A Study of TAK-062 in Treatment of Active Celiac Disease in Participants Attempting a Gluten-Free Diet

Summary

The main aim is to see how TAK-062 works to reduce celiac-related symptoms and improve small intestinal damage due to gluten exposure, in participants with celiac disease (CeD) attempting to maintain a gluten-free diet (GFD) in treated participants versus placebo controls.

Timeline

Start

2022-06-30

Primary completion

2024-11-06

Completion

2024-11-06

Outcome

Missed primary endpoint

registry analysis (superiority test); Placebo + SIGE Gluten-Bar vs TAK-062 + SIGE Gluten-Bar; p =0.847; LS Mean Difference 0.017 (95% CI -0.162 to 0.197); NCT05353985 ↗

Drugs

Indications