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/NCT06001177</url>
    </required_header>
    <id_info>
      <org_study_id>KAN-101-03</org_study_id>
      <nct_id>NCT06001177</nct_id>
    </id_info>
    <brief_title>A Study of Efficacy, Safety, and Tolerability of KAN-101 in People With Celiac Disease</brief_title>
    <acronym>SynCeD</acronym>
    <official_title>A Phase 2a Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy, Safety, and Tolerability of KAN-101 In Participants With Celiac Disease</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Kanyos Bio, Inc., a wholly-owned subsidiary of Anokion SA</agency>
        <agency_class>Industry</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Pfizer</agency>
        <agency_class>Industry</agency_class>
      </collaborator>
    </sponsors>
    <source>Anokion SA</source>
    <oversight_info>
      <has_dmc>Yes</has_dmc>
      <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        The study goal is to evaluate the efficacy, safety, and tolerability of KAN-101 in&#xD;
        participants with Celiac Disease (CeD)&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Study KAN-101-03 is a multi-center, double-blind, placebo-controlled Phase 2a study to&#xD;
        examine whether KAN-101 confers protection from gluten exposure induced histological changes&#xD;
        in the duodenum and to further evaluate the safety/tolerability of KAN-101 in adult&#xD;
        participants (≥18 years) with CeD on a gluten free diet. Up to 52 participants who meet study&#xD;
        inclusion/exclusion criteria will be randomized 1:1 to receive KAN-101 or placebo.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">December 13, 2023</start_date>
    <completion_date type="Anticipated">June 2025</completion_date>
    <primary_completion_date type="Anticipated">March 2025</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>
      <intervention_model_description>The study is a randomized, double-blind, placebo-controlled study with up to 52 participants that will receive KAN-101 or placebo</intervention_model_description>
      <primary_purpose>Treatment</primary_purpose>
      <masking>Triple (Participant, Investigator, Outcomes Assessor)</masking>
      <masking_description>Study participants and their caregivers, investigators and other staff, and sponsor staff involved in the study team will be blinded.</masking_description>
    </study_design_info>
    <primary_outcome>
      <measure>Changes from baseline in Vh:Cd as assessed by esophagogastroduodenoscopy with biopsy after 2-week gluten challenge (GC)</measure>
      <time_frame>29 days</time_frame>
      <description>Vh:Cd is the ratio of villous height to crypt depth, a histological assessment</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Change in magnitude of IL-2 response from Day 15 (first day of GC) pre GC to Day 15 post GC</measure>
      <time_frame>15 days</time_frame>
      <description>IL-2 is interleukin-2</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Changes from baseline in IEL density in duodenum biopsy after 2-week GC</measure>
      <time_frame>29 days</time_frame>
      <description>IEL is intraepithelial lymphocyte</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Incidence and severity of treatment emergent adverse events as assessed by the CTCAE</measure>
      <time_frame>42 days</time_frame>
      <description>Common Terminology Criteria for Adverse Events (CTCAE) is a scale with 5 grades to assess Adverse Event (AE) severity</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Incidence of KAN-101 ADA</measure>
      <time_frame>42 days</time_frame>
      <description>ADA is antidrug antibody</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Titer of KAN-101 ADA</measure>
      <time_frame>42 days</time_frame>
      <description>ADA is antidrug antibody</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>KAN-101 plasma concentration: AUCinf</measure>
      <time_frame>7 days</time_frame>
      <description>Pharmacokinetic (PK) sample collection at pre and post dose timepoints</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>KAN-101 plasma concentration: AUClast</measure>
      <time_frame>7 days</time_frame>
      <description>PK sample collection at pre and post dose timepoints</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>KAN-101 plasma concentration: Cmax</measure>
      <time_frame>7 days</time_frame>
      <description>PK sample collection at pre and post dose timepoints</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>KAN-101 plasma concentration: Tmax</measure>
      <time_frame>7 days</time_frame>
      <description>PK sample collection at pre and post dose timepoints</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>KAN-101 plasma concentration: T1/2</measure>
      <time_frame>7 days</time_frame>
      <description>PK sample collection at pre and post dose timepoints</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">52</enrollment>
    <condition>Celiac Disease</condition>
    <condition>Coeliac Disease</condition>
    <arm_group>
      <arm_group_label>Group 1</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>All eligible participants will receive 3 intravenous (IV) infusions of KAN-101</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Group 2</arm_group_label>
      <arm_group_type>Placebo Comparator</arm_group_type>
      <description>All eligible participants will receive 3 intravenous (IV) infusions of placebo</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>KAN-101</intervention_name>
      <description>Dose KAN-101 Intravenous (IV) Infusion</description>
      <arm_group_label>Group 1</arm_group_label>
      <other_name>Group 1, Treatment Arm</other_name>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Placebo</intervention_name>
      <description>Placebo Intravenous (IV) Infusion</description>
      <arm_group_label>Group 2</arm_group_label>
      <other_name>Group 2, Placebo Comparator Arm</other_name>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Previous diagnosis of celiac disease based on histology and positive celiac serology&#xD;
  &#xD;
            -  HLA-DQ2.5 genotype&#xD;
  &#xD;
            -  Gluten-free diet for at least 12 months&#xD;
  &#xD;
            -  Negative or weak positive for transglutaminase IgA and negative or weak positive for&#xD;
               DGP-IgA/IgG during screening&#xD;
  &#xD;
            -  Screening intestinal biopsy demonstrating Vh:Cd ratio of 2.3 or higher&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Refractory celiac disease&#xD;
  &#xD;
            -  HLA-DQ8 genotype&#xD;
  &#xD;
            -  Selective IgA deficiency&#xD;
  &#xD;
            -  Diagnosis of type-I diabetes&#xD;
  &#xD;
            -  Other Active gastrointestinal diseases&#xD;
  &#xD;
            -  History of dermatitis herpetiformis&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>70 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Study Director</last_name>
      <role>Study Director</role>
      <affiliation>Anokion SA</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Kanyos Bio, Inc (a wholly owned subsidiary of Anokion SA)</last_name>
      <phone>+1 857-320-6607</phone>
      <email>clinicaltrials@anokion.com</email>
    </overall_contact>
    <reference>
      <citation>Murray JA, Wassaf D, Dunn K, Arora S, Winkle P, Stacey H, Cooper S, Goldstein KE, Manchanda R, Kontos S, Grebe KM. Safety and tolerability of KAN-101, a liver-targeted immune tolerance therapy, in patients with coeliac disease (ACeD): a phase 1 trial. Lancet Gastroenterol Hepatol. 2023 Aug;8(8):735-747. doi: 10.1016/S2468-1253(23)00107-3. Epub 2023 Jun 14.</citation>
      <PMID>37329900</PMID>
    </reference>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 7, 2023</study_first_submitted>
    <study_first_submitted_qc>August 14, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 21, 2023</study_first_posted>
    <last_update_submitted>August 14, 2023</last_update_submitted>
    <last_update_submitted_qc>August 14, 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>
    <keyword>celiac disease</keyword>
    <keyword>HLA-DQ2.5</keyword>
    <keyword>gluten free diet</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Celiac Disease</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- 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/NCT06001177
  org study id: KAN-101-03
  nct id: NCT06001177
  lead sponsor: 
  collaborator: 
  has dmc: Yes
  is fda regulated drug: Yes
  is fda regulated device: No
  The study goal is to evaluate the efficacy, safety, and tolerability of KAN-101 in
        participants with Celiac Disease (CeD)
  Study KAN-101-03 is a multi-center, double-blind, placebo-controlled Phase 2a study to
        examine whether KAN-101 confers protection from gluten exposure induced histological changes
        in the duodenum and to further evaluate the safety/tolerability of KAN-101 in adult
        participants (≥18 years) with CeD on a gluten free diet. Up to 52 participants who meet study
        inclusion/exclusion criteria will be randomized 1:1 to receive KAN-101 or placebo.
  allocation: Randomized
  intervention model: Parallel Assignment
  intervention model description: The study is a randomized, double-blind, placebo-controlled study with up to 52 participants that will receive KAN-101 or placebo
  primary purpose: Treatment
  masking: Triple (Participant, Investigator, Outcomes Assessor)
  masking description: Study participants and their caregivers, investigators and other staff, and sponsor staff involved in the study team will be blinded.
  measure: Changes from baseline in Vh:Cd as assessed by esophagogastroduodenoscopy with biopsy after 2-week gluten challenge (GC)
  time frame: 29 days
  description: Vh:Cd is the ratio of villous height to crypt depth, a histological assessment
  measure: Change in magnitude of IL-2 response from Day 15 (first day of GC) pre GC to Day 15 post GC
  time frame: 15 days
  description: IL-2 is interleukin-2
  measure: Changes from baseline in IEL density in duodenum biopsy after 2-week GC
  time frame: 29 days
  description: IEL is intraepithelial lymphocyte
  measure: Incidence and severity of treatment emergent adverse events as assessed by the CTCAE
  time frame: 42 days
  description: Common Terminology Criteria for Adverse Events (CTCAE) is a scale with 5 grades to assess Adverse Event (AE) severity
  measure: Incidence of KAN-101 ADA
  time frame: 42 days
  description: ADA is antidrug antibody
  measure: Titer of KAN-101 ADA
  time frame: 42 days
  description: ADA is antidrug antibody
  measure: KAN-101 plasma concentration: AUCinf
  time frame: 7 days
  description: Pharmacokinetic (PK) sample collection at pre and post dose timepoints
  measure: KAN-101 plasma concentration: AUClast
  time frame: 7 days
  description: PK sample collection at pre and post dose timepoints
  measure: KAN-101 plasma concentration: Cmax
  time frame: 7 days
  description: PK sample collection at pre and post dose timepoints
  measure: KAN-101 plasma concentration: Tmax
  time frame: 7 days
  description: PK sample collection at pre and post dose timepoints
  measure: KAN-101 plasma concentration: T1/2
  time frame: 7 days
  description: PK sample collection at pre and post dose timepoints
  arm group label: Group 1
  arm group type: Experimental
  description: All eligible participants will receive 3 intravenous (IV) infusions of KAN-101
  arm group label: Group 2
  arm group type: Placebo Comparator
  description: All eligible participants will receive 3 intravenous (IV) infusions of placebo
  intervention type: Drug
  intervention name: KAN-101
  description: Dose KAN-101 Intravenous (IV) Infusion
  arm group label: Group 1
  other name: Group 1, Treatment Arm
  intervention type: Drug
  intervention name: Placebo
  description: Placebo Intravenous (IV) Infusion
  arm group label: Group 2
  other name: Group 2, Placebo Comparator Arm
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 70 Years
  healthy volunteers: No
  last name: Study Director
  role: Study Director
  affiliation: Anokion SA
  last name: Kanyos Bio, Inc (a wholly owned subsidiary of Anokion SA)
  phone: +1 857-320-6607
  email: clinicaltrials@anokion.com
  citation: Murray JA, Wassaf D, Dunn K, Arora S, Winkle P, Stacey H, Cooper S, Goldstein KE, Manchanda R, Kontos S, Grebe KM. Safety and tolerability of KAN-101, a liver-targeted immune tolerance therapy, in patients with coeliac disease (ACeD): a phase 1 trial. Lancet Gastroenterol Hepatol. 2023 Aug;8(8):735-747. doi: 10.1016/S2468-1253(23)00107-3. Epub 2023 Jun 14.
  PMID: 37329900
  responsible party type: Sponsor
  mesh term: Celiac Disease
  sharing ipd: No