<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/NCT03259308</url>
  </required_header>
  <id_info>
    <org_study_id>SHP647-302</org_study_id>
    <secondary_id>2017-000572-28</secondary_id>
    <nct_id>NCT03259308</nct_id>
  </id_info>
  <brief_title>Efficacy and Safety Study of SHP647 as Induction Therapy in Participants With Moderate to Severe Ulcerative Colitis</brief_title>
  <acronym>FIGARO UC 302</acronym>
  <official_title>A Phase 3 Randomized, Double-blind, Placebo-controlled, Parallel-group Efficacy and Safety Study of SHP647 as Induction Therapy in Subjects With Moderate to Severe Ulcerative Colitis (FIGARO UC 302)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Shire</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Takeda</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to evaluate the efficacy of SHP647 in inducing remission, based&#xD;
      on composite score of patient-reported symptoms and centrally read endoscopy, in participants&#xD;
      with moderate to severe ulcerative colitis (UC).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      27Mar2020: Enrollment of new patients into this study has been paused due to the COVID-19&#xD;
      situation. The duration of this pause is dependent on the leveling and control of the&#xD;
      COVID-19 pandemic.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Sponsor decision to discontinue the SHP647 (ontamalimab) clinical trial development program for&#xD;
    inflammatory bowel diseases (IBD) early.&#xD;
  </why_stopped>
  <start_date type="Actual">December 5, 2017</start_date>
  <completion_date type="Actual">October 6, 2020</completion_date>
  <primary_completion_date type="Actual">July 15, 2020</primary_completion_date>
  <phase>Phase 3</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of Participants With Remission Based on Composite Score at Week 12</measure>
    <time_frame>At Week 12</time_frame>
    <description>Remission was defined as a composite score of patient-reported symptoms using daily e-diary and centrally read endoscopy as stool frequency sub-score of 0 or 1 with at least a 1-point change from baseline, rectal bleeding sub-score of 0 and endoscopic sub-score of 0 or 1 (modified, excluded friability). The composite score was a recommended measure derived from the Mayo score without the physician global assessment (PGA) sub-score and ranged from 0 to 9 points. The Mayo score was a measure of Ulcerative Colitis (UC) disease activity. It ranged from 0 to 12 points and consisted of 4 sub-scores, each graded from 0 to 3 with higher scores indicating more severe disease. The sub-scores were stool frequency (0-3); rectal bleeding (0-3); findings of endoscopy (0-3); PGA (0-3).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Endoscopic Remission at Week 12</measure>
    <time_frame>At Week 12</time_frame>
    <description>Endoscopic remission was defined by centrally read endoscopic sub-score 0 or 1 (modified, excluded friability). The centrally read endoscopic sub-score of Mayo score ranged from 0 to 3 with higher scores indicating more severe disease.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Clinical Remission at Week 12</measure>
    <time_frame>At Week 12</time_frame>
    <description>Clinical remission was defined by stool frequency sub-score of 0 or 1 with at least a 1-point change from baseline in stool frequency sub-score, and rectal bleeding sub-score of 0. The stool frequency sub-score and rectal bleeding sub-score ranged from 0 to 3 with higher scores indicating more severe disease.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Clinical Response Based on Composite Score at Week 12</measure>
    <time_frame>At Week 12</time_frame>
    <description>Clinical response based on composite score was defined as a decrease from baseline in the composite score of patient-reported symptoms using daily e-diary and centrally read endoscopy of at least 2 points and at least 30 percent (%), with an accompanying decrease in the sub-score for rectal bleeding greater than or equal to (&gt;=) 1 point or a sub-score for rectal bleeding less than or equal to (&lt;=) 1. The composite score was a recommended measure derived from the Mayo score without the PGA sub-score and ranged from 0 to 9 points. The Mayo score was a measure of UC disease activity. It ranged from 0 to 12 points and consisted of 4 sub-scores, each graded from 0 to 3 with higher scores indicating more severe disease The sub-scores were stool frequency (0-3); rectal bleeding (0-3); findings of endoscopy (0-3); PGA (0-3).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Mucosal Healing Based on Endoscopic and Histological Assessment Using the Geboes Score Grading System at Week 12</measure>
    <time_frame>At Week 12</time_frame>
    <description>Mucosal healing was defined by centrally read endoscopic sub-score 0 or 1 (modified, excluded friability) and centrally read Geboes score of &lt;=2. The centrally read endoscopic sub-score of Mayo score ranged from 0 to 3 with higher scores indicating more severe disease. Geboes score grading system, was a validated score for evaluating histologic disease activity in UC as follows: grade 0 equal to (=) structural and architectural changes; grade 1 = chronic inflammatory infiltrate; grade 2 = lamina propria neutrophils and eosinophils; grade 3 = neutrophils in the epithelium; grade 4 = crypt destruction; grade 5 = erosions or ulceration. A higher Geboes score indicating more severe disease. Number of participants with mucosal healing based on endoscopic and histological assessment using the Geboes score grading system were reported.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Remission Based on Total Mayo Score at Week 12</measure>
    <time_frame>At Week 12</time_frame>
    <description>Remission was defined as a Total Mayo score of &lt;=2 with no individual sub-score (stool frequency, rectal bleeding, endoscopy [modified, excluded friability], and PGA) exceeding 1, at the Week 12. The Total Mayo score ranged from 0 to 12 points and consisted of 4 sub-scores, each graded from 0 to 3 with higher scores indicating more severe disease: stool frequency (0-3); rectal bleeding (0-3); findings of endoscopy (0-3); PGA (0-3).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Clinical Response Based on Total Mayo Score at Week 12</measure>
    <time_frame>At Week 12</time_frame>
    <description>Clinical response (Mayo) was defined as a decrease from baseline in the Total Mayo score of at least 3 points and at least 30%, with an accompanying decrease in the sub-score for rectal bleeding &gt;=1 point or an absolute sub-score for rectal bleeding &lt;=1. The Total Mayo score ranged from 0 to 12 points and consisted of the following 4 sub-scores, each graded from 0 to 3 with higher scores indicating more severe disease: stool frequency (0-3); rectal bleeding (0-3); findings of endoscopy (0-3); PGA (0-3).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Partial Mayo Score &lt;=2 With no Individual Sub-score Greater Than (&gt;) 1 at Weeks 4, 8, and 12</measure>
    <time_frame>At Weeks 4, 8, and 12</time_frame>
    <description>The partial Mayo score ranged from 0 to 9 points and consisted of the following 3 sub-scores, each graded from 0 to 3 with higher scores indicating more severe disease: Stool frequency (0-3); Rectal bleeding (0-3); PGA (0-3). The partial Mayo score did not include the endoscopy sub-score.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Clinical Remission With Stool Frequency Sub-scores of 0 or 1 and Rectal Bleeding Sub-score of 0 at Weeks 4 and 8</measure>
    <time_frame>At Weeks 4 and 8</time_frame>
    <description>Number of participants were reported with stool frequency sub-scores of 0 or 1 and rectal bleeding sub-score of 0. Clinical remission was defined as stool frequency sub-score of 0 or 1 with at least a 1-point change from baseline in stool frequency sub-score, and a rectal bleeding sub-score of 0. The stool frequency sub-score and rectal bleeding sub-score of Mayo score ranges from 0 to 3 with higher scores indicating more severe disease.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Endoscopic Remission With Sub-score of 0 at Week 12</measure>
    <time_frame>At Week 12</time_frame>
    <description>Endoscopic remission was defined by centrally read endoscopic sub-score 0 (modified, excluded friability). The centrally read endoscopic sub-score of Mayo score ranged from 0 to 3 with higher scores indicating more severe disease.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Clinical Remission With Both Rectal Bleeding and Stool Frequency Sub-scores of 0 at Weeks 4, 8, and 12</measure>
    <time_frame>At Weeks 4, 8, and 12</time_frame>
    <description>Number of participants were reported with rectal bleeding and stool frequency sub-scores of 0. Clinical remission was defined as both rectal bleeding and stool frequency sub-scores of 0. The stool frequency sub-score and rectal bleeding sub-score of Mayo score ranges from 0 to 3 with higher scores indicating more severe disease.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Deep Remission at Week 12</measure>
    <time_frame>At Week 12</time_frame>
    <description>Deep remission was defined as both endoscopic and rectal bleeding sub-scores of 0, and stool frequency sub-score &lt;=1 and a centrally read Geboes score of &lt;=2. The stool frequency sub-score, rectal bleeding sub-score and endoscopic sub-score of Mayo score ranged from 0 to 3 with higher scores indicating more severe disease. The composite score was a recommended measure consisted of the Mayo score without the PGA sub-score and ranged from 0 to 9 points. Geboes score grading system was a validated score for evaluating histologic disease activity in UC as follows: grade 0 = structural and architectural changes; grade 1 = chronic inflammatory infiltrate; grade 2 = lamina propria neutrophils and eosinophils; grade 3 = neutrophils in the epithelium; grade 4 = crypt destruction; grade 5 = erosions or ulceration. A higher Geboes score indicating more severe disease.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Average Worst Abdominal Pain Score Based on Patient Reported Outcome-ulcerative Colitis (PRO-UC) Daily e-Diary at Week 12</measure>
    <time_frame>Baseline, Week 12</time_frame>
    <description>PRO-UC signs and symptom data were collected using a daily e-diary during treatment period. Collection of daily e-diary data was begun at least 10 days before the baseline visit. Participants were asked to record the signs and symptom data of abdominal pain worst severity, as experienced over the previous 24 hours, in the e-diary. Participant's signs and symptom average scores at each scheduled visit were calculated based on data recorded over the most recent 3 days (consecutive or non-consecutive) of last 10 days prior to the scheduled visit start date excluding the following days: day of any bowel preparation, day of endoscopy, any days between day of bowel preparation and day of endoscopy, and the 2 days after the day of endoscopy. Abdominal pain's worst severity assessment was based on an 11-point numerical rating scale with 0 anchor at &quot;No pain&quot; and 10 at &quot;Worst Imaginable Pain&quot; as experienced over the previous 24 hours, in the e-diary. Higher scores indicating more severe pain.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Diarrhea (Average Loose Bowel Movements) Score Based on PRO-UC Daily e-Diary at Week 12</measure>
    <time_frame>Baseline, Week 12</time_frame>
    <description>PRO-UC signs and symptom data were collected using a daily e-diary during treatment period. Collection of daily e-diary data was begun at least 10 days before the baseline visit. Participants were asked to record the signs and symptom data for number of loose bowel movement, as experienced over the previous 24 hours, in the e-diary. Participant's signs and symptom average scores at each scheduled visit were calculated based on data recorded over the most recent 3 days (consecutive or nonconsecutive) of the last 10 days prior to the scheduled visit start date excluding the following days: day of any bowel preparation, day of endoscopy, any days between day of bowel preparation and day of endoscopy, and the 2 days after the day of endoscopy. Average number of loose bowel movement ranged from 0-27. Higher scores indicating more frequent bowel movements.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Average Bowel Movements With Urgency Score Based on PRO-UC Daily e-Diary at Week 12</measure>
    <time_frame>Baseline, Week 12</time_frame>
    <description>PRO-UC signs and symptom data were collected using a daily e-diary during treatment period. Collection of daily e-diary data was begun at least 10 days before the baseline visit. Participants were asked to record the signs and symptom data for number of bowel movement with urgency, as experienced over the previous 24 hours. Participant's signs and symptom average scores at each scheduled visit were calculated based on data recorded over the most recent 3 days (consecutive or nonconsecutive) of the last 10 days prior to the scheduled visit start date excluding the following days: day of any bowel preparation, day of endoscopy, any days between day of bowel preparation and day of endoscopy, and the 2 days after the day of endoscopy. Average number bowel movements urgency ranged from 0 to 27. Higher scores indicating more frequent bowel movements.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Absolute Stool Frequency (Average Number of Bowel Movements) Score Based on PRO-UC Daily e-Diary at Week 12</measure>
    <time_frame>Baseline, Week 12</time_frame>
    <description>PRO-UC signs and symptom data were collected using a daily e-diary during treatment period. Collection of daily e-diary data was begun at least 10 days before the baseline visit. Participants were asked to record the signs and symptom data for average number of bowel movements, as experienced over the previous 24 hours. Participant's signs and symptom average scores at each scheduled visit were calculated based on data recorded over the most recent 3 days (consecutive or nonconsecutive) of the last 10 days prior to the scheduled visit start date excluding the following days: day of any bowel preparation, day of endoscopy, any days between day of bowel preparation and day of endoscopy, and the 2 days after the day of endoscopy. Average number bowel movements ranged from 0 to 27. Higher scores indicating more frequent bowel movements.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Absolute Rectal Bleeding (Average Number Bowel Movements With Blood) Score Based on PRO-UC Daily e-Diary at Week 12</measure>
    <time_frame>Baseline, Week 12</time_frame>
    <description>PRO-UC signs and symptom data were collected using a daily e-diary during treatment period. Collection of daily e-diary data was begun at least 10 days before the baseline visit. Participants were asked to record the signs and symptom data for average number of bowel movements with blood, as experienced over the previous 24 hours. Participant's signs and symptom average scores at each scheduled visit were calculated based on data recorded over the most recent 3 days (consecutive or nonconsecutive) of the last 10 days prior to the scheduled visit start date excluding the following days: day of any bowel preparation, day of endoscopy, any days between day of bowel preparation and day of endoscopy, and the 2 days after the day of endoscopy. Average number bowel movements with blood ranged from 0 to 27. Higher scores indicating more frequent bowel movements with blood.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Total Sign/Symptom Score Based on PRO-UC Daily e-Diary at Week 12</measure>
    <time_frame>Baseline, Week 12</time_frame>
    <description>Total sign/symptom score was the average of the average scores of worst abdominal pain over the past 24 hours and the conversion scale values for number of bowel movements blood, number of bowel movements with urgency, number of bowel movements and number of loose bowel movements, with scale ranged of 0-10, with higher scores indicating higher severity.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) Domains Scores at Weeks 8 and 12</measure>
    <time_frame>Baseline, Weeks 8 and 12</time_frame>
    <description>IBDQ was a psychometrically validated participant-reported outcome (PRO) instrument for measuring the disease-specific health-related quality of life (HRQL) in participants with inflammatory bowel disease, including UC. The IBDQ consisted of 32 items, which were grouped into 4 dimensions: bowel function, emotional status, systemic symptoms, and social function. The 4 domains were scored as follows: Bowel symptoms: 10 to 70; Systemic symptoms: 5 to 35; Emotional function: 12 to 84; Social function: 5 to 35. Higher scores indicating a better quality of life.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in IBDQ Total Scores at Weeks 8 and 12</measure>
    <time_frame>Baseline, Weeks 8 and 12</time_frame>
    <description>IBDQ was a psychometrically validated PRO instrument for measuring the disease-specific HRQL in participants with inflammatory bowel disease, included UC. The IBDQ consisted of 32 items, which were grouped into 4 dimensions: bowel function, emotional status, systemic symptoms, and social function. The 4 domains were scored as follows: Bowel symptoms: 10 to 70; Systemic symptoms: 5 to 35; Emotional function: 12 to 84; Social function: 5 to 35. The total IBDQ score ranged from 32 to 224. For the total score and each domain, a higher score indicating better HRQL. A score of at least 170 corresponds to clinical remission and an increase of at least 16 points was considered to indicate a clinically meaningful improvement.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Short Form-36 Health Survey (SF-36), Version 2, Acute (Physical and Mental Component Summary Scores) at Week 12</measure>
    <time_frame>Baseline, Week 12</time_frame>
    <description>SF-36 was a generic quality-of-life instrument that had been widely used to assess health-related quality of life (HRQL) of participants. SF-36 consisted of 36 items that were aggregated into 8 multi-item scales (physical functioning [1=yes, limited a lot to 3=no, not limited at all], role-physical [1=all of the time to 5=none of the time], bodily pain [1=very severe to 6=none], general health [1=poor to 5=excellent], vitality [1=none of the time to 5=all of the time], social functioning [1=all of the time: to 5=none of the time], role emotional [1=all of the time to 5=none of the time] and mental health [1=all of the time to 5=none of the time]). Four domains comprised physical component summary (PCS) score (physical functioning, role-physical, bodily pain, general health) and remaining 4 domains comprised mental component summary (MCS) score (vitality, social functioning, role-emotional, mental health). The scores ranged from 0 to 100. Higher scores indicating better HRQL.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Short Form-36 Health Survey (SF-36), Version 2, Acute (Individual Domain Scores) at Week 12</measure>
    <time_frame>Baseline, Week 12</time_frame>
    <description>SF-36 was a generic quality-of-life instrument that had been widely used to assess HRQL of participants. Generic instruments were used in general populations to assess a wide range of domains applicable to a variety of health states, conditions, and diseases. The SF-36 consisted of 36 items that were aggregated into 8 multi-item scales (physical functioning [1=yes, limited a lot to 3=no, not limited at all], role-physical [1=all of the time to 5=none of the time], bodily pain [1=very severe to 6=none], general health [1=poor to 5=excellent], vitality [1=none of the time to 5=all of the time], social functioning [1=all of the time: to 5=none of the time], role emotional [1=all of the time to 5=none of the time] and mental health [1=all of the time to 5=none of the time]), with scores ranged from 0 to 100. Higher scores indicating better HRQL.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants Based on Inpatient Hospitalization</measure>
    <time_frame>From start of study up to follow up (Week 29)</time_frame>
    <description>Number of participants based on inpatient hospitalization due to all-cause hospitalization, gastrointestinal related, other illness/problem, and undergo gastrointestinal related procedures during the entire study period were reported.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Median Duration of Total Inpatient Days</measure>
    <time_frame>From start of study up to follow-up (Week 29)</time_frame>
    <description>Inpatient days were calculated as Date of discharge - Date of admission + 1. Median duration of total inpatient days during the entire study period was reported.</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">279</enrollment>
  <condition>Ulcerative Colitis</condition>
  <arm_group>
    <arm_group_label>Ontamalimab 25 mg</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will receive 25 milligram (mg) of ontamalimab subcutaneous (SC) injection using a prefilled syringe (PFS) on Week 0, Week 4 and Week 8.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Ontamalimab 75 mg</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will receive 75 mg of ontamalimab SC injection using PFS on Week 0, Week 4 and Week 8.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Participants will receive placebo matched to ontamalimab SC injection using PFS on Week 0, Week 4, and Week 8.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Ontamalimab</intervention_name>
    <description>Participants will receive 1 mL of ontamalimab sterile aqueous buffered solution at an appropriate concentration to provide the intended dose of drug (25 or 75 mg).</description>
    <arm_group_label>Ontamalimab 25 mg</arm_group_label>
    <arm_group_label>Ontamalimab 75 mg</arm_group_label>
    <other_name>SHP647</other_name>
    <other_name>PF- 00547659</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Participants will receive 1 mL of sterile aqueous buffered solution.</description>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        - Participants and/or their parent or legally authorized representative must have an&#xD;
        understanding, ability, and willingness to fully comply with study procedures and&#xD;
        restrictions.&#xD;
&#xD;
          -  Participants must be able to voluntarily provide written, signed, and dated informed&#xD;
             consent and/or assent, as applicable, to participate in the study.&#xD;
&#xD;
          -  Participants less than (&lt;) 18 years of age must weigh &gt;=40 kg and must have body mass&#xD;
             index (BMI) &gt;=16.5 kilogram per square metre (kg/m^2).&#xD;
&#xD;
          -  Participants must have a documented diagnosis of UC for &gt;=3 months before screening.&#xD;
             The following must be available in each participant's source documentation:&#xD;
&#xD;
             a. A biopsy report to confirm the histological diagnosis. b. A report documenting&#xD;
             disease duration based upon prior colonoscopy. Note: If this documentation is not&#xD;
             available at the time of screening, a colonoscopy with biopsy to confirm the diagnosis&#xD;
             is required during the screening period.&#xD;
&#xD;
          -  Participants must be willing to undergo a flexible sigmoidoscopy or colonoscopy,&#xD;
             including biopsy sample collection, during screening after all other inclusion&#xD;
             criteria have been met.&#xD;
&#xD;
          -  Participants must have moderate to severe active UC, defined as a total Mayo score of&#xD;
             &gt;=6, including a centrally read endoscopic subscore &gt;=2, rectal bleeding subscore &gt;=1,&#xD;
             and stool frequency subscore &gt;=1 at baseline.&#xD;
&#xD;
          -  Participants must have evidence of UC extending proximal to the rectum (ie, not&#xD;
             limited to proctitis).&#xD;
&#xD;
          -  Participants must have had an inadequate response to, or lost response to, or had an&#xD;
             intolerance to at least 1 conventional treatment such as mesalamine (5-aminosalicylate&#xD;
             [ASA]), glucocorticoids, immunosuppressants (azathioprine [AZA], 6-mercaptopurine&#xD;
             [6-MP], or methotrexate [MTX]), or anti-tumor necrosis factor (TNF).&#xD;
&#xD;
          -  Participants receiving any treatment(s) for UC are eligible provided they have been,&#xD;
             and are anticipated to be, on a stable dose for the designated period of time.&#xD;
&#xD;
          -  Participants are males or nonpregnant, nonlactating females who, if sexually active,&#xD;
             agree to comply with the contraceptive requirements of the protocol, or females of&#xD;
             nonchildbearing potential.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Participants with indeterminate colitis, microscopic colitis, non-steroidal&#xD;
             anti-inflammatory drug-induced colitis, ischemic colitis, infectious colitis, or&#xD;
             clinical/histologic findings suggestive of Crohn's disease.&#xD;
&#xD;
          -  Participants with colonic dysplasia or neoplasia. (Participants with prior history of&#xD;
             adenomatous polyps will be eligible if the polyps have been completely removed.)&#xD;
&#xD;
          -  Participants with past medical history or presence of toxic megacolon.&#xD;
&#xD;
          -  Participants with colonic stricture, past medical history of colonic resection, a&#xD;
             history of bowel surgery within 6 months before screening, or who are likely to&#xD;
             require surgery for UC during the treatment period.&#xD;
&#xD;
          -  Participants at risk for colorectal cancer must have a colonoscopy performed during&#xD;
             the screening period with results available within 10 days before the baseline visit,&#xD;
             unless the participant has had a surveillance colonoscopy performed within 1 year&#xD;
             prior to screening, and any adenomatous polyps found at that examination have been&#xD;
             excised. Colonoscopy report and pathology report (if biopsies are obtained) from the&#xD;
             colonoscopy performed during screening or in the prior year confirming no evidence of&#xD;
             dysplasia and colon cancer must be available in the source documents.&#xD;
&#xD;
        Participants at risk for colorectal cancer include, but are not limited to:&#xD;
&#xD;
          1. Participants with extensive colitis for &gt;=8 years or disease limited to left side of&#xD;
             colon (ie, distal to splenic flexure) for &gt;=10 years before screening, regardless of&#xD;
             age.&#xD;
&#xD;
          2. Participants &gt;=50 years of age at the time of signing of the informed consent form.&#xD;
&#xD;
             - Participants have had prior treatment with ontamalimab (formerly PF-00547659,&#xD;
             SHP647).&#xD;
&#xD;
             - Participants with known or suspected intolerance or hypersensitivity to the&#xD;
             investigational product(s), closely related compounds, or any of the stated&#xD;
             ingredients.&#xD;
&#xD;
             - Participants have received anti-TNF treatment within 60 days before baseline.&#xD;
&#xD;
             - Participants have received any biologic with immunomodulatory properties (other than&#xD;
             anti-TNFs) within 90 days before baseline.&#xD;
&#xD;
             - Participants have received any nonbiologic treatment with immunomodulatory&#xD;
             properties (other than their current background UC treatment) within 30 days before&#xD;
             baseline.&#xD;
&#xD;
             - Participants have ever received anti-integrin/adhesion molecule treatment (example&#xD;
             (eg): natalizumab, vedolizumab, efalizumab, etrolizumab, or any other investigational&#xD;
             anti-integrin/adhesion molecule).&#xD;
&#xD;
               -  Participants have received parenteral or rectal glucocorticoids, or rectal 5-ASA,&#xD;
                  within 14 days before screening endoscopic procedure.&#xD;
&#xD;
               -  Participants have received leukocyte apheresis or selective lymphocyte, monocyte,&#xD;
                  or granulocyte apheresis or plasma exchange within 30 days before baseline.&#xD;
&#xD;
               -  Participants have participated in other investigational studies within either 30&#xD;
                  days or 5 half-lives of investigational product used in the study (whichever is&#xD;
                  longer) before baseline.&#xD;
&#xD;
               -  Participants have received a live (attenuated) vaccine within 30 days before the&#xD;
                  baseline visit.&#xD;
&#xD;
               -  Participants with active enteric infections (positive stool culture and&#xD;
                  sensitivity), Clostridium difficile infection or pseudomembranous colitis&#xD;
                  [Participants with C. difficile infection at screening may be allowed re-test&#xD;
                  after treatment], evidence of active cytomegalovirus infection or Listeria&#xD;
                  monocytogenes, known active invasive fungal infections such as histoplasmosis or&#xD;
                  parasitic infections, clinically significant underlying disease that could&#xD;
                  predispose the participants to infections, or a history of serious infection&#xD;
                  (requiring parenteral antibiotic and/or hospitalization) within 4 weeks before&#xD;
                  the baseline visit.&#xD;
&#xD;
               -  Participants with abnormal chest x-ray findings at screening, such as presence of&#xD;
                  active tuberculosis (TB), general infections, heart failure, or malignancy.&#xD;
&#xD;
               -  Participants with evidence of active or latent infection with Mycobacterium TB or&#xD;
                  participants with this history who have not completed a generally accepted full&#xD;
                  course of treatment before randomization are excluded. All other participants&#xD;
                  must have either the Mantoux (purified protein derivative [PPD]) tuberculin skin&#xD;
                  test or interferon gamma release assay (IGRA) performed.&#xD;
&#xD;
        Participants who have no history of previously diagnosed active or latent TB are excluded&#xD;
        if they have a positive Mantoux (PPD) tuberculin skin test (ie &gt;=5 millimeter [mm]&#xD;
        induration) or a positive IGRA (the latter to be tested at the site's local laboratory)&#xD;
        during screening or within 12 weeks before screening. If IGRA test cannot be performed&#xD;
        locally, a central laboratory may be used, with prior agreement from the sponsor.&#xD;
&#xD;
          1. An IGRA is strongly recommended for participants with a prior Bacillus Calmette-Guerin&#xD;
             (BCG) vaccination, but may be used for any participant. Documentation of IGRA product&#xD;
             used and the test result must be in the participant's source documentation if&#xD;
             performed locally. Acceptable IGRA products include QuantiFERON TB Gold Plus In-Tube&#xD;
             Test.&#xD;
&#xD;
          2. If the results of the IGRA are indeterminate, the test may be repeated, and if a&#xD;
             negative result is obtained, enrollment may proceed. In participants with no history&#xD;
             of treated active or latent TB, a positive test on repeat will exclude the&#xD;
             participant. Participants with a history of active or latent TB infection must follow&#xD;
             instructions for &quot;Participants with a prior diagnosis of active or latent TB are&#xD;
             excluded unless both of the following criteria are met&quot; in this criterion.&#xD;
&#xD;
          3. Participants with repeat indeterminate IGRA results, with no prior TB history, may be&#xD;
             enrolled after consultation with a pulmonary or infectious disease specialist who&#xD;
             determines low risk of infection (ie, participant would be acceptable for&#xD;
             immunosuppressant [eg, anti-TNF] treatment without additional action). This&#xD;
             consultation must be included in source documentation.&#xD;
&#xD;
        Results from a chest x-ray, taken within the 12 weeks before or during screening must show&#xD;
        no abnormalities suggestive of active TB infection as determined by a qualified medical&#xD;
        specialist.&#xD;
&#xD;
        Participants with a prior diagnosis of active or latent TB are excluded unless both of the&#xD;
        following criteria are met:&#xD;
&#xD;
          1. The participant has previously received an adequate course of treatment for either&#xD;
             latent (eg, 9 months of isoniazid or an acceptable alternative regimen, in a locale&#xD;
             where rates of primary multidrug TB resistance are &lt;5%. Participants from regions with&#xD;
             higher rates of primary multidrug TB resistance are excluded) or active (acceptable&#xD;
             multidrug regimen) TB infection. Evidence of diagnosis and treatment must be included&#xD;
             in source documentation. Consultation with a pulmonary or infectious disease&#xD;
             specialist to confirm adequate treatment (ie, participant would be acceptable for&#xD;
             immunosuppressant [eg, anti-TNF] treatment without additional action) must be&#xD;
             performed during the screening period. The consultation report must be included in&#xD;
             source documentation prior to enrollment.&#xD;
&#xD;
          2. A chest x-ray performed within 12 weeks before screening or during screening indicates&#xD;
             no evidence of active or recurrent disease, and documentation of interpretation by a&#xD;
             qualified medical specialist must be included in source documentation.&#xD;
&#xD;
               -  Participants with a pre-existing demyelinating disorder such as multiple&#xD;
                  sclerosis or new onset seizures, unexplained sensory motor, or cognitive&#xD;
                  behavioral, neurological deficits, or significant abnormalities noted during&#xD;
                  screening.&#xD;
&#xD;
               -  Participants with any unexplained symptoms suggestive of progressive multifocal&#xD;
                  leukoencephalopathy (PML) based on the targeted neurological assessment during&#xD;
                  the screening period.&#xD;
&#xD;
               -  Participants with a transplanted organ. Skin grafts to treat pyoderma gangrenosum&#xD;
                  are allowed.&#xD;
&#xD;
               -  Participants with a significant concurrent medical condition at the time of&#xD;
                  screening or baseline, including, but not limited to, the following:&#xD;
&#xD;
          1. Any major illness/condition or evidence of an unstable clinical condition (eg, renal,&#xD;
             hepatic, hematologic, gastrointestinal (except disease under study), endocrine,&#xD;
             cardiovascular, pulmonary, immunologic [eg, Felty's syndrome], or local active&#xD;
             infection/infectious illness) that, in the investigator's judgment will substantially&#xD;
             increase the risk to the participant if he or she participates in the study.&#xD;
&#xD;
          2. Cancer or history of cancer or lymphoproliferative disease within the previous 5 years&#xD;
             (other than resected cutaneous basal cell carcinoma, squamous cell carcinoma, or&#xD;
             carcinoma in situ of the uterine cervix that has been treated with no evidence of&#xD;
             recurrence).&#xD;
&#xD;
          3. Presence of acute coronary syndrome (eg, acute myocardial infarction, unstable angina&#xD;
             pectoris) within 24 weeks before screening.&#xD;
&#xD;
          4. History of significant cerebrovascular disease within 24 weeks before screening.&#xD;
&#xD;
             - Participants who have had significant trauma or major surgery within 4 weeks before&#xD;
             the screening visit, or with any major elective surgery scheduled to occur during the&#xD;
             study.&#xD;
&#xD;
             - Participants with evidence of cirrhosis with or without decompensation.&#xD;
&#xD;
             - Participants with primary sclerosing cholangitis.&#xD;
&#xD;
             - Participants with evidence of positive hepatitis B surface antigen (HBsAg) or&#xD;
             hepatitis B core antibody (HBcAb).&#xD;
&#xD;
             Note: If a participant tests negative for HBsAg, but positive for HBcAb, the&#xD;
             participant would be considered eligible if no presence of hepatitis B virus (HBV) DNA&#xD;
             is confirmed by HBV DNA polymerase chain reaction (PCR) reflex testing performed in&#xD;
             the central laboratory.&#xD;
&#xD;
               -  Participants with chronic hepatitis C virus (HCV) (positive HCV antibody [HCVAb]&#xD;
                  and HCVRNA).&#xD;
&#xD;
             Note: Participants who are HCVAb positive without evidence of HCV RNA may be&#xD;
             considered eligible (spontaneous viral clearance or previously treated and cured&#xD;
             [defined as no evidence of HCVRNA at least 12 weeks prior to baseline]).&#xD;
&#xD;
               -  Participants with any of the following abnormalities in hematology and/or serum&#xD;
                  chemistry profiles during screening.&#xD;
&#xD;
             Note: Screening laboratory tests, if the results are considered by the investigator to&#xD;
             be transient and inconsistent with the participant's clinical condition, may be&#xD;
             repeated once during the screening period for confirmation. Results must be reviewed&#xD;
             for eligibility prior to the screening endoscopy procedure.&#xD;
&#xD;
          1. Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) levels &gt;=3.0×upper&#xD;
             limit of normal (ULN).&#xD;
&#xD;
          2. Total bilirubin level &gt;=1.5×ULN or &gt;2.0×ULN if the participant has a known documented&#xD;
             history of Gilbert's syndrome.&#xD;
&#xD;
          3. Hemoglobin level &lt;=80 gram per liter (g/L) (8.0 gram per deciliter [g/dL]).&#xD;
&#xD;
          4. Platelet count &lt;=100×10^9 per liter (/L) (100,000 cells per cubic millimeter [mm^3])&#xD;
             or &gt;=1000×10^9/L (1,000,000 cells/mm^3).&#xD;
&#xD;
          5. White blood cell count &lt;=3.5×10^9/L (3500 cells/mm^3).&#xD;
&#xD;
             - Absolute neutrophil count (ANC)&lt;2×10^9/L (2000 cells/mm^3).&#xD;
&#xD;
             - Serum creatinine level &gt;1.5 × ULN or estimated glomerular filtration rate &lt;30&#xD;
             ml/min/1.73m^2 based on the abbreviated Modification of Diet in Renal Disease Study&#xD;
             Equation.&#xD;
&#xD;
             Note: If platelet count is &lt;150,000 cells/mm^3, a further evaluation should be&#xD;
             performed to rule out cirrhosis, unless another etiology has already been identified.&#xD;
&#xD;
               -  Participants with known human immunodeficiency virus (HIV) infection based on&#xD;
                  documented history, with positive serological test, or positive HIV serologic&#xD;
                  test at screening, tested at the site's local laboratory in accordance with&#xD;
                  country requirements or tested at the central laboratory.&#xD;
&#xD;
             Note: A documented negative HIV test within 6 months of screening is acceptable and&#xD;
             does not need to be repeated.&#xD;
&#xD;
             - Participants who have, or who have a history of (within 2 years before screening),&#xD;
             serious psychiatric disease, alcohol dependency, or substance/drug abuse or dependency&#xD;
             of any kind, including abuse of medical marijuana (cannabis).&#xD;
&#xD;
             - Participants with any other severe acute or chronic medical or psychiatric condition&#xD;
             or laboratory or electrocardiogram (ECG) abnormality that may increase the risk&#xD;
             associated with study participation or investigational product administration or may&#xD;
             interfere with the interpretation of study results and, in the judgment of the&#xD;
             investigator, would make the participant inappropriate for entry into this study.&#xD;
&#xD;
             - Female participants who are planning to become pregnant during the study period.&#xD;
&#xD;
               -  Participants who do not agree to postpone donation of any organ or tissue,&#xD;
                  including male participants who are planning to bank or donate sperm and female&#xD;
                  participants who are planning to harvest or donate eggs, for the duration of the&#xD;
                  study and through 16 weeks after last dose of investigational product.&#xD;
&#xD;
               -  Participants who are investigational site staff members or relatives of those&#xD;
                  site staff members or Participants who are Shire employees directly involved in&#xD;
                  the conduct of the study.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>16 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Study Director</last_name>
    <role>Study Director</role>
    <affiliation>Shire</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Arizona Digestive Health Mesa - East</name>
      <address>
        <city>Mesa</city>
        <state>Arizona</state>
        <zip>85206</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Elite Clinical Studies - Phoenix - Clinedge - PPDS</name>
      <address>
        <city>Phoenix</city>
        <state>Arizona</state>
        <zip>85018</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Advanced Research Center</name>
      <address>
        <city>Anaheim</city>
        <state>California</state>
        <zip>92805</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kindred Medical Institute for Clinical Trials, LLC</name>
      <address>
        <city>Corona</city>
        <state>California</state>
        <zip>92879</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>United Medical Doctors</name>
      <address>
        <city>Encinitas</city>
        <state>California</state>
        <zip>92024</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of California San Diego</name>
      <address>
        <city>La Jolla</city>
        <state>California</state>
        <zip>92037</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>VA Long Beach Healthcare System - NAVREF - PPDS</name>
      <address>
        <city>Long Beach</city>
        <state>California</state>
        <zip>90822</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Facey Medical Foundation</name>
      <address>
        <city>Mission Hills</city>
        <state>California</state>
        <zip>91345</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>United Medical Doctors</name>
      <address>
        <city>Murrieta</city>
        <state>California</state>
        <zip>92563</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Alliance Clinical Research-(Vestavia Hills)</name>
      <address>
        <city>Poway</city>
        <state>California</state>
        <zip>92064</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of California San Francisco</name>
      <address>
        <city>San Francisco</city>
        <state>California</state>
        <zip>94158</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Care Access Research, San Pablo</name>
      <address>
        <city>San Pablo</city>
        <state>California</state>
        <zip>94806</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Renaissance Research Medical Group, INC</name>
      <address>
        <city>Cape Coral</city>
        <state>Florida</state>
        <zip>33991</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Gastro Florida</name>
      <address>
        <city>Clearwater</city>
        <state>Florida</state>
        <zip>33756</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hi Tech and Global Research, LLc</name>
      <address>
        <city>Coral Gables</city>
        <state>Florida</state>
        <zip>33134</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>ENCORE Borland-Groover Clinical Research - ERN - PPDS</name>
      <address>
        <city>Jacksonville</city>
        <state>Florida</state>
        <zip>32256</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>SIH Research</name>
      <address>
        <city>Kissimmee</city>
        <state>Florida</state>
        <zip>34741</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Alliance Medical Research LLC</name>
      <address>
        <city>Lighthouse Point</city>
        <state>Florida</state>
        <zip>33064</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Crystal Biomedical Research</name>
      <address>
        <city>Miami Lakes</city>
        <state>Florida</state>
        <zip>33065</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sanchez Clinical Research, Inc</name>
      <address>
        <city>Miami</city>
        <state>Florida</state>
        <zip>33157</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Pharma Research International Inc</name>
      <address>
        <city>Naples</city>
        <state>Florida</state>
        <zip>34110</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Bayside Clinical Research - New Port Richey</name>
      <address>
        <city>New Port Richey</city>
        <state>Florida</state>
        <zip>34655</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Accel Research Sites - St. Petersburg - ERN - PPDS</name>
      <address>
        <city>Pinellas Park</city>
        <state>Florida</state>
        <zip>33781</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>BRCR Medical Center Inc.</name>
      <address>
        <city>Plantation</city>
        <state>Florida</state>
        <zip>33322</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>DBC Research</name>
      <address>
        <city>Tamarac</city>
        <state>Florida</state>
        <zip>33321</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Infinite Clinical Trials</name>
      <address>
        <city>Atlanta</city>
        <state>Georgia</state>
        <zip>30349</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Atlanta Center For Gastroenterology PC</name>
      <address>
        <city>Decatur</city>
        <state>Georgia</state>
        <zip>30033</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Atlanta Gastroenterology Specialists, PC</name>
      <address>
        <city>Suwanee</city>
        <state>Georgia</state>
        <zip>30024</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Loretto Hospital</name>
      <address>
        <city>Chicago</city>
        <state>Illinois</state>
        <zip>60644</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>IL Gastroenterology Group</name>
      <address>
        <city>Gurnee</city>
        <state>Illinois</state>
        <zip>60031</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Edward Hines Jr VA Hospital - NAVREF - PPDS</name>
      <address>
        <city>Hines</city>
        <state>Illinois</state>
        <zip>60141</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Dupage Medical Group</name>
      <address>
        <city>Oakbrook Terrace</city>
        <state>Illinois</state>
        <zip>60181</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Gastroenterology Associates of Hazard</name>
      <address>
        <city>Hazard</city>
        <state>Kentucky</state>
        <zip>41701</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CroNOLA, LLC.</name>
      <address>
        <city>Houma</city>
        <state>Louisiana</state>
        <zip>70360</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Chevy Chase Clinical Research</name>
      <address>
        <city>Chevy Chase</city>
        <state>Maryland</state>
        <zip>20815</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Commonwealth Clinical Studies LLC</name>
      <address>
        <city>Brockton</city>
        <state>Massachusetts</state>
        <zip>02302</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>UMass Memorial Medical Center</name>
      <address>
        <city>Worcester</city>
        <state>Massachusetts</state>
        <zip>01655</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Michigan</name>
      <address>
        <city>Ann Arbor</city>
        <state>Michigan</state>
        <zip>48109</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Research Institute of Michigan</name>
      <address>
        <city>Chesterfield</city>
        <state>Michigan</state>
        <zip>48047</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>National Clinical, LLC</name>
      <address>
        <city>Hamtramck</city>
        <state>Michigan</state>
        <zip>48212</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Washington University in St. Louis</name>
      <address>
        <city>Saint Louis</city>
        <state>Missouri</state>
        <zip>63110</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>St Louis Center For Clinical Research</name>
      <address>
        <city>Saint Louis</city>
        <state>Missouri</state>
        <zip>63128</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Advanced Biomedical Research of America</name>
      <address>
        <city>Las Vegas</city>
        <state>Nevada</state>
        <zip>89123</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Encompass Care</name>
      <address>
        <city>North Las Vegas</city>
        <state>Nevada</state>
        <zip>89086</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>NYU Langone Long Island Clinical Research Associates</name>
      <address>
        <city>Great Neck</city>
        <state>New York</state>
        <zip>11021</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Weill Cornell Medical College</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10021</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Southtowns Gastroenterology, PLLC</name>
      <address>
        <city>Orchard Park</city>
        <state>New York</state>
        <zip>14127</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>East Carolina Gastroenterology</name>
      <address>
        <city>Jacksonville</city>
        <state>North Carolina</state>
        <zip>28546</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Prestige Clinical Research</name>
      <address>
        <city>Franklin</city>
        <state>Ohio</state>
        <zip>45005</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ohio Clinical Research Partners LLC</name>
      <address>
        <city>Mentor</city>
        <state>Ohio</state>
        <zip>44060</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Veteran's Research and Education Foundation - NAVREF - PPDS</name>
      <address>
        <city>Oklahoma City</city>
        <state>Oklahoma</state>
        <zip>73104</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Veterans Research Foundation of Pittsburgh - NAVREF - PPDS</name>
      <address>
        <city>Pittsburgh</city>
        <state>Pennsylvania</state>
        <zip>15240</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Digestive Health Associates of Texas, P.A.dba DHAT Research Institute</name>
      <address>
        <city>Garland</city>
        <state>Texas</state>
        <zip>75044</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Precision Research Institute, LLC</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77039</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Biopharma Informatic Inc.</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77043</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Southwest Clinical Trials</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77074</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Aztec Medical Research</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77079</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>BI Research Center</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77084</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Southern Star Research Institute LLC</name>
      <address>
        <city>San Antonio</city>
        <state>Texas</state>
        <zip>78229</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mid Atlantic Health Specialists</name>
      <address>
        <city>Galax</city>
        <state>Virginia</state>
        <zip>24333</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Winchester Gastroenterology Associates</name>
      <address>
        <city>Winchester</city>
        <state>Virginia</state>
        <zip>22601</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mayo Clinic Health System - PPDS</name>
      <address>
        <city>La Crosse</city>
        <state>Wisconsin</state>
        <zip>54601</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sanatorio 9 de Julio SA</name>
      <address>
        <city>San Miguel de Tucumán</city>
        <state>Tucumán</state>
        <zip>T4000DGI</zip>
        <country>Argentina</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Fundación Favaloro</name>
      <address>
        <city>Buenos Aires</city>
        <zip>C1093AAS</zip>
        <country>Argentina</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Privado Centro Médico de Córdoba</name>
      <address>
        <city>Córdoba</city>
        <country>Argentina</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>UZ Gent</name>
      <address>
        <city>Gent</city>
        <state>Oost-Vlaanderen</state>
        <zip>9000</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>UZ Gasthuisberg</name>
      <address>
        <city>Leuven</city>
        <state>Vlaams Brabant</state>
        <zip>3000</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>AZ Groeninge</name>
      <address>
        <city>Kortrijk</city>
        <state>West-Vlaanderen</state>
        <zip>8500</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU Mouscron</name>
      <address>
        <city>Mouscron</city>
        <zip>7700</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Center Banja Luka</name>
      <address>
        <city>Banja Luka</city>
        <zip>78000</zip>
        <country>Bosnia and Herzegovina</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Second Multiprofile Hospital for Active Treatment Sofia</name>
      <address>
        <city>Sofia</city>
        <state>Sofia-Grad</state>
        <zip>1202</zip>
        <country>Bulgaria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Diagnostic and Consulting Center Aleksandrovska EOOD</name>
      <address>
        <city>Sofia</city>
        <state>Sofia-Grad</state>
        <zip>1431</zip>
        <country>Bulgaria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University Multiprofile Hospital for Active Treatment Sveta Anna</name>
      <address>
        <city>Sofia</city>
        <state>Sofia-Grad</state>
        <zip>1750</zip>
        <country>Bulgaria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Acibadem City Clinic University Multiprofile Hospital for Active Treatment EOOD</name>
      <address>
        <city>Sofia</city>
        <state>Sofia-Grad</state>
        <zip>1784</zip>
        <country>Bulgaria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University Multiprofile Hospital for Active Treatment - Dr. Georgi Stranski EAD</name>
      <address>
        <city>Pleven</city>
        <zip>5800</zip>
        <country>Bulgaria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Multiprofile Hospital for Active Treatment Eurohospital</name>
      <address>
        <city>Plovdiv</city>
        <zip>4004</zip>
        <country>Bulgaria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Specialized Hospital for Active Treatment of Pneumophthisiatric Diseases Dr.D.Gramatikov- Ruse- PPDS</name>
      <address>
        <city>Ruse</city>
        <zip>7002</zip>
        <country>Bulgaria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Medical Center-1-Sevlievo EOOD</name>
      <address>
        <city>Sevlievo</city>
        <zip>5400</zip>
        <country>Bulgaria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Medical Center Excelsior OOD - PPDS</name>
      <address>
        <city>Sofia</city>
        <zip>1000</zip>
        <country>Bulgaria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University Multiprofile Hospital for Active Treatment Sv Ivan Rilski EAD</name>
      <address>
        <city>Sofia</city>
        <zip>1431</zip>
        <country>Bulgaria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University Multiprofile Hospital for Active Treatment Tsaritsa Yoanna - ISUL EAD</name>
      <address>
        <city>Sofia</city>
        <zip>1527</zip>
        <country>Bulgaria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Medical Center Convex EOOD</name>
      <address>
        <city>Sofia</city>
        <zip>1680</zip>
        <country>Bulgaria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Diagnostic Consultative Centre Mladost - M OOD</name>
      <address>
        <city>Varna</city>
        <zip>9000</zip>
        <country>Bulgaria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Percuro Clinical Research LTD</name>
      <address>
        <city>Victoria</city>
        <state>British Columbia</state>
        <zip>V8P 2P5</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Toronto Digestive Disease Associates Inc</name>
      <address>
        <city>Toronto</city>
        <state>Ontario</state>
        <zip>M3N 2V7</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Pablo Tobón Uribe</name>
      <address>
        <city>Medellin</city>
        <state>Antioquia</state>
        <zip>050034</zip>
        <country>Colombia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Fundación Clínica Shaio</name>
      <address>
        <city>Bogota</city>
        <state>Cundinamarca</state>
        <zip>111121</zip>
        <country>Colombia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Servimed S.A.S</name>
      <address>
        <city>Bucaramanga</city>
        <state>Santander</state>
        <zip>680003</zip>
        <country>Colombia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>IPS Centro Médico Julián Coronel S.A.S. - PPDS</name>
      <address>
        <city>Cali</city>
        <country>Colombia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>East Viru Central Hospital</name>
      <address>
        <city>Kohta-Järve</city>
        <zip>31025</zip>
        <country>Estonia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>OÜ LV Venter</name>
      <address>
        <city>Parnu</city>
        <zip>80010</zip>
        <country>Estonia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>West Tallinn Central Hospital</name>
      <address>
        <city>Tallinn</city>
        <zip>10617</zip>
        <country>Estonia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ippokrateio General Hospital of Athens</name>
      <address>
        <city>Athens</city>
        <state>Attiki</state>
        <zip>11527</zip>
        <country>Greece</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University General Hospital of Patras</name>
      <address>
        <city>Patras</city>
        <zip>26504</zip>
        <country>Greece</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Theageneio Anticancer Oncology Hospital of Thessaloniki</name>
      <address>
        <city>Thessaloniki</city>
        <zip>54007</zip>
        <country>Greece</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Euromedica - PPDS</name>
      <address>
        <city>Thessaloniki</city>
        <zip>54645</zip>
        <country>Greece</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Bekes Megyei Kozponti Korhaz</name>
      <address>
        <city>Bekescsaba</city>
        <zip>5600</zip>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Magyar Honvédség Egészségügyi Központ</name>
      <address>
        <city>Budapest</city>
        <zip>1062</zip>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Pannónia Magánorvosi Centrum Kft</name>
      <address>
        <city>Budapest</city>
        <zip>1136</zip>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>ENDOMEDIX Kft.</name>
      <address>
        <city>Budapest</city>
        <zip>1139</zip>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Debreceni Egyetem Klinikai Kozpont</name>
      <address>
        <city>Debrecen</city>
        <zip>4032</zip>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Bekes Megyei Kozponti Korhaz</name>
      <address>
        <city>Gyula</city>
        <zip>5700</zip>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mohacsi Korhaz</name>
      <address>
        <city>Mohacs</city>
        <zip>7700</zip>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Tolna Megyei Balassa János Kórház</name>
      <address>
        <city>Szekszard</city>
        <zip>7100</zip>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Csongrad Megyei Dr. Bugyi Istvan Korhaz</name>
      <address>
        <city>Szentes</city>
        <zip>6600</zip>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Fejer Megyei Szent Gyorgy Egyetemi Oktato Korhaz</name>
      <address>
        <city>Székesfehérvár</city>
        <zip>8000</zip>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Csolnoky Ferenc Korhaz</name>
      <address>
        <city>Veszprém</city>
        <zip>8200</zip>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Jávorszky Ödön Kórház</name>
      <address>
        <city>Vác</city>
        <zip>2600</zip>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>St Vincent's University Hospital</name>
      <address>
        <city>Dublin</city>
        <zip>Dublin 4</zip>
        <country>Ireland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sapporo Medical University Hospital</name>
      <address>
        <city>Sapporo</city>
        <state>Hokkaidô</state>
        <zip>060-8543</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Medical Corporation Aoyama Clinic</name>
      <address>
        <city>Kobe-shi</city>
        <state>Hyôgo</state>
        <zip>650-0015</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hyogo College of Medicine</name>
      <address>
        <city>Nishinomiya-shi</city>
        <state>Hyôgo</state>
        <zip>663-8501</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kunimoto Hospital</name>
      <address>
        <city>Asahikawa</city>
        <zip>070-0061</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Fukuoka University Chikushi Hospital</name>
      <address>
        <city>Chikushino</city>
        <zip>818-8502</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Aizawa Hospital</name>
      <address>
        <city>Matsumoto-shi</city>
        <zip>390-0814</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ishida Clinic of IBD and Gastroenterology</name>
      <address>
        <city>Oita</city>
        <zip>870-0823</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kinshukai Infusion Clinic</name>
      <address>
        <city>Osaka-shi</city>
        <zip>530-0011</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Chiinkai Dojima General &amp; Gastroenterology Clinic</name>
      <address>
        <city>Osaka</city>
        <zip>530-0003</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Yodogawa Christian Hospital</name>
      <address>
        <city>Osaka</city>
        <zip>533-0024</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Bellland General Hospital</name>
      <address>
        <city>Sakai</city>
        <zip>599-8247</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Toho University Sakura Medical Center</name>
      <address>
        <city>Sakura</city>
        <zip>285-8741</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Tohoku Rosai Hospital</name>
      <address>
        <city>Sendai</city>
        <zip>981-8563</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Dokkyo Medical University Hospital</name>
      <address>
        <city>Shimotsuga-gun</city>
        <zip>321-0293</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Medical Corporation Shoyu-kai Fujita Gastroenterology Hospital</name>
      <address>
        <city>Takatsuki</city>
        <zip>569-0086</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Nihonbashi Egawa Clinic</name>
      <address>
        <city>Tokyo</city>
        <zip>103-0028</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Koukokukai Ebisu Clinic</name>
      <address>
        <city>Tokyo</city>
        <zip>150-0013</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Yonsei University Wonju Severance Christian Hospital</name>
      <address>
        <city>Wonju-si</city>
        <state>Gang'weondo</state>
        <zip>26426</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHA Bundang Medical Center, CHA University</name>
      <address>
        <city>Seongnam</city>
        <state>Gyeonggido</state>
        <zip>13496</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Catholic University of Korea, St. Vincent's Hospital</name>
      <address>
        <city>Suwon</city>
        <state>Gyeonggido</state>
        <zip>16247</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Inje University Haeundae Paik Hospital</name>
      <address>
        <city>Busan</city>
        <zip>48108</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Pusan National University Hospital</name>
      <address>
        <city>Busan</city>
        <zip>49241</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kyungpook National University Hospital</name>
      <address>
        <city>Daegu</city>
        <zip>41944</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Yeungnam University Hospital</name>
      <address>
        <city>Daegu</city>
        <zip>42415</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kyungpook National University Chilgok Hospital</name>
      <address>
        <city>Daegu</city>
        <zip>702-210</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Gachon University Gil Medical Center</name>
      <address>
        <city>Incheon</city>
        <zip>405-760</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kyung Hee University Hospital</name>
      <address>
        <city>Seoul</city>
        <zip>02447</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Seoul National University Hospital</name>
      <address>
        <city>Seoul</city>
        <zip>03080</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kangbuk Samsung Hospital</name>
      <address>
        <city>Seoul</city>
        <zip>03181</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Severance Hospital Yonsei University Health System - PPDS</name>
      <address>
        <city>Seoul</city>
        <zip>03722</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Asan Medical Center - PPDS</name>
      <address>
        <city>Seoul</city>
        <zip>05505</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Samsung Medical Center PPDS</name>
      <address>
        <city>Seoul</city>
        <zip>06351</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Inje University Seoul Paik Hospital</name>
      <address>
        <city>Seoul</city>
        <zip>100-032</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Rafik Hariri University Hospital</name>
      <address>
        <city>Beirut</city>
        <country>Lebanon</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hammoud Hospital University Medical Center</name>
      <address>
        <city>Saida</city>
        <country>Lebanon</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Health Pharma Professional Research S.A de C.V.</name>
      <address>
        <city>Ciudad de Mexico</city>
        <state>Distrito Federal</state>
        <zip>03810</zip>
        <country>Mexico</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinica de Higado y Gastroenterologia Integral, S.C.</name>
      <address>
        <city>Cuernavaca</city>
        <state>Morelos</state>
        <zip>62170</zip>
        <country>Mexico</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>JM Research S.C</name>
      <address>
        <city>Cuernavaca</city>
        <state>Morelos</state>
        <zip>62290</zip>
        <country>Mexico</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Unidad de Atencion Medica e Investigacion en Salud</name>
      <address>
        <city>Merida</city>
        <state>Yucatán</state>
        <zip>97000</zip>
        <country>Mexico</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centro de Investigación Médica Aguascalientes</name>
      <address>
        <city>Aguascalientes</city>
        <zip>20116</zip>
        <country>Mexico</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Phylasis Clinicas Research S. de R.L. de C.V.</name>
      <address>
        <city>Cuautitlan Izcalli</city>
        <zip>54769</zip>
        <country>Mexico</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centro de Investigacion Clinica Acelerada, S.C.</name>
      <address>
        <city>Distrito Federal</city>
        <zip>07020</zip>
        <country>Mexico</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Instituto de Investigaciones Aplicadas a la Neurociencia A.C.</name>
      <address>
        <city>Durango</city>
        <zip>34000</zip>
        <country>Mexico</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Accelerium, S. de R.L. de C.V.</name>
      <address>
        <city>Monterrey</city>
        <zip>64000</zip>
        <country>Mexico</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Research Institute</name>
      <address>
        <city>Tlalnepantla De Baz</city>
        <zip>54055</zip>
        <country>Mexico</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigacion Biomedica para el Desarrollo de Farmacos S.A. de C.V.</name>
      <address>
        <city>Zapopan, Jalisco</city>
        <zip>45030</zip>
        <country>Mexico</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Auckland City Hospital</name>
      <address>
        <city>Grafton</city>
        <state>Auckland</state>
        <zip>1023</zip>
        <country>New Zealand</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Dunedin Hospital</name>
      <address>
        <city>Dunedin</city>
        <state>South Island</state>
        <zip>9016</zip>
        <country>New Zealand</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Wellington Hospital</name>
      <address>
        <city>Newtown</city>
        <state>Wellington</state>
        <zip>6021</zip>
        <country>New Zealand</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Waikato Hospital</name>
      <address>
        <city>Hamilton</city>
        <zip>3240</zip>
        <country>New Zealand</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital de Braga</name>
      <address>
        <city>Braga</city>
        <zip>4710-243</zip>
        <country>Portugal</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Senhora da Oliveira - Guimaraes, E.P.E</name>
      <address>
        <city>Guimarães</city>
        <zip>4835-044</zip>
        <country>Portugal</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital da Luz</name>
      <address>
        <city>Lisboa</city>
        <zip>1500-650</zip>
        <country>Portugal</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centro Hospitalar do Algarve - Hospital de Portimao</name>
      <address>
        <city>Portimão</city>
        <zip>8500-338</zip>
        <country>Portugal</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital de São Bernardo</name>
      <address>
        <city>Setubal</city>
        <zip>2910-446</zip>
        <country>Portugal</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Univerzitna nemocnica Bratislava</name>
      <address>
        <city>Bratislava</city>
        <zip>851 07</zip>
        <country>Slovakia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>KM Management, spol. s r.o.</name>
      <address>
        <city>Nitra</city>
        <zip>949 01</zip>
        <country>Slovakia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Gastro LM, s.r.o.</name>
      <address>
        <city>Presov</city>
        <zip>080 01</zip>
        <country>Slovakia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>C.H. Regional Reina Sofia - PPDS</name>
      <address>
        <city>Cordoba</city>
        <state>Córdoba</state>
        <zip>14004</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario de Fuenlabrada</name>
      <address>
        <city>Fuenlabrada</city>
        <state>Madrid</state>
        <zip>28942</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHUVI - H.U. Alvaro Cunqueiro</name>
      <address>
        <city>Vigo</city>
        <state>Pontevedra</state>
        <zip>36312</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centro Medico Teknon - Grupo Quironsalud</name>
      <address>
        <city>Barcelona</city>
        <zip>08022</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario Juan Ramon Jimenez</name>
      <address>
        <city>Huelva</city>
        <zip>21005</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario de La Princesa</name>
      <address>
        <city>Madrid</city>
        <zip>28006</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario Fundacion Jimenez Diaz</name>
      <address>
        <city>Madrid</city>
        <zip>28040</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario La Paz - PPDS</name>
      <address>
        <city>Madrid</city>
        <zip>28046</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario Virgen del Rocio - PPDS</name>
      <address>
        <city>Sevilla</city>
        <zip>41013</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitari i Politecnic La Fe de Valencia</name>
      <address>
        <city>Valencia</city>
        <zip>46026</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universität Zürich</name>
      <address>
        <city>Zürich</city>
        <state>Zürich (de)</state>
        <zip>8091</zip>
        <country>Switzerland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Istanbul Universitesi Cerrahpasa Tip Fakultesi</name>
      <address>
        <city>Istanbul</city>
        <zip>34098</zip>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mersin University Medical Faculty</name>
      <address>
        <city>Mersin</city>
        <zip>33169</zip>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Regional Municipal Non-profit Enterprise &quot;Chernivtsi Regional Clinical Hospital&quot;</name>
      <address>
        <city>Chernivtsi</city>
        <state>Chernivets'ka Oblast</state>
        <zip>58001</zip>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Municipal Nonprofit Enterprise CCH #2 n.a. prof. O.O. Shalimov of Kharkiv City Council</name>
      <address>
        <city>Kharkiv</city>
        <state>Kharkivs'ka Oblast</state>
        <zip>61037</zip>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Communal Nonprofit Enterprise Vinnytsia Regional Clinical Hospital named after N.I. Pirogov VRC</name>
      <address>
        <city>Vinnytsia</city>
        <state>Vinnyts'ka Oblast</state>
        <zip>21018</zip>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Municipal Nonprofit Enterprise Vinnytsia City Clinical Hospital #1</name>
      <address>
        <city>Vinnytsya</city>
        <state>Vinnyts'ka Oblast</state>
        <zip>21001</zip>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>ME Dnipropetrovsk Regional Clinical Hospital n.a. I.I Mechnykov Dnipropetrovsk Regional Council</name>
      <address>
        <city>Dnipro</city>
        <zip>49005</zip>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>LLC Medical Center Family Medicine Clinic</name>
      <address>
        <city>Dnipro</city>
        <zip>49038</zip>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>State Institution &quot;Institute of Gastroenterology of National Academy of Medical Sciences of Ukraine&quot;</name>
      <address>
        <city>Dnipro</city>
        <zip>49074</zip>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinic of SI National Institute of Therapy n.a. L.T. Mala of NAMS of Ukraine</name>
      <address>
        <city>Kharkiv</city>
        <zip>61039</zip>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Communal Non-Commercial Enterprize of Kharkiv Regional Council Regional Clinical Hospital</name>
      <address>
        <city>Kharkiv</city>
        <zip>61058</zip>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>MNPE of Kharkiv Regional Council Regional Clinical Specialized Dispensary of Radiation Protection</name>
      <address>
        <city>Kharkiv</city>
        <zip>61166</zip>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Municipal Non-profit Enterprise Kherson City Clinical Hospital named after Ye.Ye. Karabelesh</name>
      <address>
        <city>Kherson</city>
        <zip>73000</zip>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Municipal Enterprise Kryvyi Rih City Clinical Hospital #2 of Kryvyi Rih City Council</name>
      <address>
        <city>Kryvyi Rih</city>
        <zip>50056</zip>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Medical Center of LLC Medical Clinic Blagomed</name>
      <address>
        <city>Kyiv</city>
        <zip>01023</zip>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kyiv City Clinical Hospital #18</name>
      <address>
        <city>Kyiv</city>
        <zip>01030</zip>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Treatment and Diagnostic Center &quot;Healthy and Happy&quot; of LLC &quot;Healthy and Happy&quot;</name>
      <address>
        <city>Kyiv</city>
        <zip>01033</zip>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Municipal Institution of KRC Kyiv Regional Hospital #2</name>
      <address>
        <city>Kyiv</city>
        <zip>04073</zip>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Municipal Non-profit Enterprise of Kyiv Regional Council Kyiv Regional Clinical Hospital</name>
      <address>
        <city>Kyiv</city>
        <zip>04107</zip>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Lviv Railway Clinical Hospital of branch Health Center of Joint Stock Co. Ukrainian Railway</name>
      <address>
        <city>Lviv</city>
        <zip>79007</zip>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Municipal Nonprofit Enterprise Lviv Clinical Emergency Care Hospital</name>
      <address>
        <city>Lviv</city>
        <zip>79059</zip>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Municipal Non-profit Enterprise Odessa Regional Clinical Hospital of Odessa Regional Council</name>
      <address>
        <city>Odesa</city>
        <zip>65025</zip>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>MNPE Central City Clinical Hospital of Uzhhorod City Council</name>
      <address>
        <city>Uzhhorod</city>
        <zip>88000</zip>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Medical Clinical Research Center of Medical Center LLC Health Clinic</name>
      <address>
        <city>Vinnytsia</city>
        <zip>21009</zip>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Communal Nonprofit Enterprise Vinnytsia Regional Clinical Hospital named after N.I. Pirogov VRC</name>
      <address>
        <city>Vinnytsia</city>
        <zip>21018</zip>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>City Clinical Hospital #1</name>
      <address>
        <city>Vinnytsia</city>
        <zip>21029</zip>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Communal Non-Commercial Enterprise &quot;Vinnytsia City Clinical Hospital №1&quot;</name>
      <address>
        <city>Vinnytsia</city>
        <zip>21029</zip>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Municipal Non-profit Enterprise City Emergency Care Hospital of Zaporizhzhia Regional Council</name>
      <address>
        <city>Zaporizhzhia</city>
        <zip>69000</zip>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>MNPE City Hospital No. 6 of Zaporizhzhia City Council</name>
      <address>
        <city>Zaporizhzhia</city>
        <zip>69035</zip>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Argentina</country>
    <country>Belgium</country>
    <country>Bosnia and Herzegovina</country>
    <country>Bulgaria</country>
    <country>Canada</country>
    <country>Colombia</country>
    <country>Estonia</country>
    <country>Greece</country>
    <country>Hungary</country>
    <country>Ireland</country>
    <country>Japan</country>
    <country>Korea, Republic of</country>
    <country>Lebanon</country>
    <country>Mexico</country>
    <country>New Zealand</country>
    <country>Portugal</country>
    <country>Slovakia</country>
    <country>Spain</country>
    <country>Switzerland</country>
    <country>Turkey</country>
    <country>Ukraine</country>
    <country>United States</country>
  </location_countries>
  <removed_countries>
    <country>France</country>
  </removed_countries>
  <link>
    <url>https://clinicaltrials.takeda.com/study-detail/5f6b5fde4db2bf003ab4741c</url>
    <description>To obtain more information on the study, click here/on this link</description>
  </link>
  <verification_date>March 2021</verification_date>
  <study_first_submitted>August 21, 2017</study_first_submitted>
  <study_first_submitted_qc>August 21, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 23, 2017</study_first_posted>
  <results_first_submitted>March 26, 2021</results_first_submitted>
  <results_first_submitted_qc>March 26, 2021</results_first_submitted_qc>
  <results_first_posted type="Actual">April 26, 2021</results_first_posted>
  <last_update_submitted>March 26, 2021</last_update_submitted>
  <last_update_submitted_qc>March 26, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">April 26, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Colitis</mesh_term>
    <mesh_term>Colitis, Ulcerative</mesh_term>
    <mesh_term>Ulcer</mesh_term>
  </condition_browse>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>November 11, 2019</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/08/NCT03259308/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>November 4, 2020</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/08/NCT03259308/SAP_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <recruitment_details>The study was conducted at 205 sites between 5 December 2017 (first participant first visit) and 06 October 2020 (last participant last visit).</recruitment_details>
      <pre_assignment_details>A total of 279 participants were enrolled and randomized in this study.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Placebo</title>
          <description>Participants received placebo matched to ontamalimab subcutaneous (SC) injection, using a prefilled syringe (PFS) on Week 0, Week 4, and Week 8 in a 12-week treatment period.</description>
        </group>
        <group group_id="P2">
          <title>Ontamalimab 25 mg</title>
          <description>Participants received 25 milligrams (mg) of ontamalimab SC injection, using a PFS on Week 0, Week 4 and Week 8 in a 12-week treatment period.</description>
        </group>
        <group group_id="P3">
          <title>Ontamalimab 75 mg</title>
          <description>Participants received 75 mg of ontamalimab SC injection, using a PFS on Week 0, Week 4 and Week 8 in a 12-week treatment period.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="56"/>
                <participants group_id="P2" count="111"/>
                <participants group_id="P3" count="112"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="49"/>
                <participants group_id="P2" count="103"/>
                <participants group_id="P3" count="105"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="7"/>
                <participants group_id="P2" count="8"/>
                <participants group_id="P3" count="7"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Adverse Event</title>
              <participants_list>
                <participants group_id="P1" count="5"/>
                <participants group_id="P2" count="4"/>
                <participants group_id="P3" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="1"/>
                <participants group_id="P3" count="3"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Pregnancy</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>Protocol Deviation</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="3"/>
                <participants group_id="P3" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lack of Efficacy</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_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>Safety set consisted of all participants who had received at least 1 dose of investigational product.</population>
      <group_list>
        <group group_id="B1">
          <title>Placebo</title>
          <description>Participants received placebo matched to ontamalimab subcutaneous (SC) injection, using a prefilled syringe (PFS) on Week 0, Week 4, and Week 8 in a 12-week treatment period.</description>
        </group>
        <group group_id="B2">
          <title>Ontamalimab 25 mg</title>
          <description>Participants received 25 milligrams (mg) of ontamalimab SC injection, using a PFS on Week 0, Week 4 and Week 8 in a 12-week treatment period.</description>
        </group>
        <group group_id="B3">
          <title>Ontamalimab 75 mg</title>
          <description>Participants received 75 mg of ontamalimab SC injection, using a PFS on Week 0, Week 4 and Week 8 in a 12-week treatment period.</description>
        </group>
        <group group_id="B4">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="56"/>
            <count group_id="B2" value="111"/>
            <count group_id="B3" value="112"/>
            <count group_id="B4" value="279"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="41.6" spread="13.50"/>
                    <measurement group_id="B2" value="43.5" spread="14.16"/>
                    <measurement group_id="B3" value="43.9" spread="13.08"/>
                    <measurement group_id="B4" value="43.3" spread="13.58"/>
                  </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="23"/>
                    <measurement group_id="B2" value="46"/>
                    <measurement group_id="B3" value="45"/>
                    <measurement group_id="B4" value="114"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="33"/>
                    <measurement group_id="B2" value="65"/>
                    <measurement group_id="B3" value="67"/>
                    <measurement group_id="B4" value="165"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Ethnicity (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                    <measurement group_id="B2" value="17"/>
                    <measurement group_id="B3" value="16"/>
                    <measurement group_id="B4" value="38"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="51"/>
                    <measurement group_id="B2" value="93"/>
                    <measurement group_id="B3" value="96"/>
                    <measurement group_id="B4" value="240"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="1"/>
                  </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>
              <title>Race</title>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="5"/>
                    <measurement group_id="B3" value="3"/>
                    <measurement group_id="B4" value="8"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian: Japanese</title>
                  <measurement_list>
                    <measurement group_id="B1" value="6"/>
                    <measurement group_id="B2" value="5"/>
                    <measurement group_id="B3" value="6"/>
                    <measurement group_id="B4" value="17"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian: Korean</title>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                    <measurement group_id="B2" value="5"/>
                    <measurement group_id="B3" value="8"/>
                    <measurement group_id="B4" value="17"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian: Other</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>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="4"/>
                    <measurement group_id="B3" value="1"/>
                    <measurement group_id="B4" value="7"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="41"/>
                    <measurement group_id="B2" value="85"/>
                    <measurement group_id="B3" value="88"/>
                    <measurement group_id="B4" value="214"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Multiple</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="5"/>
                    <measurement group_id="B3" value="1"/>
                    <measurement group_id="B4" value="7"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Other (Unspecified)</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="5"/>
                    <measurement group_id="B4" value="7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Number of Participants With Remission Based on Composite Score at Week 12</title>
        <description>Remission was defined as a composite score of patient-reported symptoms using daily e-diary and centrally read endoscopy as stool frequency sub-score of 0 or 1 with at least a 1-point change from baseline, rectal bleeding sub-score of 0 and endoscopic sub-score of 0 or 1 (modified, excluded friability). The composite score was a recommended measure derived from the Mayo score without the physician global assessment (PGA) sub-score and ranged from 0 to 9 points. The Mayo score was a measure of Ulcerative Colitis (UC) disease activity. It ranged from 0 to 12 points and consisted of 4 sub-scores, each graded from 0 to 3 with higher scores indicating more severe disease. The sub-scores were stool frequency (0-3); rectal bleeding (0-3); findings of endoscopy (0-3); PGA (0-3).</description>
        <time_frame>At Week 12</time_frame>
        <population>Full analysis set (FAS) consisted of all participants in the randomized set who had received at least 1 dose of investigational product (IP).</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Participants received placebo matched to ontamalimab subcutaneous (SC) injection, using a prefilled syringe (PFS) on Week 0, Week 4, and Week 8 in a 12-week treatment period.</description>
          </group>
          <group group_id="O2">
            <title>Ontamalimab 25 mg</title>
            <description>Participants received 25 milligrams (mg) of ontamalimab SC injection, using a PFS on Week 0, Week 4 and Week 8 in a 12-week treatment period.</description>
          </group>
          <group group_id="O3">
            <title>Ontamalimab 75 mg</title>
            <description>Participants received 75 mg of ontamalimab SC injection, using a PFS on Week 0, Week 4 and Week 8 in a 12-week treatment period.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Remission Based on Composite Score at Week 12</title>
          <description>Remission was defined as a composite score of patient-reported symptoms using daily e-diary and centrally read endoscopy as stool frequency sub-score of 0 or 1 with at least a 1-point change from baseline, rectal bleeding sub-score of 0 and endoscopic sub-score of 0 or 1 (modified, excluded friability). The composite score was a recommended measure derived from the Mayo score without the physician global assessment (PGA) sub-score and ranged from 0 to 9 points. The Mayo score was a measure of Ulcerative Colitis (UC) disease activity. It ranged from 0 to 12 points and consisted of 4 sub-scores, each graded from 0 to 3 with higher scores indicating more severe disease. The sub-scores were stool frequency (0-3); rectal bleeding (0-3); findings of endoscopy (0-3); PGA (0-3).</description>
          <population>Full analysis set (FAS) consisted of all participants in the randomized set who had received at least 1 dose of investigational product (IP).</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="56"/>
                <count group_id="O2" value="111"/>
                <count group_id="O3" value="112"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7"/>
                    <measurement group_id="O2" value="30"/>
                    <measurement group_id="O3" value="33"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.027</p_value>
            <method>Cochran-Mantel-Haenszel</method>
            <method_desc>P-value was based on Cochran-Mantel-Haenszel chi-square test stratified by actual status of prior anti-TNF treatment and glucocorticoid at baseline.</method_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.014</p_value>
            <method>Cochran-Mantel-Haenszel</method>
            <method_desc>P-value was based on Cochran-Mantel-Haenszel chi-square test stratified by actual status of prior anti-TNF treatment and glucocorticoid at baseline.</method_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Endoscopic Remission at Week 12</title>
        <description>Endoscopic remission was defined by centrally read endoscopic sub-score 0 or 1 (modified, excluded friability). The centrally read endoscopic sub-score of Mayo score ranged from 0 to 3 with higher scores indicating more severe disease.</description>
        <time_frame>At Week 12</time_frame>
        <population>FAS consisted of all participants in the randomized set who had received at least 1 dose of IP.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Participants received placebo matched to ontamalimab subcutaneous (SC) injection, using a prefilled syringe (PFS) on Week 0, Week 4, and Week 8 in a 12-week treatment period.</description>
          </group>
          <group group_id="O2">
            <title>Ontamalimab 25 mg</title>
            <description>Participants received 25 milligrams (mg) of ontamalimab SC injection, using a PFS on Week 0, Week 4 and Week 8 in a 12-week treatment period.</description>
          </group>
          <group group_id="O3">
            <title>Ontamalimab 75 mg</title>
            <description>Participants received 75 mg of ontamalimab SC injection, using a PFS on Week 0, Week 4 and Week 8 in a 12-week treatment period.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Endoscopic Remission at Week 12</title>
          <description>Endoscopic remission was defined by centrally read endoscopic sub-score 0 or 1 (modified, excluded friability). The centrally read endoscopic sub-score of Mayo score ranged from 0 to 3 with higher scores indicating more severe disease.</description>
          <population>FAS consisted of all participants in the randomized set who had received at least 1 dose of IP.</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="56"/>
                <count group_id="O2" value="111"/>
                <count group_id="O3" value="112"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7"/>
                    <measurement group_id="O2" value="39"/>
                    <measurement group_id="O3" value="38"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.001</p_value>
            <method>Cochran-Mantel-Haenszel</method>
            <method_desc>P-value was based on Cochran-Mantel-Haenszel chi-square test stratified by actual status of prior anti-TNF treatment and glucocorticoid at baseline.</method_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.003</p_value>
            <method>Cochran-Mantel-Haenszel</method>
            <method_desc>P-value was based on Cochran-Mantel-Haenszel chi-square test stratified by actual status of prior anti-TNF treatment and glucocorticoid at baseline.</method_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Clinical Remission at Week 12</title>
        <description>Clinical remission was defined by stool frequency sub-score of 0 or 1 with at least a 1-point change from baseline in stool frequency sub-score, and rectal bleeding sub-score of 0. The stool frequency sub-score and rectal bleeding sub-score ranged from 0 to 3 with higher scores indicating more severe disease.</description>
        <time_frame>At Week 12</time_frame>
        <population>FAS consisted of all participants in the randomized set who had received at least 1 dose of IP.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Participants received placebo matched to ontamalimab subcutaneous (SC) injection, using a prefilled syringe (PFS) on Week 0, Week 4, and Week 8 in a 12-week treatment period.</description>
          </group>
          <group group_id="O2">
            <title>Ontamalimab 25 mg</title>
            <description>Participants received 25 milligrams (mg) of ontamalimab SC injection, using a PFS on Week 0, Week 4 and Week 8 in a 12-week treatment period.</description>
          </group>
          <group group_id="O3">
            <title>Ontamalimab 75 mg</title>
            <description>Participants received 75 mg of ontamalimab SC injection, using a PFS on Week 0, Week 4 and Week 8 in a 12-week treatment period.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Clinical Remission at Week 12</title>
          <description>Clinical remission was defined by stool frequency sub-score of 0 or 1 with at least a 1-point change from baseline in stool frequency sub-score, and rectal bleeding sub-score of 0. The stool frequency sub-score and rectal bleeding sub-score ranged from 0 to 3 with higher scores indicating more severe disease.</description>
          <population>FAS consisted of all participants in the randomized set who had received at least 1 dose of IP.</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="56"/>
                <count group_id="O2" value="111"/>
                <count group_id="O3" value="112"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10"/>
                    <measurement group_id="O2" value="50"/>
                    <measurement group_id="O3" value="56"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;0.001</p_value>
            <method>Cochran-Mantel-Haenszel</method>
            <method_desc>P-value was based on Cochran-Mantel-Haenszel chi-square test stratified by actual status of prior anti-TNF treatment and glucocorticoid at baseline.</method_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;0.001</p_value>
            <method>Cochran-Mantel-Haenszel</method>
            <method_desc>P-value was based on Cochran-Mantel-Haenszel chi-square test stratified by actual status of prior anti-TNF treatment and glucocorticoid at baseline.</method_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Clinical Response Based on Composite Score at Week 12</title>
        <description>Clinical response based on composite score was defined as a decrease from baseline in the composite score of patient-reported symptoms using daily e-diary and centrally read endoscopy of at least 2 points and at least 30 percent (%), with an accompanying decrease in the sub-score for rectal bleeding greater than or equal to (&gt;=) 1 point or a sub-score for rectal bleeding less than or equal to (&lt;=) 1. The composite score was a recommended measure derived from the Mayo score without the PGA sub-score and ranged from 0 to 9 points. The Mayo score was a measure of UC disease activity. It ranged from 0 to 12 points and consisted of 4 sub-scores, each graded from 0 to 3 with higher scores indicating more severe disease The sub-scores were stool frequency (0-3); rectal bleeding (0-3); findings of endoscopy (0-3); PGA (0-3).</description>
        <time_frame>At Week 12</time_frame>
        <population>FAS consisted of all participants in the randomized set who had received at least 1 dose of IP.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Participants received placebo matched to ontamalimab subcutaneous (SC) injection, using a prefilled syringe (PFS) on Week 0, Week 4, and Week 8 in a 12-week treatment period.</description>
          </group>
          <group group_id="O2">
            <title>Ontamalimab 25 mg</title>
            <description>Participants received 25 milligrams (mg) of ontamalimab SC injection, using a PFS on Week 0, Week 4 and Week 8 in a 12-week treatment period.</description>
          </group>
          <group group_id="O3">
            <title>Ontamalimab 75 mg</title>
            <description>Participants received 75 mg of ontamalimab SC injection, using a PFS on Week 0, Week 4 and Week 8 in a 12-week treatment period.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Clinical Response Based on Composite Score at Week 12</title>
          <description>Clinical response based on composite score was defined as a decrease from baseline in the composite score of patient-reported symptoms using daily e-diary and centrally read endoscopy of at least 2 points and at least 30 percent (%), with an accompanying decrease in the sub-score for rectal bleeding greater than or equal to (&gt;=) 1 point or a sub-score for rectal bleeding less than or equal to (&lt;=) 1. The composite score was a recommended measure derived from the Mayo score without the PGA sub-score and ranged from 0 to 9 points. The Mayo score was a measure of UC disease activity. It ranged from 0 to 12 points and consisted of 4 sub-scores, each graded from 0 to 3 with higher scores indicating more severe disease The sub-scores were stool frequency (0-3); rectal bleeding (0-3); findings of endoscopy (0-3); PGA (0-3).</description>
          <population>FAS consisted of all participants in the randomized set who had received at least 1 dose of IP.</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="56"/>
                <count group_id="O2" value="111"/>
                <count group_id="O3" value="112"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="16"/>
                    <measurement group_id="O2" value="67"/>
                    <measurement group_id="O3" value="64"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;0.001</p_value>
            <method>Cochran-Mantel-Haenszel</method>
            <method_desc>P-value was based on Cochran-Mantel-Haenszel chi-square test stratified by actual status of prior anti-TNF treatment and glucocorticoid at baseline.</method_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;0.001</p_value>
            <method>Cochran-Mantel-Haenszel</method>
            <method_desc>P-value was based on Cochran-Mantel-Haenszel chi-square test stratified by actual status of prior anti-TNF treatment and glucocorticoid at baseline.</method_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Mucosal Healing Based on Endoscopic and Histological Assessment Using the Geboes Score Grading System at Week 12</title>
        <description>Mucosal healing was defined by centrally read endoscopic sub-score 0 or 1 (modified, excluded friability) and centrally read Geboes score of &lt;=2. The centrally read endoscopic sub-score of Mayo score ranged from 0 to 3 with higher scores indicating more severe disease. Geboes score grading system, was a validated score for evaluating histologic disease activity in UC as follows: grade 0 equal to (=) structural and architectural changes; grade 1 = chronic inflammatory infiltrate; grade 2 = lamina propria neutrophils and eosinophils; grade 3 = neutrophils in the epithelium; grade 4 = crypt destruction; grade 5 = erosions or ulceration. A higher Geboes score indicating more severe disease. Number of participants with mucosal healing based on endoscopic and histological assessment using the Geboes score grading system were reported.</description>
        <time_frame>At Week 12</time_frame>
        <population>FAS consisted of all participants in the randomized set who had received at least 1 dose of IP.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Participants received placebo matched to ontamalimab subcutaneous (SC) injection, using a prefilled syringe (PFS) on Week 0, Week 4, and Week 8 in a 12-week treatment period.</description>
          </group>
          <group group_id="O2">
            <title>Ontamalimab 25 mg</title>
            <description>Participants received 25 milligrams (mg) of ontamalimab SC injection, using a PFS on Week 0, Week 4 and Week 8 in a 12-week treatment period.</description>
          </group>
          <group group_id="O3">
            <title>Ontamalimab 75 mg</title>
            <description>Participants received 75 mg of ontamalimab SC injection, using a PFS on Week 0, Week 4 and Week 8 in a 12-week treatment period.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Mucosal Healing Based on Endoscopic and Histological Assessment Using the Geboes Score Grading System at Week 12</title>
          <description>Mucosal healing was defined by centrally read endoscopic sub-score 0 or 1 (modified, excluded friability) and centrally read Geboes score of &lt;=2. The centrally read endoscopic sub-score of Mayo score ranged from 0 to 3 with higher scores indicating more severe disease. Geboes score grading system, was a validated score for evaluating histologic disease activity in UC as follows: grade 0 equal to (=) structural and architectural changes; grade 1 = chronic inflammatory infiltrate; grade 2 = lamina propria neutrophils and eosinophils; grade 3 = neutrophils in the epithelium; grade 4 = crypt destruction; grade 5 = erosions or ulceration. A higher Geboes score indicating more severe disease. Number of participants with mucosal healing based on endoscopic and histological assessment using the Geboes score grading system were reported.</description>
          <population>FAS consisted of all participants in the randomized set who had received at least 1 dose of IP.</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="56"/>
                <count group_id="O2" value="111"/>
                <count group_id="O3" value="112"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6"/>
                    <measurement group_id="O2" value="35"/>
                    <measurement group_id="O3" value="30"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.002</p_value>
            <method>Cochran-Mantel-Haenszel</method>
            <method_desc>P-value was based on Cochran-Mantel-Haenszel chi-square test stratified by actual status of prior anti-TNF treatment and glucocorticoid at baseline.</method_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.017</p_value>
            <method>Cochran-Mantel-Haenszel</method>
            <method_desc>P-value was based on Cochran-Mantel-Haenszel chi-square test stratified by actual status of prior anti-TNF treatment and glucocorticoid at baseline.</method_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Remission Based on Total Mayo Score at Week 12</title>
        <description>Remission was defined as a Total Mayo score of &lt;=2 with no individual sub-score (stool frequency, rectal bleeding, endoscopy [modified, excluded friability], and PGA) exceeding 1, at the Week 12. The Total Mayo score ranged from 0 to 12 points and consisted of 4 sub-scores, each graded from 0 to 3 with higher scores indicating more severe disease: stool frequency (0-3); rectal bleeding (0-3); findings of endoscopy (0-3); PGA (0-3).</description>
        <time_frame>At Week 12</time_frame>
        <population>FAS consisted of all participants in the randomized set who had received at least 1 dose of IP.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Participants received placebo matched to ontamalimab subcutaneous (SC) injection, using a prefilled syringe (PFS) on Week 0, Week 4, and Week 8 in a 12-week treatment period.</description>
          </group>
          <group group_id="O2">
            <title>Ontamalimab 25 mg</title>
            <description>Participants received 25 milligrams (mg) of ontamalimab SC injection, using a PFS on Week 0, Week 4 and Week 8 in a 12-week treatment period.</description>
          </group>
          <group group_id="O3">
            <title>Ontamalimab 75 mg</title>
            <description>Participants received 75 mg of ontamalimab SC injection, using a PFS on Week 0, Week 4 and Week 8 in a 12-week treatment period.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Remission Based on Total Mayo Score at Week 12</title>
          <description>Remission was defined as a Total Mayo score of &lt;=2 with no individual sub-score (stool frequency, rectal bleeding, endoscopy [modified, excluded friability], and PGA) exceeding 1, at the Week 12. The Total Mayo score ranged from 0 to 12 points and consisted of 4 sub-scores, each graded from 0 to 3 with higher scores indicating more severe disease: stool frequency (0-3); rectal bleeding (0-3); findings of endoscopy (0-3); PGA (0-3).</description>
          <population>FAS consisted of all participants in the randomized set who had received at least 1 dose of IP.</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="56"/>
                <count group_id="O2" value="111"/>
                <count group_id="O3" value="112"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5"/>
                    <measurement group_id="O2" value="28"/>
                    <measurement group_id="O3" value="26"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Clinical Response Based on Total Mayo Score at Week 12</title>
        <description>Clinical response (Mayo) was defined as a decrease from baseline in the Total Mayo score of at least 3 points and at least 30%, with an accompanying decrease in the sub-score for rectal bleeding &gt;=1 point or an absolute sub-score for rectal bleeding &lt;=1. The Total Mayo score ranged from 0 to 12 points and consisted of the following 4 sub-scores, each graded from 0 to 3 with higher scores indicating more severe disease: stool frequency (0-3); rectal bleeding (0-3); findings of endoscopy (0-3); PGA (0-3).</description>
        <time_frame>At Week 12</time_frame>
        <population>FAS consisted of all participants in the randomized set who had received at least 1 dose of IP.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Participants received placebo matched to ontamalimab subcutaneous (SC) injection, using a prefilled syringe (PFS) on Week 0, Week 4, and Week 8 in a 12-week treatment period.</description>
          </group>
          <group group_id="O2">
            <title>Ontamalimab 25 mg</title>
            <description>Participants received 25 milligrams (mg) of ontamalimab SC injection, using a PFS on Week 0, Week 4 and Week 8 in a 12-week treatment period.</description>
          </group>
          <group group_id="O3">
            <title>Ontamalimab 75 mg</title>
            <description>Participants received 75 mg of ontamalimab SC injection, using a PFS on Week 0, Week 4 and Week 8 in a 12-week treatment period.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Clinical Response Based on Total Mayo Score at Week 12</title>
          <description>Clinical response (Mayo) was defined as a decrease from baseline in the Total Mayo score of at least 3 points and at least 30%, with an accompanying decrease in the sub-score for rectal bleeding &gt;=1 point or an absolute sub-score for rectal bleeding &lt;=1. The Total Mayo score ranged from 0 to 12 points and consisted of the following 4 sub-scores, each graded from 0 to 3 with higher scores indicating more severe disease: stool frequency (0-3); rectal bleeding (0-3); findings of endoscopy (0-3); PGA (0-3).</description>
          <population>FAS consisted of all participants in the randomized set who had received at least 1 dose of IP.</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="56"/>
                <count group_id="O2" value="111"/>
                <count group_id="O3" value="112"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="19"/>
                    <measurement group_id="O2" value="66"/>
                    <measurement group_id="O3" value="63"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Partial Mayo Score &lt;=2 With no Individual Sub-score Greater Than (&gt;) 1 at Weeks 4, 8, and 12</title>
        <description>The partial Mayo score ranged from 0 to 9 points and consisted of the following 3 sub-scores, each graded from 0 to 3 with higher scores indicating more severe disease: Stool frequency (0-3); Rectal bleeding (0-3); PGA (0-3). The partial Mayo score did not include the endoscopy sub-score.</description>
        <time_frame>At Weeks 4, 8, and 12</time_frame>
        <population>FAS consisted of all participants in the randomized set who had received at least 1 dose of IP.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Participants received placebo matched to ontamalimab subcutaneous (SC) injection, using a prefilled syringe (PFS) on Week 0, Week 4, and Week 8 in a 12-week treatment period.</description>
          </group>
          <group group_id="O2">
            <title>Ontamalimab 25 mg</title>
            <description>Participants received 25 milligrams (mg) of ontamalimab SC injection, using a PFS on Week 0, Week 4 and Week 8 in a 12-week treatment period.</description>
          </group>
          <group group_id="O3">
            <title>Ontamalimab 75 mg</title>
            <description>Participants received 75 mg of ontamalimab SC injection, using a PFS on Week 0, Week 4 and Week 8 in a 12-week treatment period.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Partial Mayo Score &lt;=2 With no Individual Sub-score Greater Than (&gt;) 1 at Weeks 4, 8, and 12</title>
          <description>The partial Mayo score ranged from 0 to 9 points and consisted of the following 3 sub-scores, each graded from 0 to 3 with higher scores indicating more severe disease: Stool frequency (0-3); Rectal bleeding (0-3); PGA (0-3). The partial Mayo score did not include the endoscopy sub-score.</description>
          <population>FAS consisted of all participants in the randomized set who had received at least 1 dose of IP.</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="56"/>
                <count group_id="O2" value="111"/>
                <count group_id="O3" value="112"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>At Week 4</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6"/>
                    <measurement group_id="O2" value="26"/>
                    <measurement group_id="O3" value="23"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>At Week 8</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="12"/>
                    <measurement group_id="O2" value="53"/>
                    <measurement group_id="O3" value="41"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>At Week 12</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10"/>
                    <measurement group_id="O2" value="49"/>
                    <measurement group_id="O3" value="52"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Clinical Remission With Stool Frequency Sub-scores of 0 or 1 and Rectal Bleeding Sub-score of 0 at Weeks 4 and 8</title>
        <description>Number of participants were reported with stool frequency sub-scores of 0 or 1 and rectal bleeding sub-score of 0. Clinical remission was defined as stool frequency sub-score of 0 or 1 with at least a 1-point change from baseline in stool frequency sub-score, and a rectal bleeding sub-score of 0. The stool frequency sub-score and rectal bleeding sub-score of Mayo score ranges from 0 to 3 with higher scores indicating more severe disease.</description>
        <time_frame>At Weeks 4 and 8</time_frame>
        <population>FAS consisted of all participants in the randomized set who had received at least 1 dose of IP.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Participants received placebo matched to ontamalimab subcutaneous (SC) injection, using a prefilled syringe (PFS) on Week 0, Week 4, and Week 8 in a 12-week treatment period.</description>
          </group>
          <group group_id="O2">
            <title>Ontamalimab 25 mg</title>
            <description>Participants received 25 milligrams (mg) of ontamalimab SC injection, using a PFS on Week 0, Week 4 and Week 8 in a 12-week treatment period.</description>
          </group>
          <group group_id="O3">
            <title>Ontamalimab 75 mg</title>
            <description>Participants received 75 mg of ontamalimab SC injection, using a PFS on Week 0, Week 4 and Week 8 in a 12-week treatment period.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Clinical Remission With Stool Frequency Sub-scores of 0 or 1 and Rectal Bleeding Sub-score of 0 at Weeks 4 and 8</title>
          <description>Number of participants were reported with stool frequency sub-scores of 0 or 1 and rectal bleeding sub-score of 0. Clinical remission was defined as stool frequency sub-score of 0 or 1 with at least a 1-point change from baseline in stool frequency sub-score, and a rectal bleeding sub-score of 0. The stool frequency sub-score and rectal bleeding sub-score of Mayo score ranges from 0 to 3 with higher scores indicating more severe disease.</description>
          <population>FAS consisted of all participants in the randomized set who had received at least 1 dose of IP.</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="56"/>
                <count group_id="O2" value="111"/>
                <count group_id="O3" value="112"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>At Week 4</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                    <measurement group_id="O2" value="28"/>
                    <measurement group_id="O3" value="22"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>At Week 8</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10"/>
                    <measurement group_id="O2" value="52"/>
                    <measurement group_id="O3" value="56"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Endoscopic Remission With Sub-score of 0 at Week 12</title>
        <description>Endoscopic remission was defined by centrally read endoscopic sub-score 0 (modified, excluded friability). The centrally read endoscopic sub-score of Mayo score ranged from 0 to 3 with higher scores indicating more severe disease.</description>
        <time_frame>At Week 12</time_frame>
        <population>FAS consisted of all participants in the randomized set who had received at least 1 dose of IP.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Participants received placebo matched to ontamalimab subcutaneous (SC) injection, using a prefilled syringe (PFS) on Week 0, Week 4, and Week 8 in a 12-week treatment period.</description>
          </group>
          <group group_id="O2">
            <title>Ontamalimab 25 mg</title>
            <description>Participants received 25 milligrams (mg) of ontamalimab SC injection, using a PFS on Week 0, Week 4 and Week 8 in a 12-week treatment period.</description>
          </group>
          <group group_id="O3">
            <title>Ontamalimab 75 mg</title>
            <description>Participants received 75 mg of ontamalimab SC injection, using a PFS on Week 0, Week 4 and Week 8 in a 12-week treatment period.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Endoscopic Remission With Sub-score of 0 at Week 12</title>
          <description>Endoscopic remission was defined by centrally read endoscopic sub-score 0 (modified, excluded friability). The centrally read endoscopic sub-score of Mayo score ranged from 0 to 3 with higher scores indicating more severe disease.</description>
          <population>FAS consisted of all participants in the randomized set who had received at least 1 dose of IP.</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="56"/>
                <count group_id="O2" value="111"/>
                <count group_id="O3" value="112"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="14"/>
                    <measurement group_id="O3" value="14"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Clinical Remission With Both Rectal Bleeding and Stool Frequency Sub-scores of 0 at Weeks 4, 8, and 12</title>
        <description>Number of participants were reported with rectal bleeding and stool frequency sub-scores of 0. Clinical remission was defined as both rectal bleeding and stool frequency sub-scores of 0. The stool frequency sub-score and rectal bleeding sub-score of Mayo score ranges from 0 to 3 with higher scores indicating more severe disease.</description>
        <time_frame>At Weeks 4, 8, and 12</time_frame>
        <population>FAS consisted of all participants in the randomized set who had received at least 1 dose of IP.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Participants received placebo matched to ontamalimab subcutaneous (SC) injection, using a prefilled syringe (PFS) on Week 0, Week 4, and Week 8 in a 12-week treatment period.</description>
          </group>
          <group group_id="O2">
            <title>Ontamalimab 25 mg</title>
            <description>Participants received 25 milligrams (mg) of ontamalimab SC injection, using a PFS on Week 0, Week 4 and Week 8 in a 12-week treatment period.</description>
          </group>
          <group group_id="O3">
            <title>Ontamalimab 75 mg</title>
            <description>Participants received 75 mg of ontamalimab SC injection, using a PFS on Week 0, Week 4 and Week 8 in a 12-week treatment period.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Clinical Remission With Both Rectal Bleeding and Stool Frequency Sub-scores of 0 at Weeks 4, 8, and 12</title>
          <description>Number of participants were reported with rectal bleeding and stool frequency sub-scores of 0. Clinical remission was defined as both rectal bleeding and stool frequency sub-scores of 0. The stool frequency sub-score and rectal bleeding sub-score of Mayo score ranges from 0 to 3 with higher scores indicating more severe disease.</description>
          <population>FAS consisted of all participants in the randomized set who had received at least 1 dose of IP.</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="56"/>
                <count group_id="O2" value="111"/>
                <count group_id="O3" value="112"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>At Week 4</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="15"/>
                    <measurement group_id="O3" value="12"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>At Week 8</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5"/>
                    <measurement group_id="O2" value="29"/>
                    <measurement group_id="O3" value="19"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>At Week 12</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6"/>
                    <measurement group_id="O2" value="36"/>
                    <measurement group_id="O3" value="26"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Deep Remission at Week 12</title>
        <description>Deep remission was defined as both endoscopic and rectal bleeding sub-scores of 0, and stool frequency sub-score &lt;=1 and a centrally read Geboes score of &lt;=2. The stool frequency sub-score, rectal bleeding sub-score and endoscopic sub-score of Mayo score ranged from 0 to 3 with higher scores indicating more severe disease. The composite score was a recommended measure consisted of the Mayo score without the PGA sub-score and ranged from 0 to 9 points. Geboes score grading system was a validated score for evaluating histologic disease activity in UC as follows: grade 0 = structural and architectural changes; grade 1 = chronic inflammatory infiltrate; grade 2 = lamina propria neutrophils and eosinophils; grade 3 = neutrophils in the epithelium; grade 4 = crypt destruction; grade 5 = erosions or ulceration. A higher Geboes score indicating more severe disease.</description>
        <time_frame>At Week 12</time_frame>
        <population>FAS consisted of all participants in the randomized set who had received at least 1 dose of IP.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Participants received placebo matched to ontamalimab subcutaneous (SC) injection, using a prefilled syringe (PFS) on Week 0, Week 4, and Week 8 in a 12-week treatment period.</description>
          </group>
          <group group_id="O2">
            <title>Ontamalimab 25 mg</title>
            <description>Participants received 25 milligrams (mg) of ontamalimab SC injection, using a PFS on Week 0, Week 4 and Week 8 in a 12-week treatment period.</description>
          </group>
          <group group_id="O3">
            <title>Ontamalimab 75 mg</title>
            <description>Participants received 75 mg of ontamalimab SC injection, using a PFS on Week 0, Week 4 and Week 8 in a 12-week treatment period.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Deep Remission at Week 12</title>
          <description>Deep remission was defined as both endoscopic and rectal bleeding sub-scores of 0, and stool frequency sub-score &lt;=1 and a centrally read Geboes score of &lt;=2. The stool frequency sub-score, rectal bleeding sub-score and endoscopic sub-score of Mayo score ranged from 0 to 3 with higher scores indicating more severe disease. The composite score was a recommended measure consisted of the Mayo score without the PGA sub-score and ranged from 0 to 9 points. Geboes score grading system was a validated score for evaluating histologic disease activity in UC as follows: grade 0 = structural and architectural changes; grade 1 = chronic inflammatory infiltrate; grade 2 = lamina propria neutrophils and eosinophils; grade 3 = neutrophils in the epithelium; grade 4 = crypt destruction; grade 5 = erosions or ulceration. A higher Geboes score indicating more severe disease.</description>
          <population>FAS consisted of all participants in the randomized set who had received at least 1 dose of IP.</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="56"/>
                <count group_id="O2" value="111"/>
                <count group_id="O3" value="112"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="11"/>
                    <measurement group_id="O3" value="9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Average Worst Abdominal Pain Score Based on Patient Reported Outcome-ulcerative Colitis (PRO-UC) Daily e-Diary at Week 12</title>
        <description>PRO-UC signs and symptom data were collected using a daily e-diary during treatment period. Collection of daily e-diary data was begun at least 10 days before the baseline visit. Participants were asked to record the signs and symptom data of abdominal pain worst severity, as experienced over the previous 24 hours, in the e-diary. Participant's signs and symptom average scores at each scheduled visit were calculated based on data recorded over the most recent 3 days (consecutive or non-consecutive) of last 10 days prior to the scheduled visit start date excluding the following days: day of any bowel preparation, day of endoscopy, any days between day of bowel preparation and day of endoscopy, and the 2 days after the day of endoscopy. Abdominal pain's worst severity assessment was based on an 11-point numerical rating scale with 0 anchor at &quot;No pain&quot; and 10 at &quot;Worst Imaginable Pain&quot; as experienced over the previous 24 hours, in the e-diary. Higher scores indicating more severe pain.</description>
        <time_frame>Baseline, Week 12</time_frame>
        <population>FAS consisted of all participants in the randomized set who had received at least 1 dose of IP. Here, overall number of participants analyzed signifies participants who were evaluable for this outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Participants received placebo matched to ontamalimab subcutaneous (SC) injection, using a prefilled syringe (PFS) on Week 0, Week 4, and Week 8 in a 12-week treatment period.</description>
          </group>
          <group group_id="O2">
            <title>Ontamalimab 25 mg</title>
            <description>Participants received 25 milligrams (mg) of ontamalimab SC injection, using a PFS on Week 0, Week 4 and Week 8 in a 12-week treatment period.</description>
          </group>
          <group group_id="O3">
            <title>Ontamalimab 75 mg</title>
            <description>Participants received 75 mg of ontamalimab SC injection, using a PFS on Week 0, Week 4 and Week 8 in a 12-week treatment period.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Average Worst Abdominal Pain Score Based on Patient Reported Outcome-ulcerative Colitis (PRO-UC) Daily e-Diary at Week 12</title>
          <description>PRO-UC signs and symptom data were collected using a daily e-diary during treatment period. Collection of daily e-diary data was begun at least 10 days before the baseline visit. Participants were asked to record the signs and symptom data of abdominal pain worst severity, as experienced over the previous 24 hours, in the e-diary. Participant's signs and symptom average scores at each scheduled visit were calculated based on data recorded over the most recent 3 days (consecutive or non-consecutive) of last 10 days prior to the scheduled visit start date excluding the following days: day of any bowel preparation, day of endoscopy, any days between day of bowel preparation and day of endoscopy, and the 2 days after the day of endoscopy. Abdominal pain's worst severity assessment was based on an 11-point numerical rating scale with 0 anchor at &quot;No pain&quot; and 10 at &quot;Worst Imaginable Pain&quot; as experienced over the previous 24 hours, in the e-diary. Higher scores indicating more severe pain.</description>
          <population>FAS consisted of all participants in the randomized set who had received at least 1 dose of IP. Here, overall number of participants analyzed signifies participants who were evaluable for this outcome measure.</population>
          <units>Score on a Scale</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="47"/>
                <count group_id="O2" value="104"/>
                <count group_id="O3" value="107"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.69" spread="0.309"/>
                    <measurement group_id="O2" value="-2.49" spread="0.218"/>
                    <measurement group_id="O3" value="-1.83" spread="0.215"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Diarrhea (Average Loose Bowel Movements) Score Based on PRO-UC Daily e-Diary at Week 12</title>
        <description>PRO-UC signs and symptom data were collected using a daily e-diary during treatment period. Collection of daily e-diary data was begun at least 10 days before the baseline visit. Participants were asked to record the signs and symptom data for number of loose bowel movement, as experienced over the previous 24 hours, in the e-diary. Participant's signs and symptom average scores at each scheduled visit were calculated based on data recorded over the most recent 3 days (consecutive or nonconsecutive) of the last 10 days prior to the scheduled visit start date excluding the following days: day of any bowel preparation, day of endoscopy, any days between day of bowel preparation and day of endoscopy, and the 2 days after the day of endoscopy. Average number of loose bowel movement ranged from 0-27. Higher scores indicating more frequent bowel movements.</description>
        <time_frame>Baseline, Week 12</time_frame>
        <population>FAS consisted of all participants in the randomized set who had received at least 1 dose of IP. Here, overall number of participants analyzed signifies participants who were evaluable for this outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Participants received placebo matched to ontamalimab subcutaneous (SC) injection, using a prefilled syringe (PFS) on Week 0, Week 4, and Week 8 in a 12-week treatment period.</description>
          </group>
          <group group_id="O2">
            <title>Ontamalimab 25 mg</title>
            <description>Participants received 25 milligrams (mg) of ontamalimab SC injection, using a PFS on Week 0, Week 4 and Week 8 in a 12-week treatment period.</description>
          </group>
          <group group_id="O3">
            <title>Ontamalimab 75 mg</title>
            <description>Participants received 75 mg of ontamalimab SC injection, using a PFS on Week 0, Week 4 and Week 8 in a 12-week treatment period.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Diarrhea (Average Loose Bowel Movements) Score Based on PRO-UC Daily e-Diary at Week 12</title>
          <description>PRO-UC signs and symptom data were collected using a daily e-diary during treatment period. Collection of daily e-diary data was begun at least 10 days before the baseline visit. Participants were asked to record the signs and symptom data for number of loose bowel movement, as experienced over the previous 24 hours, in the e-diary. Participant's signs and symptom average scores at each scheduled visit were calculated based on data recorded over the most recent 3 days (consecutive or nonconsecutive) of the last 10 days prior to the scheduled visit start date excluding the following days: day of any bowel preparation, day of endoscopy, any days between day of bowel preparation and day of endoscopy, and the 2 days after the day of endoscopy. Average number of loose bowel movement ranged from 0-27. Higher scores indicating more frequent bowel movements.</description>
          <population>FAS consisted of all participants in the randomized set who had received at least 1 dose of IP. Here, overall number of participants analyzed signifies participants who were evaluable for this outcome measure.</population>
          <units>Score on a Scale</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="47"/>
                <count group_id="O2" value="104"/>
                <count group_id="O3" value="107"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.41" spread="0.405"/>
                    <measurement group_id="O2" value="-3.50" spread="0.286"/>
                    <measurement group_id="O3" value="-2.87" spread="0.284"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Average Bowel Movements With Urgency Score Based on PRO-UC Daily e-Diary at Week 12</title>
        <description>PRO-UC signs and symptom data were collected using a daily e-diary during treatment period. Collection of daily e-diary data was begun at least 10 days before the baseline visit. Participants were asked to record the signs and symptom data for number of bowel movement with urgency, as experienced over the previous 24 hours. Participant's signs and symptom average scores at each scheduled visit were calculated based on data recorded over the most recent 3 days (consecutive or nonconsecutive) of the last 10 days prior to the scheduled visit start date excluding the following days: day of any bowel preparation, day of endoscopy, any days between day of bowel preparation and day of endoscopy, and the 2 days after the day of endoscopy. Average number bowel movements urgency ranged from 0 to 27. Higher scores indicating more frequent bowel movements.</description>
        <time_frame>Baseline, Week 12</time_frame>
        <population>FAS consisted of all participants in the randomized set who had received at least 1 dose of IP. Here, overall number of participants analyzed signifies participants who were evaluable for this outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Participants received placebo matched to ontamalimab subcutaneous (SC) injection, using a prefilled syringe (PFS) on Week 0, Week 4, and Week 8 in a 12-week treatment period.</description>
          </group>
          <group group_id="O2">
            <title>Ontamalimab 25 mg</title>
            <description>Participants received 25 milligrams (mg) of ontamalimab SC injection, using a PFS on Week 0, Week 4 and Week 8 in a 12-week treatment period.</description>
          </group>
          <group group_id="O3">
            <title>Ontamalimab 75 mg</title>
            <description>Participants received 75 mg of ontamalimab SC injection, using a PFS on Week 0, Week 4 and Week 8 in a 12-week treatment period.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Average Bowel Movements With Urgency Score Based on PRO-UC Daily e-Diary at Week 12</title>
          <description>PRO-UC signs and symptom data were collected using a daily e-diary during treatment period. Collection of daily e-diary data was begun at least 10 days before the baseline visit. Participants were asked to record the signs and symptom data for number of bowel movement with urgency, as experienced over the previous 24 hours. Participant's signs and symptom average scores at each scheduled visit were calculated based on data recorded over the most recent 3 days (consecutive or nonconsecutive) of the last 10 days prior to the scheduled visit start date excluding the following days: day of any bowel preparation, day of endoscopy, any days between day of bowel preparation and day of endoscopy, and the 2 days after the day of endoscopy. Average number bowel movements urgency ranged from 0 to 27. Higher scores indicating more frequent bowel movements.</description>
          <population>FAS consisted of all participants in the randomized set who had received at least 1 dose of IP. Here, overall number of participants analyzed signifies participants who were evaluable for this outcome measure.</population>
          <units>Score on a Scale</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="47"/>
                <count group_id="O2" value="104"/>
                <count group_id="O3" value="107"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.09" spread="0.373"/>
                    <measurement group_id="O2" value="-2.87" spread="0.263"/>
                    <measurement group_id="O3" value="-2.56" spread="0.264"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Absolute Stool Frequency (Average Number of Bowel Movements) Score Based on PRO-UC Daily e-Diary at Week 12</title>
        <description>PRO-UC signs and symptom data were collected using a daily e-diary during treatment period. Collection of daily e-diary data was begun at least 10 days before the baseline visit. Participants were asked to record the signs and symptom data for average number of bowel movements, as experienced over the previous 24 hours. Participant's signs and symptom average scores at each scheduled visit were calculated based on data recorded over the most recent 3 days (consecutive or nonconsecutive) of the last 10 days prior to the scheduled visit start date excluding the following days: day of any bowel preparation, day of endoscopy, any days between day of bowel preparation and day of endoscopy, and the 2 days after the day of endoscopy. Average number bowel movements ranged from 0 to 27. Higher scores indicating more frequent bowel movements.</description>
        <time_frame>Baseline, Week 12</time_frame>
        <population>FAS consisted of all participants in the randomized set who had received at least 1 dose of IP. Here, overall number of participants analyzed signifies participants who were evaluable for this outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Participants received placebo matched to ontamalimab subcutaneous (SC) injection, using a prefilled syringe (PFS) on Week 0, Week 4, and Week 8 in a 12-week treatment period.</description>
          </group>
          <group group_id="O2">
            <title>Ontamalimab 25 mg</title>
            <description>Participants received 25 milligrams (mg) of ontamalimab SC injection, using a PFS on Week 0, Week 4 and Week 8 in a 12-week treatment period.</description>
          </group>
          <group group_id="O3">
            <title>Ontamalimab 75 mg</title>
            <description>Participants received 75 mg of ontamalimab SC injection, using a PFS on Week 0, Week 4 and Week 8 in a 12-week treatment period.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Absolute Stool Frequency (Average Number of Bowel Movements) Score Based on PRO-UC Daily e-Diary at Week 12</title>
          <description>PRO-UC signs and symptom data were collected using a daily e-diary during treatment period. Collection of daily e-diary data was begun at least 10 days before the baseline visit. Participants were asked to record the signs and symptom data for average number of bowel movements, as experienced over the previous 24 hours. Participant's signs and symptom average scores at each scheduled visit were calculated based on data recorded over the most recent 3 days (consecutive or nonconsecutive) of the last 10 days prior to the scheduled visit start date excluding the following days: day of any bowel preparation, day of endoscopy, any days between day of bowel preparation and day of endoscopy, and the 2 days after the day of endoscopy. Average number bowel movements ranged from 0 to 27. Higher scores indicating more frequent bowel movements.</description>
          <population>FAS consisted of all participants in the randomized set who had received at least 1 dose of IP. Here, overall number of participants analyzed signifies participants who were evaluable for this outcome measure.</population>
          <units>Score on a Scale</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="47"/>
                <count group_id="O2" value="104"/>
                <count group_id="O3" value="107"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.26" spread="0.386"/>
                    <measurement group_id="O2" value="-3.32" spread="0.272"/>
                    <measurement group_id="O3" value="-2.97" spread="0.272"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Absolute Rectal Bleeding (Average Number Bowel Movements With Blood) Score Based on PRO-UC Daily e-Diary at Week 12</title>
        <description>PRO-UC signs and symptom data were collected using a daily e-diary during treatment period. Collection of daily e-diary data was begun at least 10 days before the baseline visit. Participants were asked to record the signs and symptom data for average number of bowel movements with blood, as experienced over the previous 24 hours. Participant's signs and symptom average scores at each scheduled visit were calculated based on data recorded over the most recent 3 days (consecutive or nonconsecutive) of the last 10 days prior to the scheduled visit start date excluding the following days: day of any bowel preparation, day of endoscopy, any days between day of bowel preparation and day of endoscopy, and the 2 days after the day of endoscopy. Average number bowel movements with blood ranged from 0 to 27. Higher scores indicating more frequent bowel movements with blood.</description>
        <time_frame>Baseline, Week 12</time_frame>
        <population>FAS consisted of all participants in the randomized set who had received at least 1 dose of IP. Here, overall number of participants analyzed signifies participants who were evaluable for this outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Participants received placebo matched to ontamalimab subcutaneous (SC) injection, using a prefilled syringe (PFS) on Week 0, Week 4, and Week 8 in a 12-week treatment period.</description>
          </group>
          <group group_id="O2">
            <title>Ontamalimab 25 mg</title>
            <description>Participants received 25 milligrams (mg) of ontamalimab SC injection, using a PFS on Week 0, Week 4 and Week 8 in a 12-week treatment period.</description>
          </group>
          <group group_id="O3">
            <title>Ontamalimab 75 mg</title>
            <description>Participants received 75 mg of ontamalimab SC injection, using a PFS on Week 0, Week 4 and Week 8 in a 12-week treatment period.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Absolute Rectal Bleeding (Average Number Bowel Movements With Blood) Score Based on PRO-UC Daily e-Diary at Week 12</title>
          <description>PRO-UC signs and symptom data were collected using a daily e-diary during treatment period. Collection of daily e-diary data was begun at least 10 days before the baseline visit. Participants were asked to record the signs and symptom data for average number of bowel movements with blood, as experienced over the previous 24 hours. Participant's signs and symptom average scores at each scheduled visit were calculated based on data recorded over the most recent 3 days (consecutive or nonconsecutive) of the last 10 days prior to the scheduled visit start date excluding the following days: day of any bowel preparation, day of endoscopy, any days between day of bowel preparation and day of endoscopy, and the 2 days after the day of endoscopy. Average number bowel movements with blood ranged from 0 to 27. Higher scores indicating more frequent bowel movements with blood.</description>
          <population>FAS consisted of all participants in the randomized set who had received at least 1 dose of IP. Here, overall number of participants analyzed signifies participants who were evaluable for this outcome measure.</population>
          <units>Score on a Scale</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="47"/>
                <count group_id="O2" value="104"/>
                <count group_id="O3" value="107"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-2.05" spread="0.379"/>
                    <measurement group_id="O2" value="-3.74" spread="0.267"/>
                    <measurement group_id="O3" value="-3.41" spread="0.265"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Total Sign/Symptom Score Based on PRO-UC Daily e-Diary at Week 12</title>
        <description>Total sign/symptom score was the average of the average scores of worst abdominal pain over the past 24 hours and the conversion scale values for number of bowel movements blood, number of bowel movements with urgency, number of bowel movements and number of loose bowel movements, with scale ranged of 0-10, with higher scores indicating higher severity.</description>
        <time_frame>Baseline, Week 12</time_frame>
        <population>FAS consisted of all participants in the randomized set who had received at least 1 dose of IP. Here, overall number of participants analyzed signifies participants who were evaluable for this outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Participants received placebo matched to ontamalimab subcutaneous (SC) injection, using a prefilled syringe (PFS) on Week 0, Week 4, and Week 8 in a 12-week treatment period.</description>
          </group>
          <group group_id="O2">
            <title>Ontamalimab 25 mg</title>
            <description>Participants received 25 milligrams (mg) of ontamalimab SC injection, using a PFS on Week 0, Week 4 and Week 8 in a 12-week treatment period.</description>
          </group>
          <group group_id="O3">
            <title>Ontamalimab 75 mg</title>
            <description>Participants received 75 mg of ontamalimab SC injection, using a PFS on Week 0, Week 4 and Week 8 in a 12-week treatment period.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Total Sign/Symptom Score Based on PRO-UC Daily e-Diary at Week 12</title>
          <description>Total sign/symptom score was the average of the average scores of worst abdominal pain over the past 24 hours and the conversion scale values for number of bowel movements blood, number of bowel movements with urgency, number of bowel movements and number of loose bowel movements, with scale ranged of 0-10, with higher scores indicating higher severity.</description>
          <population>FAS consisted of all participants in the randomized set who had received at least 1 dose of IP. Here, overall number of participants analyzed signifies participants who were evaluable for this outcome measure.</population>
          <units>Score on a Scale</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="47"/>
                <count group_id="O2" value="104"/>
                <count group_id="O3" value="107"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.15" spread="0.246"/>
                    <measurement group_id="O2" value="-2.32" spread="0.173"/>
                    <measurement group_id="O3" value="-2.00" spread="0.172"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) Domains Scores at Weeks 8 and 12</title>
        <description>IBDQ was a psychometrically validated participant-reported outcome (PRO) instrument for measuring the disease-specific health-related quality of life (HRQL) in participants with inflammatory bowel disease, including UC. The IBDQ consisted of 32 items, which were grouped into 4 dimensions: bowel function, emotional status, systemic symptoms, and social function. The 4 domains were scored as follows: Bowel symptoms: 10 to 70; Systemic symptoms: 5 to 35; Emotional function: 12 to 84; Social function: 5 to 35. Higher scores indicating a better quality of life.</description>
        <time_frame>Baseline, Weeks 8 and 12</time_frame>
        <population>FAS consisted of all participants in the randomized set who had received at least 1 dose of IP. Here, overall number of participants analyzed signifies participants who were evaluable for this outcome measure and number analyzed refer to participants evaluable at specific time point.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Participants received placebo matched to ontamalimab subcutaneous (SC) injection, using a prefilled syringe (PFS) on Week 0, Week 4, and Week 8 in a 12-week treatment period.</description>
          </group>
          <group group_id="O2">
            <title>Ontamalimab 25 mg</title>
            <description>Participants received 25 milligrams (mg) of ontamalimab SC injection, using a PFS on Week 0, Week 4 and Week 8 in a 12-week treatment period.</description>
          </group>
          <group group_id="O3">
            <title>Ontamalimab 75 mg</title>
            <description>Participants received 75 mg of ontamalimab SC injection, using a PFS on Week 0, Week 4 and Week 8 in a 12-week treatment period.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) Domains Scores at Weeks 8 and 12</title>
          <description>IBDQ was a psychometrically validated participant-reported outcome (PRO) instrument for measuring the disease-specific health-related quality of life (HRQL) in participants with inflammatory bowel disease, including UC. The IBDQ consisted of 32 items, which were grouped into 4 dimensions: bowel function, emotional status, systemic symptoms, and social function. The 4 domains were scored as follows: Bowel symptoms: 10 to 70; Systemic symptoms: 5 to 35; Emotional function: 12 to 84; Social function: 5 to 35. Higher scores indicating a better quality of life.</description>
          <population>FAS consisted of all participants in the randomized set who had received at least 1 dose of IP. Here, overall number of participants analyzed signifies participants who were evaluable for this outcome measure and number analyzed refer to participants evaluable at specific time point.</population>
          <units>Score on a Scale</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="53"/>
                <count group_id="O2" value="108"/>
                <count group_id="O3" value="106"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>IBDQ Bowel Function Dimension Score: Change at Week 8</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="53"/>
                    <count group_id="O2" value="108"/>
                    <count group_id="O3" value="106"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9.59" spread="1.611"/>
                    <measurement group_id="O2" value="16.66" spread="1.189"/>
                    <measurement group_id="O3" value="15.36" spread="1.180"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>IBDQ Bowel Function Dimension Score: Change at Week 12</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="50"/>
                    <count group_id="O2" value="104"/>
                    <count group_id="O3" value="106"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9.51" spread="1.707"/>
                    <measurement group_id="O2" value="17.71" spread="1.250"/>
                    <measurement group_id="O3" value="15.86" spread="1.232"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>IBDQ Emotional Status Dimension Score: Change at Week 8</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="53"/>
                    <count group_id="O2" value="108"/>
                    <count group_id="O3" value="106"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8.91" spread="1.701"/>
                    <measurement group_id="O2" value="15.18" spread="1.255"/>
                    <measurement group_id="O3" value="14.41" spread="1.247"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>IBDQ Emotional Status Dimension Score: Change at Week 12</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="50"/>
                    <count group_id="O2" value="104"/>
                    <count group_id="O3" value="106"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9.94" spread="1.861"/>
                    <measurement group_id="O2" value="14.84" spread="1.359"/>
                    <measurement group_id="O3" value="14.73" spread="1.341"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>IBDQ Systemic Symptoms Dimension Score: Change at Week 8</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="53"/>
                    <count group_id="O2" value="108"/>
                    <count group_id="O3" value="106"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.84" spread="0.759"/>
                    <measurement group_id="O2" value="6.61" spread="0.561"/>
                    <measurement group_id="O3" value="5.86" spread="0.557"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>IBDQ Systemic Symptoms Dimension Score: Change at Week 12</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="50"/>
                    <count group_id="O2" value="104"/>
                    <count group_id="O3" value="106"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.85" spread="0.814"/>
                    <measurement group_id="O2" value="7.34" spread="0.596"/>
                    <measurement group_id="O3" value="6.04" spread="0.587"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>IBDQ Social Function Dimension Score: Change at Week 8</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="53"/>
                    <count group_id="O2" value="108"/>
                    <count group_id="O3" value="106"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.06" spread="0.873"/>
                    <measurement group_id="O2" value="6.97" spread="0.643"/>
                    <measurement group_id="O3" value="6.75" spread="0.640"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>IBDQ Social Function Dimension Score: Change at Week 12</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="50"/>
                    <count group_id="O2" value="104"/>
                    <count group_id="O3" value="106"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.09" spread="0.926"/>
                    <measurement group_id="O2" value="7.68" spread="0.677"/>
                    <measurement group_id="O3" value="7.03" spread="0.668"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in IBDQ Total Scores at Weeks 8 and 12</title>
        <description>IBDQ was a psychometrically validated PRO instrument for measuring the disease-specific HRQL in participants with inflammatory bowel disease, included UC. The IBDQ consisted of 32 items, which were grouped into 4 dimensions: bowel function, emotional status, systemic symptoms, and social function. The 4 domains were scored as follows: Bowel symptoms: 10 to 70; Systemic symptoms: 5 to 35; Emotional function: 12 to 84; Social function: 5 to 35. The total IBDQ score ranged from 32 to 224. For the total score and each domain, a higher score indicating better HRQL. A score of at least 170 corresponds to clinical remission and an increase of at least 16 points was considered to indicate a clinically meaningful improvement.</description>
        <time_frame>Baseline, Weeks 8 and 12</time_frame>
        <population>FAS consisted of all participants in the randomized set who had received at least 1 dose of IP. Here, overall number of participants analyzed signifies participants who were evaluable for this outcome measure and number analyzed refer to participants evaluable at specific time point.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Participants received placebo matched to ontamalimab subcutaneous (SC) injection, using a prefilled syringe (PFS) on Week 0, Week 4, and Week 8 in a 12-week treatment period.</description>
          </group>
          <group group_id="O2">
            <title>Ontamalimab 25 mg</title>
            <description>Participants received 25 milligrams (mg) of ontamalimab SC injection, using a PFS on Week 0, Week 4 and Week 8 in a 12-week treatment period.</description>
          </group>
          <group group_id="O3">
            <title>Ontamalimab 75 mg</title>
            <description>Participants received 75 mg of ontamalimab SC injection, using a PFS on Week 0, Week 4 and Week 8 in a 12-week treatment period.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in IBDQ Total Scores at Weeks 8 and 12</title>
          <description>IBDQ was a psychometrically validated PRO instrument for measuring the disease-specific HRQL in participants with inflammatory bowel disease, included UC. The IBDQ consisted of 32 items, which were grouped into 4 dimensions: bowel function, emotional status, systemic symptoms, and social function. The 4 domains were scored as follows: Bowel symptoms: 10 to 70; Systemic symptoms: 5 to 35; Emotional function: 12 to 84; Social function: 5 to 35. The total IBDQ score ranged from 32 to 224. For the total score and each domain, a higher score indicating better HRQL. A score of at least 170 corresponds to clinical remission and an increase of at least 16 points was considered to indicate a clinically meaningful improvement.</description>
          <population>FAS consisted of all participants in the randomized set who had received at least 1 dose of IP. Here, overall number of participants analyzed signifies participants who were evaluable for this outcome measure and number analyzed refer to participants evaluable at specific time point.</population>
          <units>Score on a Scale</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="53"/>
                <count group_id="O2" value="108"/>
                <count group_id="O3" value="106"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Change at Week 8</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="53"/>
                    <count group_id="O2" value="108"/>
                    <count group_id="O3" value="106"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="27.56" spread="4.574"/>
                    <measurement group_id="O2" value="45.63" spread="3.380"/>
                    <measurement group_id="O3" value="42.58" spread="3.358"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Week 12</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="50"/>
                    <count group_id="O2" value="104"/>
                    <count group_id="O3" value="106"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="28.39" spread="4.990"/>
                    <measurement group_id="O2" value="47.75" spread="3.649"/>
                    <measurement group_id="O3" value="43.85" spread="3.604"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Short Form-36 Health Survey (SF-36), Version 2, Acute (Physical and Mental Component Summary Scores) at Week 12</title>
        <description>SF-36 was a generic quality-of-life instrument that had been widely used to assess health-related quality of life (HRQL) of participants. SF-36 consisted of 36 items that were aggregated into 8 multi-item scales (physical functioning [1=yes, limited a lot to 3=no, not limited at all], role-physical [1=all of the time to 5=none of the time], bodily pain [1=very severe to 6=none], general health [1=poor to 5=excellent], vitality [1=none of the time to 5=all of the time], social functioning [1=all of the time: to 5=none of the time], role emotional [1=all of the time to 5=none of the time] and mental health [1=all of the time to 5=none of the time]). Four domains comprised physical component summary (PCS) score (physical functioning, role-physical, bodily pain, general health) and remaining 4 domains comprised mental component summary (MCS) score (vitality, social functioning, role-emotional, mental health). The scores ranged from 0 to 100. Higher scores indicating better HRQL.</description>
        <time_frame>Baseline, Week 12</time_frame>
        <population>FAS consisted of all participants in the randomized set who had received at least 1 dose of IP. Here, overall number of participants analyzed signifies participants who were evaluable for this outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Participants received placebo matched to ontamalimab subcutaneous (SC) injection, using a prefilled syringe (PFS) on Week 0, Week 4, and Week 8 in a 12-week treatment period.</description>
          </group>
          <group group_id="O2">
            <title>Ontamalimab 25 mg</title>
            <description>Participants received 25 milligrams (mg) of ontamalimab SC injection, using a PFS on Week 0, Week 4 and Week 8 in a 12-week treatment period.</description>
          </group>
          <group group_id="O3">
            <title>Ontamalimab 75 mg</title>
            <description>Participants received 75 mg of ontamalimab SC injection, using a PFS on Week 0, Week 4 and Week 8 in a 12-week treatment period.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Short Form-36 Health Survey (SF-36), Version 2, Acute (Physical and Mental Component Summary Scores) at Week 12</title>
          <description>SF-36 was a generic quality-of-life instrument that had been widely used to assess health-related quality of life (HRQL) of participants. SF-36 consisted of 36 items that were aggregated into 8 multi-item scales (physical functioning [1=yes, limited a lot to 3=no, not limited at all], role-physical [1=all of the time to 5=none of the time], bodily pain [1=very severe to 6=none], general health [1=poor to 5=excellent], vitality [1=none of the time to 5=all of the time], social functioning [1=all of the time: to 5=none of the time], role emotional [1=all of the time to 5=none of the time] and mental health [1=all of the time to 5=none of the time]). Four domains comprised physical component summary (PCS) score (physical functioning, role-physical, bodily pain, general health) and remaining 4 domains comprised mental component summary (MCS) score (vitality, social functioning, role-emotional, mental health). The scores ranged from 0 to 100. Higher scores indicating better HRQL.</description>
          <population>FAS consisted of all participants in the randomized set who had received at least 1 dose of IP. Here, overall number of participants analyzed signifies participants who were evaluable for this outcome measure.</population>
          <units>Score on a Scale</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="50"/>
                <count group_id="O2" value="104"/>
                <count group_id="O3" value="106"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Physical Component Summary: Change at Week 12</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.84" spread="0.982"/>
                    <measurement group_id="O2" value="6.45" spread="0.721"/>
                    <measurement group_id="O3" value="5.54" spread="0.709"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Mental Component Summary: Change at Week 12</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.09" spread="1.301"/>
                    <measurement group_id="O2" value="7.37" spread="0.949"/>
                    <measurement group_id="O3" value="6.68" spread="0.935"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Short Form-36 Health Survey (SF-36), Version 2, Acute (Individual Domain Scores) at Week 12</title>
        <description>SF-36 was a generic quality-of-life instrument that had been widely used to assess HRQL of participants. Generic instruments were used in general populations to assess a wide range of domains applicable to a variety of health states, conditions, and diseases. The SF-36 consisted of 36 items that were aggregated into 8 multi-item scales (physical functioning [1=yes, limited a lot to 3=no, not limited at all], role-physical [1=all of the time to 5=none of the time], bodily pain [1=very severe to 6=none], general health [1=poor to 5=excellent], vitality [1=none of the time to 5=all of the time], social functioning [1=all of the time: to 5=none of the time], role emotional [1=all of the time to 5=none of the time] and mental health [1=all of the time to 5=none of the time]), with scores ranged from 0 to 100. Higher scores indicating better HRQL.</description>
        <time_frame>Baseline, Week 12</time_frame>
        <population>FAS consisted of all participants in the randomized set who had received at least 1 dose of IP. Here, overall number of participants analyzed signifies participants who were evaluable for this outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Participants received placebo matched to ontamalimab subcutaneous (SC) injection, using a prefilled syringe (PFS) on Week 0, Week 4, and Week 8 in a 12-week treatment period.</description>
          </group>
          <group group_id="O2">
            <title>Ontamalimab 25 mg</title>
            <description>Participants received 25 milligrams (mg) of ontamalimab SC injection, using a PFS on Week 0, Week 4 and Week 8 in a 12-week treatment period.</description>
          </group>
          <group group_id="O3">
            <title>Ontamalimab 75 mg</title>
            <description>Participants received 75 mg of ontamalimab SC injection, using a PFS on Week 0, Week 4 and Week 8 in a 12-week treatment period.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Short Form-36 Health Survey (SF-36), Version 2, Acute (Individual Domain Scores) at Week 12</title>
          <description>SF-36 was a generic quality-of-life instrument that had been widely used to assess HRQL of participants. Generic instruments were used in general populations to assess a wide range of domains applicable to a variety of health states, conditions, and diseases. The SF-36 consisted of 36 items that were aggregated into 8 multi-item scales (physical functioning [1=yes, limited a lot to 3=no, not limited at all], role-physical [1=all of the time to 5=none of the time], bodily pain [1=very severe to 6=none], general health [1=poor to 5=excellent], vitality [1=none of the time to 5=all of the time], social functioning [1=all of the time: to 5=none of the time], role emotional [1=all of the time to 5=none of the time] and mental health [1=all of the time to 5=none of the time]), with scores ranged from 0 to 100. Higher scores indicating better HRQL.</description>
          <population>FAS consisted of all participants in the randomized set who had received at least 1 dose of IP. Here, overall number of participants analyzed signifies participants who were evaluable for this outcome measure.</population>
          <units>Score on a Scale</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="50"/>
                <count group_id="O2" value="104"/>
                <count group_id="O3" value="106"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Physical Functioning: Change at Week 12</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.40" spread="0.901"/>
                    <measurement group_id="O2" value="5.03" spread="0.657"/>
                    <measurement group_id="O3" value="3.79" spread="0.646"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Role-Physical: Change at Week 12</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.47" spread="1.205"/>
                    <measurement group_id="O2" value="7.39" spread="0.884"/>
                    <measurement group_id="O3" value="6.90" spread="0.874"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Bodily Pain: Change at Week 12</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.55" spread="1.293"/>
                    <measurement group_id="O2" value="8.18" spread="0.941"/>
                    <measurement group_id="O3" value="7.06" spread="0.926"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>General Health: Change at Week 12</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.93" spread="1.203"/>
                    <measurement group_id="O2" value="7.00" spread="0.880"/>
                    <measurement group_id="O3" value="6.34" spread="0.865"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Vitality: Change at Week 12</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.59" spread="1.381"/>
                    <measurement group_id="O2" value="8.23" spread="1.008"/>
                    <measurement group_id="O3" value="7.43" spread="0.993"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Social Functioning: Change at Week 12</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.59" spread="1.233"/>
                    <measurement group_id="O2" value="7.43" spread="0.898"/>
                    <measurement group_id="O3" value="6.54" spread="0.884"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Role-Emotional: Change at Week 12</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.27" spread="1.317"/>
                    <measurement group_id="O2" value="5.79" spread="0.958"/>
                    <measurement group_id="O3" value="5.68" spread="0.944"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Mental Health: Change at Week 12</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.56" spread="1.268"/>
                    <measurement group_id="O2" value="7.90" spread="0.925"/>
                    <measurement group_id="O3" value="6.47" spread="0.911"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants Based on Inpatient Hospitalization</title>
        <description>Number of participants based on inpatient hospitalization due to all-cause hospitalization, gastrointestinal related, other illness/problem, and undergo gastrointestinal related procedures during the entire study period were reported.</description>
        <time_frame>From start of study up to follow up (Week 29)</time_frame>
        <population>FAS consisted of all participants in the randomized set who had received at least 1 dose of IP.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Participants received placebo matched to ontamalimab subcutaneous (SC) injection, using a prefilled syringe (PFS) on Week 0, Week 4, and Week 8 in a 12-week treatment period.</description>
          </group>
          <group group_id="O2">
            <title>Ontamalimab 25 mg</title>
            <description>Participants received 25 milligrams (mg) of ontamalimab SC injection, using a PFS on Week 0, Week 4 and Week 8 in a 12-week treatment period.</description>
          </group>
          <group group_id="O3">
            <title>Ontamalimab 75 mg</title>
            <description>Participants received 75 mg of ontamalimab SC injection, using a PFS on Week 0, Week 4 and Week 8 in a 12-week treatment period.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants Based on Inpatient Hospitalization</title>
          <description>Number of participants based on inpatient hospitalization due to all-cause hospitalization, gastrointestinal related, other illness/problem, and undergo gastrointestinal related procedures during the entire study period were reported.</description>
          <population>FAS consisted of all participants in the randomized set who had received at least 1 dose of IP.</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="56"/>
                <count group_id="O2" value="111"/>
                <count group_id="O3" value="112"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>All-Cause Hospitalization</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="3"/>
                    <measurement group_id="O3" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Gastrointestinal Related</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="2"/>
                    <measurement group_id="O3" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Other Illness/Problem</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="2"/>
                    <measurement group_id="O3" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Undergo Gastrointestinal Related Procedures</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Median Duration of Total Inpatient Days</title>
        <description>Inpatient days were calculated as Date of discharge - Date of admission + 1. Median duration of total inpatient days during the entire study period was reported.</description>
        <time_frame>From start of study up to follow-up (Week 29)</time_frame>
        <population>FAS consisted of all participants in the randomized set who had received at least 1 dose of IP. Here, overall number of participants analyzed signifies participants who were evaluable for this outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Participants received placebo matched to ontamalimab subcutaneous (SC) injection, using a prefilled syringe (PFS) on Week 0, Week 4, and Week 8 in a 12-week treatment period.</description>
          </group>
          <group group_id="O2">
            <title>Ontamalimab 25 mg</title>
            <description>Participants received 25 milligrams (mg) of ontamalimab SC injection, using a PFS on Week 0, Week 4 and Week 8 in a 12-week treatment period.</description>
          </group>
          <group group_id="O3">
            <title>Ontamalimab 75 mg</title>
            <description>Participants received 75 mg of ontamalimab SC injection, using a PFS on Week 0, Week 4 and Week 8 in a 12-week treatment period.</description>
          </group>
        </group_list>
        <measure>
          <title>Median Duration of Total Inpatient Days</title>
          <description>Inpatient days were calculated as Date of discharge - Date of admission + 1. Median duration of total inpatient days during the entire study period was reported.</description>
          <population>FAS consisted of all participants in the randomized set who had received at least 1 dose of IP. Here, overall number of participants analyzed signifies participants who were evaluable for this outcome measure.</population>
          <units>Days</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="2"/>
                <count group_id="O2" value="3"/>
                <count group_id="O3" value="2"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10.5" lower_limit="6" upper_limit="15"/>
                    <measurement group_id="O2" value="7.0" lower_limit="6" upper_limit="11"/>
                    <measurement group_id="O3" value="2.0" lower_limit="2" upper_limit="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>From start of study drug administration up to follow-up (Week 29)</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Placebo</title>
          <description>Participants received placebo matched to ontamalimab subcutaneous (SC) injection using a prefilled syringe (PFS) on Week 0, Week 4, and Week 8.</description>
        </group>
        <group group_id="E2">
          <title>Ontamalimab 25 mg</title>
          <description>Participants received 25 milligram (mg) of ontamalimab SC injection using a PFS on Week 0, Week 4 and Week 8.</description>
        </group>
        <group group_id="E3">
          <title>Ontamalimab 75 mg</title>
          <description>Participants received 75 mg of ontamalimab SC injection using PFS on Week 0, Week 4 and Week 8.</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>MedDRA 19.1</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="56"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="111"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="112"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="56"/>
                <counts group_id="E2" subjects_affected="5" subjects_at_risk="111"/>
                <counts group_id="E3" subjects_affected="3" subjects_at_risk="112"/>
              </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="56"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="111"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="112"/>
              </event>
              <event>
                <sub_title>Leukopenia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="56"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="111"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="112"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Supraventricular tachycardia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="56"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="111"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="112"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Colitis ulcerative</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="56"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="111"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="112"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Asthenia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="56"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="111"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="112"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Pneumonia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="56"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="111"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="112"/>
              </event>
              <event>
                <sub_title>Rash pustular</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="56"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="111"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="112"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="56"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="111"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="112"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Hydrocalyx</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="56"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="111"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="112"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <default_vocab>MedDRA 19.1</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="7" subjects_at_risk="56"/>
                <counts group_id="E2" subjects_affected="5" subjects_at_risk="111"/>
                <counts group_id="E3" subjects_affected="7" subjects_at_risk="112"/>
              </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="5" subjects_affected="4" subjects_at_risk="56"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="111"/>
                <counts group_id="E3" events="9" subjects_affected="7" subjects_at_risk="112"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" events="5" subjects_affected="4" subjects_at_risk="56"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="111"/>
                <counts group_id="E3" events="3" subjects_affected="2" subjects_at_risk="112"/>
              </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>If a multicenter publication is not submitted within twelve (12) months after conclusion, abandonment or termination of the Study at all sites, or after Sponsor confirms there shall be no multicenter Study publication, the Institution and/or such Principal Investigator may publish the results from the Institution site individually.</restrictive_agreement>
    </certain_agreements>
    <limitations_and_caveats>The study was terminated as per the sponsor decision to discontinue the SHP647 (ontamalimab) clinical trial development program for inflammatory bowel diseases (IBD) early.</limitations_and_caveats>
    <point_of_contact>
      <name_or_title>Study Director</name_or_title>
      <organization>Shire</organization>
      <phone>+1 866 842 5335</phone>
      <email>ClinicalTransparency@takeda.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/NCT03259308
org study id: SHP647-302
secondary id: 2017-000572-28
nct id: NCT03259308
lead sponsor: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
The purpose of this study is to evaluate the efficacy of SHP647 in inducing remission, based
      on composite score of patient-reported symptoms and centrally read endoscopy, in participants
      with moderate to severe ulcerative colitis (UC).
27Mar2020: Enrollment of new patients into this study has been paused due to the COVID-19
      situation. The duration of this pause is dependent on the leveling and control of the
      COVID-19 pandemic.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: Number of Participants With Remission Based on Composite Score at Week 12
time frame: At Week 12
description: Remission was defined as a composite score of patient-reported symptoms using daily e-diary and centrally read endoscopy as stool frequency sub-score of 0 or 1 with at least a 1-point change from baseline, rectal bleeding sub-score of 0 and endoscopic sub-score of 0 or 1 (modified, excluded friability). The composite score was a recommended measure derived from the Mayo score without the physician global assessment (PGA) sub-score and ranged from 0 to 9 points. The Mayo score was a measure of Ulcerative Colitis (UC) disease activity. It ranged from 0 to 12 points and consisted of 4 sub-scores, each graded from 0 to 3 with higher scores indicating more severe disease. The sub-scores were stool frequency (0-3); rectal bleeding (0-3); findings of endoscopy (0-3); PGA (0-3).
measure: Number of Participants With Endoscopic Remission at Week 12
time frame: At Week 12
description: Endoscopic remission was defined by centrally read endoscopic sub-score 0 or 1 (modified, excluded friability). The centrally read endoscopic sub-score of Mayo score ranged from 0 to 3 with higher scores indicating more severe disease.
measure: Number of Participants With Clinical Remission at Week 12
time frame: At Week 12
description: Clinical remission was defined by stool frequency sub-score of 0 or 1 with at least a 1-point change from baseline in stool frequency sub-score, and rectal bleeding sub-score of 0. The stool frequency sub-score and rectal bleeding sub-score ranged from 0 to 3 with higher scores indicating more severe disease.
measure: Number of Participants With Clinical Response Based on Composite Score at Week 12
time frame: At Week 12
description: Clinical response based on composite score was defined as a decrease from baseline in the composite score of patient-reported symptoms using daily e-diary and centrally read endoscopy of at least 2 points and at least 30 percent (%), with an accompanying decrease in the sub-score for rectal bleeding greater than or equal to (>=) 1 point or a sub-score for rectal bleeding less than or equal to (<=) 1. The composite score was a recommended measure derived from the Mayo score without the PGA sub-score and ranged from 0 to 9 points. The Mayo score was a measure of UC disease activity. It ranged from 0 to 12 points and consisted of 4 sub-scores, each graded from 0 to 3 with higher scores indicating more severe disease The sub-scores were stool frequency (0-3); rectal bleeding (0-3); findings of endoscopy (0-3); PGA (0-3).
measure: Number of Participants With Mucosal Healing Based on Endoscopic and Histological Assessment Using the Geboes Score Grading System at Week 12
time frame: At Week 12
description: Mucosal healing was defined by centrally read endoscopic sub-score 0 or 1 (modified, excluded friability) and centrally read Geboes score of <=2. The centrally read endoscopic sub-score of Mayo score ranged from 0 to 3 with higher scores indicating more severe disease. Geboes score grading system, was a validated score for evaluating histologic disease activity in UC as follows: grade 0 equal to (=) structural and architectural changes; grade 1 = chronic inflammatory infiltrate; grade 2 = lamina propria neutrophils and eosinophils; grade 3 = neutrophils in the epithelium; grade 4 = crypt destruction; grade 5 = erosions or ulceration. A higher Geboes score indicating more severe disease. Number of participants with mucosal healing based on endoscopic and histological assessment using the Geboes score grading system were reported.
measure: Number of Participants With Remission Based on Total Mayo Score at Week 12
time frame: At Week 12
description: Remission was defined as a Total Mayo score of <=2 with no individual sub-score (stool frequency, rectal bleeding, endoscopy [modified, excluded friability], and PGA) exceeding 1, at the Week 12. The Total Mayo score ranged from 0 to 12 points and consisted of 4 sub-scores, each graded from 0 to 3 with higher scores indicating more severe disease: stool frequency (0-3); rectal bleeding (0-3); findings of endoscopy (0-3); PGA (0-3).
measure: Number of Participants With Clinical Response Based on Total Mayo Score at Week 12
time frame: At Week 12
description: Clinical response (Mayo) was defined as a decrease from baseline in the Total Mayo score of at least 3 points and at least 30%, with an accompanying decrease in the sub-score for rectal bleeding >=1 point or an absolute sub-score for rectal bleeding <=1. The Total Mayo score ranged from 0 to 12 points and consisted of the following 4 sub-scores, each graded from 0 to 3 with higher scores indicating more severe disease: stool frequency (0-3); rectal bleeding (0-3); findings of endoscopy (0-3); PGA (0-3).
measure: Number of Participants With Partial Mayo Score <=2 With no Individual Sub-score Greater Than (>) 1 at Weeks 4, 8, and 12
time frame: At Weeks 4, 8, and 12
description: The partial Mayo score ranged from 0 to 9 points and consisted of the following 3 sub-scores, each graded from 0 to 3 with higher scores indicating more severe disease: Stool frequency (0-3); Rectal bleeding (0-3); PGA (0-3). The partial Mayo score did not include the endoscopy sub-score.
measure: Number of Participants With Clinical Remission With Stool Frequency Sub-scores of 0 or 1 and Rectal Bleeding Sub-score of 0 at Weeks 4 and 8
time frame: At Weeks 4 and 8
description: Number of participants were reported with stool frequency sub-scores of 0 or 1 and rectal bleeding sub-score of 0. Clinical remission was defined as stool frequency sub-score of 0 or 1 with at least a 1-point change from baseline in stool frequency sub-score, and a rectal bleeding sub-score of 0. The stool frequency sub-score and rectal bleeding sub-score of Mayo score ranges from 0 to 3 with higher scores indicating more severe disease.
measure: Number of Participants With Endoscopic Remission With Sub-score of 0 at Week 12
time frame: At Week 12
description: Endoscopic remission was defined by centrally read endoscopic sub-score 0 (modified, excluded friability). The centrally read endoscopic sub-score of Mayo score ranged from 0 to 3 with higher scores indicating more severe disease.
measure: Number of Participants With Clinical Remission With Both Rectal Bleeding and Stool Frequency Sub-scores of 0 at Weeks 4, 8, and 12
time frame: At Weeks 4, 8, and 12
description: Number of participants were reported with rectal bleeding and stool frequency sub-scores of 0. Clinical remission was defined as both rectal bleeding and stool frequency sub-scores of 0. The stool frequency sub-score and rectal bleeding sub-score of Mayo score ranges from 0 to 3 with higher scores indicating more severe disease.
measure: Number of Participants With Deep Remission at Week 12
time frame: At Week 12
description: Deep remission was defined as both endoscopic and rectal bleeding sub-scores of 0, and stool frequency sub-score <=1 and a centrally read Geboes score of <=2. The stool frequency sub-score, rectal bleeding sub-score and endoscopic sub-score of Mayo score ranged from 0 to 3 with higher scores indicating more severe disease. The composite score was a recommended measure consisted of the Mayo score without the PGA sub-score and ranged from 0 to 9 points. Geboes score grading system was a validated score for evaluating histologic disease activity in UC as follows: grade 0 = structural and architectural changes; grade 1 = chronic inflammatory infiltrate; grade 2 = lamina propria neutrophils and eosinophils; grade 3 = neutrophils in the epithelium; grade 4 = crypt destruction; grade 5 = erosions or ulceration. A higher Geboes score indicating more severe disease.
measure: Change From Baseline in Average Worst Abdominal Pain Score Based on Patient Reported Outcome-ulcerative Colitis (PRO-UC) Daily e-Diary at Week 12
time frame: Baseline, Week 12
description: PRO-UC signs and symptom data were collected using a daily e-diary during treatment period. Collection of daily e-diary data was begun at least 10 days before the baseline visit. Participants were asked to record the signs and symptom data of abdominal pain worst severity, as experienced over the previous 24 hours, in the e-diary. Participant's signs and symptom average scores at each scheduled visit were calculated based on data recorded over the most recent 3 days (consecutive or non-consecutive) of last 10 days prior to the scheduled visit start date excluding the following days: day of any bowel preparation, day of endoscopy, any days between day of bowel preparation and day of endoscopy, and the 2 days after the day of endoscopy. Abdominal pain's worst severity assessment was based on an 11-point numerical rating scale with 0 anchor at "No pain" and 10 at "Worst Imaginable Pain" as experienced over the previous 24 hours, in the e-diary. Higher scores indicating more severe pain.
measure: Change From Baseline in Diarrhea (Average Loose Bowel Movements) Score Based on PRO-UC Daily e-Diary at Week 12
time frame: Baseline, Week 12
description: PRO-UC signs and symptom data were collected using a daily e-diary during treatment period. Collection of daily e-diary data was begun at least 10 days before the baseline visit. Participants were asked to record the signs and symptom data for number of loose bowel movement, as experienced over the previous 24 hours, in the e-diary. Participant's signs and symptom average scores at each scheduled visit were calculated based on data recorded over the most recent 3 days (consecutive or nonconsecutive) of the last 10 days prior to the scheduled visit start date excluding the following days: day of any bowel preparation, day of endoscopy, any days between day of bowel preparation and day of endoscopy, and the 2 days after the day of endoscopy. Average number of loose bowel movement ranged from 0-27. Higher scores indicating more frequent bowel movements.
measure: Change From Baseline in Average Bowel Movements With Urgency Score Based on PRO-UC Daily e-Diary at Week 12
time frame: Baseline, Week 12
description: PRO-UC signs and symptom data were collected using a daily e-diary during treatment period. Collection of daily e-diary data was begun at least 10 days before the baseline visit. Participants were asked to record the signs and symptom data for number of bowel movement with urgency, as experienced over the previous 24 hours. Participant's signs and symptom average scores at each scheduled visit were calculated based on data recorded over the most recent 3 days (consecutive or nonconsecutive) of the last 10 days prior to the scheduled visit start date excluding the following days: day of any bowel preparation, day of endoscopy, any days between day of bowel preparation and day of endoscopy, and the 2 days after the day of endoscopy. Average number bowel movements urgency ranged from 0 to 27. Higher scores indicating more frequent bowel movements.
measure: Change From Baseline in Absolute Stool Frequency (Average Number of Bowel Movements) Score Based on PRO-UC Daily e-Diary at Week 12
time frame: Baseline, Week 12
description: PRO-UC signs and symptom data were collected using a daily e-diary during treatment period. Collection of daily e-diary data was begun at least 10 days before the baseline visit. Participants were asked to record the signs and symptom data for average number of bowel movements, as experienced over the previous 24 hours. Participant's signs and symptom average scores at each scheduled visit were calculated based on data recorded over the most recent 3 days (consecutive or nonconsecutive) of the last 10 days prior to the scheduled visit start date excluding the following days: day of any bowel preparation, day of endoscopy, any days between day of bowel preparation and day of endoscopy, and the 2 days after the day of endoscopy. Average number bowel movements ranged from 0 to 27. Higher scores indicating more frequent bowel movements.
measure: Change From Baseline in Absolute Rectal Bleeding (Average Number Bowel Movements With Blood) Score Based on PRO-UC Daily e-Diary at Week 12
time frame: Baseline, Week 12
description: PRO-UC signs and symptom data were collected using a daily e-diary during treatment period. Collection of daily e-diary data was begun at least 10 days before the baseline visit. Participants were asked to record the signs and symptom data for average number of bowel movements with blood, as experienced over the previous 24 hours. Participant's signs and symptom average scores at each scheduled visit were calculated based on data recorded over the most recent 3 days (consecutive or nonconsecutive) of the last 10 days prior to the scheduled visit start date excluding the following days: day of any bowel preparation, day of endoscopy, any days between day of bowel preparation and day of endoscopy, and the 2 days after the day of endoscopy. Average number bowel movements with blood ranged from 0 to 27. Higher scores indicating more frequent bowel movements with blood.
measure: Change From Baseline in Total Sign/Symptom Score Based on PRO-UC Daily e-Diary at Week 12
time frame: Baseline, Week 12
description: Total sign/symptom score was the average of the average scores of worst abdominal pain over the past 24 hours and the conversion scale values for number of bowel movements blood, number of bowel movements with urgency, number of bowel movements and number of loose bowel movements, with scale ranged of 0-10, with higher scores indicating higher severity.
measure: Change From Baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) Domains Scores at Weeks 8 and 12
time frame: Baseline, Weeks 8 and 12
description: IBDQ was a psychometrically validated participant-reported outcome (PRO) instrument for measuring the disease-specific health-related quality of life (HRQL) in participants with inflammatory bowel disease, including UC. The IBDQ consisted of 32 items, which were grouped into 4 dimensions: bowel function, emotional status, systemic symptoms, and social function. The 4 domains were scored as follows: Bowel symptoms: 10 to 70; Systemic symptoms: 5 to 35; Emotional function: 12 to 84; Social function: 5 to 35. Higher scores indicating a better quality of life.
measure: Change From Baseline in IBDQ Total Scores at Weeks 8 and 12
time frame: Baseline, Weeks 8 and 12
description: IBDQ was a psychometrically validated PRO instrument for measuring the disease-specific HRQL in participants with inflammatory bowel disease, included UC. The IBDQ consisted of 32 items, which were grouped into 4 dimensions: bowel function, emotional status, systemic symptoms, and social function. The 4 domains were scored as follows: Bowel symptoms: 10 to 70; Systemic symptoms: 5 to 35; Emotional function: 12 to 84; Social function: 5 to 35. The total IBDQ score ranged from 32 to 224. For the total score and each domain, a higher score indicating better HRQL. A score of at least 170 corresponds to clinical remission and an increase of at least 16 points was considered to indicate a clinically meaningful improvement.
measure: Change From Baseline in Short Form-36 Health Survey (SF-36), Version 2, Acute (Physical and Mental Component Summary Scores) at Week 12
time frame: Baseline, Week 12
description: SF-36 was a generic quality-of-life instrument that had been widely used to assess health-related quality of life (HRQL) of participants. SF-36 consisted of 36 items that were aggregated into 8 multi-item scales (physical functioning [1=yes, limited a lot to 3=no, not limited at all], role-physical [1=all of the time to 5=none of the time], bodily pain [1=very severe to 6=none], general health [1=poor to 5=excellent], vitality [1=none of the time to 5=all of the time], social functioning [1=all of the time: to 5=none of the time], role emotional [1=all of the time to 5=none of the time] and mental health [1=all of the time to 5=none of the time]). Four domains comprised physical component summary (PCS) score (physical functioning, role-physical, bodily pain, general health) and remaining 4 domains comprised mental component summary (MCS) score (vitality, social functioning, role-emotional, mental health). The scores ranged from 0 to 100. Higher scores indicating better HRQL.
measure: Change From Baseline in Short Form-36 Health Survey (SF-36), Version 2, Acute (Individual Domain Scores) at Week 12
time frame: Baseline, Week 12
description: SF-36 was a generic quality-of-life instrument that had been widely used to assess HRQL of participants. Generic instruments were used in general populations to assess a wide range of domains applicable to a variety of health states, conditions, and diseases. The SF-36 consisted of 36 items that were aggregated into 8 multi-item scales (physical functioning [1=yes, limited a lot to 3=no, not limited at all], role-physical [1=all of the time to 5=none of the time], bodily pain [1=very severe to 6=none], general health [1=poor to 5=excellent], vitality [1=none of the time to 5=all of the time], social functioning [1=all of the time: to 5=none of the time], role emotional [1=all of the time to 5=none of the time] and mental health [1=all of the time to 5=none of the time]), with scores ranged from 0 to 100. Higher scores indicating better HRQL.
measure: Number of Participants Based on Inpatient Hospitalization
time frame: From start of study up to follow up (Week 29)
description: Number of participants based on inpatient hospitalization due to all-cause hospitalization, gastrointestinal related, other illness/problem, and undergo gastrointestinal related procedures during the entire study period were reported.
measure: Median Duration of Total Inpatient Days
time frame: From start of study up to follow-up (Week 29)
description: Inpatient days were calculated as Date of discharge - Date of admission + 1. Median duration of total inpatient days during the entire study period was reported.
arm group label: Ontamalimab 25 mg
arm group type: Experimental
description: Participants will receive 25 milligram (mg) of ontamalimab subcutaneous (SC) injection using a prefilled syringe (PFS) on Week 0, Week 4 and Week 8.
arm group label: Ontamalimab 75 mg
arm group type: Experimental
description: Participants will receive 75 mg of ontamalimab SC injection using PFS on Week 0, Week 4 and Week 8.
arm group label: Placebo
arm group type: Placebo Comparator
description: Participants will receive placebo matched to ontamalimab SC injection using PFS on Week 0, Week 4, and Week 8.
intervention type: Drug
intervention name: Ontamalimab
description: Participants will receive 1 mL of ontamalimab sterile aqueous buffered solution at an appropriate concentration to provide the intended dose of drug (25 or 75 mg).
arm group label: Ontamalimab 25 mg
arm group label: Ontamalimab 75 mg
other name: SHP647
other name: PF- 00547659
intervention type: Drug
intervention name: Placebo
description: Participants will receive 1 mL of sterile aqueous buffered solution.
arm group label: Placebo
criteria: 
gender: All
minimum age: 16 Years
maximum age: 80 Years
healthy volunteers: No
last name: Study Director
role: Study Director
affiliation: Shire
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country: Argentina
country: Belgium
country: Bosnia and Herzegovina
country: Bulgaria
country: Canada
country: Colombia
country: Estonia
country: Greece
country: Hungary
country: Ireland
country: Japan
country: Korea, Republic of
country: Lebanon
country: Mexico
country: New Zealand
country: Portugal
country: Slovakia
country: Spain
country: Switzerland
country: Turkey
country: Ukraine
country: United States
country: France
url: https://clinicaltrials.takeda.com/study-detail/5f6b5fde4db2bf003ab4741c
description: To obtain more information on the study, click here/on this link
responsible party type: Sponsor
mesh term: Colitis
mesh term: Colitis, Ulcerative
mesh term: Ulcer
provided document: 
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
limitations and caveats: The study was terminated as per the sponsor decision to discontinue the SHP647 (ontamalimab) clinical trial development program for inflammatory bowel diseases (IBD) early.
point of contact: 