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      Coeliac Disease Study

      Study Information for Patients: Investigating a potential new treatment for Coeliac disease

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

       

       

      Where is my nearest study site?

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

      AUSTRALIA:

      NSW

      • Campbelltown Hospital - Therry Rd, Campbelltown, 2560 

      QLD

      • The Wesley Medical Research, 451 Coronation Drive, Auchenflower, Brisbane, 4066
      • CDH Research Institute Pty Ltd - 503/5 Emporio Place, Maroochydore, 4558 
      • The University of Queensland - Princess Alexandra Hospital (PAH) - Health Hub, Level 1, 19/31 Dickson Rd, Morayfield, 4506 

      VIC

      • Eastern Health-Box Hill Hospital - 5 Arnold street, Level 2, Box Hill, 3128 
      • Alfred Hospital VICTORIA- 99 Commercial Road, Melbourne, VIC 3004 

      NEW ZEALAND:

      P3 Research Limited, Wellington:

      • Level 1, 121 Adelaide Road, Wellington 6021

      Optimal clinical Trials, Auckland

      • Level 2, 97 Grafton Road. Grafton, Auckland 1010

      P3 Research Limited, Dunedin

      • Unit 2/401 Moray Place, Dunedin, 9016

      P3 Research Limited, Palmerston North

      • 273 Broadway Avenue, Palmerston North, 4414

      P3 Research Limited, Hawke's Bay

      • 205 Hastings Street South, Hastings, 4122



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

      • Aged between 18 and 70 years old.
      • Have been medically diagnosed with Coeliac disease. 
      • Have a body mass index (BMI) of 18 to 35 kg/m2 at screening. 
      • Have been on a gluten-free diet for at least 12 months. 
      • You are willing to consume food containing gluten protein as part of a 3-day gluten challenge. 



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

      • Allergy to wheat
      • 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 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 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 placebo on Day 1 at the study site.
        • 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.


       

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

      • Reimbursement of costs: For out-of-pocket expenses, such as travel and parking
      • 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.


       

      What is Coeliac disease? 
      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. 

       



      Why is this study important?
      Though roughly 1 in 70 Australians have Coeliac disease and affects roughly 1.2% of adults in New Zealand, the only way to manage the symptoms of this condition is to follow a strict gluten-free diet. 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, malignancy, 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 potentially improve their quality of life. 

       



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


      Your participation in this research study has the potential to advance our understanding of medical science, lead to improved treatments, and deliver better health outcomes.

      FOR MORE INFORMATION OR TO REGISTER YOUR INTEREST,  VISIT COELIACSTUDY.COM


      This trial has been approved by an independent ethics committee

       

      1 Coeliac disease. Coeliac Australia. Accessed October 26, 2023. https://coeliac.org.au/learn/coeliac-disease/

      2 Silvester JA, Graff LA, Rigaux L, Walker JR, Duerksen DR. Symptomatic suspected gluten exposure is common among patients with coeliac disease on a gluten-free diet. Aliment Pharmacol Ther. 2016 Sep;44(6):612-9. doi: 10.1111/apt.13725. Epub 2016 Jul 22. PMID: 27443825; PMCID: PMC5283559.

      3 Complications: Coeliac disease. NHS. Accessed October 26, 2023. https://www.nhs.uk/conditions/coeliac-disease/complications/

       4 Coeliac disease: investigation and management”, bpac NZ, published 12 August 2022. Accessed 21 February 2024: https://bpac.org.nz/2022/coeliac.aspx

      Ready to register? Click here to sign up/login to Evrilink and start your clinical trial journey. 

       

       

      Still have questions? Use the form below and one of our patient experience team members will be in touch to assist with your enquiry!