A Study of Efficacy, Safety, and Tolerability of KAN-101 in People with Celiac Disease

Last updated: February 7, 2025
Sponsor: Kanyos Bio, Inc., a wholly-owned subsidiary of Anokion SA
Overall Status: Completed

Phase

2

Condition

Celiac Disease

Bowel Dysfunction

Treatment

Placebo

KAN-101

Clinical Study ID

NCT06001177
KAN-101-03
  • Ages 18-70
  • All Genders

Study Summary

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

Eligibility Criteria

Inclusion

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 forDGP-IgA/IgG during screening

  • Screening intestinal biopsy demonstrating Vh:Cd ratio of 2.3 or higher

Exclusion

Exclusion Criteria:

  • Refractory celiac disease

  • HLA-DQ8 genotype

  • Selective IgA deficiency

  • Diagnosis of type-I diabetes

  • Other Active gastrointestinal diseases

  • History of dermatitis herpetiformis

Study Design

Total Participants: 55
Treatment Group(s): 2
Primary Treatment: Placebo
Phase: 2
Study Start date:
December 13, 2023
Estimated Completion Date:
January 13, 2025

Study 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. Approximately 52 participants who meet study inclusion/exclusion criteria will be randomized 1:1 to receive KAN-101 or placebo.

Connect with a study center

  • McMaster University

    Hamilton, Ontario L8S 4L8
    Canada

    Site Not Available

  • LHSC

    London, Ontario N6A 5W9
    Canada

    Site Not Available

  • Centre Intégré de Santé et de Services Sociaux-Chaudière Appalaches - Hôtel-Dieu de Lévis

    Lévis, Quebec G6V 3Z1
    Canada

    Site Not Available

  • Hopital Du Sacre-Coeur De Montreal

    Montréal, Quebec H4J 1C5
    Canada

    Site Not Available

  • Diex Recherche Quebec Inc.

    Québec, Quebec G1V 4T3
    Canada

    Site Not Available

  • Tays Research Services

    Tampere, Pirkanmaa 33520
    Finland

    Site Not Available

  • CRST Helsinki Oy

    Helsinki, Uusimaa 00180
    Finland

    Site Not Available

  • Clinical Research Services Turku

    Turku, Varsinais-Suomi 20520
    Finland

    Site Not Available

  • Studiengesellschaft BSF Unternehmergesellschaft

    Halle, Sachsen-Anhalt 6108
    Germany

    Site Not Available

  • Our Lady of Lourdes Hospital

    Drogheda, Louth A92VW28
    Ireland

    Site Not Available

  • Midland Regional Hospital Mullingar

    Mullingar, Westmeath N91Na43
    Ireland

    Site Not Available

  • Connolly Hospital

    Dublin, D15X40D
    Ireland

    Site Not Available

  • Soroka Medical Center

    Be'er Sheva, Hadarom 8410101
    Israel

    Site Not Available

  • Rabin Medical Center

    Petah tikva, Hamerkaz 4941492
    Israel

    Site Not Available

  • Sheba Medical Center

    Ramat Gan, Hamerkaz 5265601
    Israel

    Site Not Available

  • Shaare Zedek Medical Center

    Jerusalem, Yerushalayim 9103102
    Israel

    Site Not Available

  • Albert Schweitzer Ziekenhuis, locatie Dordwijk

    Dordrecht, Zuid-Holland 3318AT
    Netherlands

    Site Not Available

  • Melita Medical

    Wrocław, Dolnośląskie 50-449
    Poland

    Site Not Available

  • Gastromed Sp. z o. o.

    Toruń, Kujawsko-pomorskie 87-100
    Poland

    Site Not Available

  • WIP Warsaw IBD Point Profesor Kierkuś

    Warszawa, Mazowieckie 00-728
    Poland

    Site Not Available

  • Centrum Medyczne Med-Gastr Sp. z o.o.

    Łódź, Łódzkie 91-034
    Poland

    Site Not Available

  • MZ Badania Slowik Zymla Spolka Jawna

    Knurów, Śląskie 44-190
    Poland

    Site Not Available

  • Peak Gastroenterology Associates

    Colorado Springs, Colorado 80907
    United States

    Site Not Available

  • Unlimited Medical Research Group

    Hialeah Gardens, Florida 33018
    United States

    Site Not Available

  • Homestead Associates in Research Inc.

    Miami, Florida 33032
    United States

    Site Not Available

  • Alliance for Multispecialty Research, LLC

    Wichita, Kansas 67207
    United States

    Site Not Available

  • Ochsner Clinic Foundation

    New Orleans, Louisiana 70121
    United States

    Site Not Available

  • Beth Israel Deaconess Medical Center

    Boston, Massachusetts 02215
    United States

    Site Not Available

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