<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/NCT02980198</url>
  </required_header>
  <id_info>
    <org_study_id>IFN-K-005-DM</org_study_id>
    <secondary_id>2016-000137-52</secondary_id>
    <nct_id>NCT02980198</nct_id>
  </id_info>
  <brief_title>Study of IFN-K in Dermatomyositis</brief_title>
  <official_title>A Phase IIa, Single Blind, Randomized, Study to Evaluate the Safety, the Immunogenicity, and the Clinical and Biological Efficacy of IFNα-Kinoid (IFN-K) in Adult Subjects With Dermatomyositis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Neovacs</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Neovacs</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study is a Proof of Concept study aiming to evaluate the production of anti-IFNα&#xD;
      antibodies (immune response) in adult subjects with dermatomyositis&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    reorganization proceedings with a potential risk of company liquidation&#xD;
  </why_stopped>
  <start_date type="Actual">May 3, 2017</start_date>
  <completion_date type="Actual">December 11, 2019</completion_date>
  <primary_completion_date type="Actual">December 11, 2019</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>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change from baseline in the expression of IFN-induced genes at Week 48</measure>
    <time_frame>Week 48</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of subjects with treatment related adverse events</measure>
    <time_frame>Week 48</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Total improvement score from IMAC Core Set Measures (CSM) following Aggarwal et al (2017) recommendations</measure>
    <time_frame>Week 0, Week 12, Week 24, Week 36, Week 48</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Others tools: Cutaneous Disease Area and Severity Index (CDASI)</measure>
    <time_frame>Week 0, Week 12, Week 24, Week 36, Week 48</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Others tools: Manual Muscle Testing (MMT5)</measure>
    <time_frame>Week 0, Week 12, Week 24, Week 36, Week 48</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Others tools: Accelerometer</measure>
    <time_frame>Week 0, Week 12, Week 24, Week 36, Week 48</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Others tools:Dermatology Life Quality Index (DLQI score)</measure>
    <time_frame>Week 0, Week 12, Week 24, Week 36, Week 48</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Immune response induced by IFN-K as measured by antibodies production</measure>
    <time_frame>Week 48</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">0</enrollment>
  <condition>Dermatomyositis</condition>
  <arm_group>
    <arm_group_label>IFN-Kinoid</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>IFN-Kinoid + ISA 51</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Placebo + ISA 51</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>IFN-Kinoid</intervention_name>
    <description>IM administration</description>
    <arm_group_label>IFN-Kinoid</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>IM administration</description>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>ISA 51</intervention_name>
    <description>adjuvant</description>
    <arm_group_label>IFN-Kinoid</arm_group_label>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patient newly diagnosed or relapsing with &quot;definite&quot; or &quot;probable&quot; dermatomyositis&#xD;
             based on ENMC criteria (2004)&#xD;
&#xD;
          -  Patient requiring corticosteroids (CS) at a dose of 1 mg/Kg and ≤ 70 mg of prednisone&#xD;
             equivalent/day or currently receiving CS at a dose of 1 mg/Kg and ≤ 70 mg of&#xD;
             prednisone equivalent/day&#xD;
&#xD;
          -  Is a male or female, aged between 18 and 65 years, inclusive, at the time of the&#xD;
             screening visit&#xD;
&#xD;
          -  study patient and his/her partner of child bearing potential has to use effective&#xD;
             method of contraception&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Is high-risk human papilloma virus (HPV) positive by (RT-PCR) on a cervical swab&#xD;
&#xD;
          -  Has cytological abnormalities ≥ HSIL on a cervical swab&#xD;
&#xD;
          -  Is positive for autoantibodies anti-NXP2, TIF1ɤ, MDA5 associated with severe pulmonary&#xD;
             disease or anti-synthetase antibodies&#xD;
&#xD;
          -  Is positive for any malignancy or has a history of any malignancy&#xD;
&#xD;
          -  Has received IV pulse dose CS (≥ 250 mg prednisone equivalent/day)&#xD;
&#xD;
          -  Has received intravenous immunoglobulin (IVIg)&#xD;
&#xD;
          -  Has received potent immunosuppressive drugs such as cyclophosphamide, methotrexate,&#xD;
             azathioprine, mycophenolate, cyclosporine A, oral tacrolimus&#xD;
&#xD;
          -  Has received abatacept, anifrolumab, belimumab, TNF antagonists or another registered&#xD;
             or investigational biological therapy&#xD;
&#xD;
          -  Has received anti-B-cell therapy (e.g. rituximab, epratuzumab)&#xD;
&#xD;
          -  Has received any live vaccine&#xD;
&#xD;
          -  Has used any investigational or non-registered product , or any investigational or&#xD;
             non-registered vaccine&#xD;
&#xD;
          -  Has inflammatory joint or skin disease other than dermatomyositis that may interfere&#xD;
             with study assessments&#xD;
&#xD;
          -  Has frequent recurrences of oral or genital herpes simplex lesions&#xD;
&#xD;
          -  Is at high risk of significant infection and/or has any current signs or symptoms of&#xD;
             infection at entry or has received intravenous antibiotics&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Research site</name>
      <address>
        <city>Lille</city>
        <zip>59037</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research site</name>
      <address>
        <city>Marseille</city>
        <zip>13354</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research site</name>
      <address>
        <city>Paris</city>
        <zip>75010</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research site</name>
      <address>
        <city>Paris</city>
        <zip>75013</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research site</name>
      <address>
        <city>Strasbourg</city>
        <zip>67098</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Charité - Universitätsmedizin Berlin Rudolf- Virchow- Haus</name>
      <address>
        <city>Berlin</city>
        <zip>10117</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research site</name>
      <address>
        <city>Padova</city>
        <zip>35128</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research site</name>
      <address>
        <city>Lausanne</city>
        <zip>1011</zip>
        <country>Switzerland</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
    <country>Germany</country>
    <country>Italy</country>
    <country>Switzerland</country>
  </location_countries>
  <removed_countries>
    <country>United Kingdom</country>
  </removed_countries>
  <verification_date>December 2019</verification_date>
  <study_first_submitted>November 25, 2016</study_first_submitted>
  <study_first_submitted_qc>November 29, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 2, 2016</study_first_posted>
  <last_update_submitted>December 31, 2019</last_update_submitted>
  <last_update_submitted_qc>December 31, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">January 3, 2020</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>Dermatomyositis</mesh_term>
  </condition_browse>
  <!-- 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/NCT02980198
org study id: IFN-K-005-DM
secondary id: 2016-000137-52
nct id: NCT02980198
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
This study is a Proof of Concept study aiming to evaluate the production of anti-IFNα
      antibodies (immune response) in adult subjects with dermatomyositis
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Participant)
measure: Change from baseline in the expression of IFN-induced genes at Week 48
time frame: Week 48
measure: Number of subjects with treatment related adverse events
time frame: Week 48
measure: Total improvement score from IMAC Core Set Measures (CSM) following Aggarwal et al (2017) recommendations
time frame: Week 0, Week 12, Week 24, Week 36, Week 48
measure: Others tools: Cutaneous Disease Area and Severity Index (CDASI)
time frame: Week 0, Week 12, Week 24, Week 36, Week 48
measure: Others tools: Manual Muscle Testing (MMT5)
time frame: Week 0, Week 12, Week 24, Week 36, Week 48
measure: Others tools: Accelerometer
time frame: Week 0, Week 12, Week 24, Week 36, Week 48
measure: Others tools:Dermatology Life Quality Index (DLQI score)
time frame: Week 0, Week 12, Week 24, Week 36, Week 48
measure: Immune response induced by IFN-K as measured by antibodies production
time frame: Week 48
arm group label: IFN-Kinoid
arm group type: Experimental
description: IFN-Kinoid + ISA 51
arm group label: Placebo
arm group type: Placebo Comparator
description: Placebo + ISA 51
intervention type: Biological
intervention name: IFN-Kinoid
description: IM administration
arm group label: IFN-Kinoid
intervention type: Other
intervention name: Placebo
description: IM administration
arm group label: Placebo
intervention type: Other
intervention name: ISA 51
description: adjuvant
arm group label: IFN-Kinoid
arm group label: Placebo
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: France
country: Germany
country: Italy
country: Switzerland
country: United Kingdom
responsible party type: Sponsor
mesh term: Dermatomyositis