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Completed Phase 2 Interventional Results available

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

ClinicalTrials.gov ID: NCT05353985

Public ClinicalTrials.gov record NCT05353985. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced May 14, 2026, 2:22 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

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

Study identification

NCT ID
NCT05353985
Recruitment status
Completed
Study type
Interventional
Phase
Phase 2
Lead sponsor
Takeda
Industry
Enrollment
153 participants

Conditions and interventions

Conditions

Interventions

  • Simulated Inadvertent Gluten Exposure (SIGE) Gluten-Bar Dietary Supplement
  • Simulated Inadvertent Gluten Exposure (SIGE) Gluten-free Bar Dietary Supplement
  • TAK-062 Drug
  • TAK-062 Placebo Drug

Dietary Supplement · Drug

Eligibility (public fields only)

Age range
12 Years and older
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Jun 29, 2022
Primary completion
Nov 5, 2024
Completion
Nov 5, 2024
Last update posted
Aug 19, 2025

2022 – 2024

United States locations

U.S. sites
61
U.S. states
25
U.S. cities
55
Facility City State ZIP Site status
University of Alabama at Birmingham Birmingham Alabama 35233
Research Solutions of Arizona, PC Litchfield Park Arizona 85340
One of a Kind Clinical Research Center LLC Paradise Valley Arizona 85253
Mayo Clinic- Arizona Scottsdale Arizona 85259
GI Alliance- Sun City Sun City Arizona 85351
Adobe Clinical Research LLC Tucson Arizona 85712
Gastroenterology and Liver Institute Escondido California 92025
Om Research LLC Lancaster California 93534
So. California Research Institute Med Group Inc./West Gastroenterology Med Group Los Angeles California 90045
UCLA Los Angeles California 90404
Providence Facey Medical Foundation Mission Hills California 91345
Stanford University School of Medicine Redwood City California 94063
Medical Associates Research Group, Inc. San Diego California 92123
Asthma and Allergy Associates, PC Colorado Springs Colorado 80907
Medical Research Center of Connecticut, LLC 300143562 Hamden Connecticut 06518
Central Connecticut Endoscopy Center Plainville Connecticut 06062
Nature Coast Clinical Research, LLC Inverness Florida 34452
University of Miami Medical Center Miami Florida 33136
Wellness Clinical Research Miami Lakes Florida 33016
Gastroenterology Associates of Pensacola, PA Pensacola Florida 32503
St. Johns Center for Clinical Research Saint Augustine Florida 32086
GCP Clinical Research, LLC Tampa Florida 33609
Agile Clinical Research Trials Alpharetta Georgia 30022
Lemah Creek Clinical Research Oakbrook Terrace Illinois 60181
Indiana University -GI Indianapolis Indiana 46202
University of Iowa Hospital and Clinics Iowa City Iowa 52242
University Medical Center New Orleans New Orleans Louisiana 70112
Massachusetts General Hospital Boston Massachusetts 02114
Beth Israel Deaconess Medical Center Boston Massachusetts 02215
Lahey Hospital and Medical Burlington Massachusetts 01805
Hawthorn Medical Associates LLC South Dartmouth Massachusetts 02747
University of Michigan Ann Arbor Michigan 48109
Clinical Research Institute of Michigan, LLC Chesterfield Michigan 48047
Revive Research Institute, Inc Farmington Hills Michigan 48334
Mayo Clinic - Rochester Rochester Minnesota 55905
Washington University, School of Medicine St Louis Missouri 63110
Manhattan Clinical Research, LLC Manhattan New York 10016
New York University Medical Center PRIME New York New York 10016
Blair S Lewis MD New York New York 10032
Rochester Clinical Research Rochester New York 14618
Tryon Medical Partners Charlotte North Carolina 28210
Carolina Digestive Diseases Greenville North Carolina 27834
Gastro Health Research Cincinnati Ohio 45219
Cleveland Clinic - Gastroenterology and Hepatology Cleveland Ohio 44195
Dayton Gastroenterology, Inc Englewood Ohio 45415
Eastern Pennsylvania Gastroeneterology and Liver Specialists Allentown Pennsylvania 18104
Thomas Jefferson University Philadelphia Pennsylvania 19107
Gastroenterology Associates, PA Greenville South Carolina 29607
Rapid City Medical Center, LLC Rapid City South Dakota 57701
Vanderbilt University Medical Center Nashville Tennessee 37232
The Methodist Hospital 150520246 Houston Texas 77030
Biopharma Informatic, LLC Houston Texas 77084
Spring Clinical Research Houston Texas 77090
Biopharma Informatic, LLC McAllen Texas 78503
Victoria Gastroenterology Victoria Texas 77904
University of Virginia Medical Center Charlottesville Virginia 22903
Blue Ridge Medical Research Lynchburg Virginia 24502
Clinical Research Partners, LLC Richmond Virginia 23220
Swedish Gastroenterology Seattle Washington 98104
University of Washington Division of Gastroenterology Seattle Washington 98195
Velocity Clinical Research Spokane Washington 99218

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 41 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT05353985, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Aug 19, 2025 · Synced May 14, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT05353985 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →