Back to search results

Study of DONQ52 in Active Celiac Disease

This study is looking into how a drug called DONQ52 might help people with active celiac disease (CeD) who are trying to stick to a gluten-free diet. Researchers want to see if DONQ52 can improve damage to the small intestine and reduce symptoms after someone is exposed to gluten. You would receive either DONQ52 or a placebo (an inactive substance) through injections under the skin, along with capsules that simulate accidental gluten exposure. To join, you need to be between 18 and 75 years old, have a confirmed diagnosis of celiac disease, and have been on a gluten-free diet for at least 12 months. The main goal is to measure changes in your small intestine's villous height to crypt depth ratio (Vh:Cd) from the start of the study to Week 27. The study is currently unclear on its recruitment status and plans to enroll 92 participants.

Study design
This is an interventional study comparing DONQ52 to a placebo. It aims to enroll 92 participants.
What's involved
You would need to be willing to take a gluten-free product and Simulated Inadvertent Gluten Exposure (SIGE) products as instructed by the study. The primary endpoint is measured at Week 27.
Compensation
Not stated in the trial record.
Follow-up
Participants are followed up to Week 27 for the primary endpoint.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07239336

Study of DONQ52 in Active Celiac Disease

Recruiting
PHASE2Ages 18–75InterventionalTreatment
Chugai Pharmaceutical
~92 participants
Updated 2026-08-14 on ClinicalTrials.gov
What's tested:Placebo DONQ52Simulated Inadvertent Gluten Exposure (SIGE) capsuleDONQ52

At a glance

Recruiting sites
74 of 74 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change in Villous Height to Crypt Depth Ratio (Vh:Cd)
Measured over Baseline to Week 27

Conditions

Celiac Disease

Explore related trials

Celiac DiseaseHLA-DQ2.5

NCT07239336

Where you'd take part

This study runs at 74 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Advanced Research Institute

    Reno, Nevadano site contact published

    Recruiting

  • Advanced Research Institute

    Ogden, Utahno site contact published

    Recruiting

  • Advanced Research Institute Sandy

    Sandy City, Utahno site contact published

    Recruiting

  • Akron Gastro Research, LLC

    Akron, Ohiono site contact published

    Recruiting

  • Associates in Gastroenterology, PC

    Colorado Springs, Coloradono site contact published

    Recruiting

  • Asthma and Allergy Associates, PC

    Colorado Springs, Coloradono site contact published

    Recruiting

  • Birmingham Digestive Health Research

    Homewood, Alabamano site contact published

    Recruiting

  • Blue Ridge Medical Research

    Lynchburg, Virginiano site contact published

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

Who to contact

Clinical trials information
[email protected]
only use Email
Email the study team

Opens a ready-to-send draft in your own email app — review before sending.

Want this trial checked against your situation?

Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.

Check eligibility for this trial ~2 min · HIPAA-protected · delete anytime
Eligibility criteria

Inclusion

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.
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

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.

What this trial measures

  • Change in Villous Height to Crypt Depth Ratio (Vh:Cd)Baseline to Week 27

    The Vh:Cd ratio represents mucosal architectural changes and a lower Vh:Cd ratio indicates more severe intestinal injury characterized by a flattening of the mucosa. The difference in the adjusted mean change from baseline (Run-in) to Week 27 in Vh:Cd between DONQ52 and placebo groups will be estimated using the analysis of covariance (ANCOVA) method. A negative change from baseline indicates worsening disease.