A Study of Efficacy, Safety, and Tolerability of KAN-101 in People With Celiac Disease

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.

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