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/NCT06021054</url>
    </required_header>
    <id_info>
      <org_study_id>VRDN-001-301</org_study_id>
      <nct_id>NCT06021054</nct_id>
    </id_info>
    <brief_title>A Randomized, Double-masked, Placebo-controlled Safety, Tolerability, and Efficacy Study of VRDN-001, a Humanized Monoclonal Antibody Directed Against the IGF-1 Receptor, in Participants With Chronic Thyroid Eye Disease (TED)</brief_title>
    <official_title>A Randomized, Double-masked, Placebo-controlled Safety, Tolerability, and Efficacy Study of VRDN-001, a Humanized Monoclonal Antibody Directed Against the IGF-1 Receptor, in Participants With Chronic Thyroid Eye Disease (TED)</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Viridian Therapeutics, Inc.</agency>
        <agency_class>Industry</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Viridian Therapeutics, Inc.</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>
      <is_us_export>No</is_us_export>
    </oversight_info>
    <brief_summary>
      <textblock>
        A randomized, double-masked, placebo-controlled safety, tolerability and efficacy study of&#xD;
        VRDN-001 in participants with chronic thyroid eye disease (TED)&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        A randomized, double-masked, placebo-controlled safety, tolerability and efficacy study of&#xD;
        VRDN-001, a humanized monoclonal antibody directed against the IGF-1 receptor, in&#xD;
        participants with chronic thyroid eye disease (TED)&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 2023</start_date>
    <completion_date type="Anticipated">September 2025</completion_date>
    <primary_completion_date type="Anticipated">December 2024</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>Double (Participant, Investigator)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Proptosis Responder Rate in the study eye</measure>
      <time_frame>3 weeks post the fifth infusion</time_frame>
      <description>Proptosis Responder Rate in the study eye (i.e., reduction of proptosis of ≥2 mm from baseline [without a corresponding increase of ≥2 mm in the fellow eye] as measured by exophthalmometer) at 3 weeks post the fifth infusion (i.e., Week 15)</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Change from Baseline in proptosis in the study eye at Week 15</measure>
      <time_frame>Week 15</time_frame>
      <description>Change from Baseline in proptosis in the study eye as measured by exophthalmometer at Week 15</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Clinical Activity Responder Rate in the study eye</measure>
      <time_frame>Week 15</time_frame>
      <description>Clinical Activity Responder Rate in the study eye</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change from baseline in CAS in the study eye</measure>
      <time_frame>Week 15</time_frame>
      <description>Change from baseline in CAS in the study eye</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Overall Response Rate in the study eye</measure>
      <time_frame>Week 15</time_frame>
      <description>Overall Response Rate in the study eye</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Diplopia Resolution Rate</measure>
      <time_frame>Week 15</time_frame>
      <description>Diplopia Resolution Rate (i.e., reduction in Diplopia Score to 0 from baseline for participants with baseline Diplopia Score &gt;0) at Week 15</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">159</enrollment>
    <condition>Thyroid Eye Disease</condition>
    <arm_group>
      <arm_group_label>VRDN-001 10 mg/kg</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Drug: 5 Infusions of VRDN-001 10 mg/kg</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Placebo Drug</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Placebo Drug: 5 Infusions of placebo</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>VRDN-001 10 mg/kg Drug:</intervention_name>
      <description>Drug: 5 Infusions of VRDN-001 10mg/ Placebo: 5 Infusions of placebo</description>
      <arm_group_label>Placebo Drug</arm_group_label>
      <arm_group_label>VRDN-001 10 mg/kg</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Must have moderate to severe chronic TED with documented evidence of ocular symptoms&#xD;
               or signs that began &gt; 15 months prior to screening&#xD;
  &#xD;
            -  Must have Clinical Activity Score (CAS) of (0-7) item scale for the study (more&#xD;
               proptotic) eye&#xD;
  &#xD;
            -  Must agree to use highly effective contraception as specified in the protocol&#xD;
  &#xD;
            -  Female TED participants must have a negative serum pregnancy test&#xD;
  &#xD;
          Key Exclusion Criteria:&#xD;
  &#xD;
            -  Must not have received prior treatment with another anti-IGF-1R monoclonal antibody&#xD;
  &#xD;
            -  Must not have used oral corticosteroids within 2 weeks prior to Day 1&#xD;
  &#xD;
            -  Must not have received rituximab, tocilizumab or other immunosuppressive agents within&#xD;
               8 weeks prior to Day 1&#xD;
  &#xD;
            -  Must not have a pre-existing ophthalmic condition in the study eye that in the opinion&#xD;
               of the Investigator would confound interpretation of the study results&#xD;
  &#xD;
            -  Must not have had previous orbital irradiation or surgery for TED in the study eye&#xD;
  &#xD;
            -  Must not have a history inflammatory bowel disease&#xD;
  &#xD;
            -  Must not have a history or screening audiometry assessment of clinically significant&#xD;
               (as determined by investigator) ear pathology, relevant ear surgery, or hearing l loss&#xD;
  &#xD;
            -  Must not have received an investigational agent for any condition&#xD;
  &#xD;
            -  Female TED participants must not be pregnant or lactating&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>August 25, 2023</study_first_submitted>
    <study_first_submitted_qc>August 25, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 1, 2023</study_first_posted>
    <last_update_submitted>September 7, 2023</last_update_submitted>
    <last_update_submitted_qc>September 7, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 11, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Graves</keyword>
    <keyword>Thyroid Eye Disease</keyword>
    <keyword>Thyroid-Associated Ophthalmopathy</keyword>
    <keyword>Dysthyroid Ophthalmopathy</keyword>
    <keyword>Graves Eye Disease</keyword>
    <keyword>Graves Orbitopathy</keyword>
    <keyword>Myopathic Ophthalmopathy</keyword>
    <keyword>Congestive Ophthalmopathy</keyword>
    <keyword>Edematous Ophthalmopathy</keyword>
    <keyword>Infiltrative Ophthalmopathy</keyword>
    <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>
    <!-- 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/NCT06021054
  org study id: VRDN-001-301
  nct id: NCT06021054
  lead sponsor: 
  has dmc: Yes
  is fda regulated drug: Yes
  is fda regulated device: No
  is us export: No
  A randomized, double-masked, placebo-controlled safety, tolerability and efficacy study of
        VRDN-001 in participants with chronic thyroid eye disease (TED)
  A randomized, double-masked, placebo-controlled safety, tolerability and efficacy study of
        VRDN-001, a humanized monoclonal antibody directed against the IGF-1 receptor, in
        participants with chronic thyroid eye disease (TED)
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: Double (Participant, Investigator)
  measure: Proptosis Responder Rate in the study eye
  time frame: 3 weeks post the fifth infusion
  description: Proptosis Responder Rate in the study eye (i.e., reduction of proptosis of ≥2 mm from baseline [without a corresponding increase of ≥2 mm in the fellow eye] as measured by exophthalmometer) at 3 weeks post the fifth infusion (i.e., Week 15)
  measure: Change from Baseline in proptosis in the study eye at Week 15
  time frame: Week 15
  description: Change from Baseline in proptosis in the study eye as measured by exophthalmometer at Week 15
  measure: Clinical Activity Responder Rate in the study eye
  time frame: Week 15
  description: Clinical Activity Responder Rate in the study eye
  measure: Change from baseline in CAS in the study eye
  time frame: Week 15
  description: Change from baseline in CAS in the study eye
  measure: Overall Response Rate in the study eye
  time frame: Week 15
  description: Overall Response Rate in the study eye
  measure: Diplopia Resolution Rate
  time frame: Week 15
  description: Diplopia Resolution Rate (i.e., reduction in Diplopia Score to 0 from baseline for participants with baseline Diplopia Score >0) at Week 15
  arm group label: VRDN-001 10 mg/kg
  arm group type: Experimental
  description: Drug: 5 Infusions of VRDN-001 10 mg/kg
  arm group label: Placebo Drug
  arm group type: Experimental
  description: Placebo Drug: 5 Infusions of placebo
  intervention type: Drug
  intervention name: VRDN-001 10 mg/kg Drug:
  description: Drug: 5 Infusions of VRDN-001 10mg/ Placebo: 5 Infusions of placebo
  arm group label: Placebo Drug
  arm group label: VRDN-001 10 mg/kg
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: Accepts Healthy Volunteers
  responsible party type: Sponsor
  mesh term: Eye Diseases
  mesh term: Graves Ophthalmopathy
  mesh term: Thyroid Diseases