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

• Status: Recruiting
• Trial end date: 2021-12-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: 9 Meters Biopharma, Inc.; Innovate Biopharmaceuticals

Criteria

Inclusion Criteria:

• Male and female adults diagnosed with celiac disease (positive celiac serology plus confirmed biopsy) for at least 6 months

• On a gluten-free diet for at least 6 months

• Experiencing symptoms (ie, abdominal pain, abdominal cramping, bloating, gas, diarrhea, loose stool, or nausea)

• Willing to maintain current gluten-free diet throughout participation in the study

Exclusion Criteria:

• Refractory celiac disease or severe complications of celiac disease

• Chronic active GI disease other than celiac disease