<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/NCT04493424</url>
  </required_header>
  <id_info>
    <org_study_id>1368-0024</org_study_id>
    <secondary_id>2020-000189-41</secondary_id>
    <nct_id>NCT04493424</nct_id>
  </id_info>
  <brief_title>A Study to Test Long-term Treatment With Spesolimab in People With Palmoplantar Pustulosis (PPP) Who Took Part in Previous Studies With Spesolimab</brief_title>
  <official_title>An Open-label, Long Term Safety Trial of Spesolimab Treatment in Patients With Palmoplantar Pustulosis (PPP) Who Have Completed Previous BI Spesolimab Trials</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Boehringer Ingelheim</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Boehringer Ingelheim</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study is open to people with palmoplantar pustulosis who took part in previous clinical&#xD;
      studies of a medicine called spesolimab. Participants who benefited from spesolimab treatment&#xD;
      in the previous studies can join this study.&#xD;
&#xD;
      The purpose of this study is to find out how safe spesolimab is and whether it helps people&#xD;
      with palmoplantar pustulosis in the long-term. Participants are in this study for up to 5&#xD;
      years. During this time they visit the study site every month to get spesolimab injections&#xD;
      under the skin.&#xD;
&#xD;
      At study visits, doctors check the severity of participants' palmoplantar pustulosis and&#xD;
      collect information on any health problems of the participants.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Sponsor decision&#xD;
  </why_stopped>
  <start_date type="Actual">September 4, 2020</start_date>
  <completion_date type="Actual">May 15, 2023</completion_date>
  <primary_completion_date type="Actual">January 16, 2023</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Occurrence of treatment emergent adverse events (TEAEs)</measure>
    <time_frame>Up to week 260</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Percent change in Palmoplantar Pustulosis Area and Severity Index (PPP ASI) from baseline in parent trial</measure>
    <time_frame>Up to week 260</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Proportion of patients with Palmoplantar Pustulosis Area and Severity Index 50% (PPP ASI50) compared to baseline in parent trial</measure>
    <time_frame>Up to week 260</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Proportion of patients with Palmoplantar Pustulosis Physician Global Assessment (PPP PGA) of 0 (clear) or 1 (almost clear)</measure>
    <time_frame>Up to week 260</time_frame>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">108</enrollment>
  <condition>Palmoplantar Pustulosis</condition>
  <arm_group>
    <arm_group_label>Treatment group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Up to 260 weeks</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Spesolimab</intervention_name>
    <description>Spesolimab</description>
    <arm_group_label>Treatment group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Signed and dated written informed consent for the current trial 1368-0024, in&#xD;
             accordance with ICH-GCP and local legislation prior to admission to the current trial&#xD;
&#xD;
          -  Male or female patients who have completed the treatment period in one of the parent&#xD;
             trials without premature discontinuation&#xD;
&#xD;
          -  Patients who have obtained an individual health benefit, per investigator judgement&#xD;
             (e.g. PPP PGA of 0 (clear) or 1 (almost clear) or other clinical improvement), from&#xD;
             treatment in the parent trial&#xD;
&#xD;
          -  Women of childbearing potential must be ready and able to use highly effective methods&#xD;
             of birth control per ICH M3 (R2) that result in a low failure rate of less than 1% per&#xD;
             year when used consistently and correctly&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Women who are pregnant, nursing, or who plan to become pregnant while in the trial&#xD;
&#xD;
          -  Patients who experienced study treatment-limiting adverse events during the parent&#xD;
             trial&#xD;
&#xD;
          -  Severe, progressive, or uncontrolled condition such as renal, hepatic, haematological,&#xD;
             endocrine, pulmonary, cardiac, neurologic, cerebral, or psychiatric disease, or signs&#xD;
             and symptoms thereof&#xD;
&#xD;
          -  Patients with congestive heart disease, as assessed by the investigator&#xD;
&#xD;
          -  Patient with a transplanted organ (with exception of a corneal transplant &gt; 12 weeks&#xD;
             prior to screening in parent trial) or who have ever received stem cell therapy (e.g.,&#xD;
             Prochymal)&#xD;
&#xD;
          -  Known history of lymphoproliferative disease, including lymphoma, or signs and&#xD;
             symptoms suggestive of possible lymphoproliferative disease (e.g. splenomegaly)&#xD;
&#xD;
          -  Any documented active or suspected malignancy or history of malignancy at screening,&#xD;
             except appropriately treated basal cell carcinoma of the skin, squamous cell carcinoma&#xD;
             of the skin or in situ carcinoma of uterine cervix&#xD;
&#xD;
          -  Patients who have developed active or severe infective disease and opportunistic&#xD;
             infections/infective diseases&#xD;
&#xD;
          -  Further exclusion criteria apply&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Total Skin and Beauty Dermatology Center, PC</name>
      <address>
        <city>Birmingham</city>
        <state>Alabama</state>
        <zip>35205</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Missouri Health System</name>
      <address>
        <city>Columbia</city>
        <state>Missouri</state>
        <zip>65212</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Psoriasis Treatment Center of Central New Jersey</name>
      <address>
        <city>East Windsor</city>
        <state>New Jersey</state>
        <zip>08520</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Pittsburgh Medical Center</name>
      <address>
        <city>Pittsburgh</city>
        <state>Pennsylvania</state>
        <zip>15213</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Menter Dermatology Research Institute</name>
      <address>
        <city>Dallas</city>
        <state>Texas</state>
        <zip>75246</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Utah Health</name>
      <address>
        <city>Murray</city>
        <state>Utah</state>
        <zip>84107</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Paratus Clinical Research Woden</name>
      <address>
        <city>Phillip</city>
        <state>Australian Capital Territory</state>
        <zip>2606</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Westmead Hospital</name>
      <address>
        <city>Westmead</city>
        <state>New South Wales</state>
        <zip>2145</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Skin Health Institute Inc</name>
      <address>
        <city>Carlton</city>
        <state>Victoria</state>
        <zip>3053</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Royal Melbourne Hospital</name>
      <address>
        <city>Parkville</city>
        <state>Victoria</state>
        <zip>3050</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Brussels - UNIV Saint-Luc</name>
      <address>
        <city>Bruxelles</city>
        <zip>1200</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>UZ Leuven</name>
      <address>
        <city>Leuven</city>
        <zip>3000</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Dr. Irina Turchin PC Inc.</name>
      <address>
        <city>Fredericton</city>
        <state>New Brunswick</state>
        <zip>E3B 1G9</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>SimcoDerm Medical and Surgical Dermatology Centre</name>
      <address>
        <city>Barrie</city>
        <state>Ontario</state>
        <zip>L4M 7G1</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Guenther Dermatology Research Centre</name>
      <address>
        <city>London</city>
        <state>Ontario</state>
        <zip>N6A 3H7</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Innovaderm Research Inc.</name>
      <address>
        <city>Montreal</city>
        <state>Quebec</state>
        <zip>H2X 2V1</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CCBR Czech a.s.</name>
      <address>
        <city>Pardubice</city>
        <zip>530 02</zip>
        <country>Czechia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sanatorium Prof. Arenebergera</name>
      <address>
        <city>Prague</city>
        <zip>11000</zip>
        <country>Czechia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Univ. Hospital Kralovske Vinohrady</name>
      <address>
        <city>Praha</city>
        <zip>100 34</zip>
        <country>Czechia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>HOP l'Archet</name>
      <address>
        <city>Nice</city>
        <zip>06200</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>HOP Saint-Louis</name>
      <address>
        <city>Paris</city>
        <zip>75010</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>HOP Larrey</name>
      <address>
        <city>Toulouse</city>
        <zip>31059</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Charité - Universitätsmedizin Berlin</name>
      <address>
        <city>Berlin</city>
        <zip>10117</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universitätsklinikum Erlangen</name>
      <address>
        <city>Erlangen</city>
        <zip>91054</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universitätsklinikum Frankfurt</name>
      <address>
        <city>Frankfurt am Main</city>
        <zip>60596</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universitätsklinikum Heidelberg</name>
      <address>
        <city>Heidelberg</city>
        <zip>69120</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universitätsklinikum Schleswig-Holstein, Campus Kiel</name>
      <address>
        <city>Kiel</city>
        <zip>24105</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Pecs</name>
      <address>
        <city>Pecs</city>
        <zip>7632</zip>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Markusovszky University Teaching Hospital</name>
      <address>
        <city>Szombathely</city>
        <zip>9700</zip>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Fujita Health University Hospital</name>
      <address>
        <city>Aichi, Toyoake</city>
        <zip>470-1192</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Tokyo Dental College Ichikawa General Hospital</name>
      <address>
        <city>Chiba, Ichikawa</city>
        <zip>272-8513</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Fukuoka University Hospital</name>
      <address>
        <city>Fukuoka, Fukuoka</city>
        <zip>814-0180</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Gifu University Hospital</name>
      <address>
        <city>Gifu, Gifu</city>
        <zip>501-1194</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Asahikawa Medical University Hospital</name>
      <address>
        <city>Hokkaido, Asahikawa</city>
        <zip>078-8510</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Takagi Dermatological Clinic</name>
      <address>
        <city>Hokkaido, Obihiro</city>
        <zip>080-0013</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Takamatsu Red Cross Hospital</name>
      <address>
        <city>Kagawa, Takamatsu</city>
        <zip>760-0017</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sagamihara National Hospital</name>
      <address>
        <city>Kanagawa, Sagamihara</city>
        <zip>252-0392</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kumamoto University Hospital</name>
      <address>
        <city>Kumamoto, Kumamoto</city>
        <zip>860-8556</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University Hospital Kyoto Prefectural University of Medicine</name>
      <address>
        <city>Kyoto, Kyoto</city>
        <zip>602-8566</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Tohoku University Hospital</name>
      <address>
        <city>Miyagi, Sendai</city>
        <zip>980-8574</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Shinshu University Hospital</name>
      <address>
        <city>Nagano, Matsumoto</city>
        <zip>390-8621</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Okayama University Hospital</name>
      <address>
        <city>Okayama, Okayama</city>
        <zip>700-8558</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of the Ryukyus Hospital</name>
      <address>
        <city>Okinawa, Nakagami-gun</city>
        <zip>903-0215</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Nakatsu Dermatology Clinic</name>
      <address>
        <city>Osaka, Osaka</city>
        <zip>531-0071</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Osaka Metropolitan University Hospital</name>
      <address>
        <city>Osaka, Osaka</city>
        <zip>545-8586</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Osaka University Hospital</name>
      <address>
        <city>Osaka, Suita</city>
        <zip>565-0871</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Shiga University of Medical Science Hospital</name>
      <address>
        <city>Shiga, Otsu</city>
        <zip>520-2192</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Jichi Medical University Hospital</name>
      <address>
        <city>Tochigi, Shimotsuke</city>
        <zip>329-0498</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Teikyo University Hospital</name>
      <address>
        <city>Tokyo, Itabashi-ku</city>
        <zip>173-8606</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Nihon University Itabashi Hospital</name>
      <address>
        <city>Tokyo, Itabashi-ku</city>
        <zip>173-8610</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Tokyo Medical University Hospital</name>
      <address>
        <city>Tokyo, Shinjuku-ku</city>
        <zip>160-0023</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Wakayama Medical University Hospital</name>
      <address>
        <city>Wakayama, Wakayama</city>
        <zip>641-8509</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Gachon University Gil Medical Center</name>
      <address>
        <city>Incheon</city>
        <zip>21565</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Seoul National University Bundang Hospital</name>
      <address>
        <city>Seongnam</city>
        <zip>13620</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Seoul National University Hospital</name>
      <address>
        <city>Seoul</city>
        <zip>03080</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Barbara Rewerska Diamond Clinic, Krakow</name>
      <address>
        <city>Krakow</city>
        <zip>31-559</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Dermoklinika medical center, Lodz</name>
      <address>
        <city>Lodz</city>
        <zip>90-436</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Independent Public Clin.Hosp.no1 Lublin</name>
      <address>
        <city>Lublin</city>
        <zip>20-081</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Municipal Hospital Complex in Olsztyn</name>
      <address>
        <city>Olsztyn</city>
        <zip>10-229</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Dermmedica Sp. z o.o., Wroclaw</name>
      <address>
        <city>Wroclaw</city>
        <zip>51-318</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>SBHI Chelyabinsk Reg.Clin.Derma.Dispen.</name>
      <address>
        <city>Chelyabinsk</city>
        <zip>454048</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>LLC &quot;Medical Center Azbuka Zdorovia&quot;</name>
      <address>
        <city>Kazan</city>
        <zip>420111</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Dermatovenereological Dispensary #10, St. Petersburg</name>
      <address>
        <city>Saint-Petersburg</city>
        <zip>194021</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>National Taiwan University Hospital</name>
      <address>
        <city>Taipei</city>
        <zip>10002</zip>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Royal Devon and Exeter Hospital</name>
      <address>
        <city>Exeter</city>
        <zip>EX2 5DW</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Guy's Hospital</name>
      <address>
        <city>London</city>
        <zip>SE1 9RT</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Australia</country>
    <country>Belgium</country>
    <country>Canada</country>
    <country>Czechia</country>
    <country>France</country>
    <country>Germany</country>
    <country>Hungary</country>
    <country>Japan</country>
    <country>Korea, Republic of</country>
    <country>Poland</country>
    <country>Russian Federation</country>
    <country>Taiwan</country>
    <country>United Kingdom</country>
    <country>United States</country>
  </location_countries>
  <link>
    <url>http://mystudywindow.com</url>
    <description>Related Info</description>
  </link>
  <verification_date>June 2023</verification_date>
  <study_first_submitted>July 28, 2020</study_first_submitted>
  <study_first_submitted_qc>July 28, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 30, 2020</study_first_posted>
  <last_update_submitted>June 7, 2023</last_update_submitted>
  <last_update_submitted_qc>June 7, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">June 8, 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>Psoriasis</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>After the study is completed and the primary manuscript is accepted for publishing, researchers can use this following link https://www.mystudywindow.com/msw/datasharing to request access to the clinical study documents regarding this study, and upon a signed &quot;Document Sharing Agreement&quot;.&#xD;
Also, Researchers can use the following link https://www.mystudywindow.com/msw/datasharing to find information in order to request access to the clinical study data, for this and other listed studies, after the submission of a research proposal and according to the terms outlined in the website.&#xD;
The data shared are the raw clinical study data sets.</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>After all regulatory activities are completed in the US and EU for the product and indication, and after the primary manuscript has been accepted for publication.</ipd_time_frame>
    <ipd_access_criteria>For study documents - upon signing of a 'Document Sharing Agreement'. For study data - 1. after the submission and approval of the research proposal (checks will be performed by both the independent review panel and the sponsor, including checking that the planned analysis does not compete with sponsor's publication plan); 2. and upon signing of a 'Data Sharing Agreement'.</ipd_access_criteria>
    <ipd_url>https://www.mystudywindow.com/msw/datasharing</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/NCT04493424
org study id: 1368-0024
secondary id: 2020-000189-41
nct id: NCT04493424
lead sponsor: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
This study is open to people with palmoplantar pustulosis who took part in previous clinical
      studies of a medicine called spesolimab. Participants who benefited from spesolimab treatment
      in the previous studies can join this study.

      The purpose of this study is to find out how safe spesolimab is and whether it helps people
      with palmoplantar pustulosis in the long-term. Participants are in this study for up to 5
      years. During this time they visit the study site every month to get spesolimab injections
      under the skin.

      At study visits, doctors check the severity of participants' palmoplantar pustulosis and
      collect information on any health problems of the participants.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Occurrence of treatment emergent adverse events (TEAEs)
time frame: Up to week 260
measure: Percent change in Palmoplantar Pustulosis Area and Severity Index (PPP ASI) from baseline in parent trial
time frame: Up to week 260
measure: Proportion of patients with Palmoplantar Pustulosis Area and Severity Index 50% (PPP ASI50) compared to baseline in parent trial
time frame: Up to week 260
measure: Proportion of patients with Palmoplantar Pustulosis Physician Global Assessment (PPP PGA) of 0 (clear) or 1 (almost clear)
time frame: Up to week 260
arm group label: Treatment group
arm group type: Experimental
description: Up to 260 weeks
intervention type: Drug
intervention name: Spesolimab
description: Spesolimab
arm group label: Treatment group
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
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country: Australia
country: Belgium
country: Canada
country: Czechia
country: France
country: Germany
country: Hungary
country: Japan
country: Korea, Republic of
country: Poland
country: Russian Federation
country: Taiwan
country: United Kingdom
country: United States
url: http://mystudywindow.com
description: Related Info
responsible party type: Sponsor
mesh term: Psoriasis
sharing ipd: Yes
ipd description: After the study is completed and the primary manuscript is accepted for publishing, researchers can use this following link https://www.mystudywindow.com/msw/datasharing to request access to the clinical study documents regarding this study, and upon a signed "Document Sharing Agreement".
Also, Researchers can use the following link https://www.mystudywindow.com/msw/datasharing to find information in order to request access to the clinical study data, for this and other listed studies, after the submission of a research proposal and according to the terms outlined in the website.
The data shared are the raw clinical study data sets.
ipd info type: Study Protocol
ipd info type: Statistical Analysis Plan (SAP)
ipd info type: Clinical Study Report (CSR)
ipd time frame: After all regulatory activities are completed in the US and EU for the product and indication, and after the primary manuscript has been accepted for publication.
ipd access criteria: For study documents - upon signing of a 'Document Sharing Agreement'. For study data - 1. after the submission and approval of the research proposal (checks will be performed by both the independent review panel and the sponsor, including checking that the planned analysis does not compete with sponsor's publication plan); 2. and upon signing of a 'Data Sharing Agreement'.
ipd url: https://www.mystudywindow.com/msw/datasharing