Study of DONQ52 in Active Celiac Disease

Recruiting now · Phase 2 · Has a placebo group

Conditions studied: Celiac Disease

In brief

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.

Key facts

Study ID

NCT07239336

Run by

Chugai Pharmaceutical

People needed

92

Starts

2025-12-16

Expected to finish

2027-12-15

Last updated by the study team

2026-08-03

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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, including hematological malignancy and solid tumors, within 5 years prior to the screening visit, or history of T cell lymphoma or B cell lymphoma ever.
• History of hypersensitivity reactions including anaphylaxis to a biological medical product or any of the excipients.
• Participants who carry the HLA-DQ8 (HLA-DQA1*03 and DQB1*0302) genotype (homozygous or heterozygous).
• Any other chronic, active gastrointestinal disease (e.g., inflammatory bowel disease, microscopic colitis, eosinophilic esophagitis, peptic ulcer, gastroesophageal reflux disease, functional dyspepsia, or irritable bowel syndrome) that might in the investigator's opinion, interfere with the assessment of GI symptoms or small intestinal histology.
• Helicobacter pylori tests that indicate current infection.
• Positive either human immunodeficiency virus (HIV) antigen or antibody test at screening.
• Positive hepatitis B surface antigen (HBsAg) test or total hepatitis B core (HBc) antibody test at screening.
• Positive hepatitis C virus (HCV) antibody test at screening, except in participants who have negative results for HCV ribonucleic acid (RNA) test at screening.
• Positive for QuantiFERON-TB Gold test at screening that indicates active tuberculosis (TB) at screening.

Where it is running

• Birmingham Digestive Health Research — Homewood, Alabama, United States (enrolling)
• East View Medical Research — Mobile, Alabama, United States (enrolling)
• Chandler Clinical Trials — Chandler, Arizona, United States (enrolling)
• Research Solutions of Arizona, PC — Litchfield, Arizona, United States (enrolling)
• One of a Kind Clinical Research Center LLC — Scottsdale, Arizona, United States (enrolling)
• Scottsdale Clinical Trials — Scottsdale, Arizona, United States (enrolling)
• GMC Clinical Research, LLC — Folsom, California, United States (enrolling)
• Velocity Clinical Research, Gardena — Gardena, California, United States (enrolling)
• Om Research LLC — Lancaster, California, United States (enrolling)
• Clinical Applications Laboratories — San Diego, California, United States (enrolling)
• California Research Foundation — San Diego, California, United States (enrolling)
• Asthma and Allergy Associates, PC — Colorado Springs, Colorado, United States (enrolling)
• Associates in Gastroenterology, PC — Colorado Springs, Colorado, United States (enrolling)
• Mountain View Clinical Research, Inc. — Denver, Colorado, United States (enrolling)
• Stamford Therapeutics Consortium — Stamford, Connecticut, United States (enrolling)
• Novum Clinical Research — Clermont, Florida, United States (enrolling)
• Encore Borland Groover Clinical Research LLC — Jacksonville, Florida, United States (enrolling)
• Global Life Research Network — Miami, Florida, United States (enrolling)
• Wellness Clinical Research — Miami Lakes, Florida, United States (enrolling)
• Ocala GI Research — Ocala, Florida, United States (enrolling)
• Tropical Clinical Trials — Palmetto Bay, Florida, United States (enrolling)
• St. Johns Center for Clinical Research — Saint Augustine, Florida, United States (enrolling)
• Guardian Angel Research Center — Tampa, Florida, United States (enrolling)
• GI Alliance - Glenview — Glenview, Illinois, United States (enrolling)
• Pinnacle Research Group, LLC — Anniston, Alabama, United States (enrolling)

Full record on ClinicalTrials.gov

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