<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/NCT04476043</url>
  </required_header>
  <id_info>
    <org_study_id>INCB 54707-204</org_study_id>
    <nct_id>NCT04476043</nct_id>
  </id_info>
  <brief_title>To Assess the Efficacy and Safety of INCB054707 in Participants With Hidradenitis Suppurativa</brief_title>
  <official_title>A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging Study of the Efficacy and Safety of INCB054707 in Participants With Hidradenitis Suppurativa</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Incyte Corporation</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Incyte Corporation</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>
      To evaluate the efficacy and safety of INCB054707 in participants with hidradenitis&#xD;
      suppurativa over a 16-week placebo-controlled treatment period followed by a 36-week&#xD;
      open-label extension period. All eligible participants will be invited to continue treatment&#xD;
      for an additional 48-week Long-term extension period (also open label).&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">September 1, 2020</start_date>
  <completion_date type="Anticipated">August 16, 2023</completion_date>
  <primary_completion_date type="Actual">December 15, 2021</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>Triple (Participant, Investigator, Outcomes Assessor)</masking>
    <masking_description>Triple</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Mean Change From Baseline in Abscess and Inflammatory Nodule (AN) Count at Week 16</measure>
    <time_frame>Baseline; Week 16</time_frame>
    <description>Change from Baseline was calculated as the post-Baseline value minus the Baseline value. The mixed model repeated measure (MMRM) included the fixed effects of treatment group (placebo and INCB054707 15, 45, and 75 mg), stratification factors (disease severity [Hurley Stage I, II, and III] and geographical region [North America and outside of North America]), visit (Weeks 2, 4, 6, 8, 12, and 16), treatment by visit interaction, and covariates of Baseline measurement and Baseline measurement by visit interaction. The variance-covariance matrix of the within-participant errors in MMRM are modeled as unstructured.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants Who Achieved a Hidradenitis Suppurativa Clinical Response (HiSCR) at Week 16</measure>
    <time_frame>Baseline; Week 16</time_frame>
    <description>HiSCR, the key secondary endpoint, was defined as at least a 50% decrease from Baseline in AN count with no increase in the number of abscesses or draining fistulas.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants Who Achieved a HiSCR at Weeks 2 Through 12</measure>
    <time_frame>Baseline; Weeks 2, 4, 6, 8, and 12</time_frame>
    <description>HiSCR was defined as at least a 50% decrease from Baseline in AN count with no increase in the number of abscesses or draining fistulas.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants Who Achieved HiSCR75 From Weeks 2 to 16</measure>
    <time_frame>Baseline; Weeks 2, 4, 6, 8, 12, and 16</time_frame>
    <description>HiSCR75 was defined as at least a 75% decrease from Baseline in AN count with no increase in the number of abscesses or draining fistulas.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean Change From Baseline in the Severity of the Disease, as Assessed by the International Hidradenitis Suppurativa Severity Score System (IHS4) Score, From Weeks 2 to 16</measure>
    <time_frame>Baseline; Weeks 2, 4, 6, 8, 12, and 16</time_frame>
    <description>Change from Baseline was calculated as the post-Baseline value minus the Baseline value. The IHS4 is a composite, dynamic score and validated tool used to determine Hidradenitis Suppurativa severity. It employs a weighted scale using the number of inflammatory nodules, the number of abscesses, and the number of draining tunnels (fistulas or sinuses), with respective weight factors of 1, 2, and 4. Scores: mild=0-3; moderate=4-10; severe ≥11. MMRM included the fixed effects of treatment group (placebo and INCB054707 15, 45, and 75 mg), stratification factors (disease severity [Hurley Stage I, II, and III] and geographical region [North America and outside of North America]), visit (Weeks 2, 4, 6, 8, 12, and 16), treatment by visit interaction, and covariates of Baseline measurement and Baseline measurement by visit interaction. The variance-covariance matrix of the within-participant errors in MMRM are modeled as unstructured.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants Who Achieved AN50, AN75, AN90, and AN100 From Weeks 2 to 16</measure>
    <time_frame>Baseline; Weeks 2, 4, 6, 8, 12, and 16</time_frame>
    <description>AN50, AN75, AN90, and AN100 were defined as at least a 50%, 75%, 90%, and 100% decrease, respectively, from Baseline in AN count.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean Change From Baseline in AN Count at Weeks 2 to 12</measure>
    <time_frame>Baseline; Weeks 2, 4, 6, 8, and 12</time_frame>
    <description>Change from Baseline was calculated as the post-Baseline value minus the Baseline value. MMRM included the fixed effects of treatment group (placebo and INCB054707 15, 45, and 75 mg), stratification factors (disease severity [Hurley Stage I, II, and III] and geographical region [North America and outside of North America]), visit (Weeks 2, 4, 6, 8, 12, and 16), treatment by visit interaction, and covariates of Baseline measurement and Baseline measurement by visit interaction. The variance-covariance matrix of the within-participant errors in MMRM are modeled as unstructured.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With a Total AN Count of 0 to 2 From Weeks 2 to 16</measure>
    <time_frame>Weeks 2, 4, 6, 8, 12, and 16</time_frame>
    <description>Total AN count was assessed throughout the study.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean Change From Baseline in Draining Fistula Count From Weeks 2 to 16</measure>
    <time_frame>Baseline; Weeks 2, 4, 6, 8, 12, and 16</time_frame>
    <description>Change from Baseline was calculated as the post-Baseline value minus the Baseline value.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean Change From Baseline in Abscess, Inflammatory Nodule (IN), and Draining Fistula (DF) (ANF) Count From Weeks 2 to 16</measure>
    <time_frame>Baseline; Weeks 2, 4, 6, 8, 12, and 16</time_frame>
    <description>Change from Baseline was calculated as the post-Baseline value minus the Baseline value. MMRM included the fixed effects of treatment group (placebo and INCB054707 15, 45, and 75 mg), stratification factors (disease severity [Hurley Stage I, II, and III] and geographical region [North America and outside of North America]), visit (Weeks 2, 4, 6, 8, 12, and 16), treatment by visit interaction, and covariates of Baseline measurement and Baseline measurement by visit interaction. The variance-covariance matrix of the within-participant errors in MMRM are modeled as unstructured.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Treatment-emergent Adverse Events (TEAEs)</measure>
    <time_frame>up to Week 16</time_frame>
    <description>An adverse event (AE) was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. An AE could have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study treatment. A TEAE was defined as any AE either reported for the first time or the worsening of a pre-existing event after the first dose of study drug until the end of the safety follow-up.</description>
  </secondary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">209</enrollment>
  <condition>Hidradenitis Suppurativa</condition>
  <condition>Acne Inversa</condition>
  <arm_group>
    <arm_group_label>INCB054707 15 mg</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will receive INCB054707 15 milligrams (mg) for 16 weeks in the Placebo-controlled Treatment Period, followed by INCB054707 75 mg for 36 weeks in the Open-label Extension Period. Participants will have the option to continue open-label treatment for an additional 48 weeks.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>INCB054707 45 mg</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will receive INCB054707 45 mg for 16 weeks in the Placebo-controlled Treatment Period, followed by INCB054707 75 mg for 36 weeks in the Open-label Extension Period. Participants will have the option to continue open-label treatment for an additional 48 weeks.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>INCB054707 75 mg</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will receive INCB054707 75 mg for 52 weeks in the Placebo-controlled Treatment Period (16 weeks) plus the Open-label Extension Period (36 weeks). Participants will have the option to continue open-label treatment for an additional 48 weeks.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo followed by INCB054707 75 mg</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Participants will receive placebo for 16 weeks in the Placebo-controlled Treatment Period, followed by INCB054707 75 mg for 36 weeks in the Open-label Extension Period. Participants will have the option to continue open-label treatment for an additional 48 weeks.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>INCB054707</intervention_name>
    <description>Oral; Tablet</description>
    <arm_group_label>INCB054707 15 mg</arm_group_label>
    <arm_group_label>INCB054707 45 mg</arm_group_label>
    <arm_group_label>INCB054707 75 mg</arm_group_label>
    <other_name>Povorcitinib</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Oral; Tablet</description>
    <arm_group_label>Placebo followed by INCB054707 75 mg</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  HS disease duration of at least 3 months before screening.&#xD;
&#xD;
          -  Willingness to avoid pregnancy or fathering children.&#xD;
&#xD;
          -  Active HS in at least 2 distinct anatomical areas.&#xD;
&#xD;
          -  Participants agree NOT to use topical antiseptics on the areas affected by HS lesions&#xD;
             during the placebo-controlled 16-week treatment period&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Draining fistula count of &gt; 20 at screening or baseline.&#xD;
&#xD;
          -  Women who are pregnant (or who are considering pregnancy) or lactating.&#xD;
&#xD;
          -  Medical history including thrombocytopenia, coagulopathy or platelet dysfunction,&#xD;
             Q-wave interval abnormalities, current or history of certain infections, cancer,&#xD;
             lymphoproliferative disorders and other medical conditions at the discretion of the&#xD;
             investigator.&#xD;
&#xD;
          -  History of failure to treatment of inflammatory diseases with JAK inhibitors.&#xD;
&#xD;
          -  Have evidence of active or latent or inadequately treated infection with Mycobacterium&#xD;
             tuberculosis.&#xD;
&#xD;
          -  Participants known to be infected with HIV, Hepatitis B, or Hepatitis C.&#xD;
&#xD;
          -  Laboratory values outside of the protocol-defined ranges.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Investigative Site 005</name>
      <address>
        <city>Hoover</city>
        <state>Alabama</state>
        <zip>35244</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigative Site 003</name>
      <address>
        <city>Gilbert</city>
        <state>Arizona</state>
        <zip>85295</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigative Site 011</name>
      <address>
        <city>Phoenix</city>
        <state>Arizona</state>
        <zip>85006</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigative Site 014</name>
      <address>
        <city>Fountain Valley</city>
        <state>California</state>
        <zip>92708</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigative Site 010</name>
      <address>
        <city>Fremont</city>
        <state>California</state>
        <zip>94538</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigative Site 012</name>
      <address>
        <city>Huntington Beach</city>
        <state>California</state>
        <zip>92647</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigative Site 022</name>
      <address>
        <city>Newbury Park</city>
        <state>California</state>
        <zip>91320</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigative Site 009</name>
      <address>
        <city>Sacramento</city>
        <state>California</state>
        <zip>95815</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigative Site 025</name>
      <address>
        <city>Cromwell</city>
        <state>Connecticut</state>
        <zip>06416</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigative Site 015</name>
      <address>
        <city>Coral Gables</city>
        <state>Florida</state>
        <zip>33134</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigative Site 021</name>
      <address>
        <city>Miami</city>
        <state>Florida</state>
        <zip>33136</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigative Site 006</name>
      <address>
        <city>Tampa</city>
        <state>Florida</state>
        <zip>33614</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigative Site 001</name>
      <address>
        <city>Tampa</city>
        <state>Florida</state>
        <zip>33624</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigative Site 016</name>
      <address>
        <city>Atlanta</city>
        <state>Georgia</state>
        <zip>30328</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigative Site 002</name>
      <address>
        <city>West Lafayette</city>
        <state>Indiana</state>
        <zip>47906</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigative Site 027</name>
      <address>
        <city>Baton Rouge</city>
        <state>Louisiana</state>
        <zip>70808</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigative Site 023</name>
      <address>
        <city>New Orleans</city>
        <state>Louisiana</state>
        <zip>70112</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigative Site 013</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02215</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigative Site 004</name>
      <address>
        <city>Fort Gratiot</city>
        <state>Michigan</state>
        <zip>48059</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigative Site 019</name>
      <address>
        <city>Saint Louis</city>
        <state>Missouri</state>
        <zip>63110</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigative Site 026</name>
      <address>
        <city>Bronx</city>
        <state>New York</state>
        <zip>10468</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigative Site 008</name>
      <address>
        <city>Chapel Hill</city>
        <state>North Carolina</state>
        <zip>27516</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigative Site 017</name>
      <address>
        <city>Winston-Salem</city>
        <state>North Carolina</state>
        <zip>27157</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigative Site 007</name>
      <address>
        <city>Hershey</city>
        <state>Pennsylvania</state>
        <zip>17033</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigative Site 018</name>
      <address>
        <city>Bellaire</city>
        <state>Texas</state>
        <zip>77401</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigative Site 101</name>
      <address>
        <city>Calgary</city>
        <state>Alberta</state>
        <zip>T1Y 0B4</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigative Site 102</name>
      <address>
        <city>Calgary</city>
        <state>Alberta</state>
        <zip>T3A 0B2</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigative Site 304</name>
      <address>
        <city>Nantes</city>
        <zip>44093</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigative Site 403</name>
      <address>
        <city>Berlin</city>
        <zip>10117</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigative Site 401</name>
      <address>
        <city>Bochum</city>
        <zip>44791</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigative Site 405</name>
      <address>
        <city>Dessau</city>
        <zip>06847</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigative Site 406</name>
      <address>
        <city>Dresden</city>
        <zip>01307</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigative Site 404</name>
      <address>
        <city>Erlangen</city>
        <zip>91054</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigative Site 402</name>
      <address>
        <city>Frankfurt Am Main</city>
        <zip>60590</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigative Site 552</name>
      <address>
        <city>Rzeszow</city>
        <zip>35-055</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigative Site 551</name>
      <address>
        <city>Wroclaw</city>
        <zip>50-566</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigative Site 553</name>
      <address>
        <city>Wroclaw</city>
        <zip>51-318</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigative Site 703</name>
      <address>
        <city>Granada</city>
        <zip>18014</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigative Site 702</name>
      <address>
        <city>Madrid</city>
        <zip>28007</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigative Site 701</name>
      <address>
        <city>Valencia</city>
        <zip>46940</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
    <country>France</country>
    <country>Germany</country>
    <country>Poland</country>
    <country>Spain</country>
    <country>United States</country>
  </location_countries>
  <verification_date>June 2023</verification_date>
  <study_first_submitted>July 15, 2020</study_first_submitted>
  <study_first_submitted_qc>July 15, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 17, 2020</study_first_posted>
  <results_first_submitted>December 14, 2022</results_first_submitted>
  <results_first_submitted_qc>January 10, 2023</results_first_submitted_qc>
  <results_first_posted type="Actual">January 26, 2023</results_first_posted>
  <last_update_submitted>June 13, 2023</last_update_submitted>
  <last_update_submitted_qc>June 13, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">June 15, 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>Hidradenitis Suppurativa</mesh_term>
    <mesh_term>Hidradenitis</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>Incyte shares data with qualified external researchers after a research proposal is submitted. These requests are reviewed and approved by a review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.&#xD;
The trial data availability is according to the criteria and process described on https://www.incyte.com/our-company/compliance-and-transparency</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
    <ipd_time_frame>Data will be shared after the primary publication or 2 years after the study has ended for market authorized products and indications.</ipd_time_frame>
    <ipd_access_criteria>Data from eligible studies will be shared with qualified researchers according to the criteria and process described in the Data Sharing section of the www.incyteclinicaltrials.com website. For approved requests, the researchers will be granted access to anonymized data under the terms of a data sharing agreement.</ipd_access_criteria>
    <ipd_url>https://www.incyte.com/our-company/compliance-and-transparency</ipd_url>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>September 10, 2021</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/43/NCT04476043/Prot_000.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Statistical Analysis Plan</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>October 12, 2021</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/43/NCT04476043/SAP_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <recruitment_details>A total of 209 participants were enrolled at 36 study centers: 26 in North America and 10 in Europe. Data are reported through the cut-off date of 15 December 2021.</recruitment_details>
      <group_list>
        <group group_id="P1">
          <title>Placebo</title>
          <description>Participants received oral placebo once a day (QD) for 16 weeks in the Placebo-controlled Treatment Period.</description>
        </group>
        <group group_id="P2">
          <title>INCB054707 15 mg</title>
          <description>Participants received oral INCB054707 15 milligrams (mg) QD for 16 weeks in the Placebo-controlled Treatment Period.</description>
        </group>
        <group group_id="P3">
          <title>INCB054707 45 mg</title>
          <description>Participants received oral INCB054707 45 mg QD for 16 weeks in the Placebo-controlled Treatment Period.</description>
        </group>
        <group group_id="P4">
          <title>INCB054707 75 mg</title>
          <description>Participants received oral INCB054707 75 mg QD for 16 weeks in the Placebo-controlled Treatment Period.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="52"/>
                <participants group_id="P2" count="52"/>
                <participants group_id="P3" count="52"/>
                <participants group_id="P4" count="53"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="48"/>
                <participants group_id="P2" count="47"/>
                <participants group_id="P3" count="45"/>
                <participants group_id="P4" count="51"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="4"/>
                <participants group_id="P2" count="5"/>
                <participants group_id="P3" count="7"/>
                <participants group_id="P4" count="2"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="3"/>
                <participants group_id="P3" count="4"/>
                <participants group_id="P4" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="1"/>
                <participants group_id="P3" count="2"/>
                <participants group_id="P4" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Adverse Event</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="1"/>
                <participants group_id="P4" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Protocol Violation</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Placebo</title>
          <description>Participants received oral placebo once a day (QD) for 16 weeks in the Placebo-controlled Treatment Period.</description>
        </group>
        <group group_id="B2">
          <title>INCB054707 15 mg</title>
          <description>Participants received oral INCB054707 15 milligrams (mg) QD for 16 weeks in the Placebo-controlled Treatment Period.</description>
        </group>
        <group group_id="B3">
          <title>INCB054707 45 mg</title>
          <description>Participants received oral INCB054707 45 mg QD for 16 weeks in the Placebo-controlled Treatment Period.</description>
        </group>
        <group group_id="B4">
          <title>INCB054707 75 mg</title>
          <description>Participants received oral INCB054707 75 mg QD for 16 weeks in the Placebo-controlled Treatment Period.</description>
        </group>
        <group group_id="B5">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="52"/>
            <count group_id="B2" value="52"/>
            <count group_id="B3" value="52"/>
            <count group_id="B4" value="53"/>
            <count group_id="B5" value="209"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="35.2" spread="9.96"/>
                    <measurement group_id="B2" value="38.2" spread="10.85"/>
                    <measurement group_id="B3" value="37.3" spread="12.51"/>
                    <measurement group_id="B4" value="37.5" spread="10.83"/>
                    <measurement group_id="B5" value="37.1" spread="11.05"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="43"/>
                    <measurement group_id="B2" value="37"/>
                    <measurement group_id="B3" value="39"/>
                    <measurement group_id="B4" value="39"/>
                    <measurement group_id="B5" value="158"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="9"/>
                    <measurement group_id="B2" value="15"/>
                    <measurement group_id="B3" value="13"/>
                    <measurement group_id="B4" value="14"/>
                    <measurement group_id="B5" value="51"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race/Ethnicity, Customized</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>White/Caucasian</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="40"/>
                    <measurement group_id="B2" value="36"/>
                    <measurement group_id="B3" value="35"/>
                    <measurement group_id="B4" value="36"/>
                    <measurement group_id="B5" value="147"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Black/African American</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="10"/>
                    <measurement group_id="B2" value="13"/>
                    <measurement group_id="B3" value="12"/>
                    <measurement group_id="B4" value="16"/>
                    <measurement group_id="B5" value="51"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Asian</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="2"/>
                    <measurement group_id="B4" value="1"/>
                    <measurement group_id="B5" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>American Indian/Alaska Native</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="1"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Captured as Other</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="2"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race/Ethnicity, Customized</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>Hispanic or Latino</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="10"/>
                    <measurement group_id="B2" value="5"/>
                    <measurement group_id="B3" value="7"/>
                    <measurement group_id="B4" value="6"/>
                    <measurement group_id="B5" value="28"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Not Hispanic or Latino</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="41"/>
                    <measurement group_id="B2" value="47"/>
                    <measurement group_id="B3" value="44"/>
                    <measurement group_id="B4" value="47"/>
                    <measurement group_id="B5" value="179"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Unknown</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Captured as Other</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="1"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Mean abscess and inflammatory nodule (AN) count</title>
          <units>abscesses and inflammatory nodules</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="11.2" spread="5.85"/>
                    <measurement group_id="B2" value="11.8" spread="7.10"/>
                    <measurement group_id="B3" value="12.9" spread="12.34"/>
                    <measurement group_id="B4" value="10.6" spread="7.24"/>
                    <measurement group_id="B5" value="11.6" spread="8.48"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Mean International Hidradenitis Suppurativa Severity Score System (IHS4) score</title>
          <description>The IHS4 is a composite, dynamic score and validated tool used to determine Hidradenitis Suppurativa severity. It employs a weighted scale using the number of inflammatory nodules, the number of abscesses, and the number of draining tunnels (fistulas or sinuses), with respective weight factors of 1, 2, and 4. Scores: mild=0-3; moderate=4-10; severe ≥11.</description>
          <units>scores on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="22.9" spread="17.02"/>
                    <measurement group_id="B2" value="22.4" spread="23.24"/>
                    <measurement group_id="B3" value="23.5" spread="22.79"/>
                    <measurement group_id="B4" value="18.9" spread="17.25"/>
                    <measurement group_id="B5" value="21.9" spread="20.21"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Mean abscess, inflammatory nodule (IN), and draining fistula (DF) (ANF) count</title>
          <units>abscesses, INs, and DFs</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="13.6" spread="6.36"/>
                    <measurement group_id="B2" value="14.1" spread="10.08"/>
                    <measurement group_id="B3" value="15.1" spread="13.51"/>
                    <measurement group_id="B4" value="12.2" spread="8.94"/>
                    <measurement group_id="B5" value="13.7" spread="10.03"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Mean Change From Baseline in Abscess and Inflammatory Nodule (AN) Count at Week 16</title>
        <description>Change from Baseline was calculated as the post-Baseline value minus the Baseline value. The mixed model repeated measure (MMRM) included the fixed effects of treatment group (placebo and INCB054707 15, 45, and 75 mg), stratification factors (disease severity [Hurley Stage I, II, and III] and geographical region [North America and outside of North America]), visit (Weeks 2, 4, 6, 8, 12, and 16), treatment by visit interaction, and covariates of Baseline measurement and Baseline measurement by visit interaction. The variance-covariance matrix of the within-participant errors in MMRM are modeled as unstructured.</description>
        <time_frame>Baseline; Week 16</time_frame>
        <population>Intent-to-Treat (ITT) Population: all randomized participants. Treatment groups for this population were defined according to the treatment assignment at randomization. Only participants with available data were analyzed.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Participants received oral placebo once a day (QD) for 16 weeks in the Placebo-controlled Treatment Period.</description>
          </group>
          <group group_id="O2">
            <title>INCB054707 15 mg</title>
            <description>Participants received oral INCB054707 15 milligrams (mg) QD for 16 weeks in the Placebo-controlled Treatment Period.</description>
          </group>
          <group group_id="O3">
            <title>INCB054707 45 mg</title>
            <description>Participants received oral INCB054707 45 mg QD for 16 weeks in the Placebo-controlled Treatment Period.</description>
          </group>
          <group group_id="O4">
            <title>INCB054707 75 mg</title>
            <description>Participants received oral INCB054707 75 mg QD for 16 weeks in the Placebo-controlled Treatment Period.</description>
          </group>
        </group_list>
        <measure>
          <title>Mean Change From Baseline in Abscess and Inflammatory Nodule (AN) Count at Week 16</title>
          <description>Change from Baseline was calculated as the post-Baseline value minus the Baseline value. The mixed model repeated measure (MMRM) included the fixed effects of treatment group (placebo and INCB054707 15, 45, and 75 mg), stratification factors (disease severity [Hurley Stage I, II, and III] and geographical region [North America and outside of North America]), visit (Weeks 2, 4, 6, 8, 12, and 16), treatment by visit interaction, and covariates of Baseline measurement and Baseline measurement by visit interaction. The variance-covariance matrix of the within-participant errors in MMRM are modeled as unstructured.</description>
          <population>Intent-to-Treat (ITT) Population: all randomized participants. Treatment groups for this population were defined according to the treatment assignment at randomization. Only participants with available data were analyzed.</population>
          <units>abscesses and inflammatory nodules</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="43"/>
                <count group_id="O2" value="45"/>
                <count group_id="O3" value="43"/>
                <count group_id="O4" value="46"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-2.5" spread="0.88"/>
                    <measurement group_id="O2" value="-5.2" spread="0.86"/>
                    <measurement group_id="O3" value="-6.9" spread="0.88"/>
                    <measurement group_id="O4" value="-6.3" spread="0.85"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0277</p_value>
            <method>MMRM</method>
            <param_type>Least squares mean (LSM) difference</param_type>
            <param_value>-2.7</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>1.23</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-5.2</ci_lower_limit>
            <ci_upper_limit>-0.3</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0006</p_value>
            <method>MMRM</method>
            <param_type>LSM difference</param_type>
            <param_value>-4.4</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>1.25</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-6.8</ci_lower_limit>
            <ci_upper_limit>-1.9</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0021</p_value>
            <method>MMRM</method>
            <param_type>LSM difference</param_type>
            <param_value>-3.8</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>1.22</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-6.2</ci_lower_limit>
            <ci_upper_limit>-1.4</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants Who Achieved a Hidradenitis Suppurativa Clinical Response (HiSCR) at Week 16</title>
        <description>HiSCR, the key secondary endpoint, was defined as at least a 50% decrease from Baseline in AN count with no increase in the number of abscesses or draining fistulas.</description>
        <time_frame>Baseline; Week 16</time_frame>
        <population>ITT Population. 95% confidence interval (CI) was based on the Clopper-Pearson exact method. Missing post-Baseline values were imputed as nonresponders.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Participants received oral placebo once a day (QD) for 16 weeks in the Placebo-controlled Treatment Period.</description>
          </group>
          <group group_id="O2">
            <title>INCB054707 15 mg</title>
            <description>Participants received oral INCB054707 15 milligrams (mg) QD for 16 weeks in the Placebo-controlled Treatment Period.</description>
          </group>
          <group group_id="O3">
            <title>INCB054707 45 mg</title>
            <description>Participants received oral INCB054707 45 mg QD for 16 weeks in the Placebo-controlled Treatment Period.</description>
          </group>
          <group group_id="O4">
            <title>INCB054707 75 mg</title>
            <description>Participants received oral INCB054707 75 mg QD for 16 weeks in the Placebo-controlled Treatment Period.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants Who Achieved a Hidradenitis Suppurativa Clinical Response (HiSCR) at Week 16</title>
          <description>HiSCR, the key secondary endpoint, was defined as at least a 50% decrease from Baseline in AN count with no increase in the number of abscesses or draining fistulas.</description>
          <population>ITT Population. 95% confidence interval (CI) was based on the Clopper-Pearson exact method. Missing post-Baseline values were imputed as nonresponders.</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="52"/>
                <count group_id="O2" value="52"/>
                <count group_id="O3" value="52"/>
                <count group_id="O4" value="53"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="28.8" lower_limit="17.1" upper_limit="43.1"/>
                    <measurement group_id="O2" value="48.1" lower_limit="34.0" upper_limit="62.4"/>
                    <measurement group_id="O3" value="44.2" lower_limit="30.5" upper_limit="58.7"/>
                    <measurement group_id="O4" value="45.3" lower_limit="31.6" upper_limit="59.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0445</p_value>
            <method>Wald test</method>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>2.3</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>1.0</ci_lower_limit>
            <ci_upper_limit>5.3</ci_upper_limit>
            <estimate_desc>Logistic regression model with treatment group and stratification factors (disease severity and geographical region).</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <param_type>Difference in response rate</param_type>
            <param_value>19.2</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>9.35</dispersion_value>
            <estimate_desc>Standard error of difference between response rates was from normal approximation.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0998</p_value>
            <method>Wald test</method>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>2.0</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.9</ci_lower_limit>
            <ci_upper_limit>4.6</ci_upper_limit>
            <estimate_desc>Logistic regression model with treatment group and stratification factors (disease severity and geographical region).</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <param_type>Difference in response rate</param_type>
            <param_value>15.4</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>9.32</dispersion_value>
            <estimate_desc>Standard error of difference between response rates was from normal approximation.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0829</p_value>
            <method>Wald test</method>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>2.1</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.9</ci_lower_limit>
            <ci_upper_limit>4.7</ci_upper_limit>
            <estimate_desc>Logistic regression model with treatment group and stratification factors (disease severity and geographical region).</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <param_type>Difference in response rate</param_type>
            <param_value>16.4</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>9.29</dispersion_value>
            <estimate_desc>Standard error of difference between response rates was from normal approximation.</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants Who Achieved a HiSCR at Weeks 2 Through 12</title>
        <description>HiSCR was defined as at least a 50% decrease from Baseline in AN count with no increase in the number of abscesses or draining fistulas.</description>
        <time_frame>Baseline; Weeks 2, 4, 6, 8, and 12</time_frame>
        <population>ITT Population. 95% CI was based on the Clopper-Pearson exact method. Missing post-Baseline values were imputed as nonresponders.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Participants received oral placebo once a day (QD) for 16 weeks in the Placebo-controlled Treatment Period.</description>
          </group>
          <group group_id="O2">
            <title>INCB054707 15 mg</title>
            <description>Participants received oral INCB054707 15 milligrams (mg) QD for 16 weeks in the Placebo-controlled Treatment Period.</description>
          </group>
          <group group_id="O3">
            <title>INCB054707 45 mg</title>
            <description>Participants received oral INCB054707 45 mg QD for 16 weeks in the Placebo-controlled Treatment Period.</description>
          </group>
          <group group_id="O4">
            <title>INCB054707 75 mg</title>
            <description>Participants received oral INCB054707 75 mg QD for 16 weeks in the Placebo-controlled Treatment Period.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants Who Achieved a HiSCR at Weeks 2 Through 12</title>
          <description>HiSCR was defined as at least a 50% decrease from Baseline in AN count with no increase in the number of abscesses or draining fistulas.</description>
          <population>ITT Population. 95% CI was based on the Clopper-Pearson exact method. Missing post-Baseline values were imputed as nonresponders.</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="52"/>
                <count group_id="O2" value="52"/>
                <count group_id="O3" value="52"/>
                <count group_id="O4" value="53"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Week 2</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="15.4" lower_limit="6.9" upper_limit="28.1"/>
                    <measurement group_id="O2" value="25.0" lower_limit="14.0" upper_limit="38.9"/>
                    <measurement group_id="O3" value="34.6" lower_limit="22.0" upper_limit="49.1"/>
                    <measurement group_id="O4" value="34.0" lower_limit="21.5" upper_limit="48.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 4</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="25.0" lower_limit="14.0" upper_limit="38.9"/>
                    <measurement group_id="O2" value="36.5" lower_limit="23.6" upper_limit="51.0"/>
                    <measurement group_id="O3" value="44.2" lower_limit="30.5" upper_limit="58.7"/>
                    <measurement group_id="O4" value="49.1" lower_limit="35.1" upper_limit="63.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 6</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="17.3" lower_limit="8.2" upper_limit="30.3"/>
                    <measurement group_id="O2" value="32.7" lower_limit="20.3" upper_limit="47.1"/>
                    <measurement group_id="O3" value="48.1" lower_limit="34.0" upper_limit="62.4"/>
                    <measurement group_id="O4" value="52.8" lower_limit="38.6" upper_limit="66.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 8</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="28.8" lower_limit="17.1" upper_limit="43.1"/>
                    <measurement group_id="O2" value="36.5" lower_limit="23.6" upper_limit="51.0"/>
                    <measurement group_id="O3" value="44.2" lower_limit="30.5" upper_limit="58.7"/>
                    <measurement group_id="O4" value="52.8" lower_limit="38.6" upper_limit="66.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 12</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="30.8" lower_limit="18.7" upper_limit="45.1"/>
                    <measurement group_id="O2" value="42.3" lower_limit="28.7" upper_limit="56.8"/>
                    <measurement group_id="O3" value="48.1" lower_limit="34.0" upper_limit="62.4"/>
                    <measurement group_id="O4" value="58.5" lower_limit="44.1" upper_limit="71.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants Who Achieved HiSCR75 From Weeks 2 to 16</title>
        <description>HiSCR75 was defined as at least a 75% decrease from Baseline in AN count with no increase in the number of abscesses or draining fistulas.</description>
        <time_frame>Baseline; Weeks 2, 4, 6, 8, 12, and 16</time_frame>
        <population>ITT Population. 95% CI was based on the Clopper-Pearson exact method. Missing post-Baseline values were imputed as nonresponders.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Participants received oral placebo once a day (QD) for 16 weeks in the Placebo-controlled Treatment Period.</description>
          </group>
          <group group_id="O2">
            <title>INCB054707 15 mg</title>
            <description>Participants received oral INCB054707 15 milligrams (mg) QD for 16 weeks in the Placebo-controlled Treatment Period.</description>
          </group>
          <group group_id="O3">
            <title>INCB054707 45 mg</title>
            <description>Participants received oral INCB054707 45 mg QD for 16 weeks in the Placebo-controlled Treatment Period.</description>
          </group>
          <group group_id="O4">
            <title>INCB054707 75 mg</title>
            <description>Participants received oral INCB054707 75 mg QD for 16 weeks in the Placebo-controlled Treatment Period.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants Who Achieved HiSCR75 From Weeks 2 to 16</title>
          <description>HiSCR75 was defined as at least a 75% decrease from Baseline in AN count with no increase in the number of abscesses or draining fistulas.</description>
          <population>ITT Population. 95% CI was based on the Clopper-Pearson exact method. Missing post-Baseline values were imputed as nonresponders.</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="52"/>
                <count group_id="O2" value="52"/>
                <count group_id="O3" value="52"/>
                <count group_id="O4" value="53"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Week 2</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.9" lower_limit="0.0" upper_limit="10.3"/>
                    <measurement group_id="O2" value="9.6" lower_limit="3.2" upper_limit="21.0"/>
                    <measurement group_id="O3" value="13.5" lower_limit="5.6" upper_limit="25.8"/>
                    <measurement group_id="O4" value="18.9" lower_limit="9.4" upper_limit="32.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 4</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7.7" lower_limit="2.1" upper_limit="18.5"/>
                    <measurement group_id="O2" value="15.4" lower_limit="6.9" upper_limit="28.1"/>
                    <measurement group_id="O3" value="21.2" lower_limit="11.1" upper_limit="34.7"/>
                    <measurement group_id="O4" value="15.1" lower_limit="6.7" upper_limit="27.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 6</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9.6" lower_limit="3.2" upper_limit="21.0"/>
                    <measurement group_id="O2" value="17.3" lower_limit="8.2" upper_limit="30.3"/>
                    <measurement group_id="O3" value="28.8" lower_limit="17.1" upper_limit="43.1"/>
                    <measurement group_id="O4" value="24.5" lower_limit="13.8" upper_limit="38.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 8</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="19.2" lower_limit="9.6" upper_limit="32.5"/>
                    <measurement group_id="O2" value="23.1" lower_limit="12.5" upper_limit="36.8"/>
                    <measurement group_id="O3" value="30.8" lower_limit="18.7" upper_limit="45.1"/>
                    <measurement group_id="O4" value="35.8" lower_limit="23.1" upper_limit="50.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 12</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="19.2" lower_limit="9.6" upper_limit="32.5"/>
                    <measurement group_id="O2" value="26.9" lower_limit="15.6" upper_limit="41.0"/>
                    <measurement group_id="O3" value="32.7" lower_limit="20.3" upper_limit="47.1"/>
                    <measurement group_id="O4" value="39.6" lower_limit="26.5" upper_limit="54.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 16</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="17.3" lower_limit="8.2" upper_limit="30.3"/>
                    <measurement group_id="O2" value="30.8" lower_limit="18.7" upper_limit="45.1"/>
                    <measurement group_id="O3" value="28.8" lower_limit="17.1" upper_limit="43.1"/>
                    <measurement group_id="O4" value="30.2" lower_limit="18.3" upper_limit="44.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Mean Change From Baseline in the Severity of the Disease, as Assessed by the International Hidradenitis Suppurativa Severity Score System (IHS4) Score, From Weeks 2 to 16</title>
        <description>Change from Baseline was calculated as the post-Baseline value minus the Baseline value. The IHS4 is a composite, dynamic score and validated tool used to determine Hidradenitis Suppurativa severity. It employs a weighted scale using the number of inflammatory nodules, the number of abscesses, and the number of draining tunnels (fistulas or sinuses), with respective weight factors of 1, 2, and 4. Scores: mild=0-3; moderate=4-10; severe ≥11. MMRM included the fixed effects of treatment group (placebo and INCB054707 15, 45, and 75 mg), stratification factors (disease severity [Hurley Stage I, II, and III] and geographical region [North America and outside of North America]), visit (Weeks 2, 4, 6, 8, 12, and 16), treatment by visit interaction, and covariates of Baseline measurement and Baseline measurement by visit interaction. The variance-covariance matrix of the within-participant errors in MMRM are modeled as unstructured.</description>
        <time_frame>Baseline; Weeks 2, 4, 6, 8, 12, and 16</time_frame>
        <population>ITT Population. Only participants with available data were analyzed.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Participants received oral placebo once a day (QD) for 16 weeks in the Placebo-controlled Treatment Period.</description>
          </group>
          <group group_id="O2">
            <title>INCB054707 15 mg</title>
            <description>Participants received oral INCB054707 15 milligrams (mg) QD for 16 weeks in the Placebo-controlled Treatment Period.</description>
          </group>
          <group group_id="O3">
            <title>INCB054707 45 mg</title>
            <description>Participants received oral INCB054707 45 mg QD for 16 weeks in the Placebo-controlled Treatment Period.</description>
          </group>
          <group group_id="O4">
            <title>INCB054707 75 mg</title>
            <description>Participants received oral INCB054707 75 mg QD for 16 weeks in the Placebo-controlled Treatment Period.</description>
          </group>
        </group_list>
        <measure>
          <title>Mean Change From Baseline in the Severity of the Disease, as Assessed by the International Hidradenitis Suppurativa Severity Score System (IHS4) Score, From Weeks 2 to 16</title>
          <description>Change from Baseline was calculated as the post-Baseline value minus the Baseline value. The IHS4 is a composite, dynamic score and validated tool used to determine Hidradenitis Suppurativa severity. It employs a weighted scale using the number of inflammatory nodules, the number of abscesses, and the number of draining tunnels (fistulas or sinuses), with respective weight factors of 1, 2, and 4. Scores: mild=0-3; moderate=4-10; severe ≥11. MMRM included the fixed effects of treatment group (placebo and INCB054707 15, 45, and 75 mg), stratification factors (disease severity [Hurley Stage I, II, and III] and geographical region [North America and outside of North America]), visit (Weeks 2, 4, 6, 8, 12, and 16), treatment by visit interaction, and covariates of Baseline measurement and Baseline measurement by visit interaction. The variance-covariance matrix of the within-participant errors in MMRM are modeled as unstructured.</description>
          <population>ITT Population. Only participants with available data were analyzed.</population>
          <units>scores on a scale</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="52"/>
                <count group_id="O2" value="52"/>
                <count group_id="O3" value="52"/>
                <count group_id="O4" value="53"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Week 2</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="47"/>
                    <count group_id="O2" value="51"/>
                    <count group_id="O3" value="48"/>
                    <count group_id="O4" value="52"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-2.4" spread="1.17"/>
                    <measurement group_id="O2" value="-3.8" spread="1.13"/>
                    <measurement group_id="O3" value="-6.7" spread="1.16"/>
                    <measurement group_id="O4" value="-6.1" spread="1.12"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="49"/>
                    <count group_id="O2" value="50"/>
                    <count group_id="O3" value="50"/>
                    <count group_id="O4" value="52"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-2.1" spread="1.52"/>
                    <measurement group_id="O2" value="-3.9" spread="1.49"/>
                    <measurement group_id="O3" value="-9.3" spread="1.51"/>
                    <measurement group_id="O4" value="-9.3" spread="1.47"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 6</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="45"/>
                    <count group_id="O2" value="47"/>
                    <count group_id="O3" value="48"/>
                    <count group_id="O4" value="49"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-3.1" spread="1.77"/>
                    <measurement group_id="O2" value="-4.7" spread="1.73"/>
                    <measurement group_id="O3" value="-10.7" spread="1.75"/>
                    <measurement group_id="O4" value="-10.6" spread="1.71"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 8</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="45"/>
                    <count group_id="O2" value="50"/>
                    <count group_id="O3" value="47"/>
                    <count group_id="O4" value="51"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-3.0" spread="1.85"/>
                    <measurement group_id="O2" value="-4.0" spread="1.79"/>
                    <measurement group_id="O3" value="-11.8" spread="1.83"/>
                    <measurement group_id="O4" value="-10.7" spread="1.78"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 12</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="45"/>
                    <count group_id="O2" value="45"/>
                    <count group_id="O3" value="45"/>
                    <count group_id="O4" value="49"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-3.1" spread="1.80"/>
                    <measurement group_id="O2" value="-5.5" spread="1.76"/>
                    <measurement group_id="O3" value="-11.8" spread="1.79"/>
                    <measurement group_id="O4" value="-11.9" spread="1.73"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 16</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="43"/>
                    <count group_id="O2" value="45"/>
                    <count group_id="O3" value="43"/>
                    <count group_id="O4" value="46"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-3.1" spread="1.96"/>
                    <measurement group_id="O2" value="-5.6" spread="1.92"/>
                    <measurement group_id="O3" value="-11.0" spread="1.96"/>
                    <measurement group_id="O4" value="-12.1" spread="1.90"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants Who Achieved AN50, AN75, AN90, and AN100 From Weeks 2 to 16</title>
        <description>AN50, AN75, AN90, and AN100 were defined as at least a 50%, 75%, 90%, and 100% decrease, respectively, from Baseline in AN count.</description>
        <time_frame>Baseline; Weeks 2, 4, 6, 8, 12, and 16</time_frame>
        <population>ITT Population. 95% CI was based on the Clopper-Pearson exact method. Missing post-Baseline values were imputed as nonresponders.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Participants received oral placebo once a day (QD) for 16 weeks in the Placebo-controlled Treatment Period.</description>
          </group>
          <group group_id="O2">
            <title>INCB054707 15 mg</title>
            <description>Participants received oral INCB054707 15 milligrams (mg) QD for 16 weeks in the Placebo-controlled Treatment Period.</description>
          </group>
          <group group_id="O3">
            <title>INCB054707 45 mg</title>
            <description>Participants received oral INCB054707 45 mg QD for 16 weeks in the Placebo-controlled Treatment Period.</description>
          </group>
          <group group_id="O4">
            <title>INCB054707 75 mg</title>
            <description>Participants received oral INCB054707 75 mg QD for 16 weeks in the Placebo-controlled Treatment Period.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants Who Achieved AN50, AN75, AN90, and AN100 From Weeks 2 to 16</title>
          <description>AN50, AN75, AN90, and AN100 were defined as at least a 50%, 75%, 90%, and 100% decrease, respectively, from Baseline in AN count.</description>
          <population>ITT Population. 95% CI was based on the Clopper-Pearson exact method. Missing post-Baseline values were imputed as nonresponders.</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="52"/>
                <count group_id="O2" value="52"/>
                <count group_id="O3" value="52"/>
                <count group_id="O4" value="53"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>AN50, Week 2</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="15.4" lower_limit="6.9" upper_limit="28.1"/>
                    <measurement group_id="O2" value="25.0" lower_limit="14.0" upper_limit="38.9"/>
                    <measurement group_id="O3" value="34.6" lower_limit="22.0" upper_limit="49.1"/>
                    <measurement group_id="O4" value="39.6" lower_limit="26.5" upper_limit="54.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>AN50, Week 4</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="30.8" lower_limit="18.7" upper_limit="45.1"/>
                    <measurement group_id="O2" value="44.2" lower_limit="30.5" upper_limit="58.7"/>
                    <measurement group_id="O3" value="46.2" lower_limit="32.2" upper_limit="60.5"/>
                    <measurement group_id="O4" value="58.5" lower_limit="44.1" upper_limit="71.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>AN50, Week 6</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="32.7" lower_limit="20.3" upper_limit="47.1"/>
                    <measurement group_id="O2" value="46.2" lower_limit="32.2" upper_limit="60.5"/>
                    <measurement group_id="O3" value="51.9" lower_limit="37.6" upper_limit="66.0"/>
                    <measurement group_id="O4" value="56.6" lower_limit="42.3" upper_limit="70.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>AN50, Week 8</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="36.5" lower_limit="23.6" upper_limit="51.0"/>
                    <measurement group_id="O2" value="55.8" lower_limit="41.3" upper_limit="69.5"/>
                    <measurement group_id="O3" value="53.8" lower_limit="39.5" upper_limit="67.8"/>
                    <measurement group_id="O4" value="54.7" lower_limit="40.4" upper_limit="68.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>AN50, Week 12</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="44.2" lower_limit="30.5" upper_limit="58.7"/>
                    <measurement group_id="O2" value="51.9" lower_limit="37.6" upper_limit="66.0"/>
                    <measurement group_id="O3" value="55.8" lower_limit="41.3" upper_limit="69.5"/>
                    <measurement group_id="O4" value="62.3" lower_limit="47.9" upper_limit="75.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>AN50, Week 16</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="36.5" lower_limit="23.6" upper_limit="51.0"/>
                    <measurement group_id="O2" value="55.8" lower_limit="41.3" upper_limit="69.5"/>
                    <measurement group_id="O3" value="57.7" lower_limit="43.2" upper_limit="71.3"/>
                    <measurement group_id="O4" value="52.8" lower_limit="38.6" upper_limit="66.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>AN75, Week 2</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.9" lower_limit="0.0" upper_limit="10.3"/>
                    <measurement group_id="O2" value="9.6" lower_limit="3.2" upper_limit="21.0"/>
                    <measurement group_id="O3" value="13.5" lower_limit="5.6" upper_limit="25.8"/>
                    <measurement group_id="O4" value="20.8" lower_limit="10.8" upper_limit="34.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>AN75, Week 4</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7.7" lower_limit="2.1" upper_limit="18.5"/>
                    <measurement group_id="O2" value="15.4" lower_limit="6.9" upper_limit="28.1"/>
                    <measurement group_id="O3" value="23.1" lower_limit="12.5" upper_limit="36.8"/>
                    <measurement group_id="O4" value="18.9" lower_limit="9.4" upper_limit="32.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>AN75, Week 6</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="13.5" lower_limit="5.6" upper_limit="25.8"/>
                    <measurement group_id="O2" value="25.0" lower_limit="14.0" upper_limit="38.9"/>
                    <measurement group_id="O3" value="32.7" lower_limit="20.3" upper_limit="47.1"/>
                    <measurement group_id="O4" value="26.4" lower_limit="15.3" upper_limit="40.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>AN75, Week 8</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="21.2" lower_limit="11.1" upper_limit="34.7"/>
                    <measurement group_id="O2" value="28.8" lower_limit="17.1" upper_limit="43.1"/>
                    <measurement group_id="O3" value="32.7" lower_limit="20.3" upper_limit="47.1"/>
                    <measurement group_id="O4" value="37.7" lower_limit="24.8" upper_limit="52.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>AN75, Week 12</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="23.1" lower_limit="12.5" upper_limit="36.8"/>
                    <measurement group_id="O2" value="32.7" lower_limit="20.3" upper_limit="47.1"/>
                    <measurement group_id="O3" value="36.5" lower_limit="23.6" upper_limit="51.0"/>
                    <measurement group_id="O4" value="39.6" lower_limit="26.5" upper_limit="54.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>AN75, Week 16</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="17.3" lower_limit="8.2" upper_limit="30.3"/>
                    <measurement group_id="O2" value="36.5" lower_limit="23.6" upper_limit="51.0"/>
                    <measurement group_id="O3" value="36.5" lower_limit="23.6" upper_limit="51.0"/>
                    <measurement group_id="O4" value="34.0" lower_limit="21.5" upper_limit="48.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>AN90, Week 2</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.0" lower_limit="0.0" upper_limit="6.8"/>
                    <measurement group_id="O2" value="3.8" lower_limit="0.5" upper_limit="13.2"/>
                    <measurement group_id="O3" value="1.9" lower_limit="0.0" upper_limit="10.3"/>
                    <measurement group_id="O4" value="11.3" lower_limit="4.3" upper_limit="23.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>AN90, Week 4</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.0" lower_limit="0.0" upper_limit="6.8"/>
                    <measurement group_id="O2" value="5.8" lower_limit="1.2" upper_limit="15.9"/>
                    <measurement group_id="O3" value="7.7" lower_limit="2.1" upper_limit="18.5"/>
                    <measurement group_id="O4" value="5.7" lower_limit="1.2" upper_limit="15.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>AN90, Week 6</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.8" lower_limit="1.2" upper_limit="15.9"/>
                    <measurement group_id="O2" value="5.8" lower_limit="1.2" upper_limit="15.9"/>
                    <measurement group_id="O3" value="11.5" lower_limit="4.4" upper_limit="23.4"/>
                    <measurement group_id="O4" value="9.4" lower_limit="3.1" upper_limit="20.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>AN90, Week 8</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.8" lower_limit="1.2" upper_limit="15.9"/>
                    <measurement group_id="O2" value="15.4" lower_limit="6.9" upper_limit="28.1"/>
                    <measurement group_id="O3" value="19.2" lower_limit="9.6" upper_limit="32.5"/>
                    <measurement group_id="O4" value="18.9" lower_limit="9.4" upper_limit="32.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>AN90, Week 12</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.8" lower_limit="1.2" upper_limit="15.9"/>
                    <measurement group_id="O2" value="17.3" lower_limit="8.2" upper_limit="30.3"/>
                    <measurement group_id="O3" value="13.5" lower_limit="5.6" upper_limit="25.8"/>
                    <measurement group_id="O4" value="20.8" lower_limit="10.8" upper_limit="34.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>AN90, Week 16</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.8" lower_limit="0.5" upper_limit="13.2"/>
                    <measurement group_id="O2" value="17.3" lower_limit="8.2" upper_limit="30.3"/>
                    <measurement group_id="O3" value="19.2" lower_limit="9.6" upper_limit="32.5"/>
                    <measurement group_id="O4" value="18.9" lower_limit="9.4" upper_limit="32.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>AN100, Week 2</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.0" lower_limit="0.0" upper_limit="6.8"/>
                    <measurement group_id="O2" value="3.8" lower_limit="0.5" upper_limit="13.2"/>
                    <measurement group_id="O3" value="1.9" lower_limit="0.0" upper_limit="10.3"/>
                    <measurement group_id="O4" value="7.5" lower_limit="2.1" upper_limit="18.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>AN100, Week 4</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.0" lower_limit="0.0" upper_limit="6.8"/>
                    <measurement group_id="O2" value="3.8" lower_limit="0.5" upper_limit="13.2"/>
                    <measurement group_id="O3" value="5.8" lower_limit="1.2" upper_limit="15.9"/>
                    <measurement group_id="O4" value="5.7" lower_limit="1.2" upper_limit="15.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>AN100, Week 6</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.0" lower_limit="0.0" upper_limit="6.8"/>
                    <measurement group_id="O2" value="3.8" lower_limit="0.5" upper_limit="13.2"/>
                    <measurement group_id="O3" value="7.7" lower_limit="2.1" upper_limit="18.5"/>
                    <measurement group_id="O4" value="9.4" lower_limit="3.1" upper_limit="20.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>AN100, Week 8</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.8" lower_limit="0.5" upper_limit="13.2"/>
                    <measurement group_id="O2" value="13.5" lower_limit="5.6" upper_limit="25.8"/>
                    <measurement group_id="O3" value="11.5" lower_limit="4.4" upper_limit="23.4"/>
                    <measurement group_id="O4" value="17.0" lower_limit="8.1" upper_limit="29.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>AN100, Week 12</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.8" lower_limit="0.5" upper_limit="13.2"/>
                    <measurement group_id="O2" value="13.5" lower_limit="5.6" upper_limit="25.8"/>
                    <measurement group_id="O3" value="11.5" lower_limit="4.4" upper_limit="23.4"/>
                    <measurement group_id="O4" value="18.9" lower_limit="9.4" upper_limit="32.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>AN100, Week 16</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.8" lower_limit="0.5" upper_limit="13.2"/>
                    <measurement group_id="O2" value="15.4" lower_limit="6.9" upper_limit="28.1"/>
                    <measurement group_id="O3" value="11.5" lower_limit="4.4" upper_limit="23.4"/>
                    <measurement group_id="O4" value="17.0" lower_limit="8.1" upper_limit="29.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Mean Change From Baseline in AN Count at Weeks 2 to 12</title>
        <description>Change from Baseline was calculated as the post-Baseline value minus the Baseline value. MMRM included the fixed effects of treatment group (placebo and INCB054707 15, 45, and 75 mg), stratification factors (disease severity [Hurley Stage I, II, and III] and geographical region [North America and outside of North America]), visit (Weeks 2, 4, 6, 8, 12, and 16), treatment by visit interaction, and covariates of Baseline measurement and Baseline measurement by visit interaction. The variance-covariance matrix of the within-participant errors in MMRM are modeled as unstructured.</description>
        <time_frame>Baseline; Weeks 2, 4, 6, 8, and 12</time_frame>
        <population>ITT Population. Only participants with available data were analyzed.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Participants received oral placebo once a day (QD) for 16 weeks in the Placebo-controlled Treatment Period.</description>
          </group>
          <group group_id="O2">
            <title>INCB054707 15 mg</title>
            <description>Participants received oral INCB054707 15 milligrams (mg) QD for 16 weeks in the Placebo-controlled Treatment Period.</description>
          </group>
          <group group_id="O3">
            <title>INCB054707 45 mg</title>
            <description>Participants received oral INCB054707 45 mg QD for 16 weeks in the Placebo-controlled Treatment Period.</description>
          </group>
          <group group_id="O4">
            <title>INCB054707 75 mg</title>
            <description>Participants received oral INCB054707 75 mg QD for 16 weeks in the Placebo-controlled Treatment Period.</description>
          </group>
        </group_list>
        <measure>
          <title>Mean Change From Baseline in AN Count at Weeks 2 to 12</title>
          <description>Change from Baseline was calculated as the post-Baseline value minus the Baseline value. MMRM included the fixed effects of treatment group (placebo and INCB054707 15, 45, and 75 mg), stratification factors (disease severity [Hurley Stage I, II, and III] and geographical region [North America and outside of North America]), visit (Weeks 2, 4, 6, 8, 12, and 16), treatment by visit interaction, and covariates of Baseline measurement and Baseline measurement by visit interaction. The variance-covariance matrix of the within-participant errors in MMRM are modeled as unstructured.</description>
          <population>ITT Population. Only participants with available data were analyzed.</population>
          <units>abscesses and inflammatory nodules</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="52"/>
                <count group_id="O2" value="52"/>
                <count group_id="O3" value="52"/>
                <count group_id="O4" value="53"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Week 2</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="47"/>
                    <count group_id="O2" value="51"/>
                    <count group_id="O3" value="48"/>
                    <count group_id="O4" value="52"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.7" spread="0.69"/>
                    <measurement group_id="O2" value="-2.7" spread="0.66"/>
                    <measurement group_id="O3" value="-3.4" spread="0.69"/>
                    <measurement group_id="O4" value="-4.0" spread="0.66"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="49"/>
                    <count group_id="O2" value="50"/>
                    <count group_id="O3" value="50"/>
                    <count group_id="O4" value="52"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-3.0" spread="0.71"/>
                    <measurement group_id="O2" value="-3.6" spread="0.70"/>
                    <measurement group_id="O3" value="-4.8" spread="0.71"/>
                    <measurement group_id="O4" value="-5.3" spread="0.69"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 6</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="45"/>
                    <count group_id="O2" value="47"/>
                    <count group_id="O3" value="48"/>
                    <count group_id="O4" value="49"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-2.7" spread="0.77"/>
                    <measurement group_id="O2" value="-4.8" spread="0.76"/>
                    <measurement group_id="O3" value="-5.3" spread="0.77"/>
                    <measurement group_id="O4" value="-6.2" spread="0.75"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 8</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="45"/>
                    <count group_id="O2" value="50"/>
                    <count group_id="O3" value="47"/>
                    <count group_id="O4" value="51"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-2.7" spread="0.82"/>
                    <measurement group_id="O2" value="-4.7" spread="0.79"/>
                    <measurement group_id="O3" value="-6.4" spread="0.82"/>
                    <measurement group_id="O4" value="-5.7" spread="0.79"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 12</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="45"/>
                    <count group_id="O2" value="45"/>
                    <count group_id="O3" value="45"/>
                    <count group_id="O4" value="49"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-2.8" spread="0.84"/>
                    <measurement group_id="O2" value="-5.0" spread="0.82"/>
                    <measurement group_id="O3" value="-6.7" spread="0.84"/>
                    <measurement group_id="O4" value="-6.5" spread="0.81"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants With a Total AN Count of 0 to 2 From Weeks 2 to 16</title>
        <description>Total AN count was assessed throughout the study.</description>
        <time_frame>Weeks 2, 4, 6, 8, 12, and 16</time_frame>
        <population>ITT Population. Only participants with available data were analyzed.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Participants received oral placebo once a day (QD) for 16 weeks in the Placebo-controlled Treatment Period.</description>
          </group>
          <group group_id="O2">
            <title>INCB054707 15 mg</title>
            <description>Participants received oral INCB054707 15 milligrams (mg) QD for 16 weeks in the Placebo-controlled Treatment Period.</description>
          </group>
          <group group_id="O3">
            <title>INCB054707 45 mg</title>
            <description>Participants received oral INCB054707 45 mg QD for 16 weeks in the Placebo-controlled Treatment Period.</description>
          </group>
          <group group_id="O4">
            <title>INCB054707 75 mg</title>
            <description>Participants received oral INCB054707 75 mg QD for 16 weeks in the Placebo-controlled Treatment Period.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With a Total AN Count of 0 to 2 From Weeks 2 to 16</title>
          <description>Total AN count was assessed throughout the study.</description>
          <population>ITT Population. Only participants with available data were analyzed.</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="52"/>
                <count group_id="O2" value="52"/>
                <count group_id="O3" value="52"/>
                <count group_id="O4" value="53"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Week 2</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="47"/>
                    <count group_id="O2" value="51"/>
                    <count group_id="O3" value="48"/>
                    <count group_id="O4" value="52"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.3"/>
                    <measurement group_id="O2" value="9.8"/>
                    <measurement group_id="O3" value="16.7"/>
                    <measurement group_id="O4" value="23.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="49"/>
                    <count group_id="O2" value="50"/>
                    <count group_id="O3" value="50"/>
                    <count group_id="O4" value="52"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="14.3"/>
                    <measurement group_id="O2" value="20.0"/>
                    <measurement group_id="O3" value="20.0"/>
                    <measurement group_id="O4" value="23.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 6</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="45"/>
                    <count group_id="O2" value="47"/>
                    <count group_id="O3" value="48"/>
                    <count group_id="O4" value="49"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="13.3"/>
                    <measurement group_id="O2" value="19.1"/>
                    <measurement group_id="O3" value="31.3"/>
                    <measurement group_id="O4" value="38.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 8</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="45"/>
                    <count group_id="O2" value="50"/>
                    <count group_id="O3" value="47"/>
                    <count group_id="O4" value="51"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="28.9"/>
                    <measurement group_id="O2" value="30.0"/>
                    <measurement group_id="O3" value="38.3"/>
                    <measurement group_id="O4" value="41.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 12</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="45"/>
                    <count group_id="O2" value="45"/>
                    <count group_id="O3" value="45"/>
                    <count group_id="O4" value="49"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="28.9"/>
                    <measurement group_id="O2" value="33.3"/>
                    <measurement group_id="O3" value="46.7"/>
                    <measurement group_id="O4" value="38.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 16</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="43"/>
                    <count group_id="O2" value="45"/>
                    <count group_id="O3" value="43"/>
                    <count group_id="O4" value="46"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="25.6"/>
                    <measurement group_id="O2" value="44.4"/>
                    <measurement group_id="O3" value="51.2"/>
                    <measurement group_id="O4" value="37.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Mean Change From Baseline in Draining Fistula Count From Weeks 2 to 16</title>
        <description>Change from Baseline was calculated as the post-Baseline value minus the Baseline value.</description>
        <time_frame>Baseline; Weeks 2, 4, 6, 8, 12, and 16</time_frame>
        <population>ITT Population. Only participants with available data were analyzed.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Participants received oral placebo once a day (QD) for 16 weeks in the Placebo-controlled Treatment Period.</description>
          </group>
          <group group_id="O2">
            <title>INCB054707 15 mg</title>
            <description>Participants received oral INCB054707 15 milligrams (mg) QD for 16 weeks in the Placebo-controlled Treatment Period.</description>
          </group>
          <group group_id="O3">
            <title>INCB054707 45 mg</title>
            <description>Participants received oral INCB054707 45 mg QD for 16 weeks in the Placebo-controlled Treatment Period.</description>
          </group>
          <group group_id="O4">
            <title>INCB054707 75 mg</title>
            <description>Participants received oral INCB054707 75 mg QD for 16 weeks in the Placebo-controlled Treatment Period.</description>
          </group>
        </group_list>
        <measure>
          <title>Mean Change From Baseline in Draining Fistula Count From Weeks 2 to 16</title>
          <description>Change from Baseline was calculated as the post-Baseline value minus the Baseline value.</description>
          <population>ITT Population. Only participants with available data were analyzed.</population>
          <units>draining fistulas</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="52"/>
                <count group_id="O2" value="52"/>
                <count group_id="O3" value="52"/>
                <count group_id="O4" value="53"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="52"/>
                    <count group_id="O2" value="52"/>
                    <count group_id="O3" value="52"/>
                    <count group_id="O4" value="53"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.4" spread="3.97"/>
                    <measurement group_id="O2" value="2.3" spread="4.44"/>
                    <measurement group_id="O3" value="2.2" spread="4.04"/>
                    <measurement group_id="O4" value="1.6" spread="2.85"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change from Baseline at Week 2</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="47"/>
                    <count group_id="O2" value="51"/>
                    <count group_id="O3" value="48"/>
                    <count group_id="O4" value="52"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.2" spread="1.23"/>
                    <measurement group_id="O2" value="-0.2" spread="1.01"/>
                    <measurement group_id="O3" value="-0.6" spread="1.62"/>
                    <measurement group_id="O4" value="-0.2" spread="1.30"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change from Baseline at Week 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="49"/>
                    <count group_id="O2" value="50"/>
                    <count group_id="O3" value="50"/>
                    <count group_id="O4" value="52"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.0" spread="1.80"/>
                    <measurement group_id="O2" value="0.0" spread="1.11"/>
                    <measurement group_id="O3" value="-0.8" spread="2.59"/>
                    <measurement group_id="O4" value="-0.6" spread="2.44"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change from Baseline at Week 6</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="45"/>
                    <count group_id="O2" value="47"/>
                    <count group_id="O3" value="48"/>
                    <count group_id="O4" value="49"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.2" spread="2.14"/>
                    <measurement group_id="O2" value="0.1" spread="1.85"/>
                    <measurement group_id="O3" value="-1.0" spread="2.95"/>
                    <measurement group_id="O4" value="-0.8" spread="2.62"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change from Baseline at Week 8</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="45"/>
                    <count group_id="O2" value="50"/>
                    <count group_id="O3" value="47"/>
                    <count group_id="O4" value="51"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.2" spread="2.46"/>
                    <measurement group_id="O2" value="0.2" spread="2.10"/>
                    <measurement group_id="O3" value="-1.1" spread="2.82"/>
                    <measurement group_id="O4" value="-0.8" spread="2.70"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change from Baseline at Week 12</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="45"/>
                    <count group_id="O2" value="45"/>
                    <count group_id="O3" value="45"/>
                    <count group_id="O4" value="49"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.3" spread="2.17"/>
                    <measurement group_id="O2" value="0.0" spread="2.71"/>
                    <measurement group_id="O3" value="-1.0" spread="2.87"/>
                    <measurement group_id="O4" value="-1.0" spread="2.61"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change from Baseline at Week 16</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="43"/>
                    <count group_id="O2" value="45"/>
                    <count group_id="O3" value="43"/>
                    <count group_id="O4" value="46"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.3" spread="2.05"/>
                    <measurement group_id="O2" value="0.1" spread="3.25"/>
                    <measurement group_id="O3" value="-0.8" spread="3.20"/>
                    <measurement group_id="O4" value="-1.1" spread="2.57"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Mean Change From Baseline in Abscess, Inflammatory Nodule (IN), and Draining Fistula (DF) (ANF) Count From Weeks 2 to 16</title>
        <description>Change from Baseline was calculated as the post-Baseline value minus the Baseline value. MMRM included the fixed effects of treatment group (placebo and INCB054707 15, 45, and 75 mg), stratification factors (disease severity [Hurley Stage I, II, and III] and geographical region [North America and outside of North America]), visit (Weeks 2, 4, 6, 8, 12, and 16), treatment by visit interaction, and covariates of Baseline measurement and Baseline measurement by visit interaction. The variance-covariance matrix of the within-participant errors in MMRM are modeled as unstructured.</description>
        <time_frame>Baseline; Weeks 2, 4, 6, 8, 12, and 16</time_frame>
        <population>ITT Population. Only participants with available data were analyzed.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Participants received oral placebo once a day (QD) for 16 weeks in the Placebo-controlled Treatment Period.</description>
          </group>
          <group group_id="O2">
            <title>INCB054707 15 mg</title>
            <description>Participants received oral INCB054707 15 milligrams (mg) QD for 16 weeks in the Placebo-controlled Treatment Period.</description>
          </group>
          <group group_id="O3">
            <title>INCB054707 45 mg</title>
            <description>Participants received oral INCB054707 45 mg QD for 16 weeks in the Placebo-controlled Treatment Period.</description>
          </group>
          <group group_id="O4">
            <title>INCB054707 75 mg</title>
            <description>Participants received oral INCB054707 75 mg QD for 16 weeks in the Placebo-controlled Treatment Period.</description>
          </group>
        </group_list>
        <measure>
          <title>Mean Change From Baseline in Abscess, Inflammatory Nodule (IN), and Draining Fistula (DF) (ANF) Count From Weeks 2 to 16</title>
          <description>Change from Baseline was calculated as the post-Baseline value minus the Baseline value. MMRM included the fixed effects of treatment group (placebo and INCB054707 15, 45, and 75 mg), stratification factors (disease severity [Hurley Stage I, II, and III] and geographical region [North America and outside of North America]), visit (Weeks 2, 4, 6, 8, 12, and 16), treatment by visit interaction, and covariates of Baseline measurement and Baseline measurement by visit interaction. The variance-covariance matrix of the within-participant errors in MMRM are modeled as unstructured.</description>
          <population>ITT Population. Only participants with available data were analyzed.</population>
          <units>abscesses, INs, and DFs</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="52"/>
                <count group_id="O2" value="52"/>
                <count group_id="O3" value="52"/>
                <count group_id="O4" value="53"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Week 2</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="47"/>
                    <count group_id="O2" value="51"/>
                    <count group_id="O3" value="48"/>
                    <count group_id="O4" value="52"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.8" spread="0.74"/>
                    <measurement group_id="O2" value="-2.9" spread="0.72"/>
                    <measurement group_id="O3" value="-4.0" spread="0.74"/>
                    <measurement group_id="O4" value="-4.4" spread="0.71"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="49"/>
                    <count group_id="O2" value="50"/>
                    <count group_id="O3" value="50"/>
                    <count group_id="O4" value="52"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-2.7" spread="0.83"/>
                    <measurement group_id="O2" value="-3.5" spread="0.82"/>
                    <measurement group_id="O3" value="-5.7" spread="0.82"/>
                    <measurement group_id="O4" value="-6.2" spread="0.80"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 6</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="45"/>
                    <count group_id="O2" value="47"/>
                    <count group_id="O3" value="48"/>
                    <count group_id="O4" value="49"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-2.6" spread="0.92"/>
                    <measurement group_id="O2" value="-4.7" spread="0.90"/>
                    <measurement group_id="O3" value="-6.4" spread="0.92"/>
                    <measurement group_id="O4" value="-7.1" spread="0.89"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 8</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="45"/>
                    <count group_id="O2" value="50"/>
                    <count group_id="O3" value="47"/>
                    <count group_id="O4" value="51"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-2.6" spread="0.96"/>
                    <measurement group_id="O2" value="-4.4" spread="0.93"/>
                    <measurement group_id="O3" value="-7.5" spread="0.96"/>
                    <measurement group_id="O4" value="-6.8" spread="0.92"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 12</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="45"/>
                    <count group_id="O2" value="45"/>
                    <count group_id="O3" value="45"/>
                    <count group_id="O4" value="49"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-2.7" spread="0.99"/>
                    <measurement group_id="O2" value="-5.0" spread="0.97"/>
                    <measurement group_id="O3" value="-7.7" spread="0.98"/>
                    <measurement group_id="O4" value="-7.6" spread="0.95"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 16</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="43"/>
                    <count group_id="O2" value="45"/>
                    <count group_id="O3" value="43"/>
                    <count group_id="O4" value="46"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-2.4" spread="1.06"/>
                    <measurement group_id="O2" value="-5.1" spread="1.03"/>
                    <measurement group_id="O3" value="-7.7" spread="1.05"/>
                    <measurement group_id="O4" value="-7.6" spread="1.02"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Treatment-emergent Adverse Events (TEAEs)</title>
        <description>An adverse event (AE) was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. An AE could have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study treatment. A TEAE was defined as any AE either reported for the first time or the worsening of a pre-existing event after the first dose of study drug until the end of the safety follow-up.</description>
        <time_frame>up to Week 16</time_frame>
        <population>Safety Population: all participants who received at least 1 dose of INCB054707 or placebo during the Placebo-controlled Period</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Participants received oral placebo once a day (QD) for 16 weeks in the Placebo-controlled Treatment Period.</description>
          </group>
          <group group_id="O2">
            <title>INCB054707 15 mg</title>
            <description>Participants received oral INCB054707 15 milligrams (mg) QD for 16 weeks in the Placebo-controlled Treatment Period.</description>
          </group>
          <group group_id="O3">
            <title>INCB054707 45 mg</title>
            <description>Participants received oral INCB054707 45 mg QD for 16 weeks in the Placebo-controlled Treatment Period.</description>
          </group>
          <group group_id="O4">
            <title>INCB054707 75 mg</title>
            <description>Participants received oral INCB054707 75 mg QD for 16 weeks in the Placebo-controlled Treatment Period.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Treatment-emergent Adverse Events (TEAEs)</title>
          <description>An adverse event (AE) was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. An AE could have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study treatment. A TEAE was defined as any AE either reported for the first time or the worsening of a pre-existing event after the first dose of study drug until the end of the safety follow-up.</description>
          <population>Safety Population: all participants who received at least 1 dose of INCB054707 or placebo during the Placebo-controlled Period</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="52"/>
                <count group_id="O2" value="52"/>
                <count group_id="O3" value="50"/>
                <count group_id="O4" value="53"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="34"/>
                    <measurement group_id="O2" value="31"/>
                    <measurement group_id="O3" value="30"/>
                    <measurement group_id="O4" value="32"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>up to Week 16</time_frame>
      <desc>Treatment-emergent adverse events (TEAEs), defined as AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug until the end of the safety follow-up, have been reported for members of the Safety Population (all participants who received at least 1 dose of INCB054707 or placebo during the Placebo-controlled Period).</desc>
      <group_list>
        <group group_id="E1">
          <title>Placebo</title>
          <description>Participants received oral placebo once a day (QD) for 16 weeks in the Placebo-controlled Treatment Period.</description>
        </group>
        <group group_id="E2">
          <title>INCB054707 15 mg</title>
          <description>Participants received oral INCB054707 15 milligrams (mg) QD for 16 weeks in the Placebo-controlled Treatment Period.</description>
        </group>
        <group group_id="E3">
          <title>INCB054707 45 mg</title>
          <description>Participants received oral INCB054707 45 mg QD for 16 weeks in the Placebo-controlled Treatment Period.</description>
        </group>
        <group group_id="E4">
          <title>INCB054707 75 mg</title>
          <description>Participants received oral INCB054707 75 mg QD for 16 weeks in the Placebo-controlled Treatment Period.</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>MedDRA 25</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="52"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="52"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="53"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="52"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="52"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="50"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="53"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Atrial fibrillation</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="52"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="52"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="53"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Hepatobiliary disorders</title>
            <event_list>
              <event>
                <sub_title>Cholecystitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="52"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="52"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="53"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Abscess limb</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="52"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="52"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="53"/>
              </event>
              <event>
                <sub_title>Bacterial infection</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="52"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="52"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="53"/>
              </event>
              <event>
                <sub_title>Pneumonia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="52"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="52"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="53"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Fall</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="52"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="52"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="53"/>
              </event>
              <event>
                <sub_title>Rib fracture</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="52"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="52"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="53"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Intervertebral disc protrusion</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="52"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="52"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="50"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="53"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Pulmonary embolism</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="52"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="52"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="53"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <default_vocab>MedDRA 25</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="15" subjects_at_risk="52"/>
                <counts group_id="E2" subjects_affected="20" subjects_at_risk="52"/>
                <counts group_id="E3" subjects_affected="17" subjects_at_risk="50"/>
                <counts group_id="E4" subjects_affected="19" subjects_at_risk="53"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Constipation</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="52"/>
                <counts group_id="E2" events="5" subjects_affected="4" subjects_at_risk="52"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="53"/>
              </event>
              <event>
                <sub_title>Diarrhoea</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="52"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="52"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="50"/>
                <counts group_id="E4" events="3" subjects_affected="3" subjects_at_risk="53"/>
              </event>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" events="6" subjects_affected="5" subjects_at_risk="52"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="52"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="50"/>
                <counts group_id="E4" events="3" subjects_affected="3" subjects_at_risk="53"/>
              </event>
              <event>
                <sub_title>Vomiting</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="52"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="52"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="50"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="53"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Fatigue</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="52"/>
                <counts group_id="E2" events="5" subjects_affected="5" subjects_at_risk="52"/>
                <counts group_id="E3" events="6" subjects_affected="6" subjects_at_risk="50"/>
                <counts group_id="E4" events="6" subjects_affected="6" subjects_at_risk="53"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Nasopharyngitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="52"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="52"/>
                <counts group_id="E3" events="3" subjects_affected="3" subjects_at_risk="50"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="53"/>
              </event>
              <event>
                <sub_title>Upper respiratory tract infection</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="52"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="52"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="50"/>
                <counts group_id="E4" events="4" subjects_affected="4" subjects_at_risk="53"/>
              </event>
              <event>
                <sub_title>Urinary tract infection</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="52"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="52"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="50"/>
                <counts group_id="E4" events="3" subjects_affected="3" subjects_at_risk="53"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Back pain</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="52"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="52"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="50"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="53"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" events="5" subjects_affected="5" subjects_at_risk="52"/>
                <counts group_id="E2" events="5" subjects_affected="4" subjects_at_risk="52"/>
                <counts group_id="E3" events="3" subjects_affected="3" subjects_at_risk="50"/>
                <counts group_id="E4" events="4" subjects_affected="4" subjects_at_risk="53"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Acne</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="52"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="52"/>
                <counts group_id="E3" events="3" subjects_affected="3" subjects_at_risk="50"/>
                <counts group_id="E4" events="3" subjects_affected="3" subjects_at_risk="53"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Hypertension</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="52"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="52"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E4" events="3" subjects_affected="3" subjects_at_risk="53"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>Following the first publication, the Institution and/or Principal Investigator may publish data or results from the Study, provided, however, that the Institution and/or Principal Investigator submits the proposed publication to the Sponsor for review at least sixty (60) days prior to the date of the proposed publication. Sponsor may remove from the proposed publication any information that is considered confidential and/or proprietary other than Study data and results.</restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Study Director</name_or_title>
      <organization>Incyte Corporation</organization>
      <phone>1-855-463-3463</phone>
      <email>medinfo@incyte.com</email>
    </point_of_contact>
  </clinical_results>
</clinical_study>


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/NCT04476043
org study id: INCB 54707-204
nct id: NCT04476043
lead sponsor: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
To evaluate the efficacy and safety of INCB054707 in participants with hidradenitis
      suppurativa over a 16-week placebo-controlled treatment period followed by a 36-week
      open-label extension period. All eligible participants will be invited to continue treatment
      for an additional 48-week Long-term extension period (also open label).
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Triple (Participant, Investigator, Outcomes Assessor)
masking description: Triple
measure: Mean Change From Baseline in Abscess and Inflammatory Nodule (AN) Count at Week 16
time frame: Baseline; Week 16
description: Change from Baseline was calculated as the post-Baseline value minus the Baseline value. The mixed model repeated measure (MMRM) included the fixed effects of treatment group (placebo and INCB054707 15, 45, and 75 mg), stratification factors (disease severity [Hurley Stage I, II, and III] and geographical region [North America and outside of North America]), visit (Weeks 2, 4, 6, 8, 12, and 16), treatment by visit interaction, and covariates of Baseline measurement and Baseline measurement by visit interaction. The variance-covariance matrix of the within-participant errors in MMRM are modeled as unstructured.
measure: Percentage of Participants Who Achieved a Hidradenitis Suppurativa Clinical Response (HiSCR) at Week 16
time frame: Baseline; Week 16
description: HiSCR, the key secondary endpoint, was defined as at least a 50% decrease from Baseline in AN count with no increase in the number of abscesses or draining fistulas.
measure: Percentage of Participants Who Achieved a HiSCR at Weeks 2 Through 12
time frame: Baseline; Weeks 2, 4, 6, 8, and 12
description: HiSCR was defined as at least a 50% decrease from Baseline in AN count with no increase in the number of abscesses or draining fistulas.
measure: Percentage of Participants Who Achieved HiSCR75 From Weeks 2 to 16
time frame: Baseline; Weeks 2, 4, 6, 8, 12, and 16
description: HiSCR75 was defined as at least a 75% decrease from Baseline in AN count with no increase in the number of abscesses or draining fistulas.
measure: Mean Change From Baseline in the Severity of the Disease, as Assessed by the International Hidradenitis Suppurativa Severity Score System (IHS4) Score, From Weeks 2 to 16
time frame: Baseline; Weeks 2, 4, 6, 8, 12, and 16
description: Change from Baseline was calculated as the post-Baseline value minus the Baseline value. The IHS4 is a composite, dynamic score and validated tool used to determine Hidradenitis Suppurativa severity. It employs a weighted scale using the number of inflammatory nodules, the number of abscesses, and the number of draining tunnels (fistulas or sinuses), with respective weight factors of 1, 2, and 4. Scores: mild=0-3; moderate=4-10; severe ≥11. MMRM included the fixed effects of treatment group (placebo and INCB054707 15, 45, and 75 mg), stratification factors (disease severity [Hurley Stage I, II, and III] and geographical region [North America and outside of North America]), visit (Weeks 2, 4, 6, 8, 12, and 16), treatment by visit interaction, and covariates of Baseline measurement and Baseline measurement by visit interaction. The variance-covariance matrix of the within-participant errors in MMRM are modeled as unstructured.
measure: Percentage of Participants Who Achieved AN50, AN75, AN90, and AN100 From Weeks 2 to 16
time frame: Baseline; Weeks 2, 4, 6, 8, 12, and 16
description: AN50, AN75, AN90, and AN100 were defined as at least a 50%, 75%, 90%, and 100% decrease, respectively, from Baseline in AN count.
measure: Mean Change From Baseline in AN Count at Weeks 2 to 12
time frame: Baseline; Weeks 2, 4, 6, 8, and 12
description: Change from Baseline was calculated as the post-Baseline value minus the Baseline value. MMRM included the fixed effects of treatment group (placebo and INCB054707 15, 45, and 75 mg), stratification factors (disease severity [Hurley Stage I, II, and III] and geographical region [North America and outside of North America]), visit (Weeks 2, 4, 6, 8, 12, and 16), treatment by visit interaction, and covariates of Baseline measurement and Baseline measurement by visit interaction. The variance-covariance matrix of the within-participant errors in MMRM are modeled as unstructured.
measure: Percentage of Participants With a Total AN Count of 0 to 2 From Weeks 2 to 16
time frame: Weeks 2, 4, 6, 8, 12, and 16
description: Total AN count was assessed throughout the study.
measure: Mean Change From Baseline in Draining Fistula Count From Weeks 2 to 16
time frame: Baseline; Weeks 2, 4, 6, 8, 12, and 16
description: Change from Baseline was calculated as the post-Baseline value minus the Baseline value.
measure: Mean Change From Baseline in Abscess, Inflammatory Nodule (IN), and Draining Fistula (DF) (ANF) Count From Weeks 2 to 16
time frame: Baseline; Weeks 2, 4, 6, 8, 12, and 16
description: Change from Baseline was calculated as the post-Baseline value minus the Baseline value. MMRM included the fixed effects of treatment group (placebo and INCB054707 15, 45, and 75 mg), stratification factors (disease severity [Hurley Stage I, II, and III] and geographical region [North America and outside of North America]), visit (Weeks 2, 4, 6, 8, 12, and 16), treatment by visit interaction, and covariates of Baseline measurement and Baseline measurement by visit interaction. The variance-covariance matrix of the within-participant errors in MMRM are modeled as unstructured.
measure: Number of Participants With Treatment-emergent Adverse Events (TEAEs)
time frame: up to Week 16
description: An adverse event (AE) was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. An AE could have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study treatment. A TEAE was defined as any AE either reported for the first time or the worsening of a pre-existing event after the first dose of study drug until the end of the safety follow-up.
arm group label: INCB054707 15 mg
arm group type: Experimental
description: Participants will receive INCB054707 15 milligrams (mg) for 16 weeks in the Placebo-controlled Treatment Period, followed by INCB054707 75 mg for 36 weeks in the Open-label Extension Period. Participants will have the option to continue open-label treatment for an additional 48 weeks.
arm group label: INCB054707 45 mg
arm group type: Experimental
description: Participants will receive INCB054707 45 mg for 16 weeks in the Placebo-controlled Treatment Period, followed by INCB054707 75 mg for 36 weeks in the Open-label Extension Period. Participants will have the option to continue open-label treatment for an additional 48 weeks.
arm group label: INCB054707 75 mg
arm group type: Experimental
description: Participants will receive INCB054707 75 mg for 52 weeks in the Placebo-controlled Treatment Period (16 weeks) plus the Open-label Extension Period (36 weeks). Participants will have the option to continue open-label treatment for an additional 48 weeks.
arm group label: Placebo followed by INCB054707 75 mg
arm group type: Placebo Comparator
description: Participants will receive placebo for 16 weeks in the Placebo-controlled Treatment Period, followed by INCB054707 75 mg for 36 weeks in the Open-label Extension Period. Participants will have the option to continue open-label treatment for an additional 48 weeks.
intervention type: Drug
intervention name: INCB054707
description: Oral; Tablet
arm group label: INCB054707 15 mg
arm group label: INCB054707 45 mg
arm group label: INCB054707 75 mg
other name: Povorcitinib
intervention type: Drug
intervention name: Placebo
description: Oral; Tablet
arm group label: Placebo followed by INCB054707 75 mg
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: No
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country: Canada
country: France
country: Germany
country: Poland
country: Spain
country: United States
responsible party type: Sponsor
mesh term: Hidradenitis Suppurativa
mesh term: Hidradenitis
sharing ipd: Yes
ipd description: Incyte shares data with qualified external researchers after a research proposal is submitted. These requests are reviewed and approved by a review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.
The trial data availability is according to the criteria and process described on https://www.incyte.com/our-company/compliance-and-transparency
ipd info type: Study Protocol
ipd info type: Statistical Analysis Plan (SAP)
ipd time frame: Data will be shared after the primary publication or 2 years after the study has ended for market authorized products and indications.
ipd access criteria: Data from eligible studies will be shared with qualified researchers according to the criteria and process described in the Data Sharing section of the www.incyteclinicaltrials.com website. For approved requests, the researchers will be granted access to anonymized data under the terms of a data sharing agreement.
ipd url: https://www.incyte.com/our-company/compliance-and-transparency
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