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A phase IIb, double-blind, randomised, placebocontrolled trial to evaluate the efficacy and tolerability of ZED1227 in celiac disease subjects experiencing symptoms despite gluten-free diet 

Research Objectives

Status

Current

Total participants required

400

Study location

Wesley Research Institute

Study Type

Industry Sponsored

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

  • A/Prof James Daveson
  • Dr Jennifer Schafer

Technical title

CEC-4/CEL

Register your interest

If you would like more information about this clinical trial, please complete the contact form below.

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You must be based in the Greater Brisbane region to be eligible for this study.
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Which if the following accurately describes you?(Required)

Is your date of diagnosis greater than 12 months?(Required)
Have you had a small bowel biopsy and blood test to confirm the diagnosis?(Required)
Have you been eating a strict gluten free diet for at least the last 12 months?(Required)
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