<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/NCT02976129</url>
  </required_header>
  <id_info>
    <org_study_id>V56502</org_study_id>
    <nct_id>NCT02976129</nct_id>
  </id_info>
  <brief_title>A Six Week Efficacy, Safety and Tolerability Study of V565 in Crohn's Disease</brief_title>
  <acronym>HarbOR</acronym>
  <official_title>Phase 2 Study to Investigate the Efficacy, Safety, and Tolerability of Six Weeks Treatment With V565 in Subjects With Active Crohn's Disease</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>VHsquared Ltd.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>VHsquared Ltd.</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to evaluate the efficacy and safety of V565 in participants with&#xD;
      active Crohn's Disease (CD).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study will be a multiple-site, double-blind, placebo-controlled, parallel-group study in&#xD;
      approximately 126 subjects with a confirmed diagnosis of CD for at least three months and&#xD;
      have CD involving the ileum and/or colon. Following a screening period of up to 28 days,&#xD;
      subjects will be randomly allocated into one of two treatment arms: either V565 or placebo&#xD;
      using a 2:1 active:placebo ratio for a treatment period of 6 weeks.&#xD;
&#xD;
      Subjects will be treated with study drug as an add-on to any permitted stable medications&#xD;
      already being taken for CD.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>December 2016</start_date>
  <completion_date type="Actual">March 8, 2019</completion_date>
  <primary_completion_date type="Actual">March 8, 2019</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>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of Subjects Achieving Response to Therapy, Defined as Reduction in the CDAI Score and in Inflammatory Markers CRP or FCP at Day 42.</measure>
    <time_frame>Day 42</time_frame>
    <description>Number of responders at Day 42, defined as subjects achieving both CDAI ≥ 70-point reduction from baseline or CDAI score &lt; 150, and a reduction of ≥ 40% from the baseline value of CRP or FCP.&#xD;
Crohn's Disease Activity Index (CDAI) is used to assess the symptoms of participants with Crohn's Disease. Scores generally range from 0 to 600, where clinical remission of Crohn's disease is defined as CDAI &lt; 150, and very severe disease is defined as CDAI &gt; 450.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of Subjects Achieving Response to Therapy, Defined as Reduction in the CDAI Score and in Inflammatory Markers CRP or FCP at Day 42.</measure>
    <time_frame>Day 42</time_frame>
    <description>Number of subjects achieving a ≥ 100-point reduction in CDAI score and a concomitant reduction of at least 50% in CRP or FCP at Day 42&#xD;
Crohn's Disease Activity Index (CDAI) is used to assess the symptoms of participants with Crohn's Disease. Scores generally range from 0 to 600, where clinical remission of Crohn's disease is defined as CDAI &lt; 150, and very severe disease is defined as CDAI &gt; 450.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Number of Subjects With Improvement in Endoscopic Mucosal Appearance</measure>
    <time_frame>Day 42</time_frame>
    <description>Subjects with a pre-treatment endoscopy Simple Endoscopic Score for Crohn's Disease (SES-CD) of at least 7 (4 if disease was confined to ileum) had a post-treatment endoscopy to evaluate changes in mucosal appearance. The central reader of the endoscopies, blinded to treatment and sequence, was asked to grade if video A was better or worse than video B. Pre- and post-treatment videos were randomly assigned to A and B. The endpoint is the number of subjects whose post-treatment endoscopy was better than their pre-treatment endoscopy.</description>
  </other_outcome>
  <other_outcome>
    <measure>Number of Subjects Achieving CRP Levels Within Normal Limits at Days 14 and 42</measure>
    <time_frame>Days 14 and 42</time_frame>
    <description>The number of subjects who entered the study with an elevated CRP who had a CRP level within normal limits at Days 14 and 42.&#xD;
Normal levels defined as CRP less than or equal to 5mg/L</description>
  </other_outcome>
  <other_outcome>
    <measure>Number of Subjects Achieving FCP Levels Within Normal Limits at Day 14 and 42</measure>
    <time_frame>Days 14 and 42</time_frame>
    <description>The number of subjects who entered the study with an elevated FCP who had an FCP level within normal limits at Days 14 and 42.&#xD;
Normal limits of FCP defined as less than or equal to 250µg/g</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">125</enrollment>
  <condition>Crohn's Disease</condition>
  <arm_group>
    <arm_group_label>V565</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>V565 three times a day (TID) PO for 6 weeks</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Placebo TID PO for 6 weeks</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>V565</intervention_name>
    <description>Daily dosing of V565 three times a day orally for 6 weeks</description>
    <arm_group_label>V565</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Daily dosing of placebo three times a day orally for 6 weeks</description>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  History of Crohn's Disease of at least 3 months duration prior to screening&#xD;
&#xD;
          -  Crohn's Disease Activity Index (CDAI) score of ≥220 to ≤450 during screening&#xD;
&#xD;
          -  C-reactive protein (CRP) ≥5 mg/L (or, if CRP is normal, faecal calprotectin (FCP) ≥250&#xD;
             µg/g) at screening&#xD;
&#xD;
          -  Permitted CD medication regimen expected to remain stable during the period of the&#xD;
             study&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Previous lack of response or current contra-indication to an anti-tumour necrosis&#xD;
             factor α (anti-TNFα) agent&#xD;
&#xD;
          -  Certain complications of Crohn's Disease that would make it hard to assess response to&#xD;
             study drug&#xD;
&#xD;
          -  Known history or suspicion of inflammatory bowel disease other than Crohn's disease&#xD;
&#xD;
          -  History of tuberculosis (TB) or latent TB infection that has not been treated&#xD;
&#xD;
          -  Any significant illness or condition which would preclude effective participation in&#xD;
             the study&#xD;
&#xD;
          -  GI infection as demonstrated by presence of enteric pathogens&#xD;
&#xD;
          -  Pregnant or lactating women&#xD;
&#xD;
          -  Abdominal surgery in the previous 6 months&#xD;
&#xD;
          -  Unsuitable for inclusion in the study in the opinion of the investigator or sponsor&#xD;
             for any reason that may compromise the subject's safety or confound data&#xD;
             interpretation&#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>Suhail Nurbhai, MBChB MRCP</last_name>
    <role>Study Director</role>
    <affiliation>VHsquared Ltd.</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Advanced Research Center, Inc.</name>
      <address>
        <city>Anaheim</city>
        <state>California</state>
        <zip>92805</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>West Central Gastroenterology</name>
      <address>
        <city>Clearwater</city>
        <state>Florida</state>
        <zip>33762</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Research of West Florida</name>
      <address>
        <city>Clearwater</city>
        <state>Florida</state>
        <zip>33765</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Galiz Research, LLC</name>
      <address>
        <city>Miami Springs</city>
        <state>Florida</state>
        <zip>33166</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Northwestern University</name>
      <address>
        <city>Evanston</city>
        <state>Illinois</state>
        <zip>60208</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Trials of America</name>
      <address>
        <city>Mount Airy</city>
        <state>North Carolina</state>
        <zip>27030</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Klinikum Klagenfurt am Wörtersee</name>
      <address>
        <city>Klagenfurt</city>
        <zip>9020</zip>
        <country>Austria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>LKH - Universitatsklinikum</name>
      <address>
        <city>Salzburg</city>
        <zip>5020</zip>
        <country>Austria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>AKH - Medizinische Universität Wien</name>
      <address>
        <city>Vienna</city>
        <zip>1090</zip>
        <country>Austria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Klinikum Wels Grieskirchen</name>
      <address>
        <city>Wels</city>
        <zip>4600</zip>
        <country>Austria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Queen Elizabeth II Health Sciences Centre</name>
      <address>
        <city>Halifax</city>
        <state>Nova Scotia</state>
        <zip>B3H 2Y9</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>London Health Science Centre</name>
      <address>
        <city>London</city>
        <state>Ontario</state>
        <zip>N6A 5A5</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>LHSC - Victoria Hospital</name>
      <address>
        <city>London</city>
        <state>Ontario</state>
        <zip>N6A 5W9</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Vojenska nemocnice Brno</name>
      <address>
        <city>Brno</city>
        <zip>636 00</zip>
        <country>Czechia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Nemocnice Horovice</name>
      <address>
        <city>Horovice</city>
        <country>Czechia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hepato-Gastroenterologie HK</name>
      <address>
        <city>Hradec Kralove</city>
        <zip>500 12</zip>
        <country>Czechia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Poliklinika MEDICINA PLUS</name>
      <address>
        <city>Praha 4</city>
        <zip>14000</zip>
        <country>Czechia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mediendo s.r.o.</name>
      <address>
        <city>Praha 8</city>
        <zip>186 00</zip>
        <country>Czechia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Praxiszentrum Alte Maelzerei</name>
      <address>
        <city>Regensburg</city>
        <state>Bayern</state>
        <zip>93053</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Klinikum der Johann Wolfgang Goethe-Universitaet</name>
      <address>
        <city>Frankfurt</city>
        <state>Hessen</state>
        <zip>60590</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universitaetsklinikum Carl Gustav Carus TU</name>
      <address>
        <city>Dresden</city>
        <state>Sachsen</state>
        <zip>01307</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universitaetsklinikum Schleswig-Holstein - Campus Kiel</name>
      <address>
        <city>Kiel</city>
        <state>Schleswig</state>
        <zip>24105</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Charite Universitaetsmedizin</name>
      <address>
        <city>Berlin</city>
        <zip>12203</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Charite Universitaetsmedizin Berlin - Campus Charite Mitte</name>
      <address>
        <city>Berlin</city>
        <zip>13353</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Staedisches Klinikum</name>
      <address>
        <city>Brandenburg</city>
        <zip>14770</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Agaplesion Markus Krankenhaus</name>
      <address>
        <city>Frankfurt</city>
        <zip>60431</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Studiengesellschaft BSF</name>
      <address>
        <city>Halle</city>
        <zip>06108</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hamburgisches Forschungsinstitut fuer CED</name>
      <address>
        <city>Hamburg</city>
        <zip>20251</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Asklepios Klinik Hamburg</name>
      <address>
        <city>Hamburg</city>
        <zip>22559</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Praxis fuer Magen</name>
      <address>
        <city>Heidelberg</city>
        <zip>69121</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>EUGASTRO GmbH</name>
      <address>
        <city>Leipzig</city>
        <zip>04103</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Klinik u Poliklinik f Gastro</name>
      <address>
        <city>Leipzig</city>
        <zip>04103</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>DRC Gyogyszervizsgalo</name>
      <address>
        <city>Balatonfüred</city>
        <zip>8230</zip>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Obudai Egeszsegugyi</name>
      <address>
        <city>Budapest</city>
        <zip>1036</zip>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Magyar Honvedseg Egeszsegugyi Kozpont</name>
      <address>
        <city>Budapest</city>
        <zip>1062</zip>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Semmelweis Egyetem</name>
      <address>
        <city>Budapest</city>
        <zip>1088</zip>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Endomedix Diagnosztikai</name>
      <address>
        <city>Budapest</city>
        <zip>1139</zip>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Petz Aladar Hospital</name>
      <address>
        <city>Győr</city>
        <zip>9024</zip>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinfan Szolgaltato Kft.</name>
      <address>
        <city>Szekszard</city>
        <zip>7100</zip>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Albert Schweitzer Ziekenhuis</name>
      <address>
        <city>Dordrecht</city>
        <zip>3318AT</zip>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Maastricht University Medical Center</name>
      <address>
        <city>Maastricht</city>
        <zip>6229 HX</zip>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Akershus universitetssykehus HF</name>
      <address>
        <city>Lørenskog</city>
        <zip>1478</zip>
        <country>Norway</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universitetssykehuset Nord-Norge</name>
      <address>
        <city>Tromsø</city>
        <zip>9019</zip>
        <country>Norway</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Polimedica Centrum Badan, Profilaktyki I Leczenia</name>
      <address>
        <city>Kielce</city>
        <zip>25-364</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Indywidualna Specjalistyczna</name>
      <address>
        <city>Knurów</city>
        <zip>44-190</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>KO-MED Centra Kliniczne Lublin II</name>
      <address>
        <city>Lublin</city>
        <zip>20-362</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>SOLUMED Centrum Medyczne</name>
      <address>
        <city>Poznań</city>
        <zip>60-529</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Gabinet Lekarski Bartosz Korczowski</name>
      <address>
        <city>Rzeszów</city>
        <zip>35-302</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Specjalistyczna Praktyka</name>
      <address>
        <city>Sopot</city>
        <zip>81-756</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>KO-MED Centra Kliniczne Staszow</name>
      <address>
        <city>Staszów</city>
        <zip>28-200</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Twoja Przychodnia-Szczecinskie Centrum Medyczne</name>
      <address>
        <city>Szczecin</city>
        <zip>71-270</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centrum Zdrowia Matki, Dziecka i Mlodziezy</name>
      <address>
        <city>Warszawa</city>
        <zip>00-632</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Center of Serbia</name>
      <address>
        <city>Belgrade</city>
        <zip>11000</zip>
        <country>Serbia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Health Center Zvezdara</name>
      <address>
        <city>Belgrade</city>
        <zip>11000</zip>
        <country>Serbia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Military Medical Academy</name>
      <address>
        <city>Belgrade</city>
        <zip>11000</zip>
        <country>Serbia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Center Zemun</name>
      <address>
        <city>Belgrade</city>
        <zip>11080</zip>
        <country>Serbia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Center Nis</name>
      <address>
        <city>Niš</city>
        <zip>18000</zip>
        <country>Serbia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Alian s.r.o</name>
      <address>
        <city>Bardejov</city>
        <zip>08501</zip>
        <country>Slovakia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Uni nemocnica Bratislava</name>
      <address>
        <city>Bratislava</city>
        <zip>82606</zip>
        <country>Slovakia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Nemocnica A.Lena Humenne, n.o</name>
      <address>
        <city>Humenné</city>
        <zip>06601</zip>
        <country>Slovakia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Nemocnica s poliklinikou S. Kukuru Michalovce, a.s</name>
      <address>
        <city>Michalovce</city>
        <zip>07101</zip>
        <country>Slovakia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>KM Management spol. s r.o.</name>
      <address>
        <city>Nitra</city>
        <zip>949 01</zip>
        <country>Slovakia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Gastromedic, s.r.o</name>
      <address>
        <city>Nové Zámky</city>
        <zip>94002</zip>
        <country>Slovakia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Gastro I, s.r.o.</name>
      <address>
        <city>Prešov</city>
        <zip>080 01</zip>
        <country>Slovakia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Svet zdravia a.s.</name>
      <address>
        <city>Rimavská Sobota</city>
        <zip>97901</zip>
        <country>Slovakia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Brovary Central District Hospital</name>
      <address>
        <city>Brovary</city>
        <zip>07400</zip>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Chernivtsi RCH Dep of Surgery HSEI of Ukr Bukovinian SMU</name>
      <address>
        <city>Chernivtsi</city>
        <zip>58001</zip>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Limited Liability Company Medical Center Family Medicine Clinic</name>
      <address>
        <city>Dnipro</city>
        <zip>49038</zip>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital for War Veterans</name>
      <address>
        <city>Kharkiv</city>
        <zip>61019</zip>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHI Kharkiv City Clinical Hospital #13</name>
      <address>
        <city>Kharkiv</city>
        <zip>61124</zip>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Municipal Institution of Public Health Kharkiv City Clinic #9</name>
      <address>
        <city>Kharkiv</city>
        <zip>61172</zip>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CI of Healthcare Kharkiv Reg Clin Hospital</name>
      <address>
        <city>Kharkiv</city>
        <zip>61204</zip>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CI Ye.Ye.Karabelesh Kherson City Clinical Hosp</name>
      <address>
        <city>Kherson</city>
        <zip>73000</zip>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>PPC Atsynus</name>
      <address>
        <city>Kirovohrad</city>
        <zip>25006</zip>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>LLC Treatment and Diagnostic Center Adonis Plus</name>
      <address>
        <city>Kyiv</city>
        <zip>02002</zip>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CI of Kyiv RC Kyiv Regional Clinical Hospital</name>
      <address>
        <city>Kyiv</city>
        <zip>04107</zip>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Medical Centre CONSILIUM MEDICAL</name>
      <address>
        <city>Kyiv</city>
        <zip>4050</zip>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Lviv Regional Clinical Hospital</name>
      <address>
        <city>L'viv</city>
        <zip>79010</zip>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Lviv Clinical Hospital at Railway Transport of Division Healthcare Center PJSC</name>
      <address>
        <city>Lviv</city>
        <zip>79007</zip>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CI Sumy City Clinical Hospital #1 Dept of Therapy Sumy SU Med Inst</name>
      <address>
        <city>Sumy</city>
        <zip>40021</zip>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CI of SRC Sumy RCH Dept of Gastroenterology Sumy SU MI</name>
      <address>
        <city>Sumy</city>
        <zip>40022</zip>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Medical Center Pulse</name>
      <address>
        <city>Vinnytsia</city>
        <zip>21001</zip>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Private Small Enterprise Medical Center Pulse</name>
      <address>
        <city>Vinnytsia</city>
        <zip>21001</zip>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Vinnytsia M.I.Pyrogov Regional Clinical Hospital</name>
      <address>
        <city>Vinnytsia</city>
        <zip>21018</zip>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CI City Clinical Hospital #6</name>
      <address>
        <city>Zaporizhzhia</city>
        <zip>69035</zip>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CI City Hospital #1</name>
      <address>
        <city>Zaporizhzhia</city>
        <zip>69104</zip>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Addenbrookes Hospital</name>
      <address>
        <city>Cambridge</city>
        <state>Cambridgeshire</state>
        <zip>CB2 0QQ</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Whipps Cross University Hospital</name>
      <address>
        <city>Leytonstone</city>
        <state>London</state>
        <zip>E11 1NR</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>St Mark's Hospital</name>
      <address>
        <city>Harrow</city>
        <state>Middlesex</state>
        <zip>HA1 3UJ</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>John Radcliffe Hospital</name>
      <address>
        <city>Oxford</city>
        <state>Oxfordshire</state>
        <zip>OX3 9DU</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Royal Hallamshire Hospital</name>
      <address>
        <city>Sheffield</city>
        <state>South Yorkshire</state>
        <zip>S10 2JF</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Queen Elizabeth University Hospital</name>
      <address>
        <city>Glasgow</city>
        <state>Strathclyde</state>
        <zip>G51 4TF</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Neath Port Talbot Hospital</name>
      <address>
        <city>Swansea</city>
        <state>West Glamorgan</state>
        <zip>SA12 7BX</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>St Thomas' Hospital</name>
      <address>
        <city>London</city>
        <zip>SE1 7EH</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Austria</country>
    <country>Canada</country>
    <country>Czechia</country>
    <country>Germany</country>
    <country>Hungary</country>
    <country>Netherlands</country>
    <country>Norway</country>
    <country>Poland</country>
    <country>Serbia</country>
    <country>Slovakia</country>
    <country>Ukraine</country>
    <country>United Kingdom</country>
    <country>United States</country>
  </location_countries>
  <removed_countries>
    <country>Czech Republic</country>
  </removed_countries>
  <verification_date>November 2021</verification_date>
  <study_first_submitted>November 23, 2016</study_first_submitted>
  <study_first_submitted_qc>November 23, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 29, 2016</study_first_posted>
  <results_first_submitted>October 15, 2021</results_first_submitted>
  <results_first_submitted_qc>November 24, 2021</results_first_submitted_qc>
  <results_first_posted type="Actual">December 22, 2021</results_first_posted>
  <last_update_submitted>November 24, 2021</last_update_submitted>
  <last_update_submitted_qc>November 24, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">December 22, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Crohn Disease</mesh_term>
  </condition_browse>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>December 2, 2016</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/29/NCT02976129/Prot_000.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Statistical Analysis Plan</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>March 12, 2019</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/29/NCT02976129/SAP_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>V565</title>
          <description>V565 three times daily (TID) PO for 6 weeks&#xD;
V565: Daily dosing of V565 three times a day orally for 6 weeks</description>
        </group>
        <group group_id="P2">
          <title>Placebo</title>
          <description>Placebo three times daily (TID) PO for 6 weeks&#xD;
Placebo: Daily dosing of placebo three times a day orally for 6 weeks</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="82"/>
                <participants group_id="P2" count="43"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="77"/>
                <participants group_id="P2" count="41"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="5"/>
                <participants group_id="P2" count="2"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>V565</title>
          <description>V565 TID PO for 6 weeks&#xD;
V565: Daily dosing of V565 three times a day orally for 6 weeks</description>
        </group>
        <group group_id="B2">
          <title>Placebo</title>
          <description>Placebo TID PO for 6 weeks&#xD;
Placebo: Daily dosing of placebo three times a day orally for 6 weeks</description>
        </group>
        <group group_id="B3">
          <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="82"/>
            <count group_id="B2" value="43"/>
            <count group_id="B3" value="125"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="82"/>
                    <count group_id="B2" value="43"/>
                    <count group_id="B3" value="125"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="37.7" spread="14.05"/>
                    <measurement group_id="B2" value="37.2" spread="12.08"/>
                    <measurement group_id="B3" value="37.5" spread="13.36"/>
                  </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>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="82"/>
                    <count group_id="B2" value="43"/>
                    <count group_id="B3" value="125"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="32"/>
                    <measurement group_id="B2" value="19"/>
                    <measurement group_id="B3" value="51"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="50"/>
                    <measurement group_id="B2" value="24"/>
                    <measurement group_id="B3" value="74"/>
                  </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>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="82"/>
                    <count group_id="B2" value="43"/>
                    <count group_id="B3" value="125"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <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_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="1"/>
                  </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_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="82"/>
                    <measurement group_id="B2" value="39"/>
                    <measurement group_id="B3" value="121"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="2"/>
                  </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>Hungary</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="82"/>
                    <count group_id="B2" value="43"/>
                    <count group_id="B3" value="125"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>United States</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="82"/>
                    <count group_id="B2" value="43"/>
                    <count group_id="B3" value="125"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Czechia</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="82"/>
                    <count group_id="B2" value="43"/>
                    <count group_id="B3" value="125"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="18"/>
                    <measurement group_id="B2" value="11"/>
                    <measurement group_id="B3" value="29"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Ukraine</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="82"/>
                    <count group_id="B2" value="43"/>
                    <count group_id="B3" value="125"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="22"/>
                    <measurement group_id="B2" value="12"/>
                    <measurement group_id="B3" value="34"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>United Kingdom</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="82"/>
                    <count group_id="B2" value="43"/>
                    <count group_id="B3" value="125"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                    <measurement group_id="B2" value="5"/>
                    <measurement group_id="B3" value="9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Canada</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="82"/>
                    <count group_id="B2" value="43"/>
                    <count group_id="B3" value="125"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Austria</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="82"/>
                    <count group_id="B2" value="43"/>
                    <count group_id="B3" value="125"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Netherlands</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="82"/>
                    <count group_id="B2" value="43"/>
                    <count group_id="B3" value="125"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Norway</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="82"/>
                    <count group_id="B2" value="43"/>
                    <count group_id="B3" value="125"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Poland</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="82"/>
                    <count group_id="B2" value="43"/>
                    <count group_id="B3" value="125"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="9"/>
                    <measurement group_id="B2" value="5"/>
                    <measurement group_id="B3" value="14"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Slovakia</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="82"/>
                    <count group_id="B2" value="43"/>
                    <count group_id="B3" value="125"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="6"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Serbia</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="82"/>
                    <count group_id="B2" value="43"/>
                    <count group_id="B3" value="125"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Germany</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="82"/>
                    <count group_id="B2" value="43"/>
                    <count group_id="B3" value="125"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Baseline Crohn's Disease Activity Index</title>
          <description>Crohn's Disease Activity Index (CDAI) is used to assess the symptoms of participants with Crohn's Disease. Scores generally range from 0 to 600, where clinical remission of Crohn's disease is defined as CDAI &lt; 150, and very severe disease is defined as CDAI &gt; 450</description>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="82"/>
                    <count group_id="B2" value="43"/>
                    <count group_id="B3" value="125"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="316.34" spread="71.283"/>
                    <measurement group_id="B2" value="296.69" spread="64.334"/>
                    <measurement group_id="B3" value="309.69" spread="69.379"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Baseline C-Reactive Protein (CRP)</title>
          <description>Baseline level of C-Reactive Protein (CRP) for those subjects qualifying for the study based on CRP</description>
          <population>Subjects were recruited into the study if their baseline CRP value was greater than or equal to 5mg/L OR if their baseline faecal calprotectin (FCP) measure was greater than or equal to 250µg/g. Data are reported for only those patients whose baseline CRP was greater than or equal to 5mg/L</population>
          <units>mg/L</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="59"/>
                    <count group_id="B2" value="33"/>
                    <count group_id="B3" value="92"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="59" spread="21.9"/>
                    <measurement group_id="B2" value="18.7" spread="14.56"/>
                    <measurement group_id="B3" value="20.8" spread="17.13"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Baseline Faecal Calprotectin (FCP)</title>
          <description>Baseline Faecal Calprotectin (FCP) level for those subjects qualifying for the study on FCP</description>
          <population>Subjects were recruited into the study if their baseline CRP value was greater than or equal to 5mg/L OR if their baseline FCP measure was greater than or equal to 250µg/g. Data are reported for only those patients whose baseline FCP was greater than or equal to 250µg/g</population>
          <units>µg/g</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="23"/>
                    <count group_id="B2" value="10"/>
                    <count group_id="B3" value="33"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="1082.619" spread="804.2154"/>
                    <measurement group_id="B2" value="1091.217" spread="974.0855"/>
                    <measurement group_id="B3" value="1085.224" spread="843.5207"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Number of Subjects Achieving Response to Therapy, Defined as Reduction in the CDAI Score and in Inflammatory Markers CRP or FCP at Day 42.</title>
        <description>Number of responders at Day 42, defined as subjects achieving both CDAI ≥ 70-point reduction from baseline or CDAI score &lt; 150, and a reduction of ≥ 40% from the baseline value of CRP or FCP.&#xD;
Crohn's Disease Activity Index (CDAI) is used to assess the symptoms of participants with Crohn's Disease. Scores generally range from 0 to 600, where clinical remission of Crohn's disease is defined as CDAI &lt; 150, and very severe disease is defined as CDAI &gt; 450.</description>
        <time_frame>Day 42</time_frame>
        <population>Intent-to-treat population.</population>
        <group_list>
          <group group_id="O1">
            <title>V565</title>
            <description>V565 TID PO for 6 weeks&#xD;
V565: Daily dosing of V565 three times a day orally for 6 weeks</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Placebo TID PO for 6 weeks&#xD;
Placebo: Daily dosing of placebo three times a day orally for 6 weeks</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Subjects Achieving Response to Therapy, Defined as Reduction in the CDAI Score and in Inflammatory Markers CRP or FCP at Day 42.</title>
          <description>Number of responders at Day 42, defined as subjects achieving both CDAI ≥ 70-point reduction from baseline or CDAI score &lt; 150, and a reduction of ≥ 40% from the baseline value of CRP or FCP.&#xD;
Crohn's Disease Activity Index (CDAI) is used to assess the symptoms of participants with Crohn's Disease. Scores generally range from 0 to 600, where clinical remission of Crohn's disease is defined as CDAI &lt; 150, and very severe disease is defined as CDAI &gt; 450.</description>
          <population>Intent-to-treat population.</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="82"/>
                <count group_id="O2" value="43"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="29"/>
                    <measurement group_id="O2" value="16"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Subjects Achieving Response to Therapy, Defined as Reduction in the CDAI Score and in Inflammatory Markers CRP or FCP at Day 42.</title>
        <description>Number of subjects achieving a ≥ 100-point reduction in CDAI score and a concomitant reduction of at least 50% in CRP or FCP at Day 42&#xD;
Crohn's Disease Activity Index (CDAI) is used to assess the symptoms of participants with Crohn's Disease. Scores generally range from 0 to 600, where clinical remission of Crohn's disease is defined as CDAI &lt; 150, and very severe disease is defined as CDAI &gt; 450.</description>
        <time_frame>Day 42</time_frame>
        <group_list>
          <group group_id="O1">
            <title>V565</title>
            <description>V565 TID PO for 6 weeks&#xD;
V565: Daily dosing of V565 three times a day orally for 6 weeks</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Placebo TID PO for 6 weeks&#xD;
Placebo: Daily dosing of placebo three times a day orally for 6 weeks</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Subjects Achieving Response to Therapy, Defined as Reduction in the CDAI Score and in Inflammatory Markers CRP or FCP at Day 42.</title>
          <description>Number of subjects achieving a ≥ 100-point reduction in CDAI score and a concomitant reduction of at least 50% in CRP or FCP at Day 42&#xD;
Crohn's Disease Activity Index (CDAI) is used to assess the symptoms of participants with Crohn's Disease. Scores generally range from 0 to 600, where clinical remission of Crohn's disease is defined as CDAI &lt; 150, and very severe disease is defined as CDAI &gt; 450.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="82"/>
                <count group_id="O2" value="43"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="20"/>
                    <measurement group_id="O2" value="9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Number of Subjects With Improvement in Endoscopic Mucosal Appearance</title>
        <description>Subjects with a pre-treatment endoscopy Simple Endoscopic Score for Crohn's Disease (SES-CD) of at least 7 (4 if disease was confined to ileum) had a post-treatment endoscopy to evaluate changes in mucosal appearance. The central reader of the endoscopies, blinded to treatment and sequence, was asked to grade if video A was better or worse than video B. Pre- and post-treatment videos were randomly assigned to A and B. The endpoint is the number of subjects whose post-treatment endoscopy was better than their pre-treatment endoscopy.</description>
        <time_frame>Day 42</time_frame>
        <population>Only those subjects who had a second endoscopy are included in this analysis.</population>
        <group_list>
          <group group_id="O1">
            <title>V565</title>
            <description>V565 TID PO for 6 weeks&#xD;
V565: Daily dosing of V565 three times a day orally for 6 weeks</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Placebo TID PO for 6 weeks&#xD;
Placebo: Daily dosing of placebo three times a day orally for 6 weeks</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Subjects With Improvement in Endoscopic Mucosal Appearance</title>
          <description>Subjects with a pre-treatment endoscopy Simple Endoscopic Score for Crohn's Disease (SES-CD) of at least 7 (4 if disease was confined to ileum) had a post-treatment endoscopy to evaluate changes in mucosal appearance. The central reader of the endoscopies, blinded to treatment and sequence, was asked to grade if video A was better or worse than video B. Pre- and post-treatment videos were randomly assigned to A and B. The endpoint is the number of subjects whose post-treatment endoscopy was better than their pre-treatment endoscopy.</description>
          <population>Only those subjects who had a second endoscopy are included in this analysis.</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="32"/>
                <count group_id="O2" value="10"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="18"/>
                    <measurement group_id="O2" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Number of Subjects Achieving CRP Levels Within Normal Limits at Days 14 and 42</title>
        <description>The number of subjects who entered the study with an elevated CRP who had a CRP level within normal limits at Days 14 and 42.&#xD;
Normal levels defined as CRP less than or equal to 5mg/L</description>
        <time_frame>Days 14 and 42</time_frame>
        <population>Patients were enrolled into the study based on either a baseline CRP measurement or a baseline FCP measurement. Only the subjects who entered the study based on their CRP measurement are included here.</population>
        <group_list>
          <group group_id="O1">
            <title>V565</title>
            <description>V565 TID PO for 6 weeks&#xD;
V565: Daily dosing of V565 three times a day orally for 6 weeks</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Placebo TID PO for 6 weeks&#xD;
Placebo: Daily dosing of placebo three times a day orally for 6 weeks</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Subjects Achieving CRP Levels Within Normal Limits at Days 14 and 42</title>
          <description>The number of subjects who entered the study with an elevated CRP who had a CRP level within normal limits at Days 14 and 42.&#xD;
Normal levels defined as CRP less than or equal to 5mg/L</description>
          <population>Patients were enrolled into the study based on either a baseline CRP measurement or a baseline FCP measurement. Only the subjects who entered the study based on their CRP measurement are included here.</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="58"/>
                <count group_id="O2" value="31"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="11"/>
                    <measurement group_id="O2" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Number of Subjects Achieving FCP Levels Within Normal Limits at Day 14 and 42</title>
        <description>The number of subjects who entered the study with an elevated FCP who had an FCP level within normal limits at Days 14 and 42.&#xD;
Normal limits of FCP defined as less than or equal to 250µg/g</description>
        <time_frame>Days 14 and 42</time_frame>
        <population>Patients were enrolled into the study based on either a baseline CRP measurement or a baseline FCP measurement. Only the subjects who entered the study based on their FCP measurement are included here.</population>
        <group_list>
          <group group_id="O1">
            <title>V565</title>
            <description>V565 TID PO for 6 weeks&#xD;
V565: Daily dosing of V565 three times a day orally for 6 weeks</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Placebo TID PO for 6 weeks&#xD;
Placebo: Daily dosing of placebo three times a day orally for 6 weeks</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Subjects Achieving FCP Levels Within Normal Limits at Day 14 and 42</title>
          <description>The number of subjects who entered the study with an elevated FCP who had an FCP level within normal limits at Days 14 and 42.&#xD;
Normal limits of FCP defined as less than or equal to 250µg/g</description>
          <population>Patients were enrolled into the study based on either a baseline CRP measurement or a baseline FCP measurement. Only the subjects who entered the study based on their FCP measurement are included here.</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="23"/>
                <count group_id="O2" value="10"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7"/>
                    <measurement group_id="O2" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>From Day 1 (first day of study medication) to Day 56 (14 days after last dose of study medication)</time_frame>
      <group_list>
        <group group_id="E1">
          <title>V565</title>
          <description>V565 TID PO for 6 weeks&#xD;
V565: Daily dosing of V565 three times a day orally for 6 weeks</description>
        </group>
        <group group_id="E2">
          <title>Placebo</title>
          <description>Placebo TID PO for 6 weeks&#xD;
Placebo: Daily dosing of placebo three times a day orally for 6 weeks</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>MedDRA 19.1</default_vocab>
        <default_assessment>Non-systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="82"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="43"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="82"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="43"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Abdominal pain</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="82"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="43"/>
              </event>
              <event>
                <sub_title>Crohns Disease</sub_title>
                <description>Worsening of Crohn's Disease 7 days after the last dose of study medication</description>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="82"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="43"/>
              </event>
              <event>
                <sub_title>Gastrointestinal haemorrhage</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="82"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="43"/>
              </event>
              <event>
                <sub_title>Vomiting</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="82"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="43"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Anal abscess</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="82"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="43"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>2</frequency_threshold>
        <default_vocab>MedDRA 19.1</default_vocab>
        <default_assessment>Non-systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="30" subjects_at_risk="82"/>
                <counts group_id="E2" subjects_affected="16" subjects_at_risk="43"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Blood and lymphatic system disorders</title>
            <event_list>
              <event>
                <sub_title>Anaemia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="82"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="43"/>
              </event>
              <event>
                <sub_title>Iron deficiency anaemia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="82"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="43"/>
              </event>
              <event>
                <sub_title>Neutrophilia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="82"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="43"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Tachycardia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="82"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="43"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Abdominal pain</sub_title>
                <counts group_id="E1" events="6" subjects_affected="4" subjects_at_risk="82"/>
                <counts group_id="E2" events="4" subjects_affected="4" subjects_at_risk="43"/>
              </event>
              <event>
                <sub_title>Crohn's Disease</sub_title>
                <counts group_id="E1" events="5" subjects_affected="5" subjects_at_risk="82"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="43"/>
              </event>
              <event>
                <sub_title>Diarrhoea</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="82"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="43"/>
              </event>
              <event>
                <sub_title>Vomiting</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="82"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="43"/>
              </event>
              <event>
                <sub_title>Dyspepsia</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="82"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="43"/>
              </event>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="82"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="43"/>
              </event>
              <event>
                <sub_title>Abdominal distension</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="82"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="43"/>
              </event>
              <event>
                <sub_title>Gastrointestinal haemorrhage</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="82"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="43"/>
              </event>
              <event>
                <sub_title>Gastrooesophageal reflux disease</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="82"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="43"/>
              </event>
              <event>
                <sub_title>Proctalgia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="82"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="43"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Oedema peripheral</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="82"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="43"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Anal abscess</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="82"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="43"/>
              </event>
              <event>
                <sub_title>Gastroenteritis</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="82"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="43"/>
              </event>
              <event>
                <sub_title>Influenza</sub_title>
                <counts group_id="E1" events="3" subjects_affected="2" subjects_at_risk="82"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="43"/>
              </event>
              <event>
                <sub_title>Pulpitis dental</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="82"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="43"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Alanine aminotransferase increased</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="82"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="43"/>
              </event>
              <event>
                <sub_title>Aspartate aminotransferase increased</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="82"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="43"/>
              </event>
              <event>
                <sub_title>Urine analysis abnormal</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="82"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="43"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Hyperglycaemia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="82"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="43"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="82"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="43"/>
              </event>
              <event>
                <sub_title>Seizure</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="82"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="43"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Insomnia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="82"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="43"/>
              </event>
              <event>
                <sub_title>Personality change</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="82"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="43"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Pollakiuria</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="82"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="43"/>
              </event>
              <event>
                <sub_title>Nephrolithiasis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="82"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="43"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Cough</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="82"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="43"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Dry skin</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="82"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="43"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.</restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Chief Medical Officer</name_or_title>
      <organization>VHsquared</organization>
      <phone>+44 (0)1223 837650</phone>
      <email>info@vhsquared.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/NCT02976129
org study id: V56502
nct id: NCT02976129
lead sponsor: 
has dmc: No
The purpose of this study is to evaluate the efficacy and safety of V565 in participants with
      active Crohn's Disease (CD).
This study will be a multiple-site, double-blind, placebo-controlled, parallel-group study in
      approximately 126 subjects with a confirmed diagnosis of CD for at least three months and
      have CD involving the ileum and/or colon. Following a screening period of up to 28 days,
      subjects will be randomly allocated into one of two treatment arms: either V565 or placebo
      using a 2:1 active:placebo ratio for a treatment period of 6 weeks.

      Subjects will be treated with study drug as an add-on to any permitted stable medications
      already being taken for CD.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: Number of Subjects Achieving Response to Therapy, Defined as Reduction in the CDAI Score and in Inflammatory Markers CRP or FCP at Day 42.
time frame: Day 42
description: Number of responders at Day 42, defined as subjects achieving both CDAI ≥ 70-point reduction from baseline or CDAI score < 150, and a reduction of ≥ 40% from the baseline value of CRP or FCP.
Crohn's Disease Activity Index (CDAI) is used to assess the symptoms of participants with Crohn's Disease. Scores generally range from 0 to 600, where clinical remission of Crohn's disease is defined as CDAI < 150, and very severe disease is defined as CDAI > 450.
measure: Number of Subjects Achieving Response to Therapy, Defined as Reduction in the CDAI Score and in Inflammatory Markers CRP or FCP at Day 42.
time frame: Day 42
description: Number of subjects achieving a ≥ 100-point reduction in CDAI score and a concomitant reduction of at least 50% in CRP or FCP at Day 42
Crohn's Disease Activity Index (CDAI) is used to assess the symptoms of participants with Crohn's Disease. Scores generally range from 0 to 600, where clinical remission of Crohn's disease is defined as CDAI < 150, and very severe disease is defined as CDAI > 450.
measure: Number of Subjects With Improvement in Endoscopic Mucosal Appearance
time frame: Day 42
description: Subjects with a pre-treatment endoscopy Simple Endoscopic Score for Crohn's Disease (SES-CD) of at least 7 (4 if disease was confined to ileum) had a post-treatment endoscopy to evaluate changes in mucosal appearance. The central reader of the endoscopies, blinded to treatment and sequence, was asked to grade if video A was better or worse than video B. Pre- and post-treatment videos were randomly assigned to A and B. The endpoint is the number of subjects whose post-treatment endoscopy was better than their pre-treatment endoscopy.
measure: Number of Subjects Achieving CRP Levels Within Normal Limits at Days 14 and 42
time frame: Days 14 and 42
description: The number of subjects who entered the study with an elevated CRP who had a CRP level within normal limits at Days 14 and 42.
Normal levels defined as CRP less than or equal to 5mg/L
measure: Number of Subjects Achieving FCP Levels Within Normal Limits at Day 14 and 42
time frame: Days 14 and 42
description: The number of subjects who entered the study with an elevated FCP who had an FCP level within normal limits at Days 14 and 42.
Normal limits of FCP defined as less than or equal to 250µg/g
arm group label: V565
arm group type: Experimental
description: V565 three times a day (TID) PO for 6 weeks
arm group label: Placebo
arm group type: Placebo Comparator
description: Placebo TID PO for 6 weeks
intervention type: Drug
intervention name: V565
description: Daily dosing of V565 three times a day orally for 6 weeks
arm group label: V565
intervention type: Drug
intervention name: Placebo
description: Daily dosing of placebo three times a day orally for 6 weeks
arm group label: Placebo
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
last name: Suhail Nurbhai, MBChB MRCP
role: Study Director
affiliation: VHsquared Ltd.
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country: Austria
country: Canada
country: Czechia
country: Germany
country: Hungary
country: Netherlands
country: Norway
country: Poland
country: Serbia
country: Slovakia
country: Ukraine
country: United Kingdom
country: United States
country: Czech Republic
responsible party type: Sponsor
mesh term: Crohn Disease
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