A Double-blind Placebo-controlled Study to Evaluate Larazotide Acetate for the Treatment of Celiac Disease

Summary

A randomized, double-blind, placebo-controlled Phase 2B study to evaluate the efficacy and safety of Larazotide Acetate in the treatment of patients with celiac disease who have persistent symptoms despite being on a gluten-free diet.

Timeline

Start

2011-11-07

Primary completion

2013-08-20

Completion

2013-08-20

Outcome

Met primary endpoint

paper The primary end point was met with the 0.5-mg dose of larazotide acetate, with fewer symptoms compared with placebo PMID 25683116 ↗

paper (analysis of covariance, P = .022; mixed model for repeated measures, P = .005). PMID 25683116 ↗

Publications

• Results Leffler DA, Kelly CP, Green PH, Fedorak RN, DiMarino A, Perrow W, Rasmussen H, Wang C, Bercik P, Bachir NM, Murray JA. Larazotide acetate for persistent symptoms of celiac disease despite a gluten-free diet: a randomized controlled trial. Gastroenterology. 2015 Jun;148(7):1311-9.e6. doi: 10.1053/j.gastro.2015.02.008. Epub 2015 Feb 13.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Larazotide	Peptide	0.5 mg	—
Subject	Larazotide	Peptide	1 mg	—
Subject	Larazotide	Peptide	2 mg	—

Indications