DONQ52 for Active Celiac Disease

Study of DONQ52 in Active Celiac Disease

Recruiting Phase 2 Interventional Study
Celiac Disease
Prior Safety Data This treatment has already been tested in at least one earlier human trial.
Ready to participate?

Review the details below, then apply to join this clinical trial.

At a Glance
Age
18 – 75
Sex
Any
Trial phase
Phase 2
Study type
Interventional
Purpose
Treatment
Participants needed
92 (estimated)
Sponsor
Chugai Pharmaceutical · Industry
Who this trial is looking for

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.

Are You a Good Fit for This Trial?

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.

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About This Trial

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.

Trial Locations
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Eligibility 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 partici…
Contacts

Clinical trials information

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clinical-trials@chugai-pharm.co.jp

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