A Study of TAK-062 in Treatment of Active Celiac Disease in Participants

Status Active, not recruiting

Clinical Trial 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.

Clinical Trial Description

The drug being tested in this study is called TAK-062. TAK-062 is 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 357 patients. Participants will be randomly assigned (by chance, like flipping a coin) to one of the two treatment groups in Cohort 1: 1. Cohort 1 (Age 18 and older): TAK-062 Placebo + SIGE Gluten-Bar 2. Cohort 1 (Age 18 and older): TAK-062 Dose 1 + SIGE Gluten-Bar After the interim analysis (IA), Cohort 1 data will be reviewed by an external independent data monitoring committee (DMC), and based on the Sponsor's decision, adolescent participants will be enrolled in Cohort 2. Adult participants, 18 years and older will be enrolled into Cohort 2 once Cohort 1 has completed enrolment. Adult participants will be 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. 1. Cohort 2 (Age 18 and older): TAK-062 Placebo + SIGE Gluten-Bar 2. Cohort 2 (Age 18 and older): TAK-062 Dose 2 + SIGE Gluten-Bar 3. Cohort 2 (Age 18 and older): TAK-062 Dose 3 + SIGE Gluten-Bar 4. Cohort 2 (Age 12 and older): TAK-062 Placebo + Gluten-free SIGE Bar 5. Cohort 2 (Age 12 and older): TAK-062 Dose 1 + Gluten-free SIGE Bar 6. 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. ;

Study Design

Related Conditions & MeSH terms

Celiac Disease

Clinical Trial Details

NCT number	NCT05353985
Study type	Interventional
Source	Takeda
Contact
Status	Active, not recruiting
Phase	Phase 2
Start date	June 30, 2022
Completion date	May 6, 2025

View Details

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

A Study of TAK-062 in Treatment of Active Celiac Disease in Participants Attempting a Gluten-Free Diet

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms