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/NCT06012240</url>
    </required_header>
    <id_info>
      <org_study_id>M23-716</org_study_id>
      <secondary_id>2023-505061-82-00</secondary_id>
      <nct_id>NCT06012240</nct_id>
    </id_info>
    <brief_title>A Study to Evaluate the Safety and Effectiveness of Upadacitinib Tablets in Adult and Adolescent Participants With Severe Alopecia Areata</brief_title>
    <acronym>Up-AA</acronym>
    <official_title>A Phase 3 Randomized, Placebo-controlled, Double-blind Program to Evaluate Efficacy and Safety of Upadacitinib in Adult and Adolescent Subjects With Severe Alopecia Areata</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>AbbVie</agency>
        <agency_class>Industry</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>AbbVie</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>Yes</is_us_export>
    </oversight_info>
    <brief_summary>
      <textblock>
        Alopecia areata (AA) is a disease that happens when the immune system attacks hair follicles&#xD;
        and causes hair loss. AA usually affects the head and face, but hair loss can happen on any&#xD;
        part of the body. The purpose of this study is to assess how safe, effective, and tolerable&#xD;
        upadacitinib is in adolescent and adult participants with severe AA.&#xD;
  &#xD;
        Upadacitinib is an approved drug being investigated for the treatment of AA. In Study 1 and&#xD;
        Study 2 Period A, participants are placed in 1 of 3 groups, called treatment arms. Each group&#xD;
        receives a different treatment. There is a 1 in 5 chance that participants will be assigned&#xD;
        to placebo. In Study 1 and Study 2 Period B, participants originally randomized to&#xD;
        upadacitinib dose group in Period A will continue their same treatment in Period B.&#xD;
        Participants originally randomized to Placebo in Period A will either remain on placebo in&#xD;
        Period B, or be randomized in 1 of 2 groups, based off of their Severity of Alopecia Tool&#xD;
        (SALT) score. Participants who complete Study 1 or Study 2, can join Study 3 and may be&#xD;
        re-randomized to receive 1 of 2 doses of upadacitinib for up to 108 weeks. Around 1500&#xD;
        participants with severe AA will be enrolled in the study at approximately 240 sites&#xD;
        worldwide.&#xD;
  &#xD;
        Participants will receive oral tablets of either upadacitinib or placebo once daily for up to&#xD;
        160 weeks with the potential of being re-randomized into a different treatment group at Weeks&#xD;
        24 and 52. Participants will be followed up for up to 30 days after last study drug dose.&#xD;
  &#xD;
        There may be higher treatment burden for participants in this trial compared to their&#xD;
        standard of care. Participants will attend regular visits during the study at a hospital or&#xD;
        clinic. The effect of the treatment will be checked by medical assessments, blood tests,&#xD;
        checking for side effects and completing questionnaires.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">October 26, 2023</start_date>
    <completion_date type="Anticipated">January 3, 2028</completion_date>
    <primary_completion_date type="Anticipated">May 26, 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>Sequential 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 with the Achievement of Severity of Alopecia Tool (SALT) Score &lt;= 20</measure>
      <time_frame>Week 24</time_frame>
      <description>The SALT is a global AA severity score based on the combination of extent and density of scalp hair loss. The score is determined by visually defining the amount of terminal hair loss in each of the 4 views of the scalp (left and right side each accounting for 18% of scalp area, the top for 40%, and the back for 24%) and adding these together with a maximum score of 100%.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Percentage of Participants with the Achievement of SALT Score &lt;= 10</measure>
      <time_frame>Week 24</time_frame>
      <description>The SALT is a global AA severity score based on the combination of extent and density of scalp hair loss. The score is determined by visually defining the amount of terminal hair loss in each of the 4 views of the scalp (left and right side each accounting for 18% of scalp area, the top for 40%, and the back for 24%) and adding these together with a maximum score of 100%.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Percentage of Participants with the Achievement of SALT Score &lt;= 20</measure>
      <time_frame>Up to Week 12</time_frame>
      <description>The SALT is a global AA severity score based on the combination of extent and density of scalp hair loss. The score is determined by visually defining the amount of terminal hair loss in each of the 4 views of the scalp (left and right side each accounting for 18% of scalp area, the top for 40%, and the back for 24%) and adding these together with a maximum score of 100%.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Percentage of Participants with the Achievement of Clinician-Reported Outcome (ClinRO) Measure for Eyebrow Hair Loss of 0 or 1</measure>
      <time_frame>Baseline to Week 24</time_frame>
      <description>The ClinRO for Eyebrow Hair Loss is a 4-point response scale where 0 = The eyebrows have full coverage and no areas of hair loss and 3 = No notable eyebrows. Responses should have a ≥ 2-point improvement from Baseline among participants with Baseline score ≥ 2.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Percentage of Participants with the Achievement of ClinRO Measure for Eyelash Hair Loss of 0 or 1</measure>
      <time_frame>Baseline to Week 24</time_frame>
      <description>The ClinRO for Eyebrow Hair Loss is a 4-point response scale where 0 = The eyelashes form a continuous line along the eyelids on both eyes and 3 = No notable eyelashes. Responses should have a ≥ 2-point improvement from Baseline among participants with Baseline score ≥ 2.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Percentage of Participants with the Achievement of SALT 75</measure>
      <time_frame>Baseline to Week 24</time_frame>
      <description>SALT 75 is defined as at least a 75% improvement [decrease] from Baseline in SALT score.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Percentage of Participants with the Achievement of SALT 90</measure>
      <time_frame>Baseline to Week 24</time_frame>
      <description>SALT 90 is defined as at least a 90% improvement [decrease] from Baseline in SALT score.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Percent Change from Baseline in SALT Score</measure>
      <time_frame>Baseline to Week 24</time_frame>
      <description>The SALT is a global AA severity score based on the combination of extent and density of scalp hair loss. The score is determined by visually defining the amount of terminal hair loss in each of the 4 views of the scalp (left and right side each accounting for 18% of scalp area, the top for 40%, and the back for 24%) and adding these together with a maximum score of 100%.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Percentage of Participants with the Achievement of Patients' Global Impression of Change of Alopecia Areata (PaGIC-AA) Score of 1 &quot;Much Better&quot; or 2 &quot;Moderately Better&quot;</measure>
      <time_frame>Up to Week 24</time_frame>
      <description>The PaGIC-AA is a single-item measure that asks participants to rate how their alopecia condition has changed overall since the start of the study using a 7-point scale. Responses range from &quot;much better&quot; to &quot;much worse.&quot;</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Percentage of Participants with the Achievement of Patient-Reported Outcome (PRO) for Scalp Hair Assessment 0/1 with ≥ 2-Point Improvement (Reduction)</measure>
      <time_frame>Baseline to Week 24</time_frame>
      <description>The PRO for Scalp Hair Assessment is single item, five-point, categorical response scale that asks respondents to look in the mirror and assess the total area of the scalp with missing hair. Response items range from &quot;No missing hair&quot; to &quot;Nearly all or all&quot; and includes percentage ranges for each category (0%, 1 to 20%, 21 to 49%, 50 to 94%, and 95 to 100%). Responses among participants with baseline score &gt;=3.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Percentage of Participants with the Achievement of SALT Score 0</measure>
      <time_frame>Week 24</time_frame>
      <description>The SALT is a global AA severity score based on the combination of extent and density of scalp hair loss. The score is determined by visually defining the amount of terminal hair loss in each of the 4 views of the scalp (left and right side each accounting for 18% of scalp area, the top for 40%, and the back for 24%) and adding these together with a maximum score of 100%.</description>
    </secondary_outcome>
    <number_of_arms>17</number_of_arms>
    <enrollment type="Anticipated">1500</enrollment>
    <condition>Alopecia Areata</condition>
    <arm_group>
      <arm_group_label>Study 1: Group 1 Upadacitinib Dose A</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Participants will receive upadacitinib Dose A once daily for 52 weeks in Period A and Period B.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Study 1: Group 2 Upadacitinib Dose B</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Participants will receive upadacitinib Dose B once daily for 52 weeks in Period A and Period B.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Study 1: Group 3 Placebo</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Participants will receive matching placebo once daily for 24 weeks in Period A.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Study 1: Group 4 Upadacitinib Dose A</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Participants initially randomized to placebo (Period A) with a SALT score &gt; 20 at Week 24 will be re-randomized to receive upadacitinib Dose A once daily for 28 weeks in Period B.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Study 1: Group 5 Upadacitinib Dose B</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Participants initially randomized to placebo (Period A) with a SALT score &gt; 20 at Week 24 will be re-randomized to receive upadacitinib Dose B once daily for 28 weeks in Period B.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Study 1: Group 6 Placebo</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Participants initially randomized to placebo with a SALT score ≤ 20 at Week 24 will continue on placebo through Week 52.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Study 2: Group 1 Upadacitinib Dose A</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Participants will receive upadacitinib Dose A once daily for 52 weeks in Period A and Period B.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Study 2: Group 2 Upadacitinib Dose B</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Participants will receive upadacitinib Dose B once daily for 52 weeks in Period A and Period B.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Study 2: Group 3 Placebo</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Participants will receive matching placebo once daily for 24 weeks in Period A.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Study 2: Group 4 Upadacitinib Dose A</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Participants initially randomized to placebo (Period A) with a SALT score &gt; 20 at Week 24 will be re-randomized to receive upadacitinib Dose A once daily for 28 weeks in Period B.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Study 2: Group 5 Upadacitinib Dose B</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Participants initially randomized to placebo (Period A) with a SALT score &gt; 20 at Week 24 will be re-randomized to receive upadacitinib Dose B once daily for 28 weeks in Period B.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Study 2: Group 6 Placebo</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Participants initially randomized to placebo with a SALT score ≤ 20 at Week 24 will continue on placebo through Week 52.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Study 3: Group 1 Upadacitinib Dose B (SALT &gt; 20)</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Participants receiving upadacitinib Dose A with a SALT score &gt; 20 at Week 52 (end of Period B) of Study 1 or Study 2 will dose escalate to upadacitinib Dose B once daily for 108 weeks.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Study 3: Group 2 Upadacitinib Dose A (SALT ≤ 20)</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Participants receiving upadacitinib Dose A with a SALT score ≤ 20 at Week 52 (end of Period B) of Study 1 or Study 2 will remain on upadacitinib Dose A once daily for 108 weeks.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Study 3: Group 3 Upadacitinib Dose B (Non-Sustained)</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Participants who end Period B on upadacitinib Dose B with a with a SALT score &gt; 20 at Week 40 or Week 52 of Study 1 or Study 2 will remain on upadacitinib Dose B once daily for 108 weeks.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Study 3: Group 4 Upadacitinib Dose B (Sustained)</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Participants who end Period B on upadacitinib Dose B with a with a SALT score ≤ 20 at Week 40 and Week 52 of Study 1 or Study 2 will be re-randomized to receive upadacitinib Dose B once daily for 108 weeks.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Study 3: Group 5 Upadacitinib Dose A (Sustained)</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Participants who end Period B on upadacitinib Dose B with a with a SALT score ≤ 20 at Week 40 and Week 52 of Study 1 or Study 2 will be re-randomized to receive upadacitinib Dose A once daily for 108 weeks.</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Upadacitinib</intervention_name>
      <description>Oral Tablets</description>
      <arm_group_label>Study 1: Group 1 Upadacitinib Dose A</arm_group_label>
      <arm_group_label>Study 1: Group 2 Upadacitinib Dose B</arm_group_label>
      <arm_group_label>Study 1: Group 4 Upadacitinib Dose A</arm_group_label>
      <arm_group_label>Study 1: Group 5 Upadacitinib Dose B</arm_group_label>
      <arm_group_label>Study 2: Group 1 Upadacitinib Dose A</arm_group_label>
      <arm_group_label>Study 2: Group 2 Upadacitinib Dose B</arm_group_label>
      <arm_group_label>Study 2: Group 4 Upadacitinib Dose A</arm_group_label>
      <arm_group_label>Study 2: Group 5 Upadacitinib Dose B</arm_group_label>
      <arm_group_label>Study 3: Group 1 Upadacitinib Dose B (SALT &gt; 20)</arm_group_label>
      <arm_group_label>Study 3: Group 2 Upadacitinib Dose A (SALT ≤ 20)</arm_group_label>
      <arm_group_label>Study 3: Group 3 Upadacitinib Dose B (Non-Sustained)</arm_group_label>
      <arm_group_label>Study 3: Group 4 Upadacitinib Dose B (Sustained)</arm_group_label>
      <arm_group_label>Study 3: Group 5 Upadacitinib Dose A (Sustained)</arm_group_label>
      <other_name>Rinvoq</other_name>
      <other_name>ABT-494</other_name>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Placebo</intervention_name>
      <description>Oral Tablets</description>
      <arm_group_label>Study 1: Group 3 Placebo</arm_group_label>
      <arm_group_label>Study 1: Group 4 Upadacitinib Dose A</arm_group_label>
      <arm_group_label>Study 1: Group 5 Upadacitinib Dose B</arm_group_label>
      <arm_group_label>Study 1: Group 6 Placebo</arm_group_label>
      <arm_group_label>Study 2: Group 3 Placebo</arm_group_label>
      <arm_group_label>Study 2: Group 4 Upadacitinib Dose A</arm_group_label>
      <arm_group_label>Study 2: Group 5 Upadacitinib Dose B</arm_group_label>
      <arm_group_label>Study 2: Group 6 Placebo</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Adult individuals &lt; 64 years old at Baseline Visit. Where permitted outside United&#xD;
               States (OUS), adolescent individuals who are at least 12 years old at Screening may&#xD;
               participate.&#xD;
  &#xD;
            -  Diagnosis of severe AA with SALT score ≥ 50 scalp hair loss at Screening and Baseline.&#xD;
  &#xD;
            -  Severe AA with no spontaneous scalp hair regrowth over the past 6 months AND no&#xD;
               significant scalp hair loss over the past 3 months.&#xD;
  &#xD;
            -  Current episode of AA of less than 8 years.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Diagnosis of primarily diffuse type of AA.&#xD;
  &#xD;
            -  Diagnosis of other types of alopecia that would interfere with evaluation of AA,&#xD;
               including but not limited to female pattern hair loss, male pattern hair loss&#xD;
               (androgenetic alopecia) Stage III or greater based on Hamilton-Norwood classification,&#xD;
               traction alopecia, lichen planopilaris (LPP), discoid lupus, frontal fibrosing&#xD;
               alopecia (FFA), central centrifugal cicatricial alopecia (CCCA), folliculitis&#xD;
               decalvans, trichotillomania, and telogen effluvium.&#xD;
  &#xD;
            -  Diagnosis of other types of inflammatory scalp, eyebrow, or eyelash disorders that&#xD;
               would interfere with evaluation of AA, including but not limited to seborrheic&#xD;
               dermatitis, scalp psoriasis, atopic dermatitis (AD), and tinea capitis.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>12 Years</minimum_age>
      <maximum_age>63 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>ABBVIE INC.</last_name>
      <role>Study Director</role>
      <affiliation>AbbVie</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>ABBVIE CALL CENTER</last_name>
      <phone>844-663-3742</phone>
      <email>abbvieclinicaltrials@abbvie.com</email>
    </overall_contact>
    <link>
      <url>https://www.abbvieclinicaltrials.com/study/?id=M23-716</url>
      <description>Related Info</description>
    </link>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 22, 2023</study_first_submitted>
    <study_first_submitted_qc>August 22, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 25, 2023</study_first_posted>
    <last_update_submitted>August 22, 2023</last_update_submitted>
    <last_update_submitted_qc>August 22, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 25, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Alopecia Areata</keyword>
    <keyword>Upadacitinib</keyword>
    <keyword>Rinvoq</keyword>
    <keyword>ABT-494</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>
    <intervention_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Upadacitinib</mesh_term>
    </intervention_browse>
    <patient_data>
      <sharing_ipd>Yes</sharing_ipd>
      <ipd_description>AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols, analyses plans, clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.</ipd_description>
      <ipd_info_type>Study Protocol</ipd_info_type>
      <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
      <ipd_info_type>Clinical Study Report (CSR)</ipd_info_type>
      <ipd_time_frame>For details on when studies are available for sharing visit https://vivli.org/ourmember/abbvie/</ipd_time_frame>
      <ipd_access_criteria>Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous independent scientific research, and will be provided following review and approval of a research proposal and statistical analysis plan and execution of a data sharing statement. Data requests can be submitted at any time after approval in the US and/or EU and a primary manuscript is accepted for publication. For more information on the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/</ipd_access_criteria>
      <ipd_url>https://vivli.org/ourmember/abbvie/</ipd_url>
    </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/NCT06012240
  org study id: M23-716
  secondary id: 2023-505061-82-00
  nct id: NCT06012240
  lead sponsor: 
  has dmc: Yes
  is fda regulated drug: Yes
  is fda regulated device: No
  is us export: Yes
  Alopecia areata (AA) is a disease that happens when the immune system attacks hair follicles
        and causes hair loss. AA usually affects the head and face, but hair loss can happen on any
        part of the body. The purpose of this study is to assess how safe, effective, and tolerable
        upadacitinib is in adolescent and adult participants with severe AA.
  
        Upadacitinib is an approved drug being investigated for the treatment of AA. In Study 1 and
        Study 2 Period A, participants are placed in 1 of 3 groups, called treatment arms. Each group
        receives a different treatment. There is a 1 in 5 chance that participants will be assigned
        to placebo. In Study 1 and Study 2 Period B, participants originally randomized to
        upadacitinib dose group in Period A will continue their same treatment in Period B.
        Participants originally randomized to Placebo in Period A will either remain on placebo in
        Period B, or be randomized in 1 of 2 groups, based off of their Severity of Alopecia Tool
        (SALT) score. Participants who complete Study 1 or Study 2, can join Study 3 and may be
        re-randomized to receive 1 of 2 doses of upadacitinib for up to 108 weeks. Around 1500
        participants with severe AA will be enrolled in the study at approximately 240 sites
        worldwide.
  
        Participants will receive oral tablets of either upadacitinib or placebo once daily for up to
        160 weeks with the potential of being re-randomized into a different treatment group at Weeks
        24 and 52. Participants will be followed up for up to 30 days after last study drug dose.
  
        There may be higher treatment burden for participants in this trial compared to their
        standard of care. Participants will attend regular visits during the study at a hospital or
        clinic. The effect of the treatment will be checked by medical assessments, blood tests,
        checking for side effects and completing questionnaires.
  allocation: Randomized
  intervention model: Sequential Assignment
  primary purpose: Treatment
  masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  measure: Percentage of Participants with the Achievement of Severity of Alopecia Tool (SALT) Score <= 20
  time frame: Week 24
  description: The SALT is a global AA severity score based on the combination of extent and density of scalp hair loss. The score is determined by visually defining the amount of terminal hair loss in each of the 4 views of the scalp (left and right side each accounting for 18% of scalp area, the top for 40%, and the back for 24%) and adding these together with a maximum score of 100%.
  measure: Percentage of Participants with the Achievement of SALT Score <= 10
  time frame: Week 24
  description: The SALT is a global AA severity score based on the combination of extent and density of scalp hair loss. The score is determined by visually defining the amount of terminal hair loss in each of the 4 views of the scalp (left and right side each accounting for 18% of scalp area, the top for 40%, and the back for 24%) and adding these together with a maximum score of 100%.
  measure: Percentage of Participants with the Achievement of SALT Score <= 20
  time frame: Up to Week 12
  description: The SALT is a global AA severity score based on the combination of extent and density of scalp hair loss. The score is determined by visually defining the amount of terminal hair loss in each of the 4 views of the scalp (left and right side each accounting for 18% of scalp area, the top for 40%, and the back for 24%) and adding these together with a maximum score of 100%.
  measure: Percentage of Participants with the Achievement of Clinician-Reported Outcome (ClinRO) Measure for Eyebrow Hair Loss of 0 or 1
  time frame: Baseline to Week 24
  description: The ClinRO for Eyebrow Hair Loss is a 4-point response scale where 0 = The eyebrows have full coverage and no areas of hair loss and 3 = No notable eyebrows. Responses should have a ≥ 2-point improvement from Baseline among participants with Baseline score ≥ 2.
  measure: Percentage of Participants with the Achievement of ClinRO Measure for Eyelash Hair Loss of 0 or 1
  time frame: Baseline to Week 24
  description: The ClinRO for Eyebrow Hair Loss is a 4-point response scale where 0 = The eyelashes form a continuous line along the eyelids on both eyes and 3 = No notable eyelashes. Responses should have a ≥ 2-point improvement from Baseline among participants with Baseline score ≥ 2.
  measure: Percentage of Participants with the Achievement of SALT 75
  time frame: Baseline to Week 24
  description: SALT 75 is defined as at least a 75% improvement [decrease] from Baseline in SALT score.
  measure: Percentage of Participants with the Achievement of SALT 90
  time frame: Baseline to Week 24
  description: SALT 90 is defined as at least a 90% improvement [decrease] from Baseline in SALT score.
  measure: Percent Change from Baseline in SALT Score
  time frame: Baseline to Week 24
  description: The SALT is a global AA severity score based on the combination of extent and density of scalp hair loss. The score is determined by visually defining the amount of terminal hair loss in each of the 4 views of the scalp (left and right side each accounting for 18% of scalp area, the top for 40%, and the back for 24%) and adding these together with a maximum score of 100%.
  measure: Percentage of Participants with the Achievement of Patients' Global Impression of Change of Alopecia Areata (PaGIC-AA) Score of 1 "Much Better" or 2 "Moderately Better"
  time frame: Up to Week 24
  description: The PaGIC-AA is a single-item measure that asks participants to rate how their alopecia condition has changed overall since the start of the study using a 7-point scale. Responses range from "much better" to "much worse."
  measure: Percentage of Participants with the Achievement of Patient-Reported Outcome (PRO) for Scalp Hair Assessment 0/1 with ≥ 2-Point Improvement (Reduction)
  time frame: Baseline to Week 24
  description: The PRO for Scalp Hair Assessment is single item, five-point, categorical response scale that asks respondents to look in the mirror and assess the total area of the scalp with missing hair. Response items range from "No missing hair" to "Nearly all or all" and includes percentage ranges for each category (0%, 1 to 20%, 21 to 49%, 50 to 94%, and 95 to 100%). Responses among participants with baseline score >=3.
  measure: Percentage of Participants with the Achievement of SALT Score 0
  time frame: Week 24
  description: The SALT is a global AA severity score based on the combination of extent and density of scalp hair loss. The score is determined by visually defining the amount of terminal hair loss in each of the 4 views of the scalp (left and right side each accounting for 18% of scalp area, the top for 40%, and the back for 24%) and adding these together with a maximum score of 100%.
  arm group label: Study 1: Group 1 Upadacitinib Dose A
  arm group type: Experimental
  description: Participants will receive upadacitinib Dose A once daily for 52 weeks in Period A and Period B.
  arm group label: Study 1: Group 2 Upadacitinib Dose B
  arm group type: Experimental
  description: Participants will receive upadacitinib Dose B once daily for 52 weeks in Period A and Period B.
  arm group label: Study 1: Group 3 Placebo
  arm group type: Experimental
  description: Participants will receive matching placebo once daily for 24 weeks in Period A.
  arm group label: Study 1: Group 4 Upadacitinib Dose A
  arm group type: Experimental
  description: Participants initially randomized to placebo (Period A) with a SALT score > 20 at Week 24 will be re-randomized to receive upadacitinib Dose A once daily for 28 weeks in Period B.
  arm group label: Study 1: Group 5 Upadacitinib Dose B
  arm group type: Experimental
  description: Participants initially randomized to placebo (Period A) with a SALT score > 20 at Week 24 will be re-randomized to receive upadacitinib Dose B once daily for 28 weeks in Period B.
  arm group label: Study 1: Group 6 Placebo
  arm group type: Experimental
  description: Participants initially randomized to placebo with a SALT score ≤ 20 at Week 24 will continue on placebo through Week 52.
  arm group label: Study 2: Group 1 Upadacitinib Dose A
  arm group type: Experimental
  description: Participants will receive upadacitinib Dose A once daily for 52 weeks in Period A and Period B.
  arm group label: Study 2: Group 2 Upadacitinib Dose B
  arm group type: Experimental
  description: Participants will receive upadacitinib Dose B once daily for 52 weeks in Period A and Period B.
  arm group label: Study 2: Group 3 Placebo
  arm group type: Experimental
  description: Participants will receive matching placebo once daily for 24 weeks in Period A.
  arm group label: Study 2: Group 4 Upadacitinib Dose A
  arm group type: Experimental
  description: Participants initially randomized to placebo (Period A) with a SALT score > 20 at Week 24 will be re-randomized to receive upadacitinib Dose A once daily for 28 weeks in Period B.
  arm group label: Study 2: Group 5 Upadacitinib Dose B
  arm group type: Experimental
  description: Participants initially randomized to placebo (Period A) with a SALT score > 20 at Week 24 will be re-randomized to receive upadacitinib Dose B once daily for 28 weeks in Period B.
  arm group label: Study 2: Group 6 Placebo
  arm group type: Experimental
  description: Participants initially randomized to placebo with a SALT score ≤ 20 at Week 24 will continue on placebo through Week 52.
  arm group label: Study 3: Group 1 Upadacitinib Dose B (SALT > 20)
  arm group type: Experimental
  description: Participants receiving upadacitinib Dose A with a SALT score > 20 at Week 52 (end of Period B) of Study 1 or Study 2 will dose escalate to upadacitinib Dose B once daily for 108 weeks.
  arm group label: Study 3: Group 2 Upadacitinib Dose A (SALT ≤ 20)
  arm group type: Experimental
  description: Participants receiving upadacitinib Dose A with a SALT score ≤ 20 at Week 52 (end of Period B) of Study 1 or Study 2 will remain on upadacitinib Dose A once daily for 108 weeks.
  arm group label: Study 3: Group 3 Upadacitinib Dose B (Non-Sustained)
  arm group type: Experimental
  description: Participants who end Period B on upadacitinib Dose B with a with a SALT score > 20 at Week 40 or Week 52 of Study 1 or Study 2 will remain on upadacitinib Dose B once daily for 108 weeks.
  arm group label: Study 3: Group 4 Upadacitinib Dose B (Sustained)
  arm group type: Experimental
  description: Participants who end Period B on upadacitinib Dose B with a with a SALT score ≤ 20 at Week 40 and Week 52 of Study 1 or Study 2 will be re-randomized to receive upadacitinib Dose B once daily for 108 weeks.
  arm group label: Study 3: Group 5 Upadacitinib Dose A (Sustained)
  arm group type: Experimental
  description: Participants who end Period B on upadacitinib Dose B with a with a SALT score ≤ 20 at Week 40 and Week 52 of Study 1 or Study 2 will be re-randomized to receive upadacitinib Dose A once daily for 108 weeks.
  intervention type: Drug
  intervention name: Upadacitinib
  description: Oral Tablets
  arm group label: Study 1: Group 1 Upadacitinib Dose A
  arm group label: Study 1: Group 2 Upadacitinib Dose B
  arm group label: Study 1: Group 4 Upadacitinib Dose A
  arm group label: Study 1: Group 5 Upadacitinib Dose B
  arm group label: Study 2: Group 1 Upadacitinib Dose A
  arm group label: Study 2: Group 2 Upadacitinib Dose B
  arm group label: Study 2: Group 4 Upadacitinib Dose A
  arm group label: Study 2: Group 5 Upadacitinib Dose B
  arm group label: Study 3: Group 1 Upadacitinib Dose B (SALT > 20)
  arm group label: Study 3: Group 2 Upadacitinib Dose A (SALT ≤ 20)
  arm group label: Study 3: Group 3 Upadacitinib Dose B (Non-Sustained)
  arm group label: Study 3: Group 4 Upadacitinib Dose B (Sustained)
  arm group label: Study 3: Group 5 Upadacitinib Dose A (Sustained)
  other name: Rinvoq
  other name: ABT-494
  intervention type: Drug
  intervention name: Placebo
  description: Oral Tablets
  arm group label: Study 1: Group 3 Placebo
  arm group label: Study 1: Group 4 Upadacitinib Dose A
  arm group label: Study 1: Group 5 Upadacitinib Dose B
  arm group label: Study 1: Group 6 Placebo
  arm group label: Study 2: Group 3 Placebo
  arm group label: Study 2: Group 4 Upadacitinib Dose A
  arm group label: Study 2: Group 5 Upadacitinib Dose B
  arm group label: Study 2: Group 6 Placebo
  criteria: 
  gender: All
  minimum age: 12 Years
  maximum age: 63 Years
  healthy volunteers: No
  last name: ABBVIE INC.
  role: Study Director
  affiliation: AbbVie
  last name: ABBVIE CALL CENTER
  phone: 844-663-3742
  email: abbvieclinicaltrials@abbvie.com
  url: https://www.abbvieclinicaltrials.com/study/?id=M23-716
  description: Related Info
  responsible party type: Sponsor
  mesh term: Alopecia
  mesh term: Alopecia Areata
  mesh term: Upadacitinib
  sharing ipd: Yes
  ipd description: AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols, analyses plans, clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.
  ipd info type: Study Protocol
  ipd info type: Statistical Analysis Plan (SAP)
  ipd info type: Clinical Study Report (CSR)
  ipd time frame: For details on when studies are available for sharing visit https://vivli.org/ourmember/abbvie/
  ipd access criteria: Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous independent scientific research, and will be provided following review and approval of a research proposal and statistical analysis plan and execution of a data sharing statement. Data requests can be submitted at any time after approval in the US and/or EU and a primary manuscript is accepted for publication. For more information on the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/
  ipd url: https://vivli.org/ourmember/abbvie/