Status:
COMPLETED
A Study of Efficacy, Safety, and Tolerability of KAN-101 in People With Celiac Disease
Lead Sponsor:
Kanyos Bio, Inc., a wholly-owned subsidiary of Anokion SA
Collaborating Sponsors:
Pfizer
Conditions:
Celiac Disease
Coeliac Disease
Eligibility:
All Genders
18-70 years
Phase:
PHASE2
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 ...
Eligibility Criteria
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
- HLA-DQ8 genotype
- Selective IgA deficiency
- Diagnosis of type-I diabetes
- Other Active gastrointestinal diseases
- History of dermatitis herpetiformis
Key Trial Info
Start Date :
December 13 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 13 2025
Estimated Enrollment :
55 Patients enrolled
Trial Details
Trial ID
NCT06001177
Start Date
December 13 2023
End Date
January 13 2025
Last Update
December 18 2025
Active Locations (28)
Enter a location and click search to find clinical trials sorted by distance.
1
Peak Gastroenterology Associates
Colorado Springs, Colorado, United States, 80907
2
Unlimited Medical Research Group
Hialeah Gardens, Florida, United States, 33018
3
Homestead Associates in Research Inc.
Miami, Florida, United States, 33032
4
Alliance for Multispecialty Research, LLC
Wichita, Kansas, United States, 67207