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

Summary

Participation Requirements

Description

The drug being tested in this study is called TAK-101. TAK-101 is being tested to treat people who have celiac disease. The study has two cohorts planned. The first cohort has 1 dose level and the second cohort may include 1 or 2 dose levels, depending on safety, tolerability, and activity observed ...

The drug being tested in this study is called TAK-101. TAK-101 is being tested to treat people who have celiac disease. The study has two cohorts planned. The first cohort has 1 dose level and the second cohort may include 1 or 2 dose levels, depending on safety, tolerability, and activity observed in the first cohort. The study will enroll approximately 108 patients. In the first cohort, approximately 45 participants will be randomly assigned in 1:2:2 ratio in one of the three arm groups -which will remain undisclosed to the participant and study doctor during the study (unless there is an urgent medical need). Eligible participants will receive: Cohort 1: Placebo: 2 infusions TAK-101 2 mg/kg: 1 infusion + placebo: 1 infusion TAK-101 2 mg/kg: 2 infusions All participants will be asked to take TAK-101 intravenous (IV) infusion and TAK-101 placebo matching infusion on Days 1 and 8. After completion of Cohort 1, Cohort 2 may start based on the review of Cohort 1 data by an external data monitoring committee (DMC). Approximately 86 participants may be randomly assigned in 1:2:2:2 ratio in Cohort 2 to receive: Cohort 2 (1 mg/kg may not be needed based on review of Cohort 1 data): Placebo: 2 infusions TAK-101 4 mg/kg : 1 infusion + placebo: 1 infusion TAK-101 4 mg/kg: 2 infusions TAK-101 1 mg/kg: 2 infusions The TAK-101 1 mg/kg, 2 infusions may be open based on an interim analysis of the cohort 1 Interferon-gamma Spot Forming Units (IFN-? SFUs) reviewed by the DMC. If TAK-101 1 mg/kg, 2 infusions is not open, approximately 86 participants will be randomly assigned in 1:2:2 ratio to receive: Placebo: 2 infusions TAK-101 1 mg/kg: 1 infusion + placebo: 1 infusion TAK-101 1 mg/kg: 2 infusions This trial will be conducted in United States and Canada. The overall time to participate in this study is approximately 26 weeks. Participants will make multiple visits to the clinic, and will be contacted by telephone OR plus a final visit after receiving their last dose of study drug for a follow-up assessment.

Tracking Information