drugset / Trial / NCT04530123
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
RandomizedParallel-groupTriple-blindPrevention
Summary
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.
Timeline
- Start
- 2022-06-23
- Primary completion
- 2025-12-09
- Completion
- 2026-01-08
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | TAK-101 | Unknown | 12.5 ug/kg | Intravenous |
| Subject | TAK-101 | Unknown | 25 ug/kg | Intravenous |
| Subject | TAK-101 | Unknown | 50 ug/kg | Intravenous |