Dr Falk
Are You Eligible?A phase IIb, double-blind, randomised, placebo–controlled trial to evaluate the efficacy and tolerability of ZED1227 in coeliac disease subjects experiencing symptoms despite gluten-free diet
Research Objectives
Status
Recruitment
Total participants required
Study location
Study type
Patient group
About this clinical trial
The purpose of this research study is to assess the effect of 3 different dosages and 2 different dosing schedules of ZED1227 oral capsules, for improvement and changes in the small intestine mucosa (the inner lining of the small intestine) and coeliac disease symptoms. The study also aims to assess the effect of ZED1227 for changes in coeliac inflammation, as well as assess how well ZED1227 is tolerated and how safe it is.
The compound ZED1227 is a newly developed inhibitor of Transglutaminase 2 (TG2). TG2 is a protein found in the small intestine lining which is central to the development of coeliac disease. TG2 has a role in activating the immune system (through T-cells) which leads to inflammation and damage of the small intestine lining.
In previous studies, ZED1227 has demonstrated favourable results, safety and tolerability profile, subject to side effects, justifying further clinical development. ZED1227 capsules are an experimental treatment. This means that it is not an approved treatment for coeliac disease by the Therapeutic Goods Administration in Australia.
CEC-4/CEL
Eligibility
- Aged 18-80 years (inclusive)
- Biopsy-confirmed diagnosis of coeliac disease for ≥12months
- Gluten-free diet ≥12 months
- BMI 17-35kg/m2 (inclusive)
Lead investigators
- Dr James Daveson
- Dr Jennifer Schafer
Clinical trial coordinators
- Leah Hingston
- Chris Henderson
Technical title
CEC-4/CEL
This clinical trial is now closed for recruitment
If you would like more information about this clinical trial, please complete the contact form below.