ALV003 in patients with Celiac disease
Research type
Research Study
Full title
A Phase 2b, Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging Study of the Efficacy and Safety of ALV003 Treatment in Symptomatic Celiac Disease Patients Maintained on a Gluten-Free Diet
IRAS ID
148947
Contact name
David Sanders
Contact email
Sponsor organisation
Alvine Pharmaceuticals, Inc.
Eudract number
2013-003660-31
Clinicaltrials.gov Identifier
Research summary
Coeliac disease is an acquired chronic immune disorder that develops in susceptible individuals of Human Leukocyte Antigen (HLA) genotype DQ2 or DQ8 related to the exposure to dietary gluten. Gluten is the storage protein of wheat, and related grains like rye and barley. The prevalence of coeliac disease in Europe and in the United States is estimated to be 1-2% of the population.
For patients with coeliac disease, lifelong complete gluten exclusion needs to be strictly followed to avoid substantially enhanced risk for the development of further complications, such as bone disorders, infertility, cancer and in increase in overall mortality.
ALV003 is a new drug being developed for use in patients who have maintained a gluten-free diet. Patients have approximately 70% chance of being treated with the study drug. The remaining 30% will be treated with placebo.
REC name
Yorkshire & The Humber - Sheffield Research Ethics Committee
REC reference
14/YH/0052
Date of REC Opinion
13 Mar 2014
REC opinion
Favourable Opinion