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Study of DONQ52 in Active Celiac Disease | Clinical Trials | Clareo Health

RECRUITINGPHASE2

Study of DONQ52 in Active Celiac Disease

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)

NCT07239336•Chugai Pharmaceutical

View on ClinicalTrials.gov

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

Age

18 - 75 years

Sex

ALL

Healthy Volunteers

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.
+1 more criteria

Locations (11)

Chandler Clinical Trials

Chandler, Arizona, United States

Scottsdale Clinical Trials

Scottsdale, Arizona, United States

Associates in Gastroenterology, PC

Colorado Springs, Colorado, United States

Stamford Therapeutics Consortium

Stamford, Connecticut, United States

Novum Clinical Research

Clermont, Florida, United States

Wellness Clinical Research

Miami Lakes, Florida, United States

Guardian Angel Research Center

Tampa, Florida, United States

Portland Gastroenterology Center

Portland, Maine, United States

Great Lakes Gastroenterology Research, LLC

Mentor, Ohio, United States

Susquehanna Research Group, LLC

Harrisburg, Pennsylvania, United States

Key Dates

Start Date

December 16, 2025

Primary Completion Date

June 15, 2027

Completion Date

December 15, 2027

Last Updated

March 12, 2026

Enrollment

ESTIMATED participants

Conditions

Celiac Disease

Interventions

Placebo DONQ52

DRUG

Simulated Inadvertent Gluten Exposure (SIGE) capsule

DIETARY_SUPPLEMENT

DONQ52

DRUG

Simulated Inadvertent Gluten Exposure (SIGE) capsule

DIETARY_SUPPLEMENT

Contacts

Clinical trials information

CONTACT

only use Email clinical-trials@chugai-pharm.co.jp

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 12, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Study of DONQ52 in Active Celiac Disease

Inclusion Criteria

Exclusion Criteria

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