GA29144 Phase III ETRO IN MODERATE TO SEVERE ACTIVE CROHNS DISEASE
Research type
Research Study
Full title
A PHASE III, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTICENTER STUDY TO EVALUATE THE EFFICACY AND SAFETY OF ETROLIZUMAB AS AN INDUCTION AND MAINTENANCE TREATMENT FOR PATIENTS WITH MODERATELY TO SEVERELY ACTIVE CROHN’S DISEASE
IRAS ID
174391
Contact name
Head, EU/International Regulatory Affairs
Contact email
Sponsor organisation
F. Hoffmann-La Roche Ltd
Eudract number
2014-003824-36
Clinicaltrials.gov Identifier
Duration of Study in the UK
3 years, 9 months, 1 days
Research summary
The purpose of this study is to determine whether etrolizumab compared to a placebo, is a safe, effective and tolerable treatment for patients with moderately to severely active Crohns Disease (CD).
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 Crohns Disease. Etrolizumab is an experimental drug which means it has not been approved by the health authorities for treatment of Crohns Disease.
The screening period is up to 28 days during which patient eligibility will be determined. After screening the study will be divided into 3 Cohorts. Cohort 1 subjects will receive either placebo, a low dose of etrolizumab or a high dose of etrolizumab. Cohort 2 subjects will receive either a low dose of etrolizumab or a high dose of etrolizumab. Cohort 3 subjects will receive either placebo, a low dose of etrolizumab or a high dose of etrolizumab but at a different patient ratio to Cohort 1.
The study duration, from screening to end of study participation for a given eligible patient, will be up to 90 weeks (4-week screening period + 14-week Induction Phase + 60-week Maintenance Phase + 12-week Safety Follow-up Phase). The total length of the treatment period will be 74 weeks (14-weeks Induction Phase + 60-week
Maintenance Phase).If eligible patients can opt to go into a 2 part Open Label Safety Monitoring study between weeks 10 and 14 or after Week 74. The study is completed after all patients have either completed the treatment and safety follow up period or discontinued early from the study.
Etrolizumab and placebo are administered via prefilled syringe.
Overall approximately 1250 patients will take part in this study in approximately 380 sites worldwide.
REC name
North East - Newcastle & North Tyneside 2 Research Ethics Committee
REC reference
15/NE/0143
Date of REC Opinion
13 Jul 2015
REC opinion
Further Information Favourable Opinion