<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/NCT03758443</url>
  </required_header>
  <id_info>
    <org_study_id>0157</org_study_id>
    <secondary_id>2018-002136-24</secondary_id>
    <nct_id>NCT03758443</nct_id>
  </id_info>
  <brief_title>Efficacy &amp; Safety of TD-1473 in Ulcerative Colitis</brief_title>
  <acronym>RHEA</acronym>
  <official_title>A Phase 2b/3 Multi-Center, Randomized, Double-Blind, Multi-Dose, Placebo-Controlled, Parallel-Group Set of Studies to Evaluate the Efficacy and Safety of Induction and Maintenance Therapy With TD-1473 in Subjects With Moderately-to-Severely Active Ulcerative Colitis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Theravance Biopharma</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Theravance Biopharma</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>
      A Phase 2b/3 set of studies to evaluate the efficacy and safety of induction and maintenance&#xD;
      therapy with TD-1473 in subjects with moderately-to-severely active ulcerative colitis with&#xD;
      up to 60 weeks of treatment.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This protocol consists of 3 separate studies: an 8-week Phase 2b dose-finding induction&#xD;
      study, an 8-week dose-confirming Phase 3 induction study, and a 44-week Phase 3 maintenance&#xD;
      study. Subjects who respond to induction will enter the maintenance study; those who do not&#xD;
      will receive TD-1473 during extended induction. The safety and efficacy data of the Phase 2b&#xD;
      study will be analyzed to select the induction and maintenance dose regimens for the&#xD;
      confirmatory Phase 3 studies. Participants who have disease relapse or complete the&#xD;
      maintenance study may be eligible to enter a separate long-term safety study. Efficacy,&#xD;
      pharmacokinetic, biomarkers, and safety will be evaluated in all 3 studies.&#xD;
&#xD;
      240 subjects are planned for the Phase 2b and the planned Primary Completion Date for this&#xD;
      portion of the study is JULY 2021. 640 subjects are planned for the Phase 3 portion of the&#xD;
      study.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Stopped early due to company decision. Company decision based on interim analysis results in&#xD;
    TD-1473-0157.&#xD;
  </why_stopped>
  <start_date type="Actual">March 11, 2019</start_date>
  <completion_date type="Actual">October 20, 2021</completion_date>
  <primary_completion_date type="Actual">October 20, 2021</primary_completion_date>
  <phase>Phase 2/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>
    <intervention_model_description>Integrated and Adaptive Design</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change From Baseline in Total Mayo Score (tMS) at Week 8</measure>
    <time_frame>Baseline to Week 8</time_frame>
    <description>Total Mayo Score (tMS) was calculated as the sum of four components: rectal bleeding (0-3), stool frequency (0-3), physician's global assessment (0-3) and Mayo endoscopic subscore (0-3). tMS was reported as a 0-12 point score with 12 reflecting the highest severity.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Phase 3 Maintenance: Number of Participants Who Demonstrated Clinical Remission by Adapted Mayo Score Components at Maintenance Week (mWeek) 44</measure>
    <time_frame>mWeek 44</time_frame>
    <description>Clinical remission by Adapted Mayo score was defined based on Adapted Mayo score components within specific ranges: stool frequency score of 0 or 1, a rectal bleeding subscore of 0 and a Mayo endoscopy subscore of 0 or 1.&#xD;
The Adapted Mayo score was the sum of three components: rectal bleeding, stool frequency, and Mayo endoscopic subscore, each measured on a scale of 0-3 with higher scores reflecting higher severity.&#xD;
Participants with missing Week 44 values were imputed as non-responders.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of Participants Who Demonstrated Clinical Remission by Adapted Mayo Score Components at Week 8</measure>
    <time_frame>Week 8</time_frame>
    <description>Clinical remission by Adapted Mayo score was defined based on Adapted Mayo score components within specific ranges: stool frequency score of 0 or 1, a rectal bleeding subscore of 0 and a Mayo endoscopy subscore of 0 or 1.&#xD;
The Adapted Mayo score was the sum of three components: rectal bleeding, stool frequency, and Mayo endoscopic subscore, each measured on a scale of 0-3 with higher scores reflecting higher severity.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Phase 3 Maintenance: Number of Participants Who Demonstrated a Clinical Response by Adapted Mayo Score Components at mWeek 44</measure>
    <time_frame>Baseline to mWeek 44</time_frame>
    <description>Clinical response was defined as a reduction from baseline in adapted Mayo score of ≥ 2 points and ≥ 30% relative to baseline. It also required ≥ 1 reduction in the rectal bleeding subscore or an absolute subscore ≤ 1.&#xD;
The Adapted Mayo score was the sum of three components: rectal bleeding, stool frequency, and Mayo endoscopic subscore, each measured on a scale of 0-3 with higher scores reflecting higher severity.&#xD;
Participants with missing Week 44 values were imputed as non-responders.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Phase 3 Maintenance: Number of Participants Who Demonstrated Endoscopic Remission by Adapted Mayo Score Components at mWeek 44</measure>
    <time_frame>mWeek 44</time_frame>
    <description>Endoscopic remission was defined as an endoscopic subscore ≤ 1.&#xD;
Endoscopic subscore was measured using scale of 0-3, where higher numbers reflected greater severity.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Phase 3 Maintenance: Number of Participants Who Demonstrated Symptomatic Remission by Adapted Mayo Score Components at mWeek 44</measure>
    <time_frame>mWeek 44</time_frame>
    <description>Symptomatic remission was defined as a stool frequency score ≤ 1 and a rectal bleeding subscore of 0.&#xD;
Stool frequency score and rectal bleeding score were each measured using scale of 0-3, where higher numbers reflected greater severity.&#xD;
Participants with missing Week 44 values were imputed as non-responders.</description>
  </secondary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">239</enrollment>
  <condition>Ulcerative Colitis (UC)</condition>
  <arm_group>
    <arm_group_label>Active Treatment TD-1473 Dose A</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will be randomized to receive an oral daily dose of TD-1473. Responders will be re-randomized into the Phase 3 Maintenance portion of the study. Non-responders may participate in an extended induction.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Active Treatment TD-1473 Dose B</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will be randomized to receive an oral daily dose of TD-1473. Responders will be re-randomized into the Phase 3 Maintenance portion of the study. Non-responders may participate in an extended induction.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Active Treatment TD-1473 Dose C</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will be randomized to receive an oral daily dose of TD-1473. Responders will be re-randomized into the Phase 3 Maintenance portion of the study. Non-responders may participate in an extended induction.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Participants will be randomized to receive an oral daily dose of placebo. Participants who received Placebo (and were non-responders) may move to an extended induction. Subjects who are on placebo will be assigned to active TD-1473 for the extended induction (they will be blinded to dose).</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>TD-1473 Dose A</intervention_name>
    <description>See Arm description</description>
    <arm_group_label>Active Treatment TD-1473 Dose A</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>TD-1473 Dose B</intervention_name>
    <description>See Arm description</description>
    <arm_group_label>Active Treatment TD-1473 Dose B</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>TD-1473 Dose C</intervention_name>
    <description>See Arm description</description>
    <arm_group_label>Active Treatment TD-1473 Dose C</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>See Arm description</description>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Is at least 18 years of age at screening&#xD;
&#xD;
          -  Has a history of UC for at least 3 months prior to screening&#xD;
&#xD;
          -  Has moderately-to-severely active UC, as defined by a Mayo endoscopic subscore of ≥2&#xD;
             points and an adapted Mayo score between 4 - 9 points inclusive&#xD;
&#xD;
          -  Is corticosteroid-dependent or has demonstrated inadequate response, or intolerance to&#xD;
             conventional therapy (aminosalicylates, corticosteroids, immunomodulators) or&#xD;
             biologics&#xD;
&#xD;
          -  Willing to use highly-effective methods of contraception during the study and for 7&#xD;
             days after the last dose&#xD;
&#xD;
          -  Additional inclusion criteria apply&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Has symptoms suggestive of fulminant colitis, megacolon or intestinal perforation&#xD;
&#xD;
          -  Likely to require surgery for UC or other major surgeries&#xD;
&#xD;
          -  Has previously received / is currently receiving prohibited medications within&#xD;
             specified timeframe&#xD;
&#xD;
          -  Is refractory to 3 biologics with ≥2 mechanisms of action&#xD;
&#xD;
          -  Has a current bacterial, parasitic, fungal, or viral infection&#xD;
&#xD;
          -  Has clinically significant abnormalities in laboratory evaluations&#xD;
&#xD;
          -  Has had any prior exposure to an approved Janus kinase (JAK) inhibitor or potential&#xD;
             exposure to an investigational JAK inhibitor that was stopped due to intolerance or&#xD;
             lack of efficacy&#xD;
&#xD;
          -  Additional exclusion criteria apply&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <gender_based>Yes</gender_based>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Medical Monitor</last_name>
    <role>Study Director</role>
    <affiliation>Theravance Biopharma</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Theravance Biopharma Investigational Site</name>
      <address>
        <city>Chula Vista</city>
        <state>California</state>
        <zip>91911</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Theravance Biopharma Investigational Site</name>
      <address>
        <city>La Jolla</city>
        <state>California</state>
        <zip>92037</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Theravance Biopharma Investigational Site</name>
      <address>
        <city>Lancaster</city>
        <state>California</state>
        <zip>93534</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Theravance Biopharma Investigational Site</name>
      <address>
        <city>Orange</city>
        <state>California</state>
        <zip>92866</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Theravance Biopharma Investigational Site</name>
      <address>
        <city>Colorado Springs</city>
        <state>Colorado</state>
        <zip>80920</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Theravance Biopharma Investigational Site</name>
      <address>
        <city>Aventura</city>
        <state>Florida</state>
        <zip>33180</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Theravance Biopharma Investigational Site</name>
      <address>
        <city>Clearwater</city>
        <state>Florida</state>
        <zip>33756</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Theravance Biopharma Investigational Site</name>
      <address>
        <city>Largo</city>
        <state>Florida</state>
        <zip>33777</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Theravance Biopharma Investigational Site</name>
      <address>
        <city>Miami</city>
        <state>Florida</state>
        <zip>33135</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Theravance Biopharma Investigational Site</name>
      <address>
        <city>Miami</city>
        <state>Florida</state>
        <zip>33155</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Theravance Biopharma Investigational Site</name>
      <address>
        <city>New Port Richey</city>
        <state>Florida</state>
        <zip>34653</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Theravance Biopharma Investigational Site</name>
      <address>
        <city>New Smyrna Beach</city>
        <state>Florida</state>
        <zip>32168</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Theravance Biopharma Investigational Site</name>
      <address>
        <city>Orlando</city>
        <state>Florida</state>
        <zip>32803</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Theravance Biopharma Investigational Site</name>
      <address>
        <city>Pembroke Pines</city>
        <state>Florida</state>
        <zip>33024</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Theravance Biopharma Investigational Site</name>
      <address>
        <city>Atlanta</city>
        <state>Georgia</state>
        <zip>30342</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Theravance Biopharma Investigational Site</name>
      <address>
        <city>Suwanee</city>
        <state>Georgia</state>
        <zip>30024</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Theravance Biopharma Investigational Site</name>
      <address>
        <city>Idaho Falls</city>
        <state>Idaho</state>
        <zip>83404</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Theravance Biopharma Investigational Site</name>
      <address>
        <city>Kansas City</city>
        <state>Kansas</state>
        <zip>66160</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Theravance Biopharma Investigational Site</name>
      <address>
        <city>Louisville</city>
        <state>Kentucky</state>
        <zip>40202</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Theravance Biopharma Investigational Site</name>
      <address>
        <city>Monroe</city>
        <state>Louisiana</state>
        <zip>71201</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Theravance Biopharma Investigational Site</name>
      <address>
        <city>Baltimore</city>
        <state>Maryland</state>
        <zip>21201</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Theravance Biopharma Investigational Site</name>
      <address>
        <city>Troy</city>
        <state>Michigan</state>
        <zip>48098</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Theravance Biopharma Investigational Site</name>
      <address>
        <city>Wyoming</city>
        <state>Michigan</state>
        <zip>48519</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Theravance Biopharma Investigational Site</name>
      <address>
        <city>Rochester</city>
        <state>Minnesota</state>
        <zip>55905</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Theravance Biopharma Investigational Site</name>
      <address>
        <city>Kansas City</city>
        <state>Missouri</state>
        <zip>64131</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Theravance Biopharma Investigational Site</name>
      <address>
        <city>Las Vegas</city>
        <state>Nevada</state>
        <zip>89123</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Theravance Biopharma Investigational Site</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10029</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Theravance Biopharma Investigational Site</name>
      <address>
        <city>Charlotte</city>
        <state>North Carolina</state>
        <zip>28215</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Theravance Biopharma Investigational Site</name>
      <address>
        <city>Gastonia</city>
        <state>North Carolina</state>
        <zip>28054</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Theravance Biopharma Investigational Site</name>
      <address>
        <city>Greenville</city>
        <state>North Carolina</state>
        <zip>27834-3761</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Theravance Biopharma Investigational Site</name>
      <address>
        <city>Pittsburgh</city>
        <state>Pennsylvania</state>
        <zip>15212</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Theravance Biopharma Investigational Site</name>
      <address>
        <city>Smithfield</city>
        <state>Pennsylvania</state>
        <zip>15478</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Theravance Biopharma Investigational Site</name>
      <address>
        <city>Greenville</city>
        <state>South Carolina</state>
        <zip>29615</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Theravance Biopharma Investigational Site</name>
      <address>
        <city>Rock Hill</city>
        <state>South Carolina</state>
        <zip>29732</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Theravance Biopharma Investigational Site</name>
      <address>
        <city>Nashville</city>
        <state>Tennessee</state>
        <zip>37212</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Theravance Biopharma Investigational Site</name>
      <address>
        <city>Garland</city>
        <state>Texas</state>
        <zip>75044</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Theravance Biopharma Investigational Site</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77002</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Theravance Biopharma Investigational Site</name>
      <address>
        <city>San Antonio</city>
        <state>Texas</state>
        <zip>78215</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Theravance Biopharma Investigational Site</name>
      <address>
        <city>South Brisbane</city>
        <state>Queensland</state>
        <zip>4101</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Theravance Biopharma Investigational Site</name>
      <address>
        <city>Woolloongabba</city>
        <state>Queensland</state>
        <zip>4102</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Theravance Biopharma Investigational Site</name>
      <address>
        <city>Malvern</city>
        <state>Victoria</state>
        <zip>3144</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Theravance Biopharma Investigational Site</name>
      <address>
        <city>Murdoch</city>
        <state>Western Australia</state>
        <zip>6150</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Theravance Biopharma Investigational Site</name>
      <address>
        <city>Sofia</city>
        <state>Sofiya</state>
        <zip>1303</zip>
        <country>Bulgaria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Theravance Biopharma Investigational Site</name>
      <address>
        <city>Sofia</city>
        <state>Sofiya</state>
        <zip>1527</zip>
        <country>Bulgaria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Theravance Biopharma Investigational Site</name>
      <address>
        <city>Sofia</city>
        <state>Sofiya</state>
        <zip>1784</zip>
        <country>Bulgaria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Theravance Biopharma Investigational Site (2)</name>
      <address>
        <city>Pleven</city>
        <zip>5800</zip>
        <country>Bulgaria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Theravance Biopharma Investigational Site</name>
      <address>
        <city>Pleven</city>
        <zip>5800</zip>
        <country>Bulgaria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Theravance Biopharma Investigational Site</name>
      <address>
        <city>Plovdiv</city>
        <zip>4002</zip>
        <country>Bulgaria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Theravance Biopharma Investigational Site</name>
      <address>
        <city>Plovdiv</city>
        <zip>4004</zip>
        <country>Bulgaria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Theravance Biopharma Investigational Site</name>
      <address>
        <city>Ruse</city>
        <zip>7005</zip>
        <country>Bulgaria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Theravance Biopharma Investigational Site</name>
      <address>
        <city>Sliven</city>
        <zip>8800</zip>
        <country>Bulgaria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Theravance Biopharma Investigational Site</name>
      <address>
        <city>Sofia</city>
        <zip>1712</zip>
        <country>Bulgaria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Theravance Biopharma Investigational Site</name>
      <address>
        <city>Stara Zagora</city>
        <zip>6000</zip>
        <country>Bulgaria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Theravance Biopharma Investigational Site</name>
      <address>
        <city>Stara Zagora</city>
        <zip>6001</zip>
        <country>Bulgaria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Theravance Biopharma Investigational Site</name>
      <address>
        <city>Veliko Tarnovo</city>
        <zip>5000</zip>
        <country>Bulgaria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Theravance Biopharma Investigational Site</name>
      <address>
        <city>Kingston</city>
        <state>Ontario</state>
        <zip>K7L 5G2</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Theravance Biopharma Investigational Site</name>
      <address>
        <city>Reims</city>
        <state>Champagne-ardenne</state>
        <zip>51092</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Theravance Biopharma Investigational Site</name>
      <address>
        <city>Montpellier Cedex 5</city>
        <state>Languedoc-roussillon</state>
        <zip>34295</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Theravance Biopharma Investigational Site</name>
      <address>
        <city>Vandœuvre-lès-Nancy Cedex</city>
        <state>Limousin</state>
        <zip>54500</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Theravance Biopharma Investigational Site</name>
      <address>
        <city>Toulouse Cedex 9</city>
        <state>Midi-pyrenees</state>
        <zip>31059</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Theravance Biopharma Investigational Site</name>
      <address>
        <city>Lille Cedex</city>
        <state>NORD Pas-de-calais</state>
        <zip>59037</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Theravance Biopharma Investigational Site</name>
      <address>
        <city>Nantes</city>
        <state>PAYS DE LA Loire</state>
        <zip>44000</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Theravance Biopharma Investigational Site</name>
      <address>
        <city>Amiens Cedex 1</city>
        <state>Picardie</state>
        <zip>80054</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Theravance Biopharma Investigational Site</name>
      <address>
        <city>Pierre Bénite</city>
        <state>Rhone-alpes</state>
        <zip>69495</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Theravance Biopharma Investigational Site</name>
      <address>
        <city>Saint-Etienne</city>
        <state>Rhone-alpes</state>
        <zip>42055</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Theravance Biopharma Investigational Site</name>
      <address>
        <city>Batumi</city>
        <zip>6010</zip>
        <country>Georgia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Theravance Biopharma Investigational Site</name>
      <address>
        <city>Tbilisi</city>
        <zip>0114</zip>
        <country>Georgia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Theravance Biopharma Investigational Site</name>
      <address>
        <city>Tbilisi</city>
        <zip>0159</zip>
        <country>Georgia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Theravance Biopharma Investigational Site</name>
      <address>
        <city>Heidelberg</city>
        <state>Baden-wuerttemberg</state>
        <zip>69121</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Theravance Biopharma Investigational Site</name>
      <address>
        <city>Ulm</city>
        <state>Baden-wuerttemberg</state>
        <zip>89081</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Theravance Biopharma Investigational Site</name>
      <address>
        <city>Kiel</city>
        <state>Schleswig-holstein</state>
        <zip>24105</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Theravance Biopharma Investigational Site</name>
      <address>
        <city>Jena</city>
        <state>Thuringen</state>
        <zip>07747</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Theravance Biopharma Investigational Site</name>
      <address>
        <city>Berlin</city>
        <zip>10117</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Theravance Biopharma Investigational Site</name>
      <address>
        <city>Berlin</city>
        <zip>13353</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Theravance Biopharma Investigational Site</name>
      <address>
        <city>Athens</city>
        <state>Attica</state>
        <zip>115 27</zip>
        <country>Greece</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Theravance Biopharma Investigational Site #2</name>
      <address>
        <city>Athens</city>
        <state>Attica</state>
        <zip>11527</zip>
        <country>Greece</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Theravance Biopharma Investigational Site</name>
      <address>
        <city>Heraklion</city>
        <state>Crete</state>
        <zip>71110</zip>
        <country>Greece</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Theravance Biopharma Investigational Site</name>
      <address>
        <city>Patra</city>
        <state>Peloponnese</state>
        <zip>265 04</zip>
        <country>Greece</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Theravance Biopharma Investigational Site</name>
      <address>
        <city>Székesfehérvár</city>
        <state>Fejer</state>
        <zip>8000</zip>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Theravance Biopharma Investigational Site</name>
      <address>
        <city>Debrecen</city>
        <state>Hajdu-bihar</state>
        <zip>4032</zip>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Theravance Biopharma Investigational Site</name>
      <address>
        <city>Szekszard</city>
        <state>Tolna</state>
        <zip>7100</zip>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Theravance Biopharma Investigational Site</name>
      <address>
        <city>Budapest</city>
        <zip>1088</zip>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Theravance Biopharma Investigational Site</name>
      <address>
        <city>Budapest</city>
        <zip>1136</zip>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Theravance Biopharma Investigational Site</name>
      <address>
        <city>Zerifin</city>
        <state>Rehoboth</state>
        <zip>7030000</zip>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Theravance Biopharma Investigational Site</name>
      <address>
        <city>Haifa</city>
        <zip>31048</zip>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Theravance Biopharma Investigational Site</name>
      <address>
        <city>Holon</city>
        <zip>5822012</zip>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Theravance Biopharma Investigational Site</name>
      <address>
        <city>Jerusalem</city>
        <zip>9362410</zip>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Theravance Biopharma Investigational Site</name>
      <address>
        <city>Nahariya</city>
        <zip>2210001</zip>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Theravance Biopharma Investigational Site</name>
      <address>
        <city>Petah Tikva</city>
        <zip>4941492</zip>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Theravance Biopharma Investigational Site</name>
      <address>
        <city>Rehovot</city>
        <zip>7661041</zip>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Theravance Biopharma Investigational Site</name>
      <address>
        <city>Rozzano</city>
        <state>Milano</state>
        <zip>20089</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Theravance Biopharma Investigational Site</name>
      <address>
        <city>Catanzaro</city>
        <zip>88100</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Theravance Biopharma Investigational Site</name>
      <address>
        <city>Pavia</city>
        <zip>27100</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Theravance Biopharma Investigational Site</name>
      <address>
        <city>Nagoya</city>
        <state>Aichi</state>
        <zip>457-8511</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Theravance Biopharma Investigational Site</name>
      <address>
        <city>Abiko</city>
        <state>Chiba</state>
        <zip>270-1168</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Theravance Biopharma Investigational Site</name>
      <address>
        <city>Sakura</city>
        <state>Chiba</state>
        <zip>285-8741</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Theravance Biopharma Investigational Site</name>
      <address>
        <city>Kurume</city>
        <state>Fukuoka</state>
        <zip>839-0809</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Theravance Biopharma Investigational Site</name>
      <address>
        <city>Ōgaki</city>
        <state>Gifu</state>
        <zip>503-8502</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Theravance Biopharma Investigational Site</name>
      <address>
        <city>Isesaki</city>
        <state>Gunma</state>
        <zip>372-0817</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Theravance Biopharma Investigational Site</name>
      <address>
        <city>Fukuyama-Shi</city>
        <state>Hiroshima-ken</state>
        <zip>720-8520</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Theravance Biopharma Investigational Site</name>
      <address>
        <city>Hatsukaichi</city>
        <state>Hiroshima</state>
        <zip>738-8503</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Theravance Biopharma Investigational Site</name>
      <address>
        <city>Kawasaki</city>
        <state>Kanagawa</state>
        <zip>211-8533</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Theravance Biopharma Investigational Site</name>
      <address>
        <city>Sendai</city>
        <state>Miyagi</state>
        <zip>981-3213</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Theravance Biopharma Investigational Site</name>
      <address>
        <city>Suwa</city>
        <state>Nagano</state>
        <zip>392-8510</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Theravance Biopharma Investigational Site</name>
      <address>
        <city>Ōita</city>
        <state>Oita</state>
        <zip>870-0033</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Theravance Biopharma Investigational Site</name>
      <address>
        <city>Fujiidera</city>
        <state>Osaka Fu</state>
        <zip>583-0027</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Theravance Biopharma Investigational Site</name>
      <address>
        <city>Izumiotsu</city>
        <state>Osaka</state>
        <zip>595-0027</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Theravance Biopharma Investigational Site</name>
      <address>
        <city>Ageo</city>
        <state>Saitama Ken</state>
        <zip>362-0075</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Theravance Biopharma Investigational Site</name>
      <address>
        <city>Tokorozawa</city>
        <state>Saitama</state>
        <zip>359-1114</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Theravance Biopharma Investigational Site</name>
      <address>
        <city>Kurobe</city>
        <state>Toyama</state>
        <zip>938-8502</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Theravance Biopharma Investigational Site</name>
      <address>
        <city>Chiba</city>
        <zip>260-0852</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Theravance Biopharma Investigational Site</name>
      <address>
        <city>Fukuoka</city>
        <zip>814-0180</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Theravance Biopharma Investigational Site</name>
      <address>
        <city>Kumamoto</city>
        <zip>860-0004</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Theravance Biopharma Investigational Site</name>
      <address>
        <city>Tokyo</city>
        <zip>135-8577</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Theravance Biopharma Investigational Site</name>
      <address>
        <city>Tokyo</city>
        <zip>136-0075</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Theravance Biopharma Investigational Site</name>
      <address>
        <city>Tokyo</city>
        <zip>152-8902</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Theravance Biopharma Investigational Site</name>
      <address>
        <city>Wŏnju</city>
        <state>Gangwon-do</state>
        <zip>26426</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Theravance Biopharma Investigational Site</name>
      <address>
        <city>Suwon</city>
        <state>Gyeonggi-do</state>
        <zip>16247</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Theravance Biopharma Investigational Site</name>
      <address>
        <city>Daegu</city>
        <zip>42415</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Theravance Biopharma Investigational Site</name>
      <address>
        <city>Seoul</city>
        <zip>03722</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Theravance Biopharma Investigational Site</name>
      <address>
        <city>Seoul</city>
        <zip>06351</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Theravance Biopharma Investigational Site</name>
      <address>
        <city>Seoul</city>
        <zip>130-702</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Theravance Biopharma Investigational Site</name>
      <address>
        <city>Seoul</city>
        <zip>5505</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Theravance Biopharma Investigational Site</name>
      <address>
        <city>Wrocław</city>
        <state>Dolnoslaskie</state>
        <zip>53-333</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Theravance Biopharma Investigational Site</name>
      <address>
        <city>Wrocław</city>
        <state>Dolnoslaskie</state>
        <zip>54-416</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Theravance Biopharma Investigational Site</name>
      <address>
        <city>Toruń</city>
        <state>Kujawsko-Pomorskie</state>
        <zip>87-100</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Theravance Biopharma Investigational Site</name>
      <address>
        <city>Włocławek</city>
        <state>Kujawsko-Pomorskie</state>
        <zip>87-800</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Theravance Biopharma Investigational Site</name>
      <address>
        <city>Ksawerów</city>
        <state>Lodzkie</state>
        <zip>95-054</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Theravance Biopharma Investigational Site</name>
      <address>
        <city>Łódź</city>
        <state>Lodzkie</state>
        <zip>91-034</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Theravance Biopharma Investigational Site</name>
      <address>
        <city>Łódź</city>
        <state>Lodzki</state>
        <zip>90-302</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Theravance Biopharma Investigational Site</name>
      <address>
        <city>Kraków</city>
        <state>Malopolskie</state>
        <zip>31-501</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Theravance Biopharma Investigational Site</name>
      <address>
        <city>Piaseczno</city>
        <state>Mazowieckie</state>
        <zip>05-500</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Theravance Biopharma Investigational Site</name>
      <address>
        <city>Warszawa</city>
        <state>Mazowieckie</state>
        <zip>00-635</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Theravance Biopharma Investigational Site</name>
      <address>
        <city>Warszawa</city>
        <state>Mazowieckie</state>
        <zip>00-728</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Theravance Biopharma Investigational Site</name>
      <address>
        <city>Warszawa</city>
        <state>Mazowieckie</state>
        <zip>02-653</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Theravance Biopharma Investigational Site</name>
      <address>
        <city>Warszawa</city>
        <state>Mazowieckie</state>
        <zip>03-580</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Theravance Biopharma Investigational Site</name>
      <address>
        <city>Sopot</city>
        <state>Pomorskie</state>
        <zip>81-756</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Theravance Biopharma Investigational Site</name>
      <address>
        <city>Tychy</city>
        <state>Slaskie</state>
        <zip>43-100</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Theravance Biopharma Investigational Site</name>
      <address>
        <city>Staszów</city>
        <state>Swietokrzyskie</state>
        <zip>28-200</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Theravance Biopharma Investigational Site</name>
      <address>
        <city>Poznań</city>
        <state>Wielkopolskie</state>
        <zip>60-369</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Theravance Biopharma Investigational Site</name>
      <address>
        <city>Poznań</city>
        <state>Wielkopolskie</state>
        <zip>61-113</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Theravance Biopharma Investigational Site</name>
      <address>
        <city>Szczecin</city>
        <state>Zachodniopomorskie</state>
        <zip>71-434</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Theravance Biopharma Investigational Site</name>
      <address>
        <city>Szczecin</city>
        <zip>71-685</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Theravance Biopharma Investigational Site</name>
      <address>
        <city>Coimbra</city>
        <zip>3000-075</zip>
        <country>Portugal</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Theravance Biopharma Investigational Site</name>
      <address>
        <city>Guimarães</city>
        <zip>4835-044</zip>
        <country>Portugal</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Theravance Biopharma Investigational Site</name>
      <address>
        <city>Leiria</city>
        <zip>2410-197</zip>
        <country>Portugal</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Theravance Biopharma Investigational Site</name>
      <address>
        <city>Lisboa</city>
        <zip>1349-019</zip>
        <country>Portugal</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Theravance Biopharma Investigational Site</name>
      <address>
        <city>Santa Maria Da Feira</city>
        <zip>4520-211</zip>
        <country>Portugal</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Theravance Biopharma Investigational Site</name>
      <address>
        <city>Senhora da Hora</city>
        <zip>4454-513</zip>
        <country>Portugal</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Theravance Biopharma Investigational Site</name>
      <address>
        <city>Viana Do Castelo</city>
        <zip>4901-858</zip>
        <country>Portugal</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Theravance Biopharma Investigational Site</name>
      <address>
        <city>Vila Nova De Gaia</city>
        <zip>4434502</zip>
        <country>Portugal</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Theravance Biopharma Investigational Site</name>
      <address>
        <city>Timişoara</city>
        <state>Timis</state>
        <zip>300002</zip>
        <country>Romania</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Theravance Biopharma Investigational Site</name>
      <address>
        <city>Bucuresti</city>
        <zip>020125</zip>
        <country>Romania</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Theravance Biopharma Investigational Site</name>
      <address>
        <city>Belgrade</city>
        <zip>11000</zip>
        <country>Serbia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Theravance Biopharma Investigational Site</name>
      <address>
        <city>Belgrade</city>
        <zip>11080</zip>
        <country>Serbia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Theravance Biopharma Investigational Site</name>
      <address>
        <city>Kragujevac</city>
        <zip>34000</zip>
        <country>Serbia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Theravance Biopharma Investigational Site</name>
      <address>
        <city>Nis</city>
        <zip>18000</zip>
        <country>Serbia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Theravance Biopharma Investigational Site</name>
      <address>
        <city>Subotica</city>
        <zip>24000</zip>
        <country>Serbia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Theravance Biopharma Investigational Site</name>
      <address>
        <city>Zrenjanin</city>
        <zip>23000</zip>
        <country>Serbia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Theravance Biopharma Investigational Site</name>
      <address>
        <city>Prešov</city>
        <state>Prešovsky</state>
        <zip>080 01</zip>
        <country>Slovakia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Theravance Biopharma Investigational Site</name>
      <address>
        <city>Nitra</city>
        <zip>949 01</zip>
        <country>Slovakia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Theravance Biopharma Investigational Site</name>
      <address>
        <city>Šahy</city>
        <zip>936 01</zip>
        <country>Slovakia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Theravance Biopharma Investigational Site</name>
      <address>
        <city>Johannesburg</city>
        <state>Gauteng</state>
        <zip>2196</zip>
        <country>South Africa</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Theravance Biopharma Investigational Site</name>
      <address>
        <city>Barcelona</city>
        <zip>08022</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Theravance Biopharma Investigational Site</name>
      <address>
        <city>Madrid</city>
        <zip>28006</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Theravance Biopharma Investigational Site</name>
      <address>
        <city>Sevilla</city>
        <zip>41013</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Theravance Biopharma Investigational Site</name>
      <address>
        <city>Valencia</city>
        <zip>46010</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Theravance Biopharma Investigational Site</name>
      <address>
        <city>Kaohsiung</city>
        <zip>83301</zip>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Theravance Biopharma Investigational Site</name>
      <address>
        <city>Taichung</city>
        <zip>40210</zip>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Theravance Biopharma Investigational Site</name>
      <address>
        <city>Tainan</city>
        <zip>71004</zip>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Theravance Biopharma Investigational Site</name>
      <address>
        <city>Taipei</city>
        <zip>116</zip>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Theravance Biopharma Investigational Site</name>
      <address>
        <city>Kiev</city>
        <state>Kiev City</state>
        <zip>04107</zip>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Theravance Biopharma Investigational Site</name>
      <address>
        <city>Kyiv</city>
        <state>Kiev</state>
        <zip>01030</zip>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Theravance Biopharma Investigational Site</name>
      <address>
        <city>Kyiv</city>
        <state>Kiev</state>
        <zip>4107</zip>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Theravance Biopharma Investigational Site</name>
      <address>
        <city>Kremenchuk</city>
        <state>Poltava</state>
        <zip>39617</zip>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Theravance Biopharma Investigational Site</name>
      <address>
        <city>Úzhgorod</city>
        <state>Transcarpathian</state>
        <zip>88000</zip>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Theravance Biopharma Investigational Site</name>
      <address>
        <city>Vinnytsia</city>
        <state>Vinnytsya</state>
        <zip>21005</zip>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Theravance Biopharma Investigational Site</name>
      <address>
        <city>Vinnytsia</city>
        <state>Vinnytsya</state>
        <zip>21029</zip>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Theravance Biopharma Investigational Site</name>
      <address>
        <city>Chernivtsi</city>
        <zip>58001</zip>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Theravance Biopharma Investigational Site</name>
      <address>
        <city>Kharkiv</city>
        <zip>61037</zip>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Theravance Biopharma Investigational Site #2</name>
      <address>
        <city>Lviv</city>
        <zip>79010</zip>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Theravance Biopharma Investigational Site</name>
      <address>
        <city>Lviv</city>
        <zip>79010</zip>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Theravance Biopharma Investigational Site</name>
      <address>
        <city>Ternopil</city>
        <zip>46001</zip>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Theravance Biopharma Investigational Site</name>
      <address>
        <city>Vinnytsia</city>
        <zip>20129</zip>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Theravance Biopharma Investigational Site</name>
      <address>
        <city>Vinnytsia</city>
        <zip>21018</zip>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Theravance Biopharma Investigational Site</name>
      <address>
        <city>Zaporizhzhya</city>
        <zip>69096</zip>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Theravance Biopharma Investigational Site</name>
      <address>
        <city>Zaporizhzhya</city>
        <zip>69600</zip>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Theravance Biopharma Investigational Site</name>
      <address>
        <city>Úzhgorod</city>
        <zip>88009</zip>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Australia</country>
    <country>Bulgaria</country>
    <country>Canada</country>
    <country>France</country>
    <country>Georgia</country>
    <country>Germany</country>
    <country>Greece</country>
    <country>Hungary</country>
    <country>Israel</country>
    <country>Italy</country>
    <country>Japan</country>
    <country>Korea, Republic of</country>
    <country>Poland</country>
    <country>Portugal</country>
    <country>Romania</country>
    <country>Serbia</country>
    <country>Slovakia</country>
    <country>South Africa</country>
    <country>Spain</country>
    <country>Taiwan</country>
    <country>Ukraine</country>
    <country>United States</country>
  </location_countries>
  <verification_date>November 2021</verification_date>
  <study_first_submitted>November 19, 2018</study_first_submitted>
  <study_first_submitted_qc>November 27, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">November 29, 2018</study_first_posted>
  <results_first_submitted>October 21, 2022</results_first_submitted>
  <results_first_submitted_qc>October 21, 2022</results_first_submitted_qc>
  <results_first_posted type="Actual">November 15, 2022</results_first_posted>
  <last_update_submitted>October 21, 2022</last_update_submitted>
  <last_update_submitted_qc>October 21, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">November 15, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>TD-1473</keyword>
  <keyword>Janus kinase inhibitor</keyword>
  <keyword>JAK inhibitor</keyword>
  <keyword>Inflammatory Bowel Disease</keyword>
  <keyword>IBD</keyword>
  <keyword>Ulcerative colitis</keyword>
  <keyword>UC</keyword>
  <keyword>Gut selective</keyword>
  <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>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>Theravance Biopharma, Inc. will not be sharing individual de-identified participant data or other relevant study documents.</ipd_description>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>May 14, 2020</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/43/NCT03758443/Prot_000.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Statistical Analysis Plan</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>October 20, 2021</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/43/NCT03758443/SAP_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <recruitment_details>A total of 239 participants were enrolled at sites in Europe, Asia/Pacific, the United States, Israel, Australia, and South Africa between 11 March 2019 and 20 October 2021.</recruitment_details>
      <group_list>
        <group group_id="P1">
          <title>Placebo</title>
          <description>Participants were randomized to receive once-daily administrations of placebo for 8 weeks during the Induction Period.&#xD;
Participants who achieved clinical response by adapted Mayo Score at Week 8 continued to receive blinded placebo in the Maintenance Period. Participants who did not achieve clinical response at Week 8 received 80 mg TD-1473 for 8 weeks in the Extended Induction Period.&#xD;
Participants who achieved clinical response to a total of 8 weeks of TD-1473 induction therapy, either at Week 8 or Week 16, were re-randomized to received placebo; 20 mg, 80 mg, or 200 mg TD-1473 for 44 weeks in the Maintenance Period. Participants who did not achieve clinical response to a total of 8 weeks of TD-1473 induction therapy underwent study exit procedures.</description>
        </group>
        <group group_id="P2">
          <title>TD-1473 20 mg</title>
          <description>Participants were randomized to receive once-daily administrations of 20 mg TD-1473 for 8 weeks during the Induction Period.&#xD;
Participants who achieved clinical response by adapted Mayo Score at Week 8 continued to receive 20 mg TD-1473 in the Maintenance Period. Participants who did not achieve clinical response at Week 8 continued to receive 20 mg TD-1473 for 8 weeks in the Extended Induction Period.&#xD;
Participants who achieved clinical response to a total of 16 weeks of TD-1473 induction therapy continued to receive 20 mg TD-1473 for 44 weeks in the Maintenance Period. Participants who did not achieve clinical response to a total of 16 weeks of TD-1473 induction therapy underwent study exit procedures.</description>
        </group>
        <group group_id="P3">
          <title>TD-1473 80 mg</title>
          <description>Participants were randomized to receive once-daily administrations of 80 mg TD-1473 for 8 weeks during the Induction Period.&#xD;
Participants who achieved clinical response by adapted Mayo Score at Week 8 continued to receive 80 mg TD-1473 in the Maintenance Period. Participants who did not achieve clinical response at Week 8 continued to receive 80 mg TD-1473 for 8 weeks in the Extended Induction Period.&#xD;
Participants who achieved clinical response to a total of 16 weeks of TD-1473 induction therapy continued to receive 80 mg TD-1473 for 44 weeks in the Maintenance Period. Participants who did not achieve clinical response to a total of 16 weeks of TD-1473 induction therapy underwent study exit procedures.</description>
        </group>
        <group group_id="P4">
          <title>TD-1473 200 mg</title>
          <description>Participants were randomized to receive once-daily administrations of 200 mg TD-1473 for 8 weeks during the Induction Period.&#xD;
Participants who achieved clinical response by adapted Mayo Score at Week 8 continued to receive 200 mg TD-1473 in the Maintenance Period. Participants who did not achieve clinical response at Week 8 continued to receive 200 mg TD-1473 for 8 weeks in the Extended Induction Period.&#xD;
Participants who achieved clinical response to a total of 16 weeks of TD-1473 induction therapy continued to receive 200 mg TD-1473 for 44 weeks in the Maintenance Period. Participants who did not achieve clinical response to a total of 16 weeks of TD-1473 induction therapy underwent study exit procedures.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Induction Period</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="61"/>
                <participants group_id="P2" count="61"/>
                <participants group_id="P3" count="59"/>
                <participants group_id="P4" count="58"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="55"/>
                <participants group_id="P2" count="54"/>
                <participants group_id="P3" count="52"/>
                <participants group_id="P4" count="50"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="6"/>
                <participants group_id="P2" count="7"/>
                <participants group_id="P3" count="7"/>
                <participants group_id="P4" count="8"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Adverse Event</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="4"/>
                <participants group_id="P3" count="2"/>
                <participants group_id="P4" count="3"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Physician Decision</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="1"/>
                <participants group_id="P3" count="3"/>
                <participants group_id="P4" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Protocol Violation</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
                <participants group_id="P2" count="2"/>
                <participants group_id="P3" count="2"/>
                <participants group_id="P4" count="4"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
        <period>
          <title>Extended Induction Period</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="42">Included only participants who did not achieve clinical response at Week 8.</participants>
                <participants group_id="P2" count="32">Included only participants who did not achieve clinical response at Week 8.</participants>
                <participants group_id="P3" count="32">Included only participants who did not achieve clinical response at Week 8.</participants>
                <participants group_id="P4" count="29">Included only participants who did not achieve clinical response at Week 8.</participants>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="29"/>
                <participants group_id="P2" count="29"/>
                <participants group_id="P3" count="23"/>
                <participants group_id="P4" count="22"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="13"/>
                <participants group_id="P2" count="3"/>
                <participants group_id="P3" count="9"/>
                <participants group_id="P4" 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="1"/>
                <participants group_id="P2" count="1"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Physician Decision</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="1"/>
                <participants group_id="P3" count="2"/>
                <participants group_id="P4" count="2"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Protocol Violation</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="8"/>
                <participants group_id="P2" count="1"/>
                <participants group_id="P3" count="7"/>
                <participants group_id="P4" count="3"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Miscellaneous</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
        <period>
          <title>Maintenance Period</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="29">Included only participants who achieved clinical response at Week 8 or Week 16.</participants>
                <participants group_id="P2" count="31">Included only participants who achieved clinical response at Week 8 or Week 16.</participants>
                <participants group_id="P3" count="25">Included only participants who achieved clinical response at Week 8 or Week 16.</participants>
                <participants group_id="P4" count="22">Included only participants who achieved clinical response at Week 8 or Week 16.</participants>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="13"/>
                <participants group_id="P2" count="11"/>
                <participants group_id="P3" count="12"/>
                <participants group_id="P4" count="9"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="16"/>
                <participants group_id="P2" count="20"/>
                <participants group_id="P3" count="13"/>
                <participants group_id="P4" count="13"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Adverse Event</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="2"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Persistent Loss of Response During Maintenance</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
                <participants group_id="P2" count="1"/>
                <participants group_id="P3" count="2"/>
                <participants group_id="P4" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Protocol Violation</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Study Terminated by Sponsor</title>
              <participants_list>
                <participants group_id="P1" count="11"/>
                <participants group_id="P2" count="16"/>
                <participants group_id="P3" count="9"/>
                <participants group_id="P4" count="11"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="1"/>
                <participants group_id="P4" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Miscellaneous</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="1"/>
                <participants group_id="P4" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>The Intent-to-treat population included all randomized participants.</population>
      <group_list>
        <group group_id="B1">
          <title>Placebo</title>
          <description>Participants were randomized to receive once-daily administrations of placebo for 8 weeks during the Induction Period.&#xD;
Participants who achieved clinical response by adapted Mayo Score at Week 8 continued to receive blinded placebo in the Maintenance Period. Participants who did not achieve clinical response at Week 8 received 80 mg TD-1473 for 8 weeks in the Extended Induction Period.&#xD;
Participants who achieved clinical response to a total of 8 weeks of TD-1473 induction therapy, either at Week 8 or Week 16, were re-randomized to received placebo; 20 mg, 80 mg, or 200 mg TD-1473 for 44 weeks in the Maintenance Period. Participants who did not achieve clinical response to a total of 8 weeks of TD-1473 induction therapy underwent study exit procedures.</description>
        </group>
        <group group_id="B2">
          <title>TD-1473 20 mg</title>
          <description>Participants were randomized to receive once-daily administrations of 20 mg TD-1473 for 8 weeks during the Induction Period.&#xD;
Participants who achieved clinical response by adapted Mayo Score at Week 8 continued to receive 20 mg TD-1473 in the Maintenance Period. Participants who did not achieve clinical response at Week 8 continued to receive 20 mg TD-1473 for 8 weeks in the Extended Induction Period.&#xD;
Participants who achieved clinical response to a total of 16 weeks of TD-1473 induction therapy continued to receive 20 mg TD-1473 for 44 weeks in the Maintenance Period. Participants who did not achieve clinical response to a total of 16 weeks of TD-1473 induction therapy underwent study exit procedures.</description>
        </group>
        <group group_id="B3">
          <title>TD-1473 80 mg</title>
          <description>Participants were randomized to receive once-daily administrations of 80 mg TD-1473 for 8 weeks during the Induction Period.&#xD;
Participants who achieved clinical response by adapted Mayo Score at Week 8 continued to receive 80 mg TD-1473 in the Maintenance Period. Participants who did not achieve clinical response at Week 8 continued to receive 80 mg TD-1473 for 8 weeks in the Extended Induction Period.&#xD;
Participants who achieved clinical response to a total of 16 weeks of TD-1473 induction therapy continued to receive 80 mg TD-1473 for 44 weeks in the Maintenance Period. Participants who did not achieve clinical response to a total of 16 weeks of TD-1473 induction therapy underwent study exit procedures.</description>
        </group>
        <group group_id="B4">
          <title>TD-1473 200 mg</title>
          <description>Participants were randomized to receive once-daily administrations of 200 mg TD-1473 for 8 weeks during the Induction Period.&#xD;
Participants who achieved clinical response by adapted Mayo Score at Week 8 continued to receive 200 mg TD-1473 in the Maintenance Period. Participants who did not achieve clinical response at Week 8 continued to receive 200 mg TD-1473 for 8 weeks in the Extended Induction Period.&#xD;
Participants who achieved clinical response to a total of 16 weeks of TD-1473 induction therapy continued to receive 200 mg TD-1473 for 44 weeks in the Maintenance Period. Participants who did not achieve clinical response to a total of 16 weeks of TD-1473 induction therapy underwent study exit procedures.</description>
        </group>
        <group group_id="B5">
          <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="61"/>
            <count group_id="B2" value="61"/>
            <count group_id="B3" value="59"/>
            <count group_id="B4" value="58"/>
            <count group_id="B5" value="239"/>
          </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="40.92" spread="15.390"/>
                    <measurement group_id="B2" value="38.87" spread="14.576"/>
                    <measurement group_id="B3" value="42.02" spread="15.317"/>
                    <measurement group_id="B4" value="44.38" spread="14.122"/>
                    <measurement group_id="B5" value="41.51" spread="14.905"/>
                  </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="27"/>
                    <measurement group_id="B2" value="17"/>
                    <measurement group_id="B3" value="20"/>
                    <measurement group_id="B4" value="29"/>
                    <measurement group_id="B5" value="93"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="34"/>
                    <measurement group_id="B2" value="44"/>
                    <measurement group_id="B3" value="39"/>
                    <measurement group_id="B4" value="29"/>
                    <measurement group_id="B5" value="146"/>
                  </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="3"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="1"/>
                    <measurement group_id="B4" value="1"/>
                    <measurement group_id="B5" value="7"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="54"/>
                    <measurement group_id="B2" value="59"/>
                    <measurement group_id="B3" value="56"/>
                    <measurement group_id="B4" value="55"/>
                    <measurement group_id="B5" value="224"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="2"/>
                    <measurement group_id="B4" value="2"/>
                    <measurement group_id="B5" value="8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race/Ethnicity, Customized</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="48"/>
                    <measurement group_id="B2" value="50"/>
                    <measurement group_id="B3" value="51"/>
                    <measurement group_id="B4" value="51"/>
                    <measurement group_id="B5" value="200"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</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="0"/>
                    <measurement group_id="B5" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="9"/>
                    <measurement group_id="B2" value="11"/>
                    <measurement group_id="B3" value="6"/>
                    <measurement group_id="B4" value="6"/>
                    <measurement group_id="B5" value="32"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Other</title>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="2"/>
                    <measurement group_id="B4" value="1"/>
                    <measurement group_id="B5" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Change From Baseline in Total Mayo Score (tMS) at Week 8</title>
        <description>Total Mayo Score (tMS) was calculated as the sum of four components: rectal bleeding (0-3), stool frequency (0-3), physician's global assessment (0-3) and Mayo endoscopic subscore (0-3). tMS was reported as a 0-12 point score with 12 reflecting the highest severity.</description>
        <time_frame>Baseline to Week 8</time_frame>
        <population>Modified Intent-to-Treat (mITT) Analysis Set (Induction Period): Comprised all randomized participants who received at least one dose of study drug.</population>
        <group_list>
          <group group_id="O1">
            <title>Induction Period: Placebo</title>
            <description>Participants were randomized to receive once-daily administrations of placebo for 8 weeks during the Induction Period.</description>
          </group>
          <group group_id="O2">
            <title>Induction Period: TD-1473 20 mg</title>
            <description>Participants were randomized to receive once-daily administrations of 20 mg TD-1473 for 8 weeks during the Induction Period.</description>
          </group>
          <group group_id="O3">
            <title>Induction Period: TD-1473 80 mg</title>
            <description>Participants were randomized to receive once-daily administrations of 80 mg TD-1473 for 8 weeks during the Induction Period.</description>
          </group>
          <group group_id="O4">
            <title>Induction Period: TD-1473 200 mg</title>
            <description>Participants were randomized to receive once-daily administrations of 200 mg TD-1473 for 8 weeks during the Induction Period.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Total Mayo Score (tMS) at Week 8</title>
          <description>Total Mayo Score (tMS) was calculated as the sum of four components: rectal bleeding (0-3), stool frequency (0-3), physician's global assessment (0-3) and Mayo endoscopic subscore (0-3). tMS was reported as a 0-12 point score with 12 reflecting the highest severity.</description>
          <population>Modified Intent-to-Treat (mITT) Analysis Set (Induction Period): Comprised all randomized participants who received at least one dose of study drug.</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="56"/>
                <count group_id="O2" value="54"/>
                <count group_id="O3" value="53"/>
                <count group_id="O4" value="55"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.75" spread="0.341"/>
                    <measurement group_id="O2" value="-2.02" spread="0.350"/>
                    <measurement group_id="O3" value="-2.12" spread="0.351"/>
                    <measurement group_id="O4" value="-2.40" spread="0.346"/>
                  </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>
            <groups_desc>Least square estimates, 95% CI, and p-values were obtained by fitting an ANCOVA model with terms for treatment, steroid use at baseline (yes, no) and prior biologic failure (yes, no), and baseline total Mayo score as covariate.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.5809</p_value>
            <method>ANCOVA</method>
            <param_type>Least Square Mean Difference</param_type>
            <param_value>-0.27</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-1.22</ci_lower_limit>
            <ci_upper_limit>0.69</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Least square estimates, 95% CI, and p-values were obtained by fitting an ANCOVA model with terms for treatment, steroid use at baseline (yes, no) and prior biologic failure (yes, no), and baseline total Mayo score as covariate.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.4501</p_value>
            <method>ANCOVA</method>
            <param_type>Least Square Mean Difference</param_type>
            <param_value>-0.37</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-1.33</ci_lower_limit>
            <ci_upper_limit>0.59</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Least square estimates, 95% CI, and p-values were obtained by fitting an ANCOVA model with terms for treatment, steroid use at baseline (yes, no) and prior biologic failure (yes, no), and baseline total Mayo score as covariate.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.1809</p_value>
            <method>ANCOVA</method>
            <param_type>Least Square Mean Difference</param_type>
            <param_value>-0.65</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-1.60</ci_lower_limit>
            <ci_upper_limit>0.30</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Phase 3 Maintenance: Number of Participants Who Demonstrated Clinical Remission by Adapted Mayo Score Components at Maintenance Week (mWeek) 44</title>
        <description>Clinical remission by Adapted Mayo score was defined based on Adapted Mayo score components within specific ranges: stool frequency score of 0 or 1, a rectal bleeding subscore of 0 and a Mayo endoscopy subscore of 0 or 1.&#xD;
The Adapted Mayo score was the sum of three components: rectal bleeding, stool frequency, and Mayo endoscopic subscore, each measured on a scale of 0-3 with higher scores reflecting higher severity.&#xD;
Participants with missing Week 44 values were imputed as non-responders.</description>
        <time_frame>mWeek 44</time_frame>
        <population>mITT Analysis Set (Maintenance Period): All participants randomized into the Phase 3 Maintenance Study who were also treated. Only participants randomized at least 44 weeks prior to database lock were included.</population>
        <group_list>
          <group group_id="O1">
            <title>Maintenance Period: Placebo</title>
            <description>Participants who were randomized to receive once-daily administrations of placebo for 8 weeks during the Induction Period and achieved clinical response by adapted Mayo Score at Week 8 of the Induction Period continued to receive blinded placebo for 44 weeks in the Maintenance Period.</description>
          </group>
          <group group_id="O2">
            <title>Maintenance Period: TD-1473 20 mg</title>
            <description>Participants who achieved clinical response to a total of 8 weeks of TD-1473 induction therapy, either at Week 8 or Week 16, and continued to receive 20 mg TD-1473 for 44 weeks in the Maintenance Period.</description>
          </group>
          <group group_id="O3">
            <title>Maintenance Period: TD-1473 80 mg</title>
            <description>Participants who achieved clinical response to a total of 8 weeks of TD-1473 induction therapy, either at Week 8 or Week 16, and continued to receive 80 mg TD-1473 for 44 weeks in the Maintenance Period.</description>
          </group>
          <group group_id="O4">
            <title>Maintenance Period: TD-1473 200 mg</title>
            <description>Participants who achieved clinical response to a total of 8 weeks of TD-1473 induction therapy, either at Week 8 or Week 16, and continued to receive 200 mg TD-1473 for 44 weeks in the Maintenance Period.</description>
          </group>
        </group_list>
        <measure>
          <title>Phase 3 Maintenance: Number of Participants Who Demonstrated Clinical Remission by Adapted Mayo Score Components at Maintenance Week (mWeek) 44</title>
          <description>Clinical remission by Adapted Mayo score was defined based on Adapted Mayo score components within specific ranges: stool frequency score of 0 or 1, a rectal bleeding subscore of 0 and a Mayo endoscopy subscore of 0 or 1.&#xD;
The Adapted Mayo score was the sum of three components: rectal bleeding, stool frequency, and Mayo endoscopic subscore, each measured on a scale of 0-3 with higher scores reflecting higher severity.&#xD;
Participants with missing Week 44 values were imputed as non-responders.</description>
          <population>mITT Analysis Set (Maintenance Period): All participants randomized into the Phase 3 Maintenance Study who were also treated. Only participants randomized at least 44 weeks prior to database lock were included.</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="9"/>
                <count group_id="O2" value="13"/>
                <count group_id="O3" value="11"/>
                <count group_id="O4" value="8"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                    <measurement group_id="O2" value="3"/>
                    <measurement group_id="O3" value="5"/>
                    <measurement group_id="O4" value="3"/>
                  </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>0.3762</p_value>
            <method>Fisher Exact</method>
          </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>1.0000</p_value>
            <method>Fisher Exact</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>1.0000</p_value>
            <method>Fisher Exact</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants Who Demonstrated Clinical Remission by Adapted Mayo Score Components at Week 8</title>
        <description>Clinical remission by Adapted Mayo score was defined based on Adapted Mayo score components within specific ranges: stool frequency score of 0 or 1, a rectal bleeding subscore of 0 and a Mayo endoscopy subscore of 0 or 1.&#xD;
The Adapted Mayo score was the sum of three components: rectal bleeding, stool frequency, and Mayo endoscopic subscore, each measured on a scale of 0-3 with higher scores reflecting higher severity.</description>
        <time_frame>Week 8</time_frame>
        <population>mITT Analysis Set (Induction Period): Comprised all randomized participants who received at least one dose of study drug.</population>
        <group_list>
          <group group_id="O1">
            <title>Induction Period: Placebo</title>
            <description>Participants were randomized to receive once-daily administrations of placebo for 8 weeks during the Induction Period.</description>
          </group>
          <group group_id="O2">
            <title>Induction Period: TD-1473 20 mg</title>
            <description>Participants were randomized to receive once-daily administrations of 20 mg TD-1473 for 8 weeks during the Induction Period.</description>
          </group>
          <group group_id="O3">
            <title>Induction Period: TD-1473 80 mg</title>
            <description>Participants were randomized to receive once-daily administrations of 80 mg TD-1473 for 8 weeks during the Induction Period.</description>
          </group>
          <group group_id="O4">
            <title>Induction Period: TD-1473 200 mg</title>
            <description>Participants were randomized to receive once-daily administrations of 200 mg TD-1473 for 8 weeks during the Induction Period.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants Who Demonstrated Clinical Remission by Adapted Mayo Score Components at Week 8</title>
          <description>Clinical remission by Adapted Mayo score was defined based on Adapted Mayo score components within specific ranges: stool frequency score of 0 or 1, a rectal bleeding subscore of 0 and a Mayo endoscopy subscore of 0 or 1.&#xD;
The Adapted Mayo score was the sum of three components: rectal bleeding, stool frequency, and Mayo endoscopic subscore, each measured on a scale of 0-3 with higher scores reflecting higher severity.</description>
          <population>mITT Analysis Set (Induction Period): Comprised all randomized participants who received at least one dose of study drug.</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="61"/>
                <count group_id="O2" value="61"/>
                <count group_id="O3" value="59"/>
                <count group_id="O4" value="58"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6"/>
                    <measurement group_id="O2" value="6"/>
                    <measurement group_id="O3" value="4"/>
                    <measurement group_id="O4" value="4"/>
                  </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>0.9542</p_value>
            <p_value_desc>P-value is shown for Cochran-Mantel Haenszel tests stratified by prior biologic failure and steroid use at baseline.</p_value_desc>
            <method>Cochran-Mantel-Haenszel</method>
            <param_type>Difference in Proportion</param_type>
            <param_value>0.00</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.104</ci_lower_limit>
            <ci_upper_limit>0.110</ci_upper_limit>
            <estimate_desc>Difference in proportion estimates used Mantel-Haenszel stratum weights.</estimate_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>0.5863</p_value>
            <p_value_desc>P-value is shown for Cochran-Mantel Haenszel tests stratified by prior biologic failure and steroid use at baseline.</p_value_desc>
            <method>Cochran-Mantel-Haenszel</method>
            <param_type>Difference in Proportion</param_type>
            <param_value>-0.03</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.126</ci_lower_limit>
            <ci_upper_limit>0.071</ci_upper_limit>
            <estimate_desc>Difference in proportion estimates used Mantel-Haenszel stratum weights.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.5408</p_value>
            <p_value_desc>P-value is shown for Conhran-Mantel Haenszel tests stratified by prior biologic failure and steroid use at baseline.</p_value_desc>
            <method>Cochran-Mantel-Haenszel</method>
            <param_type>Difference in Proportion</param_type>
            <param_value>-0.03</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.131</ci_lower_limit>
            <ci_upper_limit>0.069</ci_upper_limit>
            <estimate_desc>Difference in proportion estimates used Mantel-Haenszel stratum weights.</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Phase 3 Maintenance: Number of Participants Who Demonstrated a Clinical Response by Adapted Mayo Score Components at mWeek 44</title>
        <description>Clinical response was defined as a reduction from baseline in adapted Mayo score of ≥ 2 points and ≥ 30% relative to baseline. It also required ≥ 1 reduction in the rectal bleeding subscore or an absolute subscore ≤ 1.&#xD;
The Adapted Mayo score was the sum of three components: rectal bleeding, stool frequency, and Mayo endoscopic subscore, each measured on a scale of 0-3 with higher scores reflecting higher severity.&#xD;
Participants with missing Week 44 values were imputed as non-responders.</description>
        <time_frame>Baseline to mWeek 44</time_frame>
        <population>mITT Analysis Set (Maintenance Period): All participants randomized into the Phase 3 Maintenance Study who were also treated. Only participants randomized at least 44 weeks prior to database lock were included.</population>
        <group_list>
          <group group_id="O1">
            <title>Maintenance Period: Placebo</title>
            <description>Participants who were randomized to receive once-daily administrations of placebo for 8 weeks during the Induction Period and achieved clinical response by adapted Mayo Score at Week 8 of the Induction Period continued to receive blinded placebo for 44 weeks in the Maintenance Period.</description>
          </group>
          <group group_id="O2">
            <title>Maintenance Period: TD-1473 20 mg</title>
            <description>Participants who achieved clinical response to a total of 8 weeks of TD-1473 induction therapy, either at Week 8 or Week 16, and continued to receive 20 mg TD-1473 for 44 weeks in the Maintenance Period.</description>
          </group>
          <group group_id="O3">
            <title>Maintenance Period: TD-1473 80 mg</title>
            <description>Participants who achieved clinical response to a total of 8 weeks of TD-1473 induction therapy, either at Week 8 or Week 16, and continued to receive 80 mg TD-1473 for 44 weeks in the Maintenance Period.</description>
          </group>
          <group group_id="O4">
            <title>Maintenance Period: TD-1473 200 mg</title>
            <description>Participants who achieved clinical response to a total of 8 weeks of TD-1473 induction therapy, either at Week 8 or Week 16, and continued to receive 200 mg TD-1473 for 44 weeks in the Maintenance Period.</description>
          </group>
        </group_list>
        <measure>
          <title>Phase 3 Maintenance: Number of Participants Who Demonstrated a Clinical Response by Adapted Mayo Score Components at mWeek 44</title>
          <description>Clinical response was defined as a reduction from baseline in adapted Mayo score of ≥ 2 points and ≥ 30% relative to baseline. It also required ≥ 1 reduction in the rectal bleeding subscore or an absolute subscore ≤ 1.&#xD;
The Adapted Mayo score was the sum of three components: rectal bleeding, stool frequency, and Mayo endoscopic subscore, each measured on a scale of 0-3 with higher scores reflecting higher severity.&#xD;
Participants with missing Week 44 values were imputed as non-responders.</description>
          <population>mITT Analysis Set (Maintenance Period): All participants randomized into the Phase 3 Maintenance Study who were also treated. Only participants randomized at least 44 weeks prior to database lock were included.</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="8"/>
                <count group_id="O2" value="13"/>
                <count group_id="O3" value="11"/>
                <count group_id="O4" value="8"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5"/>
                    <measurement group_id="O2" value="5"/>
                    <measurement group_id="O3" value="8"/>
                    <measurement group_id="O4" value="6"/>
                  </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>0.6656</p_value>
            <method>Fisher Exact</method>
          </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>0.6424</p_value>
            <method>Fisher Exact</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.6199</p_value>
            <method>Fisher Exact</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Phase 3 Maintenance: Number of Participants Who Demonstrated Endoscopic Remission by Adapted Mayo Score Components at mWeek 44</title>
        <description>Endoscopic remission was defined as an endoscopic subscore ≤ 1.&#xD;
Endoscopic subscore was measured using scale of 0-3, where higher numbers reflected greater severity.</description>
        <time_frame>mWeek 44</time_frame>
        <population>mITT Analysis Set (Maintenance Period): All participants randomized into the Phase 3 Maintenance Study who were also treated. Only participants randomized at least 44 weeks prior to database lock were included.</population>
        <group_list>
          <group group_id="O1">
            <title>Maintenance Period: Placebo</title>
            <description>Participants who were randomized to receive once-daily administrations of placebo for 8 weeks during the Induction Period and achieved clinical response by adapted Mayo Score at Week 8 of the Induction Period continued to receive blinded placebo for 44 weeks in the Maintenance Period.</description>
          </group>
          <group group_id="O2">
            <title>Maintenance Period: TD-1473 20 mg</title>
            <description>Participants who achieved clinical response to a total of 8 weeks of TD-1473 induction therapy, either at Week 8 or Week 16, and continued to receive 20 mg TD-1473 for 44 weeks in the Maintenance Period.</description>
          </group>
          <group group_id="O3">
            <title>Maintenance Period: TD-1473 80 mg</title>
            <description>Participants who achieved clinical response to a total of 8 weeks of TD-1473 induction therapy, either at Week 8 or Week 16, and continued to receive 80 mg TD-1473 for 44 weeks in the Maintenance Period.</description>
          </group>
          <group group_id="O4">
            <title>Maintenance Period: TD-1473 200 mg</title>
            <description>Participants who achieved clinical response to a total of 8 weeks of TD-1473 induction therapy, either at Week 8 or Week 16, and continued to receive 200 mg TD-1473 for 44 weeks in the Maintenance Period.</description>
          </group>
        </group_list>
        <measure>
          <title>Phase 3 Maintenance: Number of Participants Who Demonstrated Endoscopic Remission by Adapted Mayo Score Components at mWeek 44</title>
          <description>Endoscopic remission was defined as an endoscopic subscore ≤ 1.&#xD;
Endoscopic subscore was measured using scale of 0-3, where higher numbers reflected greater severity.</description>
          <population>mITT Analysis Set (Maintenance Period): All participants randomized into the Phase 3 Maintenance Study who were also treated. Only participants randomized at least 44 weeks prior to database lock were included.</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="9"/>
                <count group_id="O2" value="13"/>
                <count group_id="O3" value="11"/>
                <count group_id="O4" value="8"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="3"/>
                    <measurement group_id="O4" value="2"/>
                  </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>0.2643</p_value>
            <method>Fisher Exact</method>
          </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>1.0000</p_value>
            <method>Fisher Exact</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>1.0000</p_value>
            <method>Fisher Exact</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Phase 3 Maintenance: Number of Participants Who Demonstrated Symptomatic Remission by Adapted Mayo Score Components at mWeek 44</title>
        <description>Symptomatic remission was defined as a stool frequency score ≤ 1 and a rectal bleeding subscore of 0.&#xD;
Stool frequency score and rectal bleeding score were each measured using scale of 0-3, where higher numbers reflected greater severity.&#xD;
Participants with missing Week 44 values were imputed as non-responders.</description>
        <time_frame>mWeek 44</time_frame>
        <population>mITT Analysis Set (Maintenance Period): All participants randomized into the Phase 3 Maintenance Study who were also treated. Only participants randomized at least 44 weeks prior to database lock were included.</population>
        <group_list>
          <group group_id="O1">
            <title>Maintenance Period: Placebo</title>
            <description>Participants who were randomized to receive once-daily administrations of placebo for 8 weeks during the Induction Period and achieved clinical response by adapted Mayo Score at Week 8 of the Induction Period continued to receive blinded placebo for 44 weeks in the Maintenance Period.</description>
          </group>
          <group group_id="O2">
            <title>Maintenance Period: TD-1473 20 mg</title>
            <description>Participants who achieved clinical response to a total of 8 weeks of TD-1473 induction therapy, either at Week 8 or Week 16, and continued to receive 20 mg TD-1473 for 44 weeks in the Maintenance Period.</description>
          </group>
          <group group_id="O3">
            <title>Maintenance Period: TD-1473 80 mg</title>
            <description>Participants who achieved clinical response to a total of 8 weeks of TD-1473 induction therapy, either at Week 8 or Week 16, and continued to receive 80 mg TD-1473 for 44 weeks in the Maintenance Period.</description>
          </group>
          <group group_id="O4">
            <title>Maintenance Period: TD-1473 200 mg</title>
            <description>Participants who achieved clinical response to a total of 8 weeks of TD-1473 induction therapy, either at Week 8 or Week 16, and continued to receive 200 mg TD-1473 for 44 weeks in the Maintenance Period.</description>
          </group>
        </group_list>
        <measure>
          <title>Phase 3 Maintenance: Number of Participants Who Demonstrated Symptomatic Remission by Adapted Mayo Score Components at mWeek 44</title>
          <description>Symptomatic remission was defined as a stool frequency score ≤ 1 and a rectal bleeding subscore of 0.&#xD;
Stool frequency score and rectal bleeding score were each measured using scale of 0-3, where higher numbers reflected greater severity.&#xD;
Participants with missing Week 44 values were imputed as non-responders.</description>
          <population>mITT Analysis Set (Maintenance Period): All participants randomized into the Phase 3 Maintenance Study who were also treated. Only participants randomized at least 44 weeks prior to database lock were included.</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="9"/>
                <count group_id="O2" value="13"/>
                <count group_id="O3" value="11"/>
                <count group_id="O4" value="8"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5"/>
                    <measurement group_id="O2" value="7"/>
                    <measurement group_id="O3" value="7"/>
                    <measurement group_id="O4" value="5"/>
                  </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>1.0000</p_value>
            <method>Fisher Exact</method>
          </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>1.0000</p_value>
            <method>Fisher Exact</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>1.0000</p_value>
            <method>Fisher Exact</method>
          </analysis>
        </analysis_list>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Induction Period: Up to Week 20 Maintenance Period: Up to Week 48</time_frame>
      <desc>The Safety analysis set included all participants who received at least one dose of study drug (TD-1473 or placebo).</desc>
      <group_list>
        <group group_id="E1">
          <title>Induction Period: Placebo</title>
          <description>Participants who were randomized to receive once-daily administrations of placebo for 8 weeks during the Induction Period.</description>
        </group>
        <group group_id="E2">
          <title>Induction Period: TD-1473 20 mg</title>
          <description>Participants who were randomized to receive once-daily administrations of 20 mg TD-1473 for 8 weeks during the Induction Period.&#xD;
Participants who did not achieve clinical response at Week 8 continued to receive 20 mg TD-1473 for 8 weeks in the Extended Induction Period.</description>
        </group>
        <group group_id="E3">
          <title>Induction Period: TD-1473 80 mg</title>
          <description>Participants who were randomized to receive once-daily administrations of 80 mg TD-1473 for 8 weeks during the Induction Period.&#xD;
Participants who did not achieve clinical response at Week 8 continued to receive 80 mg TD-1473 for 8 weeks in the Extended Induction Period.</description>
        </group>
        <group group_id="E4">
          <title>Induction Period: Placebo to TD-1473 80 mg</title>
          <description>Participants who were randomized to receive once-daily administrations of placebo for 8 weeks during the Induction Period.&#xD;
Participants who did not achieve clinical response at Week 8 received 80 mg TD-1473 for 8 weeks in the Extended Induction Period.</description>
        </group>
        <group group_id="E5">
          <title>Induction Period: TD-1473 200 mg</title>
          <description>Participants who were randomized to receive once-daily administrations of 200 mg TD-1473 for 8 weeks during the Induction Period.&#xD;
Participants who did not achieve clinical response at Week 8 continued to receive 200 mg TD-1473 for 8 weeks in the Extended Induction Period.</description>
        </group>
        <group group_id="E6">
          <title>Maintenance Period: Placebo</title>
          <description>Participants who were randomized to receive once-daily administrations of placebo for 8 weeks during the Induction Period and achieved clinical response by adapted Mayo Score at Week 8 of the Induction Period continued to receive blinded placebo for 44 weeks in the Maintenance Period.</description>
        </group>
        <group group_id="E7">
          <title>Maintenance Period: TD-1473 20 mg</title>
          <description>Participants who achieved clinical response to a total of 8 weeks of TD-1473 induction therapy, either at Week 8 or Week 16, and were re-randomized to 20 mg TD-1473 for 44 weeks in the Maintenance Period.</description>
        </group>
        <group group_id="E8">
          <title>Maintenance Period: TD-1473 80 mg</title>
          <description>Participants who achieved clinical response to a total of 8 weeks of TD-1473 induction therapy, either at Week 8 or Week 16, and were re-randomized to 80 mg TD-1473 for 44 weeks in the Maintenance Period.</description>
        </group>
        <group group_id="E9">
          <title>Maintenance Period: TD-1473 200 mg</title>
          <description>Participants who achieved clinical response to a total of 8 weeks of TD-1473 induction therapy, either at Week 8 or Week 16, and were re-randomized to 200 mg TD-1473 for 44 weeks in the Maintenance Period.</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>MedDRA (24.1)</default_vocab>
        <default_assessment>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="61"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="61"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="59"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="42"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="58"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="29"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="22"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="61"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="61"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="59"/>
                <counts group_id="E4" subjects_affected="3" subjects_at_risk="42"/>
                <counts group_id="E5" subjects_affected="4" subjects_at_risk="58"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="29"/>
                <counts group_id="E7" subjects_affected="2" subjects_at_risk="31"/>
                <counts group_id="E8" subjects_affected="2" subjects_at_risk="25"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="22"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Blood and lymphatic system disorders</title>
            <event_list>
              <event>
                <sub_title>Anaemia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="61"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="61"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="59"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="42"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="58"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="29"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="22"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Atrial fibrillation</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="61"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="61"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="59"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="42"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="58"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="29"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="22"/>
              </event>
              <event>
                <sub_title>Angina pectoris</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="61"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="61"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="59"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="42"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="58"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="29"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="22"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Colitis ulcerative</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="61"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="61"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="59"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="42"/>
                <counts group_id="E5" subjects_affected="2" subjects_at_risk="58"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="29"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="25"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="22"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Cytomegalovirus colitis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="61"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="61"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="59"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="42"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="58"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="29"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="22"/>
              </event>
              <event>
                <sub_title>Liver abscess</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="61"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="61"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="59"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="42"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="58"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="29"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="22"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Joint injury</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="61"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="61"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="59"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="42"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="58"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="29"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="31"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="22"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Back pain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="61"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="61"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="59"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="42"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="58"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="29"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="22"/>
              </event>
              <event>
                <sub_title>Rhabdomyolysis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="61"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="61"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="59"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="42"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="58"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="29"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="22"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Neoplasms benign, malignant and unspecified (incl cysts and polyps)</title>
            <event_list>
              <event>
                <sub_title>Adenocarcinoma of colon</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="61"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="61"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="59"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="42"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="58"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="29"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="22"/>
              </event>
              <event>
                <sub_title>Uterine leiomyoma</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="61"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="61"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="59"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="42"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="58"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="29"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="25"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="22"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Tubulointerstitial nephritis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="61"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="61"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="59"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="42"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="58"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="29"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="31"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="22"/>
              </event>
              <event>
                <sub_title>Urethral stenosis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="61"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="61"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="59"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="42"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="58"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="29"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="22"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Surgical and medical procedures</title>
            <event_list>
              <event>
                <sub_title>Large intestine operation</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="61"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="61"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="59"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="42"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="58"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="29"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="22"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>3</frequency_threshold>
        <default_vocab>MedDRA (24.1)</default_vocab>
        <default_assessment>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="61"/>
                <counts group_id="E2" subjects_affected="11" subjects_at_risk="61"/>
                <counts group_id="E3" subjects_affected="9" subjects_at_risk="59"/>
                <counts group_id="E4" subjects_affected="4" subjects_at_risk="42"/>
                <counts group_id="E5" subjects_affected="14" subjects_at_risk="58"/>
                <counts group_id="E6" subjects_affected="6" subjects_at_risk="29"/>
                <counts group_id="E7" subjects_affected="14" subjects_at_risk="31"/>
                <counts group_id="E8" subjects_affected="5" subjects_at_risk="25"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="22"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Blood and lymphatic system disorders</title>
            <event_list>
              <event>
                <sub_title>Anaemia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="61"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="61"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="59"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="42"/>
                <counts group_id="E5" subjects_affected="2" subjects_at_risk="58"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="29"/>
                <counts group_id="E7" subjects_affected="3" subjects_at_risk="31"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="22"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Colitis ulcerative</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="61"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="61"/>
                <counts group_id="E3" subjects_affected="5" subjects_at_risk="59"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="42"/>
                <counts group_id="E5" subjects_affected="7" subjects_at_risk="58"/>
                <counts group_id="E6" subjects_affected="4" subjects_at_risk="29"/>
                <counts group_id="E7" subjects_affected="6" subjects_at_risk="31"/>
                <counts group_id="E8" subjects_affected="3" subjects_at_risk="25"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="22"/>
              </event>
              <event>
                <sub_title>Haemorrhoids</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="61"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="61"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="59"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="42"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="58"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="29"/>
                <counts group_id="E7" subjects_affected="2" subjects_at_risk="31"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="22"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Pyrexia</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="61"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="61"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="59"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="42"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="58"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="29"/>
                <counts group_id="E7" subjects_affected="2" subjects_at_risk="31"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="22"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Nasopharyngitis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="61"/>
                <counts group_id="E2" subjects_affected="6" subjects_at_risk="61"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="59"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="42"/>
                <counts group_id="E5" subjects_affected="4" subjects_at_risk="58"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="29"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="25"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="22"/>
              </event>
              <event>
                <sub_title>Upper respiratory tract infection</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="61"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="61"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="59"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="42"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="58"/>
                <counts group_id="E6" subjects_affected="2" subjects_at_risk="29"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="22"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="61"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="61"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="59"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="42"/>
                <counts group_id="E5" subjects_affected="2" subjects_at_risk="58"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="29"/>
                <counts group_id="E7" subjects_affected="2" subjects_at_risk="31"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="25"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="22"/>
              </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>There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <limitations_and_caveats>The study was terminated early due to a company decision based on interim analysis results in TD-1473-0157. Therefore, the Phase 3 dose-confirming Induction Study was not conducted and the Maintenance Study was prematurely terminated.</limitations_and_caveats>
    <point_of_contact>
      <name_or_title>Medical Monitor</name_or_title>
      <organization>Theravance Biopharma</organization>
      <phone>1-855-633-8479</phone>
      <email>medinfo@theravance.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/NCT03758443
org study id: 0157
secondary id: 2018-002136-24
nct id: NCT03758443
lead sponsor: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
A Phase 2b/3 set of studies to evaluate the efficacy and safety of induction and maintenance
      therapy with TD-1473 in subjects with moderately-to-severely active ulcerative colitis with
      up to 60 weeks of treatment.
This protocol consists of 3 separate studies: an 8-week Phase 2b dose-finding induction
      study, an 8-week dose-confirming Phase 3 induction study, and a 44-week Phase 3 maintenance
      study. Subjects who respond to induction will enter the maintenance study; those who do not
      will receive TD-1473 during extended induction. The safety and efficacy data of the Phase 2b
      study will be analyzed to select the induction and maintenance dose regimens for the
      confirmatory Phase 3 studies. Participants who have disease relapse or complete the
      maintenance study may be eligible to enter a separate long-term safety study. Efficacy,
      pharmacokinetic, biomarkers, and safety will be evaluated in all 3 studies.

      240 subjects are planned for the Phase 2b and the planned Primary Completion Date for this
      portion of the study is JULY 2021. 640 subjects are planned for the Phase 3 portion of the
      study.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Integrated and Adaptive Design
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Change From Baseline in Total Mayo Score (tMS) at Week 8
time frame: Baseline to Week 8
description: Total Mayo Score (tMS) was calculated as the sum of four components: rectal bleeding (0-3), stool frequency (0-3), physician's global assessment (0-3) and Mayo endoscopic subscore (0-3). tMS was reported as a 0-12 point score with 12 reflecting the highest severity.
measure: Phase 3 Maintenance: Number of Participants Who Demonstrated Clinical Remission by Adapted Mayo Score Components at Maintenance Week (mWeek) 44
time frame: mWeek 44
description: Clinical remission by Adapted Mayo score was defined based on Adapted Mayo score components within specific ranges: stool frequency score of 0 or 1, a rectal bleeding subscore of 0 and a Mayo endoscopy subscore of 0 or 1.
The Adapted Mayo score was the sum of three components: rectal bleeding, stool frequency, and Mayo endoscopic subscore, each measured on a scale of 0-3 with higher scores reflecting higher severity.
Participants with missing Week 44 values were imputed as non-responders.
measure: Number of Participants Who Demonstrated Clinical Remission by Adapted Mayo Score Components at Week 8
time frame: Week 8
description: Clinical remission by Adapted Mayo score was defined based on Adapted Mayo score components within specific ranges: stool frequency score of 0 or 1, a rectal bleeding subscore of 0 and a Mayo endoscopy subscore of 0 or 1.
The Adapted Mayo score was the sum of three components: rectal bleeding, stool frequency, and Mayo endoscopic subscore, each measured on a scale of 0-3 with higher scores reflecting higher severity.
measure: Phase 3 Maintenance: Number of Participants Who Demonstrated a Clinical Response by Adapted Mayo Score Components at mWeek 44
time frame: Baseline to mWeek 44
description: Clinical response was defined as a reduction from baseline in adapted Mayo score of ≥ 2 points and ≥ 30% relative to baseline. It also required ≥ 1 reduction in the rectal bleeding subscore or an absolute subscore ≤ 1.
The Adapted Mayo score was the sum of three components: rectal bleeding, stool frequency, and Mayo endoscopic subscore, each measured on a scale of 0-3 with higher scores reflecting higher severity.
Participants with missing Week 44 values were imputed as non-responders.
measure: Phase 3 Maintenance: Number of Participants Who Demonstrated Endoscopic Remission by Adapted Mayo Score Components at mWeek 44
time frame: mWeek 44
description: Endoscopic remission was defined as an endoscopic subscore ≤ 1.
Endoscopic subscore was measured using scale of 0-3, where higher numbers reflected greater severity.
measure: Phase 3 Maintenance: Number of Participants Who Demonstrated Symptomatic Remission by Adapted Mayo Score Components at mWeek 44
time frame: mWeek 44
description: Symptomatic remission was defined as a stool frequency score ≤ 1 and a rectal bleeding subscore of 0.
Stool frequency score and rectal bleeding score were each measured using scale of 0-3, where higher numbers reflected greater severity.
Participants with missing Week 44 values were imputed as non-responders.
arm group label: Active Treatment TD-1473 Dose A
arm group type: Experimental
description: Participants will be randomized to receive an oral daily dose of TD-1473. Responders will be re-randomized into the Phase 3 Maintenance portion of the study. Non-responders may participate in an extended induction.
arm group label: Active Treatment TD-1473 Dose B
arm group type: Experimental
description: Participants will be randomized to receive an oral daily dose of TD-1473. Responders will be re-randomized into the Phase 3 Maintenance portion of the study. Non-responders may participate in an extended induction.
arm group label: Active Treatment TD-1473 Dose C
arm group type: Experimental
description: Participants will be randomized to receive an oral daily dose of TD-1473. Responders will be re-randomized into the Phase 3 Maintenance portion of the study. Non-responders may participate in an extended induction.
arm group label: Placebo
arm group type: Placebo Comparator
description: Participants will be randomized to receive an oral daily dose of placebo. Participants who received Placebo (and were non-responders) may move to an extended induction. Subjects who are on placebo will be assigned to active TD-1473 for the extended induction (they will be blinded to dose).
intervention type: Drug
intervention name: TD-1473 Dose A
description: See Arm description
arm group label: Active Treatment TD-1473 Dose A
intervention type: Drug
intervention name: TD-1473 Dose B
description: See Arm description
arm group label: Active Treatment TD-1473 Dose B
intervention type: Drug
intervention name: TD-1473 Dose C
description: See Arm description
arm group label: Active Treatment TD-1473 Dose C
intervention type: Drug
intervention name: Placebo
description: See Arm description
arm group label: Placebo
criteria: 
gender: All
gender based: Yes
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Medical Monitor
role: Study Director
affiliation: Theravance Biopharma
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country: Australia
country: Bulgaria
country: Canada
country: France
country: Georgia
country: Germany
country: Greece
country: Hungary
country: Israel
country: Italy
country: Japan
country: Korea, Republic of
country: Poland
country: Portugal
country: Romania
country: Serbia
country: Slovakia
country: South Africa
country: Spain
country: Taiwan
country: Ukraine
country: United States
responsible party type: Sponsor
mesh term: Colitis
mesh term: Colitis, Ulcerative
mesh term: Ulcer
sharing ipd: No
ipd description: Theravance Biopharma, Inc. will not be sharing individual de-identified participant data or other relevant study documents.
provided document: 
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
limitations and caveats: The study was terminated early due to a company decision based on interim analysis results in TD-1473-0157. Therefore, the Phase 3 dose-confirming Induction Study was not conducted and the Maintenance Study was prematurely terminated.
point of contact: 