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/NCT06013995</url>
    </required_header>
    <id_info>
      <org_study_id>IM034-1000</org_study_id>
      <secondary_id>2022-503009-39</secondary_id>
      <nct_id>NCT06013995</nct_id>
    </id_info>
    <brief_title>A Study to Investigate the Safety, Tolerability, Drug Levels and Drug Effects of BMS-986326 in Adult Participants With Different Forms of Lupus</brief_title>
    <official_title>A Phase 1b, Randomized, Double-Blind, Placebo-Controlled, Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of BMS-986326 in Adult Participants With Discoid Lupus Erythematosus, Subacute Cutaneous Lupus Erythematosus, or Systemic Lupus Erythematosus</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Bristol-Myers Squibb</agency>
        <agency_class>Industry</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Bristol-Myers Squibb</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 purpose of this study is to evaluate safety, drug levels and drug effects on cells and&#xD;
        organs of the body, after receiving multiple increasing doses of BMS-986326 via intravenous&#xD;
        (IV) infusion or subcutaneous (SC) injection, in participants with different forms of lupus.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 15, 2023</start_date>
    <completion_date type="Anticipated">August 18, 2025</completion_date>
    <primary_completion_date type="Anticipated">August 18, 2025</primary_completion_date>
    <phase>Phase 1</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Randomized</allocation>
      <intervention_model>Parallel Assignment</intervention_model>
      <primary_purpose>Treatment</primary_purpose>
      <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Number of participants with adverse events (AEs)</measure>
      <time_frame>Up to 228 days</time_frame>
    </primary_outcome>
    <primary_outcome>
      <measure>Number of participants with serious adverse events (SAEs)</measure>
      <time_frame>Up to 228 days</time_frame>
    </primary_outcome>
    <primary_outcome>
      <measure>Number of participants with clinical laboratory abnormalities</measure>
      <time_frame>Up to 228 days</time_frame>
    </primary_outcome>
    <primary_outcome>
      <measure>Number of participants with vital sign abnormalities</measure>
      <time_frame>Up to 228 days</time_frame>
    </primary_outcome>
    <primary_outcome>
      <measure>Number of participants with electrocardiogram (ECG) abnormalities</measure>
      <time_frame>Up to 228 days</time_frame>
    </primary_outcome>
    <primary_outcome>
      <measure>Number of participants with physical examination abnormalities</measure>
      <time_frame>Up to 228 days</time_frame>
    </primary_outcome>
    <secondary_outcome>
      <measure>Maximum observed serum concentration (Cmax)</measure>
      <time_frame>Predose and post-dose up to Day 167</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Time of Cmax (Tmax)</measure>
      <time_frame>Predose and post-dose up to Day 167</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Area under the serum concentration-time curve from time zero to time of last quantifiable concentration (AUC [0-T])</measure>
      <time_frame>Predose and post-dose up to Day 167</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change from baseline in regulatory T cells (Treg) count to Day 144</measure>
      <time_frame>Baseline up to Day 144</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change from baseline in Treg-to-conventional t cells (Tconv) ratio</measure>
      <time_frame>Baseline up to Day 144</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Number of participants with anti-drug antibodies</measure>
      <time_frame>Baseline up to Day 167</time_frame>
    </secondary_outcome>
    <number_of_arms>8</number_of_arms>
    <enrollment type="Anticipated">60</enrollment>
    <condition>Lupus</condition>
    <arm_group>
      <arm_group_label>Cohort A: BMS-986326 Dose 1 IV</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
    </arm_group>
    <arm_group>
      <arm_group_label>Cohort B: BMS-986326 Dose 2 IV</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
    </arm_group>
    <arm_group>
      <arm_group_label>Cohort C1: BMS-986326 Dose 3 IV</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
    </arm_group>
    <arm_group>
      <arm_group_label>Cohort C2: BMS-986326 Dose 3 SC</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
    </arm_group>
    <arm_group>
      <arm_group_label>Cohort D1: BMS-986326 Dose 4 IV</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
    </arm_group>
    <arm_group>
      <arm_group_label>Cohort D2: BMS-986326 Dose 4 SC</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
    </arm_group>
    <arm_group>
      <arm_group_label>Cohort E1: BMS-986326 Dose 3 IV</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
    </arm_group>
    <arm_group>
      <arm_group_label>Cohort E2: BMS-986326 Dose 3 SC</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>BMS-986326</intervention_name>
      <description>Specified dose on specified days</description>
      <arm_group_label>Cohort A: BMS-986326 Dose 1 IV</arm_group_label>
      <arm_group_label>Cohort B: BMS-986326 Dose 2 IV</arm_group_label>
      <arm_group_label>Cohort C1: BMS-986326 Dose 3 IV</arm_group_label>
      <arm_group_label>Cohort C2: BMS-986326 Dose 3 SC</arm_group_label>
      <arm_group_label>Cohort D1: BMS-986326 Dose 4 IV</arm_group_label>
      <arm_group_label>Cohort D2: BMS-986326 Dose 4 SC</arm_group_label>
      <arm_group_label>Cohort E1: BMS-986326 Dose 3 IV</arm_group_label>
      <arm_group_label>Cohort E2: BMS-986326 Dose 3 SC</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Placebo for BMS-986326</intervention_name>
      <description>Specified dose on specified days</description>
      <arm_group_label>Cohort A: BMS-986326 Dose 1 IV</arm_group_label>
      <arm_group_label>Cohort B: BMS-986326 Dose 2 IV</arm_group_label>
      <arm_group_label>Cohort C1: BMS-986326 Dose 3 IV</arm_group_label>
      <arm_group_label>Cohort C2: BMS-986326 Dose 3 SC</arm_group_label>
      <arm_group_label>Cohort D1: BMS-986326 Dose 4 IV</arm_group_label>
      <arm_group_label>Cohort D2: BMS-986326 Dose 4 SC</arm_group_label>
      <arm_group_label>Cohort E1: BMS-986326 Dose 3 IV</arm_group_label>
      <arm_group_label>Cohort E2: BMS-986326 Dose 3 SC</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Having a diagnosis of Discoid Lupus Erythematosus (DLE), Subacute Cutaneous Lupus&#xD;
               Erythematosus (SCLE), or Systemic Lupus Erythematosus (SLE).&#xD;
  &#xD;
            -  Participants with DLE or SCLE must have their diagnosis at least 3 months prior to&#xD;
               screening and must be confirmed by biopsy (except if only the facial/head/neck region&#xD;
               is affected) and must have some ongoing disease activity (based CLASI-A scoring).&#xD;
  &#xD;
            -  Participants with SLE must have a diagnosis of SLE at screening based on the 2019&#xD;
               EULAR/ACR Classification for SLE and have mild-moderate disease severity (based on a&#xD;
               SLEDAI-2K score).&#xD;
  &#xD;
          Exclusion criteria:&#xD;
  &#xD;
            -  SLE that is considered by the Investigator to be severe.&#xD;
  &#xD;
            -  Drug-induced CLE and drug-induced SLE.&#xD;
  &#xD;
            -  Women who are pregnant or breastfeeding.&#xD;
  &#xD;
            -  Current use of &gt;10 mg prednisone (or equivalent) per day.&#xD;
  &#xD;
          Note: Other protocol-defined inclusion/exclusion criteria apply.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>75 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Bristol-Myers Squibb</last_name>
      <role>Study Director</role>
      <affiliation>Bristol-Myers Squibb</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>BMS Study Connect Contact Center www.BMSStudyConnect.com</last_name>
      <phone>855-907-3286</phone>
      <email>Clinical.Trials@bms.com</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>First line of the email MUST contain the NCT# and Site #.</last_name>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Clinical Research of West Florida</name>
        <address>
          <city>Tampa</city>
          <state>Florida</state>
          <zip>33606</zip>
          <country>United States</country>
        </address>
      </facility>
      <contact>
        <last_name>Shanmugapriya Reddy, MD, Site 0029</last_name>
        <phone>813-870-1292</phone>
      </contact>
    </location>
    <location>
      <facility>
        <name>North Georgia Rheumatology</name>
        <address>
          <city>Lawrenceville</city>
          <state>Georgia</state>
          <zip>30046</zip>
          <country>United States</country>
        </address>
      </facility>
      <contact>
        <last_name>Theresa Lawrence Ford, Site 0011</last_name>
        <phone>111-111-1111</phone>
      </contact>
    </location>
    <location>
      <facility>
        <name>IMA Clinical Research Las Vegas</name>
        <address>
          <city>Las Vegas</city>
          <state>Nevada</state>
          <zip>89102</zip>
          <country>United States</country>
        </address>
      </facility>
      <contact>
        <last_name>Rosaly Diaz-Torruellas, Site 0062</last_name>
        <phone>702-527-7401</phone>
      </contact>
    </location>
    <location>
      <facility>
        <name>Allen Arthritis</name>
        <address>
          <city>Allen</city>
          <state>Texas</state>
          <zip>75013</zip>
          <country>United States</country>
        </address>
      </facility>
      <contact>
        <last_name>John Lavery, Site 0003</last_name>
        <phone>972-467-7921</phone>
      </contact>
    </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>
      <contact>
        <last_name>Stanley Cohen, Site 0054</last_name>
        <phone>214-879-6737</phone>
      </contact>
    </location>
    <location>
      <facility>
        <name>Local Institution - 0071</name>
        <address>
          <city>Dessau</city>
          <zip>06847</zip>
          <country>Germany</country>
        </address>
      </facility>
      <contact>
        <last_name>Site 0071</last_name>
      </contact>
    </location>
    <location>
      <facility>
        <name>Local Institution - 0073</name>
        <address>
          <city>Cuauhtémoc, Ciudad De México</city>
          <state>Distrito Federal</state>
          <zip>06100</zip>
          <country>Mexico</country>
        </address>
      </facility>
      <contact>
        <last_name>Site 0073</last_name>
      </contact>
    </location>
    <location>
      <facility>
        <name>Local Institution - 0068</name>
        <address>
          <city>Mexico City</city>
          <state>Distrito Federal</state>
          <zip>07760</zip>
          <country>Mexico</country>
        </address>
      </facility>
      <contact>
        <last_name>Site 0068</last_name>
      </contact>
    </location>
    <location>
      <facility>
        <name>Local Institution - 0069</name>
        <address>
          <city>Warszawa</city>
          <state>Mazowieckie</state>
          <zip>02-953</zip>
          <country>Poland</country>
        </address>
      </facility>
      <contact>
        <last_name>Site 0069</last_name>
      </contact>
    </location>
    <location>
      <facility>
        <name>Local Institution - 0065</name>
        <address>
          <city>Bucharest</city>
          <state>București</state>
          <zip>11658</zip>
          <country>Romania</country>
        </address>
      </facility>
      <contact>
        <last_name>Site 0065</last_name>
      </contact>
    </location>
    <location>
      <facility>
        <name>Local Institution - 0064</name>
        <address>
          <city>Cluj-Napoca</city>
          <state>Cluj</state>
          <zip>400006</zip>
          <country>Romania</country>
        </address>
      </facility>
      <contact>
        <last_name>Site 0064</last_name>
      </contact>
    </location>
    <location_countries>
      <country>Germany</country>
      <country>Mexico</country>
      <country>Poland</country>
      <country>Romania</country>
      <country>United States</country>
    </location_countries>
    <link>
      <url>https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html</url>
      <description>BMS Clinical Trial Information</description>
    </link>
    <link>
      <url>https://www.fda.gov/Safety/MedWatch/SafetyInformation/default.htm</url>
      <description>FDA Safety Alerts and Recalls</description>
    </link>
    <link>
      <url>https://www.bmsstudyconnect.com/s/US/English/USenHome</url>
      <description>BMS Clinical Trial Patient Recruiting</description>
    </link>
    <link>
      <url>https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html</url>
      <description>Investigator Inquiry Form</description>
    </link>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 23, 2023</study_first_submitted>
    <study_first_submitted_qc>August 23, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 28, 2023</study_first_posted>
    <last_update_submitted>August 23, 2023</last_update_submitted>
    <last_update_submitted_qc>August 23, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 28, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Pharmacokinetics</keyword>
    <keyword>BMS-986326</keyword>
    <keyword>Cutaneous Lupus</keyword>
    <keyword>discoid lupus erythematosus (DLE)</keyword>
    <keyword>subacute cutaneous lupus erythematosus (SCLE)</keyword>
    <keyword>Systemic lupus erythematosus (SLE)</keyword>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
      <ipd_description>BMS will provide access to individual anonymized participant data upon request from qualified researchers, and subject to certain criteria. Additional information regarding Bristol Myers Squibb's data sharing policy and process can be found at: https://www.bms.com/researchers-and-partners/clinical-trials-and-research/disclosure-commitment.html</ipd_description>
    </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/NCT06013995
  org study id: IM034-1000
  secondary id: 2022-503009-39
  nct id: NCT06013995
  lead sponsor: 
  has dmc: No
  is fda regulated drug: Yes
  is fda regulated device: No
  The purpose of this study is to evaluate safety, drug levels and drug effects on cells and
        organs of the body, after receiving multiple increasing doses of BMS-986326 via intravenous
        (IV) infusion or subcutaneous (SC) injection, in participants with different forms of lupus.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  measure: Number of participants with adverse events (AEs)
  time frame: Up to 228 days
  measure: Number of participants with serious adverse events (SAEs)
  time frame: Up to 228 days
  measure: Number of participants with clinical laboratory abnormalities
  time frame: Up to 228 days
  measure: Number of participants with vital sign abnormalities
  time frame: Up to 228 days
  measure: Number of participants with electrocardiogram (ECG) abnormalities
  time frame: Up to 228 days
  measure: Number of participants with physical examination abnormalities
  time frame: Up to 228 days
  measure: Maximum observed serum concentration (Cmax)
  time frame: Predose and post-dose up to Day 167
  measure: Time of Cmax (Tmax)
  time frame: Predose and post-dose up to Day 167
  measure: Area under the serum concentration-time curve from time zero to time of last quantifiable concentration (AUC [0-T])
  time frame: Predose and post-dose up to Day 167
  measure: Change from baseline in regulatory T cells (Treg) count to Day 144
  time frame: Baseline up to Day 144
  measure: Change from baseline in Treg-to-conventional t cells (Tconv) ratio
  time frame: Baseline up to Day 144
  measure: Number of participants with anti-drug antibodies
  time frame: Baseline up to Day 167
  arm group label: Cohort A: BMS-986326 Dose 1 IV
  arm group type: Experimental
  arm group label: Cohort B: BMS-986326 Dose 2 IV
  arm group type: Experimental
  arm group label: Cohort C1: BMS-986326 Dose 3 IV
  arm group type: Experimental
  arm group label: Cohort C2: BMS-986326 Dose 3 SC
  arm group type: Experimental
  arm group label: Cohort D1: BMS-986326 Dose 4 IV
  arm group type: Experimental
  arm group label: Cohort D2: BMS-986326 Dose 4 SC
  arm group type: Experimental
  arm group label: Cohort E1: BMS-986326 Dose 3 IV
  arm group type: Experimental
  arm group label: Cohort E2: BMS-986326 Dose 3 SC
  arm group type: Experimental
  intervention type: Drug
  intervention name: BMS-986326
  description: Specified dose on specified days
  arm group label: Cohort A: BMS-986326 Dose 1 IV
  arm group label: Cohort B: BMS-986326 Dose 2 IV
  arm group label: Cohort C1: BMS-986326 Dose 3 IV
  arm group label: Cohort C2: BMS-986326 Dose 3 SC
  arm group label: Cohort D1: BMS-986326 Dose 4 IV
  arm group label: Cohort D2: BMS-986326 Dose 4 SC
  arm group label: Cohort E1: BMS-986326 Dose 3 IV
  arm group label: Cohort E2: BMS-986326 Dose 3 SC
  intervention type: Other
  intervention name: Placebo for BMS-986326
  description: Specified dose on specified days
  arm group label: Cohort A: BMS-986326 Dose 1 IV
  arm group label: Cohort B: BMS-986326 Dose 2 IV
  arm group label: Cohort C1: BMS-986326 Dose 3 IV
  arm group label: Cohort C2: BMS-986326 Dose 3 SC
  arm group label: Cohort D1: BMS-986326 Dose 4 IV
  arm group label: Cohort D2: BMS-986326 Dose 4 SC
  arm group label: Cohort E1: BMS-986326 Dose 3 IV
  arm group label: Cohort E2: BMS-986326 Dose 3 SC
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 75 Years
  healthy volunteers: No
  last name: Bristol-Myers Squibb
  role: Study Director
  affiliation: Bristol-Myers Squibb
  last name: BMS Study Connect Contact Center www.BMSStudyConnect.com
  phone: 855-907-3286
  email: Clinical.Trials@bms.com
  last name: First line of the email MUST contain the NCT# and Site #.
  facility: 
  contact: 
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  country: Germany
  country: Mexico
  country: Poland
  country: Romania
  country: United States
  url: https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html
  description: BMS Clinical Trial Information
  url: https://www.fda.gov/Safety/MedWatch/SafetyInformation/default.htm
  description: FDA Safety Alerts and Recalls
  url: https://www.bmsstudyconnect.com/s/US/English/USenHome
  description: BMS Clinical Trial Patient Recruiting
  url: https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html
  description: Investigator Inquiry Form
  responsible party type: Sponsor
  sharing ipd: No
  ipd description: BMS will provide access to individual anonymized participant data upon request from qualified researchers, and subject to certain criteria. Additional information regarding Bristol Myers Squibb's data sharing policy and process can be found at: https://www.bms.com/researchers-and-partners/clinical-trials-and-research/disclosure-commitment.html