xml: <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/NCT05966480</url>
    </required_header>
    <id_info>
      <org_study_id>ESK-001-010</org_study_id>
      <nct_id>NCT05966480</nct_id>
    </id_info>
    <brief_title>Phase 2 Placebo-Controlled Study to Assess the Safety and Efficacy of ESK-001 in Active Systemic Lupus Erythematosus</brief_title>
    <acronym>LUMUS</acronym>
    <official_title>A Phase 2, Multicenter, Multinational, Randomized, Double-blind, Placebo-Controlled Study to Assess the Safety, Efficacy, and Pharmacokinetics of Multiple Dose Levels of ESK-001 in Adult Patients With Systemic Lupus Erythematosus</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Alumis Inc</agency>
        <agency_class>Industry</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Alumis Inc</source>
    <oversight_info>
      <has_dmc>Yes</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 purpose of this study is to assess the clinical efficacy, safety, PK, and PD of multiple&#xD;
        dose levels of ESK-001 compared with placebo in adult patients with SLE.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        This study will consist of a 5 week screening period, 48 week treatment period, and a 4 week&#xD;
        follow up period for a total of 57 weeks. Each participant will be randomized to receive&#xD;
        ESK-001 or placebo for 48 weeks. An open label extension study will be available for those&#xD;
        patients who complete the study.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">June 26, 2023</start_date>
    <completion_date type="Anticipated">December 1, 2025</completion_date>
    <primary_completion_date type="Anticipated">May 1, 2025</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>Triple (Participant, Investigator, Outcomes Assessor)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>To compare the effect on disease activity measured by the proportion of patients achieving British Isles Lupus Assessment Group (BILAG)-based Composite Lupus Assessment (BICLA) response at Week 48 between doses of ESK-001 and placebo</measure>
      <time_frame>Week 48</time_frame>
    </primary_outcome>
    <secondary_outcome>
      <measure>To assess the safety and tolerability of multiple dose levels of ESK-001</measure>
      <time_frame>Week 48</time_frame>
      <description>Safety and Tolerability will be assessed with clinical and laboratory assessments including blood tests for liver and kidney function, ECGs, hematological measures and physical examinations throughout the time of the study and safety follow up. The number and proportion of TEAEs, SAEs, AEs of greater than grade 3 severity and AEs of Clinical Interest will be recorded.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>To compare the effect on disease activity measured by the proportion of patients achieving an SLE Responder Index of ≥4 (SRI[4]) response at Week 48</measure>
      <time_frame>Week 48</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>To compare corticosteroid use in patients at Week 48</measure>
      <time_frame>Week 48</time_frame>
      <description>To compare the number and percentage of patients using corticosteroids and continuous summaries of dose used will be assessed as well as the frequency and percentage of patients able to taper corticosteroids and maintain low doses following taper.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>To compare the effect on cutaneous disease activity measured by the proportion of patients with a CLASI activity score of ≥8 at baseline achieving ≥ 50% reduction in the CLASI activity score at Week 48 between doses of ESK-001 and placebo</measure>
      <time_frame>Week 48</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>To compare the effect on disease activity measured by the proportion of patients achieving BICLA responses at Week 48 between doses of ESK-001 and placebo by stratification groups</measure>
      <time_frame>Week 48</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>To compare the Lupus Low Disease Activity State (LLDAS) response between doses of ESK-001 and placebo at Week 48</measure>
      <time_frame>Week 48</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>To compare the annualized flare rate through Week 48</measure>
      <time_frame>Week 48</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>To use the SF-36 (Short Form-36 item QoL measure) to compare the effect on health-related quality of life (HRQOL) between doses of ESK-001 and placebo</measure>
      <time_frame>Week 48</time_frame>
      <description>Efficacy: Comparing the effects of Esk-001 doses vs Placebo on Patient Reported Outcome (PRO) as it relates to Health-Related Quality of Life (HRQoL) as measured by self-reporting using the SF-36 (Short Form-36 item QoL measure) Questionnaire which uses a scale of 0 to 100. The higher numbers mean better health.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>To use the SLE-specific Lupus Quality of Life (LQoL) questionnaire to compare the effect on health-related quality of life (HRQOL) between doses of ESK-001 and placebo</measure>
      <time_frame>Week 48</time_frame>
      <description>Efficacy: Comparing the effects of Esk-001 doses vs Placebo on Patient Reported Outcome (PRO) as it relates to Health-Related Quality of Life (HRQoL) as measured by self-reporting using the SLE-specific Lupus Quality of Life (LQoL) questionnaire which uses a scale of 0 to 100. The higher numbers mean better health.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>To compare disease-specific QoL between doses of ESK-001 and placebo</measure>
      <time_frame>Week 48</time_frame>
      <description>Efficacy: To compare disease-specific QoL between doses of ESK-001 and placebo using the SLE Disease Activity Index 2000 (SLEDAI2K) measured on a scale of 0 to 105 where the higher numbers mean more disease activity.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>To compare disease-specific QoL between doses of ESK-001 and placebo</measure>
      <time_frame>Week 48</time_frame>
      <description>Efficacy: To compare disease-specific QoL between doses of ESK-001 and placebo using the British Isle Lupus Assessment Group 2004 (BILAG-2004) with a scale of A to E (A meaning very active disease and E no current or previous disease).</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>To compare disease-specific QoL between doses of ESK-001 and placebo</measure>
      <time_frame>Week 48</time_frame>
      <description>Efficacy: To compare disease-specific QoL between doses of ESK-001 and placebo using the Physician's Global Assessment (PGA) evaluating disease response using the 4-point VAS (Visual Analog Scale) of 0 to 3 (0 means no flares and 3 means severe flare in disease).</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>To compare Fatigue measured by FACIT-F between doses of ESK-001 and placebo</measure>
      <time_frame>Week 48</time_frame>
      <description>To compare patient-reported fatigue as measured by Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) questionnaire between doses of ESK-001 and placebo, where the score range is 0 to 52 and a lower score indicates greater fatigue/worse outcome.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>To compare patient global assessment of disease activity (PtGA) between doses of ESK-001 and placebo</measure>
      <time_frame>Week 48</time_frame>
      <description>Efficacy: To compare disease-specific QoL between doses of ESK-001 and placebo using the PtGA (Patient Global Assessment) instrument. Patients record on a visual analog scale (VAS) how well or badly they feel as a result of the disease in their own estimation over the course of the study.</description>
    </secondary_outcome>
    <number_of_arms>4</number_of_arms>
    <enrollment type="Anticipated">388</enrollment>
    <condition>SLE</condition>
    <arm_group>
      <arm_group_label>ESK-001 Dose Level 1</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>ESK-001 administered as an oral tablet</description>
    </arm_group>
    <arm_group>
      <arm_group_label>ESK-001 Dose Level 2</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>ESK-001 administered as an oral tablet</description>
    </arm_group>
    <arm_group>
      <arm_group_label>ESK-001 Dose Level 3</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>ESK-001 administered as an oral tablet</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Placebo</arm_group_label>
      <arm_group_type>Placebo Comparator</arm_group_type>
      <description>Placebo administered as an oral tablet</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>ESK-001</intervention_name>
      <description>Oral tablet</description>
      <arm_group_label>ESK-001 Dose Level 1</arm_group_label>
      <arm_group_label>ESK-001 Dose Level 2</arm_group_label>
      <arm_group_label>ESK-001 Dose Level 3</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Placebo</intervention_name>
      <description>Oral tablet</description>
      <arm_group_label>Placebo</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
          Patients with 6 or more months of SLE according to the 2019 EULAR/ACR criteria, have&#xD;
          positive autoantibodies or low complement at screening, and have active SLE as measured by&#xD;
          SLEDAI-2K of 6 or more, or 4 or more if joint involvement is present.&#xD;
  &#xD;
          Patients need to be on treatment which can be:&#xD;
  &#xD;
            -  A stable dose of oral corticosteroid (≤40 mg/day prednisone or equivalent) for a&#xD;
               minimum of 2 weeks prior to signing of the informed consent form (ICF) at the&#xD;
               Screening Visit. The dose of oral corticosteroid the patient is taking should not&#xD;
               increase between screening and Week 0 (Day 1).&#xD;
  &#xD;
            -  And/or antimalarial treatment (e.g., hydroxychloroquine, chloroquine, quinacrine),&#xD;
  &#xD;
            -  And/or no more than 1 of the following conventional DMARDS:&#xD;
  &#xD;
                 -  Azathioprine ≤200 mg/day&#xD;
  &#xD;
                 -  Mycophenolate mofetil ≤2 g/day or mycophenolic acid ≤1.44 g/day&#xD;
  &#xD;
                 -  Oral, subcutaneous, or intramuscular (IM) methotrexate ≤20 mg/week.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Drug-induced SLE or other autoimmune diseases that, in the opinion of the&#xD;
               Investigator, are likely to confound efficacy assessments&#xD;
  &#xD;
            -  Active, proliferative lupus nephritis that in the Investigator's opinion may require&#xD;
               treatment not allowed by the protocol&#xD;
  &#xD;
            -  Current disease other than SLE that, in the opinion of the Investigator, is likely to&#xD;
               interfere with SLE disease activity assessments. Examples include severe fibromyalgia,&#xD;
               severe osteoarthritis and severe cardiorespiratory diseases.&#xD;
  &#xD;
            -  Active severe or unstable neuropsychiatric SLE including, but not limited to the&#xD;
               following: aseptic meningitis; cerebral vasculitis; myelopathy; demyelination&#xD;
               syndromes (ascending or transverse myelitis, acute inflammatory demyelinating&#xD;
               polyradiculopathy); acute confusional state; impaired level of consciousness;&#xD;
               psychosis; acute stroke or stroke syndrome; cranial neuropathy; new seizures;&#xD;
               cerebellar ataxia; and mononeuritis multiplex.&#xD;
  &#xD;
                 -  That would make the patient unable to fully understand the ICF, or&#xD;
  &#xD;
                 -  Where, in the opinion of the Principal Investigator, protocol-specified SOC is&#xD;
                    insufficient and utilization of a more aggressive therapeutic approach not&#xD;
                    permitted in the protocol, is indicated&#xD;
  &#xD;
            -  Known history of a primary immunodeficiency or an underlying condition such as HIV&#xD;
               infection or splenectomy that predisposes the patient to infection&#xD;
  &#xD;
            -  Currently active, clinically significant infection of any kind&#xD;
  &#xD;
            -  Clinically significant chronic infection (eg, osteomyelitis, bronchiectasis) within 8&#xD;
               weeks prior to signing the ICF (chronic fungal nail infections are allowed)&#xD;
  &#xD;
            -  Any infection requiring hospitalization or treatment with IV anti-infectives not&#xD;
               completed at least 4 weeks prior to signing the ICF&#xD;
  &#xD;
            -  Any infection requiring oral anti-infectives (including antivirals) within 2 weeks&#xD;
               prior to Day 1&#xD;
  &#xD;
            -  Any severe herpes infection at any time prior to Week 0 (Day 1), including, but not&#xD;
               limited to, disseminated herpes (ever), herpes encephalitis (ever), recurrent herpes&#xD;
               zoster (defined as 2 episodes within 2 years), or ophthalmic herpes (ever)&#xD;
  &#xD;
                 -  Active herpes zoster infection within 12 weeks of prior to signing the ICF&#xD;
  &#xD;
                 -  Active herpes simplex virus within 4 weeks of Day 1&#xD;
  &#xD;
            -  Other protocol-defined inclusion/exclusion criteria apply&#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_contact>
      <last_name>Central Recruiting</last_name>
      <phone>(+1) 650-538-2502</phone>
      <email>clinicaltrials@alumis.com</email>
    </overall_contact>
    <location>
      <facility>
        <name>Investigator Site #1046</name>
        <address>
          <city>Anniston</city>
          <state>Alabama</state>
          <zip>36207</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
    </location>
    <location>
      <facility>
        <name>Investigator Site #1050</name>
        <address>
          <city>Los Alamitos</city>
          <state>California</state>
          <zip>90720</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
    </location>
    <location>
      <facility>
        <name>Investigator Site #1061</name>
        <address>
          <city>Upland</city>
          <state>California</state>
          <zip>91786</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
    </location>
    <location>
      <facility>
        <name>Investigator Site #1048</name>
        <address>
          <city>Aventura</city>
          <state>Florida</state>
          <zip>33180</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
    </location>
    <location>
      <facility>
        <name>Investigator Site #1063</name>
        <address>
          <city>Avon Park</city>
          <state>Florida</state>
          <zip>33825</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
    </location>
    <location>
      <facility>
        <name>Investigator Site #1045</name>
        <address>
          <city>Clearwater</city>
          <state>Florida</state>
          <zip>33765</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
    </location>
    <location>
      <facility>
        <name>Investigator Site #1055</name>
        <address>
          <city>Coral Gables</city>
          <state>Florida</state>
          <zip>33134</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
    </location>
    <location>
      <facility>
        <name>Investigator Site #1051</name>
        <address>
          <city>DeBary</city>
          <state>Florida</state>
          <zip>32713</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
    </location>
    <location>
      <facility>
        <name>Investigator Site # 1067</name>
        <address>
          <city>Miami Lakes</city>
          <state>Florida</state>
          <zip>33014</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
    </location>
    <location>
      <facility>
        <name>Investigator Site #1060</name>
        <address>
          <city>Miami</city>
          <state>Florida</state>
          <zip>33136</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
    </location>
    <location>
      <facility>
        <name>Investigator Site #1057</name>
        <address>
          <city>Miami</city>
          <state>Florida</state>
          <zip>33176</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
    </location>
    <location>
      <facility>
        <name>Investigator Site #1052</name>
        <address>
          <city>College Park</city>
          <state>Georgia</state>
          <zip>30329</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
    </location>
    <location>
      <facility>
        <name>Investigator Site #1058</name>
        <address>
          <city>Brooklyn</city>
          <state>New York</state>
          <zip>11201</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
    </location>
    <location>
      <facility>
        <name>Investigator Site #1056</name>
        <address>
          <city>Charlotte</city>
          <state>North Carolina</state>
          <zip>28210</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
    </location>
    <location>
      <facility>
        <name>Investigator Site #1062</name>
        <address>
          <city>Pittsburgh</city>
          <state>Pennsylvania</state>
          <zip>15224</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
    </location>
    <location>
      <facility>
        <name>Investigator Site #1044</name>
        <address>
          <city>Memphis</city>
          <state>Tennessee</state>
          <zip>38119</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
    </location>
    <location>
      <facility>
        <name>Investigator Site #1049</name>
        <address>
          <city>Colleyville</city>
          <state>Texas</state>
          <zip>76034</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
    </location>
    <location>
      <facility>
        <name>Investigator Site #1071</name>
        <address>
          <city>Fort Worth</city>
          <state>Texas</state>
          <zip>76177</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
    </location>
    <location>
      <facility>
        <name>Investigator Site #3012</name>
        <address>
          <city>Caba</city>
          <state>Buenos Aires</state>
          <zip>C1425</zip>
          <country>Argentina</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
    </location>
    <location>
      <facility>
        <name>Investigator Site #3001</name>
        <address>
          <city>Ciudad Autonoma de Buenos Aires</city>
          <state>Buenos Aires</state>
          <zip>C1221ADC</zip>
          <country>Argentina</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
    </location>
    <location>
      <facility>
        <name>Investigator Site #3016</name>
        <address>
          <city>La Plata</city>
          <state>Buenos Aires</state>
          <zip>B1900</zip>
          <country>Argentina</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
    </location>
    <location>
      <facility>
        <name>Investigator Site #3009</name>
        <address>
          <city>San Miguel de Tucuman</city>
          <state>Tucman</state>
          <zip>T4000BRD</zip>
          <country>Argentina</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
    </location>
    <location>
      <facility>
        <name>Investigator Site #3010</name>
        <address>
          <city>San Miguel De Tucumán</city>
          <state>Tucman</state>
          <zip>T4000BRD</zip>
          <country>Argentina</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
    </location>
    <location>
      <facility>
        <name>Investigator Site #3015</name>
        <address>
          <city>San Miguel De Tucumán</city>
          <state>Tucumán</state>
          <zip>T4000</zip>
          <country>Argentina</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
    </location>
    <location>
      <facility>
        <name>Investigator Site #3023</name>
        <address>
          <city>Buenos Aires</city>
          <zip>C1114 AAH</zip>
          <country>Argentina</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
    </location>
    <location>
      <facility>
        <name>Investigator Site #3008</name>
        <address>
          <city>Mendoza</city>
          <zip>M5500CPH</zip>
          <country>Argentina</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
    </location>
    <location>
      <facility>
        <name>Investigator Site #5525</name>
        <address>
          <city>Plovdiv</city>
          <zip>4003</zip>
          <country>Bulgaria</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
    </location>
    <location>
      <facility>
        <name>Investigator Site #5521</name>
        <address>
          <city>Plovdiv</city>
          <country>Bulgaria</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
    </location>
    <location>
      <facility>
        <name>Investigator Site #5529</name>
        <address>
          <city>Ruse</city>
          <zip>7002</zip>
          <country>Bulgaria</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
    </location>
    <location>
      <facility>
        <name>Investigator Site #5522</name>
        <address>
          <city>Sofia</city>
          <zip>1407</zip>
          <country>Bulgaria</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
    </location>
    <location>
      <facility>
        <name>Investigator Site #5547</name>
        <address>
          <city>Sofia</city>
          <zip>1463</zip>
          <country>Bulgaria</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
    </location>
    <location>
      <facility>
        <name>Investigator Site #5541</name>
        <address>
          <city>Sofia</city>
          <zip>1750</zip>
          <country>Bulgaria</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
    </location>
    <location>
      <facility>
        <name>Investigator Site #3006</name>
        <address>
          <city>Providencia</city>
          <zip>7510586</zip>
          <country>Chile</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
    </location>
    <location>
      <facility>
        <name>Investigator Site #3002</name>
        <address>
          <city>Santiago</city>
          <zip>75500587</zip>
          <country>Chile</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
    </location>
    <location>
      <facility>
        <name>Investigator Site #3019</name>
        <address>
          <city>Barranquilla</city>
          <zip>11111</zip>
          <country>Colombia</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
    </location>
    <location>
      <facility>
        <name>Investigator Site #3011</name>
        <address>
          <city>Barranquilla</city>
          <zip>80020</zip>
          <country>Colombia</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
    </location>
    <location>
      <facility>
        <name>Investigator Site #3021</name>
        <address>
          <city>Bogotá</city>
          <zip>110221</zip>
          <country>Colombia</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
    </location>
    <location>
      <facility>
        <name>Investigator Site #3022</name>
        <address>
          <city>Bogotá</city>
          <zip>504</zip>
          <country>Colombia</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
    </location>
    <location>
      <facility>
        <name>Investigator Site #3020</name>
        <address>
          <city>Cali</city>
          <zip>760035</zip>
          <country>Colombia</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
    </location>
    <location>
      <facility>
        <name>Investigator Site #3003</name>
        <address>
          <city>Chia</city>
          <zip>250001</zip>
          <country>Colombia</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
    </location>
    <location>
      <facility>
        <name>Investigator Site #3014</name>
        <address>
          <city>Medellín</city>
          <zip>50034</zip>
          <country>Colombia</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
    </location>
    <location>
      <facility>
        <name>Investigator Site #5542</name>
        <address>
          <city>Rijeka</city>
          <zip>51000</zip>
          <country>Croatia</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
    </location>
    <location>
      <facility>
        <name>Investigator Site #5543</name>
        <address>
          <city>Split</city>
          <zip>21000</zip>
          <country>Croatia</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
    </location>
    <location>
      <facility>
        <name>Investigator Site #4012</name>
        <address>
          <city>Aarhus</city>
          <zip>8200</zip>
          <country>Denmark</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
    </location>
    <location>
      <facility>
        <name>Investigator Site #4011</name>
        <address>
          <city>Køge</city>
          <zip>4600</zip>
          <country>Denmark</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
    </location>
    <location>
      <facility>
        <name>Investigator Site #5516</name>
        <address>
          <city>Tbilisi</city>
          <zip>0168</zip>
          <country>Georgia</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
    </location>
    <location>
      <facility>
        <name>Investigator Site #5523</name>
        <address>
          <city>Tbilisi</city>
          <zip>102</zip>
          <country>Georgia</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
    </location>
    <location>
      <facility>
        <name>Investigator Site #5538</name>
        <address>
          <city>Tbilisi</city>
          <zip>112</zip>
          <country>Georgia</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
    </location>
    <location>
      <facility>
        <name>Investigator Site #5536</name>
        <address>
          <city>Tbilisi</city>
          <zip>114</zip>
          <country>Georgia</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
    </location>
    <location>
      <facility>
        <name>Investigator Site #5534</name>
        <address>
          <city>Tbilisi</city>
          <zip>180</zip>
          <country>Georgia</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
    </location>
    <location>
      <facility>
        <name>Investigator Site #4010</name>
        <address>
          <city>Bad Bramstedt</city>
          <country>Germany</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
    </location>
    <location>
      <facility>
        <name>Investigator Site #4001</name>
        <address>
          <city>Kirchheim Unter Teck</city>
          <zip>73230</zip>
          <country>Germany</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
    </location>
    <location>
      <facility>
        <name>Investigator Site #4004</name>
        <address>
          <city>Koeln</city>
          <zip>50937</zip>
          <country>Germany</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
    </location>
    <location>
      <facility>
        <name>Investigator Site #4003</name>
        <address>
          <city>Leipzig</city>
          <zip>4103</zip>
          <country>Germany</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
    </location>
    <location>
      <facility>
        <name>Investigator Site #4005</name>
        <address>
          <city>Mainz</city>
          <zip>55131</zip>
          <country>Germany</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
    </location>
    <location>
      <facility>
        <name>Investigator Site #4006</name>
        <address>
          <city>Munich</city>
          <zip>80336</zip>
          <country>Germany</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
    </location>
    <location>
      <facility>
        <name>Investigator Site #5548</name>
        <address>
          <city>Debrecen</city>
          <zip>4032</zip>
          <country>Hungary</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
    </location>
    <location>
      <facility>
        <name>Investigator Site #5544</name>
        <address>
          <city>Gyula</city>
          <country>Hungary</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
    </location>
    <location>
      <facility>
        <name>Investigator Site # 6015</name>
        <address>
          <city>New Delhi</city>
          <state>Delhi</state>
          <zip>110 029</zip>
          <country>India</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
    </location>
    <location>
      <facility>
        <name>Investigator Site #6005</name>
        <address>
          <city>Ahmedabad</city>
          <zip>380005</zip>
          <country>India</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
    </location>
    <location>
      <facility>
        <name>Investigator Site #6010</name>
        <address>
          <city>Ahmedabad</city>
          <zip>380006</zip>
          <country>India</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
    </location>
    <location>
      <facility>
        <name>Investigator Site #6006</name>
        <address>
          <city>Ahmedabad</city>
          <zip>380015</zip>
          <country>India</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
    </location>
    <location>
      <facility>
        <name>Investigator Site #6001</name>
        <address>
          <city>Bangalore</city>
          <zip>560034</zip>
          <country>India</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
    </location>
    <location>
      <facility>
        <name>Investigator Site #6009</name>
        <address>
          <city>Bengaluru</city>
          <zip>560010</zip>
          <country>India</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
    </location>
    <location>
      <facility>
        <name>Investigator Site #6012</name>
        <address>
          <city>Chandigarh</city>
          <zip>160012</zip>
          <country>India</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
    </location>
    <location>
      <facility>
        <name>Investigator Site #6004</name>
        <address>
          <city>Haryana</city>
          <zip>122001</zip>
          <country>India</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
    </location>
    <location>
      <facility>
        <name>Investigator Site #6013</name>
        <address>
          <city>Jaipur</city>
          <zip>302004</zip>
          <country>India</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
    </location>
    <location>
      <facility>
        <name>Investigator Site #6011</name>
        <address>
          <city>Lucknow</city>
          <zip>226014</zip>
          <country>India</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
    </location>
    <location>
      <facility>
        <name>Investigator Site #6008</name>
        <address>
          <city>Nagpur</city>
          <zip>440012</zip>
          <country>India</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
    </location>
    <location>
      <facility>
        <name>Investigator Site #6014</name>
        <address>
          <city>Pune</city>
          <zip>411007</zip>
          <country>India</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
    </location>
    <location>
      <facility>
        <name>Investigator Site #6007</name>
        <address>
          <city>Pune</city>
          <zip>411057</zip>
          <country>India</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
    </location>
    <location>
      <facility>
        <name>Investigator Site #6002</name>
        <address>
          <city>Surat</city>
          <zip>395001</zip>
          <country>India</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
    </location>
    <location>
      <facility>
        <name>Investigator Site #6003</name>
        <address>
          <city>Surat</city>
          <zip>395002</zip>
          <country>India</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
    </location>
    <location>
      <facility>
        <name>Investigator Site #8002</name>
        <address>
          <city>Namdong</city>
          <state>Incheon</state>
          <zip>21565</zip>
          <country>Korea, Republic of</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
    </location>
    <location>
      <facility>
        <name>Investigator Site #8007</name>
        <address>
          <city>Anyang-si</city>
          <zip>14068</zip>
          <country>Korea, Republic of</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
    </location>
    <location>
      <facility>
        <name>Investigator Site #8004</name>
        <address>
          <city>Busan</city>
          <zip>49241</zip>
          <country>Korea, Republic of</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
    </location>
    <location>
      <facility>
        <name>Investigator Site #8016</name>
        <address>
          <city>Seoul</city>
          <zip>3080</zip>
          <country>Korea, Republic of</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
    </location>
    <location>
      <facility>
        <name>Investigator Site #8019</name>
        <address>
          <city>Seoul</city>
          <zip>5030</zip>
          <country>Korea, Republic of</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
    </location>
    <location>
      <facility>
        <name>Investigator Site #8012</name>
        <address>
          <city>Seoul</city>
          <zip>6273</zip>
          <country>Korea, Republic of</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
    </location>
    <location>
      <facility>
        <name>Investigator Site #2501</name>
        <address>
          <city>Chihuahua</city>
          <zip>31000</zip>
          <country>Mexico</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
    </location>
    <location>
      <facility>
        <name>Investigator Site #2509</name>
        <address>
          <city>Ciudad de Mexico</city>
          <zip>14080</zip>
          <country>Mexico</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
    </location>
    <location>
      <facility>
        <name>Investigator Site #2503</name>
        <address>
          <city>Ciudad de Mexico</city>
          <zip>3720</zip>
          <country>Mexico</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
    </location>
    <location>
      <facility>
        <name>Investigator Site #2506</name>
        <address>
          <city>Ciudad De Mexico</city>
          <zip>6700</zip>
          <country>Mexico</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
    </location>
    <location>
      <facility>
        <name>Investigator Site #2504</name>
        <address>
          <city>Cuauhtémoc</city>
          <zip>6720</zip>
          <country>Mexico</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
    </location>
    <location>
      <facility>
        <name>Investigator Site #2502</name>
        <address>
          <city>Guadalajara</city>
          <zip>44160</zip>
          <country>Mexico</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
    </location>
    <location>
      <facility>
        <name>Investigator Site #2512</name>
        <address>
          <city>Guadalajara</city>
          <zip>44620</zip>
          <country>Mexico</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
    </location>
    <location>
      <facility>
        <name>Investigator Site #2507</name>
        <address>
          <city>Guadalajara</city>
          <zip>44650</zip>
          <country>Mexico</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
    </location>
    <location>
      <facility>
        <name>Investigator Site #2508</name>
        <address>
          <city>Madero</city>
          <zip>7760</zip>
          <country>Mexico</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
    </location>
    <location>
      <facility>
        <name>Investigator Site #2516</name>
        <address>
          <city>Merida</city>
          <zip>97070</zip>
          <country>Mexico</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
    </location>
    <location>
      <facility>
        <name>Investigator Site #2514</name>
        <address>
          <city>Mexico City</city>
          <zip>3100</zip>
          <country>Mexico</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
    </location>
    <location>
      <facility>
        <name>Investigator Site #2511</name>
        <address>
          <city>Mérida</city>
          <zip>97070</zip>
          <country>Mexico</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
    </location>
    <location>
      <facility>
        <name>Investigator Site # 2517</name>
        <address>
          <city>Naucalpan De Juárez</city>
          <zip>54769</zip>
          <country>Mexico</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
    </location>
    <location>
      <facility>
        <name>Investigator Site #2510</name>
        <address>
          <city>Oaxaca</city>
          <zip>68000</zip>
          <country>Mexico</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
    </location>
    <location>
      <facility>
        <name>Investigator Site #2505</name>
        <address>
          <city>San Luis Potosí</city>
          <zip>78213</zip>
          <country>Mexico</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
    </location>
    <location>
      <facility>
        <name>Investigator Site #2513</name>
        <address>
          <city>Torreon</city>
          <zip>27000</zip>
          <country>Mexico</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
    </location>
    <location>
      <facility>
        <name>Investigator Site #3013</name>
        <address>
          <city>Lima</city>
          <zip>15047</zip>
          <country>Peru</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
    </location>
    <location>
      <facility>
        <name>Investigator Site #3004</name>
        <address>
          <city>Lima</city>
          <zip>15801</zip>
          <country>Peru</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
    </location>
    <location>
      <facility>
        <name>Investigator Site #3018</name>
        <address>
          <city>San Martin De Porres</city>
          <zip>15102</zip>
          <country>Peru</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
    </location>
    <location>
      <facility>
        <name>Investigator Site #3005</name>
        <address>
          <city>Santiago De Surco</city>
          <zip>15023</zip>
          <country>Peru</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
    </location>
    <location>
      <facility>
        <name>Investigator Site #3017</name>
        <address>
          <city>Trujillo</city>
          <zip>13001</zip>
          <country>Peru</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
    </location>
    <location>
      <facility>
        <name>Investigator Site #8003</name>
        <address>
          <city>Angeles City</city>
          <country>Philippines</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
    </location>
    <location>
      <facility>
        <name>Investigator Site #8009</name>
        <address>
          <city>Iloilo City</city>
          <country>Philippines</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
    </location>
    <location>
      <facility>
        <name>Investigator Site #8011</name>
        <address>
          <city>Lipa City</city>
          <country>Philippines</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
    </location>
    <location>
      <facility>
        <name>Investigator Site #8001</name>
        <address>
          <city>Manila</city>
          <country>Philippines</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
    </location>
    <location>
      <facility>
        <name>Investigator Site #8010</name>
        <address>
          <city>Manila</city>
          <country>Philippines</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
    </location>
    <location>
      <facility>
        <name>Investigator Site #8018</name>
        <address>
          <city>Manila</city>
          <country>Philippines</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
    </location>
    <location>
      <facility>
        <name>Investigator Site #8006</name>
        <address>
          <city>Quezon City</city>
          <country>Philippines</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
    </location>
    <location>
      <facility>
        <name>Investigator Site #5519</name>
        <address>
          <city>Bialystok</city>
          <zip>15-077</zip>
          <country>Poland</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
    </location>
    <location>
      <facility>
        <name>Investigator Site #5546</name>
        <address>
          <city>Białystok</city>
          <zip>15-297</zip>
          <country>Poland</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
    </location>
    <location>
      <facility>
        <name>Investigator Site #5518</name>
        <address>
          <city>Białystok</city>
          <zip>15-707</zip>
          <country>Poland</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
    </location>
    <location>
      <facility>
        <name>Investigator Site #5531</name>
        <address>
          <city>Bydgoszcz</city>
          <zip>85-168</zip>
          <country>Poland</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
    </location>
    <location>
      <facility>
        <name>Investigator Site #5520</name>
        <address>
          <city>Bytom</city>
          <zip>41-902</zip>
          <country>Poland</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
    </location>
    <location>
      <facility>
        <name>Investigator Site #5539</name>
        <address>
          <city>Częstochowa</city>
          <zip>42-200</zip>
          <country>Poland</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
    </location>
    <location>
      <facility>
        <name>Investigator Site #5533</name>
        <address>
          <city>Kraków</city>
          <zip>30-363</zip>
          <country>Poland</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
    </location>
    <location>
      <facility>
        <name>Investigator Site #5537</name>
        <address>
          <city>Nadarzyn</city>
          <zip>05-830</zip>
          <country>Poland</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
    </location>
    <location>
      <facility>
        <name>Investigator Site #5545</name>
        <address>
          <city>Poznan</city>
          <zip>61-397</zip>
          <country>Poland</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
    </location>
    <location>
      <facility>
        <name>Investigator Site #5535</name>
        <address>
          <city>Sosnowiec</city>
          <zip>41-200</zip>
          <country>Poland</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
    </location>
    <location>
      <facility>
        <name>Investigator Site #5532</name>
        <address>
          <city>Szczecin</city>
          <zip>71-252</zip>
          <country>Poland</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
    </location>
    <location>
      <facility>
        <name>Investigator Site #5527</name>
        <address>
          <city>Warsaw</city>
          <zip>00-215</zip>
          <country>Poland</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
    </location>
    <location>
      <facility>
        <name>Investigator Site #5540</name>
        <address>
          <city>Warszawa</city>
          <zip>02-637</zip>
          <country>Poland</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
    </location>
    <location>
      <facility>
        <name>Investigator Site #5528</name>
        <address>
          <city>Wrocław</city>
          <zip>50-088</zip>
          <country>Poland</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
    </location>
    <location>
      <facility>
        <name>Investigator Site #5530</name>
        <address>
          <city>Bucuresti</city>
          <zip>11025</zip>
          <country>Romania</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
    </location>
    <location>
      <facility>
        <name>Investigator Site #5549</name>
        <address>
          <city>Bucuresti</city>
          <zip>11057</zip>
          <country>Romania</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
    </location>
    <location>
      <facility>
        <name>Investigator Site #5526</name>
        <address>
          <city>Bucuresti</city>
          <zip>11172</zip>
          <country>Romania</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
    </location>
    <location>
      <facility>
        <name>Investigator Site #5524</name>
        <address>
          <city>Târgu-Mureş</city>
          <zip>540096</zip>
          <country>Romania</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
    </location>
    <location>
      <facility>
        <name>Investigator Site #4013</name>
        <address>
          <city>A Coruña</city>
          <zip>15006</zip>
          <country>Spain</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
    </location>
    <location>
      <facility>
        <name>Investigator Site #4008</name>
        <address>
          <city>Alicante</city>
          <zip>3699</zip>
          <country>Spain</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
    </location>
    <location>
      <facility>
        <name>Investigator Site #4007</name>
        <address>
          <city>Barcelona</city>
          <zip>8035</zip>
          <country>Spain</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
    </location>
    <location>
      <facility>
        <name>Investigator Site #4002</name>
        <address>
          <city>Sevilla</city>
          <zip>41014</zip>
          <country>Spain</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
    </location>
    <location>
      <facility>
        <name>Investigator Site #4009</name>
        <address>
          <city>Valencia</city>
          <zip>46010</zip>
          <country>Spain</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
    </location>
    <location>
      <facility>
        <name>Investigator Site #8013</name>
        <address>
          <city>Chiayi City</city>
          <zip>622</zip>
          <country>Taiwan</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
    </location>
    <location>
      <facility>
        <name>Investigator Site #8014</name>
        <address>
          <city>Kaohsiung City</city>
          <zip>11490</zip>
          <country>Taiwan</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
    </location>
    <location>
      <facility>
        <name>Investigator Site #8008</name>
        <address>
          <city>Taichung</city>
          <zip>40201</zip>
          <country>Taiwan</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
    </location>
    <location>
      <facility>
        <name>Investigator Site #8015</name>
        <address>
          <city>Taichung</city>
          <zip>40447</zip>
          <country>Taiwan</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
    </location>
    <location>
      <facility>
        <name>Investigator Site #8017</name>
        <address>
          <city>Taipei</city>
          <zip>100</zip>
          <country>Taiwan</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
    </location>
    <location>
      <facility>
        <name>Investigator Site #4017</name>
        <address>
          <city>Leeds</city>
          <zip>LS1 3EX</zip>
          <country>United Kingdom</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
    </location>
    <location>
      <facility>
        <name>Investigator Site #4015</name>
        <address>
          <city>London</city>
          <zip>NW1 2BU</zip>
          <country>United Kingdom</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
    </location>
    <location>
      <facility>
        <name>Investigator Site #4016</name>
        <address>
          <city>London</city>
          <zip>SE1 7RT</zip>
          <country>United Kingdom</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
    </location>
    <location>
      <facility>
        <name>Investigator Site #4014</name>
        <address>
          <city>Southampton</city>
          <zip>SO16 6YD</zip>
          <country>United Kingdom</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
    </location>
    <location_countries>
      <country>Argentina</country>
      <country>Bulgaria</country>
      <country>Chile</country>
      <country>Colombia</country>
      <country>Croatia</country>
      <country>Denmark</country>
      <country>Georgia</country>
      <country>Germany</country>
      <country>Hungary</country>
      <country>India</country>
      <country>Korea, Republic of</country>
      <country>Mexico</country>
      <country>Peru</country>
      <country>Philippines</country>
      <country>Poland</country>
      <country>Romania</country>
      <country>Spain</country>
      <country>Taiwan</country>
      <country>United Kingdom</country>
      <country>United States</country>
    </location_countries>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>June 29, 2023</study_first_submitted>
    <study_first_submitted_qc>July 21, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">July 28, 2023</study_first_posted>
    <last_update_submitted>July 21, 2023</last_update_submitted>
    <last_update_submitted_qc>July 21, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">July 28, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Autoimmune Diseases</keyword>
    <keyword>Immune System Diseases</keyword>
    <keyword>Connective Tissue Diseases</keyword>
    <keyword>Immune-mediated Diseases</keyword>
    <keyword>Active Systemic Lupus Erythematosus</keyword>
    <keyword>SLE</keyword>
    <keyword>Lupus</keyword>
    <keyword>LUMUS</keyword>
    <keyword>Lupus Erythematosus, Systemic</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>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT05966480
  org study id: ESK-001-010
  nct id: NCT05966480
  lead sponsor: 
  has dmc: Yes
  is fda regulated drug: Yes
  is fda regulated device: No
  The purpose of this study is to assess the clinical efficacy, safety, PK, and PD of multiple
        dose levels of ESK-001 compared with placebo in adult patients with SLE.
  This study will consist of a 5 week screening period, 48 week treatment period, and a 4 week
        follow up period for a total of 57 weeks. Each participant will be randomized to receive
        ESK-001 or placebo for 48 weeks. An open label extension study will be available for those
        patients who complete the study.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: Triple (Participant, Investigator, Outcomes Assessor)
  measure: To compare the effect on disease activity measured by the proportion of patients achieving British Isles Lupus Assessment Group (BILAG)-based Composite Lupus Assessment (BICLA) response at Week 48 between doses of ESK-001 and placebo
  time frame: Week 48
  measure: To assess the safety and tolerability of multiple dose levels of ESK-001
  time frame: Week 48
  description: Safety and Tolerability will be assessed with clinical and laboratory assessments including blood tests for liver and kidney function, ECGs, hematological measures and physical examinations throughout the time of the study and safety follow up. The number and proportion of TEAEs, SAEs, AEs of greater than grade 3 severity and AEs of Clinical Interest will be recorded.
  measure: To compare the effect on disease activity measured by the proportion of patients achieving an SLE Responder Index of ≥4 (SRI[4]) response at Week 48
  time frame: Week 48
  measure: To compare corticosteroid use in patients at Week 48
  time frame: Week 48
  description: To compare the number and percentage of patients using corticosteroids and continuous summaries of dose used will be assessed as well as the frequency and percentage of patients able to taper corticosteroids and maintain low doses following taper.
  measure: To compare the effect on cutaneous disease activity measured by the proportion of patients with a CLASI activity score of ≥8 at baseline achieving ≥ 50% reduction in the CLASI activity score at Week 48 between doses of ESK-001 and placebo
  time frame: Week 48
  measure: To compare the effect on disease activity measured by the proportion of patients achieving BICLA responses at Week 48 between doses of ESK-001 and placebo by stratification groups
  time frame: Week 48
  measure: To compare the Lupus Low Disease Activity State (LLDAS) response between doses of ESK-001 and placebo at Week 48
  time frame: Week 48
  measure: To compare the annualized flare rate through Week 48
  time frame: Week 48
  measure: To use the SF-36 (Short Form-36 item QoL measure) to compare the effect on health-related quality of life (HRQOL) between doses of ESK-001 and placebo
  time frame: Week 48
  description: Efficacy: Comparing the effects of Esk-001 doses vs Placebo on Patient Reported Outcome (PRO) as it relates to Health-Related Quality of Life (HRQoL) as measured by self-reporting using the SF-36 (Short Form-36 item QoL measure) Questionnaire which uses a scale of 0 to 100. The higher numbers mean better health.
  measure: To use the SLE-specific Lupus Quality of Life (LQoL) questionnaire to compare the effect on health-related quality of life (HRQOL) between doses of ESK-001 and placebo
  time frame: Week 48
  description: Efficacy: Comparing the effects of Esk-001 doses vs Placebo on Patient Reported Outcome (PRO) as it relates to Health-Related Quality of Life (HRQoL) as measured by self-reporting using the SLE-specific Lupus Quality of Life (LQoL) questionnaire which uses a scale of 0 to 100. The higher numbers mean better health.
  measure: To compare disease-specific QoL between doses of ESK-001 and placebo
  time frame: Week 48
  description: Efficacy: To compare disease-specific QoL between doses of ESK-001 and placebo using the SLE Disease Activity Index 2000 (SLEDAI2K) measured on a scale of 0 to 105 where the higher numbers mean more disease activity.
  measure: To compare disease-specific QoL between doses of ESK-001 and placebo
  time frame: Week 48
  description: Efficacy: To compare disease-specific QoL between doses of ESK-001 and placebo using the British Isle Lupus Assessment Group 2004 (BILAG-2004) with a scale of A to E (A meaning very active disease and E no current or previous disease).
  measure: To compare disease-specific QoL between doses of ESK-001 and placebo
  time frame: Week 48
  description: Efficacy: To compare disease-specific QoL between doses of ESK-001 and placebo using the Physician's Global Assessment (PGA) evaluating disease response using the 4-point VAS (Visual Analog Scale) of 0 to 3 (0 means no flares and 3 means severe flare in disease).
  measure: To compare Fatigue measured by FACIT-F between doses of ESK-001 and placebo
  time frame: Week 48
  description: To compare patient-reported fatigue as measured by Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) questionnaire between doses of ESK-001 and placebo, where the score range is 0 to 52 and a lower score indicates greater fatigue/worse outcome.
  measure: To compare patient global assessment of disease activity (PtGA) between doses of ESK-001 and placebo
  time frame: Week 48
  description: Efficacy: To compare disease-specific QoL between doses of ESK-001 and placebo using the PtGA (Patient Global Assessment) instrument. Patients record on a visual analog scale (VAS) how well or badly they feel as a result of the disease in their own estimation over the course of the study.
  arm group label: ESK-001 Dose Level 1
  arm group type: Experimental
  description: ESK-001 administered as an oral tablet
  arm group label: ESK-001 Dose Level 2
  arm group type: Experimental
  description: ESK-001 administered as an oral tablet
  arm group label: ESK-001 Dose Level 3
  arm group type: Experimental
  description: ESK-001 administered as an oral tablet
  arm group label: Placebo
  arm group type: Placebo Comparator
  description: Placebo administered as an oral tablet
  intervention type: Drug
  intervention name: ESK-001
  description: Oral tablet
  arm group label: ESK-001 Dose Level 1
  arm group label: ESK-001 Dose Level 2
  arm group label: ESK-001 Dose Level 3
  intervention type: Drug
  intervention name: Placebo
  description: Oral tablet
  arm group label: Placebo
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 70 Years
  healthy volunteers: No
  last name: Central Recruiting
  phone: (+1) 650-538-2502
  email: clinicaltrials@alumis.com
  facility: 
  status: Recruiting
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  status: Recruiting
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  status: Not yet recruiting
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  status: Not yet recruiting
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  status: Not yet recruiting
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  status: Not yet recruiting
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  status: Not yet recruiting
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  status: Not yet recruiting
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  status: Not yet recruiting
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  status: Not yet recruiting
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  status: Not yet recruiting
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  status: Not yet recruiting
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  status: Not yet recruiting
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  status: Not yet recruiting
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  status: Not yet recruiting
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  status: Not yet recruiting
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  status: Not yet recruiting
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  status: Not yet recruiting
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  status: Not yet recruiting
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  status: Not yet recruiting
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  status: Not yet recruiting
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  country: Argentina
  country: Bulgaria
  country: Chile
  country: Colombia
  country: Croatia
  country: Denmark
  country: Georgia
  country: Germany
  country: Hungary
  country: India
  country: Korea, Republic of
  country: Mexico
  country: Peru
  country: Philippines
  country: Poland
  country: Romania
  country: Spain
  country: Taiwan
  country: United Kingdom
  country: United States
  responsible party type: Sponsor
  mesh term: Lupus Erythematosus, Systemic
  sharing ipd: No