<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/NCT04493541</url>
  </required_header>
  <id_info>
    <org_study_id>IM026-027</org_study_id>
    <secondary_id>2019-004044-29</secondary_id>
    <nct_id>NCT04493541</nct_id>
  </id_info>
  <brief_title>A Study to Assess the Safety and Drug Levels of BMS-986256 in Participants With Active Cutaneous Lupus Erythematosus</brief_title>
  <official_title>A Phase 1b Randomized, Double-blind, Placebo-controlled Study to Assess the Safety and Pharmacokinetics of BMS-986256 in Participants With Active Cutaneous 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 assess the safety and drug levels of BMS-986256 in&#xD;
      participants with cutaneous lupus erythematosus.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 26, 2020</start_date>
  <completion_date type="Actual">April 21, 2023</completion_date>
  <primary_completion_date type="Actual">April 21, 2023</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>Incidence of Serious Adverse Events (SAEs)</measure>
    <time_frame>Up to 24 weeks</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Incidence of Adverse Events (AEs)</measure>
    <time_frame>Up to 20 weeks</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of laboratory test abnormalities: Hematology</measure>
    <time_frame>Up to 20 weeks</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of laboratory test abnormalities: Urinalysis</measure>
    <time_frame>Up to 20 weeks</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of laboratory test abnormalities: Clinical Chemistry</measure>
    <time_frame>Up to 20 weeks</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Incidence of clinically significant changes in physical examination findings</measure>
    <time_frame>Up to 20 weeks</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Incidence of clinically significant changes in vital signs: Body temperature</measure>
    <time_frame>Up to 20 weeks</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Incidence of clinically significant changes in vital signs: Respiratory rate</measure>
    <time_frame>Up to 20 weeks</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Incidence of clinically significant changes in vital signs: Blood pressure</measure>
    <time_frame>Up to 20 weeks</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Incidence of clinically significant changes in vital signs: Heart rate</measure>
    <time_frame>Up to 20 weeks</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Incidence of clinically significant changes in Electrocardiogram (ECG) parameters</measure>
    <time_frame>Up to 20 weeks</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Maximum observed plasma concentration (Cmax) of BMS-986256</measure>
    <time_frame>Up to 20 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to maximum concentration (Tmax) of BMS-986256</measure>
    <time_frame>Up to 20 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Trough observed plasma concentration (Ctrough) of BMS-986256</measure>
    <time_frame>Up to 20 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Area under the concentration-time curve over the dosing interval (AUC (TAU)) of BMS-986256</measure>
    <time_frame>Up to 20 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Maximum observed plasma concentration (Cmax) of metabolite BMT-271199</measure>
    <time_frame>Up to 20 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to maximum concentration (Tmax) of metabolite BMT-271199</measure>
    <time_frame>Up to 20 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Trough observed plasma concentration (Ctrough) of metabolite BMT-271199</measure>
    <time_frame>Up to 20 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Area under the concentration-time curve over the dosing interval (AUC (TAU)) of metabolite BMT-271199</measure>
    <time_frame>Up to 20 weeks</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">13</enrollment>
  <condition>Lupus Erythematosus, Cutaneous</condition>
  <arm_group>
    <arm_group_label>BMS-986256</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>BMS-986256</intervention_name>
    <description>Specified Dose on Specified Days</description>
    <arm_group_label>BMS-986256</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>BMS-986256 Placebo</intervention_name>
    <description>Specified Dose on Specified Days</description>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        a) Must have one of following diagnoses: i) Meet European League Against Rheumatoid&#xD;
        (EULAR)/American College of Rheumatology 2019 Classification Criteria for systemic lupus&#xD;
        erythematosus (SLE) OR ii) Biopsy-proven acute cutaneous lupus erythematosus (ACLE),&#xD;
        subacute cutaneous lupus erythematosus (SCLE), or discoid lupus erythematosus (DLE):&#xD;
        Participants without a concurrent SLE diagnosis are eligible b) Active cutaneous lupus&#xD;
        disease, defined as a modified Cutaneous Lupus Erythematosus Disease Area and Severity&#xD;
        Index- Activity (mCLASI-A) score ≥ 6 c) Active cutaneous lupus skin lesion(s) amenable to&#xD;
        biopsy&#xD;
&#xD;
        • Women of childbearing potential (WOCBP) and men must agree to follow instructions for&#xD;
        method(s) of contraception, if applicable&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Active severe or unstable neuropsychiatric SLE&#xD;
&#xD;
          -  Active, severe Lupus Nephritis (LN)&#xD;
&#xD;
          -  Any British Isles Lupus Assessment Group (BILAG) A or B, unless within the&#xD;
             constitutional, musculoskeletal and/or mucocutaneous domains&#xD;
&#xD;
        Other protocol-defined inclusion/exclusion criteria apply&#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>Bristol-Myers Squibb</last_name>
    <role>Study Director</role>
    <affiliation>Bristol-Myers Squibb</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Local Institution - 0001</name>
      <address>
        <city>Berlin</city>
        <zip>10117</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Germany</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.bmsstudyconnect.com/s/US/English/USenHome</url>
    <description>BMS Clinical Trial Patient Recruiting</description>
  </link>
  <link>
    <url>https://www.fda.gov/Safety/MedWatch/SafetyInformation/default.htm</url>
    <description>FDA Safety Alerts and Recalls</description>
  </link>
  <verification_date>May 2023</verification_date>
  <study_first_submitted>July 28, 2020</study_first_submitted>
  <study_first_submitted_qc>July 28, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 30, 2020</study_first_posted>
  <last_update_submitted>May 8, 2023</last_update_submitted>
  <last_update_submitted_qc>May 8, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">May 9, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Lupus Erythematosus, Systemic</mesh_term>
    <mesh_term>Lupus Erythematosus, Cutaneous</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04493541
org study id: IM026-027
secondary id: 2019-004044-29
nct id: NCT04493541
lead sponsor: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
The purpose of this study is to assess the safety and drug levels of BMS-986256 in
      participants with cutaneous lupus erythematosus.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Incidence of Serious Adverse Events (SAEs)
time frame: Up to 24 weeks
measure: Incidence of Adverse Events (AEs)
time frame: Up to 20 weeks
measure: Number of laboratory test abnormalities: Hematology
time frame: Up to 20 weeks
measure: Number of laboratory test abnormalities: Urinalysis
time frame: Up to 20 weeks
measure: Number of laboratory test abnormalities: Clinical Chemistry
time frame: Up to 20 weeks
measure: Incidence of clinically significant changes in physical examination findings
time frame: Up to 20 weeks
measure: Incidence of clinically significant changes in vital signs: Body temperature
time frame: Up to 20 weeks
measure: Incidence of clinically significant changes in vital signs: Respiratory rate
time frame: Up to 20 weeks
measure: Incidence of clinically significant changes in vital signs: Blood pressure
time frame: Up to 20 weeks
measure: Incidence of clinically significant changes in vital signs: Heart rate
time frame: Up to 20 weeks
measure: Incidence of clinically significant changes in Electrocardiogram (ECG) parameters
time frame: Up to 20 weeks
measure: Maximum observed plasma concentration (Cmax) of BMS-986256
time frame: Up to 20 weeks
measure: Time to maximum concentration (Tmax) of BMS-986256
time frame: Up to 20 weeks
measure: Trough observed plasma concentration (Ctrough) of BMS-986256
time frame: Up to 20 weeks
measure: Area under the concentration-time curve over the dosing interval (AUC (TAU)) of BMS-986256
time frame: Up to 20 weeks
measure: Maximum observed plasma concentration (Cmax) of metabolite BMT-271199
time frame: Up to 20 weeks
measure: Time to maximum concentration (Tmax) of metabolite BMT-271199
time frame: Up to 20 weeks
measure: Trough observed plasma concentration (Ctrough) of metabolite BMT-271199
time frame: Up to 20 weeks
measure: Area under the concentration-time curve over the dosing interval (AUC (TAU)) of metabolite BMT-271199
time frame: Up to 20 weeks
arm group label: BMS-986256
arm group type: Experimental
arm group label: Placebo
arm group type: Placebo Comparator
intervention type: Drug
intervention name: BMS-986256
description: Specified Dose on Specified Days
arm group label: BMS-986256
intervention type: Other
intervention name: BMS-986256 Placebo
description: Specified Dose on Specified Days
arm group label: Placebo
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
last name: Bristol-Myers Squibb
role: Study Director
affiliation: Bristol-Myers Squibb
facility: 
country: Germany
url: https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html
description: BMS Clinical Trial Information
url: https://www.bmsstudyconnect.com/s/US/English/USenHome
description: BMS Clinical Trial Patient Recruiting
url: https://www.fda.gov/Safety/MedWatch/SafetyInformation/default.htm
description: FDA Safety Alerts and Recalls
responsible party type: Sponsor
mesh term: Lupus Erythematosus, Systemic
mesh term: Lupus Erythematosus, Cutaneous