NCT00889473

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 42 (actual)
• Sponsor: 9 Meters Biopharma, Inc. · Industry
• Sex: All
• Age: 18 Years – 72 Years
• Healthy volunteers: Not accepted

Summary

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

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.

Conditions

• Celiac Disease

Interventions

Type	Name	Description
DRUG	Larazotide acetate	gelatin capsule
DRUG	Placebo	gelatin capsule
DIETARY_SUPPLEMENT	Gluten 900 mg	gelatin capsule

Timeline

• Start date: 2009-04-01
• Primary completion: 2009-11-01
• Completion: 2010-04-01
• First posted: 2009-04-29
• Last updated: 2017-09-20

Locations

15 sites across 2 countries: United States, Canada

Regulatory

• FDA-regulated drug study