DONQ52 to reduce intestinal damage from gluten in celiac disease

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a phase 2, randomized, placebo-controlled interventional trial testing DONQ52 given alongside a simulated inadvertent gluten exposure (SIGE) capsule to participants with celiac disease. Eligible participants must be HLA-DQ2.5 positive, have been attempting a gluten-free diet for at least 12 months, and have recent gluten-related symptoms. Participants will receive DONQ52 or placebo with SIGE challenges and will undergo two on-study upper endoscopies with duodenal biopsies to measure intestinal injury and treatment effect. The primary focus is on changes in small intestinal damage and symptom reduction compared with placebo.

Why it matters

Who can join: the full rules

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.

Where it's running

• Pinnacle Research Group, LLC
  Anniston, Alabama, United States Recruiting
• Birmingham Digestive Health Research
  Homewood, Alabama, United States Recruiting
• East View Medical Research
  Mobile, Alabama, United States Recruiting
• Chandler Clinical Trials
  Chandler, Arizona, United States Recruiting
• Research Solutions of Arizona, PC
  Litchfield, Arizona, United States Recruiting
• One of a Kind Clinical Research Center LLC
  Scottsdale, Arizona, United States Recruiting

+24 more sites. See ClinicalTrials.gov for the full list.

Study contacts

• Study coordinator: Clinical trials information
• Email: clinical-trials@chugai-pharm.co.jp
• Phone: only use Email

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Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.