KAN101
Are You Eligible?This study will investigate the safety and tolerability of multiple intravenous (IV) doses of KAN-101 in patients with well-controlled Coeliac Disease. It is expected to act by reprogramming immune cells to become tolerant towards gluten.
Research Objectives
Status
Recruitment
Total participants required
Study location
Study type
Patient group
About this clinical trial
Coeliac disease is digestive and autoimmune disorder that affects your small intestine. Coeliac disease can be triggered by a protein called gluten that is found in grains, like wheat, barley and rye. People with coeliac disease like you may experience symptoms like diarrhoea, bloating, abdominal pain, and other symptoms involved in multiple organs beyond the small intestine. Currently there is no drug that is available to treat coeliac disease. The only available option is following a strict gluten-free diet. This can be difficult for some patients with coeliac disease because of the uncertainty about which foods and medications contain gluten, and the cost of gluten free products.
The study drug (KAN-101) acts by reprogramming immune cells to become tolerant, or not react, specifically toward gluten. The drug is designed to not suppress the other parts of your immune system and only impact the cells that respond to gluten. This study will explore whether the study drug is effective in blocking the immune response to gluten and if it is safe for human-use.
Participants are in the study for up to 56 weeks which consists of 3 phases:
- Screening (4 weeks, includes upper gastrointestinal endoscopy and biopsy)
- Treatment (1 week, includes 3 single day infusions)
- Follow-up (51 weeks, includes 4 single day gluten challenges)
Participants will be required to visit the research site 10 times.
Trial registration information https://clinicaltrials.gov/study/NCT05574010.
KAN-101-02 Part C
Eligibility
- Biopsy & blood test results providing diagnosis
- HLA-DQ2.5 positive AND HLA-DQ8 negative
- Gluten Free Diet > 12 months
- Males & Females aged 18 – 70 years (incl)
Lead investigators
- Dr James Daveson
- Dr Jennifer Schafer
Clinical trial coordinators
- Leah Hingston
- Elise Matuzelski
Technical title
A phase 1b open-label/ phase 2 double-blind placebo-controlled study for pharmacodynamic activity, pharmacokinetics, safety and tolerability of kan-101 in patients with coeliac disease
Register your interest
If you would like more information about this clinical trial, please complete the contact form below.