xml: <clinical_study>
    <!-- This xml conforms to an XML Schema at:
      https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
    <required_header>
      <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
      <link_text>Link to the current ClinicalTrials.gov record.</link_text>
      <url>https://clinicaltrials.gov/ct2/show/NCT05969223</url>
    </required_header>
    <id_info>
      <org_study_id>M23-702</org_study_id>
      <secondary_id>2023-504154-35-00</secondary_id>
      <nct_id>NCT05969223</nct_id>
    </id_info>
    <brief_title>Study to Assess the Safety and Efficacy of Subcutaneously Injected Risankizumab in Adult Participants With Genital or Scalp Psoriasis</brief_title>
    <acronym>UnlIMMited</acronym>
    <official_title>A Phase 4 Multicenter, Randomized, Double-Blind Study of Risankizumab for the Treatment of Adult Subjects With Moderate to Severe Genital Psoriasis or Moderate to Severe Scalp Psoriasis</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>AbbVie</agency>
        <agency_class>Industry</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>AbbVie</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>
      <is_us_export>Yes</is_us_export>
    </oversight_info>
    <brief_summary>
      <textblock>
        Psoriasis (PsO) is a chronic disease characterized by marked inflammation of the skin that&#xD;
        results in thick, red, scaly plaques. This study will assess how safe and effective&#xD;
        risankizumab is in adult participants with moderate to severe genital psoriasis or moderate&#xD;
        to severe scalp psoriasis. Adverse events and change in disease signs and symptoms will be&#xD;
        monitored.&#xD;
  &#xD;
        Risankizumab (Skyrizi) is a drug being studied for the treatment of moderate to severe&#xD;
        genital psoriasis or moderate to severe scalp psoriasis. Approximately 200 participants with&#xD;
        moderate to severe genital psoriasis or moderate to severe scalp psoriasis will be enrolled&#xD;
        across approximately 45 sites globally.&#xD;
  &#xD;
        The study will be broken up into 2 sub-studies by disease location, participants with&#xD;
        moderate to severe genital psoriasis (Study G) and moderate to severe scalp psoriasis (Study&#xD;
        S). In both sub-studies participants will receive subcutaneous (SC) injections of&#xD;
        risankizumab during the 52 week treatment period, or SC injections of placebo risankizumab&#xD;
        during the 16 week treatment period followed by SC injections of risankizumab during the 36&#xD;
        week treatment period, with an 8-week follow-up period after the 52 week treatment period.&#xD;
  &#xD;
        There may be higher treatment burden for participants in this trial compared to their&#xD;
        standard of care. Participants will attend regular visits during the study at a hospital or&#xD;
        clinic. The effect of the treatment will be checked by medical assessments, blood tests,&#xD;
        checking for side effects and completing questionnaires.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">August 10, 2023</start_date>
    <completion_date type="Anticipated">August 1, 2025</completion_date>
    <primary_completion_date type="Anticipated">September 27, 2024</primary_completion_date>
    <phase>Phase 4</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Randomized</allocation>
      <intervention_model>Parallel Assignment</intervention_model>
      <primary_purpose>Treatment</primary_purpose>
      <masking>Double (Participant, Investigator)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Study-G: Percentage of Participants with Achievement of static Physician Global Assessment of Genitalia (sPGA-G) of 0 or 1</measure>
      <time_frame>Week 16</time_frame>
      <description>The sPGA-G is a 5-point score ranging from 0 to 4, with a larger score indicating greater severity, based on the physician's assessment of the average thickness, erythema, and scaling of psoriatic genital lesions.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Study-S: Percentage of Participants with Achievement of Scalp Investigator Global Assessment (IGA) of 0 or 1</measure>
      <time_frame>Week 16</time_frame>
      <description>The scalp IGA is a measurement of overall scalp involvement by the investigator at the time of evaluation. The scalp IGA is a 5-point scale ranging from 0 (clear) to 4 (severe) incorporating an assessment of the severity of the 3 primary signs of the disease: erythema, scaling, and plaque elevation.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Study-G: Percentage of Participants with Achievement of static Physician Global Assessment of Genitalia (sPGA-G) of 0</measure>
      <time_frame>Week 16</time_frame>
      <description>The sPGA-G is a 5-point score ranging from 0 to 4, with a larger score indicating greater severity, based on the physician's assessment of the average thickness, erythema, and scaling of all psoriatic lesions.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Study-G: Percentage of Participants with Achievement of Dermatology Life Quality Index (DLQI) of 0 or 1</measure>
      <time_frame>Week 16</time_frame>
      <description>The DLQI is a self-administered, 10-question questionnaire covering 6 domains (symptoms and feelings, daily activities, leisure, work and school, personal relationships, treatment) and has a 1-week recall period. The response options range from 0 (not affected at all) to 3 (very much affected). This gives an overall range of 0 to 30 where lower scores mean better quality of life.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Study-G: Percentage of Participants with Achievement of Clinically Meaningful (&gt;= 4-point) Improvement from Baseline on the Genital Psoriasis Itch Numerical Rating Scale (NRS) [Among Participants with a Baseline Score &gt;= 4]</measure>
      <time_frame>Week 16</time_frame>
      <description>The scalp Itch NRS is a self-administered NRS that asks the patients to assess their scalp itch on a scale from 0 to 10 where 0 represents no itch and 10 represents worst imaginable itch.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Study-G: Percentage of Participants with Achievement of Genital Psoriasis Sexual Frequency Questionnaire (GenPs-SFQ) Item 2 score of 0 or 1 Among Participants with a Baseline score &gt;= 2</measure>
      <time_frame>Week 16</time_frame>
      <description>The GenPs-SFQ is a patient-reported outcome(s) [PRO] measure to evaluate the impact of genital psoriasis symptoms on sexual frequency, using a 1-week recall period. It consists of 2 items that assess the impact of genital psoriasis symptoms on the frequency of sexual activity. Each item uses a Likert scale. Respondents are asked to answer the questions based on their psoriasis symptoms in the genital area. Genital area is defined as the labia majora (outer lip), labia minora (inner lip), and perineum (area between vagina and anus) for females; penis, scrotum, and perineum (area between the penis and anus) for males.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Study-S: Percentage of Participants with Achievement of Psoriasis Scalp Severity Index (PSSI 90)</measure>
      <time_frame>Week 16</time_frame>
      <description>PPSI 90 is defined as &gt;= 90% improvement from baseline in PSSI. The physician will assess the severity of scalp psoriasis using the PSSI, which consists of an assessment of erythema, induration, and desquamation on a scale from 0 (none) to 4 (very severe) and the percentage of scalp involved on a scale from 0 (&lt;10% of scalp involved) to 6 (90 to 100% of scalp involved). The composite score is calculated as the sum of the scores for erythema, induration and desquamation multiplied by the score recorded for the extent of scalp area involved. The PSSI ranges from 0 to 72.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Study-S: Percentage of Participants with Achievement of PSSI 75</measure>
      <time_frame>Week 16</time_frame>
      <description>PPSI 75 is defined as &gt;= 75% improvement from baseline in PSSI. The physician will assess the severity of scalp psoriasis using the PSSI, which consists of an assessment of erythema, induration, and desquamation on a scale from 0 (none) to 4 (very severe) and the percentage of scalp involved on a scale from 0 (&lt;10% of scalp involved) to 6 (90 to 100% of scalp involved). The composite score is calculated as the sum of the scores for erythema, induration and desquamation multiplied by the score recorded for the extent of scalp area involved. The PSSI ranges from 0 to 72.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Study-S: Change from Baseline in Psoriasis Symptom Scale (PSS)</measure>
      <time_frame>Week 16</time_frame>
      <description>The PSS is a 4-item PRO instrument that assesses the severity of psoriasis symptoms in patients with moderate to severe psoriasis, using a recall period of 1 day. The symptoms include pain, redness, itching and burning from psoriasis. Current symptom severity is assessed using a 5-point Likert-type scale ranging from 0 (none) to 4 (very severe).</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Study-S: Percentage of Participants with Achievement of PSSI 100</measure>
      <time_frame>Week 16</time_frame>
      <description>PPSI 100 is defined as &gt;= 100% improvement from baseline in PSSI. The physician will assess the severity of scalp psoriasis using the PSSI, which consists of an assessment of erythema, induration, and desquamation on a scale from 0 (none) to 4 (very severe) and the percentage of scalp involved on a scale from 0 (&lt;10% of scalp involved) to 6 (90 to 100% of scalp involved). The composite score is calculated as the sum of the scores for erythema, induration and desquamation multiplied by the score recorded for the extent of scalp area involved. The PSSI ranges from 0 to 72.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Study-S: Percentage of Participants with Achievement of PSS of 0</measure>
      <time_frame>Week 16</time_frame>
      <description>The PSS is a 4-item PRO instrument that assesses the severity of psoriasis symptoms in patients with moderate to severe psoriasis, using a recall period of 1 day. The symptoms include pain, redness, itching and burning from psoriasis. Current symptom severity is assessed using a 5-point Likert-type scale ranging from 0 (none) to 4 (very severe).</description>
    </secondary_outcome>
    <number_of_arms>4</number_of_arms>
    <enrollment type="Anticipated">200</enrollment>
    <condition>Genital Psoriasis</condition>
    <condition>Scalp Psoriasis</condition>
    <arm_group>
      <arm_group_label>Study G Risankizumab</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Participants with moderate to severe genital psoriasis will receive risankizumab during the 52 week treatment period, with an 8-week follow-up period after the 52 week treatment period.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Study G Placebo for Risankizumab</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Participants with moderate to severe genital psoriasis will receive placebo for risankizumab during the 16 week treatment period followed by risankizumab during the 36 week treatment period, with an 8-week follow-up period after the 52 week treatment period.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Study S Risankizumab</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Participants with moderate to severe scalp psoriasis will receive risankizumab during the 52 week treatment period, with an 8-week follow-up period after the 52 week treatment period.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Study S Placebo for Risankizumab</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Participants with moderate to severe scalp psoriasis will receive placebo for risankizumab during the16 week treatment period followed by risankizumab during the 36 week treatment period, with an 8-week follow-up period after the 52 week treatment period.</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Risankizumab</intervention_name>
      <description>Subcutaneous injection</description>
      <arm_group_label>Study G Placebo for Risankizumab</arm_group_label>
      <arm_group_label>Study G Risankizumab</arm_group_label>
      <arm_group_label>Study S Placebo for Risankizumab</arm_group_label>
      <arm_group_label>Study S Risankizumab</arm_group_label>
      <other_name>Skyrizi</other_name>
      <other_name>ABBV-066</other_name>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Placebo for Risankizumab</intervention_name>
      <description>Subcutaneous injection</description>
      <arm_group_label>Study G Placebo for Risankizumab</arm_group_label>
      <arm_group_label>Study S Placebo for Risankizumab</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Must have clinical diagnosis of chronic plaque psoriasis with or without psoriatic&#xD;
               arthritis for at least 6 months before the baseline visit.&#xD;
  &#xD;
            -  Must have a current diagnosis of moderate to severe genital psoriasis (Study-G)&#xD;
               defined as static Physician Global Assessment of Genitalia (sPGA-G) ≥ 3 or moderate to&#xD;
               severe scalp psoriasis (Study-S) defined as Psoriasis Scalp Severity Index (PSSI) &gt;=&#xD;
               12, scalp Investigator Global Assessment (IGA) &gt;= 3, and &gt;= 30% of the scalp affected.&#xD;
  &#xD;
            -  Must have body surface area (BSA) ≥ 1% with at least 60% of subjects having BSA ≥ 10%;&#xD;
               sPGA ≥ 3; inadequate control of psoriasis and/or intolerance to topical treatment,&#xD;
               phototherapy and/or systemic therapy; and be candidates for systemic therapy or&#xD;
               phototherapy as assessed by the investigator.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Had previous exposure to IL-23 inhibitors including but not limited to guselkumab,&#xD;
               tildrakizumab, ustekinumab, mirikizumab, or risankizumab.&#xD;
  &#xD;
            -  History of an allergic reaction or significant sensitivity to constituents of the&#xD;
               study drug (and its excipients) and/or other products in the same class.&#xD;
  &#xD;
            -  Non-plaque forms of psoriasis or other active skin disease.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>ABBVIE INC.</last_name>
      <role>Study Director</role>
      <affiliation>AbbVie</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>ABBVIE CALL CENTER</last_name>
      <phone>844-663-3742</phone>
      <email>abbvieclinicaltrials@abbvie.com</email>
    </overall_contact>
    <location>
      <facility>
        <name>Alliance Dermatology and MOHs Center, PC /ID# 255846</name>
        <address>
          <city>Phoenix</city>
          <state>Arizona</state>
          <zip>85032</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
    </location>
    <location>
      <facility>
        <name>T. Joseph Raoof Md,Inc /Id# 255334</name>
        <address>
          <city>Encino</city>
          <state>California</state>
          <zip>91436</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
    </location>
    <location>
      <facility>
        <name>Dermatology Research Associates /ID# 255347</name>
        <address>
          <city>Los Angeles</city>
          <state>California</state>
          <zip>90045</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Site Coordinator</last_name>
        <phone>310-337-7171</phone>
      </contact>
    </location>
    <location>
      <facility>
        <name>Skin Care Research - Hollywood /ID# 255394</name>
        <address>
          <city>Hollywood</city>
          <state>Florida</state>
          <zip>33021-6748</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Site Coordinator</last_name>
        <phone>+1-561-948-3116</phone>
      </contact>
    </location>
    <location>
      <facility>
        <name>GSI Clinical Research, LLC /ID# 255472</name>
        <address>
          <city>Margate</city>
          <state>Florida</state>
          <zip>33063</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
    </location>
    <location>
      <facility>
        <name>Skin and Cancer Associates, LLP /ID# 255506</name>
        <address>
          <city>Miami</city>
          <state>Florida</state>
          <zip>33137-3254</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
    </location>
    <location>
      <facility>
        <name>Renstar Medical Research /ID# 255339</name>
        <address>
          <city>Ocala</city>
          <state>Florida</state>
          <zip>34470</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
    </location>
    <location>
      <facility>
        <name>Treasure Valley Medical Research /ID# 255671</name>
        <address>
          <city>Boise</city>
          <state>Idaho</state>
          <zip>83706</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
    </location>
    <location>
      <facility>
        <name>Arlington Dermatology /ID# 255330</name>
        <address>
          <city>Rolling Meadows</city>
          <state>Illinois</state>
          <zip>60008</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
    </location>
    <location>
      <facility>
        <name>The Indiana Clinical Trials Center /ID# 255333</name>
        <address>
          <city>Plainfield</city>
          <state>Indiana</state>
          <zip>46168</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
    </location>
    <location>
      <facility>
        <name>Forest Hills Dermatology Group /ID# 255346</name>
        <address>
          <city>Kew Gardens</city>
          <state>New York</state>
          <zip>11415</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Site Coordinator</last_name>
        <phone>718-459-0900</phone>
      </contact>
    </location>
    <location>
      <facility>
        <name>Darst Dermatology /ID# 255848</name>
        <address>
          <city>Charlotte</city>
          <state>North Carolina</state>
          <zip>28277</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Site Coordinator</last_name>
        <phone>704-321-3376</phone>
      </contact>
    </location>
    <location>
      <facility>
        <name>Wright State Physicians, Inc /ID# 255395</name>
        <address>
          <city>Fairborn</city>
          <state>Ohio</state>
          <zip>45324</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Site Coordinator</last_name>
        <phone>937-245-7500</phone>
      </contact>
    </location>
    <location>
      <facility>
        <name>Oregon Dermatology and Research Center /ID# 255670</name>
        <address>
          <city>Portland</city>
          <state>Oregon</state>
          <zip>97210</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Site Coordinator</last_name>
        <phone>503-222-7546</phone>
      </contact>
    </location>
    <location>
      <facility>
        <name>Oregon Medical Research Center /ID# 255332</name>
        <address>
          <city>Portland</city>
          <state>Oregon</state>
          <zip>97239</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Site Coordinator</last_name>
        <phone>503-245-1525</phone>
      </contact>
    </location>
    <location>
      <facility>
        <name>Center for Clinical Studies - Houston (Binz) /ID# 255396</name>
        <address>
          <city>Houston</city>
          <state>Texas</state>
          <zip>77004-8097</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
    </location>
    <location>
      <facility>
        <name>Center for Clinical Studies - Houston (Binz) /ID# 255518</name>
        <address>
          <city>Houston</city>
          <state>Texas</state>
          <zip>77004-8097</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <link>
      <url>https://www.abbvieclinicaltrials.com/study/?id=M23-702</url>
      <description>Related Info</description>
    </link>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>July 24, 2023</study_first_submitted>
    <study_first_submitted_qc>July 24, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 1, 2023</study_first_posted>
    <last_update_submitted>September 13, 2023</last_update_submitted>
    <last_update_submitted_qc>September 13, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 15, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Genital Psoriasis</keyword>
    <keyword>Scalp Psoriasis</keyword>
    <keyword>Plaque Psoriasis</keyword>
    <keyword>Psoriasis</keyword>
    <keyword>ABBV066</keyword>
    <keyword>Skyrizi</keyword>
    <keyword>Risankizumab</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Psoriasis</mesh_term>
    </condition_browse>
    <intervention_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Antibodies, Monoclonal</mesh_term>
    </intervention_browse>
    <patient_data>
      <sharing_ipd>Yes</sharing_ipd>
      <ipd_description>AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols, analyses plans, clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.</ipd_description>
      <ipd_info_type>Study Protocol</ipd_info_type>
      <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
      <ipd_info_type>Clinical Study Report (CSR)</ipd_info_type>
      <ipd_time_frame>For details on when studies are available for sharing visit https://vivli.org/ourmember/abbvie/</ipd_time_frame>
      <ipd_access_criteria>Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous independent scientific research, and will be provided following review and approval of a research proposal and statistical analysis plan and execution of a data sharing statement. Data requests can be submitted at any time after approval in the US and/or EU and a primary manuscript is accepted for publication. For more information on the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/</ipd_access_criteria>
      <ipd_url>https://vivli.org/ourmember/abbvie/</ipd_url>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: download date: ClinicalTrials.gov processed this data on September 20, 2023
  link text: Link to the current ClinicalTrials.gov record.
  url: https://clinicaltrials.gov/ct2/show/NCT05969223
  org study id: M23-702
  secondary id: 2023-504154-35-00
  nct id: NCT05969223
  lead sponsor: 
  has dmc: No
  is fda regulated drug: Yes
  is fda regulated device: No
  is us export: Yes
  Psoriasis (PsO) is a chronic disease characterized by marked inflammation of the skin that
        results in thick, red, scaly plaques. This study will assess how safe and effective
        risankizumab is in adult participants with moderate to severe genital psoriasis or moderate
        to severe scalp psoriasis. Adverse events and change in disease signs and symptoms will be
        monitored.
  
        Risankizumab (Skyrizi) is a drug being studied for the treatment of moderate to severe
        genital psoriasis or moderate to severe scalp psoriasis. Approximately 200 participants with
        moderate to severe genital psoriasis or moderate to severe scalp psoriasis will be enrolled
        across approximately 45 sites globally.
  
        The study will be broken up into 2 sub-studies by disease location, participants with
        moderate to severe genital psoriasis (Study G) and moderate to severe scalp psoriasis (Study
        S). In both sub-studies participants will receive subcutaneous (SC) injections of
        risankizumab during the 52 week treatment period, or SC injections of placebo risankizumab
        during the 16 week treatment period followed by SC injections of risankizumab during the 36
        week treatment period, with an 8-week follow-up period after the 52 week treatment period.
  
        There may be higher treatment burden for participants in this trial compared to their
        standard of care. Participants will attend regular visits during the study at a hospital or
        clinic. The effect of the treatment will be checked by medical assessments, blood tests,
        checking for side effects and completing questionnaires.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: Double (Participant, Investigator)
  measure: Study-G: Percentage of Participants with Achievement of static Physician Global Assessment of Genitalia (sPGA-G) of 0 or 1
  time frame: Week 16
  description: The sPGA-G is a 5-point score ranging from 0 to 4, with a larger score indicating greater severity, based on the physician's assessment of the average thickness, erythema, and scaling of psoriatic genital lesions.
  measure: Study-S: Percentage of Participants with Achievement of Scalp Investigator Global Assessment (IGA) of 0 or 1
  time frame: Week 16
  description: The scalp IGA is a measurement of overall scalp involvement by the investigator at the time of evaluation. The scalp IGA is a 5-point scale ranging from 0 (clear) to 4 (severe) incorporating an assessment of the severity of the 3 primary signs of the disease: erythema, scaling, and plaque elevation.
  measure: Study-G: Percentage of Participants with Achievement of static Physician Global Assessment of Genitalia (sPGA-G) of 0
  time frame: Week 16
  description: The sPGA-G is a 5-point score ranging from 0 to 4, with a larger score indicating greater severity, based on the physician's assessment of the average thickness, erythema, and scaling of all psoriatic lesions.
  measure: Study-G: Percentage of Participants with Achievement of Dermatology Life Quality Index (DLQI) of 0 or 1
  time frame: Week 16
  description: The DLQI is a self-administered, 10-question questionnaire covering 6 domains (symptoms and feelings, daily activities, leisure, work and school, personal relationships, treatment) and has a 1-week recall period. The response options range from 0 (not affected at all) to 3 (very much affected). This gives an overall range of 0 to 30 where lower scores mean better quality of life.
  measure: Study-G: Percentage of Participants with Achievement of Clinically Meaningful (>= 4-point) Improvement from Baseline on the Genital Psoriasis Itch Numerical Rating Scale (NRS) [Among Participants with a Baseline Score >= 4]
  time frame: Week 16
  description: The scalp Itch NRS is a self-administered NRS that asks the patients to assess their scalp itch on a scale from 0 to 10 where 0 represents no itch and 10 represents worst imaginable itch.
  measure: Study-G: Percentage of Participants with Achievement of Genital Psoriasis Sexual Frequency Questionnaire (GenPs-SFQ) Item 2 score of 0 or 1 Among Participants with a Baseline score >= 2
  time frame: Week 16
  description: The GenPs-SFQ is a patient-reported outcome(s) [PRO] measure to evaluate the impact of genital psoriasis symptoms on sexual frequency, using a 1-week recall period. It consists of 2 items that assess the impact of genital psoriasis symptoms on the frequency of sexual activity. Each item uses a Likert scale. Respondents are asked to answer the questions based on their psoriasis symptoms in the genital area. Genital area is defined as the labia majora (outer lip), labia minora (inner lip), and perineum (area between vagina and anus) for females; penis, scrotum, and perineum (area between the penis and anus) for males.
  measure: Study-S: Percentage of Participants with Achievement of Psoriasis Scalp Severity Index (PSSI 90)
  time frame: Week 16
  description: PPSI 90 is defined as >= 90% improvement from baseline in PSSI. The physician will assess the severity of scalp psoriasis using the PSSI, which consists of an assessment of erythema, induration, and desquamation on a scale from 0 (none) to 4 (very severe) and the percentage of scalp involved on a scale from 0 (<10% of scalp involved) to 6 (90 to 100% of scalp involved). The composite score is calculated as the sum of the scores for erythema, induration and desquamation multiplied by the score recorded for the extent of scalp area involved. The PSSI ranges from 0 to 72.
  measure: Study-S: Percentage of Participants with Achievement of PSSI 75
  time frame: Week 16
  description: PPSI 75 is defined as >= 75% improvement from baseline in PSSI. The physician will assess the severity of scalp psoriasis using the PSSI, which consists of an assessment of erythema, induration, and desquamation on a scale from 0 (none) to 4 (very severe) and the percentage of scalp involved on a scale from 0 (<10% of scalp involved) to 6 (90 to 100% of scalp involved). The composite score is calculated as the sum of the scores for erythema, induration and desquamation multiplied by the score recorded for the extent of scalp area involved. The PSSI ranges from 0 to 72.
  measure: Study-S: Change from Baseline in Psoriasis Symptom Scale (PSS)
  time frame: Week 16
  description: The PSS is a 4-item PRO instrument that assesses the severity of psoriasis symptoms in patients with moderate to severe psoriasis, using a recall period of 1 day. The symptoms include pain, redness, itching and burning from psoriasis. Current symptom severity is assessed using a 5-point Likert-type scale ranging from 0 (none) to 4 (very severe).
  measure: Study-S: Percentage of Participants with Achievement of PSSI 100
  time frame: Week 16
  description: PPSI 100 is defined as >= 100% improvement from baseline in PSSI. The physician will assess the severity of scalp psoriasis using the PSSI, which consists of an assessment of erythema, induration, and desquamation on a scale from 0 (none) to 4 (very severe) and the percentage of scalp involved on a scale from 0 (<10% of scalp involved) to 6 (90 to 100% of scalp involved). The composite score is calculated as the sum of the scores for erythema, induration and desquamation multiplied by the score recorded for the extent of scalp area involved. The PSSI ranges from 0 to 72.
  measure: Study-S: Percentage of Participants with Achievement of PSS of 0
  time frame: Week 16
  description: The PSS is a 4-item PRO instrument that assesses the severity of psoriasis symptoms in patients with moderate to severe psoriasis, using a recall period of 1 day. The symptoms include pain, redness, itching and burning from psoriasis. Current symptom severity is assessed using a 5-point Likert-type scale ranging from 0 (none) to 4 (very severe).
  arm group label: Study G Risankizumab
  arm group type: Experimental
  description: Participants with moderate to severe genital psoriasis will receive risankizumab during the 52 week treatment period, with an 8-week follow-up period after the 52 week treatment period.
  arm group label: Study G Placebo for Risankizumab
  arm group type: Experimental
  description: Participants with moderate to severe genital psoriasis will receive placebo for risankizumab during the 16 week treatment period followed by risankizumab during the 36 week treatment period, with an 8-week follow-up period after the 52 week treatment period.
  arm group label: Study S Risankizumab
  arm group type: Experimental
  description: Participants with moderate to severe scalp psoriasis will receive risankizumab during the 52 week treatment period, with an 8-week follow-up period after the 52 week treatment period.
  arm group label: Study S Placebo for Risankizumab
  arm group type: Experimental
  description: Participants with moderate to severe scalp psoriasis will receive placebo for risankizumab during the16 week treatment period followed by risankizumab during the 36 week treatment period, with an 8-week follow-up period after the 52 week treatment period.
  intervention type: Drug
  intervention name: Risankizumab
  description: Subcutaneous injection
  arm group label: Study G Placebo for Risankizumab
  arm group label: Study G Risankizumab
  arm group label: Study S Placebo for Risankizumab
  arm group label: Study S Risankizumab
  other name: Skyrizi
  other name: ABBV-066
  intervention type: Drug
  intervention name: Placebo for Risankizumab
  description: Subcutaneous injection
  arm group label: Study G Placebo for Risankizumab
  arm group label: Study S Placebo for Risankizumab
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: ABBVIE INC.
  role: Study Director
  affiliation: AbbVie
  last name: ABBVIE CALL CENTER
  phone: 844-663-3742
  email: abbvieclinicaltrials@abbvie.com
  facility: 
  status: Recruiting
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  country: United States
  url: https://www.abbvieclinicaltrials.com/study/?id=M23-702
  description: Related Info
  responsible party type: Sponsor
  mesh term: Psoriasis
  mesh term: Antibodies, Monoclonal
  sharing ipd: Yes
  ipd description: AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols, analyses plans, clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.
  ipd info type: Study Protocol
  ipd info type: Statistical Analysis Plan (SAP)
  ipd info type: Clinical Study Report (CSR)
  ipd time frame: For details on when studies are available for sharing visit https://vivli.org/ourmember/abbvie/
  ipd access criteria: Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous independent scientific research, and will be provided following review and approval of a research proposal and statistical analysis plan and execution of a data sharing statement. Data requests can be submitted at any time after approval in the US and/or EU and a primary manuscript is accepted for publication. For more information on the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/
  ipd url: https://vivli.org/ourmember/abbvie/