A Phase 3, Randomized, Double-Blind, Placebo Controlled Study to Evaluate the Efficacy and Safety of Larazotide for Relief of Persistent Symptoms in Patients with Celiac Disease on a Gluten Free Diet

Updated on 23 November 2020


To assess the efficacy and safety of larazotide 0.25 mg or larazotide 0.50 mg TID versus placebo for the relief of persistent symptoms in adult patients with celiac disease on a gluten free diet (GFD)




Condition Celiac Disease
Clinical Study IdentifierTX229392
Last Modified on23 November 2020


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Inclusion Criteria

Subject has a Body Mass Index (BMI) between 16 and 45, inclusive
Subject has a diagnosis of celiac disease made ≥ 6 months before study entry as confirmed by
a. A positive celiac serology test (anti-tissue transglutaminase (tTG) antibodies, endomysial antibodies (EMA) and/or deamidated gliadin peptide (DGP) antibodies) result in the medical record
b. A pathology report on the small intestinal biopsy or medical record indicating diagnostic findings (villous atrophy, blunting, flattening, effacement, shortening, etc.)
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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