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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

Completed · Phase 2 · NCT04530123

Conditions: Celiac Disease

At a glance

Research payments reported, 2025
$3.8M
U.S. investigators named
35
Sites paid
35
Planned or actual enrollment
102

About the trial

Sponsor
Takeda
Tested
Placebo (drug), TAK-101 (drug), Gluten (dietary_supplement)
Dates
Started 2022-06-23; completion 2026-01-08
Results posted
Yes

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.

From ClinicalTrials.gov, last updated 2026-10-06. Full record, eligibility and contacts (opens in a new tab)

Industry funding

Takeda Pharmaceuticals U.S.A., Inc. reported $3.8M in research payments for this study in 2025 (1,570 payments).

Research payments usually go to hospitals, universities and research sites to run a study, not to the investigators personally. A payment is not evidence of wrongdoing.

U.S. investigators named on this study

Clinicians the company named as principal investigators in its Open Payments reports.

Sites paid to run it

Sources: CMS Open Payments research payments (program year 2025) and ClinicalTrials.gov, U.S. National Library of Medicine.