<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/NCT04433585</url>
  </required_header>
  <id_info>
    <org_study_id>17422</org_study_id>
    <secondary_id>J1P-MC-KFAJ</secondary_id>
    <secondary_id>2019-003323-38</secondary_id>
    <nct_id>NCT04433585</nct_id>
  </id_info>
  <brief_title>A Study of LY3471851 in Adults With Systemic Lupus Erythematosus (SLE)</brief_title>
  <acronym>ISLAND-SLE</acronym>
  <official_title>A Randomized, Double-Blind, Placebo-Controlled, Phase 2 Study of LY3471851 (NKTR-358) in Adults With Systemic Lupus Erythematosus</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Eli Lilly and Company</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Nektar Therapeutics</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Eli Lilly and Company</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The reason for this study is to see if the study drug LY3471851 (NKTR-358) is safe and&#xD;
      effective in adults with systemic lupus erythematosus (SLE).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      LY3471851 is a potential first-in-class therapeutic that may address an underlying immune&#xD;
      system imbalance in people with many autoimmune conditions. It targets the interleukin (IL-2)&#xD;
      receptor complex in the body in order to stimulate proliferation of inhibitory immune cells&#xD;
      known as regulatory T cells. By activating these cells, LY3471851 may act to bring the immune&#xD;
      system back into balance.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 19, 2020</start_date>
  <completion_date type="Actual">February 16, 2023</completion_date>
  <primary_completion_date type="Actual">January 10, 2023</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>Percentage of Participants who Achieve a ≥4 Point Reduction in Systemic Lupus Erythematosus Disease Activity Index (SLEDAI) 2000 (2K) Score</measure>
    <time_frame>Week 24</time_frame>
    <description>Percentage of Participants who Achieve a ≥4 Point Reduction in SLEDAI-2K Score</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants who Achieve British Isles Lupus Assessment Group (BILAG) Based Composite Lupus Assessment (BICLA) Response</measure>
    <time_frame>Week 24</time_frame>
    <description>Percentage of Participants who Achieve BICLA Response</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants who Achieve Systemic Lupus Erythematosus Responder Index 4 (SRI-4) Response</measure>
    <time_frame>Week 24</time_frame>
    <description>Percentage of Participants who Achieve SRI-4 Response</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants who Achieve Lupus Low Disease Activity State (LLDAS)</measure>
    <time_frame>Week 24</time_frame>
    <description>Percentage of Participants who Achieve LLDAS</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pharmacokinetics (PK): Trough Concentrations (Ctrough) of LY3471851</measure>
    <time_frame>Week 24</time_frame>
    <description>PK: Ctrough of LY3471851</description>
  </secondary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">291</enrollment>
  <condition>Systemic Lupus Erythematosus</condition>
  <arm_group>
    <arm_group_label>LY3471851 High Dose</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>LY3471851 administered subcutaneously (SC).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>LY3471851 Mid Dose</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>LY3471851 administered SC.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>LY3471851 Low Dose</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>LY3471851 administered SC</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Placebo administered SC.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>LY3471851</intervention_name>
    <description>Administered SC</description>
    <arm_group_label>LY3471851 High Dose</arm_group_label>
    <arm_group_label>LY3471851 Low Dose</arm_group_label>
    <arm_group_label>LY3471851 Mid Dose</arm_group_label>
    <other_name>NKTR-358</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Administered SC</description>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Have a clinical diagnosis of SLE at least 24 weeks prior to screening.&#xD;
&#xD;
          -  Have documentation of having met at least 4 of 11 Revised Criteria for Classification&#xD;
             of Systemic Lupus Erythematosus according to the 1997 Update of the 1982 American&#xD;
             College of Rheumatology (ACR) criteria for classification of SLE prior to&#xD;
             randomization.&#xD;
&#xD;
          -  Have a positive antinuclear antibody (ANA) (titer ≥1:80) and/or a positive&#xD;
             anti-double-stranded deoxyribonucleic acid (dsDNA), and/or a positive anti-Smith&#xD;
             (anti-Sm) as assessed by a central laboratory during screening.&#xD;
&#xD;
          -  Have a total Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K)&#xD;
             score ≥6 during screening.&#xD;
&#xD;
          -  Have a clinical SLEDAI-2K score ≥4 at randomization.&#xD;
&#xD;
          -  Have active arthritis and/or active rash.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Have severe active lupus nephritis.&#xD;
&#xD;
          -  Have active central nervous system (CNS) lupus.&#xD;
&#xD;
          -  Have a history or presence of cardiovascular, respiratory, hepatic, gastrointestinal,&#xD;
             endocrine, hematological, neurological, or neuropsychiatric disorders or any other&#xD;
             serious and/or unstable illness that, in the opinion of the investigator, could&#xD;
             constitute an unacceptable risk when taking investigational product or interfere with&#xD;
             the interpretation of data.&#xD;
&#xD;
          -  Have a current or recent clinically serious viral, bacterial, fungal, or parasitic&#xD;
             infection.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)</last_name>
    <role>Study Director</role>
    <affiliation>Eli Lilly and Company</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of California - San Diego</name>
      <address>
        <city>La Jolla</city>
        <state>California</state>
        <zip>92037</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Desert Medical Advances</name>
      <address>
        <city>Palm Desert</city>
        <state>California</state>
        <zip>92260</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Stanford University Hospital</name>
      <address>
        <city>Stanford</city>
        <state>California</state>
        <zip>94305</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Inland Rheumatology &amp; Osteoporosis Medical Group</name>
      <address>
        <city>Upland</city>
        <state>California</state>
        <zip>91786</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Colorado School of Medicine</name>
      <address>
        <city>Aurora</city>
        <state>Colorado</state>
        <zip>80045</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Research Center of CT/NY</name>
      <address>
        <city>Danbury</city>
        <state>Connecticut</state>
        <zip>06810</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Yale University School of Medicine</name>
      <address>
        <city>New Haven</city>
        <state>Connecticut</state>
        <zip>06519</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Stamford Therapeutics Consortium</name>
      <address>
        <city>Stamford</city>
        <state>Connecticut</state>
        <zip>06905</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Miami School of Medicine</name>
      <address>
        <city>Miami</city>
        <state>Florida</state>
        <zip>33136</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>New Horizon Research Center</name>
      <address>
        <city>Miami</city>
        <state>Florida</state>
        <zip>33165 3338</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>NECCR PrimaCare Research</name>
      <address>
        <city>Fall River</city>
        <state>Massachusetts</state>
        <zip>02721</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Washington University School of Medicine</name>
      <address>
        <city>Saint Louis</city>
        <state>Missouri</state>
        <zip>63110</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Northwell Health</name>
      <address>
        <city>Great Neck</city>
        <state>New York</state>
        <zip>11021</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>NYU Langone</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10016</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>MetroHealth Medical Center</name>
      <address>
        <city>Cleveland</city>
        <state>Ohio</state>
        <zip>44109</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Paramount Medical Research</name>
      <address>
        <city>Middleburg Heights</city>
        <state>Ohio</state>
        <zip>44130</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Oklahoma Medical Research Foundation</name>
      <address>
        <city>Oklahoma City</city>
        <state>Oklahoma</state>
        <zip>73104-5046</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Accurate Clinical Management</name>
      <address>
        <city>Baytown</city>
        <state>Texas</state>
        <zip>77521</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Metroplex Clinical Research Center</name>
      <address>
        <city>Dallas</city>
        <state>Texas</state>
        <zip>75231</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Texas Southwestern Medical Center at Dallas</name>
      <address>
        <city>Dallas</city>
        <state>Texas</state>
        <zip>75390</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Accurate Clinical Research</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77089</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Fort Bend Clinical Research, LLC</name>
      <address>
        <city>Sugar Land</city>
        <state>Texas</state>
        <zip>77479</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Washington Medical Center</name>
      <address>
        <city>Seattle</city>
        <state>Washington</state>
        <zip>98195-6422</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>DOM- Centro de Reumatologia</name>
      <address>
        <city>Caba</city>
        <state>Buenos Aires</state>
        <zip>1111</zip>
        <country>Argentina</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centro Privado de Medicina Familiar / Mindout Research</name>
      <address>
        <city>Ciudad Autónoma de Buenos Aire</city>
        <state>Buenos Aires</state>
        <zip>1417</zip>
        <country>Argentina</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>APRILLUS Asistencia E Investigacion de Arcis Salud</name>
      <address>
        <city>Caba</city>
        <state>Ciudad Autónoma De Buenos Aire</state>
        <zip>1406</zip>
        <country>Argentina</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinica Adventista Belgrano</name>
      <address>
        <city>Caba</city>
        <state>Ciudad Autónoma De Buenos Aire</state>
        <zip>C1430EGF</zip>
        <country>Argentina</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centro de Investigaciones Médicas Tucuman</name>
      <address>
        <city>SAN M. DE Tucuman</city>
        <state>Tucumán</state>
        <zip>T4000AXL</zip>
        <country>Argentina</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital J. M. Ramos Mejía</name>
      <address>
        <city>Ciudad Autónoma de Buenos Aire</city>
        <zip>C1221ADC</zip>
        <country>Argentina</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Córdoba</name>
      <address>
        <city>Córdoba</city>
        <zip>5004</zip>
        <country>Argentina</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centro Polivalente de Asistencia e Inv. Clinica CER-San Juan</name>
      <address>
        <city>San Juan</city>
        <zip>J5402DIL</zip>
        <country>Argentina</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Emeritus Research</name>
      <address>
        <city>Camberwell</city>
        <state>Victoria</state>
        <zip>3124</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Calgary</name>
      <address>
        <city>Calgary</city>
        <state>Alberta</state>
        <zip>T2N 4N1</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>INREA s.r.o.</name>
      <address>
        <city>Ostrava</city>
        <state>Ostrava Město</state>
        <zip>70300</zip>
        <country>Czechia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Revmatologicky ustav</name>
      <address>
        <city>Praha 2</city>
        <state>Praha, Hlavní Mešto</state>
        <zip>12850</zip>
        <country>Czechia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universitätsklinikum Tübingen</name>
      <address>
        <city>Tübingen</city>
        <state>Baden-Württemberg</state>
        <zip>72076</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Rheumazentrum Ruhrgebiet</name>
      <address>
        <city>Herne</city>
        <state>Nordrhein-Westfalen</state>
        <zip>44649</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universtitätsklinikum Essen AöR</name>
      <address>
        <city>Essen</city>
        <state>North Rhine-Westphalia</state>
        <zip>45147</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Klinikum Bad Bramstedt GmbH</name>
      <address>
        <city>Bad Bramstedt</city>
        <state>Schleswig-Holstein</state>
        <zip>24576</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Klinik für Innere Medizin I, Universitätsklinikum Schleswig-Holstein, Campus Kiel</name>
      <address>
        <city>Kiel</city>
        <zip>24105</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universitätsklinikum Köln</name>
      <address>
        <city>Köln</city>
        <zip>50924</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Békés Megyei Központi Kórház Pándy Kálmán Tagkórház</name>
      <address>
        <city>Gyula</city>
        <state>Békés</state>
        <zip>5700</zip>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Qualiclinic</name>
      <address>
        <city>Budapest</city>
        <zip>1036</zip>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Debreceni Egyetem Orvos-es Egészsegtudomanyi Centrum</name>
      <address>
        <city>Debrecen</city>
        <zip>4004</zip>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Krishna Institute of Medical Science</name>
      <address>
        <city>Hyderabad</city>
        <state>Andhra Pradesh</state>
        <zip>500003</zip>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>King George Hospital</name>
      <address>
        <city>Visakhapatanam</city>
        <state>Andhra Pradesh</state>
        <zip>530002</zip>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sir Ganga Ram Hospital</name>
      <address>
        <city>New Delhi</city>
        <state>Delhi</state>
        <zip>110060</zip>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Amber Clinic</name>
      <address>
        <city>Ahmedabad</city>
        <state>Gujarat</state>
        <zip>380015</zip>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Swastik Rheumatology Clinic</name>
      <address>
        <city>Ahmedabad</city>
        <state>Gujarat</state>
        <zip>380054</zip>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sushruta Multispeciality Hospital &amp; Research Centre</name>
      <address>
        <city>Hubli</city>
        <state>Karnataka</state>
        <zip>580021</zip>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Government Medical College (GMC) Aurangabad</name>
      <address>
        <city>Aurangabad</city>
        <state>Maharashtra</state>
        <zip>431001</zip>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Government Medical College</name>
      <address>
        <city>Nagpur</city>
        <state>Maharashtra</state>
        <zip>440003</zip>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Jasleen Hospital</name>
      <address>
        <city>Nagpur</city>
        <state>Maharashtra</state>
        <zip>440012</zip>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>All India Institute of Medical Sciences - Nagpur</name>
      <address>
        <city>Nagpur</city>
        <state>Maharashtra</state>
        <zip>441108</zip>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sancheti Institute for Orthopaedics &amp; Rehabilitation</name>
      <address>
        <city>Pune</city>
        <state>Maharashtra</state>
        <zip>41005</zip>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Center for Rheumatic Diseases</name>
      <address>
        <city>Pune</city>
        <state>Maharashtra</state>
        <zip>411001</zip>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sancheti HealthCare Academy</name>
      <address>
        <city>Pune</city>
        <state>Maharashtra</state>
        <zip>411005</zip>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sheba Medical Center</name>
      <address>
        <city>Ramat Gan</city>
        <state>HaMerkaz</state>
        <zip>5262100</zip>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Rambam Medical Center</name>
      <address>
        <city>Haifa</city>
        <zip>3109601</zip>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Meir Medical Center</name>
      <address>
        <city>Kfar Saba</city>
        <zip>4428164</zip>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Tel Aviv Sourasky Medical Center</name>
      <address>
        <city>Tel Aviv</city>
        <zip>6423906</zip>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kojunkai Daido Clinic</name>
      <address>
        <city>Nagoya</city>
        <state>Aichi</state>
        <zip>4570818</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Occupational and Enviromental Health</name>
      <address>
        <city>Kitakyushu</city>
        <state>Fukuoka</state>
        <zip>807-8556</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hokkaido University Hospital</name>
      <address>
        <city>Sapporo</city>
        <state>Hokkaido</state>
        <zip>060-8648</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Tohoku University Hospital</name>
      <address>
        <city>Sendai-shi</city>
        <state>Miyagi</state>
        <zip>980-8574</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Shinshu University Hospital</name>
      <address>
        <city>Matsumoto</city>
        <state>Nagano</state>
        <zip>390-8621</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sasebo Chuo Hospital</name>
      <address>
        <city>Sasebo</city>
        <state>Nagasaki</state>
        <zip>857-1195</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>National Hospital Organization Chibahigashi National Hospital</name>
      <address>
        <city>Chiba</city>
        <zip>260-8712</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>National Hospital Organization Kyushu Medical Center</name>
      <address>
        <city>Fukuoka</city>
        <zip>810 8563</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Okayama University Hospital</name>
      <address>
        <city>Okayama</city>
        <zip>700-8558</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Daini Osaka Police Hospital</name>
      <address>
        <city>Osaka</city>
        <zip>543-0042</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>St. Luke's International Hospital</name>
      <address>
        <city>Tokyo</city>
        <zip>104-8560</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Keio university hospital</name>
      <address>
        <city>Tokyo</city>
        <zip>160 8582</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Seoul National University Bundang Hospital</name>
      <address>
        <city>Seongnam-si</city>
        <state>Gyeonggi-do</state>
        <zip>13620</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Inha University Hospital</name>
      <address>
        <city>Incheon</city>
        <state>Korea</state>
        <zip>22332</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kyung Hee University Hospital</name>
      <address>
        <city>Seoul</city>
        <state>Korea</state>
        <zip>02447</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hanyang University Medical Center</name>
      <address>
        <city>Seoul</city>
        <state>Korea</state>
        <zip>04763</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Seoul National University Hospital</name>
      <address>
        <city>Seoul</city>
        <state>Seoul, Korea</state>
        <zip>03080</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centro Medico del Angel</name>
      <address>
        <city>Mexicali</city>
        <state>Baja California</state>
        <zip>21100</zip>
        <country>Mexico</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CIMAB SA de CV</name>
      <address>
        <city>Torreon</city>
        <state>Coahuila</state>
        <zip>27000</zip>
        <country>Mexico</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>RM Pharma Specialists S.A. de C.V.</name>
      <address>
        <city>Mexico City</city>
        <state>Distrito Federal</state>
        <zip>03100</zip>
        <country>Mexico</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinica para el Diagnostico y Tratamiento de la Enfermedades</name>
      <address>
        <city>Mexico City</city>
        <state>Distrito Federal</state>
        <zip>06700</zip>
        <country>Mexico</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centro Integral en Reumatologia</name>
      <address>
        <city>Guadalajara</city>
        <state>Jalisco</state>
        <zip>44160</zip>
        <country>Mexico</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinica de Investigacion en Reumatologia y Obesidad S. C.</name>
      <address>
        <city>Guadalajara</city>
        <state>Jalisco</state>
        <zip>44650</zip>
        <country>Mexico</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>MICS Centrum Medyczne Warszawa</name>
      <address>
        <city>Warszawa</city>
        <state>Mazowieckie</state>
        <zip>00874</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Nova Reuma Społka Partnerska</name>
      <address>
        <city>Bialystok</city>
        <state>Podlaskie</state>
        <zip>15-707</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Szpital Uniwersytecki Nr 2 w Bydgoszczy</name>
      <address>
        <city>Bydgoszcz</city>
        <zip>85-168</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Nzoz Bif-Med</name>
      <address>
        <city>Bytom</city>
        <state>Śląskie</state>
        <zip>41-902</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centro Reumatologico Caguas</name>
      <address>
        <city>Caguas</city>
        <zip>00725</zip>
        <country>Puerto Rico</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Latin Clinical Trial Center</name>
      <address>
        <city>San Juan</city>
        <zip>00909</zip>
        <country>Puerto Rico</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GCM Medical Group, PSC - Hato Rey Site</name>
      <address>
        <city>San Juan</city>
        <zip>00917</zip>
        <country>Puerto Rico</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mindful Medical Research</name>
      <address>
        <city>San Juan</city>
        <zip>00918</zip>
        <country>Puerto Rico</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>C.M.D.T.A. Neomed</name>
      <address>
        <city>Brasov</city>
        <state>Brașov</state>
        <zip>500283</zip>
        <country>Romania</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>SC Centrul Medical Sana SRL</name>
      <address>
        <city>Bucuresti</city>
        <zip>011025</zip>
        <country>Romania</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Spitalul Clinic Sf Maria Bucuresti</name>
      <address>
        <city>Bucuresti</city>
        <zip>011172</zip>
        <country>Romania</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Spitalul Clinic Judetean de Urgenta Sf. Apostol Andrei</name>
      <address>
        <city>Galati</city>
        <zip>800578</zip>
        <country>Romania</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Karelia Republican Hospital V.A. Baranova</name>
      <address>
        <city>Petrozavodsk</city>
        <state>Kareliya, Respublika</state>
        <zip>185019</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Moscow City Clinical Hospital Number 15</name>
      <address>
        <city>Moscow</city>
        <state>Moskva</state>
        <zip>111539</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>V.A. Nasonova Research Institute of Rheumatology</name>
      <address>
        <city>Moscow</city>
        <zip>115522</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ryazan Regional Clinical Cardiology Dispensary</name>
      <address>
        <city>Ryazan</city>
        <zip>390026</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitari Vall d'Hebron</name>
      <address>
        <city>Barcelona</city>
        <zip>08035</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Quiron Infanta Luisa</name>
      <address>
        <city>Sevilla</city>
        <zip>41010</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Chang Gung Memorial Hospital - Kaohsiung Branch</name>
      <address>
        <city>Kaohsiung City</city>
        <zip>83301</zip>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>China Medical University Hospital</name>
      <address>
        <city>Taichung City</city>
        <zip>40447</zip>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Taichung Veterans General Hospital</name>
      <address>
        <city>Taichung</city>
        <zip>40705</zip>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>National Taiwan University Hospital</name>
      <address>
        <city>Taipei City</city>
        <zip>10048</zip>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Regional Clinical Hospital Center for Emergency medical care</name>
      <address>
        <city>Kharkiv</city>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Edelweiss Medics LLC</name>
      <address>
        <city>Kyiv</city>
        <zip>02002</zip>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kyiv City Clinical Hospital #3</name>
      <address>
        <city>Kyiv</city>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Multifield Medical Center of Odesa NMU (University Clinic#1)</name>
      <address>
        <city>Odesa</city>
        <zip>65026</zip>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Vinnytsya Regional Clinical Hospital</name>
      <address>
        <city>Vinnytsya</city>
        <zip>21018</zip>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Regional Clinical Hospital of Zaporizhzhia</name>
      <address>
        <city>Zaporizhzhia</city>
        <zip>69600</zip>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Argentina</country>
    <country>Australia</country>
    <country>Canada</country>
    <country>Czechia</country>
    <country>Germany</country>
    <country>Hungary</country>
    <country>India</country>
    <country>Israel</country>
    <country>Japan</country>
    <country>Korea, Republic of</country>
    <country>Mexico</country>
    <country>Poland</country>
    <country>Puerto Rico</country>
    <country>Romania</country>
    <country>Russian Federation</country>
    <country>Spain</country>
    <country>Taiwan</country>
    <country>Ukraine</country>
    <country>United States</country>
  </location_countries>
  <removed_countries>
    <country>United Kingdom</country>
  </removed_countries>
  <link>
    <url>https://trials.lillytrialguide.com/en-US/trial/2NrKmN7Zwj52k3UG9QrLqS</url>
    <description>A Study of LY3471851 in Adults With Systemic Lupus Erythematosus (SLE) (ISLAND-SLE)</description>
  </link>
  <verification_date>April 2023</verification_date>
  <study_first_submitted>June 15, 2020</study_first_submitted>
  <study_first_submitted_qc>June 15, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 16, 2020</study_first_posted>
  <last_update_submitted>April 12, 2023</last_update_submitted>
  <last_update_submitted_qc>April 12, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">April 13, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>T regulatory cells (Tregs)</keyword>
  <keyword>Interleukin 2</keyword>
  <keyword>Interleukin-2</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Lupus Erythematosus, Systemic</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
    <ipd_info_type>Clinical Study Report (CSR)</ipd_info_type>
    <ipd_time_frame>Data are available 6 months after the primary publication and approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting.</ipd_time_frame>
    <ipd_access_criteria>A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.</ipd_access_criteria>
    <ipd_url>https://vivli.org/</ipd_url>
  </patient_data>
  <!-- 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/NCT04433585
org study id: 17422
secondary id: J1P-MC-KFAJ
secondary id: 2019-003323-38
nct id: NCT04433585
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
The reason for this study is to see if the study drug LY3471851 (NKTR-358) is safe and
      effective in adults with systemic lupus erythematosus (SLE).
LY3471851 is a potential first-in-class therapeutic that may address an underlying immune
      system imbalance in people with many autoimmune conditions. It targets the interleukin (IL-2)
      receptor complex in the body in order to stimulate proliferation of inhibitory immune cells
      known as regulatory T cells. By activating these cells, LY3471851 may act to bring the immune
      system back into balance.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: Percentage of Participants who Achieve a ≥4 Point Reduction in Systemic Lupus Erythematosus Disease Activity Index (SLEDAI) 2000 (2K) Score
time frame: Week 24
description: Percentage of Participants who Achieve a ≥4 Point Reduction in SLEDAI-2K Score
measure: Percentage of Participants who Achieve British Isles Lupus Assessment Group (BILAG) Based Composite Lupus Assessment (BICLA) Response
time frame: Week 24
description: Percentage of Participants who Achieve BICLA Response
measure: Percentage of Participants who Achieve Systemic Lupus Erythematosus Responder Index 4 (SRI-4) Response
time frame: Week 24
description: Percentage of Participants who Achieve SRI-4 Response
measure: Percentage of Participants who Achieve Lupus Low Disease Activity State (LLDAS)
time frame: Week 24
description: Percentage of Participants who Achieve LLDAS
measure: Pharmacokinetics (PK): Trough Concentrations (Ctrough) of LY3471851
time frame: Week 24
description: PK: Ctrough of LY3471851
arm group label: LY3471851 High Dose
arm group type: Experimental
description: LY3471851 administered subcutaneously (SC).
arm group label: LY3471851 Mid Dose
arm group type: Experimental
description: LY3471851 administered SC.
arm group label: LY3471851 Low Dose
arm group type: Experimental
description: LY3471851 administered SC
arm group label: Placebo
arm group type: Placebo Comparator
description: Placebo administered SC.
intervention type: Drug
intervention name: LY3471851
description: Administered SC
arm group label: LY3471851 High Dose
arm group label: LY3471851 Low Dose
arm group label: LY3471851 Mid Dose
other name: NKTR-358
intervention type: Drug
intervention name: Placebo
description: Administered SC
arm group label: Placebo
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
last name: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
role: Study Director
affiliation: Eli Lilly and Company
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country: Argentina
country: Australia
country: Canada
country: Czechia
country: Germany
country: Hungary
country: India
country: Israel
country: Japan
country: Korea, Republic of
country: Mexico
country: Poland
country: Puerto Rico
country: Romania
country: Russian Federation
country: Spain
country: Taiwan
country: Ukraine
country: United States
country: United Kingdom
url: https://trials.lillytrialguide.com/en-US/trial/2NrKmN7Zwj52k3UG9QrLqS
description: A Study of LY3471851 in Adults With Systemic Lupus Erythematosus (SLE) (ISLAND-SLE)
responsible party type: Sponsor
mesh term: Lupus Erythematosus, Systemic
sharing ipd: Yes
ipd description: Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.
ipd info type: Study Protocol
ipd info type: Statistical Analysis Plan (SAP)
ipd info type: Clinical Study Report (CSR)
ipd time frame: Data are available 6 months after the primary publication and approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting.
ipd access criteria: A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
ipd url: https://vivli.org/