Overview

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