A study of RO5459072 in people with coeliac disease; v1
Research type
Research Study
Full title
A randomized, double-blind, placebo-controlled, multiple dose, parallel study to investigate the pharmacokinetics, pharmacodynamic effects, safety and tolerability of repeated dosing of RO5459072 in volunteers with celiac disease (15-506).
IRAS ID
194650
Contact name
Malcolm Boyce
Contact email
Sponsor organisation
F. Hoffman-La Roche
Eudract number
2015-002864-18
Duration of Study in the UK
1 years, 0 months, 0 days
Research summary
RO5459072 (the study medicine) is an experimental new medicine for treating disorders of the immune system, such as coeliac disease. The immune system in people with coeliac disease reacts to gluten, which leads to damage to the lining of the gut and symptoms of bloating, diarrhoea, nausea, tiredness and headaches. The study medicine works by blocking a substance called cathepsin S, which is found in many cells of the body’s immune system, including those lining the gut, and helps the immune system to recognise harmful substances. We hope that inhibiting cathepsin S in people with coeliac disease will prevent their immune system reacting to gluten. The study medicine isn’t going to be a cure for coeliac disease, but it might prevent symptoms when someone with the condition eats gluten by accident.
We’ll give up to 22 people with coeliac disease, aged 18–60 years, twice daily doses of 100 mg study medicine, for 28 days. During the study, participants will also eat bread for 13 days in a row, and we’ll test whether the study medicine affects the body’s reaction to the gluten in bread. We’ll also find out the side effects and blood levels of the study medicine and its breakdown products, and study how genes (pieces of DNA) and other substances affect the way the body responds to and handles the study medicine.
Participants will take up to 9 weeks to finish the study. They’ll make 4 outpatient visits, and stay on the ward for on 3 occasions, for 2 days and 1 night each time.
A pharmaceutical company, F. Hoffmann-La Roche, is funding the study.
The study will take place at 1 centre in London.
REC name
East of England - Cambridgeshire and Hertfordshire Research Ethics Committee
REC reference
15/EE/0466
Date of REC Opinion
25 Jan 2016
REC opinion
Further Information Favourable Opinion