<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/NCT02222948</url>
  </required_header>
  <id_info>
    <org_study_id>DRI13839</org_study_id>
    <secondary_id>2014-001643-20</secondary_id>
    <secondary_id>U1111-1153-3840</secondary_id>
    <nct_id>NCT02222948</nct_id>
  </id_info>
  <brief_title>Efficacy and Safety of Vatelizumab in Patients With Relapsing-Remitting Multiple Sclerosis</brief_title>
  <acronym>EMPIRE</acronym>
  <official_title>A Phase 2a/2b Double-Blind, Randomized, Placebo-Controlled Study Assessing Efficacy, Safety, and Dose-Response of Vatelizumab in Patients With Relapsing-Remitting Multiple Sclerosis (RRMS)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Genzyme, a Sanofi Company</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Sanofi</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Primary Objectives:&#xD;
&#xD;
        -  To assess the efficacy of vatelizumab compared to placebo as measured by a reduction in&#xD;
           new contrast-enhancing lesions (CELs) in relapsing remitting multiple sclerosis (RRMS)&#xD;
           patients.&#xD;
&#xD;
        -  To evaluate multiple doses of vatelizumab for a dose-response.&#xD;
&#xD;
      Secondary Objectives:&#xD;
&#xD;
        -  To evaluate the safety and tolerability of vatelizumab compared to placebo.&#xD;
&#xD;
        -  To evaluate the pharmacokinetics (PK) of vatelizumab.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The duration of study per patient will be up to 108 weeks, including a screening period of up&#xD;
      to 4 weeks, a treatment period of 12 weeks and a post-treatment safety follow-up period of up&#xD;
      to 92 weeks.&#xD;
&#xD;
      Patients completing the 12-week treatment period may enter an optional long-term extension&#xD;
      study in which all subjects will receive vatelizumab.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Study discontinued based on planned interim analysis of the primary endpoint. Not linked to any&#xD;
    safety concern.&#xD;
  </why_stopped>
  <start_date>September 2014</start_date>
  <completion_date type="Actual">July 2016</completion_date>
  <primary_completion_date type="Actual">April 2016</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>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Reduction in the cumulative number of new contrast-enhancing lesions on MRI</measure>
    <time_frame>from Week 4 to Week 12</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Safety: proportion of patients experiencing adverse events</measure>
    <time_frame>up to Week 104</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pharmacokinetics: serum concentrations of vatelizumab</measure>
    <time_frame>up to Week 32</time_frame>
  </secondary_outcome>
  <number_of_arms>5</number_of_arms>
  <enrollment type="Actual">112</enrollment>
  <condition>Relapsing-remitting Multiple Sclerosis</condition>
  <arm_group>
    <arm_group_label>Vatelizumab Dose 1</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Vatelizumab dose 1 at Weeks 0, 2, 4 and 8</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Vatelizumab Dose 2</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Vatelizumab dose 2 at Weeks 0, 2, 4 and 8</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Vatelizumab Dose 3</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Vatelizumab dose 3 at Weeks 0, 2, 4 and 8</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Vatelizumab Dose 4</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Vatelizumab dose 4 at Weeks 0, 2, 4 and 8</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Placebo (for Vatelizumab) at Weeks 0, 2, 4 and 8</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Vatelizumab</intervention_name>
    <description>Pharmaceutical form: solution for infusion&#xD;
Route of administration: intravenous</description>
    <arm_group_label>Vatelizumab Dose 1</arm_group_label>
    <arm_group_label>Vatelizumab Dose 2</arm_group_label>
    <arm_group_label>Vatelizumab Dose 3</arm_group_label>
    <arm_group_label>Vatelizumab Dose 4</arm_group_label>
    <other_name>SAR339658</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo (for Vatelizumab)</intervention_name>
    <description>Pharmaceutical form: solution for infusion&#xD;
Route of administration: intravenous</description>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion criteria:&#xD;
&#xD;
        Diagnosis of relapsing-remitting multiple sclerosis (RRMS). At least 1 documented relapse&#xD;
        in the past 12 months. At least 1 contrast-enhancing lesion (CEL) on magnetic resonance&#xD;
        imaging (MRI) in the past 12 months and/or at screening.&#xD;
&#xD;
        At least 3 T2 lesions on screening MRI.&#xD;
&#xD;
        Exclusion criteria:&#xD;
&#xD;
        Diagnosis of primary progressive or secondary progressive MS. Expanded disability status&#xD;
        scale (EDSS) score &gt;5.5. Relapse within 30 days prior to enrollment. Prior&#xD;
        immunosuppressive treatment within protocol-specified time periods. Prior treatment with&#xD;
        natalizumab (Tysabri®). History of bleeding/platelet disorders, malignancy, certain&#xD;
        infections as defined in the protocol, or any other past or current medical conditions that&#xD;
        would adversely affect the patient's participation in the study.&#xD;
&#xD;
        Pregnancy or breast-feeding. Other protocol-defined inclusion/exclusion criteria may apply.&#xD;
&#xD;
        The above information is not intended to contain all considerations relevant to a patient's&#xD;
        potential participation in a clinical trial.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>55 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Clinical Sciences &amp; Operations</last_name>
    <role>Study Director</role>
    <affiliation>Sanofi</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Investigational Site Number 840004</name>
      <address>
        <city>Cullman</city>
        <state>Alabama</state>
        <zip>35058</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 840009</name>
      <address>
        <city>Phoenix</city>
        <state>Arizona</state>
        <zip>85060</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 840005</name>
      <address>
        <city>Fort Collins</city>
        <state>Colorado</state>
        <zip>80528</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 840014</name>
      <address>
        <city>Washington</city>
        <state>District of Columbia</state>
        <zip>20037</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 840007</name>
      <address>
        <city>Ormond Beach</city>
        <state>Florida</state>
        <zip>32174</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 840012</name>
      <address>
        <city>Tampa</city>
        <state>Florida</state>
        <zip>33612</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 840001</name>
      <address>
        <city>Latham</city>
        <state>New York</state>
        <zip>12210</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 840015</name>
      <address>
        <city>Knoxville</city>
        <state>Tennessee</state>
        <zip>37922</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 840003</name>
      <address>
        <city>Round Rock</city>
        <state>Texas</state>
        <zip>78681</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 840016</name>
      <address>
        <city>San Antonio</city>
        <state>Texas</state>
        <zip>78258</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 840002</name>
      <address>
        <city>Salt Lake City</city>
        <state>Utah</state>
        <zip>84103</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 840008</name>
      <address>
        <city>Seattle</city>
        <state>Washington</state>
        <zip>98122</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 124001</name>
      <address>
        <city>Greenfield Park</city>
        <zip>J4V 2J2</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 124002</name>
      <address>
        <city>QuebeC</city>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 616008</name>
      <address>
        <city>Bydgoszcz</city>
        <zip>85-079</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 616007</name>
      <address>
        <city>Lodz</city>
        <zip>90-549</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 616001</name>
      <address>
        <city>Lodz</city>
        <zip>93-121</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 616004</name>
      <address>
        <city>Lublin</city>
        <zip>20-090</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 616003</name>
      <address>
        <city>Lublin</city>
        <zip>20-718</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 616002</name>
      <address>
        <city>Szczecin</city>
        <zip>70-111</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 616006</name>
      <address>
        <city>Warszawa</city>
        <zip>02-653</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 643010</name>
      <address>
        <city>Kazan</city>
        <zip>420021</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 643009</name>
      <address>
        <city>Moscow</city>
        <zip>107150</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 643003</name>
      <address>
        <city>Moscow</city>
        <zip>127018</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 643005</name>
      <address>
        <city>Nizhniy Novgorod</city>
        <zip>603155</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 643006</name>
      <address>
        <city>Nizhny Novgorod</city>
        <zip>603076</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 643008</name>
      <address>
        <city>Novosibirsk</city>
        <zip>630087</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 643002</name>
      <address>
        <city>St-Petersburg</city>
        <zip>197089</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 643011</name>
      <address>
        <city>St-Petersburg</city>
        <zip>197110</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 643001</name>
      <address>
        <city>St-Petersburg</city>
        <zip>197376</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 752002</name>
      <address>
        <city>Göteborg</city>
        <zip>416 85</zip>
        <country>Sweden</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 752001</name>
      <address>
        <city>Stockholm</city>
        <zip>171 76</zip>
        <country>Sweden</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
    <country>Poland</country>
    <country>Russian Federation</country>
    <country>Sweden</country>
    <country>United States</country>
  </location_countries>
  <verification_date>December 2016</verification_date>
  <study_first_submitted>August 20, 2014</study_first_submitted>
  <study_first_submitted_qc>August 20, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 22, 2014</study_first_posted>
  <disposition_first_submitted>December 20, 2016</disposition_first_submitted>
  <disposition_first_submitted_qc>December 20, 2016</disposition_first_submitted_qc>
  <disposition_first_posted type="Estimate">December 21, 2016</disposition_first_posted>
  <last_update_submitted>December 20, 2016</last_update_submitted>
  <last_update_submitted_qc>December 20, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">December 21, 2016</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>Multiple Sclerosis</mesh_term>
    <mesh_term>Multiple Sclerosis, Relapsing-Remitting</mesh_term>
    <mesh_term>Sclerosis</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted, but a results disposition has been submitted           -->
</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/NCT02222948
org study id: DRI13839
secondary id: 2014-001643-20
secondary id: U1111-1153-3840
nct id: NCT02222948
lead sponsor: 
has dmc: Yes
Primary Objectives:

        -  To assess the efficacy of vatelizumab compared to placebo as measured by a reduction in
           new contrast-enhancing lesions (CELs) in relapsing remitting multiple sclerosis (RRMS)
           patients.

        -  To evaluate multiple doses of vatelizumab for a dose-response.

      Secondary Objectives:

        -  To evaluate the safety and tolerability of vatelizumab compared to placebo.

        -  To evaluate the pharmacokinetics (PK) of vatelizumab.
The duration of study per patient will be up to 108 weeks, including a screening period of up
      to 4 weeks, a treatment period of 12 weeks and a post-treatment safety follow-up period of up
      to 92 weeks.

      Patients completing the 12-week treatment period may enter an optional long-term extension
      study in which all subjects will receive vatelizumab.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Reduction in the cumulative number of new contrast-enhancing lesions on MRI
time frame: from Week 4 to Week 12
measure: Safety: proportion of patients experiencing adverse events
time frame: up to Week 104
measure: Pharmacokinetics: serum concentrations of vatelizumab
time frame: up to Week 32
arm group label: Vatelizumab Dose 1
arm group type: Experimental
description: Vatelizumab dose 1 at Weeks 0, 2, 4 and 8
arm group label: Vatelizumab Dose 2
arm group type: Experimental
description: Vatelizumab dose 2 at Weeks 0, 2, 4 and 8
arm group label: Vatelizumab Dose 3
arm group type: Experimental
description: Vatelizumab dose 3 at Weeks 0, 2, 4 and 8
arm group label: Vatelizumab Dose 4
arm group type: Experimental
description: Vatelizumab dose 4 at Weeks 0, 2, 4 and 8
arm group label: Placebo
arm group type: Placebo Comparator
description: Placebo (for Vatelizumab) at Weeks 0, 2, 4 and 8
intervention type: Drug
intervention name: Vatelizumab
description: Pharmaceutical form: solution for infusion
Route of administration: intravenous
arm group label: Vatelizumab Dose 1
arm group label: Vatelizumab Dose 2
arm group label: Vatelizumab Dose 3
arm group label: Vatelizumab Dose 4
other name: SAR339658
intervention type: Drug
intervention name: Placebo (for Vatelizumab)
description: Pharmaceutical form: solution for infusion
Route of administration: intravenous
arm group label: Placebo
criteria: 
gender: All
minimum age: 18 Years
maximum age: 55 Years
healthy volunteers: No
last name: Clinical Sciences & Operations
role: Study Director
affiliation: Sanofi
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country: Canada
country: Poland
country: Russian Federation
country: Sweden
country: United States
responsible party type: Sponsor
mesh term: Multiple Sclerosis
mesh term: Multiple Sclerosis, Relapsing-Remitting
mesh term: Sclerosis