Dose-Ranging Study of the Efficacy and Safety of TAK-101 for Prevention of Gluten-Specific T Cell Activation in Participants With Celiac Disease on a Gluten-Free Diet
Public ClinicalTrials.gov record NCT04530123. 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.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Randomized, Double-Blind, Placebo-Controlled, Phase 2 Dose-Ranging Study to Evaluate the Efficacy and Safety of TAK-101 for the Prevention of Gluten-Specific T Cell Activation in Subjects With Celiac Disease on a Gluten-Free Diet
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
The main aim of the study is to assess if TAK-101 can reduce gluten related symptoms and immune activation in adult participants with celiac disease (CeD) on a gluten-free diet (GFD). Participants will receive TAK-101 and/or placebo through the vein on Day 1 and Day 8. All participants will receive active treatment at Week 24.
Study identification
- NCT ID
- NCT04530123
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 102 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years to 75 Years
- 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 23, 2022 (Actual)
- Primary completion
- Dec 9, 2025 (Actual)
- Completion
- Jan 8, 2026 (Actual)
- Last update posted
- Oct 6, 2026
2022 – 2026
United States locations
- U.S. sites
- 26
- U.S. states
- 16
- U.S. cities
- 20
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| One of a Kind Clinical Research Center LLC | Scottsdale | Arizona | 85258 | — |
| Gastroenterology and Liver Institute | Escondido | California | 92025 | — |
| Cadena Care Institute, Inc. | Poway | California | 92064 | — |
| Asthma and Allergy Associates, PC | Colorado Springs | Colorado | 80907 | — |
| GCP Clinical Research, LLC | Tampa | Florida | 33609 | — |
| Agile Clinical Research Trials | Atlanta | Georgia | 30328 | — |
| Lemah Creek Clinical Research | Burr Ridge | Illinois | 60527 | — |
| Gastroenterology Associates, PA | Rockford | Illinois | 61107 | — |
| Rockford Gastroenterology Associates, Ltd. | Rockford | Illinois | 61107 | — |
| Berkshire Medical Center | New Albany | Indiana | 47150 | — |
| Gastroenterology Health Partners, PLLC | New Albany | Indiana | 47150 | — |
| Boston Specialists | Boston | Massachusetts | 02111 | — |
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | — |
| Beth Israel Deaconess Medical Center | Boston | Massachusetts | 02215 | — |
| Berkshire Medical Center, Inc. | Pittsfield | Massachusetts | 01201 | — |
| Clinical Research Institute of Michigan, LLC | Chesterfield | Michigan | 48048 | — |
| Wellness Clinical Research | Chesterfield | Michigan | 48048 | — |
| Mayo Clinic - Rochester | Rochester | Minnesota | 55905 | — |
| Albuquerque Clinical Trials, Inc. | Albuquerque | New Mexico | 87102 | — |
| Basil Clinical | Inwood | New York | 11096 | — |
| Mount Sinai | New York | New York | 10029 | — |
| Columbia University Medical Center. New York Presbyterian Hospital | New York | New York | 10032 | — |
| East Carolina Gastroenterology, PA | Jacksonville | North Carolina | 28546 | — |
| GI Alliance-Rhode Island | Providence | Rhode Island | 02904 | — |
| Amel Med LLC | Georgetown | Texas | 78628 | — |
| Care Access Research - Salt Lake City | Ogden | Utah | 84403 | — |
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 22 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT04530123, 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 Oct 6, 2026 · Synced Oct 20, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT04530123 live on ClinicalTrials.gov.