<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/NCT02258867</url>
  </required_header>
  <id_info>
    <org_study_id>X052133</org_study_id>
    <nct_id>NCT02258867</nct_id>
  </id_info>
  <brief_title>Efficacy and Safety Study of Gevokizumab to Treat Behcet's Disease Uveitis</brief_title>
  <acronym>EYEGUARD™-US</acronym>
  <official_title>A Randomized-Withdrawal, Double-Masked, Placebo-Controlled Study of the Efficacy and Safety of Gevokizumab in Treating Subjects With Behcet's Disease Uveitis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>XOMA (US) LLC</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>XOMA (US) LLC</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The objective of this study is to assess the efficacy and safety of gevokizumab in treating&#xD;
      Behcet's disease uveitis (BDU).&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Terminated</overall_status>
  <start_date>November 2014</start_date>
  <completion_date type="Actual">November 2015</completion_date>
  <primary_completion_date type="Actual">October 2015</primary_completion_date>
  <phase>Phase 3</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Time to first ocular exacerbation</measure>
    <time_frame>Randomization through Day 280</time_frame>
    <description>Time to first ocular exacerbation is defined as the number of days from randomization to the first ocular exacerbation.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">4</enrollment>
  <condition>Behcet's Disease Uveitis</condition>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Gevokizumab</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Solution for subcutaneous injection</description>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Gevokizumab</intervention_name>
    <description>Solution for subcutaneous injection</description>
    <arm_group_label>Gevokizumab</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Have characteristics of Behcet's disease consistent with International Criteria for&#xD;
             Behcet's disease&#xD;
&#xD;
          -  Have a documented history of active uveitis with or without retinal vasculitis within&#xD;
             the past 12 months&#xD;
&#xD;
          -  Best corrected visual acuity (BCVA) &gt;= 20 ETDRS letters in both eyes at baseline&#xD;
&#xD;
          -  Effective contraceptive measures&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Infectious uveitis and masquerade syndromes&#xD;
&#xD;
          -  End stage ocular disease&#xD;
&#xD;
          -  History of allergic or anaphylactic reactions to monoclonal antibodies&#xD;
&#xD;
          -  Active tuberculosis disease&#xD;
&#xD;
          -  History of recurrent infection or predisposition to infection; active ocular infection&#xD;
&#xD;
          -  Pregnant or nursing women&#xD;
&#xD;
        Other protocol-defined inclusion/exclusion criteria may apply&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <address>
        <city>Santa Ana</city>
        <state>California</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Chicago</city>
        <state>Illinois</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Ellsworth</city>
        <state>Maine</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Cambridge</city>
        <state>Massachusetts</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Royal Oak</city>
        <state>Michigan</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Winston-Salem</city>
        <state>North Carolina</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Fargo</city>
        <state>North Dakota</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>December 2015</verification_date>
  <study_first_submitted>October 2, 2014</study_first_submitted>
  <study_first_submitted_qc>October 2, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 8, 2014</study_first_posted>
  <last_update_submitted>December 28, 2015</last_update_submitted>
  <last_update_submitted_qc>December 28, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">December 29, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Uveitis</keyword>
  <keyword>Behcet's Disease Uveitis</keyword>
  <keyword>Behcet's Disease</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Behcet Syndrome</mesh_term>
    <mesh_term>Uveitis</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02258867
org study id: X052133
nct id: NCT02258867
lead sponsor: 
has dmc: No
The objective of this study is to assess the efficacy and safety of gevokizumab in treating
      Behcet's disease uveitis (BDU).
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Time to first ocular exacerbation
time frame: Randomization through Day 280
description: Time to first ocular exacerbation is defined as the number of days from randomization to the first ocular exacerbation.
arm group label: Placebo
arm group type: Placebo Comparator
arm group label: Gevokizumab
arm group type: Experimental
intervention type: Drug
intervention name: Placebo
description: Solution for subcutaneous injection
arm group label: Placebo
intervention type: Drug
intervention name: Gevokizumab
description: Solution for subcutaneous injection
arm group label: Gevokizumab
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: United States
responsible party type: Sponsor
mesh term: Behcet Syndrome
mesh term: Uveitis