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About the ILLUMINATE-101 Study
ILLUMINATE-101
This is a phase 2, multicentre, double-blind, randomised, 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 coeliac 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 90 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 one IV dose TAK-101 at the end of the study.
ILLUMINATE-062
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:
ILLUMINATE-101:
- Are between 18 and 75 years old
- Have biopsy-confirmed coeliac disease that is generally well controlled
- Have been on a gluten-free diet for at least 6 months
- Does not have the presence of other inflammatory gastrointestinal disorders or autoimmune diseases, such than as well-controlled autoimmune thyroid disease or well-controlled type 1 diabetes mellitus
ILLUMINATE-101:
- Are between 18 and 75 years old
- Have biopsy-confirmed celiac disease that is generally well controlled
- Have been on a gluten-free diet for at least 6 months
- Does not have the presence of other inflammatory gastrointestinal disorders or autoimmune diseases, other than well-controlled autoimmune thyroid disease or well-controlled type 1 diabetes mellitus (defined as glycosylated hemoglobin <8 and no hospitalization in the last 12 months for hyper/hypoglycemia)
ILLUMINATE-062:
- Are 12 years old or older
- Have a physician-confirmed diagnosis of celiac disease
- Have been on a gluten-free diet for at least 12 months but are having ongoing gastrointestinal symptoms related to celiac disease
- Does not have the presence of other inflammatory gastrointestinal disorders or autoimmune diseases, other than well-controlled thyroid disease or well-controlled type 1 diabetes mellitus (defined as glycosylated hemoglobin <8 and no hospitalization in the last 12 months for hyper/hypoglycemia)
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 this study?
Patients can visit this website to learn more. Thank you for your continued help in moving coeliac disease research forward.
