NCT05353985

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

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 153 (actual)
• Sponsor: Takeda · Industry
• Sex: All
• Age: 12 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Celiac Disease

Interventions

Type	Name	Description
DRUG	TAK-062	TAK-062 tablets.
DIETARY_SUPPLEMENT	Simulated Inadvertent Gluten Exposure (SIGE) Gluten-Bar	SIGE gluten bars.
DRUG	TAK-062 Placebo	TAK-062 placebo-matching tablets.
DIETARY_SUPPLEMENT	Simulated Inadvertent Gluten Exposure (SIGE) Gluten-free Bar	SIGE gluten-free bars.

Timeline

• Start date: 2022-06-30
• Primary completion: 2024-11-06
• Completion: 2024-11-06
• First posted: 2022-04-29
• Last updated: 2025-08-20
• Results posted: 2025-08-20

Locations

102 sites across 8 countries: United States, Belgium, Canada, France, Italy, Poland, Spain, United Kingdom

Regulatory

• FDA-regulated drug study