A Study of Efficacy, Safety, and Tolerability of KAN-101 in People With Celiac Disease
Sponsored by Kanyos Bio, Inc., a wholly-owned subsidiary of Anokion SA
About this trial
Last updated 8 months ago
Study ID
KAN-101-03
Status
Active, not recruiting
Type
Interventional
Phase
Phase 2
Placebo
Yes
Accepting
18 to 70 Years
All
Not accepting
Healthy Volunteers
Trial Timing
Ended 6 months ago
What is this trial about?
The study goal is to evaluate the efficacy, safety, and tolerability of KAN-101 in
participants with Celiac Disease (CeD)
What are the participation requirements?
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