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/NCT05987423</url>
    </required_header>
    <id_info>
      <org_study_id>GP44467</org_study_id>
      <secondary_id>2023-503309-13</secondary_id>
      <nct_id>NCT05987423</nct_id>
    </id_info>
    <brief_title>A Study To Evaluate The Efficacy, Safety, Pharmacokinetics, And Pharmacodynamics Of Satralizumab In Participants With Thyroid Eye Disease</brief_title>
    <official_title>A Phase III, Randomized, Double-Masked, Placebo-Controlled, Multicenter Study To Evaluate The Efficacy, Safety, Pharmacokinetics, And Pharmacodynamics Of Satralizumab In Participants With Moderate-To-Severe Thyroid Eye Disease</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Hoffmann-La Roche</agency>
        <agency_class>Industry</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Hoffmann-La Roche</source>
    <oversight_info>
      <has_dmc>Yes</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 efficacy, safety, pharmacokinetics, and&#xD;
        pharmacodynamics of subcutaneous satralizumab, a recombinant, humanized anti-interleukin-6&#xD;
        (IL-6) receptor monoclonal antibody, in participants with thyroid eye disease (TED).&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 30, 2023</start_date>
    <completion_date type="Anticipated">May 17, 2025</completion_date>
    <primary_completion_date type="Anticipated">May 17, 2025</primary_completion_date>
    <phase>Phase 3</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>Percentage of participants achieving ≥ 2mm reduction in proptosis from baseline (Day 1) at Week 24 in the study eye</measure>
      <time_frame>Baseline, Week 24</time_frame>
      <description>Provided there is no deterioration of proptosis (≥ 2mm increase) in the fellow eye</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Change in proptosis from baseline to Week 24</measure>
      <time_frame>Baseline, Week 24</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Percentage of participants achieving &gt;= 1 grade reduction/improvement in diplopia among participants with baseline diplopia</measure>
      <time_frame>Baseline, Week 24</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Percentage of participants with adverse events (AEs), with severity determined according to National cancer institute common terminology criteria for adverse events version 5 (NCI CTCAE V5)</measure>
      <time_frame>Baseline, Week 24</time_frame>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">120</enrollment>
    <condition>Thyroid Eye Disease</condition>
    <arm_group>
      <arm_group_label>Satralizumab</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>In the Part I period, participants will receive satralizumab every 4 weeks (q4w) followed by proptosis response-based individualized treatment in Part II of the study</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Placebo</arm_group_label>
      <arm_group_type>Placebo Comparator</arm_group_type>
      <description>In the part I period, participants will receive placebo every 4 weeks (q4w) followed by proptosis response-based individualized treatment in part II of the study</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Satralizumab</intervention_name>
      <description>Satralizumab will be administered by SC injection.</description>
      <arm_group_label>Satralizumab</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Placebo</intervention_name>
      <description>Placebo will be administered by SC injection</description>
      <arm_group_label>Placebo</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
          - Clinical diagnosis of thyroid eye disease (TED) based on CAS&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Decrease in CAS or proptosis of &gt;= 2 points or &gt;= 2 mm, respectively, in the study eye&#xD;
               between Screening and Study Baseline (Day 1)&#xD;
  &#xD;
            -  Requiring immediate surgical ophthalmological intervention or planning corrective&#xD;
               surgery or irradiation during the course of the study, in the judgment of the&#xD;
               investigator&#xD;
  &#xD;
            -  Identified pre-existing ophthalmic disease that, in the judgment of the investigator,&#xD;
               would preclude study participation or complicate interpretation of study results,&#xD;
               including corneal decompensation unresponsive to medical management and including&#xD;
               ophthalmic diseases that will likely require prohibited therapy during the study&#xD;
  &#xD;
            -  Any serious medical condition or abnormality in clinical laboratory tests that, in the&#xD;
               investigator's judgment, precludes an individual's safe participation in and&#xD;
               completion of the study&#xD;
  &#xD;
            -  Pregnant or breastfeeding, or intention of becoming pregnant during the study or&#xD;
               within 12 weeks after the final dose of satralizumab&#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>Clinical Trials</last_name>
      <role>Study Director</role>
      <affiliation>Hoffmann-La Roche</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Reference Study ID Number GP44467 www.roche.com/about_roche/roche_worldwide.htm</last_name>
      <phone>888-662-6728 (U.S. Only)</phone>
      <email>lobal-roche-genentech-trials@gene.com</email>
    </overall_contact>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>July 5, 2023</study_first_submitted>
    <study_first_submitted_qc>August 4, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 14, 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 5, 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>Eye Diseases</mesh_term>
      <mesh_term>Graves Ophthalmopathy</mesh_term>
      <mesh_term>Thyroid Diseases</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>Yes</sharing_ipd>
      <ipd_description>Qualified researchers may request access to individual patient level data through the request platform (www.vivli.org). Further details on Roche's criteria for eligible studies are available here (https://vivli.org/ourmember/roche/).&#xD;
  For further details on Roche's Global Policy on the Sharing of Clinical Information and how to request access to related clinical study documents, see here (https://www.roche.com/innovation/process/clinical-trials/data-sharing/).</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/NCT05987423
  org study id: GP44467
  secondary id: 2023-503309-13
  nct id: NCT05987423
  lead sponsor: 
  has dmc: Yes
  is fda regulated drug: Yes
  is fda regulated device: No
  The purpose of this study is to assess the efficacy, safety, pharmacokinetics, and
        pharmacodynamics of subcutaneous satralizumab, a recombinant, humanized anti-interleukin-6
        (IL-6) receptor monoclonal antibody, in participants with thyroid eye disease (TED).
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  measure: Percentage of participants achieving ≥ 2mm reduction in proptosis from baseline (Day 1) at Week 24 in the study eye
  time frame: Baseline, Week 24
  description: Provided there is no deterioration of proptosis (≥ 2mm increase) in the fellow eye
  measure: Change in proptosis from baseline to Week 24
  time frame: Baseline, Week 24
  measure: Percentage of participants achieving >= 1 grade reduction/improvement in diplopia among participants with baseline diplopia
  time frame: Baseline, Week 24
  measure: Percentage of participants with adverse events (AEs), with severity determined according to National cancer institute common terminology criteria for adverse events version 5 (NCI CTCAE V5)
  time frame: Baseline, Week 24
  arm group label: Satralizumab
  arm group type: Experimental
  description: In the Part I period, participants will receive satralizumab every 4 weeks (q4w) followed by proptosis response-based individualized treatment in Part II of the study
  arm group label: Placebo
  arm group type: Placebo Comparator
  description: In the part I period, participants will receive placebo every 4 weeks (q4w) followed by proptosis response-based individualized treatment in part II of the study
  intervention type: Drug
  intervention name: Satralizumab
  description: Satralizumab will be administered by SC injection.
  arm group label: Satralizumab
  intervention type: Other
  intervention name: Placebo
  description: Placebo will be administered by SC injection
  arm group label: Placebo
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Clinical Trials
  role: Study Director
  affiliation: Hoffmann-La Roche
  last name: Reference Study ID Number GP44467 www.roche.com/about_roche/roche_worldwide.htm
  phone: 888-662-6728 (U.S. Only)
  email: lobal-roche-genentech-trials@gene.com
  responsible party type: Sponsor
  mesh term: Eye Diseases
  mesh term: Graves Ophthalmopathy
  mesh term: Thyroid Diseases
  sharing ipd: Yes
  ipd description: Qualified researchers may request access to individual patient level data through the request platform (www.vivli.org). Further details on Roche's criteria for eligible studies are available here (https://vivli.org/ourmember/roche/).
  For further details on Roche's Global Policy on the Sharing of Clinical Information and how to request access to related clinical study documents, see here (https://www.roche.com/innovation/process/clinical-trials/data-sharing/).