<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/NCT04451720</url>
  </required_header>
  <id_info>
    <org_study_id>M19-135</org_study_id>
    <nct_id>NCT04451720</nct_id>
  </id_info>
  <brief_title>Study of Subcutaneous Risankizumab Injection to Assess Change in Palmoplantar Pustulosis Area and Severity Index [PPPASI] in Adult Japanese Participants With Palmoplantar Pustulosis</brief_title>
  <official_title>A Phase 3, Multicenter, Randomized, Placebo-Controlled, Double-Blind Study to Evaluate Risankizumab in Adult Japanese Subjects With Moderate to Severe Palmoplantar Pustulosis</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>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      Palmoplantar pustulosis is a chronic inflammatory skin disease that causes repeated on and&#xD;
      off symptoms like erythema (reddening, irritation), vesicle (swelling, cyst), pustules,&#xD;
      scale, and crusts in palms and soles. This study evaluates how well risankizumab works&#xD;
      compared to placebo (no medicine) to treat palmoplantar pustulosis. Study will assess change&#xD;
      in Palmoplantar Pustulosis Area and Severity Index [PPPASI].&#xD;
&#xD;
      Risankizumab is an investigational drug being developed for the treatment of palmoplantar&#xD;
      pustulosis. This study is &quot;double-blinded&quot;, which means that neither the trial participants&#xD;
      nor the study doctors will know who will be given study drug and who will receive placebo (no&#xD;
      medicine). Participants are randomly put into 1 of 2 groups, called treatment arms to receive&#xD;
      risankizumab or placebo in period A. In period B, each group receives both risankizumab and&#xD;
      placebo at different time intervals. Around 116 adult participants with palmoplantar&#xD;
      pustulosis will be enrolled in approximately 39 sites across Japan.&#xD;
&#xD;
      Participants will receive subcutaneous (SC) injections of risankizumab or placebo at Week 0&#xD;
      and Week 4 (Period A). Beginning Week 16 (Period B), both the groups will receive&#xD;
      risankizumab and placebo at different intervals. Total treatment duration is 56 weeks.&#xD;
&#xD;
      There may be a higher burden for participants in this trial compared to their standard of&#xD;
      care. Participants will attend regular visits during the course of 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>Completed</overall_status>
  <start_date type="Actual">July 20, 2020</start_date>
  <completion_date type="Actual">November 21, 2022</completion_date>
  <primary_completion_date type="Actual">November 21, 2022</primary_completion_date>
  <phase>Phase 3</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change From Baseline in Palmoplantar Pustulosis Area and Severity Index (PPPASI) Total Score</measure>
    <time_frame>Baseline (Week 0) through Week 16</time_frame>
    <description>The Palmoplantar Pustulosis Area and Severity Index (PPPASI) assesses the severity of palmoplantar pustulosis lesions and their response to therapy. In the PPPASI system, the palms and soles are divided into 4 regions: the right palm, left palm, right sole, left sole which account for 20%, 20%, 30%, and 30%, respectively, of the total surface area of the palms and soles. Each of these areas are assessed separately for erythema, pustules/vesicle and desquamation/scale, which are each rated on a scale of 0 to 4. The PPPASI produces a numeric score that can range from 0 to 72. A higher score indicates more severe disease.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants Achieving at least 50% Improvement in PPPASI (PPPASI-50)</measure>
    <time_frame>Baseline (Week 0) through Week 16</time_frame>
    <description>The Palmoplantar Pustulosis Area and Severity Index (PPPASI) assesses the severity of palmoplantar pustulosis lesions and their response to therapy. In the PPPASI system, the palms and soles are divided into 4 regions: the right palm, left palm, right sole, left sole which account for 20%, 20%, 30%, and 30%, respectively, of the total surface area of the palms and soles. Each of these areas are assessed separately for erythema, pustules/vesicle and desquamation/scale, which are each rated on a scale of 0 to 4. The PPPASI produces a numeric score that can range from 0 to 72. A higher score indicates more severe disease.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants Achieving at least 75% Improvement in PPPASI (PPPASI-75)</measure>
    <time_frame>Baseline (Week 0) through Week 16</time_frame>
    <description>The Palmoplantar Pustulosis Area and Severity Index (PPPASI) assesses the severity of palmoplantar pustulosis lesions and their response to therapy. In the PPPASI system, the palms and soles are divided into 4 regions: the right palm, left palm, right sole, left sole which account for 20%, 20%, 30%, and 30%, respectively, of the total surface area of the palms and soles. Each of these areas are assessed separately for erythema, pustules/vesicle and desquamation/scale, which are each rated on a scale of 0 to 4. The PPPASI produces a numeric score that can range from 0 to 72. A higher score indicates more severe disease.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">119</enrollment>
  <condition>Palmoplantar Pustulosis (PPP)</condition>
  <arm_group>
    <arm_group_label>Risankizumab</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>In Period A, participants will receive risankizumab dose A at Weeks 0 and 4. In Period B, participants will receive risankizumab dose A at Weeks 16, 28, 40 and 52, and also placebo at Weeks 20, 32, 44 and 56.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>In Period A, participants will receive placebo at Weeks 0 and 4. In period B, participants will receive risankizumab dose A at Weeks 16, 20,32,44 and 56. and also placebo at Weeks 28,40 and 52.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Risankizumab</intervention_name>
    <description>Subcutaneous (SC) injection</description>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_label>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</intervention_name>
    <description>Subcutaneous (SC) injection</description>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_label>Risankizumab</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Stable moderate to severe Palmoplantar Pustulosis (PPP) with a Palmoplantar Pustulosis&#xD;
             Area and Severity Index (PPPASI) total score of &gt;= 12 at the Screening and Baseline&#xD;
             Visits.&#xD;
&#xD;
          -  Moderate or severe pustules/vesicles on at least one palm or sole (&gt;= 2 PPPASI&#xD;
             severity score) at the Screening and Baseline Visits.&#xD;
&#xD;
          -  Experienced inadequate response (or intolerant) to treatment with topical&#xD;
             corticosteroids and/or vitamin D3 derivative preparations and/or phototherapy and/or&#xD;
             systemic etretinate.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        - History of active skin disease other than PPP which could interfere with the assessment&#xD;
        of PPP.&#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>
  <location>
    <facility>
      <name>Ichinomiya Municipal Hospital /ID# 222581</name>
      <address>
        <city>Ichinomiya-shi</city>
        <state>Aichi</state>
        <zip>491-8558</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Nagoya City University Hospital /ID# 221258</name>
      <address>
        <city>Nagoya shi</city>
        <state>Aichi</state>
        <zip>467-8602</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Chukyo Hospital /ID# 218894</name>
      <address>
        <city>Nagoya-shi</city>
        <state>Aichi</state>
        <zip>457-8510</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Fujita Health University Hospital /ID# 221285</name>
      <address>
        <city>Toyoake-shi</city>
        <state>Aichi</state>
        <zip>470-1192</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Toho University Sakura Medical Center /ID# 220858</name>
      <address>
        <city>Sakura-shi</city>
        <state>Chiba</state>
        <zip>285-8741</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ehime University Hospital /ID# 221260</name>
      <address>
        <city>Toon-shi</city>
        <state>Ehime</state>
        <zip>791-0295</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kurume University Hospital /ID# 222751</name>
      <address>
        <city>Kurume-shi</city>
        <state>Fukuoka</state>
        <zip>830-0011</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Fukushima Medical University Hospital /ID# 221639</name>
      <address>
        <city>Fukushima-shi</city>
        <state>Fukushima</state>
        <zip>960-1295</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Gifu University Hospital /ID# 219109</name>
      <address>
        <city>Gifu-shi</city>
        <state>Gifu</state>
        <zip>501-1194</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ogaki Municipal Hospital /ID# 220801</name>
      <address>
        <city>Ogaki-shi</city>
        <state>Gifu</state>
        <zip>503-8502</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Takagi Dermatology Clinic /ID# 220896</name>
      <address>
        <city>Obihiro-shi</city>
        <state>Hokkaido</state>
        <zip>080-0013</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Bito Dermatology Clinic /ID# 222750</name>
      <address>
        <city>Kobe-shi</city>
        <state>Hyogo</state>
        <zip>651-0095</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Meiwa Hospital /ID# 221633</name>
      <address>
        <city>Nishinomiya-shi</city>
        <state>Hyogo</state>
        <zip>663-8186</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ibaraki Prefectural Central Hospital /ID# 222712</name>
      <address>
        <city>Kasama-shi</city>
        <state>Ibaraki</state>
        <zip>309-1793</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mito Kyodo General Hospital /ID# 220799</name>
      <address>
        <city>Mito-shi</city>
        <state>Ibaraki</state>
        <zip>310-0015</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Takamatsu Red Cross Hospital /ID# 221344</name>
      <address>
        <city>Takamatsu-shi</city>
        <state>Kagawa</state>
        <zip>760-0017</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Tokai University Hospital /ID# 220945</name>
      <address>
        <city>Isehara-shi</city>
        <state>Kanagawa</state>
        <zip>259-1193</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>National Hospital Organization Sagamihara National Hospital /ID# 219082</name>
      <address>
        <city>Sagamihara-shi</city>
        <state>Kanagawa</state>
        <zip>252-0392</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Yokohama City University Hospital /ID# 220860</name>
      <address>
        <city>Yokohama-shi</city>
        <state>Kanagawa</state>
        <zip>236-0004</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University Hospital Kyoto Prefectural University of Medicine /ID# 221376</name>
      <address>
        <city>Kyoto-shi</city>
        <state>Kyoto</state>
        <zip>602-8566</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>National Hospital Organization Kyoto Medical Center /ID# 221772</name>
      <address>
        <city>Kyoto-shi</city>
        <state>Kyoto</state>
        <zip>612-8555</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mie University Hospital /ID# 221570</name>
      <address>
        <city>Tsu-shi</city>
        <state>Mie</state>
        <zip>514-8507</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Tohoku University Hospital /ID# 219017</name>
      <address>
        <city>Sendai-shi</city>
        <state>Miyagi</state>
        <zip>9808574</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Shinshu University Hospital /ID# 221343</name>
      <address>
        <city>Matsumoto-shi</city>
        <state>Nagano</state>
        <zip>390-8621</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Nagasaki University Hospital /ID# 221141</name>
      <address>
        <city>Nagasaki-shi</city>
        <state>Nagasaki</state>
        <zip>852-8501</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Nagaoka Red Cross Hospital /ID# 221375</name>
      <address>
        <city>Nagaoka-shi</city>
        <state>Niigata</state>
        <zip>940-2085</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Isonokami dermatological clinic /ID# 219023</name>
      <address>
        <city>Daito-shi</city>
        <state>Osaka</state>
        <zip>574-0046</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kansai Medical University Kori Hospital /ID# 223096</name>
      <address>
        <city>Neyagawa-shi</city>
        <state>Osaka</state>
        <zip>572-8551</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Osaka Metropolitan University Hospital /ID# 222012</name>
      <address>
        <city>Osaka-shi</city>
        <state>Osaka</state>
        <zip>545-8586</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kindai University Hospital /ID# 219022</name>
      <address>
        <city>Osakasayama-shi</city>
        <state>Osaka</state>
        <zip>589-8511</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kume Clinic /ID# 220869</name>
      <address>
        <city>Sakai-shi</city>
        <state>Osaka</state>
        <zip>5938324</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Dokkyo Medical University Saitama Medical Center /ID# 222526</name>
      <address>
        <city>Koshigaya-shi</city>
        <state>Saitama</state>
        <zip>343-8555</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Shizuoka Saiseikai Genaral Hospital /ID# 222427</name>
      <address>
        <city>Shizuoka-shi</city>
        <state>Shizuoka</state>
        <zip>422-8527</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Dokkyo Medical University Hospital /ID# 221210</name>
      <address>
        <city>Shimotsuga-gun</city>
        <state>Tochigi</state>
        <zip>321-0293</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>St.Luke's International Hospital /ID# 219019</name>
      <address>
        <city>Chuo-ku</city>
        <state>Tokyo</state>
        <zip>104-8560</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Teikyo University Hospital /ID# 221089</name>
      <address>
        <city>Itabashi-ku</city>
        <state>Tokyo</state>
        <zip>173-8606</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Jikei University Hospital /ID# 218822</name>
      <address>
        <city>Minato-ku</city>
        <state>Tokyo</state>
        <zip>105-8471</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Tokyo Medical University Hospital /ID# 218893</name>
      <address>
        <city>Shinjuku-ku</city>
        <state>Tokyo</state>
        <zip>160-0023</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Seibo Hospital /ID# 221691</name>
      <address>
        <city>Shinjuku-ku</city>
        <state>Tokyo</state>
        <zip>161-8521</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Japan</country>
  </location_countries>
  <link>
    <url>https://www.rxabbvie.com/</url>
    <description>This clinical study may be evaluating a usage that is not currently FDA approved. Please see US Prescribing Information for approved uses.</description>
  </link>
  <verification_date>December 2022</verification_date>
  <study_first_submitted>June 29, 2020</study_first_submitted>
  <study_first_submitted_qc>June 29, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 30, 2020</study_first_posted>
  <last_update_submitted>December 2, 2022</last_update_submitted>
  <last_update_submitted_qc>December 2, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">December 5, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Palmoplantar Pustulosis (PPP)</keyword>
  <keyword>Risankizumab</keyword>
  <keyword>SKYRIZI</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Psoriasis</mesh_term>
  </condition_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>


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/NCT04451720
org study id: M19-135
nct id: NCT04451720
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
is us export: No
Palmoplantar pustulosis is a chronic inflammatory skin disease that causes repeated on and
      off symptoms like erythema (reddening, irritation), vesicle (swelling, cyst), pustules,
      scale, and crusts in palms and soles. This study evaluates how well risankizumab works
      compared to placebo (no medicine) to treat palmoplantar pustulosis. Study will assess change
      in Palmoplantar Pustulosis Area and Severity Index [PPPASI].

      Risankizumab is an investigational drug being developed for the treatment of palmoplantar
      pustulosis. This study is "double-blinded", which means that neither the trial participants
      nor the study doctors will know who will be given study drug and who will receive placebo (no
      medicine). Participants are randomly put into 1 of 2 groups, called treatment arms to receive
      risankizumab or placebo in period A. In period B, each group receives both risankizumab and
      placebo at different time intervals. Around 116 adult participants with palmoplantar
      pustulosis will be enrolled in approximately 39 sites across Japan.

      Participants will receive subcutaneous (SC) injections of risankizumab or placebo at Week 0
      and Week 4 (Period A). Beginning Week 16 (Period B), both the groups will receive
      risankizumab and placebo at different intervals. Total treatment duration is 56 weeks.

      There may be a higher burden for participants in this trial compared to their standard of
      care. Participants will attend regular visits during the course of 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: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Change From Baseline in Palmoplantar Pustulosis Area and Severity Index (PPPASI) Total Score
time frame: Baseline (Week 0) through Week 16
description: The Palmoplantar Pustulosis Area and Severity Index (PPPASI) assesses the severity of palmoplantar pustulosis lesions and their response to therapy. In the PPPASI system, the palms and soles are divided into 4 regions: the right palm, left palm, right sole, left sole which account for 20%, 20%, 30%, and 30%, respectively, of the total surface area of the palms and soles. Each of these areas are assessed separately for erythema, pustules/vesicle and desquamation/scale, which are each rated on a scale of 0 to 4. The PPPASI produces a numeric score that can range from 0 to 72. A higher score indicates more severe disease.
measure: Percentage of Participants Achieving at least 50% Improvement in PPPASI (PPPASI-50)
time frame: Baseline (Week 0) through Week 16
description: The Palmoplantar Pustulosis Area and Severity Index (PPPASI) assesses the severity of palmoplantar pustulosis lesions and their response to therapy. In the PPPASI system, the palms and soles are divided into 4 regions: the right palm, left palm, right sole, left sole which account for 20%, 20%, 30%, and 30%, respectively, of the total surface area of the palms and soles. Each of these areas are assessed separately for erythema, pustules/vesicle and desquamation/scale, which are each rated on a scale of 0 to 4. The PPPASI produces a numeric score that can range from 0 to 72. A higher score indicates more severe disease.
measure: Percentage of Participants Achieving at least 75% Improvement in PPPASI (PPPASI-75)
time frame: Baseline (Week 0) through Week 16
description: The Palmoplantar Pustulosis Area and Severity Index (PPPASI) assesses the severity of palmoplantar pustulosis lesions and their response to therapy. In the PPPASI system, the palms and soles are divided into 4 regions: the right palm, left palm, right sole, left sole which account for 20%, 20%, 30%, and 30%, respectively, of the total surface area of the palms and soles. Each of these areas are assessed separately for erythema, pustules/vesicle and desquamation/scale, which are each rated on a scale of 0 to 4. The PPPASI produces a numeric score that can range from 0 to 72. A higher score indicates more severe disease.
arm group label: Risankizumab
arm group type: Experimental
description: In Period A, participants will receive risankizumab dose A at Weeks 0 and 4. In Period B, participants will receive risankizumab dose A at Weeks 16, 28, 40 and 52, and also placebo at Weeks 20, 32, 44 and 56.
arm group label: Placebo
arm group type: Experimental
description: In Period A, participants will receive placebo at Weeks 0 and 4. In period B, participants will receive risankizumab dose A at Weeks 16, 20,32,44 and 56. and also placebo at Weeks 28,40 and 52.
intervention type: Drug
intervention name: Risankizumab
description: Subcutaneous (SC) injection
arm group label: Placebo
arm group label: Risankizumab
other name: SKYRIZI
other name: ABBV-066
intervention type: Drug
intervention name: Placebo
description: Subcutaneous (SC) injection
arm group label: Placebo
arm group label: Risankizumab
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: ABBVIE INC.
role: Study Director
affiliation: AbbVie
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: Japan
url: https://www.rxabbvie.com/
description: This clinical study may be evaluating a usage that is not currently FDA approved. Please see US Prescribing Information for approved uses.
responsible party type: Sponsor
mesh term: Psoriasis
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/