GA28950 PHASE III TRIAL OF ETROLIZUMAB IN MODERATE TO SEVERE ACTIVE UC
Research type
Research Study
Full title
PHASE III, DOUBLE BLIND, PLACEBO-CONTROLLED, MULTICENTER STUDY OF THE EFFICACY AND SAFETY OF ETROLIZUMAB DURING INDUCTION AND MAINTENANCE IN PATIENTS WITH MODERATE TO SEVERE ACTIVE ULCERATIVE COLITIS WHO ARE REFRACTORY TO OR INTOLERANT OF TNF INHIBITORS
IRAS ID
144094
Contact name
Ramesh Arasaradnam
Contact email
Sponsor organisation
F. Hoffmann-La Roche Ltd
Eudract number
2013-004278-88
Clinicaltrials.gov Identifier
Research summary
The purpose of this study is to determine whether etrolizumab is a safe and effective treatment in patients with moderately to severely active ulcerative colitis (UC) and who have previously been treated with a class of drugs called tumour necrosis factor (TNF) inhibitors, but unsuccessfully.
Etrolizumab is designed to work by blocking the binding of certain white blood cells to the lining of the stomach and intestines. This is thought to reduce inflammation caused by UC. Etrolizumab is an experimental drug which means it has not been approved by the health authorities for treatment of UC.
The screening period is up to 28 days during which patient eligibility will be determined. After screening the study will be divided into 2 Cohorts. Cohort 1 subjects take etrolizumab and the doctor and subject will know they are taking etrolizumab (open-label). Cohort 2 patients take either etrolizumab or a placebo.
Neither the doctor nor patient will know if they are taking etrolizumab or a placebo (double-blind). Etrolizumab and placebo are administered via prefilled syringe once every 4 weeks.
After week 16 patients who are responding on either cohort will complete a second randomisation to etrolizumab or placebo and continue for a 52-week maintenance treatment period. The final dose is given at week 64 with a 12 week safety follow up.
If eligible and patient wants to, they can opt to go into a 2 part Open Label Safety Monitoring study after Week 64.
The study is completed after all patients have either completed the treatment and safety follow-up period or discontinued early from the study.
Overall approximately 800 patients will take part in this study in approximately 200 sites worldwide.
REC name
North East - Newcastle & North Tyneside 2 Research Ethics Committee
REC reference
14/NE/1063
Date of REC Opinion
8 Sep 2014
REC opinion
Further Information Favourable Opinion