DAISY Coeliac Disease Study

Coeliac disease is an ongoing condition where your intestine reacts negatively to gluten in your diet. When someone with coeliac disease consumes gluten, it triggers an immune response that damages the lining of the small intestine. Inside your small intestine are tiny, finger-like projections called villi. These villi are crucial for absorbing nutrients from the food you eat. In coeliac disease, these villi become inflamed and flattened, significantly reducing the surface area available for nutrient absorption. This damage can lead to various nutritional deficiencies, including Vitamin D, Vitamin B12, Folate, Iron, and Calcium.

According to international research, approximately 2% of the population may have coeliac disease. In New Zealand, this suggests up to 100,000 people could be affected, with around 30,000 being children under 18. Unfortunately, many people remain undiagnosed and unaware that they have the condition. Currently, there is no treatment available for coeliac disease, and management includes following a strict gluten-free diet  

Study Aim

The aim of this study is to learn about the study drug and evaluate its efficacy and safety in improving intestinal conditions and reducing coeliac symptoms.

About the Investigational Medication

The study medication is a potential new treatment designed specifically for coeliac disease. It works differently from a gluten-free diet by targeting the immune system's response to gluten.  

When you have coeliac disease, your immune system reacts badly to gluten. The study medication is designed to block this reaction by preventing gluten from triggering the immune response that damages your intestines. The investigational medication is administered by subcutaneous injection, meaning it is injected into the subcutaneous tissue (like an insulin shot). The injection is usually given in your abdomen (belly area), though the thigh or upper arm may be used in some cases. You would receive the injection once every two weeks for the first month of the study and then once every 4 weeks for the remainder of the study. After each injection, you'll be monitored for about 30 minutes to ensure you don't have any reactions.

About The Study

Taking part in the study involves firstly meeting with the research Doctor to find out more about your health and to see if the study is right for you. If you wish to take part and are eligible, we would like to see you for 10-12 clinic visits over 52 weeks (1 year). There is the potential to join the study extension, which is an additional 10-12 visits over another year.

During visits, we conduct health checks that may include physical examinations and blood tests. We would like to ask you questions about your coeliac disease, previous treatments, and your symptoms.

Other procedures throughout this study may include:

• Vital sign checks (blood pressure, heart rate, temperature)  
• ECGs to monitor heart activity  
• Regular blood samples  
• Endoscopies
• Duodenal biopsies (small tissue samples)
• eDairy completion for symptom tracking  
• Questionnaires   

You would take the study medication or a placebo (looks like the investigational medicine but contains no active medication). The medication is administered initially every 2 weeks as a subcutaneous (under the skin) injection. Eventually, the medication will be administered every 4 weeks. You will be monitored for up to 30 minutes after the injection.  

The study aims to investigate whether the study medication is effective and safe for treating coeliac disease patients who still have intestinal damage and symptoms despite following a gluten-free diet.  

About 234 people worldwide are participating in this study.

Reason to Participate

Your involvement in this study may help advance scientific knowledge that could contribute to the development of a new medication and better treatment for people with coeliac disease in the future. Other reasons to participate may include:  

• Receive comprehensive health monitoring by highly specialised NZ doctors and nurses