A Double-blind Placebo-controlled Study to Evaluate Larazotide Acetate for the Treatment of Celiac Disease

This is a double-blind, placebo-controlled Phase 2B study to evaluate the efficacy and
safety of three different doses (0.5, 1 and 2 mg TID) of Larazotide Acetate as an adjunct to
gluten-free diet in the treatment of patients with celiac disease (CD). The diagnosis of CD
must have been established by jejunal biopsy as well as serology at some point in time prior
to entry into the study. Patients must have symptoms despite being on a gluten-free diet as
defined by a celiac disease domain of the gastrointestinal symptoms rating scale equal to or
more than 2.0.

Inclusion Criteria (select criteria, not all inclusive):

- biopsy proven and serology-confirmed celiac disease (at any point in time prior to
study entry)

- written informed consent

- age between 18-75

- BMI between 18.5-40

- symptoms despite being on a gluten-free diet (diarrhea, nausea, stomach pain,
bloating)

- must have attempted a gluten-free diet for at least 12 months

- CeD-GSRS score

Exclusion Criteria (select criteria, not all-inclusive):

- Refractory celiac disease

- diagnosed with chronic active GI disease, such as irritable bowel syndrome,
inflammatory bowel disease etc.

- severe complications of celiac diseases