Randomized, Double-Blind, Placebo-Controlled Study of Larazotide Acetate in Subjects With Active Celiac Disease

• Status: Completed
• Trial end date: 2009-12-01
• Target enrollment: 0
• Participant gender: All

Summary

This study was conducted to assess the safety and efficacy of larazotide acetate versus placebo in inducing remission in subjects with active celiac disease.

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

Details

• Lead Sponsor: 9 Meters Biopharma, Inc.; Alba Therapeutics

Criteria

Inclusion Criteria:

• Male and female adults with celiac disease (as demonstrated by duodenal/jejunal biopsy or by capsule endoscopy plus positive anti-tTG)

• Marsh score ≥ II at screening

• Positive serum anti-tTG antibodies as determined by screening serology

• Willing to comply with a gluten-free diet for the duration of the study

Exclusion Criteria:

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

• Has chronic active GI disease other than Celiac Disease

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

• Has hemoglobin value below 8.5 g/dL