Skip to content
Bored Studies
RecruitingPhase 2

Study of DONQ52 in Active Celiac Disease

Chugai Pharmaceutical · NCT07239336

View Study & Apply (opens in a new tab)

Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.

Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Ages 18–75 · All sexes
Healthy volunteers
Not accepted (a condition is required)
Study type
Interventional · Phase 2
Target enrollment
92
US sites recruiting
58
Study start
December 16, 2025
Record last updated
August 14, 2026

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study is about

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.

Being studied: Placebo DONQ52; Simulated Inadvertent Gluten Exposure (SIGE) capsule; DONQ52; Simulated Inadvertent Gluten Exposure (SIGE) capsule

Conditions: Celiac Disease

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full 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.

Recruiting US locations

Study contacts (from the official record)

  • Clinical trials information · only use Email · clinical-trials@chugai-pharm.co.jp
Study of DONQ52 in Active Celiac Disease (NCT07239336) | Bored Studies