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The ILLUMINATE Studies
This is a phase 2, multicenter, double-blind, randomized, placebo-controlled, dose-ranging study to evaluate the efficacy and safety of TAK-101 for prevention of gluten-specific T cell activation in adult participants with celiac disease (CeD) on a gluten-free diet (GFD). Two study cohorts are planned for the study, the second of which may include 1 or 2 dose levels, depending on safety, tolerability, and activity observed in the first cohort. A total of approximately 108 participants with well controlled CeD on a GFD for at least 6 months are planned to be enrolled. Eligible participants will receive 2 intravenous (IV) infusions of TAK-101 and/or placebo, each separated by 7 days (on Days 1 and 8) and all participants will receive TAK-101 at the end of the study.
This is a phase 2, double-blind, randomized, placebo-controlled, dose-ranging study to evaluate the efficacy and safety of TAK-062, an oral pill, for the treatment of active celiac disease in participants attempting a gluten-free diet. Approximately 350 participants with CeD and both ongoing symptoms and small intestine villous atrophy on duodenal biopsy, despite attempting to maintain a gluten-free diet for at least 12 months, will be enrolled and randomly assigned into 1 of 2 treatment groups in Cohort 1 and 1 of 5 treatment groups in Cohort 2. Three TAK-062 doses versus placebo will be evaluated in this study, with a primary outcome of improvement in symptoms along with secondary outcomes of change in small intestinal mucosal injury in participants treated with TAK-062 compared with placebo.
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Please consider referring patients who fit the following criteria.
Other eligibility criteria will apply.
*Participants aged 12-17 may be included later in the study depending on findings from the first part of the study.
Do you have patients that may be eligible for these studies?
Patients can visit this website to learn more. Thank you for your continued help in moving celiac disease research forward.