At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 153 enrolled
Drug / intervention
TAK-062 +3 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging Study to Evaluate the Efficacy and Safety of TAK-062 for the Treatment of Active Celiac Disease in Subjects Attempting a Gluten-Free Diet
In Brief
A Phase 2 clinical trial evaluating TAK-062, Simulated Inadvertent Gluten Exposure (SIGE) Gluten-Bar, and 2 other interventions for Celiac Disease. Completed, enrolled 153 participants across 102 sites in 8 countries.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCeliac Disease
CountriesBelgium, Canada, France, Italy, Poland, Spain, United Kingdom, United States
Collaborators--
Timeline
Phase 2CompletedFinished
2023202420252026
First PostedApr 2022
Enrollment StartJun 2022
Primary CompletionNov 2024
TodayJul 2026
First PostedApr 29, 2022
Enrollment StartJun 30, 2022
Primary CompletionNov 6, 2024
TodayJul 2, 2026
Enrollment to primary: 2.4 yearsPosted 4.2 years ago
Interventions
TAK-062drug
TAK-062 tablets.
Simulated Inadvertent Gluten Exposure (SIGE) Gluten-Bardietary
SIGE gluten bars.
TAK-062 Placebodrug
TAK-062 placebo-matching tablets.
Simulated Inadvertent Gluten Exposure (SIGE) Gluten-free Bardietary
SIGE gluten-free bars.