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

• Status: Completed
• Trial end date: 2013-08-20
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: 9 Meters Biopharma, Inc.; Alba Therapeutics
• Collaborator: Teva Pharmaceuticals USA

Criteria

Inclusion Criteria:

• Male and female adults with biopsy proven and serology-confirmed celiac disease on a gluten-free diet for at least 12 months

• measurable serology at screening

• CeD GSRS score of ≥ 2.0 prior to randomization

• experiencing symptoms (ie, diarrhea, abdominal pain, bloating, nausea, or stomachache)

• willing to maintain current diet gluten-free diet throughout the duration of the study.

Exclusion Criteria:

• refractory celiac disease or severe complications of celiac disease (eg, EATL, ulcerative jejunitis, perforation, etc.)

• chronic active GI disease other than celiac disease

• diabetes (Type 1 or 2) or other autoimmune disease that might interfere with the conduct of the study

• hemoglobin value < 8.5 g/dL