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Taking people in AustraliaPhase 2

Study of DONQ52 in Active Celiac Disease

Key facts

Where
Box Hill, Campbelltown, Midland, Morayfield, North Sydney, Parkville, Sippy Downs, and South Brisbane, AustraliaSee the 9 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 Australia

  • Box Hill HospitalBox Hill, AustraliaTaking people
  • Sydney Clinical Trials Pty LtdCampbelltown, AustraliaTaking people
  • St John of God MidlandMidland, AustraliaTaking people
  • University of the Sunshine Coast Clinical Trials CentreMorayfield, AustraliaTaking people
  • Pioneer Clinical ResearchNorth Sydney, AustraliaTaking people
  • Royal Melbourne HospitalParkville, AustraliaTaking people
  • University of The Sunshine Coast Clinical Trials Centre (Sippy Downs)Sippy Downs, AustraliaTaking people
  • MaterSouth Brisbane, AustraliaTaking people
  • University of the Sunshine Coast Clinical Trials Centre (SouthBank)South Brisbane, AustraliaTaking 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

Under construction, not live – Study of DONQ52 in Active Celiac Disease (NCT07239336) – Frontlight Research