Overview
The study goal is to evaluate the efficacy, safety, and tolerability of KAN-101 in participants with Celiac Disease (CeD)
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. Up to 52 participants who meet study inclusion/exclusion criteria will be randomized 1:1 to receive KAN-101 or placebo.
Eligibility
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