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/NCT06007677</url>
    </required_header>
    <id_info>
      <org_study_id>STAR-0215-202</org_study_id>
      <secondary_id>2023-506540-16</secondary_id>
      <nct_id>NCT06007677</nct_id>
    </id_info>
    <brief_title>A Long-term Study of STAR-0215 in Participants With Hereditary Angioedema</brief_title>
    <official_title>A Phase 2 Long-Term Open-Label Trial to Assess the Safety and Efficacy of Repeat Dosing of STAR-0215 in Adult Patients With Hereditary Angioedema (The ALPHA-SOLAR Trial)</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Astria Therapeutics, Inc.</agency>
        <agency_class>Industry</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Astria Therapeutics, Inc.</source>
    <oversight_info>
      <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        The goal of this trial is to enable the collection of information about long-term safety and&#xD;
        clinical activity of STAR-0215 in participants with hereditary angioedema (HAE). Participants&#xD;
        will receive repeat doses of STAR-0215. The trial will continue for up to 5 years.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 2023</start_date>
    <completion_date type="Anticipated">October 2029</completion_date>
    <primary_completion_date type="Anticipated">October 2029</primary_completion_date>
    <phase>Phase 2</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Non-Randomized</allocation>
      <intervention_model>Parallel Assignment</intervention_model>
      <primary_purpose>Treatment</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Number of Participants Experiencing Treatment-emergent Adverse Events</measure>
      <time_frame>Day 1 through up to 5 years</time_frame>
    </primary_outcome>
    <secondary_outcome>
      <measure>Change From Baseline in Monthly HAE Attack Rate</measure>
      <time_frame>Day 1, up to 5 years</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Severity of HAE Attacks Experienced by Participants</measure>
      <time_frame>Day 1 through up to 5 years</time_frame>
      <description>All HAE attacks will be classified according to severity (mild, moderate, and severe).</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Duration of HAE Attacks</measure>
      <time_frame>Day 1 through up to 5 years</time_frame>
      <description>Duration will be reported as shorter than 12 hours, 12 to 24 hours, 24 to 48 hours, and longer than 48 hours.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Number of Participants Experiencing HAE Attacks Requiring On-demand Therapy</measure>
      <time_frame>Day 1 through up to 5 years</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Time to First HAE Attack After First and Last Dosing</measure>
      <time_frame>Day 1 through up to 5 years</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Number of HAE Attack-free Days</measure>
      <time_frame>Day 1 through up to 5 years</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Number of Participants Experiencing Zero HAE Attacks</measure>
      <time_frame>Day 1 through up to 5 years</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Serum Concentration of STAR-0215</measure>
      <time_frame>Every 3 months for first 2 years, Every 6 months for next 3 years</time_frame>
      <description>Blood samples will be collected on dosing days to measure the serum concentration of STAR-0215.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Plasma Levels of Cleaved High-molecular-weight Kininogen</measure>
      <time_frame>Every 3 months for first 2 years, Every 6 months for next 3 years</time_frame>
      <description>Blood samples will be collected on dosing days to measure the plasma levels of cleaved high-molecular-weight kininogen (a measure of plasma kallikrein activity).</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Number of Participants with Anti-drug Antibodies to STAR-0215</measure>
      <time_frame>Every 3 months for first 2 years, Every 6 months for next 3 years</time_frame>
      <description>Blood samples will be collected on dosing days to assess the formation of STAR-0215 anti-drug antibodies in serum.</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">56</enrollment>
    <condition>Hereditary Angioedema</condition>
    <arm_group>
      <arm_group_label>Dose Regimen 1: STAR-0215</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Participants will receive STAR-0215 every 3 months.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Dose Regimen 2: STAR-0215</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Participants will receive STAR-0215 every 6 months.</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>STAR-0215</intervention_name>
      <description>STAR-0215 will be administered as a subcutaneous injection.</description>
      <arm_group_label>Dose Regimen 1: STAR-0215</arm_group_label>
      <arm_group_label>Dose Regimen 2: STAR-0215</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
          - Open to participants from STAR-0215-201 (NCT05695248) who have met one of the following&#xD;
          conditions:&#xD;
  &#xD;
            -  Completed STAR-0215-201 (follow up through 6 months after their last dose);&#xD;
  &#xD;
            -  Eligible for STAR-0215-201 and entered the Run-In period but did not qualify for the&#xD;
               Treatment Period because they did not meet the criterion for the minimum number of HAE&#xD;
               attacks;&#xD;
  &#xD;
            -  Eligible for STAR-0215-201 and entered the Run-In period but did not complete it for&#xD;
               reasons other than not meeting the criterion for the minimum number of HAE attacks&#xD;
               (eligibility requires consultation with the Medical Monitor); or&#xD;
  &#xD;
            -  Discontinued STAR-0215-201 (for reasons other than safety) after having completed at&#xD;
               least 84 days of trial follow-up since their last dose of STAR-0215 (eligibility&#xD;
               requires consultation with the Medical Monitor).&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Any concomitant diagnosis of another form of chronic angioedema, such as acquired C1&#xD;
               inhibitor deficiency, HAE with normal C1-esterase inhibitor protein (also known as HAE&#xD;
               Type III), idiopathic angioedema, or angioedema associated with urticaria.&#xD;
  &#xD;
            -  Any exposure to angiotensin-converting enzyme inhibitors or any estrogen-containing&#xD;
               medications with systemic absorption (such as hormonal contraceptives or hormone&#xD;
               replacement therapy) within 28 days prior to Screening&#xD;
  &#xD;
            -  Any exposure to androgens (for example, stanozolol, danazol, oxandrolone,&#xD;
               methyltestosterone, testosterone) within 7 days prior to Screening.&#xD;
  &#xD;
            -  Use of therapies prescribed for the prevention of HAE attacks prior to Screening:&#xD;
  &#xD;
                 -  lanadelumab within 90 days&#xD;
  &#xD;
                 -  berotralstat within 21 days&#xD;
  &#xD;
                 -  all other prophylactic therapies, discuss with the Medical Monitor&#xD;
  &#xD;
          Note: Other inclusion and exclusion criteria may apply.&#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_contact>
      <last_name>Christopher Morabito, MD</last_name>
      <phone>1-617-349-1971</phone>
      <email>cmorabito@astriatx.com</email>
    </overall_contact>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 17, 2023</study_first_submitted>
    <study_first_submitted_qc>August 17, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 23, 2023</study_first_posted>
    <last_update_submitted>August 17, 2023</last_update_submitted>
    <last_update_submitted_qc>August 17, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 23, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>HAE</keyword>
    <keyword>Angioedema</keyword>
    <keyword>Long-term</keyword>
    <keyword>Safety</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Angioedema</mesh_term>
      <mesh_term>Angioedemas, Hereditary</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/NCT06007677
  org study id: STAR-0215-202
  secondary id: 2023-506540-16
  nct id: NCT06007677
  lead sponsor: 
  is fda regulated drug: Yes
  is fda regulated device: No
  The goal of this trial is to enable the collection of information about long-term safety and
        clinical activity of STAR-0215 in participants with hereditary angioedema (HAE). Participants
        will receive repeat doses of STAR-0215. The trial will continue for up to 5 years.
  allocation: Non-Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: None (Open Label)
  measure: Number of Participants Experiencing Treatment-emergent Adverse Events
  time frame: Day 1 through up to 5 years
  measure: Change From Baseline in Monthly HAE Attack Rate
  time frame: Day 1, up to 5 years
  measure: Severity of HAE Attacks Experienced by Participants
  time frame: Day 1 through up to 5 years
  description: All HAE attacks will be classified according to severity (mild, moderate, and severe).
  measure: Duration of HAE Attacks
  time frame: Day 1 through up to 5 years
  description: Duration will be reported as shorter than 12 hours, 12 to 24 hours, 24 to 48 hours, and longer than 48 hours.
  measure: Number of Participants Experiencing HAE Attacks Requiring On-demand Therapy
  time frame: Day 1 through up to 5 years
  measure: Time to First HAE Attack After First and Last Dosing
  time frame: Day 1 through up to 5 years
  measure: Number of HAE Attack-free Days
  time frame: Day 1 through up to 5 years
  measure: Number of Participants Experiencing Zero HAE Attacks
  time frame: Day 1 through up to 5 years
  measure: Serum Concentration of STAR-0215
  time frame: Every 3 months for first 2 years, Every 6 months for next 3 years
  description: Blood samples will be collected on dosing days to measure the serum concentration of STAR-0215.
  measure: Plasma Levels of Cleaved High-molecular-weight Kininogen
  time frame: Every 3 months for first 2 years, Every 6 months for next 3 years
  description: Blood samples will be collected on dosing days to measure the plasma levels of cleaved high-molecular-weight kininogen (a measure of plasma kallikrein activity).
  measure: Number of Participants with Anti-drug Antibodies to STAR-0215
  time frame: Every 3 months for first 2 years, Every 6 months for next 3 years
  description: Blood samples will be collected on dosing days to assess the formation of STAR-0215 anti-drug antibodies in serum.
  arm group label: Dose Regimen 1: STAR-0215
  arm group type: Experimental
  description: Participants will receive STAR-0215 every 3 months.
  arm group label: Dose Regimen 2: STAR-0215
  arm group type: Experimental
  description: Participants will receive STAR-0215 every 6 months.
  intervention type: Drug
  intervention name: STAR-0215
  description: STAR-0215 will be administered as a subcutaneous injection.
  arm group label: Dose Regimen 1: STAR-0215
  arm group label: Dose Regimen 2: STAR-0215
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Christopher Morabito, MD
  phone: 1-617-349-1971
  email: cmorabito@astriatx.com
  responsible party type: Sponsor
  mesh term: Angioedema
  mesh term: Angioedemas, Hereditary
  sharing ipd: No