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Taking people in United StatesPhase 2

Study of DONQ52 in Active Celiac Disease

Key facts

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 sites
Phase
Phase 2

Could this be for you?

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?

Source: NCT07239336, who can take part

Where in United States

  • 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

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

Trial details

Who runs it
Chugai Pharmaceutical
Trial code
NCT07239336
Record updated
14 August 2026
Original description
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.Read full original descriptionShow less

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)

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.

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; 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: 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).

ClinicalTrials.gov NCT07239336