Unfortunately, if any of the following apply to you, this study is not the right fit for you:

• Documented history of RCD (refractory coeliac disease)
• Participation in a clinical trial in the last 90 days, unless known that a placebo was received.
• History of IgE-mediated reactions to wheat, barley or rye (anaphylaxis, hives, itching, or swelling)
• Organ transplant history

Please note, additional eligibility criteria apply.

If you are deemed eligible for the study, your participation is expected to last approximately 54 weeks, and you will be required to attend the study site up to 15 times. This includes: 

• 1 initial visit where you will enter the 4 week screening period and meet with the study team.
• 14 additional visits over the remaining 50 weeks. 

*Participation in the study involves gluten exposure approximately 3 times per week (at home) per the guidelines of the study doctor throughout the treatment period. The amount of gluten provided each time  is reflective of approximately 1 small bite of white toast.

Participation in this research is voluntary, and you may withdraw from the study at any time.

This study aims to assess the safety and efficacy of the investigational product (DONQ52) in active coeliac disease patients who have persistent symptoms/damage despite attempting to maintain a Gluten Free Diet. 

Participants will be asked to partake in a gluten challenge as part of the study and will receive either the investigation product, or a placebo during the treatment window.

Coeliac disease is an autoimmune condition where the ingestion of gluten triggers an immune response that damages the lining of the small intestine. This can lead to malabsorption of nutrients and a variety of digestive and systemic symptoms.

This study is important because it aims to explore potential new treatments for Coeliac disease, a condition that currently has no cure. By advancing research, it could improve the quality of life for people living with Coeliac disease and offer more effective management options beyond a gluten-free diet.

This study is being sponsored by Chugai Pharmaceuticals, a Japanese pharmaceutical company headquartered in Tokyo, Japan.

Chugai’s founding spirit of “Creating drugs that benefit the world” remains firmly rooted as their integral business philosophy “Innovation all for the patients”.

Here is a list of all of the sites who are recruiting soon for this study:

Australia

NSW

• Sydney Clinical Trials - Level 1, Suite 16/42 Parkside Cres, Campbelltown NSW 2560
• Pioneer Clinical Research - Ground Floor/53 Walker St, North Sydney NSW 2060

QLD

• Mater - Raymond Terrace, Level 3 Aubigny Place, South Brisbane QLD 4101

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