xml: <clinical_study>
    <!-- This xml conforms to an XML Schema at:
      https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
    <required_header>
      <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
      <link_text>Link to the current ClinicalTrials.gov record.</link_text>
      <url>https://clinicaltrials.gov/ct2/show/NCT06013969</url>
    </required_header>
    <id_info>
      <org_study_id>1368-0120</org_study_id>
      <nct_id>NCT06013969</nct_id>
    </id_info>
    <brief_title>A Study to Test Whether Spesolimab Helps People With Generalized Pustular Psoriasis Who Need Treatment for Repeated Flares</brief_title>
    <official_title>An Open-label, Multicenter, Single-arm, Post-marketing Trial (in Select Countries) to Evaluate Efficacy and Safety and the Impact of Immunogenicity on Efficacy, Safety, and Pharmacokinetics of Spesolimab i.v. in Treatment of Patients With Generalized Pustular Psoriasis Presenting With a Recurrent Flare Following Their Initial GPP Flare Treatment With Spesolimab i.v.</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>No</has_dmc>
      <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        This study is open to adults with a serious skin disease called generalized pustular&#xD;
        psoriasis (GPP) who have repeated flares of GPP. The purpose of this study is to find out&#xD;
        whether a medicine called spesolimab helps people with repeated flares of GPP.&#xD;
  &#xD;
        Participants are given a single dose of spesolimab as an infusion into a vein on the first&#xD;
        day of an outbreak of GPP. They may be given a second dose 1 week later if doctors think it&#xD;
        is helpful. They are also treated for additional GPP flares.&#xD;
  &#xD;
        During the time of the study, doctors regularly examine participants' skin for signs of GPP&#xD;
        to see how well the treatment works and take blood samples. The doctors also regularly check&#xD;
        participants' health and take note of any unwanted effects.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">October 17, 2023</start_date>
    <completion_date type="Anticipated">April 8, 2027</completion_date>
    <primary_completion_date type="Anticipated">December 24, 2026</primary_completion_date>
    <phase>Phase 4</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>Achievement of a Generalized Pustular Psoriasis Physician Global Assessment (GPPGA) pustulation sub-score of 0 indicating no visible pustules at Week 1</measure>
      <time_frame>Up to week 1</time_frame>
    </primary_outcome>
    <secondary_outcome>
      <measure>Achievement of a GPPGA pustulation sub-score of 0 or 1, with a ≥2-point reduction from baseline at Week 1</measure>
      <time_frame>Up to week 1</time_frame>
    </secondary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Anticipated">40</enrollment>
    <condition>Generalized Pustular Psoriasis</condition>
    <arm_group>
      <arm_group_label>GPP Patients</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Generalized Pustular Psoriasis (GPP) patients with a recurrent flare following initial GPP flare treatment with intravenous (i.v.) spesolimab.</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Spesolimab</intervention_name>
      <description>Spesolimab intravenous (i.v.) infusion</description>
      <arm_group_label>GPP Patients</arm_group_label>
      <other_name>Spevigo®</other_name>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Patients with a Generalized Pustular Psoriasis Physician Global Assessment (GPPGA)&#xD;
               pustulation sub-score of 0 or 1 and a known and documented history of Generalized&#xD;
               Pustular Psoriasis (GPP) (per European Rare And Severe Psoriasis Expert Network -&#xD;
               ERASPEN - criteria), regardless of Interleukin 36 Receptor Antagonist (IL-36RN) gene&#xD;
               mutation status or Patients with a GPP flare and a known and documented history of GPP&#xD;
               (per ERASPEN criteria) regardless of IL-36RN gene mutation status.&#xD;
  &#xD;
            -  Patients must have a history of frequent GPP flares in the past&#xD;
  &#xD;
            -  Male or female patients, aged ≥18 years (if local legislation for age of consent&#xD;
               differs, then local legislation will be followed) at screening&#xD;
  &#xD;
            -  Signed and dated written informed consent prior to admission to the trial in&#xD;
               accordance with International Conference on Harmonisation-Good Clinical Practice&#xD;
               (ICH-GCP) and local legislation prior to start of any screening procedures&#xD;
  &#xD;
            -  Women of childbearing potential (WOCBP) must be ready and able to use highly effective&#xD;
               methods of birth control per ICH M3 (R2) that result in a low failure rate of less&#xD;
               than 1% per year when used consistently and correctly&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Drug-triggered Acute Generalized Exanthematous Pustulosis (AGEP)&#xD;
  &#xD;
            -  Patients with primary plaque psoriasis vulgaris without presence of pustules or with&#xD;
               pustules that are restricted to psoriatic plaques&#xD;
  &#xD;
            -  Patients with primary erythrodermic psoriasis vulgaris&#xD;
  &#xD;
            -  Patients with SAPHO (Synovitis-acne-pustulosis-hyperostosis-osteitis) syndrome&#xD;
  &#xD;
            -  Immediate life-threatening flare of GPP or requiring intensive care treatment,&#xD;
               according to the investigator's judgement. Life-threatening complications mainly&#xD;
               include, but are not limited to, cardiovascular/cytokine driven shock, pulmonary&#xD;
               distress syndrome, or acute renal failure&#xD;
  &#xD;
            -  Severe, progressive, or uncontrolled hepatic disease, defined as &gt;3-fold upper limit&#xD;
               normal (ULN) elevation in Aspartate Aminotransferase (AST) or Alanine Aminotransferase&#xD;
               (ALT) or alkaline phosphatase, or &gt;2-fold ULN elevation in total bilirubin&#xD;
  &#xD;
            -  Presence of acute demyelinating neuropathy&#xD;
  &#xD;
            -  Treatment with any drug considered likely to interfere with the safe conduct of the&#xD;
               trial, as assessed by the investigator&#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>
    <overall_contact>
      <last_name>Boehringer Ingelheim</last_name>
      <phone>1-800-243-0127</phone>
      <email>clintriage.rdg@boehringer-ingelheim.com</email>
    </overall_contact>
    <link>
      <url>https://www.mystudywindow.com</url>
      <description>Related Info</description>
    </link>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>August 23, 2023</study_first_submitted>
    <study_first_submitted_qc>August 23, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 28, 2023</study_first_posted>
    <last_update_submitted>September 4, 2023</last_update_submitted>
    <last_update_submitted_qc>September 4, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 6, 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>Once the criteria in section &quot;Time Frame&quot; are fulfilled, researchers can use the 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;
  Furthermore, researchers can 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.</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 structured results have been posted, 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'.&#xD;
  For study data - 1. after the submission and approval of the research proposal (checks will be performed by the sponsor and/or the independent review panel, including checking that the planned analysis does not compete with sponsor's publication plan); 2. and upon signing of a legal 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>
  
  
text: download date: ClinicalTrials.gov processed this data on September 20, 2023
  link text: Link to the current ClinicalTrials.gov record.
  url: https://clinicaltrials.gov/ct2/show/NCT06013969
  org study id: 1368-0120
  nct id: NCT06013969
  lead sponsor: 
  has dmc: No
  is fda regulated drug: Yes
  is fda regulated device: No
  This study is open to adults with a serious skin disease called generalized pustular
        psoriasis (GPP) who have repeated flares of GPP. The purpose of this study is to find out
        whether a medicine called spesolimab helps people with repeated flares of GPP.
  
        Participants are given a single dose of spesolimab as an infusion into a vein on the first
        day of an outbreak of GPP. They may be given a second dose 1 week later if doctors think it
        is helpful. They are also treated for additional GPP flares.
  
        During the time of the study, doctors regularly examine participants' skin for signs of GPP
        to see how well the treatment works and take blood samples. The doctors also regularly check
        participants' health and take note of any unwanted effects.
  allocation: N/A
  intervention model: Single Group Assignment
  primary purpose: Treatment
  masking: None (Open Label)
  measure: Achievement of a Generalized Pustular Psoriasis Physician Global Assessment (GPPGA) pustulation sub-score of 0 indicating no visible pustules at Week 1
  time frame: Up to week 1
  measure: Achievement of a GPPGA pustulation sub-score of 0 or 1, with a ≥2-point reduction from baseline at Week 1
  time frame: Up to week 1
  arm group label: GPP Patients
  arm group type: Experimental
  description: Generalized Pustular Psoriasis (GPP) patients with a recurrent flare following initial GPP flare treatment with intravenous (i.v.) spesolimab.
  intervention type: Drug
  intervention name: Spesolimab
  description: Spesolimab intravenous (i.v.) infusion
  arm group label: GPP Patients
  other name: Spevigo®
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Boehringer Ingelheim
  phone: 1-800-243-0127
  email: clintriage.rdg@boehringer-ingelheim.com
  url: https://www.mystudywindow.com
  description: Related Info
  responsible party type: Sponsor
  mesh term: Psoriasis
  sharing ipd: Yes
  ipd description: Once the criteria in section "Time Frame" are fulfilled, researchers can use the 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".
  Furthermore, researchers can 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.
  ipd info type: Study Protocol
  ipd info type: Statistical Analysis Plan (SAP)
  ipd info type: Clinical Study Report (CSR)
  ipd time frame: After structured results have been posted, 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 the sponsor and/or the independent review panel, including checking that the planned analysis does not compete with sponsor's publication plan); 2. and upon signing of a legal agreement.
  ipd url: https://www.mystudywindow.com/msw/datasharing