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

What Was Tested

This registered phase 2 trial tested Larazotide for celiac disease and gluten sensitivity.

It had three arms (groups): one (experimental), one (experimental) and Placebo (placebo comparator).

Placebo capsules.

The registry classes the interventions as drug.

Who Took Part

105 actual participants took part.

It was open to people of any sex aged from 18 years up to 75 years.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: 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.

The full record lists 4 inclusion and 4 exclusion criteria; among the exclusions: 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.

How the Study Was Run

The set-up was randomized, parallel-group and double-blind.

The celiac disease and gluten sensitivity participants were allocated by chance, so the Larazotide group and the comparison group should start out alike.

Groups ran in parallel: each of the celiac disease and gluten sensitivity participants stayed in one arm throughout.

Blinding on both sides kept the celiac disease and gluten sensitivity participants and researchers unaware of who received Larazotide.

Those kept unaware of assignments: participant and investigator.

It started in 2008-02 with completion listed for 2009-07.

It ran at 33 sites in United States (20), Spain (9) and Canada (4).

Its stated primary purpose is treatment.

What Was Measured

It also tracked 4 secondary outcomes, for example Assess the safety and tolerability of larazotide acetate and To assess the effects of larazotide acetate on inflammatory markers in subjects with active celiac disease subjects.

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Larazotide in 105 people with celiac disease and gluten sensitivity.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Larazotide compound page, Celiac disease and gluten sensitivity research.