<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/NCT03001622</url>
  </required_header>
  <id_info>
    <org_study_id>IFX-1-P2.3</org_study_id>
    <nct_id>NCT03001622</nct_id>
  </id_info>
  <brief_title>Studying Complement Inhibition in Patients With Moderate to Severe Hidradenitis Suppurativa</brief_title>
  <official_title>An Open Label Phase II Trial to Evaluate the Safety of IFX-1 in Patients With Moderate to Severe Hidradenitis Suppurativa</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>InflaRx GmbH</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>InflaRx GmbH</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The trial enrolls patients with moderate to severe Hidradenitis Suppurativa (HS). The primary&#xD;
      goal of the trial is to evaluate the safety and tolerability of IFX-1 administered over 8&#xD;
      weeks in these patients. In addition the trial aims to characterize the pharmacokinetics and&#xD;
      pharmacodynamics of IFX-1 as well as to generate preliminary data on the efficacy of IFX-1 on&#xD;
      clinical endpoints (e.g., Hidradenitis Suppurativa Clinical Response (HiSCR), Dermatology&#xD;
      Life Quality Index (DLQI), Visual Analog Scale (VAS) for disease, VAS for pain, Hidradenitis&#xD;
      Suppurativa - Physician's Global Assessment (HS-PGA), Modified Sartorius Score (mSS)).&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 2016</start_date>
  <completion_date type="Actual">July 2017</completion_date>
  <primary_completion_date type="Actual">July 2017</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>Number of patients with at least possibly related treatment-emergent adverse events (TEAEs)</measure>
    <time_frame>up to Day 134</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of patients with detection of anti-drug antibodies (pre-/post-dosing)</measure>
    <time_frame>up to Day 134</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Plasma concentration of IFX-1</measure>
    <time_frame>From Day 1 until Day 134</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Plasma concentration of C5a</measure>
    <time_frame>Data will be collected at the following time points: Day 1, Day 22, Day 50 and Day 134</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage change from baseline in total abscess and nodule (AN) count per time point</measure>
    <time_frame>Data will be collected at the following time points: Day 1, 22, 29, 36, 43, 50, 78, 106 and Day 134</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Hidradenitis Suppurativa Clinical Response (HiSCR) per time point</measure>
    <time_frame>Data will be collected at the following time points: Day 1, 22, 29, 36, 43, 50, 78, 106 and Day 134</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Achievement of Hidradenitis Suppurativa - Physician's Global Assessment (HS-PGA) of clear, minimal, or mild among patients with at least 2 grades improvement (reduction) from baseline</measure>
    <time_frame>Data will be collected at the following time points: Day 1, Day 22, Day 50 and Day 134</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>HS-PGA score per time point</measure>
    <time_frame>Data will be collected at the following time points: Day 1, 22, 29, 36, 43, 50, 78, 106 and Day 134</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Achievement of at least a 30% reduction and at least a 10 mm reduction in the Visual Analog Scale (VAS) for pain, among patients who had a baseline pain assessment ≥ 30 mm</measure>
    <time_frame>At each visit from Day 1 until Day 134</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>VAS pain score per time point</measure>
    <time_frame>At each visit from Day 1 until Day 134</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline in VAS pain score per time point</measure>
    <time_frame>At each visit from Day 1 until Day 134</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>VAS disease score per time</measure>
    <time_frame>At each visit from Day 1 until Day 134</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline in VAS disease score per time point</measure>
    <time_frame>At each visit from Day 1 until Day 134</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Dermatology Life Quality Index (DLQI) per time point</measure>
    <time_frame>Data will be collected at the following time points: Day 1, Day 22, Day 50 and Day 134</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline in DLQI per time point</measure>
    <time_frame>Data will be collected at the following time points: Day 1, Day 22, Day 50 and Day 134</time_frame>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">12</enrollment>
  <condition>Hidradenitis Suppurativa</condition>
  <arm_group>
    <arm_group_label>IFX-1</arm_group_label>
    <arm_group_type>Other</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>IFX-1</intervention_name>
    <description>chimeric, monoclonal antibody</description>
    <arm_group_label>IFX-1</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Male or female patients ≥ 18 years old&#xD;
&#xD;
          2. Written informed consent&#xD;
&#xD;
          3. Diagnosis of HS for at least 1 year&#xD;
&#xD;
          4. Hidradenitis suppurativa (HS) lesions in at least 2 distinct anatomic areas, one of&#xD;
             which is Hurley Stage II or III&#xD;
&#xD;
          5. Total AN (abscesses and nodules) count ≥3&#xD;
&#xD;
          6. Patients with either primary or secondary failure of biological treatment or are not&#xD;
             eligible for treatment with other biologicals&#xD;
&#xD;
          7. Failure of previous antimicrobial treatments&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Body weight above 150 kg or body weight below 60 kg&#xD;
&#xD;
          2. Has a draining fistula count of greater than 30 at baseline&#xD;
&#xD;
          3. Surgical management planned within the next 24 weeks&#xD;
&#xD;
          4. Occurrence of a flare-up of HS leading to intravenous antimicrobial treatment within&#xD;
             the last 14 days&#xD;
&#xD;
          5. Any other disease and condition that is likely to interfere with evaluation of study&#xD;
             product, outcome assessment or satisfactory conduct of the study&#xD;
&#xD;
               1. Active infection&#xD;
&#xD;
               2. Severe congestive heart failure (i.e., New York Heart Association (NYHA) Class&#xD;
                  IV)&#xD;
&#xD;
               3. Depression&#xD;
&#xD;
               4. History of systemic lupus erythematosus or rheumatoid arthritis&#xD;
&#xD;
               5. Any immunodeficiency disease&#xD;
&#xD;
               6. Active hematological or solid malignant tumor&#xD;
&#xD;
               7. Patients must not have had any other active skin disease or condition (e.g.,&#xD;
                  bacterial, fungal, or viral infection) that may have interfered with assessment&#xD;
                  of HS.&#xD;
&#xD;
          6. One of the following abnormal laboratory results&#xD;
&#xD;
               1. White blood cell count &lt; 2,500/mm3&#xD;
&#xD;
               2. Neutrophil count &lt; 1000/mm3&#xD;
&#xD;
               3. Serum Creatinine &gt; 3 x Upper Normal Limit (UNL)&#xD;
&#xD;
               4. Total Bilirubin &gt; 2 x UNL&#xD;
&#xD;
               5. Alanine-Aminotransferase (ALAT) &gt; 2 x UNL&#xD;
&#xD;
               6. Positive screening test for Hepatitis B, Hepatitis C, or HIV 1/2&#xD;
&#xD;
          7. Prior administration of any biological compound in the last 3 months&#xD;
&#xD;
          8. Intake of corticosteroids defined as daily intake of prednisone or equivalent more&#xD;
             than 1 mg/kg for the last three weeks;&#xD;
&#xD;
          9. Intake of Immunosuppressive drugs within past 30 days (e.g., cyclosporine, tacrolimus)&#xD;
&#xD;
         10. General exclusion criteria&#xD;
&#xD;
               1. Pregnant (in women of childbearing potential an urine pregnancy test has to be&#xD;
                  performed) or breast-feeding women&#xD;
&#xD;
               2. Women with childbearing potential (defined as within two years of their last&#xD;
                  menstruation) not willing to practice appropriate contraceptive measures (e.g.,&#xD;
                  implanon, injections, oral contraceptives, intrauterine devices, partner with&#xD;
                  vasectomy, abstinence) while participating in the trial&#xD;
&#xD;
               3. Participation in any interventional clinical trial within the last three months&#xD;
&#xD;
               4. Known intravenous drug abuse&#xD;
&#xD;
               5. Employee at the study site, spouse/partner or relative of any study staff (e.g.,&#xD;
                  investigator, sub-investigators, or study nurse) or relationship to the sponsor&#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>ATTIKON University Hospital</name>
      <address>
        <city>Athens</city>
        <zip>12462</zip>
        <country>Greece</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Greece</country>
  </location_countries>
  <verification_date>September 2017</verification_date>
  <study_first_submitted>November 29, 2016</study_first_submitted>
  <study_first_submitted_qc>December 20, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 23, 2016</study_first_posted>
  <last_update_submitted>September 15, 2017</last_update_submitted>
  <last_update_submitted_qc>September 15, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">September 19, 2017</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>Hidradenitis Suppurativa</mesh_term>
    <mesh_term>Hidradenitis</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </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/NCT03001622
org study id: IFX-1-P2.3
nct id: NCT03001622
lead sponsor: 
has dmc: No
The trial enrolls patients with moderate to severe Hidradenitis Suppurativa (HS). The primary
      goal of the trial is to evaluate the safety and tolerability of IFX-1 administered over 8
      weeks in these patients. In addition the trial aims to characterize the pharmacokinetics and
      pharmacodynamics of IFX-1 as well as to generate preliminary data on the efficacy of IFX-1 on
      clinical endpoints (e.g., Hidradenitis Suppurativa Clinical Response (HiSCR), Dermatology
      Life Quality Index (DLQI), Visual Analog Scale (VAS) for disease, VAS for pain, Hidradenitis
      Suppurativa - Physician's Global Assessment (HS-PGA), Modified Sartorius Score (mSS)).
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Number of patients with at least possibly related treatment-emergent adverse events (TEAEs)
time frame: up to Day 134
measure: Number of patients with detection of anti-drug antibodies (pre-/post-dosing)
time frame: up to Day 134
measure: Plasma concentration of IFX-1
time frame: From Day 1 until Day 134
measure: Plasma concentration of C5a
time frame: Data will be collected at the following time points: Day 1, Day 22, Day 50 and Day 134
measure: Percentage change from baseline in total abscess and nodule (AN) count per time point
time frame: Data will be collected at the following time points: Day 1, 22, 29, 36, 43, 50, 78, 106 and Day 134
measure: Hidradenitis Suppurativa Clinical Response (HiSCR) per time point
time frame: Data will be collected at the following time points: Day 1, 22, 29, 36, 43, 50, 78, 106 and Day 134
measure: Achievement of Hidradenitis Suppurativa - Physician's Global Assessment (HS-PGA) of clear, minimal, or mild among patients with at least 2 grades improvement (reduction) from baseline
time frame: Data will be collected at the following time points: Day 1, Day 22, Day 50 and Day 134
measure: HS-PGA score per time point
time frame: Data will be collected at the following time points: Day 1, 22, 29, 36, 43, 50, 78, 106 and Day 134
measure: Achievement of at least a 30% reduction and at least a 10 mm reduction in the Visual Analog Scale (VAS) for pain, among patients who had a baseline pain assessment ≥ 30 mm
time frame: At each visit from Day 1 until Day 134
measure: VAS pain score per time point
time frame: At each visit from Day 1 until Day 134
measure: Change from baseline in VAS pain score per time point
time frame: At each visit from Day 1 until Day 134
measure: VAS disease score per time
time frame: At each visit from Day 1 until Day 134
measure: Change from baseline in VAS disease score per time point
time frame: At each visit from Day 1 until Day 134
measure: Dermatology Life Quality Index (DLQI) per time point
time frame: Data will be collected at the following time points: Day 1, Day 22, Day 50 and Day 134
measure: Change from baseline in DLQI per time point
time frame: Data will be collected at the following time points: Day 1, Day 22, Day 50 and Day 134
arm group label: IFX-1
arm group type: Other
intervention type: Biological
intervention name: IFX-1
description: chimeric, monoclonal antibody
arm group label: IFX-1
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: Greece
responsible party type: Sponsor
mesh term: Hidradenitis Suppurativa
mesh term: Hidradenitis
sharing ipd: No