<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/NCT03239860</url>
  </required_header>
  <id_info>
    <org_study_id>GNC-004</org_study_id>
    <nct_id>NCT03239860</nct_id>
  </id_info>
  <brief_title>Assessing the HERV-W Env ANtagonist GNbAC1 for Evaluation in an Open Label Long-term Safety Study in Patients With Multiple Sclerosis</brief_title>
  <acronym>ANGEL-MS</acronym>
  <official_title>A Long-Term International, Extension of Study GNC-003 With GNbAC1 in Patients With Relapsing Remitting Multiple Sclerosis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>GeNeuro SA</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Les Laboratoires Servier</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Worldwide Clinical Trials</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Institut de Recherches Internationales Servier</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>GeNeuro SA</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>
      The humanised IgG4 monoclonal antibody GNbAC1 targets the envelope protein (Env) of the human&#xD;
      endogenous multiple sclerosis-associated retrovirus (HERV-W MSRV), which may play a critical&#xD;
      role in multiple sclerosis.&#xD;
&#xD;
      The study assesses the long-term safety of GNbAC1 in patients with RRMS and the long-term&#xD;
      efficacy of GNbAC1 in terms of MRI outcomes, relapse rate, disability and disease&#xD;
      progression.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Based on R&amp;D strategic reasons, our co-development Partner financing the study disengaged from&#xD;
    the development of GNbAC1.&#xD;
  </why_stopped>
  <start_date type="Actual">June 6, 2017</start_date>
  <completion_date type="Actual">November 14, 2018</completion_date>
  <primary_completion_date type="Actual">November 14, 2018</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>Long term safety of GNbAC1</measure>
    <time_frame>96 Weeks</time_frame>
    <description>The main parameters evaluated to assess the long term safety will be:&#xD;
AE and SAE, clinical safety laboratory, IgG4 dosing, vital signs, physical examination, ECGs, Anti-drug antibody and C-SSRS scale</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Long term efficacy of GNbAC1 in terms of MRI outcomes</measure>
    <time_frame>96 Weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Long term efficacy of GNbAC1 in terms of relapse rate</measure>
    <time_frame>96 Weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Long term efficacy of GNbAC1 in terms of disability</measure>
    <time_frame>96 Weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Long term efficacy of GNbAC1 in terms of disease progression</measure>
    <time_frame>96 Weeks</time_frame>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">220</enrollment>
  <condition>Multiple Sclerosis, Relapsing-Remitting</condition>
  <arm_group>
    <arm_group_label>Dose 1 GNbAC1</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Monthly IV</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Dose 2 GNbAC1</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Monthly IV</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Dose 3 GNbAC1</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Monthly IV</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>GNbAC1 Monoclonal Antibody</intervention_name>
    <description>Monthly IV</description>
    <arm_group_label>Dose 1 GNbAC1</arm_group_label>
    <arm_group_label>Dose 2 GNbAC1</arm_group_label>
    <arm_group_label>Dose 3 GNbAC1</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Main Inclusion Criteria:&#xD;
&#xD;
          -  Patients must have completed Period 2 of study GNC-003 and must meet all eligibility&#xD;
             criteria for the GNC-004 study&#xD;
&#xD;
          -  Patients (male or female with reproductive potential) must agree to use highly&#xD;
             effective methods of birth control&#xD;
&#xD;
          -  Provision of written informed consent to participate prior to any trial procedure as&#xD;
             shown by signature on the subject consent form.&#xD;
&#xD;
        Main Exclusion Criteria:&#xD;
&#xD;
          -  Patients not having completed the study GNC-003&#xD;
&#xD;
          -  Pregnancy&#xD;
&#xD;
          -  The emergence of any disease diagnosis during the course of study GNC-003 that is not&#xD;
             MS and could better explain the patient's neurological signs and symptoms&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>55 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Hospital</name>
      <address>
        <city>Sofia</city>
        <country>Bulgaria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital</name>
      <address>
        <city>Zagreb</city>
        <country>Croatia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital</name>
      <address>
        <city>Jihlava</city>
        <country>Czechia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital</name>
      <address>
        <city>Tallinn</city>
        <country>Estonia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital</name>
      <address>
        <city>Berlin</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital</name>
      <address>
        <city>Budapest</city>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital</name>
      <address>
        <city>Rome</city>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital</name>
      <address>
        <city>Warsaw</city>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital</name>
      <address>
        <city>Moscow</city>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital</name>
      <address>
        <city>Belgrade</city>
        <country>Serbia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital</name>
      <address>
        <city>Barcelona</city>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital</name>
      <address>
        <city>Kharkiv</city>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Bulgaria</country>
    <country>Croatia</country>
    <country>Czechia</country>
    <country>Estonia</country>
    <country>Germany</country>
    <country>Hungary</country>
    <country>Italy</country>
    <country>Poland</country>
    <country>Russian Federation</country>
    <country>Serbia</country>
    <country>Spain</country>
    <country>Ukraine</country>
  </location_countries>
  <verification_date>December 2018</verification_date>
  <study_first_submitted>July 12, 2017</study_first_submitted>
  <study_first_submitted_qc>August 1, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 4, 2017</study_first_posted>
  <last_update_submitted>October 19, 2020</last_update_submitted>
  <last_update_submitted_qc>October 19, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">October 20, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Multiple Sclerosis</keyword>
  <keyword>Multiple Sclerosis Relapsing-Remitting</keyword>
  <keyword>GNbAC1</keyword>
  <keyword>MRI</keyword>
  <keyword>Monoclonal antibody</keyword>
  <keyword>Multiple Sclerosis associated retrovirus MSRV</keyword>
  <keyword>MS</keyword>
  <keyword>RRMS</keyword>
  <keyword>HERV-W</keyword>
  <keyword>Temelimab</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Multiple Sclerosis</mesh_term>
    <mesh_term>Multiple Sclerosis, Relapsing-Remitting</mesh_term>
    <mesh_term>Sclerosis</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Antibodies</mesh_term>
    <mesh_term>Antibodies, Monoclonal</mesh_term>
  </intervention_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/NCT03239860
org study id: GNC-004
nct id: NCT03239860
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The humanised IgG4 monoclonal antibody GNbAC1 targets the envelope protein (Env) of the human
      endogenous multiple sclerosis-associated retrovirus (HERV-W MSRV), which may play a critical
      role in multiple sclerosis.

      The study assesses the long-term safety of GNbAC1 in patients with RRMS and the long-term
      efficacy of GNbAC1 in terms of MRI outcomes, relapse rate, disability and disease
      progression.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Long term safety of GNbAC1
time frame: 96 Weeks
description: The main parameters evaluated to assess the long term safety will be:
AE and SAE, clinical safety laboratory, IgG4 dosing, vital signs, physical examination, ECGs, Anti-drug antibody and C-SSRS scale
measure: Long term efficacy of GNbAC1 in terms of MRI outcomes
time frame: 96 Weeks
measure: Long term efficacy of GNbAC1 in terms of relapse rate
time frame: 96 Weeks
measure: Long term efficacy of GNbAC1 in terms of disability
time frame: 96 Weeks
measure: Long term efficacy of GNbAC1 in terms of disease progression
time frame: 96 Weeks
arm group label: Dose 1 GNbAC1
arm group type: Experimental
description: Monthly IV
arm group label: Dose 2 GNbAC1
arm group type: Experimental
description: Monthly IV
arm group label: Dose 3 GNbAC1
arm group type: Experimental
description: Monthly IV
intervention type: Drug
intervention name: GNbAC1 Monoclonal Antibody
description: Monthly IV
arm group label: Dose 1 GNbAC1
arm group label: Dose 2 GNbAC1
arm group label: Dose 3 GNbAC1
criteria: 
gender: All
minimum age: 18 Years
maximum age: 55 Years
healthy volunteers: No
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: Bulgaria
country: Croatia
country: Czechia
country: Estonia
country: Germany
country: Hungary
country: Italy
country: Poland
country: Russian Federation
country: Serbia
country: Spain
country: Ukraine
responsible party type: Sponsor
mesh term: Multiple Sclerosis
mesh term: Multiple Sclerosis, Relapsing-Remitting
mesh term: Sclerosis
mesh term: Antibodies
mesh term: Antibodies, Monoclonal