NCT03569007

Study to Evaluate the Efficacy and Safety of Larazotide Acetate for the Relief of CeD Symptoms

A Phase 3, Randomized, Double-Blind, Placebo Controlled Study to Evaluate the Efficacy and Safety of Larazotide Acetate for the Relief of Persistent Symptoms in Patients With Celiac Disease on a GFD

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 307 (actual)
• Sponsor: 9 Meters Biopharma, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

To assess the efficacy and safety of larazotide acetate versus placebo for the relief of persistent symptoms in adult celiac disease patients.

Detailed description

This is a phase 3, randomized, double-blind, placebo-controlled, multicenter, outpatient study to evaluate the efficacy and safety of larazotide acetate for the relief of persistent symptoms in adult patients with celiac disease on a gluten free diet.

Conditions

• Celiac Disease

Interventions

Type	Name	Description
DRUG	Larazotide	Synthetic 8-amino acid peptide formulated as enteric-coated beads in gelatin capsules
DRUG	Matching Placebo	enteric-coated beads in gelatin capsules

Timeline

• Start date: 2019-05-29
• Primary completion: 2022-07-21
• Completion: 2022-07-21
• First posted: 2018-06-26
• Last updated: 2022-07-26

Locations

160 sites across 1 country: United States

Regulatory

• FDA-regulated drug study