TAK-062 for Celiac Disease
Trial Summary
Will I have to stop taking my current medications?
The trial requires that you continue any current medications you are taking at the start of the study. There should be no changes to your medications during the study.
How is the drug TAK-062 different from other treatments for celiac disease?
What is the purpose of this trial?
This trial tests TAK-062, a drug that breaks down gluten, in people with celiac disease who are on a gluten-free diet. The goal is to see if TAK-062 can reduce symptoms and intestinal damage caused by accidental gluten exposure.
Research Team
Study Director
Principal Investigator
Takeda
Eligibility Criteria
This trial is for individuals with celiac disease who have been on a gluten-free diet for at least 12 months, are experiencing moderate to severe gastrointestinal symptoms due to gluten exposure, and have small intestinal damage. Participants must be HLA-DQ2 or HLA-DQ8 positive, understand the gluten-free diet well, and maintain their current dietary and medical regimens throughout the study.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Run-in Period
Participants undergo a run-in period to establish baseline measurements
Treatment
Participants receive TAK-062 or placebo along with SIGE Gluten-Bar for up to 24 weeks
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- TAK-062
Find a Clinic Near You
Who Is Running the Clinical Trial?
Takeda
Lead Sponsor
Dr. Naoyoshi Hirota
Takeda
Chief Medical Officer since 2020
MD from University of Tokyo
Christophe Weber
Takeda
Chief Executive Officer since 2015
PhD in Molecular Biology from Université de Montpellier