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

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ClinicalTrials.gov Identifier: NCT06001177
Recruitment Status : Recruiting
First Posted : August 21, 2023
Last Update Posted : May 6, 2024
Sponsor:
Collaborator:
Pfizer
Information provided by (Responsible Party):
Anokion SA ( Kanyos Bio, Inc., a wholly-owned subsidiary of Anokion SA )

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

Condition or disease Intervention/treatment Phase
Celiac Disease Coeliac Disease Drug: KAN-101 Drug: Placebo Phase 2

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 52 participants
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
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.
Primary Purpose: Treatment
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
Actual Study Start Date : December 13, 2023
Estimated Primary Completion Date : March 2025
Estimated Study Completion Date : June 2025

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Celiac Disease

Arms and Interventions
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Arm Intervention/treatment
Experimental: Group 1
All eligible participants will receive 3 intravenous (IV) infusions of KAN-101
 Drug: KAN-101
Dose KAN-101 Intravenous (IV) Infusion
Other Name: Group 1, Treatment Arm
Placebo Comparator: Group 2
All eligible participants will receive 3 intravenous (IV) infusions of placebo
 Drug: Placebo
Placebo Intravenous (IV) Infusion
Other Name: Group 2, Placebo Comparator Arm


Outcome Measures
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Primary Outcome Measures :
  1. Changes from baseline in Vh:Cd as assessed by esophagogastroduodenoscopy with biopsy after 2-week gluten challenge (GC) [ Time Frame: 29 days ]
    Vh:Cd is the ratio of villous height to crypt depth, a histological assessment


Secondary Outcome Measures :
  1. 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 ]
    IL-2 is interleukin-2

  2. Changes from baseline in IEL density in duodenum biopsy after 2-week GC [ Time Frame: 29 days ]
    IEL is intraepithelial lymphocyte

  3. Incidence and severity of treatment emergent adverse events as assessed by the CTCAE [ Time Frame: 42 days ]
    Common Terminology Criteria for Adverse Events (CTCAE) is a scale with 5 grades to assess Adverse Event (AE) severity

  4. Incidence of KAN-101 ADA [ Time Frame: 42 days ]
    ADA is antidrug antibody

  5. Titer of KAN-101 ADA [ Time Frame: 42 days ]
    ADA is antidrug antibody

  6. KAN-101 plasma concentration: AUCinf [ Time Frame: 7 days ]
    Pharmacokinetic (PK) sample collection at pre and post dose timepoints

  7. KAN-101 plasma concentration: AUClast [ Time Frame: 7 days ]
    PK sample collection at pre and post dose timepoints

  8. KAN-101 plasma concentration: Cmax [ Time Frame: 7 days ]
    PK sample collection at pre and post dose timepoints

  9. KAN-101 plasma concentration: Tmax [ Time Frame: 7 days ]
    PK sample collection at pre and post dose timepoints

  10. KAN-101 plasma concentration: T1/2 [ Time Frame: 7 days ]
    PK sample collection at pre and post dose timepoints


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06001177


Contacts
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Contact: Kanyos Bio, Inc (a wholly owned subsidiary of Anokion SA) +1 857-320-6607 clinicaltrials@anokion.com

Locations
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United States, Colorado
Peak Gastroenterology Associates Recruiting
Colorado Springs, Colorado, United States, 80907
Contact: Study Coordinator    719-362-2281      
United States, Florida
Unlimited Medical Research Group Recruiting
Hialeah Gardens, Florida, United States, 33018
Contact: Study Coordinator    786-646-0078      
Homestead Associates in Research Inc. Recruiting
Miami, Florida, United States, 33032
Contact: Study Coordinator    305-246-0873      
Canada, Quebec
Centre Intégré de Santé et de Services Sociaux-Chaudière Appalaches - Hôtel-Dieu de Lévis Recruiting
Lévis, Quebec, Canada, G6V 3Z1
Contact: Study Coordinator    418 835-7121 ext 11790      
Hopital Du Sacre-Coeur De Montreal Recruiting
Montréal, Quebec, Canada, H4J 1C5
Contact: Study Coordinator    514-338-2222      
Sponsors and Collaborators
Kanyos Bio, Inc., a wholly-owned subsidiary of Anokion SA
Pfizer
Investigators
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Study Director: Study Director Anokion SA
More Information
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Publications:

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Responsible Party: Kanyos Bio, Inc., a wholly-owned subsidiary of Anokion SA
ClinicalTrials.gov Identifier: NCT06001177    
Other Study ID Numbers: KAN-101-03
First Posted: August 21, 2023    Key Record Dates
Last Update Posted: May 6, 2024
Last Verified: May 2024
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Anokion SA ( Kanyos Bio, Inc., a wholly-owned subsidiary of Anokion SA ):
celiac disease
HLA-DQ2.5
gluten free diet
Additional relevant MeSH terms:
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Celiac Disease
Malabsorption Syndromes
Intestinal Diseases
 Gastrointestinal Diseases
Digestive System Diseases
Metabolic Diseases