The drug being tested in this study is called TAK-062. TAK-062 designed to break down gluten in the stomach and is being tested to treat people who have active CeD, attempting to maintain a GFD.~The study will enroll approximately 377 patients. Participants will be randomly assigned (by chance, like flipping a coin) to one of the two treatment groups in Cohort 1:~Cohort 1 (Age 18-75): TAK-062 Placebo + SIGE Gluten-Bar and Gluten-free SIGE Bar~Cohort 1 (Age 18-75): TAK-062 Dose 1 + SIGE Gluten-Bar and Gluten-free SIGE Bar~After the interim analysis, Cohort 1 data will be reviewed by an external independent data monitoring committee (DMC), and based on the Sponsor's decision, approximately 36 adult participants will be enrolled in Cohort 2 and randomly assigned to one of the five study drug and SIGE treatment groups (Groups a-e), and approximately 21 adolescent participants will be enrolled and randomly assigned to Groups d, e, and f (adolescents only). Adolescents in Cohort 2 will receive only gluten-free SIGE bars.~Cohort 2 (Age 18-75): TAK-062 Placebo + SIGE Gluten-Bar and Gluten-free SIGE Bar~Cohort 2 (Age 18-75): TAK-062 Dose 2 + SIGE Gluten-Bar and Gluten-free SIGE Bar~Cohort 2 (Age 18-75): TAK-062 Dose 3 + SIGE Gluten-Bar and Gluten-free SIGE Bar~Cohort 2 (Age 12-75): TAK-062 Placebo + Gluten-free SIGE Bar~Cohort 2 (Age 12-75): TAK-062 Dose 1 + Gluten-free SIGE Bar~Cohort 2 (Age 12-17): TAK-062 Dose 2 + Gluten-free SIGE Bar~This multi-center trial will be conducted in the United States (US), Canada, United Kingdom and the European Union. The overall time to participate in this study is approximately 36 weeks.
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.