Open label study of BI 655066 in patients with Crohn's disease.
Research type
Research Study
Full title
An open label, single group, long term safety extension trial of BI 655066, in patients with moderately to severely active Crohn’s disease.
IRAS ID
182062
Contact name
Arthur Kaser
Contact email
Sponsor organisation
Abbvie Limited
Eudract number
2015-001834-15
Duration of Study in the UK
4 years, 3 months, 11 days
Research summary
This is an open label, single group, long term safety extension trial of BI 655066, in patients with moderately to severely active Crohn`s disease. The purpose of the study is to provide those patients who are currently benefitting from treatment with BI655066 in the preceding trial (1311.6) with a long-term treatment option. The trial will also look at the the long term safety of BI655066 in patients with moderate to severely active Crohn's disease. Every patient in the trial will receive BI655066. It is hoped to recruit 60 people worldwide in this study in 30 investigative sites. It is expected that each patients participation in the study will last from between 221 weeks to 231 weeks.
REC name
East Midlands - Leicester Central Research Ethics Committee
REC reference
15/EM/0324
Date of REC Opinion
7 Sep 2015
REC opinion
Further Information Favourable Opinion