The global multi-center, randomized, double-blind, placebo-controlled study will evaluate the clinical and histological efficacy, safety and tolerability of larazotide acetate in 106 active celiac disease subjects adhering to a gluten-free diet, while also testing components of a celiac disease activity rating index, a new patient reported outcomes instrument.
Francisco Leon, head of clinical R&D at Alba, said: “By conducting this important pioneering clinical study we believe we can learn more about celiac disease and provide insights for physicians and celiac patients.”