<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/NCT03272269</url>
  </required_header>
  <id_info>
    <org_study_id>IMCY-T1D-001</org_study_id>
    <nct_id>NCT03272269</nct_id>
  </id_info>
  <brief_title>Study of IMCY-0098 in Patients With Recent Onset Type 1 Diabetes</brief_title>
  <official_title>A Phase I Placebo-controlled, Double-blind, Dose Escalation Clinical Trial to Evaluate the Safety and Immune Responses of Imcyse's IMCY-0098 in Patients With Recent Onset Type 1 Diabetes</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Imcyse SA</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Imcyse 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>
      This clinical study will evaluate the safety of an innovative approach expected to be&#xD;
      disease-modifying by stopping the auto-immune-mediated destruction of islet β-cells in the&#xD;
      pancreas. Three doses of the investigational product will be tested in successive cohorts.&#xD;
      Although safety is the first objective of this study, we will gather efficacy data and&#xD;
      perform a set of immunological tests to further understand the mechanism of action of this&#xD;
      new approach in young adults with recent onset type 1 diabetes.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 23, 2017</start_date>
  <completion_date type="Actual">August 30, 2019</completion_date>
  <primary_completion_date type="Actual">April 17, 2019</primary_completion_date>
  <phase>Phase 1</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Sequential Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Triple (Participant, Care Provider, Investigator)</masking>
    <masking_description>Double-blind, placebo controlled</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Incidence of all adverse events reported for subjects</measure>
    <time_frame>up to 24 weeks</time_frame>
    <description>Safety assessed through measurement and comparison of any reactions or hypersensitivity to IMCY-0098 injection vs placebo. Number of adverse events will also be compared between groups with the addition of safety monitoring blood tests</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Assessment of residual beta cell function and markers of metabolic control</measure>
    <time_frame>up to 24 weeks</time_frame>
    <description>Measured by a change in stimulated C-peptide production, daily insulin usage, glycated haemoglobin levels and glucose levels and excursions from baseline and between groups</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Assessment of T lymphocyte immune response to IMCY-0098</measure>
    <time_frame>up to 24 weeks</time_frame>
    <description>Comparison of changes in IMCY-0098 specific T lymphocyte responses longitudinally following peptide treatment and versus placebo.</description>
  </other_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">41</enrollment>
  <condition>Type 1 Diabetes Mellitus</condition>
  <arm_group>
    <arm_group_label>Cohort 1, low dose</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>4 SC injections of IMCY-0098 or Placebo</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Cohort 2, medium dose</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>4 SC injections of IMCY-0098 or Placebo</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Cohort 3, high dose</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>4 SC injections of IMCY-0098 or Placebo</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>IMCY-0098</intervention_name>
    <description>Small synthetic peptide for SC admin. Solvent: alum hydroxide</description>
    <arm_group_label>Cohort 1, low dose</arm_group_label>
    <arm_group_label>Cohort 2, medium dose</arm_group_label>
    <arm_group_label>Cohort 3, high dose</arm_group_label>
    <other_name>Imotope</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Solvent: alum hydroxide</description>
    <arm_group_label>Cohort 1, low dose</arm_group_label>
    <arm_group_label>Cohort 2, medium dose</arm_group_label>
    <arm_group_label>Cohort 3, high dose</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Male or female 18 to 30 years of age&#xD;
&#xD;
          2. Initial diagnosis of Type 1 diabetes according to ADA/WHO criteria within the past 6&#xD;
             months&#xD;
&#xD;
          3. Insulin requirement, as determined by the investigator&#xD;
&#xD;
          4. Presence of at least one autoantibody (GAD65, IA-2, or ZnT8)&#xD;
&#xD;
          5. Fasting C-peptide at screening &gt;0.2 nmol/L and/or stimulated C-peptide ≥ 0,4 nmol/L.&#xD;
&#xD;
          6. HLADR3-positive and/or HLADR4-positive&#xD;
&#xD;
          7. Willingness to undergo the insulin treatment prescribed by the physician&#xD;
&#xD;
          8. Body mass index (BMI) between 17-28 kg/m2 at screening&#xD;
&#xD;
          9. Fully informed written consent obtained&#xD;
&#xD;
         10. Males with reproductive potential should use barrier method of contraception (condom)&#xD;
             from screening up to 90 days after last treatment with investigational product.&#xD;
&#xD;
         11. Women of childbearing potential should use an highly effective contraception method&#xD;
             from screening and for the whole duration of the study.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Ongoing or planned pregnancy during the whole duration of the study or lactation&#xD;
&#xD;
          2. Presence of significant medical conditions in particular chronic liver condition,&#xD;
             chronic hematological disease, renal dysfunction of grade 2 or more according to the&#xD;
             World Health Organization (WHO) Toxicity Scale .&#xD;
&#xD;
          3. Has any current signs or symptoms of infection at entry or within 2 weeks of entry or&#xD;
             has received intravenous antibiotics within 2 months prior to the first planned&#xD;
             administration of the study product&#xD;
&#xD;
          4. Has received any live, attenuated vaccine within 3 months prior to the first planned&#xD;
             administration of the study product (i.e. oral poliomyelitis vaccine,&#xD;
             measles-mumps-rubella vaccine, yellow fever vaccine, Japanese encephalitis vaccine,&#xD;
             dengue vaccine, rotavirus vaccine, varicella vaccine, live-attenuated zoster vaccine,&#xD;
             Bacillus Calmette-Guérin [BCG] vaccine, oral typhoid vaccine)&#xD;
&#xD;
          5. History of, or current malignancy (except excised basal cell skin cancer)&#xD;
&#xD;
          6. Clinical evidence of a diabetes-related complication that could interfere with&#xD;
             patient's participation/completion of study&#xD;
&#xD;
          7. Primary or secondary immune deficiency disorders&#xD;
&#xD;
          8. Human Immunodeficiency virus (HIV), chronic hepatitis B virus (HBV) or hepatitis C&#xD;
             virus (HCV) infection&#xD;
&#xD;
          9. Presence at screening of abnormal laboratory values grade 2 or more according to the&#xD;
             World Health Organization (WHO) Toxicity Scale&#xD;
&#xD;
         10. Anti-diabetic treatments other than insulin in the week prior to first study drug&#xD;
             administration&#xD;
&#xD;
         11. Ongoing treatment with immunosuppressive agents or treatment within the past year with&#xD;
             the exception of topical or intra nasal corticosteroids.&#xD;
&#xD;
         12. Treatment with immunotherapy within the past 3 months&#xD;
&#xD;
         13. Treatment with an investigational drug within the past 3 months&#xD;
&#xD;
         14. Patients with a known hypersensitivity to any component of the drug product should be&#xD;
             excluded from the study&#xD;
&#xD;
         15. Patients under treatment with statins at the time of screening.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>30 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Pierre Vandepapelière, MD</last_name>
    <role>Study Director</role>
    <affiliation>Imcyse SA</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Christian Boitard, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Hôpital Cochin, Paris, France</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Hôpital Erasme</name>
      <address>
        <city>Brussels</city>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>UZ Brussel</name>
      <address>
        <city>Brussels</city>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>UZ Gent</name>
      <address>
        <city>Gent</city>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Bispebjerg and Frederiksberg Hospital</name>
      <address>
        <city>Copenhagen</city>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU de Nantes, Hôpital Laennec</name>
      <address>
        <city>Nantes</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GWT-TUD GmbH</name>
      <address>
        <city>Dresden</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Klaipeda University Hospital</name>
      <address>
        <city>Klaipėda</city>
        <country>Lithuania</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University Hospital Santaros Klinikos</name>
      <address>
        <city>Vilnius</city>
        <country>Lithuania</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Trial Center, CTC</name>
      <address>
        <city>Göteborg</city>
        <country>Sweden</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>ProbarE Stockholm</name>
      <address>
        <city>Stockholm</city>
        <country>Sweden</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cambridge University Hospitals NHS Foundation Trust</name>
      <address>
        <city>Cambridge</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cardiff University</name>
      <address>
        <city>Cardiff</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Royal Devon and Exeter NHS Trust</name>
      <address>
        <city>Exeter</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Guy's and St. Thomas NHS Trust</name>
      <address>
        <city>London</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>St. Bartholomew's Hospital (Barts Health NHS Trust)</name>
      <address>
        <city>London</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Newcastle University</name>
      <address>
        <city>Newcastle upon Tyne</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Oxford University Hospitals NHS Foundation Trust</name>
      <address>
        <city>Oxford</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Belgium</country>
    <country>Denmark</country>
    <country>France</country>
    <country>Germany</country>
    <country>Lithuania</country>
    <country>Sweden</country>
    <country>United Kingdom</country>
  </location_countries>
  <link>
    <url>http://www.bdronline.be/index.php?n=169&amp;id=267&amp;sid=267&amp;taal=F&amp;mnav=2</url>
    <description>Registre belge du diabète</description>
  </link>
  <link>
    <url>http://www.bdronline.be/index.php?n=164&amp;id=265&amp;sid=265&amp;taal=N&amp;mnav=2</url>
    <description>Belgisch diabetes register</description>
  </link>
  <link>
    <url>http://www.address2.org/t1d-studies/</url>
    <description>Research study for people with Type 1 Diabetes: EXALT</description>
  </link>
  <reference>
    <citation>Carlier VA, VanderElst L, Janssens W, Jacquemin MG, Saint-Remy JM. Increased synapse formation obtained by T cell epitopes containing a CxxC motif in flanking residues convert CD4+ T cells into cytolytic effectors. PLoS One. 2012;7(10):e45366. doi: 10.1371/journal.pone.0045366. Epub 2012 Oct 9.</citation>
    <PMID>23056200</PMID>
  </reference>
  <reference>
    <citation>Malek Abrahimians E, Carlier VA, Vander Elst L, Saint-Remy JM. MHC Class II-Restricted Epitopes Containing an Oxidoreductase Activity Prompt CD4(+) T Cells with Apoptosis-Inducing Properties. Front Immunol. 2015 Sep 2;6:449. doi: 10.3389/fimmu.2015.00449. eCollection 2015.</citation>
    <PMID>26388872</PMID>
  </reference>
  <reference>
    <citation>Malek Abrahimians E, Vander Elst L, Carlier VA, Saint-Remy JM. Thioreductase-Containing Epitopes Inhibit the Development of Type 1 Diabetes in the NOD Mouse Model. Front Immunol. 2016 Mar 2;7:67. doi: 10.3389/fimmu.2016.00067. eCollection 2016. Erratum In: Front Immunol. 2018 Jul 09;9:1600.</citation>
    <PMID>26973647</PMID>
  </reference>
  <verification_date>September 2019</verification_date>
  <study_first_submitted>August 29, 2017</study_first_submitted>
  <study_first_submitted_qc>September 1, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 5, 2017</study_first_posted>
  <last_update_submitted>September 4, 2019</last_update_submitted>
  <last_update_submitted_qc>September 4, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">September 6, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Diabetes Mellitus type 1</keyword>
  <keyword>Autoimmune disease</keyword>
  <keyword>Immunotherapy</keyword>
  <keyword>Diabetes treatment</keyword>
  <keyword>Residual beta cell function</keyword>
  <keyword>Adult patients</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Diabetes Mellitus</mesh_term>
    <mesh_term>Diabetes Mellitus, Type 1</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/NCT03272269
org study id: IMCY-T1D-001
nct id: NCT03272269
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
This clinical study will evaluate the safety of an innovative approach expected to be
      disease-modifying by stopping the auto-immune-mediated destruction of islet β-cells in the
      pancreas. Three doses of the investigational product will be tested in successive cohorts.
      Although safety is the first objective of this study, we will gather efficacy data and
      perform a set of immunological tests to further understand the mechanism of action of this
      new approach in young adults with recent onset type 1 diabetes.
allocation: Randomized
intervention model: Sequential Assignment
primary purpose: Treatment
masking: Triple (Participant, Care Provider, Investigator)
masking description: Double-blind, placebo controlled
measure: Incidence of all adverse events reported for subjects
time frame: up to 24 weeks
description: Safety assessed through measurement and comparison of any reactions or hypersensitivity to IMCY-0098 injection vs placebo. Number of adverse events will also be compared between groups with the addition of safety monitoring blood tests
measure: Assessment of residual beta cell function and markers of metabolic control
time frame: up to 24 weeks
description: Measured by a change in stimulated C-peptide production, daily insulin usage, glycated haemoglobin levels and glucose levels and excursions from baseline and between groups
measure: Assessment of T lymphocyte immune response to IMCY-0098
time frame: up to 24 weeks
description: Comparison of changes in IMCY-0098 specific T lymphocyte responses longitudinally following peptide treatment and versus placebo.
arm group label: Cohort 1, low dose
arm group type: Experimental
description: 4 SC injections of IMCY-0098 or Placebo
arm group label: Cohort 2, medium dose
arm group type: Experimental
description: 4 SC injections of IMCY-0098 or Placebo
arm group label: Cohort 3, high dose
arm group type: Experimental
description: 4 SC injections of IMCY-0098 or Placebo
intervention type: Drug
intervention name: IMCY-0098
description: Small synthetic peptide for SC admin. Solvent: alum hydroxide
arm group label: Cohort 1, low dose
arm group label: Cohort 2, medium dose
arm group label: Cohort 3, high dose
other name: Imotope
intervention type: Other
intervention name: Placebo
description: Solvent: alum hydroxide
arm group label: Cohort 1, low dose
arm group label: Cohort 2, medium dose
arm group label: Cohort 3, high dose
criteria: 
gender: All
minimum age: 18 Years
maximum age: 30 Years
healthy volunteers: No
last name: Pierre Vandepapelière, MD
role: Study Director
affiliation: Imcyse SA
last name: Christian Boitard, MD
role: Principal Investigator
affiliation: Hôpital Cochin, Paris, France
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: Belgium
country: Denmark
country: France
country: Germany
country: Lithuania
country: Sweden
country: United Kingdom
url: http://www.bdronline.be/index.php?n=169&id=267&sid=267&taal=F&mnav=2
description: Registre belge du diabète
url: http://www.bdronline.be/index.php?n=164&id=265&sid=265&taal=N&mnav=2
description: Belgisch diabetes register
url: http://www.address2.org/t1d-studies/
description: Research study for people with Type 1 Diabetes: EXALT
citation: Carlier VA, VanderElst L, Janssens W, Jacquemin MG, Saint-Remy JM. Increased synapse formation obtained by T cell epitopes containing a CxxC motif in flanking residues convert CD4+ T cells into cytolytic effectors. PLoS One. 2012;7(10):e45366. doi: 10.1371/journal.pone.0045366. Epub 2012 Oct 9.
PMID: 23056200
citation: Malek Abrahimians E, Carlier VA, Vander Elst L, Saint-Remy JM. MHC Class II-Restricted Epitopes Containing an Oxidoreductase Activity Prompt CD4(+) T Cells with Apoptosis-Inducing Properties. Front Immunol. 2015 Sep 2;6:449. doi: 10.3389/fimmu.2015.00449. eCollection 2015.
PMID: 26388872
citation: Malek Abrahimians E, Vander Elst L, Carlier VA, Saint-Remy JM. Thioreductase-Containing Epitopes Inhibit the Development of Type 1 Diabetes in the NOD Mouse Model. Front Immunol. 2016 Mar 2;7:67. doi: 10.3389/fimmu.2016.00067. eCollection 2016. Erratum In: Front Immunol. 2018 Jul 09;9:1600.
PMID: 26973647
responsible party type: Sponsor
mesh term: Diabetes Mellitus
mesh term: Diabetes Mellitus, Type 1
sharing ipd: No