Who is eligible for clinical trial NCT07239336?

Participants must meet protocol criteria for Celiac Disease. Confirm exact inclusion and exclusion requirements with the study coordinator.

Does clinical trial NCT07239336 provide travel or cost reimbursement?

Check with the site coordinator at the participating facility for travel and lodging stipend availability, and for which routine-care costs are covered.

🏛️ Verified NIH Record • Updated 2026-08-13

Study of DONQ52 in Active Celiac Disease (NCT07239336)

🟢 Recruiting Phase2 💊 Investigational Drug / Biologic Sponsor: Chugai Pharmaceutical

🩺 Plain-English Summary (8th-Grade Level)

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 join: To join this study, participants generally need to meet the listed inclusion criteria (8 items) and avoid the listed exclusions (12 items).

Location: Pinnacle Research Group, LLC — Anniston, Alabama

📋 "Do I Qualify?" — 1-Minute Self Screener

Instant Checklist

Check every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).

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

Usually NOT eligible if any of the following apply:

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, 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.

🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.

📍 All Participating Trial Locations (74 Sites)

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

💰 Cost, Insurance & Patient Rights

100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

🏛️ View Official NIH Record ↗