<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/NCT03759041</url>
  </required_header>
  <id_info>
    <org_study_id>SERES-201</org_study_id>
    <nct_id>NCT03759041</nct_id>
  </id_info>
  <brief_title>A Study to Assess Efficacy and Safety of SER-287 in Adults With Active Mild-to-Moderate Ulcerative Colitis</brief_title>
  <acronym>ECO-RESET</acronym>
  <official_title>ECO-RESET: A Phase 2B, Randomized, Double-Blind, Placebo-Controlled, Multiple Dose, Multicenter Study to Assess Efficacy and Safety of SER-287 in Adults With Active Mild-to-Moderate Ulcerative Colitis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Seres Therapeutics, Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Seres Therapeutics, Inc.</source>
  <oversight_info>
    <has_dmc>No</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 Randomized, Double-Blind, Placebo-Controlled, Multiple Dose, Multicenter Study to Assess&#xD;
      Efficacy and Safety of SER-287 in Adults with Active Mild-to-Moderate Ulcerative Colitis&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a Phase 2B randomized, double-blind, placebo-controlled, multiple dose, multicenter&#xD;
      study designed to evaluate the efficacy, safety and microbiome alterations associated with&#xD;
      two dose levels of SER-287, after pre-treatment with vancomycin, in adult subjects, age&#xD;
      18-80, with active mild-to-moderate ulcerative colitis (UC).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Due to the lack of a clinical efficacy signal in the induction treatment phase, Seres closed&#xD;
    the dosing phases of open label and maintenance portions of the study. Patients who had&#xD;
    received prior doses were followed for safety data.&#xD;
  </why_stopped>
  <start_date type="Actual">December 19, 2018</start_date>
  <completion_date type="Actual">October 13, 2021</completion_date>
  <primary_completion_date type="Actual">May 28, 2021</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Triple (Participant, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Clinical Remission (Count of Participants)</measure>
    <time_frame>After 10 weeks of induction dosing</time_frame>
    <description>Clinical remission for the induction treatment period:&#xD;
Stool Frequency subscore = 0 or 1, with at least 1-point decrease from baseline&#xD;
Rectal Bleeding subscore = 0&#xD;
Endoscopic subscore = 0 or 1 on modified Mayo Score, with at least 1-point decrease from baseline&#xD;
No occurrence of UC Flare during the treatment period&#xD;
Clinical remission was measured using 3 components of the modified Mayo Score (stool frequency, rectal bleeding and endoscopic subscore), a measure of UC disease activity. These 3 components are each graded from 0 to 3, and are summed together for a composite score, with a higher overall score indicating more severe disease (0 = no disease; 9 = worst disease). The modified Mayo endoscopic subscore excludes friability from an endoscopic subscore of 1.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Endoscopic Improvement (Count of Participants)</measure>
    <time_frame>After 10 weeks of induction dosing</time_frame>
    <description>Endoscopic subscore decrease from baseline of at least 1 point, as assessed by flexible sigmoidoscopy or colonoscopy.&#xD;
Endoscopic improvement was measured using the modified Mayo Score endoscopic subscore, graded from 0 to 3, with higher scores indicating more severe disease. The modified Mayo endoscopic subscore excludes friability from an endoscopic subscore of 1.</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">203</enrollment>
  <condition>Ulcerative Colitis</condition>
  <arm_group>
    <arm_group_label>Placebo (after placebo pre-treatment)</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Once-daily dosing of Placebo (after placebo pre-treatment)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>SER-287 Induction Dosing (after vancomycin pre-treatment)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Once-daily dosing of SER-287 (Induction Dose, after vancomycin pre-treatment)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>SER-287 Step-Down Induction Dosing (after vancomycin pre-treatment)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Once-daily dosing of SER-287 (Step-Down Induction Dose, after vancomycin pre-treatment)</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Vancomycin Pre-Treatment</intervention_name>
    <description>Four times per day dosing of vancomycin pre-treatment</description>
    <arm_group_label>SER-287 Induction Dosing (after vancomycin pre-treatment)</arm_group_label>
    <arm_group_label>SER-287 Step-Down Induction Dosing (after vancomycin pre-treatment)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo for Vancomycin Pre-Treatment</intervention_name>
    <description>Four times per day dosing of placebo pre-treatment</description>
    <arm_group_label>Placebo (after placebo pre-treatment)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>SER-287</intervention_name>
    <description>Once-daily dosing of SER-287</description>
    <arm_group_label>SER-287 Induction Dosing (after vancomycin pre-treatment)</arm_group_label>
    <arm_group_label>SER-287 Step-Down Induction Dosing (after vancomycin pre-treatment)</arm_group_label>
    <other_name>Eubacterial Spores, Purified Suspension, Encapsulated</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo for SER-287</intervention_name>
    <description>Once-daily dosing of Placebo for SER-287</description>
    <arm_group_label>Placebo (after placebo pre-treatment)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Documented diagnosis of UC at least three months prior to screening, and with a&#xD;
             minimum disease extent of 15 cm from the anal verge&#xD;
&#xD;
          -  Active mild-to-moderate UC&#xD;
&#xD;
          -  Inadequate response to, loss of response to, or intolerance of, at least one of the&#xD;
             following conventional therapies: 5-ASA compounds, corticosteroids, 6-mercaptopurine&#xD;
             (6-MP) or azathioprine (AZA), anti-TNFα, anti-integrin or tofacitinib&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Known history of Crohn's disease&#xD;
&#xD;
          -  No previous history of treatment for UC (treatment-naïve)&#xD;
&#xD;
          -  Subjects on steroid medication who are unable to have steroids tapered and be&#xD;
             completely off steroids at least two weeks prior to screening&#xD;
&#xD;
          -  Unable to stop steroid enemas or suppositories, or 5-ASA enemas or suppositories, at&#xD;
             least two weeks prior to screening&#xD;
&#xD;
          -  Subjects who have received any investigational or approved biologic therapy within&#xD;
             eight weeks or five half-lives prior to screening (whichever is longer)&#xD;
&#xD;
          -  Subjects who have received any investigational or approved non-biologic therapy,&#xD;
             except for those specifically listed in the Permitted Concomitant Medications, for the&#xD;
             treatment of underlying disease, within 30 days or five half-lives prior to screening&#xD;
             (whichever is longer)&#xD;
&#xD;
          -  Major gastrointestinal surgery (not including appendectomy or cholecystectomy) within&#xD;
             two months before screening, or any history of total colectomy&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Lisa von Moltke, MD</last_name>
    <role>Study Director</role>
    <affiliation>Seres Therapeutics, Inc.</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>(Investigator site)</name>
      <address>
        <city>Phoenix</city>
        <state>Arizona</state>
        <zip>85018</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>(Investigator site)</name>
      <address>
        <city>North Little Rock</city>
        <state>Arkansas</state>
        <zip>72117</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>(Investigator site)</name>
      <address>
        <city>La Jolla</city>
        <state>California</state>
        <zip>92037</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>(Investigator site)</name>
      <address>
        <city>Lancaster</city>
        <state>California</state>
        <zip>93534</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>(Investigator site)</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>90067</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>(Investigator site)</name>
      <address>
        <city>Mountain View</city>
        <state>California</state>
        <zip>94040</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>(Investigator site)</name>
      <address>
        <city>San Diego</city>
        <state>California</state>
        <zip>92103</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>(Investigator site)</name>
      <address>
        <city>San Diego</city>
        <state>California</state>
        <zip>92123</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>(Investigator site)</name>
      <address>
        <city>Wheat Ridge</city>
        <state>Colorado</state>
        <zip>80033</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>(Investigator site)</name>
      <address>
        <city>Danbury</city>
        <state>Connecticut</state>
        <zip>06810</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>(Investigator site)</name>
      <address>
        <city>Hamden</city>
        <state>Connecticut</state>
        <zip>06518</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>(Investigator site)</name>
      <address>
        <city>Boca Raton</city>
        <state>Florida</state>
        <zip>33487</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>(Investigator site)</name>
      <address>
        <city>Clearwater</city>
        <state>Florida</state>
        <zip>33762</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>(Investigator site)</name>
      <address>
        <city>Crystal River</city>
        <state>Florida</state>
        <zip>34429</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>(Investigator site)</name>
      <address>
        <city>Fort Lauderdale</city>
        <state>Florida</state>
        <zip>33308</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>(Investigator site)</name>
      <address>
        <city>Hialeah</city>
        <state>Florida</state>
        <zip>33012</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>(Investigator site)</name>
      <address>
        <city>Jacksonville</city>
        <state>Florida</state>
        <zip>32256</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>(Investigator site)</name>
      <address>
        <city>Miami</city>
        <state>Florida</state>
        <zip>33136</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>(Investigator site)</name>
      <address>
        <city>Miami</city>
        <state>Florida</state>
        <zip>33176</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>(Investigator site)</name>
      <address>
        <city>Naples</city>
        <state>Florida</state>
        <zip>34102</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>(Investigator site)</name>
      <address>
        <city>Ocala</city>
        <state>Florida</state>
        <zip>34474</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>(Investigator site)</name>
      <address>
        <city>Orlando</city>
        <state>Florida</state>
        <zip>32803</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>(Investigator site)</name>
      <address>
        <city>Pompano Beach</city>
        <state>Florida</state>
        <zip>33060</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>(Investigator site)</name>
      <address>
        <city>Port Orange</city>
        <state>Florida</state>
        <zip>32127</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>(Investigator site)</name>
      <address>
        <city>Tampa</city>
        <state>Florida</state>
        <zip>33609</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>(Investigator site)</name>
      <address>
        <city>Athens</city>
        <state>Georgia</state>
        <zip>30607</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>(Investigator site)</name>
      <address>
        <city>Atlanta</city>
        <state>Georgia</state>
        <zip>30322</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>(Investigator site)</name>
      <address>
        <city>Marietta</city>
        <state>Georgia</state>
        <zip>30060</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>(Investigator site)</name>
      <address>
        <city>Chicago</city>
        <state>Illinois</state>
        <zip>60611</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>(Investigator site)</name>
      <address>
        <city>Chicago</city>
        <state>Illinois</state>
        <zip>60612</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>(Investigator site)</name>
      <address>
        <city>Chicago</city>
        <state>Illinois</state>
        <zip>60637</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>(Investigator site)</name>
      <address>
        <city>Indianapolis</city>
        <state>Indiana</state>
        <zip>46202</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>(Investigator site)</name>
      <address>
        <city>Lexington</city>
        <state>Kentucky</state>
        <zip>40536</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>(Investigator site)</name>
      <address>
        <city>Lake Charles</city>
        <state>Louisiana</state>
        <zip>70601</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>(Investigator site)</name>
      <address>
        <city>Metairie</city>
        <state>Louisiana</state>
        <zip>70006</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>(Investigator site)</name>
      <address>
        <city>Monroe</city>
        <state>Louisiana</state>
        <zip>71201</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>(Investigator site)</name>
      <address>
        <city>New Orleans</city>
        <state>Louisiana</state>
        <zip>70121</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>(Investigator site)</name>
      <address>
        <city>Shreveport</city>
        <state>Louisiana</state>
        <zip>71105</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>(Investigator site)</name>
      <address>
        <city>Baltimore</city>
        <state>Maryland</state>
        <zip>21287</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>(Investigator site)</name>
      <address>
        <city>Glen Burnie</city>
        <state>Maryland</state>
        <zip>21208</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>(Investigator site)</name>
      <address>
        <city>Ann Arbor</city>
        <state>Michigan</state>
        <zip>48109</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>(Investigator site)</name>
      <address>
        <city>Farmington Hills</city>
        <state>Michigan</state>
        <zip>48334</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>(Investigator site)</name>
      <address>
        <city>Rochester</city>
        <state>Minnesota</state>
        <zip>55905</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>(Investigator site)</name>
      <address>
        <city>Bridgeton</city>
        <state>Missouri</state>
        <zip>63044</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>(Investigator site)</name>
      <address>
        <city>Creve Coeur</city>
        <state>Missouri</state>
        <zip>63141</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>(Investigator site)</name>
      <address>
        <city>Las Vegas</city>
        <state>Nevada</state>
        <zip>89123</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>(Investigator site)</name>
      <address>
        <city>Reno</city>
        <state>Nevada</state>
        <zip>89511</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>(Investigator site)</name>
      <address>
        <city>Lebanon</city>
        <state>New Hampshire</state>
        <zip>03756</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>(Investigator site)</name>
      <address>
        <city>Great Neck</city>
        <state>New York</state>
        <zip>11021</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>(Investigator site)</name>
      <address>
        <city>Hartsdale</city>
        <state>New York</state>
        <zip>10530</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>(Investigator site)</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10016</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>(Investigator site)</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10032</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>(Investigator site)</name>
      <address>
        <city>Asheville</city>
        <state>North Carolina</state>
        <zip>28801</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>(Investigator site)</name>
      <address>
        <city>Chapel Hill</city>
        <state>North Carolina</state>
        <zip>27599</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>(Investigator site)</name>
      <address>
        <city>Durham</city>
        <state>North Carolina</state>
        <zip>27710</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>(Investigator site)</name>
      <address>
        <city>Raleigh</city>
        <state>North Carolina</state>
        <zip>27612</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>(Investigator site)</name>
      <address>
        <city>Winston-Salem</city>
        <state>North Carolina</state>
        <zip>27103</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>(Investigator site)</name>
      <address>
        <city>Winston-Salem</city>
        <state>North Carolina</state>
        <zip>27157</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>(Investigator site)</name>
      <address>
        <city>Cincinnati</city>
        <state>Ohio</state>
        <zip>45219</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>(Investigator site)</name>
      <address>
        <city>Oklahoma City</city>
        <state>Oklahoma</state>
        <zip>73104</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>(Investigator site)</name>
      <address>
        <city>Columbia</city>
        <state>South Carolina</state>
        <zip>29203</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>(Investigator site)</name>
      <address>
        <city>Greenville</city>
        <state>South Carolina</state>
        <zip>29615</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>(Investigator site)</name>
      <address>
        <city>Memphis</city>
        <state>Tennessee</state>
        <zip>38119</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>(Investigator site)</name>
      <address>
        <city>Nashville</city>
        <state>Tennessee</state>
        <zip>37212</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>(Investigator site)</name>
      <address>
        <city>Bedford</city>
        <state>Texas</state>
        <zip>76022</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>(Investigator site)</name>
      <address>
        <city>Fort Sam Houston</city>
        <state>Texas</state>
        <zip>78219</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>(Investigator site)</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77030</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>(Investigator site)</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77043</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>(Investigator site)</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77090</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>(Investigator site)</name>
      <address>
        <city>McAllen</city>
        <state>Texas</state>
        <zip>78504</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>(Investigator site)</name>
      <address>
        <city>San Antonio</city>
        <state>Texas</state>
        <zip>78229</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>(Investigator site)</name>
      <address>
        <city>Temple</city>
        <state>Texas</state>
        <zip>76508</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>(Investigator site)</name>
      <address>
        <city>Ogden</city>
        <state>Utah</state>
        <zip>84405</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>(Investigator site)</name>
      <address>
        <city>Salt Lake City</city>
        <state>Utah</state>
        <zip>84124</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>(Investigator site)</name>
      <address>
        <city>Leesburg</city>
        <state>Virginia</state>
        <zip>20176</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>(Investigator site)</name>
      <address>
        <city>Lynchburg</city>
        <state>Virginia</state>
        <zip>24502</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>(Investigator site)</name>
      <address>
        <city>Reston</city>
        <state>Virginia</state>
        <zip>20191</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>(Investigator site)</name>
      <address>
        <city>Richmond</city>
        <state>Virginia</state>
        <zip>23249</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>(Investigator site)</name>
      <address>
        <city>Spokane</city>
        <state>Washington</state>
        <zip>99202</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>(Investigator site)</name>
      <address>
        <city>Madison</city>
        <state>Wisconsin</state>
        <zip>53792</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>(Investigator site)</name>
      <address>
        <city>Milwaukee</city>
        <state>Wisconsin</state>
        <zip>53215</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>(Investigator site)</name>
      <address>
        <city>Edmonton</city>
        <state>Alberta</state>
        <zip>T6G 2L7</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>(Investigator site)</name>
      <address>
        <city>Edmonton</city>
        <state>Alberta</state>
        <zip>T6L 6K3</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>(Investigator site)</name>
      <address>
        <city>New Westminster</city>
        <state>British Columbia</state>
        <zip>V3L 3W4</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>(Investigator site)</name>
      <address>
        <city>Bridgewater</city>
        <state>Ontario</state>
        <zip>B4V 3K9</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>(Investigator site)</name>
      <address>
        <city>Lindsay</city>
        <state>Ontario</state>
        <zip>K9V 5G6</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>(Investigator site)</name>
      <address>
        <city>London</city>
        <state>Ontario</state>
        <zip>N6A 5A5</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>(Investigator site)</name>
      <address>
        <city>London</city>
        <state>Ontario</state>
        <zip>N6A 5W9</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>(Investigator site)</name>
      <address>
        <city>Sudbury</city>
        <state>Ontario</state>
        <zip>P3C 5K6</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>(Investigator site)</name>
      <address>
        <city>Toronto</city>
        <state>Ontario</state>
        <zip>M5T 3A9</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>(Investigator site)</name>
      <address>
        <city>Vaughan</city>
        <state>Ontario</state>
        <zip>L4L 4Y7</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>(Investigator site)</name>
      <address>
        <city>Greenfield Park</city>
        <state>Quebec</state>
        <zip>J4V 2H1</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>(Investigator site)</name>
      <address>
        <city>Saskatoon</city>
        <state>Saskatchewan</state>
        <zip>S7N 0W8</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
    <country>United States</country>
  </location_countries>
  <verification_date>July 2022</verification_date>
  <study_first_submitted>November 27, 2018</study_first_submitted>
  <study_first_submitted_qc>November 28, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">November 29, 2018</study_first_posted>
  <results_first_submitted>May 24, 2022</results_first_submitted>
  <results_first_submitted_qc>May 24, 2022</results_first_submitted_qc>
  <results_first_posted type="Actual">June 21, 2022</results_first_posted>
  <last_update_submitted>July 19, 2022</last_update_submitted>
  <last_update_submitted_qc>July 19, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">August 12, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>microbiome</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>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Vancomycin</mesh_term>
  </intervention_browse>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>October 8, 2019</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/41/NCT03759041/Prot_000.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Statistical Analysis Plan: Clinical SAP</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>April 21, 2021</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/41/NCT03759041/SAP_001.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Statistical Analysis Plan: Microbiome SAP</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>April 27, 2021</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/41/NCT03759041/SAP_002.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Placebo (After Placebo Pre-treatment)</title>
          <description>Once-daily dosing of Placebo (after placebo pre-treatment)&#xD;
Placebo for Vancomycin Pre-Treatment: Four times per day dosing of placebo pre-treatment&#xD;
Placebo for SER-287: Once-daily dosing of Placebo for SER-287</description>
        </group>
        <group group_id="P2">
          <title>SER-287 Induction Dosing (After Vancomycin Pre-treatment)</title>
          <description>Once-daily dosing of SER-287 (Induction Dose, after vancomycin pre-treatment)&#xD;
Vancomycin Pre-Treatment: Four times per day dosing of vancomycin pre-treatment&#xD;
SER-287: Once-daily dosing of SER-287</description>
        </group>
        <group group_id="P3">
          <title>SER-287 Step-Down Induction Dosing (After Vancomycin Pre-treatment)</title>
          <description>Once-daily dosing of SER-287 (Step-Down Induction Dose, after vancomycin pre-treatment)&#xD;
Vancomycin Pre-Treatment: Four times per day dosing of vancomycin pre-treatment&#xD;
SER-287: Once-daily dosing of SER-287</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="69"/>
                <participants group_id="P2" count="68"/>
                <participants group_id="P3" count="66"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="42"/>
                <participants group_id="P2" count="34"/>
                <participants group_id="P3" count="38"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="27"/>
                <participants group_id="P2" count="34"/>
                <participants group_id="P3" count="28"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="4"/>
                <participants group_id="P2" count="10"/>
                <participants group_id="P3" count="10"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Adverse Event</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="3"/>
                <participants group_id="P3" count="4"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lack of Efficacy</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Study Terminated by Sponsor</title>
              <participants_list>
                <participants group_id="P1" count="15"/>
                <participants group_id="P2" count="16"/>
                <participants group_id="P3" count="10"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Other reason for discontinuation</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="2"/>
                <participants group_id="P3" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="7"/>
                <participants group_id="P2" count="2"/>
                <participants group_id="P3" count="2"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Subjects did not have a discontinuation page completed</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
                <participants group_id="P3" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>Intent-to-treat</population>
      <group_list>
        <group group_id="B1">
          <title>Placebo (After Placebo Pre-treatment)</title>
          <description>Once-daily dosing of Placebo (after placebo pre-treatment)&#xD;
Placebo for Vancomycin Pre-Treatment: Four times per day dosing of placebo pre-treatment&#xD;
Placebo for SER-287: Once-daily dosing of Placebo for SER-287</description>
        </group>
        <group group_id="B2">
          <title>SER-287 Induction Dosing (After Vancomycin Pre-treatment)</title>
          <description>Once-daily dosing of SER-287 (Induction Dose, after vancomycin pre-treatment)&#xD;
Vancomycin Pre-Treatment: Four times per day dosing of vancomycin pre-treatment&#xD;
SER-287: Once-daily dosing of SER-287</description>
        </group>
        <group group_id="B3">
          <title>SER-287 Step-Down Induction Dosing (After Vancomycin Pre-treatment)</title>
          <description>Once-daily dosing of SER-287 (Step-Down Induction Dose, after vancomycin pre-treatment)&#xD;
Vancomycin Pre-Treatment: Four times per day dosing of vancomycin pre-treatment&#xD;
SER-287: Once-daily dosing of SER-287</description>
        </group>
        <group group_id="B4">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="69"/>
            <count group_id="B2" value="68"/>
            <count group_id="B3" value="66"/>
            <count group_id="B4" value="203"/>
          </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="46.6" spread="13.24"/>
                    <measurement group_id="B2" value="45.7" spread="14.37"/>
                    <measurement group_id="B3" value="44.4" spread="14.70"/>
                    <measurement group_id="B4" value="45.6" spread="14.07"/>
                  </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="28"/>
                    <measurement group_id="B2" value="36"/>
                    <measurement group_id="B3" value="34"/>
                    <measurement group_id="B4" value="98"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="41"/>
                    <measurement group_id="B2" value="32"/>
                    <measurement group_id="B3" value="32"/>
                    <measurement group_id="B4" value="105"/>
                  </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="7"/>
                    <measurement group_id="B2" value="10"/>
                    <measurement group_id="B3" value="6"/>
                    <measurement group_id="B4" value="23"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="61"/>
                    <measurement group_id="B2" value="57"/>
                    <measurement group_id="B3" value="59"/>
                    <measurement group_id="B4" value="177"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="1"/>
                    <measurement group_id="B4" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="6"/>
                    <measurement group_id="B3" value="3"/>
                    <measurement group_id="B4" value="12"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="9"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="6"/>
                    <measurement group_id="B4" value="18"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="56"/>
                    <measurement group_id="B2" value="59"/>
                    <measurement group_id="B3" value="55"/>
                    <measurement group_id="B4" value="170"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="NA">Data not collected</measurement>
                    <measurement group_id="B2" value="NA">Data not collected</measurement>
                    <measurement group_id="B3" value="NA">Data not collected</measurement>
                    <measurement group_id="B4" value="NA">Total not calculated because data are not available (NA) in one or more arms.</measurement>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="2"/>
                    <measurement group_id="B4" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>Canada</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="8"/>
                    <measurement group_id="B2" value="12"/>
                    <measurement group_id="B3" value="7"/>
                    <measurement group_id="B4" value="27"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="61"/>
                    <measurement group_id="B2" value="56"/>
                    <measurement group_id="B3" value="59"/>
                    <measurement group_id="B4" value="176"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Clinical Remission (Count of Participants)</title>
        <description>Clinical remission for the induction treatment period:&#xD;
Stool Frequency subscore = 0 or 1, with at least 1-point decrease from baseline&#xD;
Rectal Bleeding subscore = 0&#xD;
Endoscopic subscore = 0 or 1 on modified Mayo Score, with at least 1-point decrease from baseline&#xD;
No occurrence of UC Flare during the treatment period&#xD;
Clinical remission was measured using 3 components of the modified Mayo Score (stool frequency, rectal bleeding and endoscopic subscore), a measure of UC disease activity. These 3 components are each graded from 0 to 3, and are summed together for a composite score, with a higher overall score indicating more severe disease (0 = no disease; 9 = worst disease). The modified Mayo endoscopic subscore excludes friability from an endoscopic subscore of 1.</description>
        <time_frame>After 10 weeks of induction dosing</time_frame>
        <population>Intent-to-treat</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo (After Placebo Pre-treatment)</title>
            <description>Once-daily dosing of Placebo (after placebo pre-treatment)&#xD;
Placebo for Vancomycin Pre-Treatment: Four times per day dosing of placebo pre-treatment&#xD;
Placebo for SER-287: Once-daily dosing of Placebo for SER-287</description>
          </group>
          <group group_id="O2">
            <title>SER-287 Induction Dosing (After Vancomycin Pre-treatment)</title>
            <description>Once-daily dosing of SER-287 (Induction Dose, after vancomycin pre-treatment)&#xD;
Vancomycin Pre-Treatment: Four times per day dosing of vancomycin pre-treatment&#xD;
SER-287: Once-daily dosing of SER-287</description>
          </group>
          <group group_id="O3">
            <title>SER-287 Step-Down Induction Dosing (After Vancomycin Pre-treatment)</title>
            <description>Once-daily dosing of SER-287 (Step-Down Induction Dose, after vancomycin pre-treatment)&#xD;
Vancomycin Pre-Treatment: Four times per day dosing of vancomycin pre-treatment&#xD;
SER-287: Once-daily dosing of SER-287</description>
          </group>
        </group_list>
        <measure>
          <title>Clinical Remission (Count of Participants)</title>
          <description>Clinical remission for the induction treatment period:&#xD;
Stool Frequency subscore = 0 or 1, with at least 1-point decrease from baseline&#xD;
Rectal Bleeding subscore = 0&#xD;
Endoscopic subscore = 0 or 1 on modified Mayo Score, with at least 1-point decrease from baseline&#xD;
No occurrence of UC Flare during the treatment period&#xD;
Clinical remission was measured using 3 components of the modified Mayo Score (stool frequency, rectal bleeding and endoscopic subscore), a measure of UC disease activity. These 3 components are each graded from 0 to 3, and are summed together for a composite score, with a higher overall score indicating more severe disease (0 = no disease; 9 = worst disease). The modified Mayo endoscopic subscore excludes friability from an endoscopic subscore of 1.</description>
          <population>Intent-to-treat</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="69"/>
                <count group_id="O2" value="68"/>
                <count group_id="O3" value="66"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8"/>
                    <measurement group_id="O2" value="7"/>
                    <measurement group_id="O3" value="7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Endoscopic Improvement (Count of Participants)</title>
        <description>Endoscopic subscore decrease from baseline of at least 1 point, as assessed by flexible sigmoidoscopy or colonoscopy.&#xD;
Endoscopic improvement was measured using the modified Mayo Score endoscopic subscore, graded from 0 to 3, with higher scores indicating more severe disease. The modified Mayo endoscopic subscore excludes friability from an endoscopic subscore of 1.</description>
        <time_frame>After 10 weeks of induction dosing</time_frame>
        <population>Intent-to-treat</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo (After Placebo Pre-treatment)</title>
            <description>Once-daily dosing of Placebo (after placebo pre-treatment)&#xD;
Placebo for Vancomycin Pre-Treatment: Four times per day dosing of placebo pre-treatment&#xD;
Placebo for SER-287: Once-daily dosing of Placebo for SER-287</description>
          </group>
          <group group_id="O2">
            <title>SER-287 Induction Dosing (After Vancomycin Pre-treatment)</title>
            <description>Once-daily dosing of SER-287 (Induction Dose, after vancomycin pre-treatment)&#xD;
Vancomycin Pre-Treatment: Four times per day dosing of vancomycin pre-treatment&#xD;
SER-287: Once-daily dosing of SER-287</description>
          </group>
          <group group_id="O3">
            <title>SER-287 Step-Down Induction Dosing (After Vancomycin Pre-treatment)</title>
            <description>Once-daily dosing of SER-287 (Step-Down Induction Dose, after vancomycin pre-treatment)&#xD;
Vancomycin Pre-Treatment: Four times per day dosing of vancomycin pre-treatment&#xD;
SER-287: Once-daily dosing of SER-287</description>
          </group>
        </group_list>
        <measure>
          <title>Endoscopic Improvement (Count of Participants)</title>
          <description>Endoscopic subscore decrease from baseline of at least 1 point, as assessed by flexible sigmoidoscopy or colonoscopy.&#xD;
Endoscopic improvement was measured using the modified Mayo Score endoscopic subscore, graded from 0 to 3, with higher scores indicating more severe disease. The modified Mayo endoscopic subscore excludes friability from an endoscopic subscore of 1.</description>
          <population>Intent-to-treat</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="69"/>
                <count group_id="O2" value="68"/>
                <count group_id="O3" value="66"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="17"/>
                    <measurement group_id="O2" value="17"/>
                    <measurement group_id="O3" value="16"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Adverse events presented here are for the 10-week Induction Treatment Period of the study, as well as the 1-week Pre-Treatment Period.</time_frame>
      <desc>Adverse events are reported for subjects who received any amount of study drug.</desc>
      <group_list>
        <group group_id="E1">
          <title>Placebo (After Placebo Pre-treatment)</title>
          <description>Once-daily dosing of Placebo (after placebo pre-treatment)&#xD;
Placebo for Vancomycin Pre-Treatment: Four times per day dosing of placebo pre-treatment&#xD;
Placebo for SER-287: Once-daily dosing of Placebo for SER-287</description>
        </group>
        <group group_id="E2">
          <title>SER-287 Induction Dosing (After Vancomycin Pre-treatment)</title>
          <description>Once-daily dosing of SER-287 (Induction Dose, after vancomycin pre-treatment)&#xD;
Vancomycin Pre-Treatment: Four times per day dosing of vancomycin pre-treatment&#xD;
SER-287: Once-daily dosing of SER-287</description>
        </group>
        <group group_id="E3">
          <title>SER-287 Step-Down Induction Dosing (After Vancomycin Pre-treatment)</title>
          <description>Once-daily dosing of SER-287 (Step-Down Induction Dose, after vancomycin pre-treatment)&#xD;
Vancomycin Pre-Treatment: Four times per day dosing of vancomycin pre-treatment&#xD;
SER-287: Once-daily dosing of SER-287</description>
        </group>
      </group_list>
      <serious_events>
        <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="69"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="65"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="69"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="68"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="65"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Cardiac failure congestive</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="69"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="65"/>
              </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="69"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="68"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="65"/>
              </event>
              <event>
                <sub_title>Colon dysplasia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="69"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="68"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="65"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Appendicitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="69"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="68"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="65"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Haemoglobin decreased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="69"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="65"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <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="6" subjects_at_risk="69"/>
                <counts group_id="E2" subjects_affected="23" subjects_at_risk="68"/>
                <counts group_id="E3" subjects_affected="12" subjects_at_risk="65"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Colitis ulcerative</sub_title>
                <counts group_id="E1" subjects_affected="6" subjects_at_risk="69"/>
                <counts group_id="E2" subjects_affected="8" subjects_at_risk="68"/>
                <counts group_id="E3" subjects_affected="7" subjects_at_risk="65"/>
              </event>
              <event>
                <sub_title>Diarrhoea</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="69"/>
                <counts group_id="E2" subjects_affected="10" subjects_at_risk="68"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="65"/>
              </event>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="69"/>
                <counts group_id="E2" subjects_affected="6" subjects_at_risk="68"/>
                <counts group_id="E3" subjects_affected="3" subjects_at_risk="65"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Cough</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="69"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="68"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="65"/>
              </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>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Lisa von Moltke, MD, Chief Medical Officer</name_or_title>
      <organization>Seres Therapeutics</organization>
      <phone>617-945-9626</phone>
      <email>clinicalstudies@serestherapeutics.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/NCT03759041
org study id: SERES-201
nct id: NCT03759041
lead sponsor: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
A Randomized, Double-Blind, Placebo-Controlled, Multiple Dose, Multicenter Study to Assess
      Efficacy and Safety of SER-287 in Adults with Active Mild-to-Moderate Ulcerative Colitis
This is a Phase 2B randomized, double-blind, placebo-controlled, multiple dose, multicenter
      study designed to evaluate the efficacy, safety and microbiome alterations associated with
      two dose levels of SER-287, after pre-treatment with vancomycin, in adult subjects, age
      18-80, with active mild-to-moderate ulcerative colitis (UC).
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Triple (Participant, Investigator, Outcomes Assessor)
measure: Clinical Remission (Count of Participants)
time frame: After 10 weeks of induction dosing
description: Clinical remission for the induction treatment period:
Stool Frequency subscore = 0 or 1, with at least 1-point decrease from baseline
Rectal Bleeding subscore = 0
Endoscopic subscore = 0 or 1 on modified Mayo Score, with at least 1-point decrease from baseline
No occurrence of UC Flare during the treatment period
Clinical remission was measured using 3 components of the modified Mayo Score (stool frequency, rectal bleeding and endoscopic subscore), a measure of UC disease activity. These 3 components are each graded from 0 to 3, and are summed together for a composite score, with a higher overall score indicating more severe disease (0 = no disease; 9 = worst disease). The modified Mayo endoscopic subscore excludes friability from an endoscopic subscore of 1.
measure: Endoscopic Improvement (Count of Participants)
time frame: After 10 weeks of induction dosing
description: Endoscopic subscore decrease from baseline of at least 1 point, as assessed by flexible sigmoidoscopy or colonoscopy.
Endoscopic improvement was measured using the modified Mayo Score endoscopic subscore, graded from 0 to 3, with higher scores indicating more severe disease. The modified Mayo endoscopic subscore excludes friability from an endoscopic subscore of 1.
arm group label: Placebo (after placebo pre-treatment)
arm group type: Placebo Comparator
description: Once-daily dosing of Placebo (after placebo pre-treatment)
arm group label: SER-287 Induction Dosing (after vancomycin pre-treatment)
arm group type: Experimental
description: Once-daily dosing of SER-287 (Induction Dose, after vancomycin pre-treatment)
arm group label: SER-287 Step-Down Induction Dosing (after vancomycin pre-treatment)
arm group type: Experimental
description: Once-daily dosing of SER-287 (Step-Down Induction Dose, after vancomycin pre-treatment)
intervention type: Drug
intervention name: Vancomycin Pre-Treatment
description: Four times per day dosing of vancomycin pre-treatment
arm group label: SER-287 Induction Dosing (after vancomycin pre-treatment)
arm group label: SER-287 Step-Down Induction Dosing (after vancomycin pre-treatment)
intervention type: Drug
intervention name: Placebo for Vancomycin Pre-Treatment
description: Four times per day dosing of placebo pre-treatment
arm group label: Placebo (after placebo pre-treatment)
intervention type: Drug
intervention name: SER-287
description: Once-daily dosing of SER-287
arm group label: SER-287 Induction Dosing (after vancomycin pre-treatment)
arm group label: SER-287 Step-Down Induction Dosing (after vancomycin pre-treatment)
other name: Eubacterial Spores, Purified Suspension, Encapsulated
intervention type: Drug
intervention name: Placebo for SER-287
description: Once-daily dosing of Placebo for SER-287
arm group label: Placebo (after placebo pre-treatment)
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
last name: Lisa von Moltke, MD
role: Study Director
affiliation: Seres Therapeutics, Inc.
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country: Canada
country: United States
responsible party type: Sponsor
mesh term: Colitis
mesh term: Colitis, Ulcerative
mesh term: Ulcer
mesh term: Vancomycin
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