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DONQ52 to reduce intestinal damage from gluten in 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)

Phase 2 Interventional Chugai Pharmaceutical · NCT07239336

This study will try DONQ52 in people with celiac disease on a gluten-free diet to see if it reduces small intestinal damage and symptoms after simulated inadvertent gluten exposure.

Quick facts

PhasePhase 2
Study typeInterventional
Enrollment92 (estimated)
Ages18 Years to 75 Years
SexAll
SponsorChugai Pharmaceutical Industry-sponsored
Locations38 sites (Anniston, Alabama and 37 other locations)
Trial IDNCT07239336 on ClinicalTrials.gov

What this trial studies

This is a phase 2, randomized, placebo-controlled interventional trial testing DONQ52 given alongside a simulated inadvertent gluten exposure (SIGE) capsule to participants with celiac disease. Eligible participants must be HLA-DQ2.5 positive, have been attempting a gluten-free diet for at least 12 months, and have recent gluten-related symptoms. Participants will receive DONQ52 or placebo with SIGE challenges and will undergo two on-study upper endoscopies with duodenal biopsies to measure intestinal injury and treatment effect. The primary focus is on changes in small intestinal damage and symptom reduction compared with placebo.

Who should consider this trial

Good fit: Adults with medically documented celiac disease who are HLA-DQ2.5 positive, have been trying a gluten-free diet for at least 12 months, have recent gluten-related symptoms, a BMI of 18–40, and are willing to ingest SIGE products and undergo two endoscopies.

Not a fit: People without HLA-DQ2.5, those not attempting a gluten-free diet, asymptomatic individuals, or patients with refractory celiac disease are unlikely to benefit from this intervention.

Why it matters

Potential benefit: If successful, DONQ52 could reduce intestinal injury and lessen symptoms after accidental gluten exposure, making daily management easier for people with celiac disease.

How similar studies have performed: Previous trials of gluten-digesting enzymes and barrier agents have produced mixed results, with some symptomatic improvements in subgroups but no definitive, widely adopted protective therapy to date.

Eligibility criteria

Show full inclusion / exclusion criteria 
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.

Where this trial is running

Anniston, Alabama and 37 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Celiac Disease
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.