Study of the Efficacy of Larazotide Acetate to Treat Celiac Disease

A Phase IIb, Randomized, Double-blind, Placebo Controlled, Dose Ranging, Multicenter Study to Determine the Safety, Tolerance, and Efficacy of Larazotide Acetate (AT-1001) in Celiac Disease Subjects During a Gluten Challenge

This study is designed to evaluate the efficacy of a single dose of larazotide acetate in preventing intestinal permeability changes induced by a 6-week gluten challenge in subjects with celiac disease

This study is an extension of Study CLIN1001-006 (NCT 00492960). This is a Phase IIb, randomized, double-blind, placebo-controlled, dose ranging, multicenter study to determine the safety, tolerance, and efficacy of larazotide acetate in subjects with celiac disease during a gluten challenge. Subjects will remain on their gluten-free diet throughout the duration of the trial.

Study drug or drug placebo capsules will be administered TID 15 minutes before each meal. Gluten or gluten placebo capsules will be taken TID with each meal.

Inclusion Criteria:

• Male and female adults with biopsy proven celiac disease on a gluten-free diet for at least the past 6 months
• Anti-Tissue Transglutaminase (anti-tTG) ≤ 10 EU.
• BMI between 18.5 and 38, inclusive.

Exclusion Criteria

• Has chronic active GI disease other than celiac disease
• Has diabetes (Type 1 or Type 2).
• Unable to abstain from alcohol consumption or NSAID use for 48 hours prior to each intestinal permeability collection throughout the study.
• Has hemoglobin value below 8.5 g/dL