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.
