CEC-4/CEL

Coeliac Disease

The purpose of this research study is to assess the effect of 3 different dosages and 2 different dosing schedules of ZED1227 oral capsules in the treatment of Celiac Disease that is symptomatic despite a gluten free diet.

The compound ZED1227 is a newly developed inhibitor of Transglutaminase 2 (TG2). TG2 is a protein found in the small intestine mucosa 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 mucosa. This study will look at the effects of ZED1227 including changes in the small intestine mucosa (duodenal mucosa) and changes in Coeliac disease symptoms. Other effects studied include changes in inflammation due to Coeliac disease and the safety and tolerability of ZED 1227.

Category
Trial Status
Active, not recruiting
Trial Phase
Phase 2 Drug Trial
Registry Listing
ERM Project ID
98025
Trial contact details
Contact Person
Sharyn Grossman
What you need to know

Who can take part?

Inclusion

  • aged 18-80
  • biopsy proven Coeliac disease (CeD) not less than 12 months ago
  • gluten free diet (GFD) for not less than 12 months
  • genetic testing for CeD
  • maintain GFD
  • negative pregnancy test

Exclusion

  • IgA deficiency
  • refractory CeD
  • complications from CeD
  • intestinal diseases eg. Crohn's Disease, Ulcerative Colitis etc
  • certain medications and medical conditions

What is involved for you?

  • Up to 27 weeks commitment
  • Oral ZED1227 or placebo for up to 17 weeks before each major meal
  • Blood & urine samples across 9 study visits
  • Endoscopy at screening & end of study

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