Do you have coeliac disease and are on a gluten free diet?

This is a study to evaluate a new experimental treatment for coeliac disease called Nexvax2

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.

Anticipated date that enrolment will close: Ongoing

Who can take part

Inclusion Criteria:
  • 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)
Exclusion Criteria:
  • 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)
check
Observational
Phase 1
Phase 2
Phase 3
Phase 4

For more information

Quote reference number
2018.215
Cathy Pizzey / Brooke Flanders