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/NCT05964413</url>
    </required_header>
    <id_info>
      <org_study_id>IFX-1-P3.4</org_study_id>
      <nct_id>NCT05964413</nct_id>
    </id_info>
    <brief_title>Phase III Trial to Investigate Efficacy and Safety of Vilobelimab in Ulcerative Pyoderma Gangrenosum</brief_title>
    <official_title>A Randomized, Double-blind, Placebo-controlled, Multicenter, Adaptive Phase III Trial to Investigate Efficacy and Safety of Vilobelimab in the Treatment of Ulcerative Pyoderma Gangrenosum</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>InflaRx GmbH</agency>
        <agency_class>Industry</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>InflaRx GmbH</source>
    <oversight_info>
      <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        A randomized, double-blind, placebo-controlled, multicenter, adaptive phase III trial to&#xD;
        investigate efficacy and safety of vilobelimab in the treatment of ulcerative pyoderma&#xD;
        gangrenosum&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">August 15, 2023</start_date>
    <completion_date type="Anticipated">May 15, 2026</completion_date>
    <primary_completion_date type="Anticipated">February 13, 2026</primary_completion_date>
    <phase>Phase 3</phase>
    <study_type>Interventional</study_type>
    <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>Efficacy of treatment with vilobelimab compared to placebo</measure>
      <time_frame>Week 1 to Week 26</time_frame>
      <description>Efficacy of Vilobelimab compared to placebo - complete closure of the ulcer</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Efficacy of treatment with vilobelimab compared to placebo</measure>
      <time_frame>2 weeks between study visits</time_frame>
      <description>Proportion of patients achieving disease remission up to and including EOT visit; where disease remission is assessed by the investigator as complete re-epithelization (defined as wound covered by epithelial skin layer or scar) of all PG ulcers, without drainage or dressing requirements</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Pain reduction</measure>
      <time_frame>Week 10 through study completion</time_frame>
      <description>Proportion of patients achieving a pain reduction related to the target ulcer of at least 3 points compared to baseline</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">90</enrollment>
    <condition>Pyoderma Gangrenosum</condition>
    <arm_group>
      <arm_group_label>vilobelimab</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Patients will be treated with vilobelimab IV, Q2W for 26 weeks</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Placebo</arm_group_label>
      <arm_group_type>Placebo Comparator</arm_group_type>
      <description>Patients will receive placebo IV in the same schedule as patients in Arm 1</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>vilobelimab</intervention_name>
      <description>vilobelimab infusion</description>
      <arm_group_label>vilobelimab</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Placebo</intervention_name>
      <description>Placebo Infusion</description>
      <arm_group_label>Placebo</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Main Inclusion Criteria:&#xD;
  &#xD;
            1. 18 years or older at the time of signing the informed consent.&#xD;
  &#xD;
            2. Investigator confirmed clinical diagnosis of ulcerative PG. Diagnosis shall be&#xD;
               supported by clinical assessment of PG symptoms via PARACELSUS score (Jockenhofer,&#xD;
               Wollina et al. 2019) of 10 points or more (see Appendix - Section 12.1). Note: in case&#xD;
               of PARACELSUS score &lt; 10, additional justification shall be provided by the&#xD;
               investigator to support clinical diagnosis of ulcerative PG.&#xD;
  &#xD;
            3. Minimum of 1 evaluable PG ulcer (other than peristomal) which qualifies as the target&#xD;
               ulcer by meeting the following criteria (Orfaly, Reese et al. 2022): area of ≥ 5 cm 2&#xD;
               at screening and baseline&#xD;
  &#xD;
                 -  circulated by intact skin&#xD;
  &#xD;
                 -  evaluable by at least 2-dimensional measurement&#xD;
  &#xD;
          Main Exclusion Criteria:&#xD;
  &#xD;
            1. Patients with target ulcers exceeding 80 cm 2 .&#xD;
  &#xD;
            2. Patients with target ulcer in transplanted skin.&#xD;
  &#xD;
            3. Surgical wound debridement or negative pressure wound therapy (NPWT) for the target&#xD;
               ulcer within 4 weeks before baseline (i.e., start of treatment with IMP).&#xD;
  &#xD;
            4. Patient with previous exposure to vilobelimab (IFX-1) prior to baseline (i.e., start&#xD;
               of treatment with IMP).&#xD;
  &#xD;
            5. Patient receives/has received a vaccine within 2 weeks prior to baseline (i.e., start&#xD;
               of treatment with IMP).&#xD;
  &#xD;
            6. Any active infection requiring systemic antibiotic or other systemic treatment or&#xD;
               suppressive anti-infective therapy within 2 weeks prior to baseline (i.e., start of&#xD;
               treatment with IMP).&#xD;
  &#xD;
            7. Patients received any systemic medical treatment for PG within 4 weeks prior to&#xD;
               baseline&#xD;
  &#xD;
            8. Patients received any biological or immunomodulatory therapy for PG within 4 weeks&#xD;
               prior to baseline (i.e., start of treatment with IMP), except existing biologic or&#xD;
               immunomodulatory therapy used for an underlying disease (other than PG at a stable&#xD;
               therapy with no dose adjustments for at least two maintenance doses prior to screening&#xD;
               this is allowed to be continued.&#xD;
  &#xD;
            9. Patients receiving corticosteroids treatment for PG of more than 10 mg/day of&#xD;
               prednisone or equivalent within 4 weeks prior to baseline (i.e., start of treatment&#xD;
               with IMP).&#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>Camilla Chong, MD</last_name>
      <phone>+49 89 414 189 78 00</phone>
      <email>camilla.chong@inflarx.de</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Alex GO Loayza, Prof, MD</last_name>
      <phone>+49 89 414 189 78 00</phone>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Inflarx Site 102</name>
        <address>
          <city>Florida City</city>
          <state>Florida</state>
          <zip>15416</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>June 29, 2023</study_first_submitted>
    <study_first_submitted_qc>July 24, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">July 27, 2023</study_first_posted>
    <last_update_submitted>August 18, 2023</last_update_submitted>
    <last_update_submitted_qc>August 18, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 21, 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>Pyoderma</mesh_term>
      <mesh_term>Pyoderma Gangrenosum</mesh_term>
    </condition_browse>
    <intervention_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Vilobelimab</mesh_term>
    </intervention_browse>
    <!-- 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/NCT05964413
  org study id: IFX-1-P3.4
  nct id: NCT05964413
  lead sponsor: 
  is fda regulated drug: Yes
  is fda regulated device: No
  A randomized, double-blind, placebo-controlled, multicenter, adaptive phase III trial to
        investigate efficacy and safety of vilobelimab in the treatment of ulcerative pyoderma
        gangrenosum
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  measure: Efficacy of treatment with vilobelimab compared to placebo
  time frame: Week 1 to Week 26
  description: Efficacy of Vilobelimab compared to placebo - complete closure of the ulcer
  measure: Efficacy of treatment with vilobelimab compared to placebo
  time frame: 2 weeks between study visits
  description: Proportion of patients achieving disease remission up to and including EOT visit; where disease remission is assessed by the investigator as complete re-epithelization (defined as wound covered by epithelial skin layer or scar) of all PG ulcers, without drainage or dressing requirements
  measure: Pain reduction
  time frame: Week 10 through study completion
  description: Proportion of patients achieving a pain reduction related to the target ulcer of at least 3 points compared to baseline
  arm group label: vilobelimab
  arm group type: Experimental
  description: Patients will be treated with vilobelimab IV, Q2W for 26 weeks
  arm group label: Placebo
  arm group type: Placebo Comparator
  description: Patients will receive placebo IV in the same schedule as patients in Arm 1
  intervention type: Drug
  intervention name: vilobelimab
  description: vilobelimab infusion
  arm group label: vilobelimab
  intervention type: Drug
  intervention name: Placebo
  description: Placebo Infusion
  arm group label: Placebo
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Camilla Chong, MD
  phone: +49 89 414 189 78 00
  email: camilla.chong@inflarx.de
  last name: Alex GO Loayza, Prof, MD
  phone: +49 89 414 189 78 00
  facility: 
  status: Recruiting
  country: United States
  responsible party type: Sponsor
  mesh term: Pyoderma
  mesh term: Pyoderma Gangrenosum
  mesh term: Vilobelimab