Do you have coeliac disease and are on a gluten free diet?
A gluten-free diet is the only current treatment for coeliac disease but it is complex and not always effective. Even patients who strictly adhere to it can suffer short and long-term adverse effects from gluten exposure.
We are seeking participants for a study testing a new experimental treatment for coeliac disease called Nexvax2. It is a Phase 2 double-blind, randomized, placebo-controlled, multicentre study. The study consists of 3 periods: a screening period of 6 weeks, an approximately 16 week treatment period, and a 4 week observational follow-up period.
Who can take part
- Adults 18 to 70 years of age with biopsy proven coeliac disease and following a gluten free diet for at least 12 months
- Willingness to consume a moderate amount of gluten
- Worsening of gastrointestinal symptoms in response to an oral gluten challenge
- Coeliac gene HLA-DQ 2.5 positive (if not known, this will be tested)
- Unwilling or unable to perform self-injections
- History of inflammatory bowel disease and/or microscopic colitis.
- Use of immunomodulatory or immune-suppressing medical treatment during the 6 months prior to screening
- Use of oral or parenteral corticosteroids, within the 6 weeks prior to screening. Topical or inhaled corticosteroids are acceptable.
- Females who are lactating or pregnant.
What is involved for you
- Twice weekly injections during treatment phase
- Blood samples
- Vital signs (Blood Pressure and Pulse)
- Completion of questionnaires
- Daily electronic diary
- Gastroscopy and biopsy (in a proportion)