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Units

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Brief description/objective

This is a double-blind, randomised, multicentre, placebo-controlled, comparative
phase IIb dose-finding and efficacy trial. The trial will be conducted with four
treatment groups in the form of a parallel group comparison and will serve to
compare oral treatment with daily doses of 30 mg/50 mg/75 mg ZED1227 vs
placebo for treatment of celiac disease using two different dosing schedules.
The screening period will be up to 8 weeks, followed by a 5-week single-blind
placebo run-in period, a 12-week treatment period, and a 4-week treatment-free
follow-up period. The trial will be performed according to a 2-stage groupsequential
adaptive design with possible sample size adjustment and treatment
arm selection after the planned interim analysis.