<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/NCT04504383</url>
  </required_header>
  <id_info>
    <org_study_id>PN-943-03</org_study_id>
    <nct_id>NCT04504383</nct_id>
  </id_info>
  <brief_title>PN-943 in Adults With Moderate to Severe Active Ulcerative Colitis (UC)</brief_title>
  <official_title>A Phase 2 Randomized, Double-blind, Placebo-controlled, Parallel-group, Multi-center Study to Evaluate the Safety and Efficacy of Oral PN-943 in Subjects With Moderate to Severe Active Ulcerative Colitis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Protagonist Therapeutics, Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Protagonist Therapeutics, Inc.</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of the study is to evaluate the safety, tolerability, and clinical efficacy of&#xD;
      PN-943 450 mg twice daily [BID] and PN-943 150 mg BID, compared with placebo BID, in subjects&#xD;
      with moderate to severe active Ulcerative Colitis (UC).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The study consists of a 12-week double-blind, placebo-controlled treatment period.&#xD;
      Participants will be randomized in a 1:1:1 ratio to PN-943 450 mg BID, PN-943 150 mg BID, or&#xD;
      matching placebo BID.&#xD;
&#xD;
      Participants who successfully complete the double-blind period may be eligible for an&#xD;
      extended treatment period of 40 weeks duration.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 5, 2020</start_date>
  <completion_date type="Actual">February 16, 2023</completion_date>
  <primary_completion_date type="Actual">February 16, 2023</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <intervention_model_description>12-week randomized, double-blind, placebo-controlled, parallel design study in patients with moderate to severe active UC. It will be followed by 40 weeks of Extended Active Treatment.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Triple (Participant, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Proportion of subjects achieving clinical remission at Week 12 compared to placebo.</measure>
    <time_frame>Week 12</time_frame>
    <description>Clinical remission is determined using the Adapted Mayo score (sum of 3 subscores from the Mayo score):&#xD;
Stool frequency subscore (SFS)&#xD;
Rectal bleeding subscore (RBS)&#xD;
Endoscopic subscore (ESS)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Comparison between PN-943 high-dose and low-dose individually to placebo.</measure>
    <time_frame>Week 12</time_frame>
    <description>Proportion of subjects with endoscopic improvement.&#xD;
Proportion of subjects achieving endoscopic remission.&#xD;
Proportion of subjects with histological improvement.&#xD;
Proportion of subjects achieving histological remission.&#xD;
Proportion of subjects with mucosal healing.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Proportion of subjects achieving clinical remission at Week 52.</measure>
    <time_frame>Week 52</time_frame>
    <description>Clinical remission is determined using the Adapted Mayo score (sum of 3 subscores from the Mayo score):&#xD;
Stool frequency subscore (SFS)&#xD;
Rectal bleeding subscore (RBS)&#xD;
Endoscopic subscore (ESS)</description>
  </other_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">169</enrollment>
  <condition>Ulcerative Colitis Chronic Moderate</condition>
  <condition>Ulcerative Colitis Chronic Severe</condition>
  <arm_group>
    <arm_group_label>PN-943 450 mg BID</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Oral administration of PN-943 450 mg BID</description>
  </arm_group>
  <arm_group>
    <arm_group_label>PN-943 150 mg BID</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Oral administration of PN-943 150 mg BID</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo BID</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Oral administration of matching placebo</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>PN-943</intervention_name>
    <description>Administered by the oral route BID for the duration of the study.</description>
    <arm_group_label>PN-943 150 mg BID</arm_group_label>
    <arm_group_label>PN-943 450 mg BID</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Administered by the oral route BID for 12 weeks.</description>
    <arm_group_label>Placebo BID</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Key Inclusion Criteria:&#xD;
&#xD;
          1. Male and female subjects age 18 (or the minimum country specific age of consent if&#xD;
             &gt;18) to 75 years.&#xD;
&#xD;
          2. Subject understands the study procedures and agrees to participate in the study by&#xD;
             giving written informed consent.&#xD;
&#xD;
          3. Diagnosis of UC supported by appropriate documentation of biopsy results consistent&#xD;
             with UC.&#xD;
&#xD;
          4. Moderate to severe active UC.&#xD;
&#xD;
          5. Demonstrated inadequate response, loss of response, or intolerance of at least 1 of&#xD;
             oral aminosalicylates (5-ASAs), corticosteroids, immunomodulators, or a biologic&#xD;
             (excluding vedolizumab).&#xD;
&#xD;
        Key Exclusion Criteria:&#xD;
&#xD;
          1. Subject with a current diagnosis of Crohn's disease (CD), indeterminate colitis (IC),&#xD;
             microscopic colitis, ischemic colitis, radiation colitis.&#xD;
&#xD;
          2. History of colonic dysplasia other than completely removed low-grade dysplastic&#xD;
             lesion.&#xD;
&#xD;
          3. History of active bacterial, viral, fungal or mycobacterial infection requiring&#xD;
             hospitalization or IV antibiotic/anti-infective treatment within 4 weeks of screening&#xD;
             or oral antibiotics/anti-infectives within 2 weeks of screening.&#xD;
&#xD;
          4. Prior treatment with vedolizumab, natalizumab, or any agent targeting the α4β7 or β1&#xD;
             integrin or planned during the study.&#xD;
&#xD;
          5. Positive stool test for C. difficile.&#xD;
&#xD;
          6. Chronic recurrent or serious infection.&#xD;
&#xD;
          7. Known primary or secondary immunodeficiency.&#xD;
&#xD;
          8. Pregnant or lactating female or considering becoming pregnant during the study or&#xD;
             within 30 days after the last dose of study medication.&#xD;
&#xD;
          9. History of any major neurological disorders.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Protagonist Investigational Site</name>
      <address>
        <city>Tucson</city>
        <state>Arizona</state>
        <zip>85712</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Protagonist Investigational Site</name>
      <address>
        <city>Garden Grove</city>
        <state>California</state>
        <zip>92845</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Protagonist Investigational Site</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>90036</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Protagonist Investigational Site</name>
      <address>
        <city>Murrieta</city>
        <state>California</state>
        <zip>92563</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Protagonist Investigational Site</name>
      <address>
        <city>San Francisco</city>
        <state>California</state>
        <zip>94158</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Protagonist Investigational Site</name>
      <address>
        <city>Colorado Springs</city>
        <state>Colorado</state>
        <zip>80907</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Protagonist Investigational Site</name>
      <address>
        <city>Kissimmee</city>
        <state>Florida</state>
        <zip>34741</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Protagonist Investigational Site</name>
      <address>
        <city>Miami</city>
        <state>Florida</state>
        <zip>33125</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Protagonist Investigational Site</name>
      <address>
        <city>Miami</city>
        <state>Florida</state>
        <zip>33175</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Protagonist Investigational Site</name>
      <address>
        <city>Miami</city>
        <state>Florida</state>
        <zip>33180</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Protagonist Investigational site</name>
      <address>
        <city>Orlando</city>
        <state>Florida</state>
        <zip>32819</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Protagonist Investigational Site</name>
      <address>
        <city>Saint Augustine</city>
        <state>Florida</state>
        <zip>32086</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Protagonist Investigational Site</name>
      <address>
        <city>Wesley Chapel</city>
        <state>Florida</state>
        <zip>33544</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Protagonist Investigational Site</name>
      <address>
        <city>Metairie</city>
        <state>Louisiana</state>
        <zip>70006</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Protagonist Investigational Site</name>
      <address>
        <city>Glen Burnie</city>
        <state>Maryland</state>
        <zip>21061</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Protagonist Investigational Site</name>
      <address>
        <city>Chesterfield</city>
        <state>Michigan</state>
        <zip>48047</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Protagonist Investigational Site</name>
      <address>
        <city>Troy</city>
        <state>Michigan</state>
        <zip>48098</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Protagonist Investigational Site</name>
      <address>
        <city>Jackson</city>
        <state>Mississippi</state>
        <zip>39216</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Protagonist Investigational Site</name>
      <address>
        <city>Saint Louis</city>
        <state>Missouri</state>
        <zip>63110</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Protagonist Investigational Site</name>
      <address>
        <city>Englewood</city>
        <state>New Jersey</state>
        <zip>07631</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Protagonist Investigational Site</name>
      <address>
        <city>North Massapequa</city>
        <state>New York</state>
        <zip>11758</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Protagonist Investigational Site</name>
      <address>
        <city>Charlotte</city>
        <state>North Carolina</state>
        <zip>28210</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Protagonist Investigational Site</name>
      <address>
        <city>Norman</city>
        <state>Oklahoma</state>
        <zip>73071</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Protagonist Investigational Site</name>
      <address>
        <city>Oklahoma City</city>
        <state>Oklahoma</state>
        <zip>73103</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Protagonist Investigational Site</name>
      <address>
        <city>Orangeburg</city>
        <state>South Carolina</state>
        <zip>29118</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Protagonist Investigational Site</name>
      <address>
        <city>Nashville</city>
        <state>Tennessee</state>
        <zip>37212</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Protagonist Investigational Site</name>
      <address>
        <city>Austin</city>
        <state>Texas</state>
        <zip>78742</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Protagonist Investigational site</name>
      <address>
        <city>Garland</city>
        <state>Texas</state>
        <zip>75044</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Protagonist Investigational Site</name>
      <address>
        <city>Pasadena</city>
        <state>Texas</state>
        <zip>77505</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Protagonist Investigational Site</name>
      <address>
        <city>Spring</city>
        <state>Texas</state>
        <zip>77388</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Protagonist Investigational site</name>
      <address>
        <city>Lynchburg</city>
        <state>Virginia</state>
        <zip>24502</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Protagonist Investigational Site</name>
      <address>
        <city>Innsbruck</city>
        <zip>6020</zip>
        <country>Austria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Protagonist Investigational Site</name>
      <address>
        <city>Salzburg</city>
        <zip>5020</zip>
        <country>Austria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Protagonist Investigational Site</name>
      <address>
        <city>Vienna</city>
        <zip>1090</zip>
        <country>Austria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Protagonist Investigational Site</name>
      <address>
        <city>Sofia</city>
        <zip>1303</zip>
        <country>Bulgaria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Protagonist Investigational Site</name>
      <address>
        <city>Sofia</city>
        <zip>1407</zip>
        <country>Bulgaria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Protagonist Investigational Site</name>
      <address>
        <city>Kelowna</city>
        <state>British Columbia</state>
        <zip>V1Y 4N7</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Protagonist Investigational Site</name>
      <address>
        <city>Vancouver</city>
        <state>British Columbia</state>
        <zip>V6K 2K5</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Protagonist Investigational Site</name>
      <address>
        <city>West Vancouver</city>
        <state>British Columbia</state>
        <zip>V7T 1C5</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Protagonist Investigational Site</name>
      <address>
        <city>North Bay</city>
        <state>Ontario</state>
        <zip>P1B 2H3</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Protagonist Investigational Site</name>
      <address>
        <city>Toronto</city>
        <state>Ontario</state>
        <zip>M5T 3A9</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Protagonist Investigational Site</name>
      <address>
        <city>Vaughan</city>
        <state>Ontario</state>
        <zip>L4L 4Y7</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Protagonist Investigational Site</name>
      <address>
        <city>Tbilisi</city>
        <zip>0141</zip>
        <country>Georgia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Protagonist Investigational Site</name>
      <address>
        <city>Tbilisi</city>
        <zip>0144</zip>
        <country>Georgia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Protagonist Investigational Site</name>
      <address>
        <city>Tbilisi</city>
        <zip>0159</zip>
        <country>Georgia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Protagonist Investigational Site</name>
      <address>
        <city>Tbilisi</city>
        <zip>0160</zip>
        <country>Georgia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Protagonist Investigational Site</name>
      <address>
        <city>Tbilisi</city>
        <zip>0186</zip>
        <country>Georgia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Protagonist Investigational Site</name>
      <address>
        <city>Berlin</city>
        <zip>14050</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Protagonist Investigational Site</name>
      <address>
        <city>Berlin</city>
        <zip>14163</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Protagonist Investigational Site</name>
      <address>
        <city>Kiel</city>
        <zip>24105</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Protagonist Investigational Site</name>
      <address>
        <city>Tuebingen</city>
        <zip>72076</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Protagonist Investigational Site</name>
      <address>
        <city>Budapest</city>
        <zip>H-1033</zip>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Protagonist Investigational Site</name>
      <address>
        <city>Debrecen</city>
        <zip>4025</zip>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Protagonist Investigational Site</name>
      <address>
        <city>Székesfehérvár</city>
        <zip>8000</zip>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Protagonist Investigational Site</name>
      <address>
        <city>Castellana Grotte</city>
        <zip>70013</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Protagonist Investigational Site</name>
      <address>
        <city>Modena</city>
        <zip>41124</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Protagonist Investigational Site</name>
      <address>
        <city>Negrar</city>
        <zip>37024</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Protagonist Investigational Site</name>
      <address>
        <city>Padova</city>
        <zip>35128</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Protagonist Investigational Site</name>
      <address>
        <city>Roma</city>
        <zip>00152</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Protagonist Investigational Site</name>
      <address>
        <city>Roma</city>
        <zip>00168</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Protagonist Investigational Site</name>
      <address>
        <city>San Giovanni Rotondo</city>
        <zip>71013</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Protagonist Investigational Site</name>
      <address>
        <city>Busan</city>
        <zip>48079</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Protagonist Investigational Site</name>
      <address>
        <city>Busan</city>
        <zip>49201</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Protagonist Investigational Site</name>
      <address>
        <city>Daegu</city>
        <zip>42415</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Protagonist Investigational Site</name>
      <address>
        <city>Daegu</city>
        <zip>42601</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Protagonist Investigational Site</name>
      <address>
        <city>Daejeon</city>
        <zip>34943</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Protagonist Investigational Site</name>
      <address>
        <city>Seoul</city>
        <zip>06351</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Protagonist Investigational Site</name>
      <address>
        <city>Seoul</city>
        <zip>06591</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Protagonist Investigational site</name>
      <address>
        <city>Seoul</city>
        <zip>06973</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Protagonist Investigational Site</name>
      <address>
        <city>Poznań</city>
        <state>Wielkopolskie</state>
        <zip>60-848</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Protagonist Investigational Site</name>
      <address>
        <city>Bydgoszcz</city>
        <zip>85-079</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Protagonist Investigational Site</name>
      <address>
        <city>Bydgoszcz</city>
        <zip>85794</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Protagonist Investigational Site</name>
      <address>
        <city>Czestochowa</city>
        <zip>42-200</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Protagonist Investigational Site</name>
      <address>
        <city>Czestochowa</city>
        <zip>42217</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Protagonist Investigational Site</name>
      <address>
        <city>Katowice</city>
        <zip>40-748</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Protagonist Investigational Site</name>
      <address>
        <city>Kraków</city>
        <zip>31-501</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Protagonist Investigational Site</name>
      <address>
        <city>Ksawerów</city>
        <zip>95-054</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Protagonist Investigational Site</name>
      <address>
        <city>Lublin</city>
        <zip>20-582</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Protagonist Investigational Site</name>
      <address>
        <city>Nowy Targ</city>
        <zip>34-400</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Protagonist Investigational Site</name>
      <address>
        <city>Piotrków Trybunalski</city>
        <zip>97-300</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Protagonist Investigational Site</name>
      <address>
        <city>Poznań</city>
        <zip>60-529</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Protagonist Investigational Site</name>
      <address>
        <city>Poznań</city>
        <zip>61-441</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Protagonist Investigational Site</name>
      <address>
        <city>Rzeszów</city>
        <zip>35-326</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Protagonist Investigational Site</name>
      <address>
        <city>Sopot</city>
        <zip>81-756</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Protagonist Investigational Site</name>
      <address>
        <city>Swidnica</city>
        <zip>58-100</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Protagonist Investigational Site</name>
      <address>
        <city>Toruń</city>
        <zip>87-100</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Protagonist Investigational Site</name>
      <address>
        <city>Tychy</city>
        <zip>43-100</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Protagonist Investigational Site</name>
      <address>
        <city>Warsaw</city>
        <zip>00-635</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Protagonist Investigational Site</name>
      <address>
        <city>Warsaw</city>
        <zip>00-728</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Protagonist Investigational Site</name>
      <address>
        <city>Warszawa</city>
        <zip>00-332</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Protagonist Investigational Site</name>
      <address>
        <city>Wrocław</city>
        <zip>50449</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Protagonist Investigational Site</name>
      <address>
        <city>Wrocław</city>
        <zip>51-162</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Protagonist Investigational Site</name>
      <address>
        <city>Wrocław</city>
        <zip>51-685</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Protagonist Investigational Site</name>
      <address>
        <city>Wrocław</city>
        <zip>52210</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Protagonist Investigational Site</name>
      <address>
        <city>Włocławek</city>
        <zip>87-800</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Protagonist Investigational Site</name>
      <address>
        <city>Łódź</city>
        <zip>90-349</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Protagonist Investigational Site</name>
      <address>
        <city>Łódź</city>
        <zip>90-644</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Protagonist Investigational Site</name>
      <address>
        <city>Chelyabinsk</city>
        <zip>454076</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Protagonist Investigational Site</name>
      <address>
        <city>Moscow</city>
        <zip>105554</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Protagonist Investigational Site</name>
      <address>
        <city>Novosibirsk</city>
        <zip>630087</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Protagonist Investigational Site</name>
      <address>
        <city>Novosibirsk</city>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Protagonist Investigational Site</name>
      <address>
        <city>Perm</city>
        <zip>614068</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Protagonist Investigational Site</name>
      <address>
        <city>Pyatigorsk</city>
        <zip>357500</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Protagonist Investigational Site</name>
      <address>
        <city>Saint Petersburg</city>
        <zip>196143</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Protagonist Investigational Site</name>
      <address>
        <city>Saint Petersburg</city>
        <zip>196257</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Protagonist Investigational Site</name>
      <address>
        <city>Saint Petersburg</city>
        <zip>197089</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Protagonist Investigational Site</name>
      <address>
        <city>Saint Petersburg</city>
        <zip>197110</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Protagonist Investigational Site</name>
      <address>
        <city>Samara</city>
        <zip>443029</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Protagonist Investigational Site</name>
      <address>
        <city>Saratow</city>
        <zip>410053</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Protagonist Investigational Site</name>
      <address>
        <city>Stavropol'</city>
        <zip>355000</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Protagonist Investigational Site</name>
      <address>
        <city>Tomsk</city>
        <zip>634063</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Protagonist Investigational Site</name>
      <address>
        <city>Tyumen</city>
        <zip>625026</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Protagonist Investigational Site</name>
      <address>
        <city>Zrenjanin</city>
        <zip>23000</zip>
        <country>Serbia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Protagonist Investigational Site</name>
      <address>
        <city>Ivano-Frankivs'k</city>
        <zip>76018</zip>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Protagonist Investigational Site</name>
      <address>
        <city>Kherson</city>
        <zip>73000</zip>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Protagonist Investigational Site</name>
      <address>
        <city>Kyiv</city>
        <zip>01030</zip>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Protagonist Investigational Site</name>
      <address>
        <city>Kyiv</city>
        <zip>01103</zip>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Protagonist Investigational Site</name>
      <address>
        <city>Kyiv</city>
        <zip>04073</zip>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Protagonist Investigational Site</name>
      <address>
        <city>Lviv</city>
        <zip>79007</zip>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Protagonist Investigational Site</name>
      <address>
        <city>Vinnytsia</city>
        <zip>21000</zip>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Protagonist Investigational Site</name>
      <address>
        <city>Vinnytsia</city>
        <zip>21018</zip>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Protagonist Investigational Site</name>
      <address>
        <city>Zhytomyr</city>
        <zip>10003</zip>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Austria</country>
    <country>Bulgaria</country>
    <country>Canada</country>
    <country>Georgia</country>
    <country>Germany</country>
    <country>Hungary</country>
    <country>Italy</country>
    <country>Korea, Republic of</country>
    <country>Poland</country>
    <country>Russian Federation</country>
    <country>Serbia</country>
    <country>Ukraine</country>
    <country>United States</country>
  </location_countries>
  <verification_date>April 2023</verification_date>
  <study_first_submitted>August 5, 2020</study_first_submitted>
  <study_first_submitted_qc>August 5, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">August 7, 2020</study_first_posted>
  <last_update_submitted>April 24, 2023</last_update_submitted>
  <last_update_submitted_qc>April 24, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">April 25, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Inflammatory Bowel Disease (IBD)</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>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</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/NCT04504383
org study id: PN-943-03
nct id: NCT04504383
lead sponsor: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
The purpose of the study is to evaluate the safety, tolerability, and clinical efficacy of
      PN-943 450 mg twice daily [BID] and PN-943 150 mg BID, compared with placebo BID, in subjects
      with moderate to severe active Ulcerative Colitis (UC).
The study consists of a 12-week double-blind, placebo-controlled treatment period.
      Participants will be randomized in a 1:1:1 ratio to PN-943 450 mg BID, PN-943 150 mg BID, or
      matching placebo BID.

      Participants who successfully complete the double-blind period may be eligible for an
      extended treatment period of 40 weeks duration.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: 12-week randomized, double-blind, placebo-controlled, parallel design study in patients with moderate to severe active UC. It will be followed by 40 weeks of Extended Active Treatment.
primary purpose: Treatment
masking: Triple (Participant, Investigator, Outcomes Assessor)
measure: Proportion of subjects achieving clinical remission at Week 12 compared to placebo.
time frame: Week 12
description: Clinical remission is determined using the Adapted Mayo score (sum of 3 subscores from the Mayo score):
Stool frequency subscore (SFS)
Rectal bleeding subscore (RBS)
Endoscopic subscore (ESS)
measure: Comparison between PN-943 high-dose and low-dose individually to placebo.
time frame: Week 12
description: Proportion of subjects with endoscopic improvement.
Proportion of subjects achieving endoscopic remission.
Proportion of subjects with histological improvement.
Proportion of subjects achieving histological remission.
Proportion of subjects with mucosal healing.
measure: Proportion of subjects achieving clinical remission at Week 52.
time frame: Week 52
description: Clinical remission is determined using the Adapted Mayo score (sum of 3 subscores from the Mayo score):
Stool frequency subscore (SFS)
Rectal bleeding subscore (RBS)
Endoscopic subscore (ESS)
arm group label: PN-943 450 mg BID
arm group type: Experimental
description: Oral administration of PN-943 450 mg BID
arm group label: PN-943 150 mg BID
arm group type: Experimental
description: Oral administration of PN-943 150 mg BID
arm group label: Placebo BID
arm group type: Placebo Comparator
description: Oral administration of matching placebo
intervention type: Drug
intervention name: PN-943
description: Administered by the oral route BID for the duration of the study.
arm group label: PN-943 150 mg BID
arm group label: PN-943 450 mg BID
intervention type: Drug
intervention name: Placebo
description: Administered by the oral route BID for 12 weeks.
arm group label: Placebo BID
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: No
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country: Austria
country: Bulgaria
country: Canada
country: Georgia
country: Germany
country: Hungary
country: Italy
country: Korea, Republic of
country: Poland
country: Russian Federation
country: Serbia
country: Ukraine
country: United States
responsible party type: Sponsor
mesh term: Colitis
mesh term: Colitis, Ulcerative
mesh term: Ulcer
sharing ipd: No