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

Completed · Phase 2 · Has a placebo group

Conditions studied: Celiac Disease

In brief

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

Key facts

Study ID

NCT00620451

Run by

9 Meters Biopharma, Inc.

People needed

105

Starts

2008-02-01

Expected to finish

2009-12-01

Last updated by the study team

2017-09-20

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Study Site — Orange, California, United States
• Study Site — San Francisco, California, United States
• Study Site — Torrington, Connecticut, United States
• Study Site — Jacksonville, Florida, United States
• Study Site — Topeka, Kansas, United States
• Study Site — Lexington, Kentucky, United States
• Study Site — Hagerstown, Maryland, United States
• Study Site — Silver Spring, Maryland, United States
• Study Site — Chesterfield, Michigan, United States
• Study Site — Troy, Michigan, United States
• Study Site — Rochester, Minnesota, United States
• Study Site — Asheville, North Carolina, United States
• Study Site — Harrisburg, North Carolina, United States
• Study Site — Gallipolis, Ohio, United States
• Study Site — Paoli, Pennsylvania, United States
• Study Site — Philadelphia, Pennsylvania, United States
• Study Site — Pittsburgh, Pennsylvania, United States
• Study Site — Sioux Falls, South Dakota, United States
• Study Site — Franklin, Tennessee, United States
• Study Site — Houston, Texas, United States
• Study Site — Edmonton, Alberta, Canada
• Study Site — Abbotsford British Columbia, British Columbia, Canada
• Study Site — Kelowna, British Columbia, Canada
• Study Site — Richmond Hill, Ontario, Canada
• Study Site — Palma, Mallorca, Spain

Full record on ClinicalTrials.gov

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