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

NCT05353985 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 153

Last updated 2025-08-20

Study results available
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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.

Conditions

Interventions

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.

Sponsors & Collaborators

Principal Investigators

  • Medical Director · Takeda

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
12 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-06-30
Primary Completion
2024-11-06
Completion
2024-11-06
FDA Drug
Yes

Countries

  • United States
  • Belgium
  • Canada
  • France
  • Italy
  • Poland
  • Spain
  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05353985 on ClinicalTrials.gov