<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/NCT04399837</url>
  </required_header>
  <id_info>
    <org_study_id>1368-0027</org_study_id>
    <secondary_id>2018-003081-14</secondary_id>
    <nct_id>NCT04399837</nct_id>
  </id_info>
  <brief_title>A Study to Test Whether BI 655130 (Spesolimab) Prevents Flare-ups in Patients With Generalized Pustular Psoriasis</brief_title>
  <official_title>Effisayil™ 2: Multi-center, Randomized, Parallel Group, Double Blind, Placebo Controlled, Phase IIb Dose-finding Study to Evaluate Efficacy and Safety of BI 655130 (Spesolimab) Compared to Placebo in Preventing Generalized Pustular Psoriasis (GPP) Flares in Patients With History of GPP</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 is a study in adolescents and adults with Generalized Pustular Psoriasis (GPP). People&#xD;
      between 12 and 75 years old can take part in the study. The study is open to people who had&#xD;
      GPP flare-ups in the past but whose skin is clear or almost clear when they join the study.&#xD;
      The purpose of the study is to test 3 different doses of a medicine called spesolimab and to&#xD;
      see whether it helps to prevent GPP flare-ups.&#xD;
&#xD;
      Participants are put into 4 groups by chance. Three groups get different doses of spesolimab.&#xD;
      The fourth group gets a placebo. Placebo looks like spesolimab but does not contain any&#xD;
      medicine.&#xD;
&#xD;
      Spesolimab and placebo are given as an injection under the skin. Participants are in the&#xD;
      study for about 1 year and 4 months. During this time, they visit the study site about 15&#xD;
      times. For the first 11 months, participants get spesolimab or placebo injections every&#xD;
      month. At the study visits, the doctors check participants' skin for signs of a new GPP&#xD;
      flare-up. The doctors also check the general health of the participants.&#xD;
&#xD;
      If a participant has a GPP flare-up during the study, more visits may be necessary. In case&#xD;
      of a flare-up, participants get a dose of spesolimab as an infusion into a vein.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 4, 2020</start_date>
  <completion_date type="Actual">November 23, 2022</completion_date>
  <primary_completion_date type="Actual">November 23, 2022</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Time to first Generalized Pustular Psoriasis (GPP) flare</measure>
    <time_frame>up to 48 weeks</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Occurrence of at least one GPP flare</measure>
    <time_frame>up to 48 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to first worsening of Psoriasis Symptom Scale (PSS)</measure>
    <time_frame>up to 48 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to first worsening of Dermatology Quality of Life Index (DLQI)</measure>
    <time_frame>up to 48 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Sustained remission</measure>
    <time_frame>up to 48 weeks</time_frame>
    <description>Defined as a patient with a GPPGA score of 0 or 1 (clear or almost clear) at all visits up to week 48, without intake of rescue medication, or investigator-prescribed Standard of Care (SoC).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Occurrence of treatment emergent adverse events (TEAEs)</measure>
    <time_frame>up to 64 weeks</time_frame>
  </secondary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">123</enrollment>
  <condition>Generalized Pustular Psoriasis</condition>
  <arm_group>
    <arm_group_label>Spesolimab SC low dose</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Spesolimab SC medium dose</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Spesolimab SC high dose</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Spesolimab</intervention_name>
    <description>Solution for injection</description>
    <arm_group_label>Spesolimab SC high dose</arm_group_label>
    <arm_group_label>Spesolimab SC low dose</arm_group_label>
    <arm_group_label>Spesolimab SC medium dose</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Solution for injection</description>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients with a known and documented history of GPP per ERASPEN criteria (see Section&#xD;
             3.3.1) regardless of IL36RN mutation status, with at least 2 presentations of moderate&#xD;
             to severe GPP flares with fresh pustulation (new appearance or worsening) in the past.&#xD;
&#xD;
          -  Patients with a GPPGA score of 0 or 1 at screening and randomization.&#xD;
&#xD;
          -  Patients who are not on concomitant GPP treatment at time of randomization (V2) must&#xD;
             have had at least two presentations of moderate to severe GPP flare in the past year,&#xD;
             at least one of which had evidence of either fever and/or elevated CRP and/or elevated&#xD;
             WBC, and/or asthenia and/or myalgia.&#xD;
&#xD;
          -  Patients who are not on concomitant GPP treatment at time of randomization (V2) but&#xD;
             who were on concomitant GPP treatment until shortly before randomization (V2) (≤ 12&#xD;
             weeks before randomization), these patients must have a history of flaring while on&#xD;
             concomitant treatment for GPP or in case of dose reduction or discontinuation of their&#xD;
             concomitant medication.&#xD;
&#xD;
          -  Patients who are on concomitant treatment regimen with retinoids and/or methotrexate&#xD;
             and/or cyclosporine must stop at the day of randomization (V2). These patients must&#xD;
             have a history of flaring while on concomitant treatment for GPP or in case of dose&#xD;
             reduction or discontinuation of these concomitant medications.&#xD;
&#xD;
          -  Male or female patients, aged 12 to 75 years at screening. For all patients, a minimum&#xD;
             weight of 40 kg is required.&#xD;
&#xD;
          -  Signed and dated written informed consent and assent in accordance with ICH-GCP and&#xD;
             local legislation prior to admission in the trial.&#xD;
&#xD;
          -  Women of childbearing potential (WOCBP)1 must be ready and able to use highly&#xD;
             effective methods of birth control per ICH M3 (R2) that result in a low failure rate&#xD;
             of less than 1% per year when used consistently and correctly. A list of contraception&#xD;
             methods meeting these criteria is provided in the CTP as well as in the patient,&#xD;
             parent(s) (or patient's legal guardian) information.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Patients with SAPHO (Synovitis-acne-pustulosis-hyperostosis-osteitis) syndrome.&#xD;
&#xD;
          2. Patients with primary erythrodermic psoriasis vulgaris.&#xD;
&#xD;
          3. Severe, progressive, or uncontrolled hepatic disease, defined as &gt;3-fold Upper Limit&#xD;
             of Normal (ULN) elevation in Aspartate Aminotransferase (AST) or Alanine&#xD;
             Aminotransferase (ALT) or alkaline phosphatase, or &gt;2-fold ULN elevation in total&#xD;
             bilirubin.&#xD;
&#xD;
          4. Treatment with:&#xD;
&#xD;
               1. Any restricted medication as specified in the CTP, or any drug considered likely&#xD;
                  to interfere with the safe conduct of the study, as assessed by the investigator.&#xD;
&#xD;
               2. Any prior exposure to BI 655130 or another IL36R inhibitor biologic.&#xD;
&#xD;
          5. Increased risk of infectious complications (e.g. recent pyogenic infection, any&#xD;
             congenital or acquired immunodeficiency (e.g. HIV), past organ or stem cell&#xD;
             transplantation), as assessed by the investigator.&#xD;
&#xD;
          6. Relevant chronic or acute infections including active tuberculosis, human&#xD;
             immunodeficiency virus (HIV) infection or viral hepatitis at the time of&#xD;
             randomization. A patient can be re-screened if the patient was treated and is cured&#xD;
             from the acute infection.&#xD;
&#xD;
          7. Active or Latent Tuberculosis (TB):&#xD;
&#xD;
               -  Patients with active tuberculosis should be excluded&#xD;
&#xD;
               -  Patients with a positive QuantiFERON® (or if applicable, T-Spot®) TB test during&#xD;
                  screening are excluded, unless the patient had previous diagnosis of active or&#xD;
                  latent TB and has completed appropriate treatment per the discretion of the local&#xD;
                  investigator within the last 3 years and at the latest at the time of screening&#xD;
                  (i.e. 2 to 4 weeks before study drug administration); patients may be re-screened&#xD;
                  once to meet this criterion)&#xD;
&#xD;
               -  Patients with suspected false positive or indeterminate QuantiFERON® (or if&#xD;
                  applicable, T-Spot®) TB result may be re-tested once&#xD;
&#xD;
               -  If QuantiFERON® (or if applicable, T-Spot®) TB testing is not available or&#xD;
                  provides indeterminate results after repeat testing, a tuberculin skin test (TST)&#xD;
                  can be performed: A TST reaction of ≥10mm (≥5mm if receiving ≥15mg/d prednisone&#xD;
                  or its equivalent) is considered positive.&#xD;
&#xD;
          8. History of allergy/hypersensitivity to the systemically administered trial medication&#xD;
             agent or its excipients.&#xD;
&#xD;
        Further exclusion criteria apply.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>12 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Oakland Hills Dermatology</name>
      <address>
        <city>Auburn Hills</city>
        <state>Michigan</state>
        <zip>48326</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Washington University School of Medicine</name>
      <address>
        <city>Saint Louis</city>
        <state>Missouri</state>
        <zip>63108</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Buenos Aires Skin S.A.</name>
      <address>
        <city>Caba</city>
        <zip>C1055AA0</zip>
        <country>Argentina</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Italiano de Buenos Aires</name>
      <address>
        <city>Caba</city>
        <zip>C1056AB</zip>
        <country>Argentina</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>Clínica Dermacross S.A.</name>
      <address>
        <city>Vitacura</city>
        <zip>7640881</zip>
        <country>Chile</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sun yet-sen Memorial Hospital, Sun yet-sen Univesity</name>
      <address>
        <city>Guangzhou</city>
        <zip>510288</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Second Affiliated Hospital Zhejiang University School of Medicine</name>
      <address>
        <city>Hangzhou</city>
        <zip>310009</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Shanghai Skin Disease Hospital</name>
      <address>
        <city>Shanghai</city>
        <zip>200000</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Huashan Hospital, Fudan University</name>
      <address>
        <city>Shanghai</city>
        <zip>200040</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The First Hospital of China Medical University</name>
      <address>
        <city>Shenyang</city>
        <zip>110001</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Tianjin Academy of Traditional Chinese Medicine Affiliated Hospital</name>
      <address>
        <city>Tianjin</city>
        <zip>300120</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Second Affiliated Hospital of Xi'an JiaoTong University</name>
      <address>
        <city>Xi'An</city>
        <zip>710004</zip>
        <country>China</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>Fachklinik Bad Bentheim</name>
      <address>
        <city>Bad Bentheim</city>
        <zip>48455</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universitätsklinikum Bonn AöR</name>
      <address>
        <city>Bonn</city>
        <zip>53127</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>Klinikum der Universität München - Campus Innenstadt</name>
      <address>
        <city>München</city>
        <zip>80337</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universitätsklinikum Münster</name>
      <address>
        <city>Münster</city>
        <zip>48149</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Klinikum Oldenburg AöR</name>
      <address>
        <city>Oldenburg</city>
        <zip>26133</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universitätsklinikum Würzburg AÖR</name>
      <address>
        <city>Würzburg</city>
        <zip>97080</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>General Hospital of Thessaloniki &quot;Ippokrateio&quot;</name>
      <address>
        <city>Thessaloniki</city>
        <zip>54643</zip>
        <country>Greece</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Istituto Clinico Humanitas</name>
      <address>
        <city>Rozzano (MI)</city>
        <zip>20089</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Nagoya City University Hospital</name>
      <address>
        <city>Aichi, Nagoya</city>
        <zip>467-8602</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kyushu Rosai Hospital</name>
      <address>
        <city>Fukuoka, Kitakyushu</city>
        <zip>800-0296</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Tokyo Medical University Ibaraki Medical Center</name>
      <address>
        <city>Ibaraki, Inashiki-gun</city>
        <zip>300-0395</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Saitama Medical University Hospital</name>
      <address>
        <city>Saitama, Iruma-gun</city>
        <zip>350-0495</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Tokyo Medical University Hachioji Medical Center</name>
      <address>
        <city>Tokyo, Hachioji</city>
        <zip>193-0998</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>Pusan National Univ. Hosp</name>
      <address>
        <city>Busan</city>
        <zip>49241</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Severance Hospital</name>
      <address>
        <city>Seoul</city>
        <zip>03722</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Pulau Pinang</name>
      <address>
        <city>Georgetown Pulau Pinang</city>
        <zip>10990</zip>
        <country>Malaysia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Raja Permaisuri Bainun</name>
      <address>
        <city>Ipoh</city>
        <zip>30450</zip>
        <country>Malaysia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Sultanah Aminah</name>
      <address>
        <city>Johor Bahru</city>
        <zip>80100</zip>
        <country>Malaysia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Sultan Ismail</name>
      <address>
        <city>Johor Bahru</city>
        <zip>81100</zip>
        <country>Malaysia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Queen Elizabeth Hospital</name>
      <address>
        <city>Kota Kinabalu</city>
        <zip>88586</zip>
        <country>Malaysia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Kuala Lumpur</name>
      <address>
        <city>Kuala Lumpur</city>
        <zip>50586</zip>
        <country>Malaysia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sarawak General Hospital</name>
      <address>
        <city>Kuching, Sarawak</city>
        <zip>93586</zip>
        <country>Malaysia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Pakar Sultanah Fatimah</name>
      <address>
        <city>Muar</city>
        <zip>84000</zip>
        <country>Malaysia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centro de Investigación de Enfermedades Autoinmunes S.C.</name>
      <address>
        <city>Guadalajara</city>
        <zip>44610</zip>
        <country>Mexico</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario Dr Jose Eleuterio Gonzalez</name>
      <address>
        <city>Monterrey</city>
        <zip>64460</zip>
        <country>Mexico</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Erasmus Medisch Centrum</name>
      <address>
        <city>Rotterdam</city>
        <zip>3015 GD</zip>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Southern Philippines Medical Center</name>
      <address>
        <city>Davao City</city>
        <zip>8000</zip>
        <country>Philippines</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Iloilo Doctors Hospital</name>
      <address>
        <city>Iloilo City, Iloilo</city>
        <zip>5000</zip>
        <country>Philippines</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Center for Skin Research, Testing and Product Development</name>
      <address>
        <city>Makati City</city>
        <zip>1229</zip>
        <country>Philippines</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>FSBEI HE &quot;Kirov State Medical University&quot;</name>
      <address>
        <city>Kirov</city>
        <zip>610035</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>1stPavlov St.Med.Univ.St.-Petersburg Res.Inst.</name>
      <address>
        <city>Saint-Petersburg</city>
        <zip>197022</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Saratov State Med.Univ.n.a.Razumovskogo</name>
      <address>
        <city>Saratov</city>
        <zip>410028</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>LLC Skin Disease Clinic of Pier Volkenstein, St. Petersburg</name>
      <address>
        <city>St. Petersburg</city>
        <zip>190123</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>LLC &quot;Avrora Medfort&quot;</name>
      <address>
        <city>St. Petersburg</city>
        <zip>194156</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Arthritis Clinical Research Trials</name>
      <address>
        <city>Cape Town</city>
        <zip>7405</zip>
        <country>South Africa</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Sant Joan de Déu</name>
      <address>
        <city>Esplugues Del Llobregat</city>
        <zip>08950</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario 12 de Octubre</name>
      <address>
        <city>Madrid</city>
        <zip>28041</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Chang Gung Medical Foundation (CGMF) - Linkou Bran</name>
      <address>
        <city>Linkou</city>
        <zip>333</zip>
        <country>Taiwan</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>King Chulalongkorn Memorial Hospital</name>
      <address>
        <city>Bangkok</city>
        <zip>10330</zip>
        <country>Thailand</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Institute of Dermatology</name>
      <address>
        <city>Bangkok</city>
        <zip>10400</zip>
        <country>Thailand</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ramathibodi Hospital</name>
      <address>
        <city>Ratchatewi, Bangkok</city>
        <zip>10400</zip>
        <country>Thailand</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Farhat Hached Hospital</name>
      <address>
        <city>Sousse</city>
        <zip>4000</zip>
        <country>Tunisia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hedi Chaker Hospital, Department of Dermatology</name>
      <address>
        <city>Tunisia</city>
        <zip>1053</zip>
        <country>Tunisia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>La Rabta Hospital</name>
      <address>
        <city>Tunis</city>
        <zip>1007</zip>
        <country>Tunisia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Charles Nicolle Hospital</name>
      <address>
        <city>Tunis</city>
        <zip>1008</zip>
        <country>Tunisia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Habib Thameur Hospital</name>
      <address>
        <city>Tunis</city>
        <zip>1008</zip>
        <country>Tunisia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Uludag University Medicine Faculty Departmant of Dermatology</name>
      <address>
        <city>Bursa</city>
        <zip>16059</zip>
        <country>Turkey</country>
      </address>
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  </location>
  <location>
    <facility>
      <name>Bezmi Alem Valide Sultan Vakif Gureba Egitim ve Arastirma Hastanesi</name>
      <address>
        <city>Istanbul</city>
        <zip>34093</zip>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Istanbul Universitesi Cerrahpasa Tip Fakultesi</name>
      <address>
        <city>Istanbul</city>
        <zip>34098</zip>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Marmara Universitesi Tip Fakultesi</name>
      <address>
        <city>Istanbul</city>
        <zip>34460</zip>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>National Hospital of Dermatology and Venereology</name>
      <address>
        <city>Ha Noi</city>
        <zip>10000</zip>
        <country>Vietnam</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>HCMC Hospital of Dermato-Venereology</name>
      <address>
        <city>Ho Chi Minh</city>
        <zip>70000</zip>
        <country>Vietnam</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Argentina</country>
    <country>Belgium</country>
    <country>Chile</country>
    <country>China</country>
    <country>France</country>
    <country>Germany</country>
    <country>Greece</country>
    <country>Italy</country>
    <country>Japan</country>
    <country>Korea, Republic of</country>
    <country>Malaysia</country>
    <country>Mexico</country>
    <country>Netherlands</country>
    <country>Philippines</country>
    <country>Russian Federation</country>
    <country>South Africa</country>
    <country>Spain</country>
    <country>Taiwan</country>
    <country>Thailand</country>
    <country>Tunisia</country>
    <country>Turkey</country>
    <country>United States</country>
    <country>Vietnam</country>
  </location_countries>
  <removed_countries>
    <country>Australia</country>
    <country>Bulgaria</country>
    <country>Colombia</country>
    <country>Croatia</country>
    <country>Czechia</country>
    <country>Georgia</country>
    <country>Poland</country>
    <country>Singapore</country>
  </removed_countries>
  <link>
    <url>http://www.mystudywindow.com</url>
    <description>Related Info</description>
  </link>
  <verification_date>April 2023</verification_date>
  <study_first_submitted>May 20, 2020</study_first_submitted>
  <study_first_submitted_qc>May 20, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">May 22, 2020</study_first_posted>
  <last_update_submitted>April 18, 2023</last_update_submitted>
  <last_update_submitted_qc>April 18, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">April 20, 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 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/NCT04399837
org study id: 1368-0027
secondary id: 2018-003081-14
nct id: NCT04399837
lead sponsor: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
This is a study in adolescents and adults with Generalized Pustular Psoriasis (GPP). People
      between 12 and 75 years old can take part in the study. The study is open to people who had
      GPP flare-ups in the past but whose skin is clear or almost clear when they join the study.
      The purpose of the study is to test 3 different doses of a medicine called spesolimab and to
      see whether it helps to prevent GPP flare-ups.

      Participants are put into 4 groups by chance. Three groups get different doses of spesolimab.
      The fourth group gets a placebo. Placebo looks like spesolimab but does not contain any
      medicine.

      Spesolimab and placebo are given as an injection under the skin. Participants are in the
      study for about 1 year and 4 months. During this time, they visit the study site about 15
      times. For the first 11 months, participants get spesolimab or placebo injections every
      month. At the study visits, the doctors check participants' skin for signs of a new GPP
      flare-up. The doctors also check the general health of the participants.

      If a participant has a GPP flare-up during the study, more visits may be necessary. In case
      of a flare-up, participants get a dose of spesolimab as an infusion into a vein.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Time to first Generalized Pustular Psoriasis (GPP) flare
time frame: up to 48 weeks
measure: Occurrence of at least one GPP flare
time frame: up to 48 weeks
measure: Time to first worsening of Psoriasis Symptom Scale (PSS)
time frame: up to 48 weeks
measure: Time to first worsening of Dermatology Quality of Life Index (DLQI)
time frame: up to 48 weeks
measure: Sustained remission
time frame: up to 48 weeks
description: Defined as a patient with a GPPGA score of 0 or 1 (clear or almost clear) at all visits up to week 48, without intake of rescue medication, or investigator-prescribed Standard of Care (SoC).
measure: Occurrence of treatment emergent adverse events (TEAEs)
time frame: up to 64 weeks
arm group label: Spesolimab SC low dose
arm group type: Experimental
arm group label: Spesolimab SC medium dose
arm group type: Experimental
arm group label: Spesolimab SC high dose
arm group type: Experimental
arm group label: Placebo
arm group type: Placebo Comparator
intervention type: Drug
intervention name: Spesolimab
description: Solution for injection
arm group label: Spesolimab SC high dose
arm group label: Spesolimab SC low dose
arm group label: Spesolimab SC medium dose
intervention type: Drug
intervention name: Placebo
description: Solution for injection
arm group label: Placebo
criteria: 
gender: All
minimum age: 12 Years
maximum age: 75 Years
healthy volunteers: No
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country: Argentina
country: Belgium
country: Chile
country: China
country: France
country: Germany
country: Greece
country: Italy
country: Japan
country: Korea, Republic of
country: Malaysia
country: Mexico
country: Netherlands
country: Philippines
country: Russian Federation
country: South Africa
country: Spain
country: Taiwan
country: Thailand
country: Tunisia
country: Turkey
country: United States
country: Vietnam
country: Australia
country: Bulgaria
country: Colombia
country: Croatia
country: Czechia
country: Georgia
country: Poland
country: Singapore
url: http://www.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 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