TAK-062-2001
Recruitment Complete
A Study of TAK-062 in Treatment of Active Celiac Disease in Participants Attempting a Gluten-Free Diet
Clinicaltrials.gov
#NCT05353985EudraCT
#2020-005438-14About this clinical trial
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.
US
IT
PL
5+
Interventional Phase 2 clinical trial.
At a glance
What medical conditions were being studied?
Celiac Disease
What was the clinical trial testing?
TAK-062, Simulated Inadvertent Gluten Exposure (SIGE) Gluten-Bar, TAK-062 Placebo, Simulated Inadvertent Gluten Exposure (SIGE) Gluten-free Bar
How many participants were enrolled?
357
Were placebos part of the clinical trial?
Yes
When was the clinical trial conducted?
Jun 2022 - May 2025
How long was participation in the clinical trial?
Approximately 36 weeks
Key requirements
Sexes
All
Age
12+ years
Healthy volunteers?
No
Entry criteria
Both men and women can take part.
Must be 12 years and older. Adolescents aged 12 to 17 years, inclusive, will be enrolled in Cohort 2 of the study.
Must have biopsy-confirmed Celiac Disease.
Must be attempting to maintain a gluten-free diet for at least 12 months.
Additional entry criteria will be discussed with the study doctor.