<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/NCT03817424</url>
  </required_header>
  <id_info>
    <org_study_id>VIB7734.P1b.S1</org_study_id>
    <secondary_id>2018-003767-60</secondary_id>
    <nct_id>NCT03817424</nct_id>
  </id_info>
  <brief_title>A Study to Evaluate VIB7734 in Participants With Systemic Lupus Erythematosus (SLE), Cutaneous Lupus Erythematosus (CLE), Sjogren's Syndrome, Systemic Sclerosis, Polymyositis, and Dermatomyositis</brief_title>
  <official_title>A Phase 1 Randomized, Placebo-Controlled, Blinded, Multiple Ascending Dose Study to Evaluate VIB7734 in Systemic Lupus Erythematosus, Cutaneous Lupus Erythematosus, Sjogren's Syndrome, Systemic Sclerosis, Polymyositis, and Dermatomyositis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Viela Bio</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Viela Bio (acquired by Horizon Therapeutics)</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 the safety and tolerability of escalating, multiple&#xD;
      subcutaneous (SC) doses of VIB7734 in participants with Systemic Lupus Erythematosus (SLE),&#xD;
      Cutaneous Lupus Erythematosus (CLE), Sjogren's Syndrome, Systemic Sclerosis, Polymyositis,&#xD;
      and Dermatomyositis.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study will have 3 periods: screening, treatment period, and extended follow-up. The&#xD;
      screening period is 28 days. A total of 32 participants will be enrolled in 3 cohorts with 8&#xD;
      participants in Cohort 1, and 12 participants each in Cohorts 2 and 3. In Cohort 1,&#xD;
      participants will be randomized in a 3:1 ratio to receive VIB7734 or matching placebo by&#xD;
      injection every 4 weeks (q4w) for a total of 3 doses on Days 1, 29, and 57. In Cohorts 2 and&#xD;
      3, participants diagnosed with lupus only will be randomized in a 2:1 ratio to receive&#xD;
      VIB7734 or matching placebo by injection q4w for 3 doses on Days 1, 29, and 57. Participants&#xD;
      will be followed until at least Day 141. After the Day 141 visit, participants will exit the&#xD;
      study if participants meets adequate plasmacytoid dendritic cells (pDCs). If an adequate pDC&#xD;
      level does not meet at Day 141 visit, the participant will continue the follow-up for pDC&#xD;
      repletion until they meet the protocol defined adequate pDC level or Day 337 visit has been&#xD;
      reached.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 13, 2018</start_date>
  <completion_date type="Actual">July 20, 2020</completion_date>
  <primary_completion_date type="Actual">July 20, 2020</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>Sequential Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Triple (Participant, Care Provider, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs)</measure>
    <time_frame>Day 1 up to Day 337</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of Participants With Adverse Events of Special Interest (AESIs)</measure>
    <time_frame>Day 1 up to Day 337</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of Participants With Laboratory Abnormalities Reported as TEAEs</measure>
    <time_frame>Day 1 up to Day 337</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of Participants With Vital Sign Abnormalities Reported as TEAEs</measure>
    <time_frame>Day 1 up to Day 337</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of Participants With 12-Lead Electrocardiogram Abnormalities Reported as TEAEs</measure>
    <time_frame>Day 1 up to Day 337</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Maximum Observed Serum Concentration (Cmax) of VIB7734 Maximum Observed Serum Concentration (Cmax) of VIB7734</measure>
    <time_frame>Days 1 (pre-dose), 8, 15, 29 (pre-dose), 36, 43, 57 (pre-dose), 64, 71, 85, 113, 141, 169, 197, 225, and 253</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Area Under the Concentration-time Curve (AUC) of VIB7734</measure>
    <time_frame>Days 1 (pre-dose), 8, 15, 29 (pre-dose), 36, 43, 57 (pre-dose), 64, 71, 85, 113, 141, 169, 197, 225, and 253</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Systemic Clearance (CL) of VIB7734</measure>
    <time_frame>Days 1 (pre-dose), 8, 15, 29 (pre-dose), 36, 43, 57 (pre-dose), 64, 71, 85, 113, 141, 169, 197, 225, and 253</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Terminal Half-life (t1/2) of VIB7734</measure>
    <time_frame>Days 1 (pre-dose), 8, 15, 29 (pre-dose), 36, 43, 57 (pre-dose), 64, 71, 85, 113, 141, 169, 197, 225, and 253</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Positive Anti-Drug Antibodies of VIB7734</measure>
    <time_frame>Day 1 up to Day 309</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from Baseline in Cutaneous Lupus Erythematosus Disease Area and Severity Index (CLASI) Activity Score (Cohorts 2 and 3)</measure>
    <time_frame>Day 1 up to Day 253</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Blood Levels of pDCs</measure>
    <time_frame>Day 1 up to Day 337</time_frame>
  </secondary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">31</enrollment>
  <condition>Systemic Lupus Erythematosus</condition>
  <condition>Cutaneous Lupus Erythematosus</condition>
  <condition>Sjogren's Syndrome</condition>
  <condition>Systemic Sclerosis</condition>
  <condition>Polymyositis</condition>
  <condition>Dermatomyositis</condition>
  <arm_group>
    <arm_group_label>Cohort 1: VIB7734 Dose 1</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will receive VIB7734 Dose 1 via injection q4w for a total of 3 doses on Days 1, 29, and 57.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Cohort 2: VIB7734 Dose 2</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will receive VIB7734 Dose 2 via injection q4w for a total of 3 doses on Days 1, 29, and 57.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Cohort 3: VIB7734 Dose 3</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will receive VIB7734 Dose 3 via injection q4w for a total of 3 doses on Days 1, 29, and 57.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Participants will receive placebo matching to VIB7734 via injection q4w for a total of 3 doses on Days 1, 29, and 57.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>VIB7734</intervention_name>
    <description>Participants will receive VIB7734 via injection.</description>
    <arm_group_label>Cohort 1: VIB7734 Dose 1</arm_group_label>
    <arm_group_label>Cohort 2: VIB7734 Dose 2</arm_group_label>
    <arm_group_label>Cohort 3: VIB7734 Dose 3</arm_group_label>
    <other_name>MEDI7734</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Participants will receive placebo matching to VIB7734 via injection.</description>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Participants aged 18 through 75 years at the time of screening&#xD;
&#xD;
          -  Participants with at least one of the following diagnoses:&#xD;
&#xD;
               1. Systemic Lupus Erythematosus&#xD;
&#xD;
               2. Cutaneous lupus erythematosus, including acute CLE, subacute CLE, and discoid&#xD;
                  lupus erythematosus&#xD;
&#xD;
               3. Sjogren's syndrome (for Cohort 1 only)&#xD;
&#xD;
               4. Systemic sclerosis (for Cohort 1 only)&#xD;
&#xD;
               5. Probable or definite polymyositis (for Cohort 1 only)&#xD;
&#xD;
               6. Probable or definite dermatomyositis (for Cohort 1 only)&#xD;
&#xD;
          -  For Cohorts 2 and 3 only: Participants with CLASI activity score greater than or equal&#xD;
             to (&gt;=) 8 at both Visits 1 (screening) and 2 (baseline)&#xD;
&#xD;
          -  For Cohorts 2 and 3 only: a skin lesion amenable to punch skin biopsy and willingness&#xD;
             of the participant to undergo skin biopsy at two time points&#xD;
&#xD;
          -  For Cohorts 2 and 3 only: photographs of skin lesions must be submitted for review to&#xD;
             confirm the diagnosis of SLE or CLE with active skin lesions confirmation of the&#xD;
             diagnosis by the central reviewer must be received prior to randomization&#xD;
&#xD;
          -  Females of childbearing potential and nonsterilized males who are ready to use&#xD;
             protocol defined contraception methods&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Severe manifestations of the diseases under study that could impact the participant&#xD;
             safety&#xD;
&#xD;
          -  Known history of a primary immunodeficiency or an underlying condition such as known&#xD;
             human immunodeficiency virus (HIV) infection, a positive result for HIV infection,&#xD;
             splenectomy, or any underlying condition that predisposes the participant to infection&#xD;
&#xD;
          -  At screening, have adequate central laboratory test results: aspartate transaminase&#xD;
             greater than (&gt;) 2.5 x upper limit of normal (ULN); alanine transaminase &gt;2.5 x ULN;&#xD;
             total bilirubin 1.5 x ULN; total immunoglobulin &lt; 500 gram/decilitre; neutrophil count&#xD;
             less than (&lt;) 1,000/μL; platelet count &lt; 85,000/μL; haemoglobin &lt; 10 g/dL;&#xD;
             glycosylated haemoglobin &gt; 8 percent (%); total lymphocyte count &lt; 300 cells/mm^3;&#xD;
             glomerular filtration rate &lt; 50 mL/min/1.73 m^2; plasmacytoid dendritic cells (pDC)&#xD;
             level &lt; 0.02% of peripheral blood mononuclear cells (PBMCs)&#xD;
&#xD;
          -  Positive test for chronic hepatitis B infection at screening and for hepatitis C virus&#xD;
             antibody&#xD;
&#xD;
          -  History of or active tuberculosis (TB), or a positive QuantiFERON®-TB Gold test at&#xD;
             screening; a primary immunodeficiency or an underlying condition such as known human&#xD;
             immunodeficiency virus (HIV) infection, a positive result for HIV infection per&#xD;
             central laboratory; cancer; clinically significant cardiac disease&#xD;
&#xD;
          -  Herpes zoster infection within 3 months before randomization and/or any severe herpes&#xD;
             virus family infection at any time prior to randomization&#xD;
&#xD;
          -  Any acute illness or evidence of clinically significant active infection, such as&#xD;
             fever &gt;= 38.0 degrees Celsius (&gt;= 100.5 degrees Fahrenheit) at screening (Visit 1) or&#xD;
             Day 1 (Visit 2)&#xD;
&#xD;
          -  Cohorts 2 and 3 only: use of Group 1 (super-high potency) or Group 2 (high potency)&#xD;
             topical corticosteroids&#xD;
&#xD;
          -  Receipt of a live-attenuated vaccine within 4 weeks prior to Day 1&#xD;
&#xD;
          -  Cohorts 2 and 3 only: have received changing doses of mycophenolate mofetil,&#xD;
             methotrexate, leflunomide, azathioprine, or non-steroidal topical immunosuppressants&#xD;
             within 28 days before study Day 1 or changing doses of oral or topical corticosteroids&#xD;
             within 14 days before study Day 1&#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>Jack Ratchford, MD</last_name>
    <role>Study Director</role>
    <affiliation>Viela Bio</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Viela Bio Investigative Site</name>
      <address>
        <city>Anniston</city>
        <state>Alabama</state>
        <zip>36201</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Viela Bio Investigative Site</name>
      <address>
        <city>Birmingham</city>
        <state>Alabama</state>
        <zip>35294</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Viela Bio Investigative Site</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>90022</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Viela Bio Investigative Site</name>
      <address>
        <city>Upland</city>
        <state>California</state>
        <zip>91786</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Viela Bio Investigative Site</name>
      <address>
        <city>Danbury</city>
        <state>Connecticut</state>
        <zip>06810</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Viela Bio Investigative Site</name>
      <address>
        <city>Fort Lauderdale</city>
        <state>Florida</state>
        <zip>33309</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Viela Bio Investigative Site</name>
      <address>
        <city>Hialeah</city>
        <state>Florida</state>
        <zip>33016</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Viela Bio Investigative Site</name>
      <address>
        <city>Jacksonville</city>
        <state>Florida</state>
        <zip>32216</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Viela Bio Investigative Site</name>
      <address>
        <city>Miami Lakes</city>
        <state>Florida</state>
        <zip>33014</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Viela Bio Investigative Site</name>
      <address>
        <city>Saint Petersburg</city>
        <state>Florida</state>
        <zip>33710</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Viela Bio Investigative Site</name>
      <address>
        <city>Lawrenceville</city>
        <state>Georgia</state>
        <zip>30046</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Viela Bio Investigative Site</name>
      <address>
        <city>Great Neck</city>
        <state>New York</state>
        <zip>11021</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Viela Bio Investigative Site</name>
      <address>
        <city>Charlotte</city>
        <state>North Carolina</state>
        <zip>28204</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Viela Bio Investigative Site</name>
      <address>
        <city>Durham</city>
        <state>North Carolina</state>
        <zip>27713</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Viela Bio Investigative Site</name>
      <address>
        <city>Duncansville</city>
        <state>Pennsylvania</state>
        <zip>16635</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Viela Bio Investigative Site</name>
      <address>
        <city>Philadelphia</city>
        <state>Pennsylvania</state>
        <zip>19104</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Viela Bio Investigative Site</name>
      <address>
        <city>Memphis</city>
        <state>Tennessee</state>
        <zip>38119</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Viela Bio Investigative Site</name>
      <address>
        <city>Allen</city>
        <state>Texas</state>
        <zip>75013</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Viela Bio Investigative Site</name>
      <address>
        <city>Mesquite</city>
        <state>Texas</state>
        <zip>75150</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Viela Bio Investigative Site</name>
      <address>
        <city>Białystok</city>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Viela Bio Investigative Site</name>
      <address>
        <city>Bydgoszcz</city>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Viela Bio Investigative Site</name>
      <address>
        <city>Kraków</city>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Viela Bio Investigative Site</name>
      <address>
        <city>Poznań</city>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Viela Bio Investigative Site</name>
      <address>
        <city>Rzeszów</city>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Viela Bio Investigative Site</name>
      <address>
        <city>Warsaw</city>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Viela Bio Investigative Site</name>
      <address>
        <city>Wrocław</city>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Viela Bio Investigative Site</name>
      <address>
        <city>Barcelona</city>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Viela Bio Investigative Site</name>
      <address>
        <city>Bilbao</city>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Viela Bio Investigative Site</name>
      <address>
        <city>Madrid</city>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Viela Bio Investigative Site</name>
      <address>
        <city>Sevilla</city>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Poland</country>
    <country>Spain</country>
    <country>United States</country>
  </location_countries>
  <verification_date>August 2020</verification_date>
  <study_first_submitted>January 22, 2019</study_first_submitted>
  <study_first_submitted_qc>January 22, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 25, 2019</study_first_posted>
  <last_update_submitted>August 11, 2020</last_update_submitted>
  <last_update_submitted_qc>August 11, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">August 13, 2020</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>Sjogren's Syndrome</mesh_term>
    <mesh_term>Dermatomyositis</mesh_term>
    <mesh_term>Polymyositis</mesh_term>
    <mesh_term>Lupus Erythematosus, Systemic</mesh_term>
    <mesh_term>Scleroderma, Systemic</mesh_term>
    <mesh_term>Scleroderma, Diffuse</mesh_term>
    <mesh_term>Lupus Erythematosus, Cutaneous</mesh_term>
    <mesh_term>Syndrome</mesh_term>
    <mesh_term>Sclerosis</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03817424
org study id: VIB7734.P1b.S1
secondary id: 2018-003767-60
nct id: NCT03817424
lead sponsor: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
The purpose of this study is to evaluate the safety and tolerability of escalating, multiple
      subcutaneous (SC) doses of VIB7734 in participants with Systemic Lupus Erythematosus (SLE),
      Cutaneous Lupus Erythematosus (CLE), Sjogren's Syndrome, Systemic Sclerosis, Polymyositis,
      and Dermatomyositis.
This study will have 3 periods: screening, treatment period, and extended follow-up. The
      screening period is 28 days. A total of 32 participants will be enrolled in 3 cohorts with 8
      participants in Cohort 1, and 12 participants each in Cohorts 2 and 3. In Cohort 1,
      participants will be randomized in a 3:1 ratio to receive VIB7734 or matching placebo by
      injection every 4 weeks (q4w) for a total of 3 doses on Days 1, 29, and 57. In Cohorts 2 and
      3, participants diagnosed with lupus only will be randomized in a 2:1 ratio to receive
      VIB7734 or matching placebo by injection q4w for 3 doses on Days 1, 29, and 57. Participants
      will be followed until at least Day 141. After the Day 141 visit, participants will exit the
      study if participants meets adequate plasmacytoid dendritic cells (pDCs). If an adequate pDC
      level does not meet at Day 141 visit, the participant will continue the follow-up for pDC
      repletion until they meet the protocol defined adequate pDC level or Day 337 visit has been
      reached.
allocation: Randomized
intervention model: Sequential Assignment
primary purpose: Treatment
masking: Triple (Participant, Care Provider, Investigator)
measure: Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs)
time frame: Day 1 up to Day 337
measure: Number of Participants With Adverse Events of Special Interest (AESIs)
time frame: Day 1 up to Day 337
measure: Number of Participants With Laboratory Abnormalities Reported as TEAEs
time frame: Day 1 up to Day 337
measure: Number of Participants With Vital Sign Abnormalities Reported as TEAEs
time frame: Day 1 up to Day 337
measure: Number of Participants With 12-Lead Electrocardiogram Abnormalities Reported as TEAEs
time frame: Day 1 up to Day 337
measure: Maximum Observed Serum Concentration (Cmax) of VIB7734 Maximum Observed Serum Concentration (Cmax) of VIB7734
time frame: Days 1 (pre-dose), 8, 15, 29 (pre-dose), 36, 43, 57 (pre-dose), 64, 71, 85, 113, 141, 169, 197, 225, and 253
measure: Area Under the Concentration-time Curve (AUC) of VIB7734
time frame: Days 1 (pre-dose), 8, 15, 29 (pre-dose), 36, 43, 57 (pre-dose), 64, 71, 85, 113, 141, 169, 197, 225, and 253
measure: Systemic Clearance (CL) of VIB7734
time frame: Days 1 (pre-dose), 8, 15, 29 (pre-dose), 36, 43, 57 (pre-dose), 64, 71, 85, 113, 141, 169, 197, 225, and 253
measure: Terminal Half-life (t1/2) of VIB7734
time frame: Days 1 (pre-dose), 8, 15, 29 (pre-dose), 36, 43, 57 (pre-dose), 64, 71, 85, 113, 141, 169, 197, 225, and 253
measure: Number of Participants With Positive Anti-Drug Antibodies of VIB7734
time frame: Day 1 up to Day 309
measure: Change from Baseline in Cutaneous Lupus Erythematosus Disease Area and Severity Index (CLASI) Activity Score (Cohorts 2 and 3)
time frame: Day 1 up to Day 253
measure: Blood Levels of pDCs
time frame: Day 1 up to Day 337
arm group label: Cohort 1: VIB7734 Dose 1
arm group type: Experimental
description: Participants will receive VIB7734 Dose 1 via injection q4w for a total of 3 doses on Days 1, 29, and 57.
arm group label: Cohort 2: VIB7734 Dose 2
arm group type: Experimental
description: Participants will receive VIB7734 Dose 2 via injection q4w for a total of 3 doses on Days 1, 29, and 57.
arm group label: Cohort 3: VIB7734 Dose 3
arm group type: Experimental
description: Participants will receive VIB7734 Dose 3 via injection q4w for a total of 3 doses on Days 1, 29, and 57.
arm group label: Placebo
arm group type: Placebo Comparator
description: Participants will receive placebo matching to VIB7734 via injection q4w for a total of 3 doses on Days 1, 29, and 57.
intervention type: Drug
intervention name: VIB7734
description: Participants will receive VIB7734 via injection.
arm group label: Cohort 1: VIB7734 Dose 1
arm group label: Cohort 2: VIB7734 Dose 2
arm group label: Cohort 3: VIB7734 Dose 3
other name: MEDI7734
intervention type: Drug
intervention name: Placebo
description: Participants will receive placebo matching to VIB7734 via injection.
arm group label: Placebo
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: No
last name: Jack Ratchford, MD
role: Study Director
affiliation: Viela Bio
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: Poland
country: Spain
country: United States
responsible party type: Sponsor
mesh term: Sjogren's Syndrome
mesh term: Dermatomyositis
mesh term: Polymyositis
mesh term: Lupus Erythematosus, Systemic
mesh term: Scleroderma, Systemic
mesh term: Scleroderma, Diffuse
mesh term: Lupus Erythematosus, Cutaneous
mesh term: Syndrome
mesh term: Sclerosis
sharing ipd: No