A randomized, double-blind, placebo-controlled Phase 2B study to evaluate the efficacy and safety of Larazotide Acetate in the treatment of patients with celiac disease who have persistent symptoms despite being on a gluten-free diet.

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:

• Male and female adults with biopsy proven and serology-confirmed celiac disease on a gluten-free diet for at least 12 months
• measurable serology at screening
• CeD GSRS score of ≥ 2.0 prior to randomization
• experiencing symptoms (ie, diarrhea, abdominal pain, bloating, nausea, or stomachache)
• willing to maintain current diet gluten-free diet throughout the duration of the study.

Exclusion Criteria:

• refractory celiac disease or severe complications of celiac disease (eg, EATL, ulcerative jejunitis, perforation, etc.)
• chronic active GI disease other than celiac disease
• diabetes (Type 1 or 2) or other autoimmune disease that might interfere with the conduct of the study
• hemoglobin value < 8.5 g/dL

double-blind