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A Study of Efficacy, Safety, and Tolerability of KAN-101 in People With Celiac Disease (SynCeD)

Primary Purpose

Celiac Disease, Coeliac Disease

Status
Not yet recruiting
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
KAN-101
Placebo
Sponsored by
Kanyos Bio, Inc., a wholly-owned subsidiary of Anokion SA
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Celiac Disease focused on measuring celiac disease, HLA-DQ2.5, gluten free diet

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Previous diagnosis of celiac disease based on histology and positive celiac serology HLA-DQ2.5 genotype Gluten-free diet for at least 12 months Negative or weak positive for transglutaminase IgA and negative or weak positive for DGP-IgA/IgG during screening Screening intestinal biopsy demonstrating Vh:Cd ratio of 2.3 or higher Exclusion Criteria: Refractory celiac disease HLA-DQ8 genotype Selective IgA deficiency Diagnosis of type-I diabetes Other Active gastrointestinal diseases History of dermatitis herpetiformis

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Placebo Comparator

    Arm Label

    Group 1

    Group 2

    Arm Description

    All eligible participants will receive 3 intravenous (IV) infusions of KAN-101

    All eligible participants will receive 3 intravenous (IV) infusions of placebo

    Outcomes

    Primary Outcome Measures

    Changes from baseline in Vh:Cd as assessed by esophagogastroduodenoscopy with biopsy after 2-week gluten challenge (GC)
    Vh:Cd is the ratio of villous height to crypt depth, a histological assessment

    Secondary Outcome Measures

    Change in magnitude of IL-2 response from Day 15 (first day of GC) pre GC to Day 15 post GC
    IL-2 is interleukin-2
    Changes from baseline in IEL density in duodenum biopsy after 2-week GC
    IEL is intraepithelial lymphocyte
    Incidence and severity of treatment emergent adverse events as assessed by the CTCAE
    Common Terminology Criteria for Adverse Events (CTCAE) is a scale with 5 grades to assess Adverse Event (AE) severity
    Incidence of KAN-101 ADA
    ADA is antidrug antibody
    Titer of KAN-101 ADA
    ADA is antidrug antibody
    KAN-101 plasma concentration: AUCinf
    Pharmacokinetic (PK) sample collection at pre and post dose timepoints
    KAN-101 plasma concentration: AUClast
    PK sample collection at pre and post dose timepoints
    KAN-101 plasma concentration: Cmax
    PK sample collection at pre and post dose timepoints
    KAN-101 plasma concentration: Tmax
    PK sample collection at pre and post dose timepoints
    KAN-101 plasma concentration: T1/2
    PK sample collection at pre and post dose timepoints

    Full Information

    First Posted
    August 7, 2023
    Last Updated
    August 14, 2023
    Sponsor
    Kanyos Bio, Inc., a wholly-owned subsidiary of Anokion SA
    Collaborators
    Pfizer
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    1. Study Identification

    Unique Protocol Identification Number
    NCT06001177
    Brief Title
    A Study of Efficacy, Safety, and Tolerability of KAN-101 in People With Celiac Disease
    Acronym
    SynCeD
    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
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    December 13, 2023 (Anticipated)
    Primary Completion Date
    March 2025 (Anticipated)
    Study Completion Date
    June 2025 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Kanyos Bio, Inc., a wholly-owned subsidiary of Anokion SA
    Collaborators
    Pfizer

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    Yes
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    The study goal is to evaluate the efficacy, safety, and tolerability of KAN-101 in participants with Celiac Disease (CeD)
    Detailed Description
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Celiac Disease, Coeliac Disease
    Keywords
    celiac disease, HLA-DQ2.5, gluten free diet

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Interventional Study Model
    Parallel Assignment
    Model Description
    The study is a randomized, double-blind, placebo-controlled study with up to 52 participants that will receive KAN-101 or placebo
    Masking
    ParticipantInvestigatorOutcomes Assessor
    Masking Description
    Study participants and their caregivers, investigators and other staff, and sponsor staff involved in the study team will be blinded.
    Allocation
    Randomized
    Enrollment
    52 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Group 1
    Arm Type
    Experimental
    Arm Description
    All eligible participants will receive 3 intravenous (IV) infusions of KAN-101
    Arm Title
    Group 2
    Arm Type
    Placebo Comparator
    Arm Description
    All eligible participants will receive 3 intravenous (IV) infusions of placebo
    Intervention Type
    Drug
    Intervention Name(s)
    KAN-101
    Other Intervention Name(s)
    Group 1, Treatment Arm
    Intervention Description
    Dose KAN-101 Intravenous (IV) Infusion
    Intervention Type
    Drug
    Intervention Name(s)
    Placebo
    Other Intervention Name(s)
    Group 2, Placebo Comparator Arm
    Intervention Description
    Placebo Intravenous (IV) Infusion
    Primary Outcome Measure Information:
    Title
    Changes from baseline in Vh:Cd as assessed by esophagogastroduodenoscopy with biopsy after 2-week gluten challenge (GC)
    Description
    Vh:Cd is the ratio of villous height to crypt depth, a histological assessment
    Time Frame
    29 days
    Secondary Outcome Measure Information:
    Title
    Change in magnitude of IL-2 response from Day 15 (first day of GC) pre GC to Day 15 post GC
    Description
    IL-2 is interleukin-2
    Time Frame
    15 days
    Title
    Changes from baseline in IEL density in duodenum biopsy after 2-week GC
    Description
    IEL is intraepithelial lymphocyte
    Time Frame
    29 days
    Title
    Incidence and severity of treatment emergent adverse events as assessed by the CTCAE
    Description
    Common Terminology Criteria for Adverse Events (CTCAE) is a scale with 5 grades to assess Adverse Event (AE) severity
    Time Frame
    42 days
    Title
    Incidence of KAN-101 ADA
    Description
    ADA is antidrug antibody
    Time Frame
    42 days
    Title
    Titer of KAN-101 ADA
    Description
    ADA is antidrug antibody
    Time Frame
    42 days
    Title
    KAN-101 plasma concentration: AUCinf
    Description
    Pharmacokinetic (PK) sample collection at pre and post dose timepoints
    Time Frame
    7 days
    Title
    KAN-101 plasma concentration: AUClast
    Description
    PK sample collection at pre and post dose timepoints
    Time Frame
    7 days
    Title
    KAN-101 plasma concentration: Cmax
    Description
    PK sample collection at pre and post dose timepoints
    Time Frame
    7 days
    Title
    KAN-101 plasma concentration: Tmax
    Description
    PK sample collection at pre and post dose timepoints
    Time Frame
    7 days
    Title
    KAN-101 plasma concentration: T1/2
    Description
    PK sample collection at pre and post dose timepoints
    Time Frame
    7 days

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    70 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Previous diagnosis of celiac disease based on histology and positive celiac serology HLA-DQ2.5 genotype Gluten-free diet for at least 12 months Negative or weak positive for transglutaminase IgA and negative or weak positive for DGP-IgA/IgG during screening Screening intestinal biopsy demonstrating Vh:Cd ratio of 2.3 or higher Exclusion Criteria: Refractory celiac disease HLA-DQ8 genotype Selective IgA deficiency Diagnosis of type-I diabetes Other Active gastrointestinal diseases History of dermatitis herpetiformis
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Kanyos Bio, Inc (a wholly owned subsidiary of Anokion SA)
    Phone
    +1 857-320-6607
    Email
    clinicaltrials@anokion.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Study Director
    Organizational Affiliation
    Anokion SA
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    37329900
    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.
    Results Reference
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    A Study of Efficacy, Safety, and Tolerability of KAN-101 in People With Celiac Disease

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