurement group_id="O3" value="63.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Moderate</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="33.3"/>
                    <measurement group_id="O2" value="42.9"/>
                    <measurement group_id="O3" value="39.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Severe</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.8"/>
                    <measurement group_id="O2" value="9.5"/>
                    <measurement group_id="O3" value="6.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants With at Least One Serious Adverse Event During the Study</title>
        <description>A serious adverse event (SAE) was any untoward medical occurrence that at any dose: Resulted in death, was life-threatening, required in patient hospitalization or prolongation of existing hospitalisation, was a congenital anomaly or birth defect, was an infection that required treatment parenteral antibiotics, other important medical events which based on medical or scientific judgement may have jeopardised the patients, or may have required medical or surgical intervention to prevent any of the above.</description>
        <time_frame>From Screening to Safety Follow-Up (Week 30)</time_frame>
        <population>The Safety Set (SS) consisted of all study participants who received at least 1 dose (full or partial) of IMP.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo (SS)</title>
            <description>Participants received matching placebo subcutaneous (SC) injections at Baseline, followed by Week 2, 4, 5, 6, 7, 8, 9, and 10 to maintain study blinding, forming the Safety Set (SS).</description>
          </group>
          <group group_id="O2">
            <title>Adalimumab (SS)</title>
            <description>Participants received one adalimumab 160 milligrams (mg) SC injection as loading dose started from Baseline, followed by adalimumab 80 mg SC injection at Week 2 and adalimumab 40 mg SC injections from Weeks 4 to 10. Participants also received matching Placebo SC injection at Week 4, 6, 8 and 10 to maintain study blinding, forming the SS.</description>
          </group>
          <group group_id="O3">
            <title>Bimekizumab (SS)</title>
            <description>Participants received one bimekizumab 640 mg SC injection as loading dose started from Baseline, followed by bimekizumab 320 mg SC injections at Weeks 2, 4, 6, 8 and 10. Participants also received matching Placebo SC injections at Week 5, 7 and 9 to maintain study blinding, forming the SS.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With at Least One Serious Adverse Event During the Study</title>
          <description>A serious adverse event (SAE) was any untoward medical occurrence that at any dose: Resulted in death, was life-threatening, required in patient hospitalization or prolongation of existing hospitalisation, was a congenital anomaly or birth defect, was an infection that required treatment parenteral antibiotics, other important medical events which based on medical or scientific judgement may have jeopardised the patients, or may have required medical or surgical intervention to prevent any of the above.</description>
          <population>The Safety Set (SS) consisted of all study participants who received at least 1 dose (full or partial) of IMP.</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="21"/>
                <count group_id="O2" value="21"/>
                <count group_id="O3" value="46"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9.5"/>
                    <measurement group_id="O2" value="4.8"/>
                    <measurement group_id="O3" value="4.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants With at Least One Serious Adverse Event Categorized by Severity During the Study</title>
        <description>A serious adverse event (SAE) was any untoward medical occurrence that at any dose: Resulted in death, was life-threatening, required in patient hospitalization or prolongation of existing hospitalization, was a congenital anomaly or birth defect, was an infection that required treatment parenteral antibiotics, other important medical events which based on medical or scientific judgement may have jeopardised the patients, or may have required medical or surgical intervention to prevent any of the above. To record the intensity of an AE Investigator used the following criteria: Mild: study participant was aware of sign or symptom (syndrome), but it did not interfere with his/her usual activities and/or was of no clinical consequence; Moderate: AE interfered with usual activities of study participant or it was of some clinical consequence; Severe: the study participant was unable to work normally or to carry out his/her usual activities, or the AE was of definite clinical consequence.</description>
        <time_frame>From Screening to Safety Follow-Up (Week 30)</time_frame>
        <population>The Safety Set (SS) consisted of all study participants who received at least 1 dose (full or partial) of IMP.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo (SS)</title>
            <description>Participants received matching placebo subcutaneous (SC) injections at Baseline, followed by Week 2, 4, 5, 6, 7, 8, 9, and 10 to maintain study blinding, forming the Safety Set (SS).</description>
          </group>
          <group group_id="O2">
            <title>Adalimumab (SS)</title>
            <description>Participants received one adalimumab 160 milligrams (mg) SC injection as loading dose started from Baseline, followed by adalimumab 80 mg SC injection at Week 2 and adalimumab 40 mg SC injections from Weeks 4 to 10. Participants also received matching Placebo SC injection at Week 4, 6, 8 and 10 to maintain study blinding, forming the SS.</description>
          </group>
          <group group_id="O3">
            <title>Bimekizumab (SS)</title>
            <description>Participants received one bimekizumab 640 mg SC injection as loading dose started from Baseline, followed by bimekizumab 320 mg SC injections at Weeks 2, 4, 6, 8 and 10. Participants also received matching Placebo SC injections at Week 5, 7 and 9 to maintain study blinding, forming the SS.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With at Least One Serious Adverse Event Categorized by Severity During the Study</title>
          <description>A serious adverse event (SAE) was any untoward medical occurrence that at any dose: Resulted in death, was life-threatening, required in patient hospitalization or prolongation of existing hospitalization, was a congenital anomaly or birth defect, was an infection that required treatment parenteral antibiotics, other important medical events which based on medical or scientific judgement may have jeopardised the patients, or may have required medical or surgical intervention to prevent any of the above. To record the intensity of an AE Investigator used the following criteria: Mild: study participant was aware of sign or symptom (syndrome), but it did not interfere with his/her usual activities and/or was of no clinical consequence; Moderate: AE interfered with usual activities of study participant or it was of some clinical consequence; Severe: the study participant was unable to work normally or to carry out his/her usual activities, or the AE was of definite clinical consequence.</description>
          <population>The Safety Set (SS) consisted of all study participants who received at least 1 dose (full or partial) of IMP.</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="21"/>
                <count group_id="O2" value="21"/>
                <count group_id="O3" value="46"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Mild</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="4.8"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Moderate</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.8"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Severe</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.8"/>
                    <measurement group_id="O2" value="4.8"/>
                    <measurement group_id="O3" value="4.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants That Withdrew Due to Adverse Events During the Study</title>
        <description>An adverse event (AE) was any untoward medical occurrence in a patient or clinical investigation study participant administered a pharmaceutical product that did not necessarily have a causal relationship with this treatment. An AE could therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.</description>
        <time_frame>From Screening to Safety Follow-Up (Week 30)</time_frame>
        <population>The Safety Set (SS) consisted of all study participants who received at least 1 dose (full or partial) of IMP.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo (SS)</title>
            <description>Participants received matching placebo subcutaneous (SC) injections at Baseline, followed by Week 2, 4, 5, 6, 7, 8, 9, and 10 to maintain study blinding, forming the Safety Set (SS).</description>
          </group>
          <group group_id="O2">
            <title>Adalimumab (SS)</title>
            <description>Participants received one adalimumab 160 milligrams (mg) SC injection as loading dose started from Baseline, followed by adalimumab 80 mg SC injection at Week 2 and adalimumab 40 mg SC injections from Weeks 4 to 10. Participants also received matching Placebo SC injection at Week 4, 6, 8 and 10 to maintain study blinding, forming the SS.</description>
          </group>
          <group group_id="O3">
            <title>Bimekizumab (SS)</title>
            <description>Participants received one bimekizumab 640 mg SC injection as loading dose started from Baseline, followed by bimekizumab 320 mg SC injections at Weeks 2, 4, 6, 8 and 10. Participants also received matching Placebo SC injections at Week 5, 7 and 9 to maintain study blinding, forming the SS.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants That Withdrew Due to Adverse Events During the Study</title>
          <description>An adverse event (AE) was any untoward medical occurrence in a patient or clinical investigation study participant administered a pharmaceutical product that did not necessarily have a causal relationship with this treatment. An AE could therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.</description>
          <population>The Safety Set (SS) consisted of all study participants who received at least 1 dose (full or partial) of IMP.</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="21"/>
                <count group_id="O2" value="21"/>
                <count group_id="O3" value="46"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="2.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline Until Safety Follow-up Visit in Vital Signs (Blood Pressure)</title>
        <description>Blood pressure was measured in millimeters of mercury (mmHg).</description>
        <time_frame>From Baseline to Safety Follow-Up (Week 30)</time_frame>
        <population>The Safety Set (SS) consisted of all study participants who received at least 1 dose (full or partial) of IMP. Here, number of participants analyzed included all participants who were evaluable for this Outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo (SS)</title>
            <description>Participants received matching placebo subcutaneous (SC) injections at Baseline, followed by Week 2, 4, 5, 6, 7, 8, 9, and 10 to maintain study blinding, forming the Safety Set (SS).</description>
          </group>
          <group group_id="O2">
            <title>Adalimumab (SS)</title>
            <description>Participants received one adalimumab 160 milligrams (mg) SC injection as loading dose started from Baseline, followed by adalimumab 80 mg SC injection at Week 2 and adalimumab 40 mg SC injections from Weeks 4 to 10. Participants also received matching Placebo SC injection at Week 4, 6, 8 and 10 to maintain study blinding, forming the SS.</description>
          </group>
          <group group_id="O3">
            <title>Bimekizumab (SS)</title>
            <description>Participants received one bimekizumab 640 mg SC injection as loading dose started from Baseline, followed by bimekizumab 320 mg SC injections at Weeks 2, 4, 6, 8 and 10. Participants also received matching Placebo SC injections at Week 5, 7 and 9 to maintain study blinding, forming the SS.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline Until Safety Follow-up Visit in Vital Signs (Blood Pressure)</title>
          <description>Blood pressure was measured in millimeters of mercury (mmHg).</description>
          <population>The Safety Set (SS) consisted of all study participants who received at least 1 dose (full or partial) of IMP. Here, number of participants analyzed included all participants who were evaluable for this Outcome measure.</population>
          <units>mmHg</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="18"/>
                <count group_id="O2" value="19"/>
                <count group_id="O3" value="38"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Systolic Blood Pressure</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-2.9" spread="14.8"/>
                    <measurement group_id="O2" value="4.5" spread="14.5"/>
                    <measurement group_id="O3" value="-0.4" spread="13.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Diastolic Blood Pressure</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.8" spread="8.4"/>
                    <measurement group_id="O2" value="-0.6" spread="9.1"/>
                    <measurement group_id="O3" value="-2.2" spread="11.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline Until Safety Follow-up Visit in Vital Signs (Pulse Rate)</title>
        <description>Pulse rate was measured in beats per minute (beats/min).</description>
        <time_frame>From Baseline to Safety Follow-Up (Week 30)</time_frame>
        <population>The Safety Set (SS) consisted of all study participants who received at least 1 dose (full or partial) of IMP. Here, number of participants analyzed included all participants who were evaluable for this Outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo (SS)</title>
            <description>Participants received matching placebo subcutaneous (SC) injections at Baseline, followed by Week 2, 4, 5, 6, 7, 8, 9, and 10 to maintain study blinding, forming the Safety Set (SS).</description>
          </group>
          <group group_id="O2">
            <title>Adalimumab (SS)</title>
            <description>Participants received one adalimumab 160 milligrams (mg) SC injection as loading dose started from Baseline, followed by adalimumab 80 mg SC injection at Week 2 and adalimumab 40 mg SC injections from Weeks 4 to 10. Participants also received matching Placebo SC injection at Week 4, 6, 8 and 10 to maintain study blinding, forming the SS.</description>
          </group>
          <group group_id="O3">
            <title>Bimekizumab (SS)</title>
            <description>Participants received one bimekizumab 640 mg SC injection as loading dose started from Baseline, followed by bimekizumab 320 mg SC injections at Weeks 2, 4, 6, 8 and 10. Participants also received matching Placebo SC injections at Week 5, 7 and 9 to maintain study blinding, forming the SS.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline Until Safety Follow-up Visit in Vital Signs (Pulse Rate)</title>
          <description>Pulse rate was measured in beats per minute (beats/min).</description>
          <population>The Safety Set (SS) consisted of all study participants who received at least 1 dose (full or partial) of IMP. Here, number of participants analyzed included all participants who were evaluable for this Outcome measure.</population>
          <units>beats/min</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="18"/>
                <count group_id="O2" value="19"/>
                <count group_id="O3" value="38"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.4" spread="10.2"/>
                    <measurement group_id="O2" value="-1.8" spread="10.8"/>
                    <measurement group_id="O3" value="-1.6" spread="10.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline Until Safety Follow-up Visit in Body Weight</title>
        <description>Body weight was measured in kilograms (kg).</description>
        <time_frame>From Baseline to Safety Follow-Up (Week 30)</time_frame>
        <population>The Safety Set (SS) consisted of all study participants who received at least 1 dose (full or partial) of IMP. Here, number of participants analyzed included all participants who were evaluable for this Outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo (SS)</title>
            <description>Participants received matching placebo subcutaneous (SC) injections at Baseline, followed by Week 2, 4, 5, 6, 7, 8, 9, and 10 to maintain study blinding, forming the Safety Set (SS).</description>
          </group>
          <group group_id="O2">
            <title>Adalimumab (SS)</title>
            <description>Participants received one adalimumab 160 milligrams (mg) SC injection as loading dose started from Baseline, followed by adalimumab 80 mg SC injection at Week 2 and adalimumab 40 mg SC injections from Weeks 4 to 10. Participants also received matching placebo SC injection at Week 4, 6, 8 and 10 to maintain study blinding, forming the SS.</description>
          </group>
          <group group_id="O3">
            <title>Bimekizumab (SS)</title>
            <description>Participants received one bimekizumab 640 mg SC injection as loading dose started from Baseline, followed by bimekizumab 320 mg SC injections at Weeks 2, 4, 6, 8 and 10. Participants also received matching placebo SC injections at Week 5, 7 and 9 to maintain study blinding, forming the SS.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline Until Safety Follow-up Visit in Body Weight</title>
          <description>Body weight was measured in kilograms (kg).</description>
          <population>The Safety Set (SS) consisted of all study participants who received at least 1 dose (full or partial) of IMP. Here, number of participants analyzed included all participants who were evaluable for this Outcome measure.</population>
          <units>kg</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="18"/>
                <count group_id="O2" value="19"/>
                <count group_id="O3" value="38"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.90" spread="7.39"/>
                    <measurement group_id="O2" value="1.82" spread="3.94"/>
                    <measurement group_id="O3" value="0.42" spread="6.89"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline Until Safety Follow-up Visit in ECG Parameters (ECG Mean Heart Rate)</title>
        <description>Electrocardiogram (ECG) Mean Heart Rate was measured in beats/min.</description>
        <time_frame>From Baseline to Safety Follow-Up (Week 30)</time_frame>
        <population>The Safety Set (SS) consisted of all study participants who received at least 1 dose (full or partial) of IMP. Here, number of participants analyzed included all participants who were evaluable for this Outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo (SS)</title>
            <description>Participants received matching placebo subcutaneous (SC) injections at Baseline, followed by Week 2, 4, 5, 6, 7, 8, 9, and 10 to maintain study blinding, forming the Safety Set (SS).</description>
          </group>
          <group group_id="O2">
            <title>Adalimumab (SS)</title>
            <description>Participants received one adalimumab 160 milligrams (mg) SC injection as loading dose started from Baseline, followed by adalimumab 80 mg SC injection at Week 2 and adalimumab 40 mg SC injections from Weeks 4 to 10. Participants also received matching placebo SC injection at Week 4, 6, 8 and 10 to maintain study blinding, forming the SS.</description>
          </group>
          <group group_id="O3">
            <title>Bimekizumab (SS)</title>
            <description>Participants received one bimekizumab 640 mg SC injection as loading dose started from Baseline, followed by bimekizumab 320 mg SC injections at Weeks 2, 4, 6, 8 and 10. Participants also received matching placebo SC injections at Week 5, 7 and 9 to maintain study blinding, forming the SS.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline Until Safety Follow-up Visit in ECG Parameters (ECG Mean Heart Rate)</title>
          <description>Electrocardiogram (ECG) Mean Heart Rate was measured in beats/min.</description>
          <population>The Safety Set (SS) consisted of all study participants who received at least 1 dose (full or partial) of IMP. Here, number of participants analyzed included all participants who were evaluable for this Outcome measure.</population>
          <units>beats/min</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="18"/>
                <count group_id="O2" value="15"/>
                <count group_id="O3" value="37"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-2.1" spread="12.4"/>
                    <measurement group_id="O2" value="-2.1" spread="11.1"/>
                    <measurement group_id="O3" value="1.5" spread="10.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline Until Safety Follow-up Visit in ECG Parameters (PR Interval, QRS Duration, QT Interval, QTcF Interval)</title>
        <description>PR Interval, QRS duration, QT interval and QT corrected for heart rate using Fridericia's correction (QTcF) Interval were measured in milliseconds (msec).</description>
        <time_frame>From Baseline to Safety Follow-Up (Week 30)</time_frame>
        <population>The Safety Set (SS) consisted of all study participants who received at least 1 dose (full or partial) of IMP. Here, number of participants analyzed included all participants who were evaluable for this Outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo (SS)</title>
            <description>Participants received matching placebo subcutaneous (SC) injections at Baseline, followed by Week 2, 4, 5, 6, 7, 8, 9, and 10 to maintain study blinding, forming the Safety Set (SS).</description>
          </group>
          <group group_id="O2">
            <title>Adalimumab (SS)</title>
            <description>Participants received one adalimumab 160 milligrams (mg) SC injection as loading dose started from Baseline, followed by adalimumab 80 mg SC injection at Week 2 and adalimumab 40 mg SC injections from Weeks 4 to 10. Participants also received matching placebo SC injection at Week 4, 6, 8 and 10 to maintain study blinding, forming the SS.</description>
          </group>
          <group group_id="O3">
            <title>Bimekizumab (SS)</title>
            <description>Participants received one bimekizumab 640 mg SC injection as loading dose started from Baseline, followed by bimekizumab 320 mg SC injections at Weeks 2, 4, 6, 8 and 10. Participants also received matching placebo SC injections at Week 5, 7 and 9 to maintain study blinding, forming the SS.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline Until Safety Follow-up Visit in ECG Parameters (PR Interval, QRS Duration, QT Interval, QTcF Interval)</title>
          <description>PR Interval, QRS duration, QT interval and QT corrected for heart rate using Fridericia's correction (QTcF) Interval were measured in milliseconds (msec).</description>
          <population>The Safety Set (SS) consisted of all study participants who received at least 1 dose (full or partial) of IMP. Here, number of participants analyzed included all participants who were evaluable for this Outcome measure.</population>
          <units>msec</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="18"/>
                <count group_id="O2" value="15"/>
                <count group_id="O3" value="37"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>PR Interval</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.8" spread="18.8"/>
                    <measurement group_id="O2" value="2.4" spread="10.5"/>
                    <measurement group_id="O3" value="3.6" spread="18.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>QRS duration</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.3" spread="7.1"/>
                    <measurement group_id="O2" value="0.2" spread="5.2"/>
                    <measurement group_id="O3" value="0.6" spread="7.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>QT interval</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.8" spread="20.2"/>
                    <measurement group_id="O2" value="4.2" spread="26.7"/>
                    <measurement group_id="O3" value="1.8" spread="27.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>QTcF Interval</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-11.7" spread="49.9"/>
                    <measurement group_id="O2" value="-0.3" spread="14.4"/>
                    <measurement group_id="O3" value="2.4" spread="12.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Erythrocytes)</title>
        <description>Erythrocytes was measured in number of red blood cells per liter (10^12/L).</description>
        <time_frame>From Baseline to Safety Follow-Up (Week 30)</time_frame>
        <population>The Safety Set (SS) consisted of all study participants who received at least 1 dose (full or partial) of IMP. Here, number of participants analyzed included all participants who were evaluable for this Outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo (SS)</title>
            <description>Participants received matching placebo subcutaneous (SC) injections at Baseline, followed by Week 2, 4, 5, 6, 7, 8, 9, and 10 to maintain study blinding, forming the Safety Set (SS).</description>
          </group>
          <group group_id="O2">
            <title>Adalimumab (SS)</title>
            <description>Participants received one adalimumab 160 milligrams (mg) SC injection as loading dose started from Baseline, followed by adalimumab 80 mg SC injection at Week 2 and adalimumab 40 mg SC injections from Weeks 4 to 10. Participants also received matching placebo SC injection at Week 4, 6, 8 and 10 to maintain study blinding, forming the SS.</description>
          </group>
          <group group_id="O3">
            <title>Bimekizumab (SS)</title>
            <description>Participants received one bimekizumab 640 mg SC injection as loading dose started from Baseline, followed by bimekizumab 320 mg SC injections at Weeks 2, 4, 6, 8 and 10. Participants also received matching placebo SC injections at Week 5, 7 and 9 to maintain study blinding, forming the SS.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Erythrocytes)</title>
          <description>Erythrocytes was measured in number of red blood cells per liter (10^12/L).</description>
          <population>The Safety Set (SS) consisted of all study participants who received at least 1 dose (full or partial) of IMP. Here, number of participants analyzed included all participants who were evaluable for this Outcome measure.</population>
          <units>10^12 red blood cells per liter</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="14"/>
                <count group_id="O2" value="18"/>
                <count group_id="O3" value="33"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.144" spread="0.349"/>
                    <measurement group_id="O2" value="-0.151" spread="0.416"/>
                    <measurement group_id="O3" value="-0.013" spread="0.274"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Hematocrit)</title>
        <description>Hematocrit was measured in volume percentage (%) of red blood cells in blood.</description>
        <time_frame>From Baseline to Safety Follow-Up (Week 30)</time_frame>
        <population>The Safety Set (SS) consisted of all study participants who received at least 1 dose (full or partial) of IMP. Here, number of participants analyzed included all participants who were evaluable for this Outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo (SS)</title>
            <description>Participants received matching placebo subcutaneous (SC) injections at Baseline, followed by Week 2, 4, 5, 6, 7, 8, 9, and 10 to maintain study blinding, forming the Safety Set (SS).</description>
          </group>
          <group group_id="O2">
            <title>Adalimumab (SS)</title>
            <description>Participants received one adalimumab 160 milligrams (mg) SC injection as loading dose started from Baseline, followed by adalimumab 80 mg SC injection at Week 2 and adalimumab 40 mg SC injections from Weeks 4 to 10. Participants also received matching placebo SC injection at Week 4, 6, 8 and 10 to maintain study blinding, forming the SS.</description>
          </group>
          <group group_id="O3">
            <title>Bimekizumab (SS)</title>
            <description>Participants received one bimekizumab 640 mg SC injection as loading dose started from Baseline, followed by bimekizumab 320 mg SC injections at Weeks 2, 4, 6, 8 and 10. Participants also received matching placebo SC injections at Week 5, 7 and 9 to maintain study blinding, forming the SS.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Hematocrit)</title>
          <description>Hematocrit was measured in volume percentage (%) of red blood cells in blood.</description>
          <population>The Safety Set (SS) consisted of all study participants who received at least 1 dose (full or partial) of IMP. Here, number of participants analyzed included all participants who were evaluable for this Outcome measure.</population>
          <units>volume % of red blood cells</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="14"/>
                <count group_id="O2" value="18"/>
                <count group_id="O3" value="33"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.01" spread="2.83"/>
                    <measurement group_id="O2" value="-0.81" spread="4.30"/>
                    <measurement group_id="O3" value="0.39" spread="2.69"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Hemoglobin, Erythrocytes Mean Corpuscular Hemoglobin (HGB) Concentration)</title>
        <description>Hemoglobin, erythrocytes mean corpuscular hemoglobin (HGB) concentration were measured in grams per liter (g/L).</description>
        <time_frame>From Baseline to Safety Follow-Up (Week 30)</time_frame>
        <population>The Safety Set (SS) consisted of all study participants who received at least 1 dose (full or partial) of IMP. Here, number of participants analyzed included all participants who were evaluable for this Outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo (SS)</title>
            <description>Participants received matching placebo subcutaneous (SC) injections at Baseline, followed by Week 2, 4, 5, 6, 7, 8, 9, and 10 to maintain study blinding, forming the Safety Set (SS).</description>
          </group>
          <group group_id="O2">
            <title>Adalimumab (SS)</title>
            <description>Participants received one adalimumab 160 milligrams (mg) SC injection as loading dose started from Baseline, followed by adalimumab 80 mg SC injection at Week 2 and adalimumab 40 mg SC injections from Weeks 4 to 10. Participants also received matching placebo SC injection at Week 4, 6, 8 and 10 to maintain study blinding, forming the SS.</description>
          </group>
          <group group_id="O3">
            <title>Bimekizumab (SS)</title>
            <description>Participants received one bimekizumab 640 mg SC injection as loading dose started from Baseline, followed by bimekizumab 320 mg SC injections at Weeks 2, 4, 6, 8 and 10. Participants also received matching placebo SC injections at Week 5, 7 and 9 to maintain study blinding, forming the SS.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Hemoglobin, Erythrocytes Mean Corpuscular Hemoglobin (HGB) Concentration)</title>
          <description>Hemoglobin, erythrocytes mean corpuscular hemoglobin (HGB) concentration were measured in grams per liter (g/L).</description>
          <population>The Safety Set (SS) consisted of all study participants who received at least 1 dose (full or partial) of IMP. Here, number of participants analyzed included all participants who were evaluable for this Outcome measure.</population>
          <units>g/L</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="14"/>
                <count group_id="O2" value="18"/>
                <count group_id="O3" value="33"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Hemoglobin</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.3" spread="11.6"/>
                    <measurement group_id="O2" value="-3.7" spread="11.6"/>
                    <measurement group_id="O3" value="1.1" spread="7.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Erythrocytes mean corpuscular HGB</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.4" spread="16.2"/>
                    <measurement group_id="O2" value="-2.6" spread="13.4"/>
                    <measurement group_id="O3" value="-0.2" spread="13.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Erythrocytes Mean Corpuscular Hemoglobin (HGB))</title>
        <description>Erythrocytes mean corpuscular hemoglobin (HGB) was measured in picograms (pg).</description>
        <time_frame>From Baseline to Safety Follow-Up (Week 30)</time_frame>
        <population>The Safety Set (SS) consisted of all study participants who received at least 1 dose (full or partial) of IMP. Here, number of participants analyzed included all participants who were evaluable for this Outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo (SS)</title>
            <description>Participants received matching placebo subcutaneous (SC) injections at Baseline, followed by Week 2, 4, 5, 6, 7, 8, 9, and 10 to maintain study blinding, forming the Safety Set (SS).</description>
          </group>
          <group group_id="O2">
            <title>Adalimumab (SS)</title>
            <description>Participants received one adalimumab 160 milligrams (mg) SC injection as loading dose started from Baseline, followed by adalimumab 80 mg SC injection at Week 2 and adalimumab 40 mg SC injections from Weeks 4 to 10. Participants also received matching placebo SC injection at Week 4, 6, 8 and 10 to maintain study blinding, forming the SS.</description>
          </group>
          <group group_id="O3">
            <title>Bimekizumab (SS)</title>
            <description>Participants received one bimekizumab 640 mg SC injection as loading dose started from Baseline, followed by bimekizumab 320 mg SC injections at Weeks 2, 4, 6, 8 and 10. Participants also received matching placebo SC injections at Week 5, 7 and 9 to maintain study blinding, forming the SS.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Erythrocytes Mean Corpuscular Hemoglobin (HGB))</title>
          <description>Erythrocytes mean corpuscular hemoglobin (HGB) was measured in picograms (pg).</description>
          <population>The Safety Set (SS) consisted of all study participants who received at least 1 dose (full or partial) of IMP. Here, number of participants analyzed included all participants who were evaluable for this Outcome measure.</population>
          <units>picograms (pg)</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="14"/>
                <count group_id="O2" value="18"/>
                <count group_id="O3" value="33"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.29" spread="0.76"/>
                    <measurement group_id="O2" value="0.21" spread="0.78"/>
                    <measurement group_id="O3" value="0.30" spread="0.99"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Erythrocytes Mean Corpuscular Volume)</title>
        <description>Erythrocytes mean corpuscular volume was measured in femtoliters (fL).</description>
        <time_frame>From Baseline to Safety Follow-Up (Week 30)</time_frame>
        <population>The Safety Set (SS) consisted of all study participants who received at least 1 dose (full or partial) of IMP. Here, number of participants analyzed included all participants who were evaluable for this Outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo (SS)</title>
            <description>Participants received matching placebo subcutaneous (SC) injections at Baseline, followed by Week 2, 4, 5, 6, 7, 8, 9, and 10 to maintain study blinding, forming the Safety Set (SS).</description>
          </group>
          <group group_id="O2">
            <title>Adalimumab (SS)</title>
            <description>Participants received one adalimumab 160 milligrams (mg) SC injection as loading dose started from Baseline, followed by adalimumab 80 mg SC injection at Week 2 and adalimumab 40 mg SC injections from Weeks 4 to 10. Participants also received matching placebo SC injection at Week 4, 6, 8 and 10 to maintain study blinding, forming the SS.</description>
          </group>
          <group group_id="O3">
            <title>Bimekizumab (SS)</title>
            <description>Participants received one bimekizumab 640 mg SC injection as loading dose started from Baseline, followed by bimekizumab 320 mg SC injections at Weeks 2, 4, 6, 8 and 10. Participants also received matching placebo SC injections at Week 5, 7 and 9 to maintain study blinding, forming the SS.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Erythrocytes Mean Corpuscular Volume)</title>
          <description>Erythrocytes mean corpuscular volume was measured in femtoliters (fL).</description>
          <population>The Safety Set (SS) consisted of all study participants who received at least 1 dose (full or partial) of IMP. Here, number of participants analyzed included all participants who were evaluable for this Outcome measure.</population>
          <units>femtoliters (fL)</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="14"/>
                <count group_id="O2" value="18"/>
                <count group_id="O3" value="33"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.49" spread="2.95"/>
                    <measurement group_id="O2" value="1.36" spread="3.21"/>
                    <measurement group_id="O3" value="1.04" spread="4.03"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Platelets)</title>
        <description>Platelets was measured in number of platelets per liter (10^9/L).</description>
        <time_frame>From Baseline to Safety Follow-Up (Week 30)</time_frame>
        <population>The Safety Set (SS) consisted of all study participants who received at least 1 dose (full or partial) of IMP. Here, number of participants analyzed included all participants who were evaluable for this Outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo (SS)</title>
            <description>Participants received matching placebo subcutaneous (SC) injections at Baseline, followed by Week 2, 4, 5, 6, 7, 8, 9, and 10 to maintain study blinding, forming the Safety Set (SS).</description>
          </group>
          <group group_id="O2">
            <title>Adalimumab (SS)</title>
            <description>Participants received one adalimumab 160 milligrams (mg) SC injection as loading dose started from Baseline, followed by adalimumab 80 mg SC injection at Week 2 and adalimumab 40 mg SC injections from Weeks 4 to 10. Participants also received matching placebo SC injection at Week 4, 6, 8 and 10 to maintain study blinding, forming the SS.</description>
          </group>
          <group group_id="O3">
            <title>Bimekizumab (SS)</title>
            <description>Participants received one bimekizumab 640 mg SC injection as loading dose started from Baseline, followed by bimekizumab 320 mg SC injections at Weeks 2, 4, 6, 8 and 10. Participants also received matching placebo SC injections at Week 5, 7 and 9 to maintain study blinding, forming the SS.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Platelets)</title>
          <description>Platelets was measured in number of platelets per liter (10^9/L).</description>
          <population>The Safety Set (SS) consisted of all study participants who received at least 1 dose (full or partial) of IMP. Here, number of participants analyzed included all participants who were evaluable for this Outcome measure.</population>
          <units>10^9 platelets per liter</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="14"/>
                <count group_id="O2" value="18"/>
                <count group_id="O3" value="33"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-17.4" spread="38.7"/>
                    <measurement group_id="O2" value="2.3" spread="61.6"/>
                    <measurement group_id="O3" value="-19.2" spread="51.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Leukocytes, Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils)</title>
        <description>Leukocytes, basophils, eosinophils, lymphocytes, monocytes and neutrophils were measured in number of white blood cells per liter (10^9/L).</description>
        <time_frame>From Baseline to Safety Follow-Up (Week 30)</time_frame>
        <population>The Safety Set (SS) consisted of all study participants who received at least 1 dose (full or partial) of IMP. Here, number of participants analyzed included all participants who were evaluable for this Outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo (SS)</title>
            <description>Participants received matching placebo subcutaneous (SC) injections at Baseline, followed by Week 2, 4, 5, 6, 7, 8, 9, and 10 to maintain study blinding, forming the Safety Set (SS).</description>
          </group>
          <group group_id="O2">
            <title>Adalimumab (SS)</title>
            <description>Participants received one adalimumab 160 milligrams (mg) SC injection as loading dose started from Baseline, followed by adalimumab 80 mg SC injection at Week 2 and adalimumab 40 mg SC injections from Weeks 4 to 10. Participants also received matching placebo SC injection at Week 4, 6, 8 and 10 to maintain study blinding, forming the SS.</description>
          </group>
          <group group_id="O3">
            <title>Bimekizumab (SS)</title>
            <description>Participants received one bimekizumab 640 mg SC injection as loading dose started from Baseline, followed by bimekizumab 320 mg SC injections at Weeks 2, 4, 6, 8 and 10. Participants also received matching placebo SC injections at Week 5, 7 and 9 to maintain study blinding, forming the SS.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Leukocytes, Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils)</title>
          <description>Leukocytes, basophils, eosinophils, lymphocytes, monocytes and neutrophils were measured in number of white blood cells per liter (10^9/L).</description>
          <population>The Safety Set (SS) consisted of all study participants who received at least 1 dose (full or partial) of IMP. Here, number of participants analyzed included all participants who were evaluable for this Outcome measure.</population>
          <units>10^9 white blood cells per liter</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="14"/>
                <count group_id="O2" value="18"/>
                <count group_id="O3" value="33"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Leukocytes</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.281" spread="2.621"/>
                    <measurement group_id="O2" value="-0.114" spread="2.997"/>
                    <measurement group_id="O3" value="-0.122" spread="2.308"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Basophils</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.009" spread="0.026"/>
                    <measurement group_id="O2" value="0.033" spread="0.077"/>
                    <measurement group_id="O3" value="0.015" spread="0.048"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Eosinophils</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.007" spread="0.077"/>
                    <measurement group_id="O2" value="-0.012" spread="0.100"/>
                    <measurement group_id="O3" value="0.002" spread="0.056"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Lymphocytes</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.029" spread="0.812"/>
                    <measurement group_id="O2" value="0.241" spread="0.682"/>
                    <measurement group_id="O3" value="0.038" spread="0.570"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Monocytes</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.072" spread="0.420"/>
                    <measurement group_id="O2" value="-0.032" spread="0.322"/>
                    <measurement group_id="O3" value="0.060" spread="0.192"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Neutrophils</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.396" spread="2.076"/>
                    <measurement group_id="O2" value="-0.341" spread="2.460"/>
                    <measurement group_id="O3" value="-0.240" spread="2.234"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Basophils/Leukocytes, Eosinophils/Leukocytes, Lymphocytes/Leukocytes, Monocytes/Leukocytes, Neutrophils/Leukocytes)</title>
        <description>Basophils/leukocytes, eosinophils/leukocytes, lymphocytes/leukocytes, monocytes/leukocytes and neutrophils/leukocytes were measured in percentages (%).</description>
        <time_frame>From Baseline to Safety Follow-Up (Week 30)</time_frame>
        <population>The Safety Set (SS) consisted of all study participants who received at least 1 dose (full or partial) of IMP. Here, number of participants analyzed included all participants who were evaluable for this Outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo (SS)</title>
            <description>Participants received matching placebo subcutaneous (SC) injections at Baseline, followed by Week 2, 4, 5, 6, 7, 8, 9, and 10 to maintain study blinding, forming the Safety Set (SS).</description>
          </group>
          <group group_id="O2">
            <title>Adalimumab (SS)</title>
            <description>Participants received one adalimumab 160 milligrams (mg) SC injection as loading dose started from Baseline, followed by adalimumab 80 mg SC injection at Week 2 and adalimumab 40 mg SC injections from Weeks 4 to 10. Participants also received matching placebo SC injection at Week 4, 6, 8 and 10 to maintain study blinding, forming the SS.</description>
          </group>
          <group group_id="O3">
            <title>Bimekizumab (SS)</title>
            <description>Participants received one bimekizumab 640 mg SC injection as loading dose started from Baseline, followed by bimekizumab 320 mg SC injections at Weeks 2, 4, 6, 8 and 10. Participants also received matching placebo SC injections at Week 5, 7 and 9 to maintain study blinding, forming the SS.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Basophils/Leukocytes, Eosinophils/Leukocytes, Lymphocytes/Leukocytes, Monocytes/Leukocytes, Neutrophils/Leukocytes)</title>
          <description>Basophils/leukocytes, eosinophils/leukocytes, lymphocytes/leukocytes, monocytes/leukocytes and neutrophils/leukocytes were measured in percentages (%).</description>
          <population>The Safety Set (SS) consisted of all study participants who received at least 1 dose (full or partial) of IMP. Here, number of participants analyzed included all participants who were evaluable for this Outcome measure.</population>
          <units>% of white blood cells per leukocytes</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="14"/>
                <count group_id="O2" value="18"/>
                <count group_id="O3" value="33"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Basophils/leukocytes</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.13" spread="0.23"/>
                    <measurement group_id="O2" value="0.42" spread="0.93"/>
                    <measurement group_id="O3" value="0.13" spread="0.65"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Eosinophils/leukocytes</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.12" spread="1.92"/>
                    <measurement group_id="O2" value="-0.03" spread="1.09"/>
                    <measurement group_id="O3" value="0.12" spread="1.12"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Lymphocytes/leukocytes</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.43" spread="5.47"/>
                    <measurement group_id="O2" value="2.04" spread="6.73"/>
                    <measurement group_id="O3" value="2.04" spread="8.07"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Monocytes/leukocytes</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.49" spread="4.35"/>
                    <measurement group_id="O2" value="-0.20" spread="2.79"/>
                    <measurement group_id="O3" value="1.00" spread="2.17"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Neutrophils/leukocytes</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.93" spread="6.84"/>
                    <measurement group_id="O2" value="-2.24" spread="7.50"/>
                    <measurement group_id="O3" value="-3.29" spread="9.55"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Bicarbonate, Chloride, Potassium, Sodium, Calcium, Magnesium, Urea Nitrogen, Cholesterol, Glucose)</title>
        <description>Bicarbonate, chloride, potassium, sodium, calcium, magnesium, urea nitrogen, cholesterol and glucose were measured in millimoles per liter (mmol/L).</description>
        <time_frame>From Baseline to Safety Follow-Up (Week 30)</time_frame>
        <population>The Safety Set (SS) consisted of all study participants who received at least 1 dose (full or partial) of IMP. Here, number of participants analyzed included all participants who were evaluable for this Outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo (SS)</title>
            <description>Participants received matching placebo subcutaneous (SC) injections at Baseline, followed by Week 2, 4, 5, 6, 7, 8, 9, and 10 to maintain study blinding, forming the Safety Set (SS).</description>
          </group>
          <group group_id="O2">
            <title>Adalimumab (SS)</title>
            <description>Participants received one adalimumab 160 milligrams (mg) SC injection as loading dose started from Baseline, followed by adalimumab 80 mg SC injection at Week 2 and adalimumab 40 mg SC injections from Weeks 4 to 10. Participants also received matching placebo SC injection at Week 4, 6, 8 and 10 to maintain study blinding, forming the SS.</description>
          </group>
          <group group_id="O3">
            <title>Bimekizumab (SS)</title>
            <description>Participants received one bimekizumab 640 mg SC injection as loading dose started from Baseline, followed by bimekizumab 320 mg SC injections at Weeks 2, 4, 6, 8 and 10. Participants also received matching placebo SC injections at Week 5, 7 and 9 to maintain study blinding, forming the SS.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Bicarbonate, Chloride, Potassium, Sodium, Calcium, Magnesium, Urea Nitrogen, Cholesterol, Glucose)</title>
          <description>Bicarbonate, chloride, potassium, sodium, calcium, magnesium, urea nitrogen, cholesterol and glucose were measured in millimoles per liter (mmol/L).</description>
          <population>The Safety Set (SS) consisted of all study participants who received at least 1 dose (full or partial) of IMP. Here, number of participants analyzed included all participants who were evaluable for this Outcome measure.</population>
          <units>mmol/L</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="15"/>
                <count group_id="O2" value="19"/>
                <count group_id="O3" value="36"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Bicarbonate</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.1" spread="2.1"/>
                    <measurement group_id="O2" value="0.7" spread="2.8"/>
                    <measurement group_id="O3" value="0.6" spread="2.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Chloride</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.9" spread="1.5"/>
                    <measurement group_id="O2" value="1.3" spread="2.4"/>
                    <measurement group_id="O3" value="0.1" spread="2.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Potassium</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.13" spread="0.79"/>
                    <measurement group_id="O2" value="-0.09" spread="0.37"/>
                    <measurement group_id="O3" value="0.03" spread="0.41"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Sodium</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.4" spread="1.5"/>
                    <measurement group_id="O2" value="0.4" spread="1.6"/>
                    <measurement group_id="O3" value="0.1" spread="2.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Calcium</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.027" spread="0.065"/>
                    <measurement group_id="O2" value="0.008" spread="0.144"/>
                    <measurement group_id="O3" value="0.067" spread="0.095"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Magnesium</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.029" spread="0.087"/>
                    <measurement group_id="O2" value="-0.027" spread="0.052"/>
                    <measurement group_id="O3" value="-0.009" spread="0.081"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Urea nitrogen</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.00" spread="1.46"/>
                    <measurement group_id="O2" value="-0.43" spread="1.37"/>
                    <measurement group_id="O3" value="0.29" spread="1.79"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Cholesterol</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.311" spread="0.667"/>
                    <measurement group_id="O2" value="-0.177" spread="0.634"/>
                    <measurement group_id="O3" value="0.157" spread="0.585"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Glucose</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.049" spread="1.835"/>
                    <measurement group_id="O2" value="0.436" spread="2.990"/>
                    <measurement group_id="O3" value="0.439" spread="2.212"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Creatinine, Bilirubin, Urate)</title>
        <description>Creatinine, bilirubin, and urate were measured in micromols per liter (μmol/L).</description>
        <time_frame>From Baseline to Safety Follow-Up (Week 30)</time_frame>
        <population>The Safety Set (SS) consisted of all study participants who received at least 1 dose (full or partial) of IMP. Here, number of participants analyzed included all participants who were evaluable for this Outcome measure and 'n' (Number analyzed) signifies participants who were evaluable for each parameter.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo (SS)</title>
            <description>Participants received matching placebo subcutaneous (SC) injections at Baseline, followed by Week 2, 4, 5, 6, 7, 8, 9, and 10 to maintain study blinding, forming the Safety Set (SS).</description>
          </group>
          <group group_id="O2">
            <title>Adalimumab (SS)</title>
            <description>Participants received one adalimumab 160 milligrams (mg) SC injection as loading dose started from Baseline, followed by adalimumab 80 mg SC injection at Week 2 and adalimumab 40 mg SC injections from Weeks 4 to 10. Participants also received matching placebo SC injection at Week 4, 6, 8 and 10 to maintain study blinding, forming the SS.</description>
          </group>
          <group group_id="O3">
            <title>Bimekizumab (SS)</title>
            <description>Participants received one bimekizumab 640 mg SC injection as loading dose started from Baseline, followed by bimekizumab 320 mg SC injections at Weeks 2, 4, 6, 8 and 10. Participants also received matching placebo SC injections at Week 5, 7 and 9 to maintain study blinding, forming the SS.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Creatinine, Bilirubin, Urate)</title>
          <description>Creatinine, bilirubin, and urate were measured in micromols per liter (μmol/L).</description>
          <population>The Safety Set (SS) consisted of all study participants who received at least 1 dose (full or partial) of IMP. Here, number of participants analyzed included all participants who were evaluable for this Outcome measure and 'n' (Number analyzed) signifies participants who were evaluable for each parameter.</population>
          <units>μmol/L</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="15"/>
                <count group_id="O2" value="19"/>
                <count group_id="O3" value="36"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Creatinine</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="15"/>
                    <count group_id="O2" value="19"/>
                    <count group_id="O3" value="36"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.73" spread="9.92"/>
                    <measurement group_id="O2" value="-1.72" spread="9.04"/>
                    <measurement group_id="O3" value="3.84" spread="9.22"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Bilirubin</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="15"/>
                    <count group_id="O2" value="19"/>
                    <count group_id="O3" value="34"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.17" spread="3.48"/>
                    <measurement group_id="O2" value="-1.38" spread="3.04"/>
                    <measurement group_id="O3" value="0.18" spread="4.35"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Urate</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="15"/>
                    <count group_id="O2" value="19"/>
                    <count group_id="O3" value="34"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8.7" spread="52.2"/>
                    <measurement group_id="O2" value="-8.9" spread="50.5"/>
                    <measurement group_id="O3" value="1.5" spread="43.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (C Reactive Protein High Sensitivity)</title>
        <description>C reactive protein high sensitivity was measured in milligrams per liter (mg/L).</description>
        <time_frame>From Baseline to Safety Follow-Up (Week 30)</time_frame>
        <population>The Safety Set (SS) consisted of all study participants who received at least 1 dose (full or partial) of IMP. Here, number of participants analyzed included all participants who were evaluable for this Outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo (SS)</title>
            <description>Participants received matching placebo subcutaneous (SC) injections at Baseline, followed by Week 2, 4, 5, 6, 7, 8, 9, and 10 to maintain study blinding, forming the Safety Set (SS).</description>
          </group>
          <group group_id="O2">
            <title>Adalimumab (SS)</title>
            <description>Participants received one adalimumab 160 milligrams (mg) SC injection as loading dose started from Baseline, followed by adalimumab 80 mg SC injection at Week 2 and adalimumab 40 mg SC injections from Weeks 4 to 10. Participants also received matching placebo SC injection at Week 4, 6, 8 and 10 to maintain study blinding, forming the SS.</description>
          </group>
          <group group_id="O3">
            <title>Bimekizumab (SS)</title>
            <description>Participants received one bimekizumab 640 mg SC injection as loading dose started from Baseline, followed by bimekizumab 320 mg SC injections at Weeks 2, 4, 6, 8 and 10. Participants also received matching placebo SC injections at Week 5, 7 and 9 to maintain study blinding, forming the SS.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (C Reactive Protein High Sensitivity)</title>
          <description>C reactive protein high sensitivity was measured in milligrams per liter (mg/L).</description>
          <population>The Safety Set (SS) consisted of all study participants who received at least 1 dose (full or partial) of IMP. Here, number of participants analyzed included all participants who were evaluable for this Outcome measure.</population>
          <units>mg/L</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="15"/>
                <count group_id="O2" value="19"/>
                <count group_id="O3" value="36"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-2.801" spread="16.851"/>
                    <measurement group_id="O2" value="-4.865" spread="21.863"/>
                    <measurement group_id="O3" value="-2.810" spread="10.853"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase, Lactate Dehydrogenase)</title>
        <description>Alanine aminotransferase, alkaline phosphatase, aspartate aminotransferase, gamma glutamyl transferase, lactate dehydrogenase were measured in units per liter (U/L).</description>
        <time_frame>From Baseline to Safety Follow-Up (Week 30)</time_frame>
        <population>The Safety Set (SS) consisted of all study participants who received at least 1 dose (full or partial) of IMP. Here, number of participants analyzed included all participants who were evaluable for this Outcome measure and 'n' (Number analyzed) signifies participants who were evaluable for each parameter.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo (SS)</title>
            <description>Participants received matching placebo subcutaneous (SC) injections at Baseline, followed by Week 2, 4, 5, 6, 7, 8, 9, and 10 to maintain study blinding, forming the Safety Set (SS).</description>
          </group>
          <group group_id="O2">
            <title>Adalimumab (SS)</title>
            <description>Participants received one adalimumab 160 milligrams (mg) SC injection as loading dose started from Baseline, followed by adalimumab 80 mg SC injection at Week 2 and adalimumab 40 mg SC injections from Weeks 4 to 10. Participants also received matching placebo SC injection at Week 4, 6, 8 and 10 to maintain study blinding, forming the SS.</description>
          </group>
          <group group_id="O3">
            <title>Bimekizumab (SS)</title>
            <description>Participants received one bimekizumab 640 mg SC injection as loading dose started from Baseline, followed by bimekizumab 320 mg SC injections at Weeks 2, 4, 6, 8 and 10. Participants also received matching placebo SC injections at Week 5, 7 and 9 to maintain study blinding, forming the SS.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase, Lactate Dehydrogenase)</title>
          <description>Alanine aminotransferase, alkaline phosphatase, aspartate aminotransferase, gamma glutamyl transferase, lactate dehydrogenase were measured in units per liter (U/L).</description>
          <population>The Safety Set (SS) consisted of all study participants who received at least 1 dose (full or partial) of IMP. Here, number of participants analyzed included all participants who were evaluable for this Outcome measure and 'n' (Number analyzed) signifies participants who were evaluable for each parameter.</population>
          <units>U/L</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="15"/>
                <count group_id="O2" value="19"/>
                <count group_id="O3" value="36"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Alanine aminotransferase</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="15"/>
                    <count group_id="O2" value="19"/>
                    <count group_id="O3" value="34"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-3.3" spread="8.3"/>
                    <measurement group_id="O2" value="-3.6" spread="9.8"/>
                    <measurement group_id="O3" value="3.6" spread="23.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Alkaline phosphatase</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="15"/>
                    <count group_id="O2" value="19"/>
                    <count group_id="O3" value="36"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-2.0" spread="12.2"/>
                    <measurement group_id="O2" value="-2.4" spread="13.5"/>
                    <measurement group_id="O3" value="-3.4" spread="11.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Aspartate aminotransferase</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="15"/>
                    <count group_id="O2" value="19"/>
                    <count group_id="O3" value="36"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.6" spread="3.6"/>
                    <measurement group_id="O2" value="-1.0" spread="5.8"/>
                    <measurement group_id="O3" value="2.0" spread="13.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Gamma glutamyl transferase</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="15"/>
                    <count group_id="O2" value="19"/>
                    <count group_id="O3" value="36"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-2.0" spread="9.5"/>
                    <measurement group_id="O2" value="1.8" spread="14.2"/>
                    <measurement group_id="O3" value="2.3" spread="10.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Lactate dehydrogenase</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="15"/>
                    <count group_id="O2" value="19"/>
                    <count group_id="O3" value="36"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-17.0" spread="29.9"/>
                    <measurement group_id="O2" value="-16.3" spread="35.6"/>
                    <measurement group_id="O3" value="-12.8" spread="61.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline Until Safety Follow-up Visit in Urinalysis Parameters (Urine pH)</title>
        <description>Urine pH was measured on a pH scale.</description>
        <time_frame>From Baseline to Safety Follow-Up (Week 30)</time_frame>
        <population>The Safety Set (SS) consisted of all study participants who received at least 1 dose (full or partial) of IMP. Here, number of participants analyzed included all participants who were evaluable for this Outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo (SS)</title>
            <description>Participants received matching placebo subcutaneous (SC) injections at Baseline, followed by Week 2, 4, 5, 6, 7, 8, 9, and 10 to maintain study blinding, forming the Safety Set (SS).</description>
          </group>
          <group group_id="O2">
            <title>Adalimumab (SS)</title>
            <description>Participants received one adalimumab 160 milligrams (mg) SC injection as loading dose started from Baseline, followed by adalimumab 80 mg SC injection at Week 2 and adalimumab 40 mg SC injections from Weeks 4 to 10. Participants also received matching placebo SC injection at Week 4, 6, 8 and 10 to maintain study blinding, forming the SS.</description>
          </group>
          <group group_id="O3">
            <title>Bimekizumab (SS)</title>
            <description>Participants received one bimekizumab 640 mg SC injection as loading dose started from Baseline, followed by bimekizumab 320 mg SC injections at Weeks 2, 4, 6, 8 and 10. Participants also received matching placebo SC injections at Week 5, 7 and 9 to maintain study blinding, forming the SS.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline Until Safety Follow-up Visit in Urinalysis Parameters (Urine pH)</title>
          <description>Urine pH was measured on a pH scale.</description>
          <population>The Safety Set (SS) consisted of all study participants who received at least 1 dose (full or partial) of IMP. Here, number of participants analyzed included all participants who were evaluable for this Outcome measure.</population>
          <units>pH</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="14"/>
                <count group_id="O2" value="16"/>
                <count group_id="O3" value="31"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.43" spread="0.98"/>
                    <measurement group_id="O2" value="-0.25" spread="0.55"/>
                    <measurement group_id="O3" value="-0.03" spread="0.69"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline Until Safety Follow-up Visit in Urinalysis Parameters (Urine Albumin)</title>
        <description>Urine albumin was measured in milligrams per liter (mg/L).</description>
        <time_frame>From Baseline to Safety Follow-Up (Week 30)</time_frame>
        <population>The Safety Set (SS) consisted of all study participants who received at least 1 dose (full or partial) of IMP. Here, number of participants analyzed included all participants who were evaluable for this Outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo (SS)</title>
            <description>Participants received matching placebo subcutaneous (SC) injections at Baseline, followed by Week 2, 4, 5, 6, 7, 8, 9, and 10 to maintain study blinding, forming the Safety Set (SS).</description>
          </group>
          <group group_id="O2">
            <title>Adalimumab (SS)</title>
            <description>Participants received one adalimumab 160 milligrams (mg) SC injection as loading dose started from Baseline, followed by adalimumab 80 mg SC injection at Week 2 and adalimumab 40 mg SC injections from Weeks 4 to 10. Participants also received matching placebo SC injection at Week 4, 6, 8 and 10 to maintain study blinding, forming the SS.</description>
          </group>
          <group group_id="O3">
            <title>Bimekizumab (SS)</title>
            <description>Participants received one bimekizumab 640 mg SC injection as loading dose started from Baseline, followed by bimekizumab 320 mg SC injections at Weeks 2, 4, 6, 8 and 10. Participants also received matching placebo SC injections at Week 5, 7 and 9 to maintain study blinding, forming the SS.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline Until Safety Follow-up Visit in Urinalysis Parameters (Urine Albumin)</title>
          <description>Urine albumin was measured in milligrams per liter (mg/L).</description>
          <population>The Safety Set (SS) consisted of all study participants who received at least 1 dose (full or partial) of IMP. Here, number of participants analyzed included all participants who were evaluable for this Outcome measure.</population>
          <units>mg/L</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="15"/>
                <count group_id="O2" value="18"/>
                <count group_id="O3" value="34"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="50.80" spread="211.30"/>
                    <measurement group_id="O2" value="-28.25" spread="121.29"/>
                    <measurement group_id="O3" value="0.49" spread="19.92"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants Who Shifted From Baseline Until Safety Follow-up Visit in Urinalysis Parameters (Urine Glucose)</title>
        <time_frame>From Baseline to Safety Follow-Up (Week 30)</time_frame>
        <population>The Safety Set (SS) consisted of all study participants who received at least 1 dose (full or partial) of IMP. Here, number of participants analyzed included all the participants with non-missing urinalysis results at Baseline and at Week 30 for this outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo (SS)</title>
            <description>Participants received matching placebo subcutaneous (SC) injections at Baseline, followed by Week 2, 4, 5, 6, 7, 8, 9, and 10 to maintain study blinding, forming the Safety Set (SS).</description>
          </group>
          <group group_id="O2">
            <title>Adalimumab (SS)</title>
            <description>Participants received one adalimumab 160 milligrams (mg) SC injection as loading dose started from Baseline, followed by adalimumab 80 mg SC injection at Week 2 and adalimumab 40 mg SC injections from Weeks 4 to 10. Participants also received matching placebo SC injection at Week 4, 6, 8 and 10 to maintain study blinding, forming the SS.</description>
          </group>
          <group group_id="O3">
            <title>Bimekizumab (SS)</title>
            <description>Participants received one bimekizumab 640 mg SC injection as loading dose started from Baseline, followed by bimekizumab 320 mg SC injections at Weeks 2, 4, 6, 8 and 10. Participants also received matching placebo SC injections at Week 5, 7 and 9 to maintain study blinding, forming the SS.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants Who Shifted From Baseline Until Safety Follow-up Visit in Urinalysis Parameters (Urine Glucose)</title>
          <population>The Safety Set (SS) consisted of all study participants who received at least 1 dose (full or partial) of IMP. Here, number of participants analyzed included all the participants with non-missing urinalysis results at Baseline and at Week 30 for this outcome measure.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="14"/>
                <count group_id="O2" value="16"/>
                <count group_id="O3" value="31"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline Low - Week 30 Low</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Baseline Low - Week 30 Normal</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Baseline Low - Week 30 High</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Baseline Normal - Week 30 Low</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Baseline Normal - Week 30 Normal</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="12"/>
                    <measurement group_id="O2" value="14"/>
                    <measurement group_id="O3" value="28"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Baseline Normal - Week 30 High</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Baseline High - Week 30 Low</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Baseline High - Week 30 Normal</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Baseline High - Week 30 High</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants Who Shifted From Baseline Until Safety Follow-up Visit in Urinalysis Parameters (Urine Leukocyte Esterase)</title>
        <time_frame>From Baseline to Safety Follow-Up (Week 30)</time_frame>
        <population>The Safety Set (SS) consisted of all study participants who received at least 1 dose (full or partial) of IMP. Here, number of participants analyzed included all the participants with non-missing urinalysis results at Baseline and at Week 30 for this outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo (SS)</title>
            <description>Participants received matching placebo subcutaneous (SC) injections at Baseline, followed by Week 2, 4, 5, 6, 7, 8, 9, and 10 to maintain study blinding, forming the Safety Set (SS).</description>
          </group>
          <group group_id="O2">
            <title>Adalimumab (SS)</title>
            <description>Participants received one adalimumab 160 milligrams (mg) SC injection as loading dose started from Baseline, followed by adalimumab 80 mg SC injection at Week 2 and adalimumab 40 mg SC injections from Weeks 4 to 10. Participants also received matching placebo SC injection at Week 4, 6, 8 and 10 to maintain study blinding, forming the SS.</description>
          </group>
          <group group_id="O3">
            <title>Bimekizumab (SS)</title>
            <description>Participants received one bimekizumab 640 mg SC injection as loading dose started from Baseline, followed by bimekizumab 320 mg SC injections at Weeks 2, 4, 6, 8 and 10. Participants also received matching placebo SC injections at Week 5, 7 and 9 to maintain study blinding, forming the SS.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants Who Shifted From Baseline Until Safety Follow-up Visit in Urinalysis Parameters (Urine Leukocyte Esterase)</title>
          <population>The Safety Set (SS) consisted of all study participants who received at least 1 dose (full or partial) of IMP. Here, number of participants analyzed included all the participants with non-missing urinalysis results at Baseline and at Week 30 for this outcome measure.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="14"/>
                <count group_id="O2" value="16"/>
                <count group_id="O3" value="31"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline Low - Week 30 Low</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Baseline Low - Week 30 Normal</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Baseline Low - Week 30 High</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Baseline Normal - Week 30 Low</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Baseline Normal - Week 30 Normal</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8"/>
                    <measurement group_id="O2" value="9"/>
                    <measurement group_id="O3" value="19"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Baseline Normal - Week 30 High</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Baseline High - Week 30 Low</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Baseline High - Week 30 Normal</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="3"/>
                    <measurement group_id="O3" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Baseline High - Week 30 High</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="4"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants Who Shifted From Baseline Until Safety Follow-up Visit in Urinalysis Parameters (Urine Bacteria)</title>
        <time_frame>From Baseline to Safety Follow-Up (Week 30)</time_frame>
        <population>The Safety Set (SS) consisted of all study participants who received at least 1 dose (full or partial) of IMP. Here, number of participants analyzed included all the participants with non-missing urinalysis results at Baseline and at Week 30 for this outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo (SS)</title>
            <description>Participants received matching placebo subcutaneous (SC) injections at Baseline, followed by Week 2, 4, 5, 6, 7, 8, 9, and 10 to maintain study blinding, forming the Safety Set (SS).</description>
          </group>
          <group group_id="O2">
            <title>Adalimumab (SS)</title>
            <description>Participants received one adalimumab 160 milligrams (mg) SC injection as loading dose started from Baseline, followed by adalimumab 80 mg SC injection at Week 2 and adalimumab 40 mg SC injections from Weeks 4 to 10. Participants also received matching placebo SC injection at Week 4, 6, 8 and 10 to maintain study blinding, forming the SS.</description>
          </group>
          <group group_id="O3">
            <title>Bimekizumab (SS)</title>
            <description>Participants received one bimekizumab 640 mg SC injection as loading dose started from Baseline, followed by bimekizumab 320 mg SC injections at Weeks 2, 4, 6, 8 and 10. Participants also received matching placebo SC injections at Week 5, 7 and 9 to maintain study blinding, forming the SS.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants Who Shifted From Baseline Until Safety Follow-up Visit in Urinalysis Parameters (Urine Bacteria)</title>
          <population>The Safety Set (SS) consisted of all study participants who received at least 1 dose (full or partial) of IMP. Here, number of participants analyzed included all the participants with non-missing urinalysis results at Baseline and at Week 30 for this outcome measure.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="3"/>
                <count group_id="O2" value="6"/>
                <count group_id="O3" value="2"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline Low - Week 30 Low</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Baseline Low - Week 30 Normal</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Baseline Low - Week 30 High</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Baseline Normal - Week 30 Low</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Baseline Normal - Week 30 Normal</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Baseline Normal - Week 30 High</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Baseline High - Week 30 Low</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Baseline High - Week 30 Normal</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Baseline High - Week 30 High</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="6"/>
                    <measurement group_id="O3" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants Who Shifted From Baseline Until Safety Follow-up Visit in Urinalysis Parameters (Urine Erythrocytes)</title>
        <time_frame>From Baseline to Safety Follow-Up (Week 30)</time_frame>
        <population>The Safety Set (SS) consisted of all study participants who received at least 1 dose (full or partial) of IMP. Here, number of participants analyzed included all the participants with non-missing urinalysis results at Baseline and at Week 30 for this outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo (SS)</title>
            <description>Participants received matching placebo subcutaneous (SC) injections at Baseline, followed by Week 2, 4, 5, 6, 7, 8, 9, and 10 to maintain study blinding, forming the Safety Set (SS).</description>
          </group>
          <group group_id="O2">
            <title>Adalimumab (SS)</title>
            <description>Participants received one adalimumab 160 milligrams (mg) SC injection as loading dose started from Baseline, followed by adalimumab 80 mg SC injection at Week 2 and adalimumab 40 mg SC injections from Weeks 4 to 10. Participants also received matching placebo SC injection at Week 4, 6, 8 and 10 to maintain study blinding, forming the SS.</description>
          </group>
          <group group_id="O3">
            <title>Bimekizumab (SS)</title>
            <description>Participants received one bimekizumab 640 mg SC injection as loading dose started from Baseline, followed by bimekizumab 320 mg SC injections at Weeks 2, 4, 6, 8 and 10. Participants also received matching placebo SC injections at Week 5, 7 and 9 to maintain study blinding, forming the SS.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants Who Shifted From Baseline Until Safety Follow-up Visit in Urinalysis Parameters (Urine Erythrocytes)</title>
          <population>The Safety Set (SS) consisted of all study participants who received at least 1 dose (full or partial) of IMP. Here, number of participants analyzed included all the participants with non-missing urinalysis results at Baseline and at Week 30 for this outcome measure.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="3"/>
                <count group_id="O2" value="1"/>
                <count group_id="O3" value="1"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline Low - Week 30 Low</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Baseline Low - Week 30 Normal</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Baseline Low - Week 30 High</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Baseline Normal - Week 30 Low</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Baseline Normal - Week 30 Normal</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Baseline Normal - Week 30 High</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Baseline High - Week 30 Low</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Baseline High - Week 30 Normal</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Baseline High - Week 30 High</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants Who Shifted From Baseline Until Safety Follow-up Visit in Physical Examination</title>
        <time_frame>From Baseline to Safety Follow-Up (Week 30)</time_frame>
        <population>The Safety Set (SS) consisted of all study participants who received at least 1 dose (full or partial) of IMP. Here, number of participants analyzed included all the participants with a normal/at least one abnormal physical examination assessment and with non-missing physical examination assessment results at Baseline and at Week 30 for this outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo (SS)</title>
            <description>Participants received matching placebo subcutaneous (SC) injections at Baseline, followed by Week 2, 4, 5, 6, 7, 8, 9, and 10 to maintain study blinding, forming the Safety Set (SS).</description>
          </group>
          <group group_id="O2">
            <title>Adalimumab (SS)</title>
            <description>Participants received one adalimumab 160 milligrams (mg) SC injection as loading dose started from Baseline, followed by adalimumab 80 mg SC injection at Week 2 and adalimumab 40 mg SC injections from Weeks 4 to 10. Participants also received matching placebo SC injection at Week 4, 6, 8 and 10 to maintain study blinding, forming the SS.</description>
          </group>
          <group group_id="O3">
            <title>Bimekizumab (SS)</title>
            <description>Participants received one bimekizumab 640 mg SC injection as loading dose started from Baseline, followed by bimekizumab 320 mg SC injections at Weeks 2, 4, 6, 8 and 10. Participants also received matching placebo SC injections at Week 5, 7 and 9 to maintain study blinding, forming the SS.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants Who Shifted From Baseline Until Safety Follow-up Visit in Physical Examination</title>
          <population>The Safety Set (SS) consisted of all study participants who received at least 1 dose (full or partial) of IMP. Here, number of participants analyzed included all the participants with a normal/at least one abnormal physical examination assessment and with non-missing physical examination assessment results at Baseline and at Week 30 for this outcome measure.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="18"/>
                <count group_id="O2" value="19"/>
                <count group_id="O3" value="38"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline Normal - Week 30 Normal</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="14"/>
                    <measurement group_id="O2" value="15"/>
                    <measurement group_id="O3" value="28"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Baseline Normal - Week 30 Abnormal</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="2"/>
                    <measurement group_id="O3" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Baseline Abnormal - Week 30 Normal</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Baseline Abnormal - Week 30 Abnormal</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants With Positive Bimekizumab Anti-drug Antibody (ADA) Concentration at Day 1</title>
        <description>The overall status of a study participant was 'Positive' if at any post-Baseline visit the result was positive. Percentages were based on the number of study participants with a non-missing measurement, from samples that did not contain BKZ concentration levels above the drug tolerance, at the visit.</description>
        <time_frame>Day 1</time_frame>
        <population>The Pharmacokinetic Per-Protocol Set (PK-PPS) consisted of all randomized study participants who received at least 1 dose of investigational medicinal product (IMP) and had at least 1 quantifiable postdose plasma concentration.</population>
        <group_list>
          <group group_id="O1">
            <title>Bimekizumab (PK-PPS)</title>
            <description>Participants received one bimekizumab 640 mg SC injection as loading dose started from Baseline, followed by bimekizumab 320 mg SC injections at Weeks 2, 4, 6, 8 and 10. Participants also received matching placebo SC injections at Week 5, 7 and 9 to maintain study blinding, forming the PK-PPS.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With Positive Bimekizumab Anti-drug Antibody (ADA) Concentration at Day 1</title>
          <description>The overall status of a study participant was 'Positive' if at any post-Baseline visit the result was positive. Percentages were based on the number of study participants with a non-missing measurement, from samples that did not contain BKZ concentration levels above the drug tolerance, at the visit.</description>
          <population>The Pharmacokinetic Per-Protocol Set (PK-PPS) consisted of all randomized study participants who received at least 1 dose of investigational medicinal product (IMP) and had at least 1 quantifiable postdose plasma concentration.</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="46"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants With Positive Bimekizumab Anti-drug Antibody (ADA) Concentration at Week 2</title>
        <description>The overall status of a study participant was 'Positive' if at any post-Baseline visit the result was positive. Percentages were based on the number of study participants with a non-missing measurement, from samples that did not contain BKZ concentration levels above the drug tolerance, at the visit.</description>
        <time_frame>Week 2</time_frame>
        <population>The Pharmacokinetic Per-Protocol Set (PK-PPS) consisted of all randomized study participants who received at least 1 dose of investigational medicinal product (IMP) and had at least 1 quantifiable postdose plasma concentration. Here, the number of participants analyzed included all participants who were evaluable with a non-missing measurement for this Outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>Bimekizumab (PK-PPS)</title>
            <description>Participants received one bimekizumab 640 mg SC injection as loading dose started from Baseline, followed by bimekizumab 320 mg SC injections at Weeks 2, 4, 6, 8 and 10. Participants also received matching placebo SC injections at Week 5, 7 and 9 to maintain study blinding, forming the PK-PPS.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With Positive Bimekizumab Anti-drug Antibody (ADA) Concentration at Week 2</title>
          <description>The overall status of a study participant was 'Positive' if at any post-Baseline visit the result was positive. Percentages were based on the number of study participants with a non-missing measurement, from samples that did not contain BKZ concentration levels above the drug tolerance, at the visit.</description>
          <population>The Pharmacokinetic Per-Protocol Set (PK-PPS) consisted of all randomized study participants who received at least 1 dose of investigational medicinal product (IMP) and had at least 1 quantifiable postdose plasma concentration. Here, the number of participants analyzed included all participants who were evaluable with a non-missing measurement for this Outcome measure.</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="45"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants With Positive Bimekizumab Anti-drug Antibody (ADA) Concentration at Week 4</title>
        <description>The overall status of a study participant was 'Positive' if at any post-Baseline visit the result was positive. Percentages were based on the number of study participants with a non-missing measurement, from samples that did not contain BKZ concentration levels above the drug tolerance, at the visit.</description>
        <time_frame>Week 4</time_frame>
        <population>The Pharmacokinetic Per-Protocol Set (PK-PPS) consisted of all randomized study participants who received at least 1 dose of investigational medicinal product (IMP) and had at least 1 quantifiable postdose plasma concentration.</population>
        <group_list>
          <group group_id="O1">
            <title>Bimekizumab (PK-PPS)</title>
            <description>Participants received one bimekizumab 640 mg SC injection as loading dose started from Baseline, followed by bimekizumab 320 mg SC injections at Weeks 2, 4, 6, 8 and 10. Participants also received matching placebo SC injections at Week 5, 7 and 9 to maintain study blinding, forming the PK-PPS.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With Positive Bimekizumab Anti-drug Antibody (ADA) Concentration at Week 4</title>
          <description>The overall status of a study participant was 'Positive' if at any post-Baseline visit the result was positive. Percentages were based on the number of study participants with a non-missing measurement, from samples that did not contain BKZ concentration levels above the drug tolerance, at the visit.</description>
          <population>The Pharmacokinetic Per-Protocol Set (PK-PPS) consisted of all randomized study participants who received at least 1 dose of investigational medicinal product (IMP) and had at least 1 quantifiable postdose plasma concentration.</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="46"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants With Positive Bimekizumab Anti-drug Antibody (ADA) Concentration at Week 8</title>
        <description>The overall status of a study participant was 'Positive' if at any post-Baseline visit the result was positive. Percentages were based on the number of study participants with a non-missing measurement, from samples that did not contain BKZ concentration levels above the drug tolerance, at the visit.</description>
        <time_frame>Week 8</time_frame>
        <population>The Pharmacokinetic Per-Protocol Set (PK-PPS) consisted of all randomized study participants who received at least 1 dose of investigational medicinal product (IMP) and had at least 1 quantifiable postdose plasma concentration. Here, the number of participants analyzed included all participants who were evaluable with a non-missing measurement for this Outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>Bimekizumab (PK-PPS)</title>
            <description>Participants received one bimekizumab 640 mg SC injection as loading dose started from Baseline, followed by bimekizumab 320 mg SC injections at Weeks 2, 4, 6, 8 and 10. Participants also received matching placebo SC injections at Week 5, 7 and 9 to maintain study blinding, forming the PK-PPS.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With Positive Bimekizumab Anti-drug Antibody (ADA) Concentration at Week 8</title>
          <description>The overall status of a study participant was 'Positive' if at any post-Baseline visit the result was positive. Percentages were based on the number of study participants with a non-missing measurement, from samples that did not contain BKZ concentration levels above the drug tolerance, at the visit.</description>
          <population>The Pharmacokinetic Per-Protocol Set (PK-PPS) consisted of all randomized study participants who received at least 1 dose of investigational medicinal product (IMP) and had at least 1 quantifiable postdose plasma concentration. Here, the number of participants analyzed included all participants who were evaluable with a non-missing measurement for this Outcome measure.</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="42"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants With Positive Bimekizumab Anti-drug Antibody (ADA) Concentration at Week 12</title>
        <description>The overall status of a study participant was 'Positive' if at any post-Baseline visit the result was positive. Percentages were based on the number of study participants with a non-missing measurement, from samples that did not contain BKZ concentration levels above the drug tolerance, at the visit.</description>
        <time_frame>Week 12</time_frame>
        <population>The Pharmacokinetic Per-Protocol Set (PK-PPS) consisted of all randomized study participants who received at least 1 dose of investigational medicinal product (IMP) and had at least 1 quantifiable postdose plasma concentration. Here, the number of participants analyzed included all participants who were evaluable with a non-missing measurement for this Outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>Bimekizumab (PK-PPS)</title>
            <description>Participants received one bimekizumab 640 mg SC injection as loading dose started from Baseline, followed by bimekizumab 320 mg SC injections at Weeks 2, 4, 6, 8 and 10. Participants also received matching placebo SC injections at Week 5, 7 and 9 to maintain study blinding, forming the PK-PPS.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With Positive Bimekizumab Anti-drug Antibody (ADA) Concentration at Week 12</title>
          <description>The overall status of a study participant was 'Positive' if at any post-Baseline visit the result was positive. Percentages were based on the number of study participants with a non-missing measurement, from samples that did not contain BKZ concentration levels above the drug tolerance, at the visit.</description>
          <population>The Pharmacokinetic Per-Protocol Set (PK-PPS) consisted of all randomized study participants who received at least 1 dose of investigational medicinal product (IMP) and had at least 1 quantifiable postdose plasma concentration. Here, the number of participants analyzed included all participants who were evaluable with a non-missing measurement for this Outcome measure.</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="42"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants With Positive Bimekizumab Anti-drug Antibody (ADA) Concentration at Week 30</title>
        <description>The overall status of a study participant was 'Positive' if at any post-Baseline visit the result was positive. Percentages were based on the number of study participants with a non-missing measurement, from samples that did not contain BKZ concentration levels above the drug tolerance, at the visit.</description>
        <time_frame>Week 30</time_frame>
        <population>The Pharmacokinetic Per-Protocol Set (PK-PPS) consisted of all randomized study participants who received at least 1 dose of investigational medicinal product (IMP) and had at least 1 quantifiable postdose plasma concentration. Here, the number of participants analyzed included all participants who were evaluable with a non-missing measurement for this Outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>Bimekizumab (PK-PPS)</title>
            <description>Participants received one bimekizumab 640 mg SC injection as loading dose started from Baseline, followed by bimekizumab 320 mg SC injections at Weeks 2, 4, 6, 8 and 10. Participants also received matching placebo SC injections at Week 5, 7 and 9 to maintain study blinding, forming the PK-PPS.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With Positive Bimekizumab Anti-drug Antibody (ADA) Concentration at Week 30</title>
          <description>The overall status of a study participant was 'Positive' if at any post-Baseline visit the result was positive. Percentages were based on the number of study participants with a non-missing measurement, from samples that did not contain BKZ concentration levels above the drug tolerance, at the visit.</description>
          <population>The Pharmacokinetic Per-Protocol Set (PK-PPS) consisted of all randomized study participants who received at least 1 dose of investigational medicinal product (IMP) and had at least 1 quantifiable postdose plasma concentration. Here, the number of participants analyzed included all participants who were evaluable with a non-missing measurement for this Outcome measure.</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="36"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="13.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Treatment-emergent adverse events (TEAEs) were collected from Baseline (Day 1) until the Safety Follow-Up Visit (Week 30)</time_frame>
      <desc>A treatment-emergent AE (TEAE) was defined as any AE with a start date/time at the time of or after the first dose of IMP up until 140 days after the last dose of IMP.</desc>
      <group_list>
        <group group_id="E1">
          <title>Placebo (SS)</title>
          <description>Participants received matching placebo subcutaneous (SC) injections at Baseline, followed by Week 2, 4, 5, 6, 7, 8, 9, and 10 to maintain study blinding, forming the Safety Set (SS).</description>
        </group>
        <group group_id="E2">
          <title>Adalimumab (SS)</title>
          <description>Participants received one adalimumab 160 milligrams (mg) SC injection as loading dose started from Baseline, followed by adalimumab 80 mg SC injection at Week 2 and adalimumab 40 mg SC injections from Weeks 4 to 10. Participants also received matching placebo SC injection at Week 4, 6, 8 and 10 to maintain study blinding, forming the SS.</description>
        </group>
        <group group_id="E3">
          <title>Bimekizumab (SS)</title>
          <description>Participants received one bimekizumab 640 mg SC injection as loading dose started from Baseline, followed by bimekizumab 320 mg SC injections at Weeks 2, 4, 6, 8 and 10. Participants also received matching placebo SC injections at Week 5, 7 and 9 to maintain study blinding, forming the SS.</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>MedDRA19.0</default_vocab>
        <default_assessment>Non-systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="46"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="21"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="21"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="46"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Blood and lymphatic system disorders</title>
            <event_list>
              <event>
                <sub_title>Anaemia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="46"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Myocardial infarction</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="21"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="46"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Empyema</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="46"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="21"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="46"/>
              </event>
              <event>
                <sub_title>Dizziness</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="21"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="46"/>
              </event>
              <event>
                <sub_title>Hypoaesthesia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="21"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="46"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Hidradenitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E2" events="2" subjects_affected="1" subjects_at_risk="21"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="46"/>
              </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="5" subjects_at_risk="21"/>
                <counts group_id="E2" subjects_affected="12" subjects_at_risk="21"/>
                <counts group_id="E3" subjects_affected="21" subjects_at_risk="46"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Diarrhoea</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E2" events="2" subjects_affected="1" subjects_at_risk="21"/>
                <counts group_id="E3" events="5" subjects_affected="3" subjects_at_risk="46"/>
              </event>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="21"/>
                <counts group_id="E3" events="3" subjects_affected="3" subjects_at_risk="46"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Fatigue</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="21"/>
                <counts group_id="E3" events="4" subjects_affected="4" subjects_at_risk="46"/>
              </event>
              <event>
                <sub_title>Pyrexia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="21"/>
                <counts group_id="E3" events="2" subjects_affected="1" subjects_at_risk="46"/>
              </event>
              <event>
                <sub_title>Injection site reaction</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E3" events="4" subjects_affected="3" subjects_at_risk="46"/>
              </event>
              <event>
                <sub_title>Injection site pain</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E3" events="3" subjects_affected="3" subjects_at_risk="46"/>
              </event>
              <event>
                <sub_title>Injection site pruritus</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="21"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="46"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Oral candidiasis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="21"/>
                <counts group_id="E3" events="4" subjects_affected="3" subjects_at_risk="46"/>
              </event>
              <event>
                <sub_title>Influenza</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="21"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="46"/>
              </event>
              <event>
                <sub_title>Nasopharyngitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="21"/>
                <counts group_id="E3" events="4" subjects_affected="3" subjects_at_risk="46"/>
              </event>
              <event>
                <sub_title>Upper respiratory tract infection</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="21"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="46"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Arthralgia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="21"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="21"/>
                <counts group_id="E3" events="3" subjects_affected="1" subjects_at_risk="46"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" events="4" subjects_affected="3" subjects_at_risk="21"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E3" events="4" subjects_affected="3" subjects_at_risk="46"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Hidradenitis</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="21"/>
                <counts group_id="E2" events="6" subjects_affected="6" subjects_at_risk="21"/>
                <counts group_id="E3" events="9" subjects_affected="8" subjects_at_risk="46"/>
              </event>
              <event>
                <sub_title>Intertrigo</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="21"/>
                <counts group_id="E3" events="3" subjects_affected="3" subjects_at_risk="46"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Hypertension</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E3" events="3" subjects_affected="3" subjects_at_risk="46"/>
              </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>+1-844-599-2273</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/NCT03248531
org study id: HS0001
secondary id: 2017-000892-10
nct id: NCT03248531
lead sponsor: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
is us export: Yes
Hidradenitis suppurativa (HS) is a painful, long-term skin condition that causes abscesses
      and scarring on the skin.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Percentage of Participants Achieving Clinical Response as Measured by Hidradenitis Suppurativa Clinical Response (HiSCR) at Week 12
time frame: Week 12
description: HiSCR was defined as at least a 50 % reduction from Baseline in the total abscess and inflammatory nodule (AN) count, with no increase from Baseline in abscess or draining fistula count. Results were based on a Bayesian logistic regression model where the number of responders were assumed to follow a binomial distribution. Participants with missing data at Week 12 were considered as nonresponders in the analysis. Posterior mean response rates and 95% credible intervals in each group are presented.
measure: Bimekizumab Plasma Concentration at Day 1 (Prior to First Dose)
time frame: Day 1 (Prior to first dose)
description: Plasma concentration of Bimekizumab was expressed in nanograms per milliliter (ng/mL). Values Below Limit of Quantification (BLQ) were replaced by value of Lower Limit of Quantification (LLOQ) divided by 2 (75 ng/mL) in calculations of Means and Coefficient of Variations (CVs).
measure: Bimekizumab Plasma Concentration at Week 2
time frame: Week 2
description: Plasma concentration of Bimekizumab was expressed in ng/mL. Values BLQ were replaced by value of LLOQ/2 (75 ng/mL) in calculations of Means and CVs.
measure: Bimekizumab Plasma Concentration at Week 4
time frame: Week 4
description: Plasma concentration of Bimekizumab was expressed in ng/mL. Values BLQ were replaced by value of LLOQ/2 (75 ng/mL) in calculations of Means and CVs.
measure: Bimekizumab Plasma Concentration at Week 8
time frame: Week 8
description: Plasma concentration of Bimekizumab was expressed in ng/mL. Values BLQ were replaced by value of LLOQ/2 (75 ng/mL) in calculations of Means and CVs.
measure: Bimekizumab Plasma Concentration at Week 12
time frame: Week 12
description: Plasma concentration of Bimekizumab was expressed in ng/mL. Values BLQ were replaced by value of LLOQ/2 (75 ng/mL) in calculations of Means and CVs.
measure: Bimekizumab Plasma Concentration at Week 30
time frame: Week 30
description: Plasma concentration of Bimekizumab was expressed in ng/mL. Values BLQ were replaced by value of LLOQ/2 (75 ng/mL) in calculations of Means and CVs.
measure: Percentage of Participants With at Least One Adverse Event During the Study
time frame: From Screening to Safety Follow-Up (Week 30)
description: An adverse event (AE) was any untoward medical occurrence in a patient or clinical investigation study participant administered a pharmaceutical product that did not necessarily have a causal relationship with this treatment. An AE could therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.
measure: Percentage of Participants With at Least One Adverse Event Categorized by Maximum Severity During the Study
time frame: From Screening to Safety Follow-Up (Week 30)
description: An adverse event (AE) was any untoward medical occurrence in a patient or clinical investigation study participant administered a pharmaceutical product that did not necessarily have a causal relationship with this treatment. An AE could therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product. To record the intensity of an AE Investigator used the following criteria: Mild: the study participant was aware of sign or symptom (syndrome), but it did not interfere with his/her usual activities and/or was of no clinical consequence; Moderate: AE interfered with the usual activities of the study participant or it was of some clinical consequence; Severe: the study participant was unable to work normally or to carry out his/her usual activities, or the AE was of definite clinical consequence.
measure: Percentage of Participants With at Least One Serious Adverse Event During the Study
time frame: From Screening to Safety Follow-Up (Week 30)
description: A serious adverse event (SAE) was any untoward medical occurrence that at any dose: Resulted in death, was life-threatening, required in patient hospitalization or prolongation of existing hospitalisation, was a congenital anomaly or birth defect, was an infection that required treatment parenteral antibiotics, other important medical events which based on medical or scientific judgement may have jeopardised the patients, or may have required medical or surgical intervention to prevent any of the above.
measure: Percentage of Participants With at Least One Serious Adverse Event Categorized by Severity During the Study
time frame: From Screening to Safety Follow-Up (Week 30)
description: A serious adverse event (SAE) was any untoward medical occurrence that at any dose: Resulted in death, was life-threatening, required in patient hospitalization or prolongation of existing hospitalization, was a congenital anomaly or birth defect, was an infection that required treatment parenteral antibiotics, other important medical events which based on medical or scientific judgement may have jeopardised the patients, or may have required medical or surgical intervention to prevent any of the above. To record the intensity of an AE Investigator used the following criteria: Mild: study participant was aware of sign or symptom (syndrome), but it did not interfere with his/her usual activities and/or was of no clinical consequence; Moderate: AE interfered with usual activities of study participant or it was of some clinical consequence; Severe: the study participant was unable to work normally or to carry out his/her usual activities, or the AE was of definite clinical consequence.
measure: Percentage of Participants That Withdrew Due to Adverse Events During the Study
time frame: From Screening to Safety Follow-Up (Week 30)
description: An adverse event (AE) was any untoward medical occurrence in a patient or clinical investigation study participant administered a pharmaceutical product that did not necessarily have a causal relationship with this treatment. An AE could therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.
measure: Change From Baseline Until Safety Follow-up Visit in Vital Signs (Blood Pressure)
time frame: From Baseline to Safety Follow-Up (Week 30)
description: Blood pressure was measured in millimeters of mercury (mmHg).
measure: Change From Baseline Until Safety Follow-up Visit in Vital Signs (Pulse Rate)
time frame: From Baseline to Safety Follow-Up (Week 30)
description: Pulse rate was measured in beats per minute (beats/min).
measure: Change From Baseline Until Safety Follow-up Visit in Body Weight
time frame: From Baseline to Safety Follow-Up (Week 30)
description: Body weight was measured in kilograms (kg).
measure: Change From Baseline Until Safety Follow-up Visit in ECG Parameters (ECG Mean Heart Rate)
time frame: From Baseline to Safety Follow-Up (Week 30)
description: Electrocardiogram (ECG) Mean Heart Rate was measured in beats/min.
measure: Change From Baseline Until Safety Follow-up Visit in ECG Parameters (PR Interval, QRS Duration, QT Interval, QTcF Interval)
time frame: From Baseline to Safety Follow-Up (Week 30)
description: PR Interval, QRS duration, QT interval and QT corrected for heart rate using Fridericia's correction (QTcF) Interval were measured in milliseconds (msec).
measure: Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Erythrocytes)
time frame: From Baseline to Safety Follow-Up (Week 30)
description: Erythrocytes was measured in number of red blood cells per liter (10^12/L).
measure: Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Hematocrit)
time frame: From Baseline to Safety Follow-Up (Week 30)
description: Hematocrit was measured in volume percentage (%) of red blood cells in blood.
measure: Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Hemoglobin, Erythrocytes Mean Corpuscular Hemoglobin (HGB) Concentration)
time frame: From Baseline to Safety Follow-Up (Week 30)
description: Hemoglobin, erythrocytes mean corpuscular hemoglobin (HGB) concentration were measured in grams per liter (g/L).
measure: Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Erythrocytes Mean Corpuscular Hemoglobin (HGB))
time frame: From Baseline to Safety Follow-Up (Week 30)
description: Erythrocytes mean corpuscular hemoglobin (HGB) was measured in picograms (pg).
measure: Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Erythrocytes Mean Corpuscular Volume)
time frame: From Baseline to Safety Follow-Up (Week 30)
description: Erythrocytes mean corpuscular volume was measured in femtoliters (fL).
measure: Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Platelets)
time frame: From Baseline to Safety Follow-Up (Week 30)
description: Platelets was measured in number of platelets per liter (10^9/L).
measure: Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Leukocytes, Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils)
time frame: From Baseline to Safety Follow-Up (Week 30)
description: Leukocytes, basophils, eosinophils, lymphocytes, monocytes and neutrophils were measured in number of white blood cells per liter (10^9/L).
measure: Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Basophils/Leukocytes, Eosinophils/Leukocytes, Lymphocytes/Leukocytes, Monocytes/Leukocytes, Neutrophils/Leukocytes)
time frame: From Baseline to Safety Follow-Up (Week 30)
description: Basophils/leukocytes, eosinophils/leukocytes, lymphocytes/leukocytes, monocytes/leukocytes and neutrophils/leukocytes were measured in percentages (%).
measure: Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Bicarbonate, Chloride, Potassium, Sodium, Calcium, Magnesium, Urea Nitrogen, Cholesterol, Glucose)
time frame: From Baseline to Safety Follow-Up (Week 30)
description: Bicarbonate, chloride, potassium, sodium, calcium, magnesium, urea nitrogen, cholesterol and glucose were measured in millimoles per liter (mmol/L).
measure: Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Creatinine, Bilirubin, Urate)
time frame: From Baseline to Safety Follow-Up (Week 30)
description: Creatinine, bilirubin, and urate were measured in micromols per liter (μmol/L).
measure: Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (C Reactive Protein High Sensitivity)
time frame: From Baseline to Safety Follow-Up (Week 30)
description: C reactive protein high sensitivity was measured in milligrams per liter (mg/L).
measure: Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase, Lactate Dehydrogenase)
time frame: From Baseline to Safety Follow-Up (Week 30)
description: Alanine aminotransferase, alkaline phosphatase, aspartate aminotransferase, gamma glutamyl transferase, lactate dehydrogenase were measured in units per liter (U/L).
measure: Change From Baseline Until Safety Follow-up Visit in Urinalysis Parameters (Urine pH)
time frame: From Baseline to Safety Follow-Up (Week 30)
description: Urine pH was measured on a pH scale.
measure: Change From Baseline Until Safety Follow-up Visit in Urinalysis Parameters (Urine Albumin)
time frame: From Baseline to Safety Follow-Up (Week 30)
description: Urine albumin was measured in milligrams per liter (mg/L).
measure: Number of Participants Who Shifted From Baseline Until Safety Follow-up Visit in Urinalysis Parameters (Urine Glucose)
time frame: From Baseline to Safety Follow-Up (Week 30)
measure: Number of Participants Who Shifted From Baseline Until Safety Follow-up Visit in Urinalysis Parameters (Urine Leukocyte Esterase)
time frame: From Baseline to Safety Follow-Up (Week 30)
measure: Number of Participants Who Shifted From Baseline Until Safety Follow-up Visit in Urinalysis Parameters (Urine Bacteria)
time frame: From Baseline to Safety Follow-Up (Week 30)
measure: Number of Participants Who Shifted From Baseline Until Safety Follow-up Visit in Urinalysis Parameters (Urine Erythrocytes)
time frame: From Baseline to Safety Follow-Up (Week 30)
measure: Number of Participants Who Shifted From Baseline Until Safety Follow-up Visit in Physical Examination
time frame: From Baseline to Safety Follow-Up (Week 30)
measure: Percentage of Participants With Positive Bimekizumab Anti-drug Antibody (ADA) Concentration at Day 1
time frame: Day 1
description: The overall status of a study participant was 'Positive' if at any post-Baseline visit the result was positive. Percentages were based on the number of study participants with a non-missing measurement, from samples that did not contain BKZ concentration levels above the drug tolerance, at the visit.
measure: Percentage of Participants With Positive Bimekizumab Anti-drug Antibody (ADA) Concentration at Week 2
time frame: Week 2
description: The overall status of a study participant was 'Positive' if at any post-Baseline visit the result was positive. Percentages were based on the number of study participants with a non-missing measurement, from samples that did not contain BKZ concentration levels above the drug tolerance, at the visit.
measure: Percentage of Participants With Positive Bimekizumab Anti-drug Antibody (ADA) Concentration at Week 4
time frame: Week 4
description: The overall status of a study participant was 'Positive' if at any post-Baseline visit the result was positive. Percentages were based on the number of study participants with a non-missing measurement, from samples that did not contain BKZ concentration levels above the drug tolerance, at the visit.
measure: Percentage of Participants With Positive Bimekizumab Anti-drug Antibody (ADA) Concentration at Week 8
time frame: Week 8
description: The overall status of a study participant was 'Positive' if at any post-Baseline visit the result was positive. Percentages were based on the number of study participants with a non-missing measurement, from samples that did not contain BKZ concentration levels above the drug tolerance, at the visit.
measure: Percentage of Participants With Positive Bimekizumab Anti-drug Antibody (ADA) Concentration at Week 12
time frame: Week 12
description: The overall status of a study participant was 'Positive' if at any post-Baseline visit the result was positive. Percentages were based on the number of study participants with a non-missing measurement, from samples that did not contain BKZ concentration levels above the drug tolerance, at the visit.
measure: Percentage of Participants With Positive Bimekizumab Anti-drug Antibody (ADA) Concentration at Week 30
time frame: Week 30
description: The overall status of a study participant was 'Positive' if at any post-Baseline visit the result was positive. Percentages were based on the number of study participants with a non-missing measurement, from samples that did not contain BKZ concentration levels above the drug tolerance, at the visit.
arm group label: Bimekizumab
arm group type: Experimental
description: Subjects will receive one Bimekizumab loading dose 1 and several Bimekizumab dose 2 applications.
arm group label: Adalimumab
arm group type: Active Comparator
description: Subjects will receive one Adalimumab loading (dose 1) and several Adalimumab dose 2 and dose 3 applications.
arm group label: Placebo
arm group type: Placebo Comparator
description: Subjects will receive several placebo applications to keep the blinding.
intervention type: Drug
intervention name: Bimekizumab
description: Bimekizumab in different dosages (dose 1 and 2).
arm group label: Bimekizumab
other name: UCB4940
intervention type: Drug
intervention name: Adalimumab
description: Adalimumab in different dosages (dose 1, 2 and 3).
arm group label: Adalimumab
other name: Humira®
intervention type: Other
intervention name: Placebo
description: Placebo will be provided matching Bimekizumab.
arm group label: Placebo
criteria: 
gender: All
gender based: Yes
minimum age: 18 Years
maximum age: 70 Years
healthy volunteers: No
last name: UCB Cares
role: Study Director
affiliation: +1-844-599-2273 (UCB)
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country: Australia
country: Belgium
country: Denmark
country: Germany
country: Greece
country: Norway
country: Russian Federation
country: United States
citation: Glatt S, Jemec GBE, Forman S, Sayed C, Schmieder G, Weisman J, Rolleri R, Seegobin S, Baeten D, Ionescu L, Zouboulis CC, Shaw S. Efficacy and Safety of Bimekizumab in Moderate to Severe Hidradenitis Suppurativa: A Phase 2, Double-blind, Placebo-Controlled Randomized Clinical Trial. JAMA Dermatol. 2021 Nov 1;157(11):1279-1288. doi: 10.1001/jamadermatol.2021.2905. Erratum In: JAMA Dermatol. 2021 Nov 1;157(11):1384.
PMID: 34406364
responsible party type: Sponsor
mesh term: Hidradenitis Suppurativa
mesh term: Hidradenitis
mesh term: Adalimumab
sharing ipd: No
provided document: 
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participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 