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/NCT06041568</url>
    </required_header>
    <id_info>
      <org_study_id>IGM-2323-101</org_study_id>
      <nct_id>NCT06041568</nct_id>
    </id_info>
    <brief_title>A Phase 1b Study of Imvotamab in Severe Systemic Lupus Erythematosus</brief_title>
    <official_title>A Phase 1b, Open-Label, Multicenter Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Imvotamab in Participants With Severe Systemic Lupus Erythematosus Who Have Failed Standard Therapies</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>IGM Biosciences, Inc.</agency>
        <agency_class>Industry</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>IGM Biosciences, Inc.</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 determine the safety and tolerability of imvotamab in&#xD;
        patients with severe systemic lupus erythematosus who have failed prior therapies.&#xD;
  &#xD;
        Participants will be given imvotamab through a vein (i.e., intravenously).&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        This is a Phase 1b, randomized, placebo-controlled, multicenter study to determine the&#xD;
        safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of imvotamab in adult&#xD;
        participants with systemic lupus erythematosus (SLE). Approximately 18 participants will be&#xD;
        assigned to different sequentially dose escalation cohorts.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">August 15, 2023</start_date>
    <completion_date type="Anticipated">May 2026</completion_date>
    <primary_completion_date type="Anticipated">June 2025</primary_completion_date>
    <phase>Phase 1</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>N/A</allocation>
      <intervention_model>Single Group Assignment</intervention_model>
      <primary_purpose>Treatment</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Safety and tolerability of imvotamab</measure>
      <time_frame>Up to Week 52</time_frame>
      <description>Incidence of adverse events (AEs), serious adverse events (SAEs), including serious infectious events and opportunistic infections</description>
    </primary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Anticipated">18</enrollment>
    <condition>Systemic Lupus Erythematosus</condition>
    <condition>Lupus Erythematosus</condition>
    <arm_group>
      <arm_group_label>Imvotamab (Dose Escalation)</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Imvotamab administered intravenously</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Imvotamab</intervention_name>
      <description>Administered intravenously</description>
      <arm_group_label>Imvotamab (Dose Escalation)</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Key Inclusion Criteria:&#xD;
  &#xD;
          Age ≥ 18 years at the time of signing ICF&#xD;
  &#xD;
          Diagnosis of SLE according to the 2019 European League Against Rheumatism/American College&#xD;
          of Rheumatology (ACR) Classification Criteria at least 16 weeks or more prior to screening&#xD;
  &#xD;
          Highly active SLE disease, as demonstrated by a total systemic lupus erythematosus disease&#xD;
          activity index (SLEDAI-2K) total score of ≥ 10 at screening&#xD;
  &#xD;
          Active SLE disease despite treatment with at least 1 immunosuppressive or biologic&#xD;
          standard-of-care agent (e.g., methotrexate, azathioprine, mycophenolate mofetil, belimumab,&#xD;
          anifrolumab) determined at the discretion of the investigator after at least 3 months of&#xD;
          treatment.&#xD;
  &#xD;
          It must be planned that the background standard-of-care treatment remains at a stable dose&#xD;
          throughout the Screening Period and up to Week 8.&#xD;
  &#xD;
          Key Exclusion Criteria:&#xD;
  &#xD;
          Pregnant or breastfeeding or intending to become pregnant during the study or within 3&#xD;
          months after the final dose of imvotamab&#xD;
  &#xD;
          Any lupus-associated neuropsychiatric disease.&#xD;
  &#xD;
          Active lupus nephritis with estimated glomerular filtration rate (eGFR) &lt; 30 mL/min/1.73&#xD;
          m2, calculated according to the Chronic Kidney Disease Epidemiology Collaboration equation,&#xD;
          classified as World Health Organization (WHO) Class IV.&#xD;
  &#xD;
          Prednisone-equivalent &gt; 30 mg/day, including immediate and extended-release oral&#xD;
          formulations&#xD;
  &#xD;
          Drug-induced lupus.&#xD;
  &#xD;
          Participants with a history of catastrophic or severe anti-phospholipid syndrome within 12&#xD;
          months prior to screening.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Rebecca Kunder</last_name>
      <role>Study Director</role>
      <affiliation>IGM Biosciences</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Clinical Trials</last_name>
      <phone>(877) 544-6728</phone>
      <email>IGM-2323-101@igmbio.com</email>
    </overall_contact>
    <location>
      <facility>
        <name>East Bay Rheumatology</name>
        <address>
          <city>San Leandro</city>
          <state>California</state>
          <zip>94578</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Clinical Trials</last_name>
        <email>IGM-2323-101@igmbio.com</email>
      </contact>
    </location>
    <location>
      <facility>
        <name>Omega Research, DeBary</name>
        <address>
          <city>DeBary</city>
          <state>Florida</state>
          <zip>32713</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Clinical Trials</last_name>
        <email>IGM-2323-101@igmbio.com</email>
      </contact>
    </location>
    <location>
      <facility>
        <name>Care and Cure Clinic</name>
        <address>
          <city>Houston</city>
          <state>Texas</state>
          <zip>77090</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Clinical Trials</last_name>
        <email>IGM-2323-101@igmbio.com</email>
      </contact>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>September 11, 2023</study_first_submitted>
    <study_first_submitted_qc>September 11, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 18, 2023</study_first_posted>
    <last_update_submitted>September 11, 2023</last_update_submitted>
    <last_update_submitted_qc>September 11, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 18, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Lupus</keyword>
    <keyword>SLE</keyword>
    <keyword>Severe Lupus</keyword>
    <keyword>Severe systemic lupus erythematosus</keyword>
    <keyword>Systemic lupus erythematosus</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Lupus Erythematosus, Systemic</mesh_term>
    </condition_browse>
    <!-- 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/NCT06041568
  org study id: IGM-2323-101
  nct id: NCT06041568
  lead sponsor: 
  has dmc: No
  is fda regulated drug: Yes
  is fda regulated device: No
  The purpose of this study is to determine the safety and tolerability of imvotamab in
        patients with severe systemic lupus erythematosus who have failed prior therapies.
  
        Participants will be given imvotamab through a vein (i.e., intravenously).
  This is a Phase 1b, randomized, placebo-controlled, multicenter study to determine the
        safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of imvotamab in adult
        participants with systemic lupus erythematosus (SLE). Approximately 18 participants will be
        assigned to different sequentially dose escalation cohorts.
  allocation: N/A
  intervention model: Single Group Assignment
  primary purpose: Treatment
  masking: None (Open Label)
  measure: Safety and tolerability of imvotamab
  time frame: Up to Week 52
  description: Incidence of adverse events (AEs), serious adverse events (SAEs), including serious infectious events and opportunistic infections
  arm group label: Imvotamab (Dose Escalation)
  arm group type: Experimental
  description: Imvotamab administered intravenously
  intervention type: Drug
  intervention name: Imvotamab
  description: Administered intravenously
  arm group label: Imvotamab (Dose Escalation)
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Rebecca Kunder
  role: Study Director
  affiliation: IGM Biosciences
  last name: Clinical Trials
  phone: (877) 544-6728
  email: IGM-2323-101@igmbio.com
  facility: 
  status: Recruiting
  contact: 
  facility: 
  status: Recruiting
  contact: 
  facility: 
  status: Recruiting
  contact: 
  country: United States
  responsible party type: Sponsor
  mesh term: Lupus Erythematosus, Systemic