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

NCT04530123 ↗

Phase 2 Completed 102 enrolled Takeda
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

EvaluationDrugModalityDoseRoute
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

Indications