Now recruiting 

Join our Coeliac Disease (DAISY) Study.

Take part in a new research study for a potential new treatment for Coeliac Disease. 

This study aims to assess the safety and efficacy of the investigational treatment. The trial is open for coeliac disease patients who have persistent symptoms/damage despite maintaining a Gluten Free Diet. 

18 - 75
Age range
54 wks
Total time
Up to 15
Site Visits
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What participants receive

If you take part in this research, there will be:

Reimbursement of costs

For out-of-pocket expenses, such as travel and parking.

Contribution to research

Help investigate a potential new treatment that could improve the lives of individuals with coeliac disease.

Free study-related 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.

Eligibility

Who can take part?

You may be able to take part if the following apply. Eligibility is confirmed at a free screening visit (other criteria apply).

Aged 18 - 75 years old
Medically diagnosed with Coeliac disease with persisting symptoms
BMI between 18 and 40
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.
Where

Where is my nearest study site?

New South Wales
  • CampbelltownSydney Clinical Trials
  • North SydneyPioneer Clinical Research North Sydney
Victoria
  • Box HillBox Hill Hospital
  • MelbourneThe Alfred Hospital
  • ParkvilleRoyal Melbourne Hospital
Western Australia
  • MidlandSt John of God Midland
Queensland
  • South BrisbaneMater
New Zealand
  • AucklandPCRN Auckland
  • ChristchurchCGM Research Trust
  • HamiltonPCRN Waikato
  • PukekoheMomentum Pukekohe
  • Upper HuttPCRN Wellington
  • WellingtonMomentum Wellington
About this study

Study Guide

01Who can take part in this study?-

To take part in this study, participants will need to meet all the following (other criteria apply):

  • 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.
02Who is unable to take part in this study?+

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.

03What does the study involve for participants?+

If you are deemed eligible for the study, you 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. 

04What is the purpose of this study?+

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. 

05What 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.

06Why is this study important?+

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.

07Who is sponsoring this study?+

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".

08What if I have other questions about the study?+

We're here for you! Click or tap the button below to read the study FAQs or to send an email to our friendly Patient Experience team:

Contact us

Register your interest now

It takes only a few minutes to see if you, or someone you care for, may be eligible — with no obligation to take part.

Register Now →
Approved by an independent Human Research Ethics Committee ·