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 (DAISY STUDY)
The main aim is to see how DONQ52 works to improve small intestinal damage and reduce celiac-related symptoms due to gluten exposure, in participants with celiac disease (CeD) attempting to maintain a gluten-free diet (GFD) in treated participants versus placebo controls.
• Body mass index (BMI) of 18 to 40 (kg/m2) at screening.
• Willingness to ingest a gluten-free product and Simulated Inadvertent Gluten Exposure (SIGE) products as per the study protocol.
• History of medically diagnosed, and adequately documented (i.e., included in the participant's medical records), CeD
• Attempting a GFD for at least 12 months prior to the screening visit.
• \- The participants should be instructed not to alter dietary habits including a GFD during the study period.
• Valid results from central testing of blood documenting a positive result for the HLA DQ2.5 genotype (HLA-DQA1\*05 and HLA-DQB1\*02) (homozygous or heterozygous).
• 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.
• Willingness to undergo 2 on-study upper gastrointestinal endoscopies with duodenal biopsies.
• Presence of ongoing duodenal mucosal damage defined as Vh:Cd of 2.5 or less