A phase II, double-blind, randomised, placebo-controlled trial to evaluate the efficacy and tolerability of ZED1227 in celiac disease subjects experiencing symptoms despite gluten-free diet (CEC-013/CEL)

Research summary

This is a double-blind, randomised, multicentre, placebo-controlled, comparative phase II efficacy trial. The trial will be conducted with two treatment groups in the form of a parallel group comparison and will serve to compare oral treatment with daily doses of 75 mg [25 mg three times a day (TID)] and potentially 30 mg (10 mg TID) of ZED1227 vs placebo for treatment of celiac disease. The screening period will be up to 4 weeks, followed by a 3-week single-blind placebo run-in period (Trial Period A), a 12-week treatment period (Trial Period B), and a 4-week treatment-free follow-up period. At screening, subjects will consume an open-label gluten-free (GF) simulated inadvertent gluten exposure (SIGE) bar to identify subjects with intolerance to ingredients other than gluten; all subsequent SIGE bars (Trial Period A and B) will contain gluten (0.5 g/bar). During the single-blind run-in period (Trial Period A), subjects will receive single-blind placebo capsules for oral use TID and consume SIGE bar with gluten 3 times a week (TIW) with a meal. 1

Principal Investigator

Dr Michael Fitzpatrick

Contact us

Email: ctf.research@ouh.nhs.uk

IRAS number

1008894