Cedar Coeliac Study

Coeliac disease is an autoimmune disorder where the ingestion of gluten leads to damage in the small intestine. The immune system attacks the small intestine's lining, causing inflammation and affecting nutrient absorption.

According to the New Zealand Medical Journal, the prevalence of coeliac disease in New Zealand is estimated to be around 1% of the population, which is similar to global rates. Coeliac New Zealand estimates that approximately 65,000 New Zealanders have coeliac disease, though many are undiagnosed. The condition appears to be more common among people of European descent and in women.

Common symptoms include:
o Gastrointestinal issues (diarrhoea, bloating, abdominal pain)
o Fatigue
o Weight loss
o Iron deficiency anaemia
o Skin rashes (dermatitis herpetiformis)
o Neurological symptoms

Diagnosis typically involves:
o Blood tests for specific antibodies
o Genetic testing for HLA DQ2 and DQ8
o Small intestine biopsy/endoscopy

Primary treatment for coeliac disease usually involves nutritional support and dietary management and sometimes steroids in severe cases.

About the investigational medication
The investigational medication is an antibody that is administered either intravenously or as an injection. Participants will receive multiple doses throughout the study given at regular intervals.

The investigated treatment targets part of the immune system that may be involved in causing coeliac disease. It's designed to possibly help prevent or reduce the damage that happens in the intestines when people with coeliac disease are exposed to gluten.

Study Aim

The main purpose of this study is to learn about the investigational treatment to assess:
o Its safety and effectiveness
o See how well the body processes the investigational treatment
o Investigate if the intestines are protected from gluten damage
o Understand how well it may help people with coeliac disease

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 the same disease in the future

About the study 
Around 60 people with coeliac disease around the world are taking part in this study. If you are eligible for this study, we would like to see you for 14 clinic visits over a period of around 30 weeks.

The study involves regular health checks and examinations that include:
o Bloods draws, vital signs & health monitoring
o ECGs and heart x-rays
o 2 endoscopies (1 at screening and 1 at day 43 or end of treatment)
o Some participants will be asked to do the gluten challenge

The study also requires the completion of questionaries and daily symptom diaries.

Participants will be administered the investigational treatment or a placebo (looks like the investigational medicine but contains no active medication). There are 3 doses throughout the study treatment period. Please note, doses will be given subcutaneously (SC) at the study site by healthcare professionals.

The study aims to investigate the safety and tolerability of the potential new treatment and to show whether it could help with managing and reducing symptoms of coeliac.