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Clinical Trials in the USA / NCT07239336
Recruiting Phase 2

Study of DONQ52 in Active Celiac Disease

NCT07239336 · tracked via the Priya Life Science USA tracker
Sponsor
Chugai Pharmaceutical
Phase
Phase 2
Started
2025-12-16
Last updated
2026-08-14

Condition(s) studied

Celiac Disease

Investigational drug(s) / intervention(s)

Placebo DONQ52Simulated Inadvertent Gluten Exposure (SIGE) capsuleDONQ52Simulated Inadvertent Gluten Exposure (SIGE) capsule

Placebo DONQ52: Placebo DONQ52 subcutaneous injection

Simulated Inadvertent Gluten Exposure (SIGE) capsule: SIGE gluten capsules orally

DONQ52: DONQ52 subcutaneous injection

Simulated Inadvertent Gluten Exposure (SIGE) capsule: SIGE gluten capsules orally

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
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, 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.

Primary outcome measure(s)

Trial sites (74)

FacilityCityRegionStatus
Pinnacle Research Group, LLC Anniston Alabama Recruiting
Birmingham Digestive Health Research Homewood Alabama Recruiting
East View Medical Research Mobile Alabama Recruiting
Chandler Clinical Trials Chandler Arizona Recruiting
Research Solutions of Arizona, PC Litchfield Arizona Recruiting
One of a Kind Clinical Research Center LLC Scottsdale Arizona Recruiting
Scottsdale Clinical Trials Scottsdale Arizona Recruiting
Gastroenterology and Liver Institute Escondido California Recruiting
GMC Clinical Research, LLC Folsom California Recruiting
Velocity Clinical Research, Gardena Gardena California Recruiting
Om Research LLC Lancaster California Recruiting
Clinical Applications Laboratories San Diego California Recruiting
California Research Foundation San Diego California Recruiting
Asthma and Allergy Associates, PC Colorado Springs Colorado Recruiting
Associates in Gastroenterology, PC Colorado Springs Colorado Recruiting
Mountain View Clinical Research, Inc. Denver Colorado Recruiting
Stamford Therapeutics Consortium Stamford Connecticut Recruiting
Novum Clinical Research Clermont Florida Recruiting
Encore Borland Groover Clinical Research LLC Jacksonville Florida Recruiting
Global Life Research Network Miami Florida Recruiting
Wellness Clinical Research Miami Lakes Florida Recruiting
Ocala GI Research Ocala Florida Recruiting
Tropical Clinical Trials Palmetto Bay Florida Recruiting
St. Johns Center for Clinical Research Saint Augustine Florida Recruiting
Guardian Angel Research Center Tampa Florida Recruiting
GI Alliance - Glenview Glenview Illinois Recruiting
GI Alliance -Gurnee Gurnee Illinois Recruiting
Rockford Gastroenterology Associates, Ltd. Rockford Illinois Recruiting
GI Alliance Metairie Louisiana Recruiting
Velocity Clinical Research New Orleans New Orleans Louisiana Recruiting
Portland Gastroenterology Center Portland Maine Recruiting
Massachusetts General Hospital Boston Massachusetts Recruiting
Mayo Clinic - Rochester Rochester Minnesota Recruiting
GI Associates Research, LLC Columbia Missouri Recruiting
Gateway GI Research, LLC St Louis Missouri Recruiting
Oasis Clinical Research Las Vegas Nevada Recruiting
Advanced Research Institute Reno Nevada Recruiting
Akron Gastro Research, LLC Akron Ohio Recruiting
Great Lakes Gastroenterology Research, LLC Mentor Ohio Recruiting
Central Sooner Research Norman Oklahoma Recruiting

+ 34 more sites — see the full list on the official registry below.

More Chugai Pharmaceutical trials in the USA

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07239336 on ClinicalTrials.gov ↗ ← All trials in the USA