Beyond the gluten-free diet: Innovations in celiac disease therapeutics

Table 3 Phase 2 studies on tight junction modulator (larazotide acetate) in patients with celiac disease

NCT number	Study title	Study status (Completion date)	Drug	Mechanism	Primary outcome measures	Sponsor	Phases
NCT00492960	Study to assess the efficacy of larazotide acetate for the treatment of CD	Completed (March 2009)	Larazotide acetate vs placebo (dietary supplement: 900 mg gluten)	Larazotide acetate intervenes by blocking the zonulin receptors and thus preventing the dissolution of the tight junction and the associated increase in intestinal permeability	Efficacy of multiple doses larazotide acetate in preventing intestinal permeability changes induced by a 6-week gluten challenge on days 7, 21, 35, 49, and 56	9 Meters Biopharma Inc.	Phase 2
NCT00362856	Safety and tolerability study of larazotide acetate in patients with CD	Completed (March 6, 2007)	Larazotide vs placebo	Larazotide acetate intervenes by blocking the zonulin receptors and thus preventing the dissolution of the tight junction and the associated increase in intestinal permeability	Safety endpoints assessed were adverse events. Measured at screening and on days 0, 7, 14, and 21 (‘End of Study’). Efficacy of multiple dose levels of larazotide acetate in preventing intestinal permeability changes induced by gluten challenge, measured as urinary LAMA ratio the day 0-to-day 14 change	9 Meters Biopharma, Inc.	Phase 2
NCT01396213	A double-blind placebo-controlled study to evaluate larazotide acetate for the treatment of CD	Completed (August 20, 2013)	Larazotide vs placebo	Larazotide acetate intervenes by blocking the zonulin receptors thus preventing the dissolution of the tight junction and the associated increase in intestinal permeability	The primary efficacy endpoint was the changes in the average on-treatment (baseline to week 12) score of the CD gastrointestinal symptom rating scale	9 Meters Biopharma, Inc.	Phase 2
NCT00620451	Randomized, double-blind, placebo-controlled study of larazotide acetate in subjects with active CD	Completed (December 2009)	Larazotide acetate vs placebo	Larazotide acetate intervenes by blocking the zonulin receptors and thus preventing the dissolution of the tight junction and the associated increase in intestinal permeability	Assess the efficacy of larazotide acetate. Remission was defined as an improvement in the Vh:Cd ratio obtained by duodenojejunal biopsy at baseline and day 56	9 Meters Biopharma, Inc.	Phase 2
NCT00889473	Study of the efficacy of larazotide acetate in CD	Completed (April 2010)	Larazotide acetate vs placebo (dietary supplement: gluten 900 mg)	Larazotide acetate intervenes by blocking the zonulin receptors and thus preventing the dissolution of the tight junction and the associated increase in intestinal permeability	Response to gluten at 6 weeks	9 Meters Biopharma, Inc.	Phase 2

CD: Celiac disease; LAMA: Lactulose to mannitol; Vh:Cd: Villous height to crypt depth ratio.