A Study of Efficacy, Safety, and Tolerability of KAN-101 in People With Celiac Disease (SynCeD)
Celiac Disease, Coeliac Disease
About this trial
This is an interventional treatment trial for Celiac Disease focused on measuring celiac disease, HLA-DQ2.5, gluten free diet
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Experimental
Placebo Comparator
Group 1
Group 2
All eligible participants will receive 3 intravenous (IV) infusions of KAN-101
All eligible participants will receive 3 intravenous (IV) infusions of placebo