NCT00492960

Study to Assess the Efficacy of Larazotide Acetate for the Treatment of 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: 171 (actual)
• Sponsor: 9 Meters Biopharma, Inc. · Industry
• Sex: All
• Age: 18 Years – 72 Years
• Healthy volunteers: Not accepted

Summary

This study was conducted to evaluate the efficacy of multiple doses of larazotide acetate in preventing intestinal permeability changes induced by a 6- week gluten challenge in subjects with celiac disease.

Detailed description

This was 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 remained on their gluten-free diet throughout the duration of the trial. Study drug or drug placebo capsules were 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 capsules
DRUG	placebo	gelatin capsules
DIETARY_SUPPLEMENT	900 mg gluten	gelatin capsules

Timeline

• Start date: 2007-08-01
• Primary completion: 2008-10-01
• Completion: 2009-03-01
• First posted: 2007-06-27
• Last updated: 2017-09-20

Locations

23 sites across 2 countries: United States, Canada

Regulatory

• FDA-regulated drug study