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

• Significant medical conditions or diseases (these will be discussed during phone screening).
• Refractory Coeliac disease (persistent or recurrent symptoms despite a strict gluten-free diet (GFD) for more than 12 months)
• Have any other chronic, active gastrointestinal disease, such as inflammatory bowel disease or microscopic colitis. 
• Pregnant or breastfeeding, or intend to become pregnant during the study or for at least 176 days after receiving the investigational medication. 

Please note, additional eligibility criteria apply.

If you are deemed eligible for the study, your participation is expected to last approximately 30 weeks, and you will be required to attend the study site up to 13 times. This includes: 

• A screening period of 28 days.
•  A randomisation and treatment period of 29 days, including: 
  • Treatment with the investigational medication or a matching placebo on Day 1.
  • On Day 9, you will commence a 3-day gluten challenge at the study site.
  • On Days 10 and 11, you will continue the 3-day gluten challenge from home.
  • Thereafter, you will visit the study site on an outpatient basis until the last observation on Day 29. 
• A follow-up period from Day 30 to Day 176, during which you will need to return to the study site 5 more times. 

This is a double-blind study, which means neither you nor the study doctor will know if you receive the investigational medication or a placebo. A placebo looks like the study medicine but does not contain any study medicine (active ingredient). Researchers use a placebo to see if a study medicine is safer than not taking anything at all. Eligible participants will have a 50% (one in two) chance of receiving the investigational medication.

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

This study aims to evaluate the safety and effectiveness of an investigational medicinal product, DONQ52, in Coeliac disease patients who are undergoing a gluten challenge. DONQ52 is expected to block the immune responses known to cause Coeliac disease symptoms when gluten is ingested.

Coeliac disease is an autoimmune condition in which a person's immune system mistakenly attacks their own tissues when they ingest gluten, a naturally occurring protein found in wheat, barley, and rye. This can damage the small intestine and impair the body’s ability to absorb nutrients. As such, after a person with Coeliac disease eats gluten, they can experience fatigue, abdominal pain, and a variety of digestive issues, including constipation, diarrhoea, and vomiting.

Though roughly 1 in 70 Australians have Coeliac disease, the only way to manage the symptoms of this condition is to follow a strict gluten-free diet. However, cross-contamination in food preparation settings, including restaurants, supermarkets, and healthcare facilities, can increase a person's risk of gluten exposure and complications from untreated Coeliac disease, such as malnutrition, anaemia, and osteoporosis. As such, by striving to develop a standard treatment option for people with Coeliac disease, this study could free them from the daily struggle of self-management and improve their quality of life.

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”.

We are currently recruiting for this study in the following locations:

QLD

• The Wesley Medical Research, 451 Coronation Drive, Auchenflower, Brisbane, 4066
• CDH Research Institute Pty Ltd - 503/5 Emporio Place, Maroochydore, 4558 

NSW

• Campbelltown Hospital - Therry Rd, Campbelltown, 2560 

We will soon be recruiting for this study in the following locations:

QLD

• The University of Queensland - Princess Alexandra Hospital (PAH) - Health Hub, Level 1, 19/31 Dickson Rd, Morayfield, 4506 (TBA)
  

VIC

• Royal Melbourne Hospital (RMH) - 300 Grattan Street Parkville, 3050 (TBA)
• Alfred Hospital - Level 4, Main Ward Block, Commercial Road, Melbourne, 3004 (TBA)
• Eastern Health-Box Hill Hospital - 5 Arnold street, Level 2, Box Hill, 3128 (TBA)

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