Study of the Efficacy of Larazotide Acetate to Treat Celiac Disease

Study Overview
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Brief Summary
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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

Detailed Description
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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.

Official Title
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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

Conditions
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Celiac Disease

Intervention / Treatment
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* Drug: Larazotide acetate
* Drug: Placebo
* Dietary Supplement: Gluten 900 mg


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 72 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: randomized, double-blind, placebo-controlled, dose ranging, multicenter
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Larazotide acetate 1 mg<br>larazotide acetate 1 mg capsules TID + 900 mg gluten capsules TID for 6 weeks | Drug: Larazotide acetate<br>* gelatin capsule<br>* Other names: INN-202;Dietary Supplement: Gluten 900 mg<br>* gelatin capsule<br>|
| Placebo Comparator: Placebo<br>placebo capsules TID + 900 mg gluten capsules TID for 6 weeks | Drug: Placebo<br>* gelatin capsule<br>Dietary Supplement: Gluten 900 mg<br>* gelatin capsule<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Response to gluten |  | 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Anti-transglutaminase |  | 6 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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larazotide acetate, gluten