A Phase II, Randomized, Double-blind, Placebo-controlled, Multicenter Study to Evaluate The Efficacy and Safety of DONQ52 in Active Celiac Disease Patients Who Have Duodenal Mucosal Damage and Persistent Symptoms Despite Attempting A Gluten-free Diet (NCT07239336)

This is a parallel-group, randomized, double-blind, placebo-controlled, multicenter study to evaluate the efficacy and safety of DONQ52 in active celiac disease (CeD) patients who have current duodenal mucosal damage and persistent symptoms despite attempting a gluten-free diet (GFD).

Trial phase

Phase 2

Trial participation type

This trial has been designed for the Clinical Research of a Drug.

Principal investigator

Dr Shara Ket

Key inclusion data

Age 18–75 years at the time of signing the Informed Consent Form. Attempting a Gluten Free Diet for at least 12 months prior to the screening visit. Experienced at least 2 gluten-related symptom events (i.e., 2 different gluten-related symptoms which are diarrhea, abdominal pain, bloating, nausea, tiredness or 1 gluten-related symptom occurred twice) within a month before the screening.