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A Phase 2a Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy, Safety, and Tolerability of KAN-101 In Participants With Celiac Disease
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. Approximately 52 participants who meet study inclusion/exclusion criteria will be randomized 1:1 to receive KAN-101 or placebo.
Age
18 - 70 years
Sex
ALL
Healthy Volunteers
No
Peak Gastroenterology Associates
Colorado Springs, Colorado, United States
Unlimited Medical Research Group
Hialeah Gardens, Florida, United States
Homestead Associates in Research Inc.
Miami, Florida, United States
Alliance for Multispecialty Research, LLC
Wichita, Kansas, United States
Ochsner Clinic Foundation
New Orleans, Louisiana, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States
McMaster University
Hamilton, Ontario, Canada
LHSC
London, Ontario, Canada
Centre Intégré de Santé et de Services Sociaux-Chaudière Appalaches - Hôtel-Dieu de Lévis
Lévis, Quebec, Canada
Hopital Du Sacre-Coeur De Montreal
Montreal, Quebec, Canada
Start Date
December 13, 2023
Primary Completion Date
January 3, 2025
Completion Date
January 13, 2025
Last Updated
December 18, 2025
55
ACTUAL participants
KAN-101
DRUG
Placebo
DRUG
Lead Sponsor
Kanyos Bio, Inc., a wholly-owned subsidiary of Anokion SA
Collaborators
NCT07239336
NCT06356220
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT07069127