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/NCT06018428</url>
    </required_header>
    <id_info>
      <org_study_id>ADX-914-203</org_study_id>
      <secondary_id>SIGNAL-AA</secondary_id>
      <nct_id>NCT06018428</nct_id>
    </id_info>
    <brief_title>Randomized, Double-Blind, Placebo-Controlled Phase 2a, Proof-of-Concept Trial of ADX-914 Phase 2a Trial for the Treatment of Severe Alopecia Areata</brief_title>
    <acronym>SIGNAL-AA</acronym>
    <official_title>A Phase 2a, Randomized, Double-blind, Placebo-Controlled, Proof-of-Concept Trial of ADX-914 for the Treatment of Severe Alopecia Areata</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Q32 Bio Inc.</agency>
        <agency_class>Industry</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Innovaderm Research</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>Q32 Bio 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>
        This is a Phase IIa, Randomized, Double-blind, Placebo-controlled, multi-center&#xD;
        Proof-of-Concept (POC) Trial in subjects with severe Alopecia Areata.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        This is a Phase IIa, Randomized, Double-blind, Placebo-controlled, multi-center&#xD;
        Proof-of-Concept (POC) study in adult subjects with severe Alopecia Areata (AA). ADX-914 or&#xD;
        matching placebo is administered subcutaneously in the clinic setting every 2 weeks for 24&#xD;
        weeks, with follow-up for 12 weeks. Subjects will be randomized 3:1 to drug vs placebo.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">August 28, 2023</start_date>
    <completion_date type="Anticipated">September 2024</completion_date>
    <primary_completion_date type="Anticipated">June 2024</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>Parallel Assignment</intervention_model>
      <primary_purpose>Treatment</primary_purpose>
      <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Mean relative percent change in SALT score.</measure>
      <time_frame>24 Weeks</time_frame>
    </primary_outcome>
    <secondary_outcome>
      <measure>Mean relative percentage change SALT score compared with baseline at Weeks 6,12, and 18.</measure>
      <time_frame>18 Weeks</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Mean relative percentage change in SALT score at 24 weeks compared with treatment nadir.</measure>
      <time_frame>24 Weeks</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Absolute change in SALT score compared with baseline at Weeks 6, 12, 18, and 24.</measure>
      <time_frame>24 Weeks</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Proportion of participants who achieve ≥30% and ≥50% relative reduction in SALT score compared with baseline at Weeks 12, 18, and 24.</measure>
      <time_frame>24 Weeks</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Proportion of participants with absolute SALT score ≤5, ≤10, ≤20, and ≤30 at Weeks 12, 18, and 24.</measure>
      <time_frame>24 Weeks</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Overall Safety as evaluated by number of adverse events (AEs).</measure>
      <time_frame>40 Weeks</time_frame>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">40</enrollment>
    <condition>Alopecia Areata</condition>
    <arm_group>
      <arm_group_label>Experimental: ADX-914</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>200mg dose of ADX-914 administered via injection under the skin every 2 weeks for a total of 24 weeks.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Placebo Comparator</arm_group_label>
      <arm_group_type>Placebo Comparator</arm_group_type>
      <description>ADX-914 matched placebo administered via injection under the skin every 2 weeks for a total of 24 weeks.</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>ADX-914</intervention_name>
      <description>Subcutaneous administration of ADX-914</description>
      <arm_group_label>Experimental: ADX-914</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Placebo</intervention_name>
      <description>Subcutaneous administration of placebo</description>
      <arm_group_label>Placebo Comparator</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Key Inclusion Criteria:&#xD;
  &#xD;
            1. Age 18 to 75 years, inclusive, at time of informed consent, with severe AA (duration&#xD;
               of current episode of hair loss &gt;6 months and &lt;10 years)&#xD;
  &#xD;
            2. Moderate to severe disease activity at baseline and screening defined as:&#xD;
  &#xD;
                 1. SALT score ≥ 50%&#xD;
  &#xD;
          Key Exclusion Criteria:&#xD;
  &#xD;
            1. Body weight &lt;48 kg or &gt;105 kg at screening.&#xD;
  &#xD;
            2. Active forms of other inflammatory skin disease(s) or evidence of other skin&#xD;
               conditions (eg, psoriasis, seborrheic dermatitis, lupus) at the time of screening and&#xD;
               through Day 1 that, in the opinion of the investigator, may interfere with evaluation&#xD;
               of AA and the assessment of the disease activity measures&#xD;
  &#xD;
            3. History of or diagnosis at screening of another form of alopecia based on assessment&#xD;
               by investigator (except for androgenic alopecia).&#xD;
  &#xD;
            4. History of male or female pattern hair loss of Hamilton stage &gt;III or Ludwig stage&#xD;
               &gt;II.&#xD;
  &#xD;
            5. History (lifetime) or presence of hair transplants.&#xD;
  &#xD;
            6. History (lifetime) or presence of micropigmentation of the scalp (Note: Microblading&#xD;
               of the eyebrows is permitted).&#xD;
  &#xD;
            7. Use of systemic, topical, or device-based therapy for AA.&#xD;
  &#xD;
            8. History of, recent, or current clinically serious viral, bacterial, fungal, or&#xD;
               parasitic infection or mycobacterial infection or at risk of serious infection.&#xD;
  &#xD;
            9. A positive QuantiFERON®TB Gold test at Screening or history of tuberculosis (TB)&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>75 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>Kristin Orr</last_name>
      <phone>9193950132</phone>
      <email>korr@q32bio.com</email>
    </overall_contact>
    <location>
      <facility>
        <name>Houston, Texas</name>
        <address>
          <city>Houston</city>
          <state>Texas</state>
          <zip>77056</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Kristin Orr</last_name>
        <email>korr@q32bio.com</email>
      </contact>
    </location>
    <location>
      <facility>
        <name>Spokane, Washington</name>
        <address>
          <city>Spokane</city>
          <state>Washington</state>
          <zip>99202</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Kristin Orr</last_name>
        <email>korr@q32bio.com</email>
      </contact>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>August 15, 2023</study_first_submitted>
    <study_first_submitted_qc>August 23, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 30, 2023</study_first_posted>
    <last_update_submitted>September 12, 2023</last_update_submitted>
    <last_update_submitted_qc>September 12, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 14, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Areata, Alopecia</keyword>
    <keyword>Alopecia</keyword>
    <keyword>Dermatitis</keyword>
    <keyword>Hair Loss</keyword>
    <keyword>Trichoscopy</keyword>
    <keyword>Atopic</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Alopecia</mesh_term>
      <mesh_term>Alopecia Areata</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/NCT06018428
  org study id: ADX-914-203
  secondary id: SIGNAL-AA
  nct id: NCT06018428
  lead sponsor: 
  collaborator: 
  has dmc: No
  is fda regulated drug: Yes
  is fda regulated device: No
  This is a Phase IIa, Randomized, Double-blind, Placebo-controlled, multi-center
        Proof-of-Concept (POC) Trial in subjects with severe Alopecia Areata.
  This is a Phase IIa, Randomized, Double-blind, Placebo-controlled, multi-center
        Proof-of-Concept (POC) study in adult subjects with severe Alopecia Areata (AA). ADX-914 or
        matching placebo is administered subcutaneously in the clinic setting every 2 weeks for 24
        weeks, with follow-up for 12 weeks. Subjects will be randomized 3:1 to drug vs placebo.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  measure: Mean relative percent change in SALT score.
  time frame: 24 Weeks
  measure: Mean relative percentage change SALT score compared with baseline at Weeks 6,12, and 18.
  time frame: 18 Weeks
  measure: Mean relative percentage change in SALT score at 24 weeks compared with treatment nadir.
  time frame: 24 Weeks
  measure: Absolute change in SALT score compared with baseline at Weeks 6, 12, 18, and 24.
  time frame: 24 Weeks
  measure: Proportion of participants who achieve ≥30% and ≥50% relative reduction in SALT score compared with baseline at Weeks 12, 18, and 24.
  time frame: 24 Weeks
  measure: Proportion of participants with absolute SALT score ≤5, ≤10, ≤20, and ≤30 at Weeks 12, 18, and 24.
  time frame: 24 Weeks
  measure: Overall Safety as evaluated by number of adverse events (AEs).
  time frame: 40 Weeks
  arm group label: Experimental: ADX-914
  arm group type: Experimental
  description: 200mg dose of ADX-914 administered via injection under the skin every 2 weeks for a total of 24 weeks.
  arm group label: Placebo Comparator
  arm group type: Placebo Comparator
  description: ADX-914 matched placebo administered via injection under the skin every 2 weeks for a total of 24 weeks.
  intervention type: Drug
  intervention name: ADX-914
  description: Subcutaneous administration of ADX-914
  arm group label: Experimental: ADX-914
  intervention type: Drug
  intervention name: Placebo
  description: Subcutaneous administration of placebo
  arm group label: Placebo Comparator
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 75 Years
  healthy volunteers: No
  last name: Kristin Orr
  phone: 9193950132
  email: korr@q32bio.com
  facility: 
  status: Recruiting
  contact: 
  facility: 
  status: Recruiting
  contact: 
  country: United States
  responsible party type: Sponsor
  mesh term: Alopecia
  mesh term: Alopecia Areata