Illuminate-062
Research type
Research Study
Full title
A Phase 2, Randomized, Double-blind, Placebo-Controlled, Dose-Ranging Study to Evaluate the Efficacy and Safety of TAK-062 for the Treatment of Active Celiac Disease in Subjects Attempting a Gluten-Free Diet
IRAS ID
1005821
Contact name
DAN LEFFLER
Contact email
Sponsor organisation
TAKEDA
Eudract number
2020-005438-14
Clinicaltrials.gov Identifier
Research summary
The purpose of this study is to learn more about the Takeda study drug called ‘TAK 062’. This drug is being developed to be used together with a gluten-free diet for the treatment of coeliac disease (CeD). CeD is a disorder in which eating gluten can create an immune response that causes the body to attack the small intestine.
There's no cure for CeD but following a gluten-free diet (GFD) should help control symptoms. Unfortunately many individuals with CeD continue to have symptoms and suffer intestinal damage due to accidental exposure to gluten despite attempts to maintain a GFD. The study drug, TAK-062, is a protein designed to break down the gluten present in food which may help in reducing symptoms and intestinal damage associated with CeD.
The purpose of this study is to look at:
• Whether the study drug works for people with CeD in addition to a GFD.
• How safe the study drug is.
• How well the body handles taking the study drug (e.g. side effects).
• How the study drug changes substances in the blood called “biomarkers” and how it affects the intestine.This study consists of two parts. Part 1 will include adult participants (18-75 years old). Part 2 will include adult and adolescent participants (12-75 years old) and may be started once the investigators have checked the safety of the study drug during Part 1.
Each part of the study will consist of 4 periods: screening period (up to 4 weeks), run-in period (4 weeks), treatment period (24 weeks), and follow-up period (4 weeks). The total amount of time you may be involved in the study is up to 36 weeks (about 9 months).
There will be about 350 participants taking part in this study at approximately 88 study clinics in countries such as the US, Canada, United Kingdom (UK) and some countries in the European Union (EU). About 120 participants will join Part 1 of the study and about 230 participants will join Part 2 of the study.
REC name
Yorkshire & The Humber - Sheffield Research Ethics Committee
REC reference
22/YH/0253
Date of REC Opinion
16 Jan 2023
REC opinion
Further Information Favourable Opinion