Improving tolerance to gluten in people living with coeliac disease may enhance their quality of life
About the study
Currently, the only treatment for coeliac disease is a strict lifelong gluten-free diet. We are assessing a new drug treatment for coeliac disease, KAN-101, aimed at inducing tolerance to gluten!
It is a randomised, controlled, phase 2 study that will compare KAN-1101 to a placebo. In prior studies, KAN-101 showed a favourable safety and tolerability profile in people with coeliac disease. In this study, we will continue to assess the safety and tolerability of KAN-101 in coeliac disease and investigate immune tolerance markers during a gluten-free diet and before and after gluten challenges.
Who can take part
You may be eligible to participate in this study if you meet all the following criteria:
- Aged 18-70 years
- Have coeliac disease diagnosed by a blood test and a small bowel biopsy
- Have been on a gluten-free diet for greater than 12 months
What's involved
- The study runs for approximately 58 weeks
- It includes 11 visits to the study centre plus 2 upper endoscopies (gastroscopies) at the beginning and end of the study
- Three doses of treatment (as an infusion into a vein) given as a day-patient
- A total of five single gluten challenges across the study: One before treatment and four after the treatment (approximately 12 weeks apart)
- Completing symptom diaries throughout the study
Ethics
All research in Australia involving human participants is reviewed by an independent group called a Human Research Ethics Committee (HREC). The ethical aspects of this research study have been approved by the Royal Melbourne Hospital HREC.
This study is being carried out according to the National Statement on Ethical Conduct in Human Research (2007). This statement protects the interests of people who agree to participate in human research studies.