DONQ52 for Active Celiac Disease
Study of DONQ52 in Active Celiac Disease
- Age
- 18 – 75
- Sex
- Any
- Trial phase
- Phase 2
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 92 (estimated)
- Sponsor
- Chugai Pharmaceutical · Industry
This trial is looking for people with celiac disease who have trouble sticking to a gluten-free diet. Participants will take a medication called DONQ52 to see if it helps improve their symptoms when accidentally exposed to gluten.
You may be able to join if
- I have a body mass index (BMI) between 18 and 40.
- I have been diagnosed with celiac disease.
- I have been on a gluten-free diet for at least 12 months.
- I have experienced at least 2 different gluten-related symptoms in the last month.
- I am willing to have 2 endoscopies with biopsies during the study.
- I have ongoing damage in my small intestine.
- I am willing to consume gluten-free and study products.
You may not be able to join if
- I have a history of refractory celiac disease.
- I have had severe allergic reactions to gluten or study product ingredients.
- I have been diagnosed with cancer in the last 5 years.
- I have a history of severe allergic reactions to medical products.
- I have the HLA-DQ8 genotype.
- I have any other active gastrointestinal disease.
- I currently have a Helicobacter pylori infection.
- I test positive for HIV, hepatitis B, or hepatitis C.
Summarized in plain language from this trial's official eligibility criteria. The full criteria are further down this page — only the research team can confirm whether you qualify.
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
Check Your EligibilityThe 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.
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