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Taking people in United StatesPhase 2

DONQ52 for Celiac Disease With Ongoing Symptoms Despite a Gluten-Free Diet

Tests DONQ52 against placebo in adults with celiac disease on a gluten-free diet.

Key facts

Who runs it
Chugai Pharmaceutical
Where
Akron, Anniston, Bellevue, Boston, Chandler, Clermont, Colorado Springs, Columbia, Denver, Escondido, Folsom, Gardena, Garland, Glenview, Gurnee, Harrisburg, Hermitage, Homewood, Jacksonville, Katy, Lancaster, Las Vegas, Litchfield, Lynchburg, Mentor, Metairie, Miami, Miami Lakes, Mobile, New Orleans, Norman, Ocala, Ogden, Palmetto Bay, Portland, Providence, Reno, Richmond, Rochester, Rockford, Saint Augustine, San Diego, Sandy City, Scottsdale, St Louis, Stamford, Sugar Land, Tampa, Tomball, Waco, West Jordan, and Wichita Falls, United StatesSee the 58 sitesAlso in 2 other countries, 16 sites
Trial code
Registry title
Study of DONQ52 in Active Celiac Disease
Status
Recruiting
Phase
Phase 2
People taking part
92 people, planned
Started
16 Dec 2025
Expected to end
15 Dec 2027
Type of study
Interventional, 2 groupsOne group gets a placebo (a dummy treatment), for comparison.
Treatments tested
  • Placebo DONQ52
  • Simulated Inadvertent Gluten Exposure (SIGE) capsule
  • DONQ52
Record updated
14 August 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults with celiac disease who still have gut damage and symptoms despite trying a gluten-free diet.

Age
18 Years to 75 Years
Sex
All sexes can join.
Disease stage
Active celiac disease diagnosed by a doctor and written in medical records. Ongoing damage to the lining of the small intestine (Vh:Cd of 2.5 or less). At least 2 gluten-related symptom events (diarrhea, abdominal pain, bloating, nausea, tiredness) within a month before screening. Body mass index (BMI) of 18 to 40 (kg/m2).
Earlier treatment
Must have tried a gluten-free diet for at least 12 months before screening. Must be willing to eat study gluten products and have 2 endoscopies with small-bowel biopsies.
Biomarker or test result
Blood test showing the HLA DQ2.5 genotype (HLA-DQA1*05 and HLA-DQB1*02), one or two copies. People with HLA-DQ8 cannot join.

Main reasons for not taking part

  • Refractory celiac disease (celiac disease that does not respond to diet), diagnosed or suspected
  • Cancer within 5 years, or T cell or B cell lymphoma ever
  • IgE allergy to wheat, barley, rye or study product ingredients, or severe allergy to biological medicines
  • Other chronic active gut disease, or current Helicobacter pylori infection
  • Positive test for HIV, hepatitis B, hepatitis C (unless HCV RNA negative) or active tuberculosis

The registry criteria, word for word

Show all 19 criteriaShow less

Who can take part

  • 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

Who cannot take part

  • 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
  • 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
  • Participants who carry the HLA-DQ8 (HLA-DQA1*03 and DQB1*0302) genotype (homozygous or heterozygous)

Check if you might fit

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

  • Are you between 18 and 75 years old?

Where in United States

Also in 2 other countries, 16 sites

  • Akron Gastro Research, LLCAkron, United StatesTaking people
  • Pinnacle Research Group, LLCAnniston, United StatesTaking people
  • GI AllianceBellevue, United StatesTaking people
  • Massachusetts General HospitalBoston, United StatesTaking people
  • Chandler Clinical TrialsChandler, United StatesTaking people
  • Novum Clinical ResearchClermont, United StatesTaking people
  • Associates in Gastroenterology, PCColorado Springs, United StatesTaking people
  • Asthma and Allergy Associates, PCColorado Springs, United StatesTaking people
  • Columbia Digestive Health ResearchColumbia, United StatesTaking people
  • GI Associates Research, LLCColumbia, United StatesTaking people
  • Mountain View Clinical Research, IncDenver, United StatesTaking people
  • Gastroenterology and Liver InstituteEscondido, United StatesTaking people
  • GMC Clinical Research, LLCFolsom, United StatesTaking people
  • Velocity Clinical Research, GardenaGardena, United StatesTaking people
  • GI Alliance - GarlandGarland, United StatesTaking people
  • GI Alliance GlenviewGlenview, United StatesTaking people
  • GI Alliance GurneeGurnee, United StatesTaking people
  • Susquehanna Research Group, LLCHarrisburg, United StatesTaking people
  • Digestive Health Research, LCHermitage, United StatesTaking people
  • Birmingham Digestive Health ResearchHomewood, United StatesTaking people
  • Encore Borland Groover Clinical Research LLCJacksonville, United StatesTaking people
  • Vitality Clinical ResearchKaty, United StatesTaking people
  • Vitality Digestive Institute Clinical ResearchKaty, United StatesTaking people
  • Om Research LLCLancaster, United StatesTaking people
  • Oasis Clinical ResearchLas Vegas, United StatesTaking people
  • Research Solutions of Arizona, PCLitchfield, United StatesTaking people
  • Blue Ridge Medical ResearchLynchburg, United StatesTaking people
  • Great Lakes Gastroenterology Research, LLCMentor, United StatesTaking people
  • GI AllianceMetairie, United StatesTaking people
  • Global Life Research NetworkMiami, United StatesTaking people
  • Wellness Clinical ResearchMiami Lakes, United StatesTaking people
  • East View Medical ResearchMobile, United StatesTaking people
  • Velocity Clinical Research, New OrleansNew Orleans, United StatesTaking people
  • Central Sooner ResearchNorman, United StatesTaking people
  • Ocala GI ResearchOcala, United StatesTaking people
  • Advanced Research InstituteOgden, United StatesTaking people
  • Care Access Research, OgdenOgden, United StatesTaking people
  • Tropical Clinical TrialsPalmetto Bay, United StatesTaking people
  • Portland Gastroenterology CenterPortland, United StatesTaking people
  • GI Alliance Rhode IslandProvidence, United StatesTaking people
  • Advanced Research InstituteReno, United StatesTaking people
  • Clinical Research Partners, LLCRichmond, United StatesTaking people
  • Mayo Clinic - RochesterRochester, United StatesTaking people
  • Rockford Gastroenterology Associates, Ltd.Rockford, United StatesTaking people
  • St. Johns Center for Clinical ResearchSaint Augustine, United StatesTaking people
  • California Research FoundationSan Diego, United StatesTaking people
  • Clinical Applications LaboratoriesSan Diego, United StatesTaking people
  • Advanced Research Institute - SandySandy City, United StatesTaking people
  • One of a Kind Clinical Research Center LLCScottsdale, United StatesTaking people
  • Scottsdale Clinical TrialsScottsdale, United StatesTaking people
  • Gateway GI Research, LLCSt Louis, United StatesTaking people
  • Stamford Therapeutics ConsortiumStamford, United StatesTaking people
  • Texas Medical CenterSugar Land, United StatesTaking people
  • Guardian Angel Research CenterTampa, United StatesTaking people
  • DM Clinical Research - Cyfair Clinical Research CenterTomball, United StatesTaking people
  • Digestive Research of Central Texas, LLCWaco, United StatesTaking people
  • Velocity Clinical Research, Salt Lake CityWest Jordan, United StatesTaking people
  • Digestive Health Research of North TexasWichita Falls, United StatesTaking people

About the trial

What the trial wants to find out

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.

The 2 groups in the trial

  • Placebo + SIGE Gluten capsulePlacebo, for comparison

    Placebo subcutaneous (SC) injection as per protocol + SIGE Gluten capsule orally

    Treatment: Placebo DONQ52 and Simulated Inadvertent Gluten Exposure (SIGE) capsule

  • DONQ52 + SIGE Gluten capsuleTreatment being tested

    DONQ52 subcutaneous (SC) injection as per protocol + SIGE Gluten capsule orally

    Treatment: DONQ52 and Simulated Inadvertent Gluten Exposure (SIGE) capsule

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
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)
Plain-language title
DONQ52 for Celiac Disease With Ongoing Symptoms Despite a Gluten-Free DietGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 14 November 2026.
Fit questions
Built from NCT07239336, who can take part
Record updated
14 August 2026