Coeliac Disease (DAISY) Study

Quick Reference:

What is the purpose of this study?

Where is my nearest study site?

Who can participate?

Who cannot participate?

What is involved? 

Reimbursements

What is the purpose of this study?

This is a Phase 2 study, known as Daisy, that is aiming to assess the safety and efficacy of the investigational product (DONQ52) in active coeliac disease patients who have persistent symptoms/damage despite maintaining a Gluten Free Diet. 

Where is my nearest study site?

Here is a list of all of the sites who are currently recruiting 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

Who can participate?

To take part in this study, you will need to meet all the following:

• Aged 18 to 75 years old
• BMI between 18 and 40
• Medically diagnosed with Coeliac disease with persisting symptoms
• Be comfortable participating in a gluten challenge.
• You have attempted to maintain a Gluten Free diet for the last 12 months and still experience gluten related symptoms occasionally.

Who cannot participate?

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 significant reactions to wheat, barley or rye (anaphylaxis, hives, itching, or swelling)
• Organ transplant history
• History of cancer within the past 5 years, excluding excised basal cell carcinoma, squamous cell carcinoma or in situ carcinoma of the cervix that has been treated by curative therapy more than 1 year ago.

Please note, additional eligibility criteria apply and will be discussed in a phone call with our team.

What is involved?

If you are deemed eligible for the study, your participation is expected to last approximately 54 weeks. 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 of the study period.
• 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 2 small bites of white toast.

If you take part in the research study, there will be:

• Reimbursement of costs; For out-of-pocket expenses, such as travel and parking.
• Convenience; There are no overnight stays.
• Free study-related medical care; Be among the first to access potential new research treatments before they are widely available.
• Expert medical monitoring; Receive top-tier medical care and monitoring from experienced healthcare professionals.
• Contribution to medical research; Help investigate a potential new treatment that could improve the lives of individuals with Coeliac Disease.
  
  

What is Coeliac Disease?

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. 

Why is this study important?

This study is important because it aims to continue 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.

Who is involved? 

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”.