Study of DONQ52 in Active Celiac Disease (NCT07239336) | Clinical Trial Compass
RecruitingPhase 2
Study of DONQ52 in Active Celiac Disease
United States92 participantsStarted 2025-12-16
Plain-language summary
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.
Who can participate
Age range18 Years – 75 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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
Exclusion Criteria:
* Participants with documented history (i.e., included in the participant's medical records) of medically diagnosed Refractory Celiac Disease (RCD) or suspected RCD by the investigator.
* History of IgE-mediated reactions to wheat, barley, rye, or other ingredients in gluten-free and SIGE products used in this study (i.e., methylcellulose, and gelatin).
* History of cancer, includ…
What they're measuring
1
Change in Villous Height to Crypt Depth Ratio (Vh:Cd)