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/NCT06025110</url>
    </required_header>
    <id_info>
      <org_study_id>TCD601F201</org_study_id>
      <nct_id>NCT06025110</nct_id>
    </id_info>
    <brief_title>A Study of TCD601 (Siplizumab) in New Onset Type 1 Diabetes Patients</brief_title>
    <acronym>STRIDE</acronym>
    <official_title>A 12-month, Randomized, Single-blind, Placebo-controlled Exposure-response Study of TCD601 (Siplizumab) in New Onset Type 1 Diabetes Patients (STRIDE)</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>ITB-Med LLC</agency>
        <agency_class>Industry</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>ITB-Med LLC</source>
    <oversight_info>
      <has_dmc>Yes</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        The goal of this study is to determine if treatment with TCD601 improves beta-cell function&#xD;
        in adults recently diagnosed with type 1 diabetes compared to placebo.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">January 23, 2023</start_date>
    <completion_date type="Anticipated">January 2025</completion_date>
    <primary_completion_date type="Anticipated">January 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>Sequential Assignment</intervention_model>
      <primary_purpose>Treatment</primary_purpose>
      <masking>Single (Participant)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Change from baseline in beta-cell function as compared to placebo at week 52.</measure>
      <time_frame>52 weeks</time_frame>
      <description>Assess any changes in beta-cell function at the end of the study (week 52) for patients treated with TCD601 (study drug) compared to subjects treated with placebo (the comparator).</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Assess the incidence and severity of adverse</measure>
      <time_frame>52 weeks</time_frame>
      <description>Number of adverse events compared to placebo at week 52.</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">96</enrollment>
    <condition>Diabetes Mellitus, Type 1</condition>
    <arm_group>
      <arm_group_label>TCD601</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Administered one of three doses of TCD601 over a 12 week treatment period.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Placebo</arm_group_label>
      <arm_group_type>Placebo Comparator</arm_group_type>
      <description>Placebo is administered over a 12 week treatment period.</description>
    </arm_group>
    <intervention>
      <intervention_type>Biological</intervention_type>
      <intervention_name>TCD601</intervention_name>
      <description>Investigational Product</description>
      <arm_group_label>TCD601</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Placebo</intervention_name>
      <description>Comparator</description>
      <arm_group_label>Placebo</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Able to understand the study requirements and provide written informed consent before&#xD;
               any study assessment is performed&#xD;
  &#xD;
            -  Male or female patients ≥ 18 to 45 years of age&#xD;
  &#xD;
            -  A diagnosis of type 1 diabetes&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Women who are pregnant, lactating, or planning on pregnancy during the study&#xD;
  &#xD;
            -  History of cancer&#xD;
  &#xD;
            -  History of heart disease&#xD;
  &#xD;
            -  Recent infection&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>45 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Kellie Kennon, BSN</last_name>
      <role>Study Director</role>
      <affiliation>ITB-MED</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Elma Redzic</last_name>
      <phone>+46 70946 4048</phone>
      <email>elma.redzic@itb-med.com</email>
    </overall_contact>
    <location>
      <facility>
        <name>Karolinska University Hosptial</name>
        <address>
          <city>Stockholm</city>
          <state>Huddinge</state>
          <zip>14157</zip>
          <country>Sweden</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Ingela Bredenberg</last_name>
      </contact>
      <investigator>
        <last_name>Lisa Juntti-Berggren, MD</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>Sweden</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 25, 2023</study_first_submitted>
    <study_first_submitted_qc>September 1, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 6, 2023</study_first_posted>
    <last_update_submitted>September 1, 2023</last_update_submitted>
    <last_update_submitted_qc>September 1, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 6, 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>Diabetes Mellitus</mesh_term>
      <mesh_term>Diabetes Mellitus, Type 1</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/NCT06025110
  org study id: TCD601F201
  nct id: NCT06025110
  lead sponsor: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  The goal of this study is to determine if treatment with TCD601 improves beta-cell function
        in adults recently diagnosed with type 1 diabetes compared to placebo.
  allocation: Randomized
  intervention model: Sequential Assignment
  primary purpose: Treatment
  masking: Single (Participant)
  measure: Change from baseline in beta-cell function as compared to placebo at week 52.
  time frame: 52 weeks
  description: Assess any changes in beta-cell function at the end of the study (week 52) for patients treated with TCD601 (study drug) compared to subjects treated with placebo (the comparator).
  measure: Assess the incidence and severity of adverse
  time frame: 52 weeks
  description: Number of adverse events compared to placebo at week 52.
  arm group label: TCD601
  arm group type: Experimental
  description: Administered one of three doses of TCD601 over a 12 week treatment period.
  arm group label: Placebo
  arm group type: Placebo Comparator
  description: Placebo is administered over a 12 week treatment period.
  intervention type: Biological
  intervention name: TCD601
  description: Investigational Product
  arm group label: TCD601
  intervention type: Other
  intervention name: Placebo
  description: Comparator
  arm group label: Placebo
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 45 Years
  healthy volunteers: No
  last name: Kellie Kennon, BSN
  role: Study Director
  affiliation: ITB-MED
  last name: Elma Redzic
  phone: +46 70946 4048
  email: elma.redzic@itb-med.com
  facility: 
  status: Recruiting
  contact: 
  investigator: 
  country: Sweden
  responsible party type: Sponsor
  mesh term: Diabetes Mellitus
  mesh term: Diabetes Mellitus, Type 1
  sharing ipd: No