<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/NCT02194400</url>
  </required_header>
  <id_info>
    <org_study_id>132-02</org_study_id>
    <nct_id>NCT02194400</nct_id>
  </id_info>
  <brief_title>Dose Escalation Study of RSLV-132 in Subjects With Systemic Lupus Erythematosus</brief_title>
  <official_title>A Double-Blind, Placebo-Controlled Dose Escalation Study of the Administration of Multiple Intravenous Doses of RSLV-132 in Subjects With Systemic Lupus Erythematosus</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Resolve Therapeutics</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Resolve Therapeutics</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      A one month multi-dose study will evaluate the safety and tolerability of 3 intravenous&#xD;
      infusions of RSLV-132 in subjects with inactive to mild SLE.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>July 2014</start_date>
  <completion_date type="Actual">November 2015</completion_date>
  <primary_completion_date type="Actual">November 2015</primary_completion_date>
  <phase>Phase 1</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>Number of participants with treatment-related adverse events as assessed by CTCAE v4.0</measure>
    <time_frame>30 days</time_frame>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">32</enrollment>
  <condition>Systemic Lupus Erythematosus</condition>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Saline infusion</description>
  </arm_group>
  <arm_group>
    <arm_group_label>RSLV-132</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>0.3 - 10 mg/kg experimental drug</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>RSLV-132</intervention_name>
    <description>0.3 - 10.0 mg/kg RSLV-132 weekly for 4 weeks</description>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_label>RSLV-132</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Stable SLE with no anticipated change in medications for the next 60 days&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Other biologic drugs&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>James Posada, Ph.D.</last_name>
    <role>Study Chair</role>
    <affiliation>Resolve Therapeutics</affiliation>
  </overall_official>
  <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>West Michigan Rheumatology</name>
      <address>
        <city>Grand Rapids</city>
        <state>Michigan</state>
        <zip>49546</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Altoona Center for Clinical Research</name>
      <address>
        <city>Duncansville</city>
        <state>Pennsylvania</state>
        <zip>16635</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Metroplex Clinical Research</name>
      <address>
        <city>Dallas</city>
        <state>Texas</state>
        <zip>75231</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>http://www.resolvebio.com</url>
    <description>Resolve Therapeutics Website</description>
  </link>
  <link>
    <url>http://www.lupustrials.org</url>
    <description>Lupus Research Institute</description>
  </link>
  <verification_date>December 2015</verification_date>
  <study_first_submitted>July 16, 2014</study_first_submitted>
  <study_first_submitted_qc>July 17, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 18, 2014</study_first_posted>
  <last_update_submitted>December 8, 2015</last_update_submitted>
  <last_update_submitted_qc>December 8, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">December 9, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>RSLV-132</keyword>
  <keyword>Systemic Lupus Erythematosus</keyword>
  <keyword>Lupus</keyword>
  <keyword>SLE</keyword>
  <keyword>Resolve</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Lupus Erythematosus, Systemic</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/NCT02194400
org study id: 132-02
nct id: NCT02194400
lead sponsor: 
has dmc: Yes
A one month multi-dose study will evaluate the safety and tolerability of 3 intravenous
      infusions of RSLV-132 in subjects with inactive to mild SLE.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
time frame: 30 days
arm group label: Placebo
arm group type: Placebo Comparator
description: Saline infusion
arm group label: RSLV-132
arm group type: Experimental
description: 0.3 - 10 mg/kg experimental drug
intervention type: Biological
intervention name: RSLV-132
description: 0.3 - 10.0 mg/kg RSLV-132 weekly for 4 weeks
arm group label: Placebo
arm group label: RSLV-132
criteria: 
gender: All
minimum age: 18 Years
maximum age: 70 Years
healthy volunteers: No
last name: James Posada, Ph.D.
role: Study Chair
affiliation: Resolve Therapeutics
facility: 
facility: 
facility: 
facility: 
country: United States
url: http://www.resolvebio.com
description: Resolve Therapeutics Website
url: http://www.lupustrials.org
description: Lupus Research Institute
responsible party type: Sponsor
mesh term: Lupus Erythematosus, Systemic