A Study of Efficacy, Safety, and Tolerability of KAN-101 in People With Celiac Disease
Key facts
- Where
- Boston, Colorado Springs, Hialeah Gardens, Miami, New Orleans, and Wichita, United StatesSee the 6 sites
- Phase
- Phase 2
Where in United States
- Beth Israel Deaconess Medical CenterBoston, United StatesNo longer taking part
- Peak Gastroenterology AssociatesColorado Springs, United StatesNo longer taking part
- Unlimited Medical Research GroupHialeah Gardens, United StatesNo longer taking part
- Homestead Associates in Research Inc.Miami, United StatesNo longer taking part
- Ochsner Clinic FoundationNew Orleans, United StatesNo longer taking part
- Alliance for Multispecialty Research LLCWichita, United StatesNo longer taking part
Trial details
- Who runs it
- Kanyos Bio, Inc., a wholly-owned subsidiary of Anokion SA
- Trial code
- NCT06001177EU 2023-507240-37-00
- Record updated
- 18 December 2025
- Original description
The study goal is to evaluate the efficacy, safety, and tolerability of KAN-101 in participants with Celiac Disease (CeD)Read full original descriptionShow less
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)
Inclusion: 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: Refractory celiac disease; Diagnosis of type-I diabetes; Other Active gastrointestinal diseases; History of dermatitis herpetiformis; HLA-DQ8 genotype; Selective IgA deficiency.